<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/NCT04496141</url>
  </required_header>
  <id_info>
    <org_study_id>RC-2020-12</org_study_id>
    <nct_id>NCT04496141</nct_id>
  </id_info>
  <brief_title>Evaluation of Commercial SARS-CoV-2 Antibody Immunoassays for COVID-19</brief_title>
  <official_title>Evaluation of Commercial SARS-CoV-2 Antibody Immunoassays for COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hong Kong Sanatorium &amp; Hospital</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hong Kong Sanatorium &amp; Hospital</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>
      Achieved serum samples of persons with or without evidence of COVID-19 infection are tested&#xD;
      using the different commercial SARS-CoV-2 antibody immunoassays. The performance of the&#xD;
      immunoassays is then assessed by comparing the 2 groups of samples.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Achieved serum samples of the different testing groups are retrieved and tested with the&#xD;
      immunoassays according to manufacturer's instruction.&#xD;
&#xD;
      The test results are then compared and analyzed with statistical tests to assess the&#xD;
      immunoassays'performance&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 27, 2020</start_date>
  <completion_date type="Anticipated">November 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 30, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The accuracy of the different commercial SARS-CoV-2 antibody immunoassays</measure>
    <time_frame>1 month</time_frame>
    <description>To investigate the accuracy (including sensitivity, specificity, positive and negative predictive value) of the commercial SARS-CoV-2 antibody immunoassays</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>With COVID-19 infection</arm_group_label>
    <description>Subjects with a positive SARS-CoV-2 PCR</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Without COVID-19 infection</arm_group_label>
    <description>Subjects with COVID-19 negative serum</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>SARS-CoV-2 antibody immunoassays</intervention_name>
    <description>Different commercial SARS-CoV-2 antibody immunoassays</description>
    <arm_group_label>With COVID-19 infection</arm_group_label>
    <arm_group_label>Without COVID-19 infection</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who attended clinic and had a positive SARS-CoV-2 PCR and subjects who had&#xD;
        COVID-19 negative serum during the epidemic in Hong Kong.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria for COVID-19 infected sera: any patient with PCR confirmed COVID-19&#xD;
        infection&#xD;
&#xD;
        Inclusion criteria for COVID-19 negative sera: sera collected after a negative SARS-CoV-2&#xD;
        PCR&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#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>Jonpaul Sze Tsing Zee, MBChB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hong Kong Sanatorium &amp; Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hong Kong Sanatorium &amp; Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>July 31, 2020</last_update_submitted>
  <last_update_submitted_qc>July 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hong Kong Sanatorium &amp; Hospital</investigator_affiliation>
    <investigator_full_name>Dr. Jonpaul ST Zee</investigator_full_name>
    <investigator_title>Specialist in Infectious Disease</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antibodies</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04496141
org study id: RC-2020-12
nct id: NCT04496141
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Achieved serum samples of persons with or without evidence of COVID-19 infection are tested
      using the different commercial SARS-CoV-2 antibody immunoassays. The performance of the
      immunoassays is then assessed by comparing the 2 groups of samples.
Achieved serum samples of the different testing groups are retrieved and tested with the
      immunoassays according to manufacturer's instruction.

      The test results are then compared and analyzed with statistical tests to assess the
      immunoassays'performance
observational model: Cohort
time perspective: Retrospective
measure: The accuracy of the different commercial SARS-CoV-2 antibody immunoassays
time frame: 1 month
description: To investigate the accuracy (including sensitivity, specificity, positive and negative predictive value) of the commercial SARS-CoV-2 antibody immunoassays
arm group label: With COVID-19 infection
description: Subjects with a positive SARS-CoV-2 PCR
arm group label: Without COVID-19 infection
description: Subjects with COVID-19 negative serum
intervention type: Diagnostic Test
intervention name: SARS-CoV-2 antibody immunoassays
description: Different commercial SARS-CoV-2 antibody immunoassays
arm group label: With COVID-19 infection
arm group label: Without COVID-19 infection
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: Jonpaul Sze Tsing Zee, MBChB
role: Principal Investigator
affiliation: Hong Kong Sanatorium & Hospital
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Hong Kong Sanatorium & Hospital
investigator full name: Dr. Jonpaul ST Zee
investigator title: Specialist in Infectious Disease
mesh term: COVID-19
mesh term: Antibodies
sharing ipd: No