<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03285295</url>
  </required_header>
  <id_info>
    <org_study_id>9DY-02-14U01-03</org_study_id>
    <nct_id>NCT03285295</nct_id>
  </id_info>
  <brief_title>Abbott Laboratories Alinity s Blood Screening Assays - Clinical Evaluation Protocol</brief_title>
  <official_title>Abbott Laboratories Alinity s Blood Screening Assays - Clinical Evaluation Protocol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Diagnostics Division</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Diagnostics Division</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to demonstrate the performance and intended use of each of the&#xD;
      Alinity s investigational assays in a donor screening environment using clinical specimens to&#xD;
      evaluate assay performance characteristics. A comparison of assay performance will be done&#xD;
      versus the Food and Drug Administration (FDA) licensed assays. The data will be used to&#xD;
      support regulatory submissions and/or publications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study evaluates Alinity s investigational assays using the Alinity s System. The Alinity&#xD;
      s System is a high-volume, automated, blood-screening analyzer that is designed to determine&#xD;
      the presence of specific antigens and antibodies by using chemiluminescent microparticle&#xD;
      immunoassay (CMIA) detection technology. The system performs high-throughput routine and stat&#xD;
      processing that features continuous access and automated retesting.&#xD;
&#xD;
      The Alinity s System is used for infectious disease marker testing in blood-screening and&#xD;
      plasma laboratories for the following assays: Anti-HBc, Anti-HCV, HTLV I/II, Chagas, HBsAg,&#xD;
      HBsAg Confirmatory and HIV Ag/Ab Combo.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2017</start_date>
  <completion_date type="Actual">June 21, 2018</completion_date>
  <primary_completion_date type="Actual">May 23, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Evaluation of assay performance characteristics.&#xD;
Participants:&#xD;
Alinity s HBsAg: 17987&#xD;
Alinity s HTLV I/II: 17685&#xD;
Alinity s Anti-HCV: 17904&#xD;
Alinity s HIV Ag/Ab Combo: 19571&#xD;
Alinity s Anti-HBc: 16776&#xD;
Alinity s Chagas: 16958</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Alinity s HBsAg Assay Specificity</measure>
    <time_frame>10 months</time_frame>
    <description>Total of 16993 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s HBsAg Assay. Repeatedly reactive specimens were further tested with Alinity s HBsAg Confirmatory and supplemental assays, if required.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alinity s HBsAg and HBsAg Confirmatory Assay Sensitivity</measure>
    <time_frame>10 months</time_frame>
    <description>Total of 432 specimens from subjects known to be HBsAg positive were tested with Alinity s HBsAg and HBsAg Confirmatory assay.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alinity s HTLV I/II Assay Specificity</measure>
    <time_frame>10 months</time_frame>
    <description>Total of 15877 serum and plasma specimens from whole blood donors specimens were tested with Alinity s HTLV I/II Assay. Repeatedly reactive specimens were further tested with Alinity s HTLV I/II and supplemental assays, if required.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alinity s HTLV I/II Assay Sensitivity</measure>
    <time_frame>10 months</time_frame>
    <description>Total of 706 specimens from subjects known to be HTLV positive were tested with Alinity s HTLV I/II assay. The population consists of the following:&#xD;
Anti-HTLV I Positive n = 461 Anti-HTLV II positive n = 141 Anti-HTLV III positive - Undifferentiated n = 4 Individual with HTLV I/II Associated Diseases n = 100</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alinity s Anti-HCV Assay Specificity</measure>
    <time_frame>10 months</time_frame>
    <description>Total of 16,999 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s Anti-HCV assay. Repeatedly reactive specimens were tested further with supplemental assays, if required.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alinity s Anti-HCV Assay Sensitivity</measure>
    <time_frame>10 months</time_frame>
    <description>Total of 402 specimens from subjects known to be Anti-HCV positive were tested with Alinity s Anti-HCV assay.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alinity s HIV Ag/Ab Combo Assay Specificity</measure>
    <time_frame>10 months</time_frame>
    <description>Total of 16996 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s HIV Ag/Ab Combo Assay. Repeatedly reactive specimens were further tested with supplemental assays, if required.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alinity s HIV Ag/Ab Combo Assay Sensitivity</measure>
    <time_frame>10 months</time_frame>
    <description>Total of 1336 specimens from subjects known to be HIV-1/2 positive were tested with Alinity s HIV Ag/Ab Combo assay.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alinity s Anti-HBc Assay Specificity</measure>
    <time_frame>10 months</time_frame>
    <description>Total of 15877 serum and plasma specimens from whole blood donor specimens were tested with Alinity s Anti-HBc Assay. Repeatedly reactive specimens were further tested with supplemental assays, if required.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alinity s Anti-HBc Assay Sensitivity</measure>
    <time_frame>10 months</time_frame>
    <description>Total of 404 specimens from individuals with hepatitis B infection were tested with investigational Alinity s Anti-HBc assay. The population consists of the following:&#xD;
Acute Hepatitis B infection n = 28 Chronic Hepatitis B infection n = 97 Recovered Hepatitis B infection n = 279</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alinity s Chagas Assay Specificity</measure>
    <time_frame>10 months</time_frame>
    <description>Total of 15804 serum and plasma specimens from whole blood donors specimens were tested with Alinity s Chagas Assay. Repeatedly reactive specimens were further tested with Alinity s Chagas and supplemental assays, if required.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alinity s Chagas Assay Sensitivity</measure>
    <time_frame>10 months</time_frame>
    <description>Total of 320 specimens from subjects known to be Chagas positive were tested with investigational Alinity s Chagas assay.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Alinity s HBsAg Assay Increased Risk of HBV Infection</measure>
    <time_frame>10 months</time_frame>
    <description>Total of 403 specimens from subjects known to be at increased risk for HBV infection were tested with investigational Alinity s HBsAg assay.&#xD;
Sensitivity and Specificity not applicable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alinity s HBsAg Assay Recovered HBV Infection</measure>
    <time_frame>10 months</time_frame>
    <description>Total of 51 specimens from subjects classified as recovered HBV infection were tested with investigational Alinity s HBsAg assay.&#xD;
Sensitivity/Specificity calculation for this population not applicable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alinity s HTLV Assay Increased Risk of HTLV Infection</measure>
    <time_frame>10 months</time_frame>
    <description>Total of 502 specimens from subjects known to be at increased risk for HTLV I/II infection were tested with investigational Alinity s HTLV I/II assay.&#xD;
Sensitivity and Specificity not applicable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alinity s HTLV I/II Assay Endemics</measure>
    <time_frame>10 months</time_frame>
    <description>Total of 509 specimens from subjects collected from areas known to be endemic for HTLV I/II infection were tested with investigational Alinity s HTLV I/II assay. Sensitivity and Specificity not applicable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alinity s Anti-HCV Assay Increased Risk for HCV</measure>
    <time_frame>10 months</time_frame>
    <description>Total of 407 specimens from subjects known to be at increased risk for HCV infection were tested with investigational Alinity s Anti-HCV assay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alinity s HIV Ag/Ab Combo Assay Increased Risk of HIV-1/2</measure>
    <time_frame>10 months</time_frame>
    <description>Total of 605 specimens from subjects known to be at increased risk for HIV-1/2 infection were tested with investigational Alinity s HIV Ag/Ab Combo assay.&#xD;
Sensitivity and Specificity not applicable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alinity s HIV Ag/Ab Combo Assay Endemics</measure>
    <time_frame>10 months</time_frame>
    <description>Total of 535 specimens from subjects collected from areas known to be endemic for HIV infection were tested with investigational Alinity s HIV Ag/Ab Combo assay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alinity s Anti-HBc Assay Increased Risk for HBV</measure>
    <time_frame>10 months</time_frame>
    <description>Total of 403 specimens from subjects known to be at increased risk for HBV infection were tested with investigational Alinity s Anti-HBc assay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alinity s Chagas Assay Endemics</measure>
    <time_frame>10 months</time_frame>
    <description>Total of 615 specimens from subjects collected from areas known to be endemic for Chagas infection were tested with investigational Alinity s Chagas assay</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">106881</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Screening</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will be tested with at least one of the investigational Alinity s assays (Anti-HBc, Anti-HCV, HTLV I/II, Chagas, HBsAg, HBsAg Confirmatory, HIV Ag/Ab Combo) on Alinity s system.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Alinity s HBsAg and Alinity s HBsAg Confirmatory Assay</intervention_name>
    <description>For all donor specimens with investigational Alinity s HBsAg and Alinity s HBsAg Confirmatory results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.</description>
    <arm_group_label>Screening</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Alinity s HTLV I/II Assay</intervention_name>
    <description>For all donor specimens with investigational Alinity s HTLV I/II results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.</description>
    <arm_group_label>Screening</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Alinity s Anti-HCV Assay</intervention_name>
    <description>For all donor specimens with investigational Alinity s Anti-HCV results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.</description>
    <arm_group_label>Screening</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Alinity s HIV Ag/Ab Combo Assay</intervention_name>
    <description>For all donor specimens with investigational Alinity s HIV Ag/Ab Combo results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.</description>
    <arm_group_label>Screening</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Alinity s Anti-HBc Assay</intervention_name>
    <description>For all donor specimens with investigational Alinity s Anti-HBc results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.</description>
    <arm_group_label>Screening</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Alinity s Chagas Assay</intervention_name>
    <description>For all donor specimens with investigational Alinity s Chagas results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.</description>
    <arm_group_label>Screening</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy donors who consented to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  For testing with the Alinity s Chagas assay, exclude donors that have been screened on&#xD;
             a previous donation using a licensed test for antibodies to T cruzi.&#xD;
&#xD;
        Note: A subject may participate at different times during the study for separate assay&#xD;
        studies, but each subject should be represented only once for each assay.&#xD;
&#xD;
        The protocol does not define an age limit. A donor must be at least 17 years old to donate&#xD;
        to the general blood supply, or 16 years old with parental/guardian consent, if allowed by&#xD;
        state law.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nancy R Haley, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bloodworks Northwest</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Thomas S Jones, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>QualTex Laboratories</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Susan S Ganz, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Biotest Pharmaceuticals Corporation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Toby L Simon, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>CSL Plasma Inc.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Susan L Stramer, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>American Red Cross National Testing Laboratory</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Biotest Pharmaceuticals Corporation</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33431</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>American Red Cross National Testing Laboratory</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CSL Plasma Inc.</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37932</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QualTex Laboratories</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bloodworks Northwest</name>
