<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/NCT04403035</url>
  </required_header>
  <id_info>
    <org_study_id>1599159</org_study_id>
    <nct_id>NCT04403035</nct_id>
  </id_info>
  <brief_title>Comparison of the ID NOW and Accula Point-of-Care Assays for Detection of COVID-19</brief_title>
  <official_title>Comparison of the ID NOW and Accula Point-of-Care Assays for the Detection of Severe Acute Respiratory System CoV-2 (SARS-CoV-2)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ascension South East Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ascension South East Michigan</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a comparison of the ID Now COVID-19 (Abbott) assay to the Accula SARS-CoV-2&#xD;
      (Mesa Biotech) assay to assist in the identification of infection with COVID-19. The tests&#xD;
      will be compared for sensitivity, specificity, positive predictive value and negative&#xD;
      predictive value.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In response to the pandemic, the Food and Drug Administration (FDA) approved several&#xD;
      platforms under emergency use authorization (EUA). These platforms do not have full FDA&#xD;
      approval and may be used for COVID-19 testing temporarily in a clinical laboratory until the&#xD;
      manufacturer receives full FDA clearance for use in the U.S.&#xD;
&#xD;
      Two point of care (POC) platforms with current EUA approval are the ID NOW COVID-19 (Abbott)&#xD;
      and the Accula SARS-CoV-2 tests (Mesa Biotech). Both tests are designated as clinical&#xD;
      laboratory improvement amendments (CLIA) waived complexity. POCs play a vital role in the&#xD;
      diagnosis of COVID-19, especially in laboratories and clinics where testing including&#xD;
      molecular assays and serology is not available.&#xD;
&#xD;
      The purpose of this study is to compare SARS-CoV-2 results from clinical specimens on the ID&#xD;
      NOW and the Accula systems. If the Accula system is comparable or demonstrates superior test&#xD;
      parameters including sensitivity, then this assay may potentially assist in improving&#xD;
      turnaround times for COVID-19 results and facilitate reinstating elective procedures.&#xD;
&#xD;
      Patients with orders for rapid Covid-19 testing and who have consented to participate will be&#xD;
      included. For these patients one additional clinical specimen, a nasal specimen will be&#xD;
      collected from the patient at the same time as the initial specimen for the ID NOW. If there&#xD;
      is a discrepancy between the ID NOW and Accula test results, an additional specimen (nasal)&#xD;
      will be collected from the patient, if possible (i.e. if the patient remains in-house) to&#xD;
      confirm the COVID-19 results. We will also include patients who did not have an initial swab&#xD;
      but tested positive by PCR. They will be swabbed by both systems.&#xD;
&#xD;
      This study will evaluate accuracy by comparing Accula results to the ID NOW, precision&#xD;
      (reproducibility) by repeating select specimens with different users and on different&#xD;
      analyzers, limit of detection by diluting commercial SARS-CoV-2 controls with a known&#xD;
      concentration and cross-reactivity by testing known respiratory viruses (including influenza&#xD;
      A, B and RSV) on the Accula.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Unable to get adequate resources to do the study&#xD;
  </why_stopped>
  <start_date type="Actual">May 10, 2020</start_date>
  <completion_date type="Anticipated">May 9, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2020</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Test characteristics</measure>
    <time_frame>3 months</time_frame>
    <description>Comparison of accuracy, sensitivity, specificity, and positive and negative predictive values between the two assays.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Covid-19</condition>
  <arm_group>
    <arm_group_label>ID NOW vs. Acccula arm</arm_group_label>
    <description>Each patient serves as his or her own control. The ID NOW test is the one that is being currently used (i.e. the control) and the Accula test is the newer test being evaluated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ID NOW vs. Accula</intervention_name>
    <description>Comparison of the ID Now assay vs. the Accula assay in detecting Covid-19.</description>
    <arm_group_label>ID NOW vs. Acccula arm</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with orders for rapid COVID-19 testing who have consented to participate&#xD;
        will be included in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Covid-19 testing has been ordered in the Emergency Dept. or for inpatients in the&#xD;
             hospital or patient has already tested positive via PCR.&#xD;
&#xD;
          -  Adult patients&#xD;
&#xD;
          -  Consent obtained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Testing not ordered or tested negative via PCR.&#xD;
&#xD;
          -  Children&#xD;
&#xD;
          -  Do not consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Melphine Harriott, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ascension St. John Hospital, Detroit, Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ascension St. John Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html</url>
    <description>US Centers for Disease Control and Prevention (CDC) Guidelines</description>
  </link>
  <results_reference>
    <citation>Accula SARS-CoV-2 Test IFU (EUA). Mesa Biotech, 2020.</citation>
  </results_reference>
  <results_reference>
    <citation>ID NOW COVID-19 Assay IFU (EUA). Abbott, 2020.</citation>
  </results_reference>
  <results_reference>
    <citation>Laboratory testing for 2019 novel coronavirus (2019-nCoV) in suspected human cases: Interim guidance. World Health Organization. 19 March 2020.</citation>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>July 19, 2021</last_update_submitted>
  <last_update_submitted_qc>July 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2021</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>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <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>June 22, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT04403035/Prot_SAP_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</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>June 22, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT04403035/ICF_003.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04403035
org study id: 1599159
nct id: NCT04403035
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study is a comparison of the ID Now COVID-19 (Abbott) assay to the Accula SARS-CoV-2
      (Mesa Biotech) assay to assist in the identification of infection with COVID-19. The tests
      will be compared for sensitivity, specificity, positive predictive value and negative
      predictive value.
In response to the pandemic, the Food and Drug Administration (FDA) approved several
      platforms under emergency use authorization (EUA). These platforms do not have full FDA
      approval and may be used for COVID-19 testing temporarily in a clinical laboratory until the
      manufacturer receives full FDA clearance for use in the U.S.

