Evaluation of Non-Inferiority of Two Fast Follower Nucleic Acid Amplification Tests for the Diagnosis of Pulmonary Tuberculosis in Comparison to Geneexpert MTB/RIF
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 504
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of Epistem Genedrive® MTB iD
研究概览
简要总结
Assess sensitivity and specificity of two nucleic acid amplification tests, namely Epistem Genedrive® and MolbioTruenat™ in raw sputum compared to the WHO-endorsed GeneXpert® MTB/RIF assay using a gold standard of four cultures
详细描述
- Estimate the accuracy of the Epistem Genedrive® and MolbioTruenat™ in raw sputum and in sputum pellets.
- Assess the operational feasibility of Epistem Genedrive® and MolbioTruenat™
- Determine and compare costs between the Epistem Genedrive®, MolbioTruenat™, and Xpert MTB/RIF tests
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •• Clinical suspicion of pulmonary TB (including cough ≥2 weeks and at least 1 other symptom typical of TB);
- •Age 18 years or above;
- •Willingness to have a study follow-up visit, if necessary, approximately two months after enrollment
- •Willingness to provide 3 sputum specimens at enrollment
- •Provision of informed consent.
排除标准
- •• Receipt of ≥48 cumulative hours OR three or more doses of anti-TB treatment (defined as combination anti-TB therapy intended to treat active TB) within 60 days prior to completion of sputum collection;
- •Inability to provide informed consent (e.g. mentally impaired)
- •Enrolled individuals who do not provide a first sputum sample of ≥ 2ml and a second and third sputum sample of ≥ 1ml each will be classified as early exclusions.
结局指标
主要结局
Sensitivity and specificity of Epistem Genedrive® MTB iD
时间窗: 4 months
Sensitivity and specificity of Epistem Genedrive® MTB iD Test on raw sputum before homogenization, homogenized raw sputum and sputum pellet against a gold standard of concentrated smear and four cultures.
Non-inferiority of tests
时间窗: 4 months
Non-inferiority of Epistem Genedrive® MTB iD Test and MolBio Truenat™ TB Assay to GeneXpert MTB/RIF using a non-inferiority margin of 5% for sensitivity in smear-positive, culture-positive; 7% for overall C+ sensitivity; and 3% for specificity in smear-negative, culture-negatives
Sensitivity and specificity of MolBio Truenat™ TB Assay
时间窗: 4 months
Sensitivity and specificity of MolBio Truenat™ TB Assay on homogenized raw sputum and sputum pellet against a gold standard of concentrated smear and four cultures.
次要结局
- Failure rate for the Epistem Genedrive® system assay and for the MolBio Truenat™ assay(10 months)
- Operational feasibility(10 months)
- Training needs for each assay(10 months)
- Cost-comparison between assays(10 months)