Clinical Research Directory

Bioneer Q-RFIA Clinical Evaluation

Sponsor: Foundation for Innovative New Diagnostics, Switzerland

Summary

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.

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.

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