🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Bioneer Q-RFIA Clinical Evaluation

Recruitingn/aAges 18 Years - anyAllFoundation for Innovative New Diagnostics, Switze…
NCT05117788 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
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 it tests

  • 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
📍

Where

5 sites
KEMRI
Nairobi, Kenya
Institute of Pneumology "Chiril Draganiuc"
Chisinau, Moldova
Instituto de Medicina Tropical Alexander von Humboldt - Universidad Peruana Cayetano Heredia
Lima, Peru
V.N Karazin Kharkiv National University
Kharkiv, Ukraine
Centre for Infectious Disease Research in Zambia
Lusaka, Zambia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy