Clinical Validation of Isothermal Nucleic Acid Amplification Bioassays Modules - DRC

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.

NCT Number	NCT07688083
Lead Sponsor	Institute of Tropical Medicine, Belgium Collaborators: Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
Conditions	Ebola Hemorrhagic Fever
Enrollment	100 participants
Start Date	2027-01
Primary Completion	2027-12 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2026-07-07