      <address>
        <city>Renton</city>
        <state>Washington</state>
        <zip>98057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <results_first_submitted>July 12, 2019</results_first_submitted>
  <results_first_submitted_qc>September 17, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 9, 2019</results_first_posted>
  <disposition_first_submitted>May 3, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>May 15, 2019</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">October 9, 2019</disposition_first_posted>
  <last_update_submitted>September 17, 2019</last_update_submitted>
  <last_update_submitted_qc>September 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis C Antibodies</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form: Alinity s Follow-Up Study - Donor Consent for Central IRB</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 17, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/95/NCT03285295/ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form: Alinity s Follow-Up Study - Donor Consent for Local IRB</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 17, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/95/NCT03285295/ICF_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 24, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/95/NCT03285295/Prot_SAP_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form: Information Sheet for Central IRB</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 23, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/95/NCT03285295/ICF_003.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form: Information Sheet for Local IRB</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 17, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/95/NCT03285295/ICF_004.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Alinity s HBsAg: 17987 Alinity s HTLV I/II: 17685 Alinity s Anti-HCV: 17904 Alinity s HIV Ag/Ab Combo: 19571 Alinity s Anti-HBc: 16776 Alinity s Chagas: 16958</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Specificity</title>
          <description>US blood and/or plasmapheresis donor specimens collected as part of routine blood and/or plasma donation were tested with the investigational Alinity s HBsAg and HBsAg Confirmatory, HTLV I/II, Anti-HCV, HIV Ag/Ab Combo, Anti-HBc, and Chagas assays.</description>
        </group>
        <group group_id="P2">
          <title>Sensitivity</title>
          <description>Specimens characterized as positive obtained from specimen vendors or collected under separate specimen collection protocols were tested by the investigational Alinity s HBsAg and HBsAg Confirmatory, HTLV I/II, Anti-HCV, HIV Ag/Ab Combo, Anti-HBc, and Chagas assays.</description>
        </group>
        <group group_id="P3">
          <title>Increased Risk Population</title>
          <description>Specimens with Increased Risk of Infection obtained from specimen vendors or collected under separate specimen collection protocols were tested with investigational Alinity s assays. This population includes specimens from US population with risk for HBV, HTLV I/II, HCV, and HIV infection.</description>
        </group>
        <group group_id="P4">
          <title>Endemic Population</title>
          <description>Specimens from endemic areas obtained from specimen vendors or collected under separate specimen collection protocols were tested with investigational Alinity s assays. This population includes specimens from individuals which reside in an HTLV I/II, HIV, and Chagas endemic area.</description>
        </group>
        <group group_id="P5">
          <title>HBV Recovered Population</title>
          <description>Specimens classified as recovered HBV Infection based on 4 marker hepatitis testing obtained from specimen vendors or collected under separate specimen collection protocols were tested with investigational Alinity s HBsAg assay.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Alinity s HBsAg</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17095"/>
                <participants group_id="P2" count="438"/>
                <participants group_id="P3" count="403"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16993"/>
                <participants group_id="P2" count="432"/>
                <participants group_id="P3" count="403"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="102"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No Result on Comparator Assay</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No Results Generated</title>
              <participants_list>
                <participants group_id="P1" count="74"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Alinity s HBsAg Confirmatory</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="432"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="432"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Alinity s HBsAg Follow-Up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Alinity s HTLV I/II</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15968"/>
                <participants group_id="P2" count="706"/>
                <participants group_id="P3" count="502"/>
                <participants group_id="P4" count="509"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15877"/>
                <participants group_id="P2" count="706"/>
                <participants group_id="P3" count="502"/>
                <participants group_id="P4" count="509"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="91"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No Result on Comparator Assay</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No Results Generated</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Alinity s HTLV I/II Follow-Up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Alinity s Anti-HCV</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17095"/>
                <participants group_id="P2" count="402"/>
                <participants group_id="P3" count="407"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16999"/>
                <participants group_id="P2" count="402"/>
                <participants group_id="P3" count="407"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="96"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No Results on Comparator Assay</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No Results Generated</title>
              <participants_list>
                <participants group_id="P1" count="71"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Alinity s Anti-HCV Follow-Up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Alinity s HIV Ag/Ab Combo</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17095"/>
                <participants group_id="P2" count="1336"/>
                <participants group_id="P3" count="605"/>
                <participants group_id="P4" count="535">Individuals at Increased Risk of HIV Infection from HIV-2 Endemic Areas</participants>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16996"/>
                <participants group_id="P2" count="1336"/>
                <participants group_id="P3" count="605"/>
                <participants group_id="P4" count="535">Individuals at Increased Risk of HIV Infection from HIV-2 Endemic Areas</participants>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="99"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No Results on Comparator Assay</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No Results Generated</title>
              <participants_list>
                <participants group_id="P1" count="72"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Alinity s HIV Ag/Ab Combo Follow-Up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Alinity s Anti-HBc</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15968"/>
                <participants group_id="P2" count="405"/>
                <participants group_id="P3" count="403"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15877"/>
                <participants group_id="P2" count="404"/>
                <participants group_id="P3" count="403"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="91"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No Results on Comparator Assay</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No Results Generated</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Alinity s Anti-HBc Follow-Up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Alinity s Chagas</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16023"/>
                <participants group_id="P2" count="320"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="615"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15804"/>
                <participants group_id="P2" count="320"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="615"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="219"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="76"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No Results on Comparator Assay</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No Results Generated</title>
              <participants_list>
                <participants group_id="P1" count="105"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Alinity s Chagas Follow-Up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Donors and pedigree</population>
      <group_list>
        <group group_id="B1">
          <title>Specificity</title>
          <description>US blood and/or plasmapheresis donor specimens collected as part of routine blood and/or plasma donation were tested with the investigational Alinity s HBsAg and HBsAg Confirmatory, HTLV I/II, Anti-HCV, HIV Ag/Ab Combo, Anti-HBc, and Chagas assays.</description>
        </group>
        <group group_id="B2">
          <title>Sensitivity</title>
          <description>Specimens characterized as positive obtained from specimen vendors or collected under separate specimen collection protocols were tested by the investigational Alinity s HBsAg and HBsAg Confirmatory, HTLV I/II, Anti-HCV, HIV Ag/Ab Combo, Anti-HBc, and Chagas assays.</description>
        </group>
        <group group_id="B3">
          <title>Increased Risk Population</title>
          <description>Specimens with Increased Risk of Infection obtained from specimen vendors or collected under separate specimen collection protocols were tested with investigational Alinity s assays. This population includes specimens from US population with risk for HBV, HTLV I/II, HCV, and HIV infection.</description>
        </group>
        <group group_id="B4">
          <title>Endemic Population</title>
          <description>Specimens from endemic areas obtained from specimen vendors or collected under separate specimen collection protocols were tested with investigational Alinity s assays. This population includes specimens from individuals which reside in an HTLV I/II, HIV, and Chagas endemic areas.</description>
        </group>
        <group group_id="B5">
          <title>HBV Recovered Population</title>
          <description>Specimens classified as recovered HBV Infection based on 4 marker hepatitis testing obtained from specimen vendors or collected under separate specimen collection protocols were tested with investigational Alinity s HBsAg assay.</description>
        </group>
        <group group_id="B6">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="98546"/>
            <count group_id="B2" value="3600"/>
            <count group_id="B3" value="2320"/>
            <count group_id="B4" value="1659"/>
            <count group_id="B5" value="51"/>
            <count group_id="B6" value="106176"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>≥16 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="98546"/>
                    <count group_id="B2" value="3600"/>
                    <count group_id="B3" value="2320"/>
                    <count group_id="B4" value="1659"/>
                    <count group_id="B5" value="51"/>
                    <count group_id="B6" value="106176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Alinity s HBsAg</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16993"/>
                    <measurement group_id="B2" value="432"/>
                    <measurement group_id="B3" value="403"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="51"/>
                    <measurement group_id="B6" value="17879"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HTLV I/II</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15877"/>
                    <measurement group_id="B2" value="706"/>
                    <measurement group_id="B3" value="502"/>
                    <measurement group_id="B4" value="509"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="17594"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Anti-HCV</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16999"/>
                    <measurement group_id="B2" value="402"/>
                    <measurement group_id="B3" value="407"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="17808"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HIV Ag/Ab Combo</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16996"/>
                    <measurement group_id="B2" value="1336"/>
                    <measurement group_id="B3" value="605"/>
