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在参考实验室评估TB-LAMP测定

By LabMedica International staff writers
Posted on 01 May 2018
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图片:LAMP检验的结果显示阳性样本发出绿荧光(图片蒙创新诊断产品基金会惠赐)。
图片:LAMP检验的结果显示阳性样本发出绿荧光(图片蒙创新诊断产品基金会惠赐)。
涂片显微镜检是检测肺结核(TB)的一线检验,其灵敏度不高且波动剧烈,范围在30%到70%之间。在固体培养基上的常规培养法灵敏度为80%-90%,但是需要二至八周才能得到结果。
 
使用核酸扩增检验(NAAT)等分子方法也许能更快得出结果,且灵敏度和特异性高。新颖的环介导恒温扩增(LAMP)是一种诱人的诊断平台,因为它的运行时间不到两小时,只需很少的仪器,用肉眼能看到产生的荧光结果。
 
瑞士日内瓦创新诊断产品基金会(www.finddx.org)的科学家主持了一项大型多中心研究,他们收集了每人的两份痰样,样本来自秘鲁、南非、巴西和越南的参考实验室里有结核症状的参与者。用日本东京荣研化学株式会社(www.eiken.co.jp)的TB-LAMP测定检验每份痰样。参考标准包括四份直接涂片、四份培养物和临床观察结果与放射影像结果。8周后对常规检验阴性结果者进行随访。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测定检测新鲜样本或冷冻样本,与分子检验比对。
 
科研小组在2012年1月到12月共招募了1,036名疑似肺结核的成人。培养法证实了375例结核病例,涉及750份痰样,其中TB-LAMP检测到75.6% (95%置信区间(CI)为71.8–79.4%),包括97.9% (95% CI 96.4–99.4%)的涂片阳性结核样本及46.6% (95% CI 40.6–52.7%)的涂片阴性结核样本。477名培养物阴性者未接受结核处理(954份痰样),他们的特异性为98.7% (95% CI 97.9–99.6%)。0.3%的病例的TB-LAMP检验结果难下定论。
 
该研究的论文发表于2018年3月号的《国际传染病杂志》。作者总结说,这项研究发现TB-LAMP的实验室性能接近Xpert MTB/RIF的性能,建议在目标应用场景下做进一步研究,以评估这些预期优点。采用人工技术也许让TB-LAMP有望以低于自动化技术的成本进入市场。
 
Related Links:

创新诊断产品基金会>>> www.finddx.org

荣研化学株式会社>>> www.eiken.co.jp

Cepheid Inc >>> www.cepheid.com


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