NCT05117788Recruiting
Bioneer Q-RFIA Clinical Evaluation
Multicentre Clinical Study to Assess the Diagnostic Accuracy of the Bioneer Q-RFIA PCR Kit on IRON qPCR for the Detection of MTB and Resistance to Rifampicin, Isoniazid, Fluoroquinolones and Aminoglycosides.
Source: ClinicalTrials.gov · Last updated 23 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2350 (estimated)
- First submitted
- 1 Nov 2021
- Start date
- 30 Jun 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Diseases
- Tuberculosis
- NCT number
- NCT05117788
What you commit to
- Study type: Observational
- Planned participants: 2350
- From 30 Jun 2026 to the primary completion date, 30 Jun 2027
- 5 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receipt of any TB treatment dose within the 6 months prior to enrolment.
Other
- 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;
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| KEMRI Coordinator of this site? Confirm its status | Nairobi | Kenya | Recruiting |
| Institute of Pneumology "Chiril Draganiuc" Coordinator of this site? Confirm its status | Chisinau | Moldova | Not yet recruiting |
| Instituto de Medicina Tropical Alexander von Humboldt - Universidad Peruana Cayetano Heredia Coordinator of this site? Confirm its status | Lima | Peru | Not yet recruiting |
| V.N Karazin Kharkiv National University Coordinator of this site? Confirm its status | Kharkiv | Ukraine | Not yet recruiting |
| Centre for Infectious Disease Research in Zambia Coordinator of this site? Confirm its status | Lusaka | Zambia | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.