Multi-center Study to Assess the Non-inferiority of YD REBA MTB-MDR® and Hain GenoType® MTBDRplus V2 Line Probe Assays Compared to Hain GenoType® MTBDRplus V1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 888
- 主要终点
- INH/RIF Resistance Detection
研究概览
简要总结
This is a multi-center, blinded study to determine the performance of the YD Diagnostic Corporation (YD) REBA MTB-MDR® and Hain Genotype MTBDRplus V2 kit in a total of 600 clinical isolates and 900 residual sputum samples from patients with symptoms of pulmonary TB (PTB) and at risk of drug resistance. All testing was done on stored, de-identified leftover samples.
The study involved three World Health Organization (WHO) Supranational Reference Laboratories with well-characterized strain collections and access to sputum samples with significant rates of drug resistance.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
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
- •Age over 18 years
- •Informed consent
- •Patients evaluated for pulmonary TB
排除标准
- 未提供
研究组 & 干预措施
All Subjects
All strains in Phase 1 and all Sputum samples in Phase 2 were tested with Hain Genotype MTBDRplus V1, Hain Genotype MTBDRplus V2, and YD REBA MTB-MDR diagnostic tests.
Investigators and Operators were blinded to all other results for a sample upon data entry.
干预措施: YD REBA MTB-MDR (Device)
All Subjects
All strains in Phase 1 and all Sputum samples in Phase 2 were tested with Hain Genotype MTBDRplus V1, Hain Genotype MTBDRplus V2, and YD REBA MTB-MDR diagnostic tests.
Investigators and Operators were blinded to all other results for a sample upon data entry.
干预措施: Hain Genotype MTBDRplus V1 (Device)
All Subjects
All strains in Phase 1 and all Sputum samples in Phase 2 were tested with Hain Genotype MTBDRplus V1, Hain Genotype MTBDRplus V2, and YD REBA MTB-MDR diagnostic tests.
Investigators and Operators were blinded to all other results for a sample upon data entry.
干预措施: Hain Genotype MTBDRplus V2 (Device)
结局指标
主要结局
INH/RIF Resistance Detection
时间窗: At the end of study 9-10 Months after the Study started
次要结局
- Multi-Drug Resistant TB detection(At the end of study 9-10 Months after the Study started)