<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/NCT04468386</url>
  </required_header>
  <id_info>
    <org_study_id>CV19-Col-004</org_study_id>
    <nct_id>NCT04468386</nct_id>
  </id_info>
  <brief_title>Specimen Collection Study Protocol</brief_title>
  <official_title>Specimen Collection Study Protocol; Internal Biomerica Normal Specimen Collection and Banking for Use in COVID-19 Serological Product Development</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biomerica</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biomerica</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 specimens collected will be used to evaluate matrix equivalency in an immunoassay in&#xD;
      development for the detection of IgG or IgA or IgM antibodies to SARS - CoV2 in human serum.&#xD;
      These reagents are for in vitro diagnostic use only.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to acquire paired serum, plasma and whole blood collected on a&#xD;
      collection card from subjects with no known history of COVID-19 infection. The specimens will&#xD;
      be collected at Biomerica in Irvine CA for specimen collection, banking, and matrix&#xD;
      equivalency studies for projects in development at Biomerica for detection to IgG or IgA or&#xD;
      IgM antibodies to Sars-CoV2 antibodies. Subject will also be asked to self-collect a nasal&#xD;
      swab for COVID-19 PCR&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 7, 2020</start_date>
  <completion_date type="Actual">May 30, 2021</completion_date>
  <primary_completion_date type="Actual">May 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Matrix Equivalency</measure>
    <time_frame>1 day</time_frame>
    <description>This study is designed to collect specimens to support specimen matrix equivalency in an in vitro diagnostic assay for the detection of COVID-19 antibodies.&#xD;
Additionally, specimens collected via finger stick will be used to validate a whole blood collection card that could be used in the field by trained professionals and sent back to central reference laboratories for testing.</description>
  </primary_outcome>
  <enrollment type="Actual">47</enrollment>
  <condition>Focus in on Collecting Paired Specimens for Matrix Equivalency</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum, Plasma and Dried Blood Spots (DBS - whole blood dried on filter paper). Serum and&#xD;
      Plasma will be retained the DBS will be depleted and not retained&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will consist of subjects identified as meeting the inclusion/exclusion&#xD;
        criteria from Biomerica employees and/or friends and family of Biomerica's employees. There&#xD;
        will be no outside advertising or recruiting. All subjects must be willing to sign the&#xD;
        informed consent and undergo the venipuncture and finger stick blood collection process and&#xD;
        perform the nasal swab collection.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 21 and older&#xD;
&#xD;
          -  Able to read, speak, and understand English&#xD;
&#xD;
          -  Must weigh a minimum of 110 pounds&#xD;
&#xD;
          -  Willing and able to donate 20 mLs of whole blood via venipuncture. [approximately ˂ 2&#xD;
             tablespoons]&#xD;
&#xD;
          -  Willing and able to donate 0.040 mLs of whole blood via fingerstick&#xD;
&#xD;
          -  Willing and able to sign the informed consent (self or authorized representative)&#xD;
&#xD;
          -  Willing and able to self-collect a nasal swab per the provided instruction shee&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Aged less than 21 years old&#xD;
&#xD;
          -  Unable to provide consent.&#xD;
&#xD;
          -  Unable to donate blood via venipuncture and fingerstick.&#xD;
&#xD;
          -  Unable to self-collect a nasal swab&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elisabeth Laderman, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Biomerica, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Biomerica, Inc.</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>November 23, 2021</last_update_submitted>
  <last_update_submitted_qc>November 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04468386
org study id: CV19-Col-004
nct id: NCT04468386
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The specimens collected will be used to evaluate matrix equivalency in an immunoassay in
      development for the detection of IgG or IgA or IgM antibodies to SARS - CoV2 in human serum.
      These reagents are for in vitro diagnostic use only.
The objective of this study is to acquire paired serum, plasma and whole blood collected on a
      collection card from subjects with no known history of COVID-19 infection. The specimens will
      be collected at Biomerica in Irvine CA for specimen collection, banking, and matrix
      equivalency studies for projects in development at Biomerica for detection to IgG or IgA or
      IgM antibodies to Sars-CoV2 antibodies. Subject will also be asked to self-collect a nasal
      swab for COVID-19 PCR
observational model: Case-Only
time perspective: Prospective
measure: Matrix Equivalency
time frame: 1 day
description: This study is designed to collect specimens to support specimen matrix equivalency in an in vitro diagnostic assay for the detection of COVID-19 antibodies.
Additionally, specimens collected via finger stick will be used to validate a whole blood collection card that could be used in the field by trained professionals and sent back to central reference laboratories for testing.
Serum, Plasma and Dried Blood Spots (DBS - whole blood dried on filter paper). Serum and
      Plasma will be retained the DBS will be depleted and not retained
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Elisabeth Laderman, Ph.D.
role: Principal Investigator
affiliation: Biomerica, Inc.
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No