                    <measurement group_id="B4" value="535"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="19472"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Anti-HBc</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15877"/>
                    <measurement group_id="B2" value="404"/>
                    <measurement group_id="B3" value="403"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="16684"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Chagas</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15804"/>
                    <measurement group_id="B2" value="320"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="615"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="16739"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <population>Each row represents a different population as a subset of a total enrollment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Alinity s HBsAg Gender</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="16993"/>
                    <count group_id="B2" value="432"/>
                    <count group_id="B3" value="403"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="51"/>
                    <count group_id="B6" value="17879"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="312"/>
                    <measurement group_id="B3" value="288"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="23"/>
                    <measurement group_id="B6" value="623"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="92"/>
                    <measurement group_id="B3" value="115"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="28"/>
                    <measurement group_id="B6" value="235"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16993"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="17021"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alinity s HTLV I/II Gender</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15877"/>
                    <count group_id="B2" value="706"/>
                    <count group_id="B3" value="502"/>
                    <count group_id="B4" value="509"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="17594"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="182"/>
                    <measurement group_id="B3" value="335"/>
                    <measurement group_id="B4" value="316"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="833"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="290"/>
                    <measurement group_id="B3" value="167"/>
                    <measurement group_id="B4" value="193"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="650"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15877"/>
                    <measurement group_id="B2" value="234"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="16111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alinity s Anti-HCV Gender</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="16999"/>
                    <count group_id="B2" value="402"/>
                    <count group_id="B3" value="407"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="17808"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="241"/>
                    <measurement group_id="B3" value="291"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="532"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="161"/>
                    <measurement group_id="B3" value="116"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="277"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16999"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="16999"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alinity s HIV Ag/Ab Combo Gender</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="16996"/>
                    <count group_id="B2" value="1336"/>
                    <count group_id="B3" value="605"/>
                    <count group_id="B4" value="535"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="19472"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="891"/>
                    <measurement group_id="B3" value="420"/>
                    <measurement group_id="B4" value="279"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1590"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="222"/>
                    <measurement group_id="B3" value="185"/>
                    <measurement group_id="B4" value="256"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="663"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16996"/>
                    <measurement group_id="B2" value="223"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="17219"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alinity s Anti-HBc Gender</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15877"/>
                    <count group_id="B2" value="404"/>
                    <count group_id="B3" value="403"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="16684"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="230"/>
                    <measurement group_id="B3" value="288"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="518"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="165"/>
                    <measurement group_id="B3" value="115"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="280"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15877"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="15886"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alinity s Chagas Gender</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15804"/>
                    <count group_id="B2" value="320"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="615"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="16739"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="104"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="216"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="320"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="102"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="399"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="501"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15804"/>
                    <measurement group_id="B2" value="114"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="15918"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <population>Each row represents a different population as a subset of a total enrollment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Alinity s HBsAg Race/Ethnicity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="16993"/>
                    <count group_id="B2" value="432"/>
                    <count group_id="B3" value="403"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="51"/>
                    <count group_id="B6" value="17879"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="123"/>
                    <measurement group_id="B3" value="244"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="373"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="79"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="13"/>
                    <measurement group_id="B6" value="137"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="71"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="106"/>
                  </measurement_list>
                </category>
                <category>
                  <title>American Indian or Alaskan Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16993"/>
                    <measurement group_id="B2" value="184"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="27"/>
                    <measurement group_id="B6" value="17204"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alinity s HTLV I/II Race/Ethnicity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15877"/>
                    <count group_id="B2" value="706"/>
                    <count group_id="B3" value="502"/>
                    <count group_id="B4" value="509"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="17594"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="154"/>
                    <measurement group_id="B4" value="305"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="522"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="114"/>
                    <measurement group_id="B3" value="256"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="370"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="224"/>
                    <measurement group_id="B3" value="87"/>
                    <measurement group_id="B4" value="204"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="515"/>
                  </measurement_list>
                </category>
                <category>
                  <title>American Indian or Alaskan Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15877"/>
                    <measurement group_id="B2" value="267"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="16144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alinity s Anti-HCV Race/Ethnicity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="16999"/>
                    <count group_id="B2" value="402"/>
                    <count group_id="B3" value="407"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="17808"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="95"/>
                    <measurement group_id="B3" value="239"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="334"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="100"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="114"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="62"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="74"/>
                  </measurement_list>
                </category>
                <category>
                  <title>American Indian or Alaskan Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16999"/>
                    <measurement group_id="B2" value="281"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="17282"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alinity s HIV Ag/Ab Combo Race/Ethnicity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="16996"/>
                    <count group_id="B2" value="1336"/>
                    <count group_id="B3" value="605"/>
                    <count group_id="B4" value="535"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="19472"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="364"/>
                    <measurement group_id="B3" value="404"/>
                    <measurement group_id="B4" value="535"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1303"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="286"/>
                    <measurement group_id="B3" value="115"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="401"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="430"/>
                    <measurement group_id="B3" value="81"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="511"/>
                  </measurement_list>
                </category>
                <category>
                  <title>American Indian or Alaskan Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16996"/>
                    <measurement group_id="B2" value="243"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="17239"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alinity s Anti-HBc Race/Ethnicity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15877"/>
                    <count group_id="B2" value="404"/>
                    <count group_id="B3" value="403"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="16684"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="244"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="284"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="79"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="118"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="71"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="75"/>
                  </measurement_list>
                </category>
                <category>
                  <title>American Indian or Alaskan Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15877"/>
                    <measurement group_id="B2" value="297"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="16174"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alinity s Chagas Race/Ethnicity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15804"/>
                    <count group_id="B2" value="320"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="615"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="16739"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="205"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="576"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="781"/>
                  </measurement_list>
                </category>
                <category>
                  <title>American Indian or Alaskan Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="30"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15804"/>
                    <measurement group_id="B2" value="114"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="15918"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <population>Each row represents a different country with populations within that country as a subset of a total enrollment for each assay.&#xD;
Not collected represents total number across all Alinity s assays: HBsAg, HTLV I/II, Anti-HCV, HIV Ag/Ab Combo, Anti-HBc, and Chagas.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="98546"/>
