Bioneer Q-RFIA Clinical Evaluation

Robust evidence on the clinical diagnostic accuracy and operational characteristics of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR is required to comprehensively evaluate validity of the Bioneer RFIA assay to support both global and national policy decision-making. The rapid diagnosis and appropriate treatment of M/XDR-TB is essential to prevent significant morbidity, mortality and further transmission of disease. The FQ are key components of the new bedaquiline-containing 6-9 month regimen, and so it is necessary to rule-out resistance to these compounds prior to treating patients with the shorter regimen. Currently there are no WHO endorsed test that can diagnose MTB and identify resistance to both first and second-line drugs in a single assay cartridge with integrated sample preparation.

NCT Number	NCT05117788
Lead Sponsor	Foundation for Innovative New Diagnostics, Switzerland Collaborators: V. N. Karazin Kharkiv National University, Kenya Medical Research Institute, Universidad Peruana Cayetano Heredia, BIONEER Corporation, Centre for Infectious Disease Research in Zambia, Institute of Pneumology "Chiril Draganiuc" National TB Reference Laboratory
Conditions	Tuberculosis, Multidrug-Resistant
Enrollment	2,350 participants
Start Date	2022-02-23
Primary Completion	2027-06-30 (estimated)
Study Completion	2027-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-02-09