环介导等温扩增法检测临床标本中结核分枝杆菌的系统评价

doi:10.3969/j.issn.1000-6621.2014.04.008

摘要/Abstract

摘要： 目的采用Meta分析的方法评价环介导等温扩增法（LAMP）检测临床标本中结核分枝杆菌的准确性。方法通过检索PubMed、Embase、Web of Science、Cochrane Library、CNKI、万方、维普数据库广泛收集文献，根据QUADAS质量评价标准评价纳入文献的质量，最终纳入16篇相关文献,共计18项研究。应用Meta-Disc 软件对环介导等温扩增法检测临床标本中结核分枝杆菌的敏感度、特异度、诊断比值比进行合并分析，对纳入的研究绘制受试者工作特征曲线。对纳入的研究进行异质性检验，采用Meta回归分析异质性的来源。Meta回归会生成相对诊断比值比（relative diagnostic odds ratios，RDOR）。当RDOR＞1.0，表明某个研究特征比没有这个特征的诊断准确性要高。结果最终纳入16篇文献，共计18项研究综合分析所有数据，合并敏感度为0.91（95%CI：0.90～0.93）；合并特异度为0.97（95%CI：0.96～0.97）；合并诊断比值比为283.02（95%CI：157.37～509.00）；受试者工作曲线曲线下面积为0.9829。研究间异质性来源与结果判断相关，紫外灯判读试验的精确性比肉眼判读试验的精确性高5.66倍(RDOR=5.66,95%CI：1.32～24.22,P=0.0225)。结论对纳入的研究分析证实，环介导等温扩增法检测临床标本中的结核分枝杆菌的敏感度和特异度很高，表明该方法在结核病的快速诊断方面具有优势。

关键词: 分枝杆菌, 结核, 核酸扩增技术, 敏感性与特异性

Abstract: Objective To evaluate the diagnostic accuracy of loop-mediated isothermal amplification (LAMP) in detecting Mycobacterium tuberculosis in clinical samples. Methods A fully recursive literature search was conducted by searching PubMed, Embase, Web of Science，Cochrane Library, CNKI，Wanfang and VIP databases. QUADAS criteria were used to evaluate the quality of the included studies, and Meta-Disc software was used to analyze data collected from the included studies. Sensitivity, specificity and summary receiver operator characteristic curve （SROC）were chosen as the indicators to assess the diagnostic accuracy of every individual diagnostic test. Heterogeneity between the individual studies was analysed by Meta regression. Results A total of 16 articles which including 18 studies were enrolled in the assay. Meta-analysis showed that the pooled sensitivity of LAMP was 0.91（95%CI 0.90-0.93）, the pooled specificity was 0.97（95%CI 0.96-0.97）, the pooled diagnostic odds (DOR) was 283.02（95%CI 157.37-509.00），the area below SROC curve(AUC) was 0.9829.Meta regression analysis showed that the studies with result interpretation by UV light have 5.66(RDOR=5.66,95%CI：1.32-24.22, P=0.0225) RDOR than the studies with result interpretation by naked eyes. Conclusion The conducted researches confirm that LAMP assay is a highly specific test for the detection of Mycobacterium tuberculosis from clinical samples and has a potential in improving the diagnostic accuracy of in detecting Mycobacterium tuberculosis.

Key words: Mycobacterium tuberculosis, Nucleic acid amplication techniques, Sensitivity and specificity

于霞，马异峰，付育红，刘冠，王晓波，黄海荣. 环介导等温扩增法检测临床标本中结核分枝杆菌的系统评价[J]. 中国防痨杂志, 2014, 36(4): 260-266. doi: 10.3969/j.issn.1000-6621.2014.04.008

YU Xia, MA Yi-feng, FU Yu-hong, LIU Guan, WANG Xiao-bo, HUANG Hai-rong. Loop-mediated isothermal amplification assay for detection of Mycobacterium tuberculosis in clinical specimens: a systemtic review[J]. Chinese Journal of Antituberculosis, 2014, 36(4): 260-266. doi: 10.3969/j.issn.1000-6621.2014.04.008

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