现场评估一个现场检测活跃结核病 (TriageTB) 的临床诊断试验
Tracy R Richardson1, Bronwyn Smith2, Stephanus T Malherbe2
1Stellenbosch University, Cape Town, South Africa. cummins@sun.ac.za.
BMC infectious diseases
|July 3, 2023
概括
这项研究旨在开发和验证结核病 (TB) 诊断的临床多生物标志物测试. 新的测试可以显著减少不必要的确认测试,改善资源使用和患者护理.
科学领域:
- 传染性疾病 传染性疾病
- 生物标志物发现发现
- 诊断发展 诊断发展
背景情况:
- 世界卫生组织 (WHO) 建议用于结核病 (TB) 诊断的非唾液基分拣试验.
- 主体生物标志物测试显示出排除活跃结核病的可能性,但普遍性需要进一步研究.
- 这项TriageTB研究旨在验证一个临床多生物标志物测试 (MBT).
研究的目的:
- 评估活跃肺结核 (TB) 的诊断试验候选人的准确性.
- 进行现场测试,最终确定设计,并验证护理点多生物标志物测试 (MBT).
- 满足或超过世界卫生组织针对结核病分类测试的目标产品概况 (90%的灵敏度,70%的特异性).
主要方法:
- 观察性诊断研究,评估生物标志物候选者的敏感性和特异性.
- 与黄金标准复合结核病结果分类的比较.
- 两个阶段的设计:第一阶段用于MBT的最终确定,第二阶段用于高结核病流行地 (南非,乌干达,冈比亚,越南) 的验证.
主要成果:
- 这项研究旨在确定具有高灵敏度和特异性的护理点测试.
- 成功验证可以避免75%的负面GeneXpert Ultra (GXPU) 测试.
- 减少确认性测试预计将降低诊断成本和患者损失.
结论:
- 定位确认性结核病检测,以积极的分拣结果,可以提高资源利用率.
- 通过有效的分类测试来简化结核病诊断,可以提高整体结核病护理.
- 经过验证的MBT预计将达到或超过世界卫生组织对结核病选试验的最低性能标准.
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