评估肺结核的快速诊断检验
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By LabMedica International staff writers Posted on 02 May 2018 |
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图片：Xpert MTB/RIF试剂载入GeneXpert 4模块仪器（图片蒙Cepheid公司惠赐）。
在资源有限的场合诊断涂片阴性肺结核与肺外结核(TB)仍是一项挑战。确认涂片阴性与肺外结核病例需要阳性的结核分枝杆菌培养物，需要长达八周时间制备。
研究人员评估了是否能实现用商用的快速分子诊断检验日常诊断涂片阴性或肺外的结核，评估了其诊断准确度，还评估了现实场合HIV的患病率。
一组来自多国的科学家与瑞士日内瓦大学医院(www.hug-ge.ch)的科学家合作，在两年期间开展了一项前瞻性队列研究，相继纳入了疑似涂片阴性肺结核/肺外结核的所有病例。将病例分为四类：确实、很可能、可能有结核或有其它诊断结果。在马达加斯加的一家当地医院对疑似肺结核患者的痰液样本进行齐尔-尼尔森染色后直接做显微镜检。
来自肺结核患者和肺外结核患者的所有的抗酸杆菌(AFB)阴性涂片都被送到结核分枝杆菌实验室做二次涂片检查、培养，并用美国加利福尼亚州森尼韦尔市Cepheid股份有限公司(www.cepheid.com)的Xpert MTB/RIF进行筛查。生物液（脑脊液、腹膜液、胸腔积液）的标准分析（细胞学分析与生化分析），还对组织样本（淋巴结、皮肤活检样本、胸腔活检样本和滑膜活检样本）做了病理检查。对所有患者进行HIV血清检验。通过三种不同的构象快速检验证实了HIV的状态。
科学家发现，纳入研究的363名患者中，183人(50.4%)有疑似的涂片阴性肺结核，180人(49.6%)有疑似的肺外结核。用Xpert MTB/RIF检测经过证实的病例，灵敏度、特异性、阳性预测值、阴性预测值分别为82.4%、98.8%、98.3%和86.6%；如果把经过证实的病例和可能性大的病例一起算，这些值分别为65%、98.8%、98.5%和64%。肺外结核的诊断准确度略低于涂片阴性的肺结核。HIV感染的患病率为12.1%，但是几乎半数病例没有结核（其它诊断结果组）。
该研究的论文发表于2018年4月号的《国际传染病杂志》(International Journal of Infectious Diseases)。作者总结说，在资源贫乏场合实施结核的快速诊断是可行的。Xpert-MTB/RIF检测难诊人群的性能十分突出。这项研究得出的HIV患病率远高于所报的马达加斯加大众的患病率、结核患者的患病率以及结核以外病症患者的患病率。
日内瓦大学医院>>> www.hug-ge.ch
Cepheid >>> www.cepheid.com
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