Clinical Validation of Isothermal Nucleic Acid Amplification Bioassays Modules - GUINEA

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.

NCT Number	NCT07681752
Lead Sponsor	Institute of Tropical Medicine, Belgium Collaborators: National Center for Training and Research of Maferinyah, Guinea, Gamal Abdel Nasser University of Conakry
Conditions	Ebola Hemorrhagic Fever, Lassa Hemorrhagic Fever
Enrollment	150 participants
Start Date	2027-01
Primary Completion	2027-12 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2026-07-02