在低患病率环境中进行结核病初始诊断的分子试验:一项比较研究
Ana Fernández-Blázquez1, Álvaro Leal-Negredo1, Christian Sabater-Cabrera1
1Regional Mycobacteria Reference Unit, Microbiology Laboratory, Central University Hospital of Asturias, Oviedo, Asturias, Spain; Health Research Institute of the Principality of Asturias, Translational Microbiology Group (ISPA), Oviedo, Asturias, Spain.
概括
快速分子分析,如实时聚合酶链反应 (RT-PCR),显著提高结核病 (TB) 初始诊断的准确性. 这些测试提供了更好的灵敏度和特异性,帮助全球减少结核病的努力.
科学领域:
- 临床微生物学 临床微生物学
- 分子诊断学 分子诊断学
- 传染病流行病学 传染病流行病学
背景情况:
- 世界卫生组织的结核病终结战略倡导在初步结核病诊断中进行快速分子测试.
- 这项研究评估了商业分子平台在低流行环境下诊断结核病 (TB) 的有效性.
研究的目的:
- 评估各种商业实时聚合酶链反应 (RT-PCR) 测定用于结核病诊断的有效性.
- 将五种不同的RT-PCR平台的性能与培养结果进行比较.
主要方法:
- 100个临床样本 (80个呼吸道,20个非呼吸道) 的前性分析.
- 使用五种RT-PCR试验进行盲测并行测试:Xpert-MTB/Rif-Ultra,BDMAX-MDR-TB,实时MTB,型MTBDR和Anyplex-MTB/NTM.
- 计算灵敏度,特异性,概率比率和科恩的卡帕来评估准确性和与文化的一致性.
主要成果:
- RT-PCR测定显示出高灵敏度 (88.89-100%) 和特异性 (96.70-98.98%).
- 与传统方法相比,初始查准确度提高了30-40%.
- 观察到优异的区分能力,结核病患者通过RT-PCR检测阳性的可能性是26.9-91.0倍.
- 在RT-PCR和培养结果之间存在实质性至优异的一致性 (科恩卡帕:0.78-0.94).
结论:
- 实时聚合酶链反应 (RT-PCR) 显著提高了结核病的初始诊断.
- 这些分子平台为各种实验室环境提供灵活,定制的解决方案.
- 采用RT-PCR可以彻底改变全球结核病控制策略.
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