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<docDscr>
  <citation>
    <titlStmt>
      <titl>Study of the comparative analytical performance of a new COVID-19 rapid molecular detection kit (Loop-Xplore) in the outpatient setting (non-expert mode, low throughput - point of care) and in the virology laboratory (expert mode, high throughput, medical diagnosis).</titl>
      <IDNo>FRESH-PEF74042-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE CAEN NORMANDIE (CHU)" role="">Astrid VABRET</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Study of the comparative analytical performance of a new COVID-19 rapid molecular detection kit (Loop-Xplore) in the outpatient setting (non-expert mode, low throughput - point of care) and in the virology laboratory (expert mode, high throughput, medical diagnosis).            </titl>
      <altTitl>
                    Rapid'COVID                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF74042-en            </IDNo>
      <IDNo agency="PEF">
                    74042                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF74042                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Astrid VABRET                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE CAEN NORMANDIE (CHU)">
        <ExtLink title="ROR" URI="https://ror.org/027arzy69" role="organisation id"/>
        <ExtLink title="SIREN" URI="261400931" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="Loop Dee Science Company Louis-Marie ROCQUE" type="collaboration">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            CENTRE HOSPITALIER UNIVERSITAIRE DE CAEN NORMANDIE (CHU)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE CAEN NORMANDIE (CHU)" email="legouil-me@chu-caen.fr">
                    Meriadeg;LE GOUIL
                                            <ExtLink title="ROR" URI="https://ror.org/027arzy69" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="261400931" role="organisation id"/>
                                    </contact>
      <contact affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE CAEN NORMANDIE (CHU)" email="vabret-a@chu-caen.fr">
                    Astrid;VABRET
                                            <ExtLink title="ROR" URI="https://ror.org/027arzy69" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="261400931" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-16"/>
      <distDate date="2026-06-16"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <topcClas vocab="health theme">
                        Infectious disease medicine                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/fa2ceeab-3b2f-45e9-9243-e5a8005b98de"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D055552"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        COVID-19                                            </topcClas>
    </subject>
    <abstract contentType="purpose">Evaluate the concordance between the rapid molecular detection tool for SARS-CoV-2 (Loop-Xplore technique) in nasopharyngeal and salivary samples taken on an outpatient basis and the reference PCR technique performed in the virology laboratory at Caen University Hospital.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2020-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogCover>Normandie</geogCover>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">General population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Young Adult (19 to 24 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D055815"/>
                                                    </universe>
      <universe level="age" clusion="I">Adult (25 to 44 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000328"/>
                                                    </universe>
      <universe level="age" clusion="I">Middle Aged (45 to 64 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008875"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged (65 to 79 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000368"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged, 80 and over (80 years and more)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000369"/>
                                                    </universe>
      <dataKind>Participant-reported health data</dataKind>
      <dataKind>Biological data</dataKind>
      <dataKind>Socio-demographic data</dataKind>
    </sumDscr>
  </stdyInfo>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through organizations (health services or institutions</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>schools</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>businesses</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>etc.)</unitType>
        </frameUnit>
      </sampleFrame>
      <collMode>Interview with the participant (including clinical)                                                            <concept vocab="CESSDA" vocabURI="Interview"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <anlyInfo>
      <respRate>1000</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            To be defined                                                    </avlStatus>
    </setAvail>
  </dataAccs>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