                    <count group_id="B2" value="3394"/>
                    <count group_id="B3" value="2320"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="51"/>
                    <count group_id="B6" value="104311"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Alinity s HBsAg</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16993"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="403"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="17396"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HTLV I/II</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15877"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="15877"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Anti-HCV</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16999"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="407"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="17406"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HIV Ag/Ab Combo</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16996"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="605"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="17601"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Anti-HBc</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15877"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="403"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="16280"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Chagas</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15804"/>
                    <measurement group_id="B2" value="114"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="15918"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not collected</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3280"/>
                    <measurement group_id="B3" value="502"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="51"/>
                    <measurement group_id="B6" value="3833"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Haiti</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="204"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="204"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Alinity s HBsAg</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HTLV I/II</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="204"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="204"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Anti-HCV</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HIV Ag/Ab Combo</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Anti-HBc</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Chagas</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not collected</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Africa</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="635"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="635"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Alinity s HBsAg</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HTLV I/II</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="100"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="100"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Anti-HCV</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HIV Ag/Ab Combo</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="535"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="535"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Anti-HBc</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Chagas</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not collected</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mexico</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="100"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="109"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Alinity s HBsAg</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HTLV I/II</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Anti-HCV</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HIV Ag/Ab Combo</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Anti-HBc</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Chagas</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="100"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="109"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not collected</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>South America</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="197"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="521"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="718"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Alinity s HBsAg</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HTLV I/II</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="205"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="205"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Anti-HCV</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HIV Ag/Ab Combo</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Anti-HBc</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Chagas</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="197"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="316"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="513"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not collected</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Central America</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="199"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="199"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Alinity s HBsAg</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HTLV I/II</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Anti-HCV</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HIV Ag/Ab Combo</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Anti-HBc</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Chagas</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="199"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="199"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not collected</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Alinity s HBsAg Assay Specificity</title>
        <description>Total of 16993 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s HBsAg Assay. Repeatedly reactive specimens were further tested with Alinity s HBsAg Confirmatory and supplemental assays, if required.</description>
        <time_frame>10 months</time_frame>
        <population>All blood and plasmapheresis donor specimens tested with Alinity s HBsAg assay per protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Alinity s HBsAg Assay Specificity</title>
            <description>US blood and plasmapheresis donor specimens collected as part of routine blood and plasma donation were tested with the investigational Alinity s assay.</description>
          </group>
        </group_list>
        <measure>
          <title>Alinity s HBsAg Assay Specificity</title>
          <description>Total of 16993 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s HBsAg Assay. Repeatedly reactive specimens were further tested with Alinity s HBsAg Confirmatory and supplemental assays, if required.</description>
          <population>All blood and plasmapheresis donor specimens tested with Alinity s HBsAg assay per protocol.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16993"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Alinity s HBsAg Nonreactive HBsAg Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16985"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HBsAg Repeatedly Reactive HBsAg Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HBsAg Positive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Clinical Specificity (%)</param_type>
            <param_value>99.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>99.92</ci_lower_limit>
            <ci_upper_limit>99.99</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Alinity s HBsAg and HBsAg Confirmatory Assay Sensitivity</title>
        <description>Total of 432 specimens from subjects known to be HBsAg positive were tested with Alinity s HBsAg and HBsAg Confirmatory assay.</description>
        <time_frame>10 months</time_frame>
        <population>Specimens from 432 individuals known to be positive for HBsAg were tested with Alinity s HBsAg and HBsAg Confirmatory assay per protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Alinity s HBsAg and HBsAg Confirmatory Assay Sensitivity</title>
            <description>Preselected HBsAg positive samples were obtained from specimen vendors or collected under separate specimen collection protocols were tested by the investigational Alinity s HBsAg and HBsAg Confirmatory assays. This population included individuals with acute hepatitis B infection, and individuals with chronic hepatitis B infection. HBV classification was determined using 4 HBV reference marker testing or medically diagnosed.</description>
          </group>
        </group_list>
        <measure>
          <title>Alinity s HBsAg and HBsAg Confirmatory Assay Sensitivity</title>
          <description>Total of 432 specimens from subjects known to be HBsAg positive were tested with Alinity s HBsAg and HBsAg Confirmatory assay.</description>
          <population>Specimens from 432 individuals known to be positive for HBsAg were tested with Alinity s HBsAg and HBsAg Confirmatory assay per protocol.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="432"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Alinity s HBsAg Nonreactive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HBsAg Reactive Confirmed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="432"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HBsAg Reactive Not Confirmed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>95% Confidence Interval provided.</non_inferiority_desc>
            <param_type>Point Estimate</param_type>
            <param_value>100.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>99.15</ci_lower_limit>
            <ci_upper_limit>100.00</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Alinity s HTLV I/II Assay Specificity</title>
        <description>Total of 15877 serum and plasma specimens from whole blood donors specimens were tested with Alinity s HTLV I/II Assay. Repeatedly reactive specimens were further tested with Alinity s HTLV I/II and supplemental assays, if required.</description>
        <time_frame>10 months</time_frame>
        <population>All blood donor specimens tested with Alinity s HTLV I/II assay per protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Alinity s HTLV I/II Assay Specificity</title>
            <description>US blood donor specimens collected as part of routine blood and plasma donation were tested with the investigational Alinity s HTLV I/II assay.</description>
          </group>
        </group_list>
        <measure>
          <title>Alinity s HTLV I/II Assay Specificity</title>
          <description>Total of 15877 serum and plasma specimens from whole blood donors specimens were tested with Alinity s HTLV I/II Assay. Repeatedly reactive specimens were further tested with Alinity s HTLV I/II and supplemental assays, if required.</description>
          <population>All blood donor specimens tested with Alinity s HTLV I/II assay per protocol.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15877"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Alinity s HTLV Nonreactive HTLV Neg</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15864"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HTLV Repeatedly Reactive HTLV Neg</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>HTLV Positive or Indeterminate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Clinical Specificity (%)</param_type>
            <param_value>99.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>99.95</ci_lower_limit>
            <ci_upper_limit>100.00</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Alinity s HTLV I/II Assay Sensitivity</title>
        <description>Total of 706 specimens from subjects known to be HTLV positive were tested with Alinity s HTLV I/II assay. The population consists of the following:&#xD;
Anti-HTLV I Positive n = 461 Anti-HTLV II positive n = 141 Anti-HTLV III positive - Undifferentiated n = 4 Individual with HTLV I/II Associated Diseases n = 100</description>
        <time_frame>10 months</time_frame>
        <population>Specimens from 706 individuals known to be positive for HTLV were tested with Alinity s HTLV I/II assay per protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Alinity s HTLV I/II Assay Sensitivity</title>
            <description>This population includes both archived and leftover not individually identifiable specimens that are extensively characterized. The specimens were confirmed positive by research use only HTLV-I Western blot and HTLV-I and HTLV-II radioimmunoprecipitation assay (RIPA) and typed as HTLV-I or HTLV-II by immunofluorescence assay (IFA) titration.&#xD;
Individuals with HTLV-I/II Associated Diseases includes specimens prospectively collected from individuals diagnosed with adult T-cell leukemia/lymphoma (ATL) or HTLV-I associated myelopathy/tropical spastic paraparesis (HAM/TSP) using IRB-approved protocols sponsored by specimen vendors.</description>
          </group>
        </group_list>
        <measure>
          <title>Alinity s HTLV I/II Assay Sensitivity</title>
