Last reviewed · How we verify
NCT05117788
Bioneer Q-RFIA Clinical Evaluation
trial testing Estimate the diagnostic accuracy of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR for MTB detection using culture as reference standard. Estimate the diagnostic accuracy of the Bioneer Ac in Tuberculosis, Multidrug-Resistant in 2,350 participants. Participants enrolled and being followed up; not accepting new ones.
30 June 2027
Quick facts
| Lead sponsor | Foundation for Innovative New Diagnostics, Switzerland |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 2,350 |
| Start date | 23 February 2022 |
| Primary completion | 30 June 2027 |
| Estimated completion | 30 June 2027 |
| Sites | 5 locations across Ukraine, Peru, Zambia, Moldova, Kenya |
Drugs / interventions tested
- Estimate the diagnostic accuracy of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR for MTB detection using culture as reference standard. Estimate the diagnostic accuracy of the Bioneer Ac
Conditions studied
- Tuberculosis, Multidrug-Resistant — all drugs for Tuberculosis, Multidrug-Resistant →
Sponsor
Foundation for Innovative New Diagnostics, Switzerland
Who can join
18 and older, any sex, with Tuberculosis, Multidrug-Resistant. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Designing molecular diagnostics for current tuberculosis drug regimens.
Georghiou SB, de Vos M, Velen K, Miotto P, et al · · 2023 · cited 18× · PMID 36752055 · DOI 10.1080/22221751.2023.2178243
Verify or expand the search:
- PubMed search for NCT05117788
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Foundation for Innovative New Diagnostics, Switzerland trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05117788 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Foundation for Innovative New Diagnostics, Switzerland
- Last refreshed: 9 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05117788.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing