[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645378":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":36,"locations":10,"responsibleParty":42,"collaborators":44,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":10,"eligibilityCriteria":55,"healthyVolunteers":52,"sex":56,"minAge":10,"maxAge":10,"enrollmentInfo":57,"targetDuration":10,"studyType":60,"phases":10,"briefSummary":61,"conditions":62,"keywords":10,"overallStatus":65,"whyStopped":10,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":10},{"fullName":5,"class":6},"Institute of Tropical Medicine, Belgium","OTHER",[8,13,16],{"label":9,"type":10,"description":10,"interventionNames":11},"LASV positives",null,[12],"Diagnostic Test: FORTIFIEDx and DECIPHER bioassays",{"label":14,"type":10,"description":10,"interventionNames":15},"EBOV positives",[12],{"label":17,"type":10,"description":10,"interventionNames":18},"LASV and EBOV negatives",[12],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DIAGNOSTIC_TEST","FORTIFIEDx and DECIPHER bioassays","FORTIFIEDx bioassay, using recombinase polymerase amplification for a qualitative readout and DECIPHER bioassay, using recombinase polymerase amplification for a quantitative readout",[14,17,9],[26,30,33],{"name":27,"affiliation":28,"role":29},"Karifa Kourouma, MD, MSc","Centre National de Formation et de Recherche en Santé Rurale, Maferinyah, Guinea","PRINCIPAL_INVESTIGATOR",{"name":31,"affiliation":32,"role":29},"Alimou Camara, Dr.","Centre de Recherche en Virologie, Laboratoire des Fièvres Hémorragiques Virales de Guinée, Conakry, Guinea",{"name":34,"affiliation":35,"role":29},"Koen Vercauteren, Dr. Prof.","Institute of Tropical Medicine, Antwerp, Belgium",[37],{"name":38,"role":39,"phone":40,"phoneExt":10,"email":41},"Koen Vercauteren, Prof. Dr.","CONTACT","+32 3 247 63 32","kvercauteren@itg.be",{"type":43,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[45,48],{"name":46,"class":47},"National Center for Training and Research of Maferinyah, Guinea","UNKNOWN",{"name":49,"class":6},"Gamal Abdel Nasser University of Conakry","100645378","clinical-validation-of-isothermal-nucleic-acid-amplification-bioassays-modules---guinea-100645378",false,"NCT07681752","Clinical Validation of Isothermal Nucleic Acid Amplification Bioassays Modules - GUINEA","Inclusion Criteria:\n\n* EBOV and LASV test positive and negative biobanked patient samples\n\nExclusion Criteria:\n\n* not applicable","ALL",{"count":58,"type":59},150,"ESTIMATED","OBSERVATIONAL","This study aim to validate the clinical performances of two newly developed isothermal nucleic acid amplification bioassays modules for EBOV and LASV. Two retrospective studies will be conducted using biobanked patient samples such as plasma samples and buccal swabs already collected by the Centre de Recherche en Virologie, Laboratoire des Fièvres Hémorragiques Virales de Guinée (CRV-LFHVG) as part of their surveillance and outbreak activities. The diagnostic sensitivity and specificity of the EBOV and LASV bioassays modules will be compared to the gold-standard reverse transcriptase polymerase chain reaction (RT-PCR) technologies used in the national reference lab.",[63,64],"Ebola Hemorrhagic Fever","Lassa Hemorrhagic Fever","NOT_YET_RECRUITING","2026-06-30",{"date":68,"type":69},"2026-07-02","ACTUAL",{"date":71,"type":59},"2027-01",{"date":73,"type":59},"2027-12",{"name":5,"class":6}]