          <description>Total of 706 specimens from subjects known to be HTLV positive were tested with Alinity s HTLV I/II assay. The population consists of the following:&#xD;
Anti-HTLV I Positive n = 461 Anti-HTLV II positive n = 141 Anti-HTLV III positive - Undifferentiated n = 4 Individual with HTLV I/II Associated Diseases n = 100</description>
          <population>Specimens from 706 individuals known to be positive for HTLV were tested with Alinity s HTLV I/II assay per protocol.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="706"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Alinity s HTLV I/II Nonreactive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HTLV I/II Repeatedly Reactive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="706"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>95% Confidence Interval provided.</non_inferiority_desc>
            <param_type>Point Estimate</param_type>
            <param_value>100.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>99.48</ci_lower_limit>
            <ci_upper_limit>100.00</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Alinity s Anti-HCV Assay Specificity</title>
        <description>Total of 16,999 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s Anti-HCV assay. Repeatedly reactive specimens were tested further with supplemental assays, if required.</description>
        <time_frame>10 months</time_frame>
        <population>All blood and plasmapheresis donor specimens tested with Alinity s Anti-HCV assay per protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Alinity s Anti-HCV Assay Specificity</title>
            <description>US blood and plasmapheresis donor specimens collected as part of routine blood and plasma donation were tested with the investigational Alinity s Anti-HCV assay.</description>
          </group>
        </group_list>
        <measure>
          <title>Alinity s Anti-HCV Assay Specificity</title>
          <description>Total of 16,999 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s Anti-HCV assay. Repeatedly reactive specimens were tested further with supplemental assays, if required.</description>
          <population>All blood and plasmapheresis donor specimens tested with Alinity s Anti-HCV assay per protocol.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16999"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Alinity s Anti-HCV Nonreactive HCV Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16975"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Anti-HCV Repeatedly Reactive HCV Neg</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>HCV Positive or Indeterminate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Clinical Specificity (%)</param_type>
            <param_value>99.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>99.86</ci_lower_limit>
            <ci_upper_limit>99.95</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Alinity s Anti-HCV Assay Sensitivity</title>
        <description>Total of 402 specimens from subjects known to be Anti-HCV positive were tested with Alinity s Anti-HCV assay.</description>
        <time_frame>10 months</time_frame>
        <population>Specimens from 402 individuals known to be positive for Anti-HCV were tested with Alinity s Anti-HCV assay per protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Alinity s Anti-HCV Assay Sensitivity</title>
            <description>This population includes specimens prospectively collected using IRB-approved protocols sponsored by Abbott Laboratories and vendor-collected leftover specimens that were not individually identifiable. A subset of these specimens was confirmed positive by an HCV recombinant immunoblot assay (RIBA). The remaining specimens were collected from subjects with a medical diagnosis of chronic HCV infection and history of greater than 6 months of HCV RNA/anti-HCV positivity. For these specimens, a current anti-HCV result was obtained.</description>
          </group>
        </group_list>
        <measure>
          <title>Alinity s Anti-HCV Assay Sensitivity</title>
          <description>Total of 402 specimens from subjects known to be Anti-HCV positive were tested with Alinity s Anti-HCV assay.</description>
          <population>Specimens from 402 individuals known to be positive for Anti-HCV were tested with Alinity s Anti-HCV assay per protocol.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="402"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Alinity s Anti-HCV Nonreactive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Anti-HCV Repeatedly Reactive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="402"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>95% Confidence Interval provided.</non_inferiority_desc>
            <param_type>Point Estimate</param_type>
            <param_value>100.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>99.09</ci_lower_limit>
            <ci_upper_limit>100.00</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Alinity s HIV Ag/Ab Combo Assay Specificity</title>
        <description>Total of 16996 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s HIV Ag/Ab Combo Assay. Repeatedly reactive specimens were further tested with supplemental assays, if required.</description>
        <time_frame>10 months</time_frame>
        <population>All fresh whole blood and plasmapheresis donor specimens tested with Alinity s HIV Ag/Ab Combo assay per protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Alinity s HIV Ag/Ab Combo Assay Specificity</title>
            <description>US blood and plasmapheresis donor specimens collected as part of routine blood and plasma donation were tested with the investigational Alinity s HIV Ag/Ab Combo assay.</description>
          </group>
        </group_list>
        <measure>
          <title>Alinity s HIV Ag/Ab Combo Assay Specificity</title>
          <description>Total of 16996 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s HIV Ag/Ab Combo Assay. Repeatedly reactive specimens were further tested with supplemental assays, if required.</description>
          <population>All fresh whole blood and plasmapheresis donor specimens tested with Alinity s HIV Ag/Ab Combo assay per protocol.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16996"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Alinity s HIV Nonreactive HIV Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16981"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HIV Repeatedly Reactive HIV Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>HIV Indeterminate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Clinical Specificity (%)</param_type>
            <param_value>99.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>99.87</ci_lower_limit>
            <ci_upper_limit>99.96</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Alinity s HIV Ag/Ab Combo Assay Sensitivity</title>
        <description>Total of 1336 specimens from subjects known to be HIV-1/2 positive were tested with Alinity s HIV Ag/Ab Combo assay.</description>
        <time_frame>10 months</time_frame>
        <population>Specimens from 1336 individuals known to be positive for HIV-1/2 were tested with Alinity s HIV Ag/Ab Combo assay per protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Alinity s HIV Ag/Ab Combo Assay Sensitivity</title>
            <description>Preselected HIV-1/2 positive samples were obtained from specimen vendors or collected under separate specimen collection protocols were tested by the investigational Alinity s HIV Ag/Ab Combo assays. This population included individuals with HIV-1 and HIV-2 infection. The HIV-1 specimens were confirmed positive by HIV-1 Western blot and categorized by revised surveillance case definitions for HIV infection (2008) as stage 1 (n=488), stage 2 (n=427) or stage 3 (n=101) using CD4 counts and associated diagnosis. The specimens were confirmed positive for HIV-2 by HIV-2 Western blot and typed as HIV-2 only by Bio-Rad Multispot HIV-1/HIV-2 Rapid Test.The remaining are for Anti-HIV 2 (n=232), HIV-1 antigen (n=35), and HIV-1 viral isolates (n=53).</description>
          </group>
        </group_list>
        <measure>
          <title>Alinity s HIV Ag/Ab Combo Assay Sensitivity</title>
          <description>Total of 1336 specimens from subjects known to be HIV-1/2 positive were tested with Alinity s HIV Ag/Ab Combo assay.</description>
          <population>Specimens from 1336 individuals known to be positive for HIV-1/2 were tested with Alinity s HIV Ag/Ab Combo assay per protocol.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1336"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Alinity s HIV Ag/Ab Combo Nonreactive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HIV Ag/Ab Combo Repeatedly Reactive Pos</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1336"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HIV Ag/Ab Combo Repeatedly Reactive Neg</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>95% Confidence Interval provided.</non_inferiority_desc>
            <param_type>Point Estimate</param_type>
            <param_value>100.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>99.72</ci_lower_limit>
            <ci_upper_limit>100.00</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Alinity s Anti-HBc Assay Specificity</title>
        <description>Total of 15877 serum and plasma specimens from whole blood donor specimens were tested with Alinity s Anti-HBc Assay. Repeatedly reactive specimens were further tested with supplemental assays, if required.</description>
        <time_frame>10 months</time_frame>
        <population>All fresh whole blood donor specimens tested with Alinity s Anti-HBc assay per protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Alinity s Anti-HBc Assay Specificity</title>
            <description>US blood donor specimens collected as part of routine blood and plasma donation were tested with the investigational Alinity s Anti-HBc assay.</description>
          </group>
        </group_list>
        <measure>
          <title>Alinity s Anti-HBc Assay Specificity</title>
          <description>Total of 15877 serum and plasma specimens from whole blood donor specimens were tested with Alinity s Anti-HBc Assay. Repeatedly reactive specimens were further tested with supplemental assays, if required.</description>
          <population>All fresh whole blood donor specimens tested with Alinity s Anti-HBc assay per protocol.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15877"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Alinity s Anti-HBc Nonreactive Anti-HBc Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15833"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Anti-HBc Repeatedly Reactive AntiHBc Neg</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Anti-HBc Positive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Clinical Specificity (%)</param_type>
            <param_value>99.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>99.84</ci_lower_limit>
            <ci_upper_limit>99.94</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Alinity s Anti-HBc Assay Sensitivity</title>
        <description>Total of 404 specimens from individuals with hepatitis B infection were tested with investigational Alinity s Anti-HBc assay. The population consists of the following:&#xD;
Acute Hepatitis B infection n = 28 Chronic Hepatitis B infection n = 97 Recovered Hepatitis B infection n = 279</description>
        <time_frame>10 months</time_frame>
        <population>Specimens from 404 individuals with Hepatitis B infection were tested with Alinity s Anti-HBc assay per protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Alinity s Anti-HBc Assay Sensitivity</title>
            <description>Preselected Anti-HBc Positive specimens were obtained from individuals with acute hepatitis B infection, individuals with chronic hepatitis B infection, and individuals with recovered hepatitis B infection.</description>
          </group>
        </group_list>
        <measure>
          <title>Alinity s Anti-HBc Assay Sensitivity</title>
          <description>Total of 404 specimens from individuals with hepatitis B infection were tested with investigational Alinity s Anti-HBc assay. The population consists of the following:&#xD;
Acute Hepatitis B infection n = 28 Chronic Hepatitis B infection n = 97 Recovered Hepatitis B infection n = 279</description>
          <population>Specimens from 404 individuals with Hepatitis B infection were tested with Alinity s Anti-HBc assay per protocol.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="404"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Alinity s Anti-HBc Nonreactive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Anti-HBc Repeatedly Reactive Positive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="404"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Anti-HBc Repeatedly Reactive Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>95% Confidence Interval provided.</non_inferiority_desc>
            <param_type>Point Estimate</param_type>
            <param_value>100.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>99.09</ci_lower_limit>
            <ci_upper_limit>100.00</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Alinity s Chagas Assay Specificity</title>
        <description>Total of 15804 serum and plasma specimens from whole blood donors specimens were tested with Alinity s Chagas Assay. Repeatedly reactive specimens were further tested with Alinity s Chagas and supplemental assays, if required.</description>
