Bioneer Q-RFIA Clinical Evaluation
brief 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.
detailed description
Multicentre Clinical Study to Assess the Performance of the Bioneer IRONqPCR ™ RFIA Kit for INH-, RIF-, FQ- and AG-Resistance Detection
Background and rationale Evidence of the clinical diagnostic accuracy and operational characteristics of the Bioneer IRONqPCR ™ RFIA Kit is needed to comprehensively evaluate Bioneer RFIA validity and inform global and national policy decision-making.
The Bioneer IRONqPCR ™ RFIA Kit. The Investigational Use Only (IUO) product is intended for the detection of MTB and mutations associated with RIF, INH, FQ and AMG drug resistance. The assay which is run as a kit cartridge physically consists of two parts; a nucleic extraction body part and the PCR plate. The cartridge is intended to be used with the IRON qPCR system.
The IRON qPCR system provided for this study should only be used for testing IUO product and study samples. The IRON qPCR instrument developed by Bioneer is intended to be used at lower healthcare systems. The instrument has a small footprint ((30.5(W) x 27(D) x 39.5(H) cm), weight (\< 15 kg) and can be operated on a battery charge. The system has the capability to fully automate the detection of 40 targets and to provide sample-to-result within 30 minutes.) The investigational product will be strictly accounted for, including receipt and inventory, storage, use during the trial, and return or disposal, as detailed in the Study Manual for this study.
Other diagnostic tests (2nd comparators and reference tests) provided for use in this Trial are:
* Xpert MTB/RIF Ultra assay * Xpert MTB/XDR assay * Hain MTBDRplus assay * Hain MTBDRsl assay Instructions for use of the investigational product(s) are provided in the IP package inserts.
The Bioneer IRONqPCR ™ RFIA Kit assay detects Mtb and mutations associated with INH, RIF, FQ and aminoglycoside resistance direct from sputum. In line with this intended use, clinical samples will be directly tested by the Bioneer Accupower Q-RFIA assay. However, the assay will also be used to test the culture isolate. This additional Bioneer IRONqPCR ™ RFIA Kit assay testing will allow for a comparison of performance and non-determinant rates between testing directly from the sample and testing from the culture isolate. It will also support resolution of potential discordant LPA and NGS results from the initial Bioneer IRONqPCR ™ RFIA Kit test result, as these tests will also be performed from the culture isolate (discordance may arise as a result of infections with a mix of different strains, with only one strain being grown out in culture). Furthermore, as all assays will be performed on the same culture, there is also no risk of any assay being tested on a different quality sample.
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.