<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/NCT03776903</url>
  </required_header>
  <id_info>
    <org_study_id>ZIKV-2016-01</org_study_id>
    <nct_id>NCT03776903</nct_id>
  </id_info>
  <brief_title>Evaluation of the Clinical Performance of the ZIKV Detect™ 2.0 IgM Capture ELISA</brief_title>
  <official_title>Evaluation of the Clinical Performance of the ZIKV Detect™ 2.0 IgM Capture ELISA</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>InBios International, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fast-Track Drugs &amp; Biologics, LLC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Biomedical Advanced Research and Development Authority</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>InBios International, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the performance of the ZIKV Detect™ 2.0 IgM Capture&#xD;
      ELISA using archived confirmed ZIKV positive and confirmed ZIKV negative human serum samples.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to evaluate the performance of the ZIKV Detect™ 2.0 IgM Capture&#xD;
      ELISA using archived confirmed ZIKV positive and confirmed ZIKV negative human serum samples.&#xD;
      The FDA guidance document (ZIKA SEROLOGY DE NOVO/510(K) PRE-MARKET SUBMISSIONS - Recommended&#xD;
      Analytical and Clinical Studies for Zika Virus IgM Assays; Dated 02Jun2017; FDA/CDRH/OIR/DMD)&#xD;
      allows for the utilization of archival serum specimens to evaluate test performance. This&#xD;
      study will follow this guidance. Test samples will be collected from endemic sites (both&#xD;
      presumed positive and presumed negative samples) and from non-endemic sites (presumed&#xD;
      negative samples). All samples will be shipped to the sponsor for randomization and will be&#xD;
      tested at three sites in the United States.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">August 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Positive Percent Agreement and Negative Percent Agreement</measure>
    <time_frame>From symptom onset to 12 weeks after symptom onset.</time_frame>
    <description>The positive percent agreement (PPA) and negative percent agreement (NPA) of the ZIKV Detect™ 2.0 IgM Capture ELISA versus the reference test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of Positive Percent Agreement</measure>
    <time_frame>From symptom onset to 12 weeks after symptom onset.</time_frame>
    <description>The time period relative to onset of symptoms that a positive result can be identified and the time period after onset of symptoms that the positive percent agreement is maximized and the longest elapsed time after symptom onset that positive test results are observed.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">600</enrollment>
  <condition>Zika Virus Infection</condition>
  <arm_group>
    <arm_group_label>endemic</arm_group_label>
    <description>Samples collected from areas endemic for zika. Subject specimens underwent testing with the study device and reference method.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-endemic</arm_group_label>
    <description>Samples collected from areas non-endemic for zika. Subject specimens underwent testing with the study device and reference method.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ZIKV Detect™ 2.0 IgM Capture ELISA</intervention_name>
    <description>De-identified archive specimens are tested by ELISA and compared to reference testing (RT-PCR and CDC MAC-ELISA)</description>
    <arm_group_label>endemic</arm_group_label>
    <arm_group_label>non-endemic</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Human males and females of varying ages and geographical locations where Zika virus is&#xD;
        endemic and not endemic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Human males and females of varying ages and geographical locations where Zika virus is&#xD;
             endemic and not endemic.&#xD;
&#xD;
          -  Retrospective (archived) and prospective human serum samples. Archived samples will&#xD;
             fall under the category of &quot;leftover&quot; specimens as described by FDA guidance.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        • Samples that are not de-identified.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frances Chu, PhD</last_name>
    <role>Study Director</role>
    <affiliation>InBios International</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>InBios International</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>December 13, 2018</last_update_submitted>
  <last_update_submitted_qc>December 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Zika Virus Infection</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03776903
org study id: ZIKV-2016-01
nct id: NCT03776903
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the performance of the ZIKV Detect™ 2.0 IgM Capture
      ELISA using archived confirmed ZIKV positive and confirmed ZIKV negative human serum samples.
The purpose of this study is to evaluate the performance of the ZIKV Detect™ 2.0 IgM Capture
      ELISA using archived confirmed ZIKV positive and confirmed ZIKV negative human serum samples.
      The FDA guidance document (ZIKA SEROLOGY DE NOVO/510(K) PRE-MARKET SUBMISSIONS - Recommended
      Analytical and Clinical Studies for Zika Virus IgM Assays; Dated 02Jun2017; FDA/CDRH/OIR/DMD)
      allows for the utilization of archival serum specimens to evaluate test performance. This
      study will follow this guidance. Test samples will be collected from endemic sites (both
      presumed positive and presumed negative samples) and from non-endemic sites (presumed
      negative samples). All samples will be shipped to the sponsor for randomization and will be
      tested at three sites in the United States.
observational model: Cohort
time perspective: Other
measure: Positive Percent Agreement and Negative Percent Agreement
time frame: From symptom onset to 12 weeks after symptom onset.
description: The positive percent agreement (PPA) and negative percent agreement (NPA) of the ZIKV Detect™ 2.0 IgM Capture ELISA versus the reference test.
measure: Duration of Positive Percent Agreement
time frame: From symptom onset to 12 weeks after symptom onset.
description: The time period relative to onset of symptoms that a positive result can be identified and the time period after onset of symptoms that the positive percent agreement is maximized and the longest elapsed time after symptom onset that positive test results are observed.
arm group label: endemic
description: Samples collected from areas endemic for zika. Subject specimens underwent testing with the study device and reference method.
arm group label: non-endemic
description: Samples collected from areas non-endemic for zika. Subject specimens underwent testing with the study device and reference method.
intervention type: Other
intervention name: ZIKV Detect™ 2.0 IgM Capture ELISA
description: De-identified archive specimens are tested by ELISA and compared to reference testing (RT-PCR and CDC MAC-ELISA)
arm group label: endemic
arm group label: non-endemic
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Frances Chu, PhD
role: Study Director
affiliation: InBios International
facility: 
country: United States
responsible party type: Sponsor
mesh term: Zika Virus Infection