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.
- Tuberculosis, Multidrug-Resistant
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Enrolment target
- 2,350
- Started
- 30 June 2026
- Main results due
- 30 June 2027
- Study sites
- 5
- Registry updated
- 23 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility 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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(5)
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
Showing 5 of 5 sites. 1 of the 5 sites on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT05117788. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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