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<docDscr>
  <citation>
    <titlStmt>
      <titl>Comparison of strategies based on RT-PCR or antigenic testing for screening for SARS-CoV-2 infection in the general population from self-samples.</titl>
      <IDNo>FRESH-PEF73973-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE" role="">Amandine BAUDOT</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Comparison of strategies based on RT-PCR or antigenic testing for screening for SARS-CoV-2 infection in the general population from self-samples.            </titl>
      <altTitl>
                    AutoCoV                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF73973-en            </IDNo>
      <IDNo agency="PEF">
                    73973                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF73973                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Julie GAGNAIRE                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE">
        <ExtLink title="ROR" URI="https://ror.org/04pn6vp43" role="organisation id"/>
        <ExtLink title="SIREN" URI="264200304" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Bruno POZZETTO                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE">
        <ExtLink title="ROR" URI="https://ror.org/04pn6vp43" role="organisation id"/>
        <ExtLink title="SIREN" URI="264200304" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE" email="julie.gagnaire@chu-st-etienne.fr">
                    Julie;GAGNAIRE
                                            <ExtLink title="ROR" URI="https://ror.org/04pn6vp43" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="264200304" role="organisation id"/>
                                    </contact>
      <contact affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE" email="bruno.pozzetto@chu-st-etienne.fr">
                    Bruno;POZZETTO
                                            <ExtLink title="ROR" URI="https://ror.org/04pn6vp43" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="264200304" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-17"/>
      <distDate date="2026-06-17"/>
    </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">The main objective is to evaluate, for the screening of SARSCoV-2 infection, the performance of a strategy that would combine 1) a salivary self-sampling associated with a previous nasal self-sampling and 2) an antigenic diagnostic test that can be directly performed in the field, in comparison with the reference technique of RT-PCR on salivary samples recently validated by the HAS. ; Secondary objectives:; - Determine the prevalence of SARS-CoV-2 infection in the population tested by the reference test ;; - Determine the prevalence of circulation of the different SARS-CoV-2 variants of interest in the population tested ;; - Evaluate the acceptability of self-sampling as a function of age and socio-professional category;; - Evaluate the feasibility of the two screening strategies;; - Evaluate the cost-effectiveness of the new diagnostic strategy compared with the reference technique (RT-PCR on saliva);; - Reinforce adherence to barrier measures and instructions for early isolation of positive cases, by means of rapid tests and support from people trained in the motivational approach;; - Evaluate health support for people in isolation;; - Evaluate, on a sample of positive and negative test subjects, knowledge of barrier measures and isolation instructions, through the use of rapid tests and support from anti-COVID mediators.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2021-01-01"/>
      <collDate event="end" date="2021-12-31"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogCover>Auvergne Rhône-Alpes</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">Child (6 to 12 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D002648"/>
                                                    </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>
    </sumDscr>
  </stdyInfo>
  <method>
    <dataColl>
      <timeMeth>Repeated cross-sectional study</timeMeth>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through independent healthcare practitioners 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>Converting or copying information into a structured record                                                            <concept vocab="CESSDA" vocabURI="Transcription"/>
                                                    </collMode>
      <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>7100</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            To be defined                                                    </avlStatus>
    </setAvail>
  </dataAccs>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
