[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646802":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":22,"centralContacts":30,"locations":10,"responsibleParty":35,"collaborators":37,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":10,"eligibilityCriteria":45,"healthyVolunteers":42,"sex":46,"minAge":10,"maxAge":10,"enrollmentInfo":47,"targetDuration":10,"studyType":50,"phases":10,"briefSummary":51,"conditions":52,"keywords":10,"overallStatus":54,"whyStopped":10,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":10},{"fullName":5,"class":6},"Institute of Tropical Medicine, Belgium","OTHER",[8,13],{"label":9,"type":10,"description":10,"interventionNames":11},"EBOV positives",null,[12],"Diagnostic Test: DECIPHER bioassay",{"label":14,"type":10,"description":10,"interventionNames":15},"EBOV negatives",[12],[17],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":10},"DIAGNOSTIC_TEST","DECIPHER bioassay","DECIPHER bioassay, using recombinase polymerase amplification for a quantitative readout",[14,9],[23,27],{"name":24,"affiliation":25,"role":26},"Placide Mbala, Prof.","Institut National de Recherche Biomédicale, Kinshasa, Democratic Republic of the Congo","PRINCIPAL_INVESTIGATOR",{"name":28,"affiliation":29,"role":26},"Koen Vercauteren, Prof. Dr.","Institute of Tropical Medicine, Antwerp, Belgium",[31],{"name":28,"role":32,"phone":33,"phoneExt":10,"email":34},"CONTACT","+32 3 247 63 32","kvercauteren@itg.be",{"type":36,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[38],{"name":39,"class":6},"Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo","100646802","clinical-validation-of-isothermal-nucleic-acid-amplification-bioassays-modules---drc-100646802",false,"NCT07688083","Clinical Validation of Isothermal Nucleic Acid Amplification Bioassays Modules - DRC","Inclusion Criteria:\n\n* EBOV test positive and negative biobanked patient samples\n\nExclusion Criteria:\n\n* not applicable","ALL",{"count":48,"type":49},100,"ESTIMATED","OBSERVATIONAL","This study aims to validate the clinical performance of a newly developed isothermal nucleic acid amplification bioassay module for EBOV. A retrospective studies will be conducted using biobanked patient samples such as plasma samples and buccal swabs already collected by the Institut National de Recherches Biomédicales (INRB) in Kinshasa, DRC as part of their surveillance and outbreak activities. The diagnostic sensitivity and specificity of the EBOV bioassay module will be compared to the gold-standard reverse transcriptase polymerase chain reaction (RT-PCR) technologies used in the national reference lab.",[53],"Ebola Hemorrhagic Fever","NOT_YET_RECRUITING","2026-06-30",{"date":57,"type":58},"2026-07-07","ACTUAL",{"date":60,"type":49},"2027-01",{"date":62,"type":49},"2027-12",{"name":5,"class":6}]