        <time_frame>10 months</time_frame>
        <population>All blood donor specimens tested with Alinity s Chagas assay per protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Alinity s Chagas Assay Specificity</title>
            <description>US blood donor specimens collected as part of routine blood and plasma donation were tested with the investigational Alinity s Chagas assay.</description>
          </group>
        </group_list>
        <measure>
          <title>Alinity s Chagas Assay Specificity</title>
          <description>Total of 15804 serum and plasma specimens from whole blood donors specimens were tested with Alinity s Chagas Assay. Repeatedly reactive specimens were further tested with Alinity s Chagas and supplemental assays, if required.</description>
          <population>All blood donor specimens tested with Alinity s Chagas assay per protocol.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15804"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Alinity s Chagas Nonreactive Chagas Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15787"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Chagas Repeatedly Reactive Chagas Neg</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Chagas Positive or Indeterminate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Clinical Specificity (%)</param_type>
            <param_value>99.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>99.94</ci_lower_limit>
            <ci_upper_limit>100.00</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Alinity s Chagas Assay Sensitivity</title>
        <description>Total of 320 specimens from subjects known to be Chagas positive were tested with investigational Alinity s Chagas assay.</description>
        <time_frame>10 months</time_frame>
        <population>Specimens from 320 individuals known to be positive for Chagas were tested with investigational Alinity s Chagas assay per protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Alinity s Chagas Assay Sensitivity</title>
            <description>Preselected T cruzi Parasitology Positive (n = 112) and preselected T cruzi Serology Positive (n = 208) samples were obtained from specimen vendors or collected under separate specimen collection protocols were tested by the investigational Alinity s Chagas assay.</description>
          </group>
        </group_list>
        <measure>
          <title>Alinity s Chagas Assay Sensitivity</title>
          <description>Total of 320 specimens from subjects known to be Chagas positive were tested with investigational Alinity s Chagas assay.</description>
          <population>Specimens from 320 individuals known to be positive for Chagas were tested with investigational Alinity s Chagas assay per protocol.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="320"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Alinity s Chagas Nonreactive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Chagas Repeatedly Reactive Positive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="320"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Chagas Repeatedly Reactive Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>95% Confidence Interval provided.</non_inferiority_desc>
            <param_type>Point Estimate</param_type>
            <param_value>100.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>98.85</ci_lower_limit>
            <ci_upper_limit>100.00</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alinity s HBsAg Assay Increased Risk of HBV Infection</title>
        <description>Total of 403 specimens from subjects known to be at increased risk for HBV infection were tested with investigational Alinity s HBsAg assay.&#xD;
Sensitivity and Specificity not applicable.</description>
        <time_frame>10 months</time_frame>
        <population>Specimens from 403 individuals with increased risk for HBV infection were tested with Alinity s HBsAg assay per protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Alinity s HBsAg Assay Increased Risk of HBV Infection</title>
            <description>Specimens with Increased Risk of Infection obtained from specimen vendors or collected under separate specimen collection protocols were tested with investigational Alinity s assays. This population includes specimens from US population with risk for HBV infection.</description>
          </group>
        </group_list>
        <measure>
          <title>Alinity s HBsAg Assay Increased Risk of HBV Infection</title>
          <description>Total of 403 specimens from subjects known to be at increased risk for HBV infection were tested with investigational Alinity s HBsAg assay.&#xD;
Sensitivity and Specificity not applicable.</description>
          <population>Specimens from 403 individuals with increased risk for HBV infection were tested with Alinity s HBsAg assay per protocol.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="403"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Alinity s HBsAg Nonreactive Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="400"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HBsAg Nonreactive Positive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HBsAg Reactive Confirmed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HBsAg Reactive Not Confirmed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alinity s HBsAg Assay Recovered HBV Infection</title>
        <description>Total of 51 specimens from subjects classified as recovered HBV infection were tested with investigational Alinity s HBsAg assay.&#xD;
Sensitivity/Specificity calculation for this population not applicable.</description>
        <time_frame>10 months</time_frame>
        <population>Specimens from 51 individuals classified as recovered HBV infection were tested with Alinity s HBsAg assay per protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Alinity s HBsAg Assay Recovered HBV Infection</title>
            <description>Specimens classified as recovered HBV Infection based on 4 marker hepatitis testing obtained from specimen vendors or collected under separate specimen collection protocols were tested with investigational Alinity s HBsAg assay.</description>
          </group>
        </group_list>
        <measure>
          <title>Alinity s HBsAg Assay Recovered HBV Infection</title>
          <description>Total of 51 specimens from subjects classified as recovered HBV infection were tested with investigational Alinity s HBsAg assay.&#xD;
Sensitivity/Specificity calculation for this population not applicable.</description>
          <population>Specimens from 51 individuals classified as recovered HBV infection were tested with Alinity s HBsAg assay per protocol.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Alinity s HBsAg Nonreactive Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HBsAg Nonreactive Positive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HBsAg Reactive Confirmed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HBsAg Reactive Not Confirmed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alinity s HTLV Assay Increased Risk of HTLV Infection</title>
        <description>Total of 502 specimens from subjects known to be at increased risk for HTLV I/II infection were tested with investigational Alinity s HTLV I/II assay.&#xD;
Sensitivity and Specificity not applicable.</description>
        <time_frame>10 months</time_frame>
        <population>Specimens from 502 individuals with increased risk for HTLV I/II infection were tested with Alinity s HTLV I/II assay per protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Alinity s HTLV Assay Increased Risk of HTLV-I/II Infection</title>
            <description>Specimens with Increased Risk of Infection obtained from specimen vendors or collected under separate specimen collection protocols were tested with investigational Alinity s assays. This population includes specimens from US population with risk for HTLV I/II infection.</description>
          </group>
        </group_list>
        <measure>
          <title>Alinity s HTLV Assay Increased Risk of HTLV Infection</title>
          <description>Total of 502 specimens from subjects known to be at increased risk for HTLV I/II infection were tested with investigational Alinity s HTLV I/II assay.&#xD;
Sensitivity and Specificity not applicable.</description>
          <population>Specimens from 502 individuals with increased risk for HTLV I/II infection were tested with Alinity s HTLV I/II assay per protocol.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="502"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Alinity s HTLV I/II Nonreactive Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="491"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HTLV I/II Nonreactive Positive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HTLV I/II Nonreactive Indeterminate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HTLV I/II Reactive Indeterminate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HTLV I/II Reactive Positive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HTLV I/II Reactive Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alinity s HTLV I/II Assay Endemics</title>
        <description>Total of 509 specimens from subjects collected from areas known to be endemic for HTLV I/II infection were tested with investigational Alinity s HTLV I/II assay. Sensitivity and Specificity not applicable.</description>
        <time_frame>10 months</time_frame>
        <population>Specimens from 509 individuals collected from areas known to be endemic for HTLV I/II infection were tested with Alinity s HTLV I/II assay per protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Alinity s HTLV I/II Assay Endemics</title>
            <description>Specimens from endemic areas obtained from specimen vendors or collected under separate specimen collection protocols were tested with investigational Alinity s assays. This population includes specimens from individuals which reside in an HTLV I/II endemic area.</description>
          </group>
        </group_list>
        <measure>
          <title>Alinity s HTLV I/II Assay Endemics</title>
          <description>Total of 509 specimens from subjects collected from areas known to be endemic for HTLV I/II infection were tested with investigational Alinity s HTLV I/II assay. Sensitivity and Specificity not applicable.</description>
          <population>Specimens from 509 individuals collected from areas known to be endemic for HTLV I/II infection were tested with Alinity s HTLV I/II assay per protocol.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="509"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Alinity s HTLV I/II Nonreactive Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="495"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HTLV I/II Nonreactive Positive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HTLV I/II Nonreactive Indeterminate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HTLV I/II Reactive Indeterminate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HTLV I/II Reactive Positive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HTLV I/II Reactive Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alinity s Anti-HCV Assay Increased Risk for HCV</title>
        <description>Total of 407 specimens from subjects known to be at increased risk for HCV infection were tested with investigational Alinity s Anti-HCV assay.</description>
        <time_frame>10 months</time_frame>
        <population>Specimens from 407 individuals with increased risk for HCV infection were tested with Alinity s Anti-HCV assay per protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Alinity s Anti-HCV Assay Increased Risk for HCV</title>
            <description>Specimens with Increased Risk of Infection obtained from specimen vendors or collected under separate specimen collection protocols were tested with investigational Alinity s assays. This population includes specimens from US population with risk for HCV infection.</description>
          </group>
        </group_list>
        <measure>
          <title>Alinity s Anti-HCV Assay Increased Risk for HCV</title>
          <description>Total of 407 specimens from subjects known to be at increased risk for HCV infection were tested with investigational Alinity s Anti-HCV assay.</description>
          <population>Specimens from 407 individuals with increased risk for HCV infection were tested with Alinity s Anti-HCV assay per protocol.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="407"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Alinity s Anti-HCV Nonreactive Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="316"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Anti-HCV Noreactive Positive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Anti-HCV Nonreactive Indeterminate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Anti-HCV Reactive Indeterminate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Anti-HCV Reactive Positive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="90"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Anti-HCV Reactive Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Sensitivity</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>95% Confidence Interval provided.</non_inferiority_desc>
            <param_type>Point Estimate</param_type>
