Bioneer RFIA Diagnostic Evaluation for Drug-Resistant TB
Official title: 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.
Run by Foundation for Innovative New Diagnostics, Switzerland · NCT05117788 · Data updated 2026-11-12
This study tests whether the Bioneer Accupower Q-RFIA PCR kit on the IRON qPCR system can accurately detect TB and resistance to key drugs in adults with suspected pulmonary TB.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2350 (estimated) |
| Sponsor | Foundation for Innovative New Diagnostics, Switzerland Academic / other |
| Locations | 5 sites (Nairobi, Nairobi County and 4 other locations) |
| Status | Recruiting |
| Started | June 30, 2026 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | September 23, 2026 |
| Trial ID | NCT05117788 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with clinical signs of pulmonary TB, including cough and at least one additional typical symptom, who have not recently received TB treatment.
✕Probably not a fit
Patients without MTB infection or with atypical presentations may not benefit from this diagnostic approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter observational study evaluates the clinical performance and operational characteristics of the Bioneer IRONqPCR RFIA kit for detecting MTB and mutations associated with rifampicin, isoniazid, fluoroquinolones, and amikacin resistance. The assay uses a cartridge with automated nucleic acid extraction and PCR on the IRON qPCR platform, aiming to provide rapid, sample-to-result testing. Participants are adults with pulmonary TB symptoms and at least one additional TB symptom, enrolled at sites in Kenya, Moldova, and Peru. The study compares RFIA results to a culture reference standard and includes other diagnostic tests as comparators. The primary goal is to inform policy decisions by assessing diagnostic accuracy and operational feasibility in diverse settings.
Why it matters
Potential benefit: If successful, this assay could enable rapid, comprehensive detection of TB and drug resistance to guide timely treatment decisions.
How similar studies have gone: Previous studies of similar integrated cartridge-based TB assays have shown variable but promising diagnostic performance in diverse settings.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Kemri
Nairobi, Nairobi County, Kenya Recruiting -
Institute of Pneumology "Chiril Draganiuc"
Chisinau, Moldova Not yet recruiting -
Instituto de Medicina Tropical Alexander von Humboldt - Universidad Peruana Cayetano Heredia
Lima, Peru Not yet recruiting -
V.N Karazin Kharkiv National University
Kharkiv, Ukraine Not yet recruiting -
Centre for Infectious Disease Research in Zambia
Lusaka, Zambia Not yet recruiting
Study contacts
- Study coordinator: Vinzeigh Leukes, PhD
- Email: Vinzeigh.Leukes@finddx.org
- Phone: +27 84 419 9113
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.