      Two point of care (POC) platforms with current EUA approval are the ID NOW COVID-19 (Abbott)
      and the Accula SARS-CoV-2 tests (Mesa Biotech). Both tests are designated as clinical
      laboratory improvement amendments (CLIA) waived complexity. POCs play a vital role in the
      diagnosis of COVID-19, especially in laboratories and clinics where testing including
      molecular assays and serology is not available.

      The purpose of this study is to compare SARS-CoV-2 results from clinical specimens on the ID
      NOW and the Accula systems. If the Accula system is comparable or demonstrates superior test
      parameters including sensitivity, then this assay may potentially assist in improving
      turnaround times for COVID-19 results and facilitate reinstating elective procedures.

      Patients with orders for rapid Covid-19 testing and who have consented to participate will be
      included. For these patients one additional clinical specimen, a nasal specimen will be
      collected from the patient at the same time as the initial specimen for the ID NOW. If there
      is a discrepancy between the ID NOW and Accula test results, an additional specimen (nasal)
      will be collected from the patient, if possible (i.e. if the patient remains in-house) to
      confirm the COVID-19 results. We will also include patients who did not have an initial swab
      but tested positive by PCR. They will be swabbed by both systems.

      This study will evaluate accuracy by comparing Accula results to the ID NOW, precision
      (reproducibility) by repeating select specimens with different users and on different
      analyzers, limit of detection by diluting commercial SARS-CoV-2 controls with a known
      concentration and cross-reactivity by testing known respiratory viruses (including influenza
      A, B and RSV) on the Accula.
observational model: Cohort
time perspective: Prospective
measure: Test characteristics
time frame: 3 months
description: Comparison of accuracy, sensitivity, specificity, and positive and negative predictive values between the two assays.
arm group label: ID NOW vs. Acccula arm
description: Each patient serves as his or her own control. The ID NOW test is the one that is being currently used (i.e. the control) and the Accula test is the newer test being evaluated.
intervention type: Diagnostic Test
intervention name: ID NOW vs. Accula
description: Comparison of the ID Now assay vs. the Accula assay in detecting Covid-19.
arm group label: ID NOW vs. Acccula arm
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 95 Years
last name: Melphine Harriott, PhD
role: Principal Investigator
affiliation: Ascension St. John Hospital, Detroit, Michigan
facility: 
country: United States
url: http://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html
description: US Centers for Disease Control and Prevention (CDC) Guidelines
citation: Accula SARS-CoV-2 Test IFU (EUA). Mesa Biotech, 2020.
citation: ID NOW COVID-19 Assay IFU (EUA). Abbott, 2020.
citation: Laboratory testing for 2019 novel coronavirus (2019-nCoV) in suspected human cases: Interim guidance. World Health Organization. 19 March 2020.
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No
provided document: 
provided document: 