Two-site Laboratory-based Diagnostic Accuracy and Feasibility Study of the Xpert MTB/XDR Assay for Detection of Isoniazid, Fluoroquinolone, Ethionamide and Second-line Injectable Anti-tuberculosis Drug Resistance
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 753
- 试验地点
- 2
- 主要终点
- Sensitivity and specificity of Xpert MTB/XDR assay
研究概览
简要总结
The Cepheid Xpert MTB/XDR cartridge, which runs on the same platform as Xpert MTB/RIF Ultra, has been developed to detect additional resistance to isoniazid, fluoroquinolones and second-line injectable anti-tuberculosis drugs and provides results within 2 hours and on primary samples. An evaluation of the the Xpert MTB/XDR assay is currently underway in clinical settings in South Africa, India and Moldova. The TB-CAPT MTB/XDR Study will add further diagnostic accuracy and feasibility data to the evidence base for the Xpert MTB/XDR assay.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mtb-positive, rifampicin-resistant respiratory specimen identified on Xpert MTB/RIF Ultra
排除标准
- •Residual SR-sputum mix not retained or not found
- •Patient previously included in the study
- •Exclusion for diagnostic accuracy and time-to-result endpoints:
- •Insufficient residual SR-sputum mix remaining for Xpert MTB/XDR (<2 ml)
- •Xpert MTB/XDR unsuccessful
- •No second / follow-up specimen received
- •Second / follow-up specimen culture-negative, contaminated or not available
- •Reference standard uninterpretable (phenotyping or WGS)
- •Where phenotypic susceptibility testing results are uninterpretable, specimens will still be included in WGS comparison
- •Where WGS results are uninterpretable, specimens will still be included in phenotypic susceptibility testing comparison
结局指标
主要结局
Sensitivity and specificity of Xpert MTB/XDR assay
时间窗: enrolment
Sensitivity and specificity of Xpert MTB/XDR assay vs. the composite reference standard for detection of resistance to Isoniazid, Fluoroquinolones, Ethionamide, Second-line injectable anti-tuberculosis drugs
次要结局
- Sensitivity and specificity of Xpert MTB/XDR assay compared to phenotypic anti-tuberculosis drug susceptibility testing and WGS separately(enrolment)