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.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,350
- 试验地点
- 5
- 主要终点
- Diagnostic accuracy for MTB detection
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
TB suspects
Sputum specimens will be collected from TB suspects enrolled in the study. The specimens will be tested with
- Bioneer Accupower Q-FRIA assay using the Iron q-PCR instrument (investigational product)
- Xpert MTB/RIF Ultra and Xpert MTB/XDR (comparators products)
干预措施: 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 (Diagnostic Test)
结局指标
主要结局
Diagnostic accuracy for MTB detection
时间窗: 8 months
Point estimates of sensitivity and specificity with 95% confidence intervals (CI) for MTB detection using culture as reference standard.
Diagnostic accuracy for isoniazid (INH), rifampicin (RIF), fluoroquinolone (FQ) and aminoglycoside (AMG) resistance detection
时间窗: 8 months
Point estimates of sensitivity and specificity with 95% CI for INH, RIF, FQ, and AMG resistance detection using phenotypic DST and sequencing as composite reference standard.
次要结局
- Compare the diagnostic accuracy of the Bioneer IRONqPCR ™ RFIA Kit for resistance detection to Xpert MTB/XDR(8 months)
- Compare the diagnostic accuracy of the Bioneer IRONqPCR ™ RFIA Kit for resistance detection to the GenoType MTBDRplus and MTBDRsl assays(8 months)
- Compare the diagnostic accuracy of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR for MTB detection to Xpert Ultra, using culture as the reference standard.(3 months)
- Compare the diagnostic accuracy of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR for RIF resistance detection to Xpert Ultra using a composite reference standard comprising phenotypic DST and targeted sequencing (subset of culture positive specimens)(8 months)
- Diagnostic accuracy of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR for resistance detection to the GenoType MTBDRplus and MTBDRsl assays using composite reference standard comprising phenotypic DST and targeted sequencing, on the subset of culture(8 months)
- Compare the diagnostic accuracy of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR for resistance detection to Xpert MTB/XDR using a composite reference standard comprising phenotypic(8 months)
- Assess the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR technical performance, including non-determinant rates.(8 months)