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.

Inclusion Criteria: People (aged ≥18 years) with clinical signs and symptoms of pulmonary TB including cough of any duration and ≥1 other symptom typical of pulmonary TB Exclusion criteria comprise absence of informed consent, insufficient sample volume or number, only extra-pulmonary TB signs \& symptoms, and receipt of any dose of TB treatment within six months prior to enrolment (for objectives relating to MTB detection). Exclusion Criteria: Participants will be excluded from the study if any of the following apply: * Unwilling or unable to provide informed consent; * Unwilling to provide two sputum specimens at enrolment; * Presenting with only extra-pulmonary TB signs \& symptoms; * Receipt of any TB treatment dose within the 6 months prior to enrolment.