            <param_value>100.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>95.98</ci_lower_limit>
            <ci_upper_limit>100.00</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alinity s HIV Ag/Ab Combo Assay Increased Risk of HIV-1/2</title>
        <description>Total of 605 specimens from subjects known to be at increased risk for HIV-1/2 infection were tested with investigational Alinity s HIV Ag/Ab Combo assay.&#xD;
Sensitivity and Specificity not applicable.</description>
        <time_frame>10 months</time_frame>
        <population>Specimens from 605 individuals with increased risk for HIV-I/2 infection were tested with Alinity s HIV Ag/Ab Combo assay per protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Alinity s HIV Ag/Ab Combo Assay Increased Risk for HIV-1/2</title>
            <description>Specimens with Increased Risk of Infection obtained from specimen vendors or collected under separate specimen collection protocols were tested with investigational Alinity s assays. This population includes specimens from US population with risk for HIV infection.</description>
          </group>
        </group_list>
        <measure>
          <title>Alinity s HIV Ag/Ab Combo Assay Increased Risk of HIV-1/2</title>
          <description>Total of 605 specimens from subjects known to be at increased risk for HIV-1/2 infection were tested with investigational Alinity s HIV Ag/Ab Combo assay.&#xD;
Sensitivity and Specificity not applicable.</description>
          <population>Specimens from 605 individuals with increased risk for HIV-I/2 infection were tested with Alinity s HIV Ag/Ab Combo assay per protocol.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="605"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Alinity s HIV Ag/Ab Combo Nonreactive Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="582"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HIV Ag/Ab Combo Nonreactive Positive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HIV Ag/Ab Comb Nonreactive Indeterminate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HIV Ag/Ab Combo Reactive Indeterminate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HIV Ag/Ab Combo Reactive Positive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HIV Ag/Ab Combo Reactive Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alinity s HIV Ag/Ab Combo Assay Endemics</title>
        <description>Total of 535 specimens from subjects collected from areas known to be endemic for HIV infection were tested with investigational Alinity s HIV Ag/Ab Combo assay.</description>
        <time_frame>10 months</time_frame>
        <population>Specimens from 535 individuals collected from areas known to be endemic for HIV infection were tested with Alinity s HIV Ag/Ab Combo assay per protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Alinity s HIV Ag/Ab Combo Assay Endemics</title>
            <description>Specimens from endemic areas obtained from specimen vendors or collected under separate specimen collection protocols were tested with investigational Alinity s assays. This population includes specimens from individuals which reside in an HIV endemic area.</description>
          </group>
        </group_list>
        <measure>
          <title>Alinity s HIV Ag/Ab Combo Assay Endemics</title>
          <description>Total of 535 specimens from subjects collected from areas known to be endemic for HIV infection were tested with investigational Alinity s HIV Ag/Ab Combo assay.</description>
          <population>Specimens from 535 individuals collected from areas known to be endemic for HIV infection were tested with Alinity s HIV Ag/Ab Combo assay per protocol.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="535"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Alinity s HIV Ag/Ab Combo Nonreactive Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="472"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HIV Ag/Ab Combo Nonreactive Positive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HIV Ag/Ab Comb Nonreactive Indeterminate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HIV Ag/Ab Combo Reactive Indeterminate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HIV Ag/Ab Combo Reactive Positive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s HIV Ag/Ab Combo Reactive Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Sensitivity</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>95% Confidence Interval provided.</non_inferiority_desc>
            <param_type>Point Estimate</param_type>
            <param_value>100.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>92.75</ci_lower_limit>
            <ci_upper_limit>100.00</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alinity s Anti-HBc Assay Increased Risk for HBV</title>
        <description>Total of 403 specimens from subjects known to be at increased risk for HBV infection were tested with investigational Alinity s Anti-HBc assay.</description>
        <time_frame>10 months</time_frame>
        <population>Specimens from 403 individuals with increased risk for HBV infection were tested with Alinity s Anti-HBc assay per protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Alinity s Anti-HBc Assay Increased Risk for HBV</title>
            <description>Specimens with Increased Risk of Infection obtained from specimen vendors or collected under separate specimen collection protocols were tested with investigational Alinity s assays. This population includes specimens from US population with risk for HBV infection</description>
          </group>
        </group_list>
        <measure>
          <title>Alinity s Anti-HBc Assay Increased Risk for HBV</title>
          <description>Total of 403 specimens from subjects known to be at increased risk for HBV infection were tested with investigational Alinity s Anti-HBc assay.</description>
          <population>Specimens from 403 individuals with increased risk for HBV infection were tested with Alinity s Anti-HBc assay per protocol.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="403"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Alinity s Anti-HBc Nonreactive Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="319"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Anti-HBc Nonreactive Positive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Anti-HBc Reactive Positive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Anti-HBc Reactive Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Sensitivity</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>95% Confidence Interval provided.</non_inferiority_desc>
            <param_type>Point Estimate</param_type>
            <param_value>100.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>94.87</ci_lower_limit>
            <ci_upper_limit>100.00</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alinity s Chagas Assay Endemics</title>
        <description>Total of 615 specimens from subjects collected from areas known to be endemic for Chagas infection were tested with investigational Alinity s Chagas assay</description>
        <time_frame>10 months</time_frame>
        <population>Specimens from 615 subjects collected from areas known to be endemic for Chagas infection were tested with Alinity s Chagas assay per protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Alinity s Chagas Assay Endemics</title>
            <description>Specimens from endemic areas obtained from specimen vendors or collected under separate specimen collection protocols were tested with investigational Alinity s assays. This population includes specimens from individuals which reside in Chagas endemic area.</description>
          </group>
        </group_list>
        <measure>
          <title>Alinity s Chagas Assay Endemics</title>
          <description>Total of 615 specimens from subjects collected from areas known to be endemic for Chagas infection were tested with investigational Alinity s Chagas assay</description>
          <population>Specimens from 615 subjects collected from areas known to be endemic for Chagas infection were tested with Alinity s Chagas assay per protocol.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="615"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Alinity s Chagas Nonreactive Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="466"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Chagas Noreactive Positive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Chagas Nonreactive Indeterminate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Chagas Reactive Indeterminate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Chagas Reactive Positive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="146"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alinity s Chagas Reactive Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Sensitivity</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>95% Confidence Interval provided.</non_inferiority_desc>
            <param_type>Point Estimate</param_type>
            <param_value>98.65</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>95.20</ci_lower_limit>
            <ci_upper_limit>99.84</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Subject adverse events related to blood collection during the 3-6 months of donor follow-up specimen collection.</time_frame>
      <desc>Subject adverse event reporting was only applicable to donors that returned for follow-up specimen collection.&#xD;
Adverse events were not applicable for blood and plasmapheresis donor specimens collected as part of routine blood donation and specimens provided by Abbott to testing sites.&#xD;
There were no subject or device adverse events associated with testing.</desc>
      <group_list>
        <group group_id="E1">
          <title>Alinity s HBsAg Follow-Up Specimen Collection</title>
          <description>For all donor specimens with investigational Alinity s results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.&#xD;
No donors required for follow-up collection for Alinity s HBsAg study.</description>
        </group>
        <group group_id="E2">
          <title>Alinity s HTLV I/II Follow-Up Specimen Collection</title>
          <description>For all donor specimens with investigational Alinity s results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.&#xD;
12 donors were eligible for follow-up collection for Alinity s HTLV I/II study. 8 out of 12 were able to provide follow-up specimen.</description>
        </group>
        <group group_id="E3">
          <title>Alinity s Anti-HCV Follow-Up Specimen Collection</title>
          <description>For all donor specimens with investigational Alinity s results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.&#xD;
20 donors were eligible for follow-up collection for Alinity s Anti-HCV study. 2 out of 20 were able to provide follow-up specimen.</description>
        </group>
        <group group_id="E4">
          <title>Alinity s HIV Ag/Ab Combo Follow-Up Specimen Collection</title>
          <description>For all donor specimens with investigational Alinity s results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.&#xD;
15 donors were eligible for follow-up collection for Alinity s HIV Ag/Ab Combo study.&#xD;
4 out of 15 were able to provide follow-up specimen.</description>
        </group>
        <group group_id="E5">
          <title>Alinity s Anti-HBc Follow-Up Specimen Collection</title>
          <description>For all donor specimens with investigational Alinity s results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.&#xD;
16 donors were eligible for follow-up collection for Alinity s Anti-HBc study. 2 out of 16 were able to provide follow-up specimen.</description>
        </group>
        <group group_id="E6">
          <title>Alinity s Chagas Follow-Up Specimen Collection</title>
          <description>For all donor specimens with investigational Alinity s results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.&#xD;
14 donors were eligible for follow-up collection for Alinity s Chagas study.&#xD;
1 out of 14 were able to provide follow-up specimen.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The PI must provide a copy of any proposed publication/presentation at least 60 days prior to submission for sponsor's review/approval. The PI must incorporate changes as the sponsor requires in order to protect the sponsor's proprietary rights and interests. The sponsor may require the PI to include acknowledgement of the sponsor's role in the study. The PI may be requested to delay publication/presentation an extra 60 days to enable sponsor to secure patent or other proprietary protection.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>George Chen (Associate Director Clinical Affairs)</name_or_title>
      <organization>Abbott Laboratories</organization>
      <phone>224-668-9185</phone>
      <email>george.chen@abbott.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03285295
org study id: 9DY-02-14U01-03
nct id: NCT03285295
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The objective of this study is to demonstrate the performance and intended use of each of the
      Alinity s investigational assays in a donor screening environment using clinical specimens to
      evaluate assay performance characteristics. A comparison of assay performance will be done
      versus the Food and Drug Administration (FDA) licensed assays. The data will be used to
      support regulatory submissions and/or publications.
