{"doc_desc":{"title":"Etude des performances analytiques compar\u00e9es d'un nouveau kit de d\u00e9tection mol\u00e9culaire du COVID-19 rapides (Loop-Xplore) en ambulatoire (mode non-expert, bas d\u00e9bit - point of care) et en laboratoire de virologie (mode expert, haut d\u00e9bit, diagnostic m\u00e9dical).","idno":"FRESH-PEF74042-fr","producers":[{"name":"Astrid VABRET","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE CAEN NORMANDIE (CHU)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF74042-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"74042"},{"agency":"FReSH","code":"FRESH-PEF74042"}]},"title":"Etude des performances analytiques compar\u00e9es d'un nouveau kit de d\u00e9tection mol\u00e9culaire du COVID-19 rapides (Loop-Xplore) en ambulatoire (mode non-expert, bas d\u00e9bit - point of care) et en laboratoire de virologie (mode expert, haut d\u00e9bit, diagnostic m\u00e9dical).","alternate_title":"Rapid'COVID"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Astrid;VABRET","firstname":"Astrid","lastname":"VABRET","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/027arzy69","role":"organisation id"},{"title":"SIREN","uri":"261400931","role":"organisation id"}],"email":"vabret-a@chu-caen.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE CAEN NORMANDIE (CHU)","PILabo":"CHU de Caen \/ Laboratoire de virologie","isContact":true}],"oth_id":[{"name":"Soci\u00e9t\u00e9 Loop Dee Science Louis-Marie ROCQUE","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE CAEN NORMANDIE (CHU)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/027arzy69","role":"sponsor id"},{"title":"SIREN","uri":"261400931","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":"Meriadeg;LE GOUIL","lastname":"LE GOUIL","firstname":"Meriadeg","type":"contact","email":"legouil-me@chu-caen.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE CAEN NORMANDIE (CHU)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/027arzy69","role":"organisation id","title":"ROR"},{"uri":"261400931","role":"organisation id","title":"SIREN"}]},{"name":"Astrid;VABRET","lastname":"VABRET","firstname":"Astrid","type":"contact","email":"vabret-a@chu-caen.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE CAEN NORMANDIE (CHU)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/027arzy69","role":"organisation id","title":"ROR"},{"uri":"261400931","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[],"topics":[{"topic":"Infectiologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/fa2ceeab-3b2f-45e9-9243-e5a8005b98de"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D055552"}]},{"topic":"COVID-19","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1730556128","title":"CIM-11"}]}],"purpose":"Evaluer la concordance entre l'outil de d\u00e9tection mol\u00e9culaire rapide du virus SARS-CoV-2 (technique Loop-Xplore) dans les pr\u00e9l\u00e8vements nasopharyng\u00e9s et salivaires en ambulatoire et la technique PCR de r\u00e9f\u00e9rence r\u00e9alis\u00e9e au laboratoire de virologie du CHU de Caen.","abstract":"","coll_dates":[{"start":"2020-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Normandie']","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \" Patient majeur adress\u00e9 pour la r\u00e9alisation d'un test nasopharyng\u00e9 de diagnostic d'infection \u00e0 SARS-CoV-2 (COVID19) - Patient ayant \u00e9t\u00e9 inform\u00e9 de l'\u00e9tude et ayant accept\u00e9 de participer  - Patient francophone et affili\u00e9 au r\u00e9gime de la s\u00e9curit\u00e9 sociale\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude','Donn\u00e9es biologiques','Donn\u00e9es socio-d\u00e9mographiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"","sources":[],"target_sample_size":"[500-1000[ individus","response_rate":"1000"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"A d\u00e9finir\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"----","lastUpdatedAuto":null,"lastUpdatedManual":"01-10-2021","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":true},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":false,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Interrogatoire","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":""},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"R\u00e9sultat du test PCR SARS COV-2 r\u00e9alis\u00e9 au CHU de Caen","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}