This study evaluates Alinity s investigational assays using the Alinity s System. The Alinity
      s System is a high-volume, automated, blood-screening analyzer that is designed to determine
      the presence of specific antigens and antibodies by using chemiluminescent microparticle
      immunoassay (CMIA) detection technology. The system performs high-throughput routine and stat
      processing that features continuous access and automated retesting.

      The Alinity s System is used for infectious disease marker testing in blood-screening and
      plasma laboratories for the following assays: Anti-HBc, Anti-HCV, HTLV I/II, Chagas, HBsAg,
      HBsAg Confirmatory and HIV Ag/Ab Combo.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Evaluation of assay performance characteristics.
Participants:
Alinity s HBsAg: 17987
Alinity s HTLV I/II: 17685
Alinity s Anti-HCV: 17904
Alinity s HIV Ag/Ab Combo: 19571
Alinity s Anti-HBc: 16776
Alinity s Chagas: 16958
primary purpose: Screening
masking: None (Open Label)
measure: Alinity s HBsAg Assay Specificity
time frame: 10 months
description: Total of 16993 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s HBsAg Assay. Repeatedly reactive specimens were further tested with Alinity s HBsAg Confirmatory and supplemental assays, if required.
measure: Alinity s HBsAg and HBsAg Confirmatory Assay Sensitivity
time frame: 10 months
description: Total of 432 specimens from subjects known to be HBsAg positive were tested with Alinity s HBsAg and HBsAg Confirmatory assay.
measure: Alinity s HTLV I/II Assay Specificity
time frame: 10 months
description: Total of 15877 serum and plasma specimens from whole blood donors specimens were tested with Alinity s HTLV I/II Assay. Repeatedly reactive specimens were further tested with Alinity s HTLV I/II and supplemental assays, if required.
measure: Alinity s HTLV I/II Assay Sensitivity
time frame: 10 months
description: Total of 706 specimens from subjects known to be HTLV positive were tested with Alinity s HTLV I/II assay. The population consists of the following:
Anti-HTLV I Positive n = 461 Anti-HTLV II positive n = 141 Anti-HTLV III positive - Undifferentiated n = 4 Individual with HTLV I/II Associated Diseases n = 100
measure: Alinity s Anti-HCV Assay Specificity
time frame: 10 months
description: Total of 16,999 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s Anti-HCV assay. Repeatedly reactive specimens were tested further with supplemental assays, if required.
measure: Alinity s Anti-HCV Assay Sensitivity
time frame: 10 months
description: Total of 402 specimens from subjects known to be Anti-HCV positive were tested with Alinity s Anti-HCV assay.
measure: Alinity s HIV Ag/Ab Combo Assay Specificity
time frame: 10 months
description: Total of 16996 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s HIV Ag/Ab Combo Assay. Repeatedly reactive specimens were further tested with supplemental assays, if required.
measure: Alinity s HIV Ag/Ab Combo Assay Sensitivity
time frame: 10 months
description: Total of 1336 specimens from subjects known to be HIV-1/2 positive were tested with Alinity s HIV Ag/Ab Combo assay.
measure: Alinity s Anti-HBc Assay Specificity
time frame: 10 months
description: Total of 15877 serum and plasma specimens from whole blood donor specimens were tested with Alinity s Anti-HBc Assay. Repeatedly reactive specimens were further tested with supplemental assays, if required.
measure: Alinity s Anti-HBc Assay Sensitivity
time frame: 10 months
description: Total of 404 specimens from individuals with hepatitis B infection were tested with investigational Alinity s Anti-HBc assay. The population consists of the following:
Acute Hepatitis B infection n = 28 Chronic Hepatitis B infection n = 97 Recovered Hepatitis B infection n = 279
measure: Alinity s Chagas Assay Specificity
time frame: 10 months
description: Total of 15804 serum and plasma specimens from whole blood donors specimens were tested with Alinity s Chagas Assay. Repeatedly reactive specimens were further tested with Alinity s Chagas and supplemental assays, if required.
measure: Alinity s Chagas Assay Sensitivity
time frame: 10 months
description: Total of 320 specimens from subjects known to be Chagas positive were tested with investigational Alinity s Chagas assay.
measure: Alinity s HBsAg Assay Increased Risk of HBV Infection
time frame: 10 months
description: Total of 403 specimens from subjects known to be at increased risk for HBV infection were tested with investigational Alinity s HBsAg assay.
Sensitivity and Specificity not applicable.
measure: Alinity s HBsAg Assay Recovered HBV Infection
time frame: 10 months
description: Total of 51 specimens from subjects classified as recovered HBV infection were tested with investigational Alinity s HBsAg assay.
Sensitivity/Specificity calculation for this population not applicable.
measure: Alinity s HTLV Assay Increased Risk of HTLV Infection
time frame: 10 months
description: Total of 502 specimens from subjects known to be at increased risk for HTLV I/II infection were tested with investigational Alinity s HTLV I/II assay.
Sensitivity and Specificity not applicable.
measure: Alinity s HTLV I/II Assay Endemics
time frame: 10 months
description: Total of 509 specimens from subjects collected from areas known to be endemic for HTLV I/II infection were tested with investigational Alinity s HTLV I/II assay. Sensitivity and Specificity not applicable.
measure: Alinity s Anti-HCV Assay Increased Risk for HCV
time frame: 10 months
description: Total of 407 specimens from subjects known to be at increased risk for HCV infection were tested with investigational Alinity s Anti-HCV assay.
measure: Alinity s HIV Ag/Ab Combo Assay Increased Risk of HIV-1/2
time frame: 10 months
description: Total of 605 specimens from subjects known to be at increased risk for HIV-1/2 infection were tested with investigational Alinity s HIV Ag/Ab Combo assay.
Sensitivity and Specificity not applicable.
measure: Alinity s HIV Ag/Ab Combo Assay Endemics
time frame: 10 months
description: Total of 535 specimens from subjects collected from areas known to be endemic for HIV infection were tested with investigational Alinity s HIV Ag/Ab Combo assay.
measure: Alinity s Anti-HBc Assay Increased Risk for HBV
time frame: 10 months
description: Total of 403 specimens from subjects known to be at increased risk for HBV infection were tested with investigational Alinity s Anti-HBc assay.
measure: Alinity s Chagas Assay Endemics
time frame: 10 months
description: Total of 615 specimens from subjects collected from areas known to be endemic for Chagas infection were tested with investigational Alinity s Chagas assay
arm group label: Screening
arm group type: Experimental
description: All subjects will be tested with at least one of the investigational Alinity s assays (Anti-HBc, Anti-HCV, HTLV I/II, Chagas, HBsAg, HBsAg Confirmatory, HIV Ag/Ab Combo) on Alinity s system.
intervention type: Device
intervention name: Alinity s HBsAg and Alinity s HBsAg Confirmatory Assay
description: For all donor specimens with investigational Alinity s HBsAg and Alinity s HBsAg Confirmatory results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.
arm group label: Screening
intervention type: Device
intervention name: Alinity s HTLV I/II Assay
description: For all donor specimens with investigational Alinity s HTLV I/II results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.
arm group label: Screening
intervention type: Device
intervention name: Alinity s Anti-HCV Assay
description: For all donor specimens with investigational Alinity s Anti-HCV results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.
arm group label: Screening
intervention type: Device
intervention name: Alinity s HIV Ag/Ab Combo Assay
description: For all donor specimens with investigational Alinity s HIV Ag/Ab Combo results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.
arm group label: Screening
intervention type: Device
intervention name: Alinity s Anti-HBc Assay
description: For all donor specimens with investigational Alinity s Anti-HBc results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.
arm group label: Screening
intervention type: Device
intervention name: Alinity s Chagas Assay
description: For all donor specimens with investigational Alinity s Chagas results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.
arm group label: Screening
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Nancy R Haley, M.D.
role: Principal Investigator
affiliation: Bloodworks Northwest
last name: Thomas S Jones, Ph.D.
role: Principal Investigator
affiliation: QualTex Laboratories
last name: Susan S Ganz, M.D.
role: Principal Investigator
affiliation: Biotest Pharmaceuticals Corporation
last name: Toby L Simon, M.D.
role: Principal Investigator
affiliation: CSL Plasma Inc.
last name: Susan L Stramer, Ph.D.
role: Principal Investigator
affiliation: American Red Cross National Testing Laboratory
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hepatitis C Antibodies
sharing ipd: No
provided document: 
provided document: 
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 