Feng J N, Gao L, Sun Y X, Yang J C, Deng S W, Sun F, Zhan S Y
Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing 100191, China.
Beijing Da Xue Xue Bao Yi Xue Ban. 2020 Oct 20;53(2):320-326. doi: 10.19723/j.issn.1671-167X.2021.02.015.
To systematically review the diagnostic accuracy of Xpert /rifampicin (Xpert MTB/RIF) for the detection of active tuberculosis (TB) and rifampicin-resistance TB in Chinese patients.
Four Chinese databases (SinoMed, CNKI, WanFang database, and VIP) and three English databases (PubMed, Embase, and The Cochrane Library) were searched from January 1, 2000 to September 15, 2017, to identify diagnostic tests about the accuracy of Xpert MTB/RIF in Chinese patients. Two investigators screened the articles and extracted the information independently, and then the quality of each included study was evaluated by Quality Assessment of Diagnostic Accuracy Studies (QUADAS)-2. Bivariate random-effects meta-analysis was conducted to pool the sensitivity and specificity. In addition, subgroup analyses were performed based on patient type (TB patient and TB suspected patient), sample type (sputum, bronchoalveolar lavage fluid and others). All statistical analyses were conducted with Stata version 13.0.
A total of 47 articles were included in this systematic review. Most of them (38 articles) were in Chinese and only 9 articles were in English. All the articles were published during 2014 to 2017, and the sample size ranged from 31 to 3 151. Forty articles including 42 comparisons about TB were finally included with the pooled sensitivity of 0.94 (95%: 0.92, 0.95) and the pooled specificity of 0.87 (95%: 0.84, 0.91). Subgroup analysis showed that different patient and specimen types had no significant differences on sensitivity, but the specificity of sputum group was higher than that of bronchoalveolar lavage fluid. As for the detection of rifampicin-resistant TB, 33 articles (38 comparisons) were analyzed, the pooled sensitivity and specificity were 0.92 (95%: 0.89, 0.94) and 0.98 (95%: 0.97, 0.99) respectively. There were no significant differences between the patient and specimen in the subgroup analyses. The Deeks funnel plot showed a possible publication bias for detecting active tuberculosis (=0.08) and no publication bias for rifampicin-resistant TB (=0.24). The likelihood ratio scatter gram showed that in clinical applications, Xpert MTB/RIF had a good diagnostic ability for detecting active tuberculosis, and it had good clinical diagnostic value in detecting rifampicin-resistant TB.
Xpert MTB/RIF has good sensitivity and specificity in detecting TB and rifampicin-resistant TB in Chinese people. In particular, it has good clinical value in diagnosing rifampicin-resistance TB.
系统评价Xpert/利福平（Xpert MTB/RIF）检测中国患者活动性肺结核（TB）及耐利福平TB的诊断准确性。
检索2000年1月1日至2017年9月15日的四个中文数据库（中国生物医学文献数据库、中国知网、万方数据库和维普资讯网）和三个英文数据库（PubMed、Embase和考克兰图书馆），以识别关于Xpert MTB/RIF在中国患者中诊断准确性的诊断试验。两名研究者独立筛选文章并提取信息，然后采用诊断准确性研究质量评估（QUADAS）-2对每项纳入研究的质量进行评估。进行双变量随机效应荟萃分析以汇总敏感性和特异性。此外，根据患者类型（TB患者和疑似TB患者）、样本类型（痰液、支气管肺泡灌洗液等）进行亚组分析。所有统计分析均使用Stata 13.0版进行。
本系统评价共纳入47篇文章。其中大部分（38篇）为中文，仅9篇为英文。所有文章均发表于2014年至2017年，样本量从31至3151不等。最终纳入40篇文章，其中包括42项关于TB的比较，汇总敏感性为0.94（95%：0.92，0.95），汇总特异性为0.87（95%：0.84，0.91）。亚组分析显示，不同患者和标本类型的敏感性无显著差异，但痰液组的特异性高于支气管肺泡灌洗液组。对于耐利福平TB的检测，分析了33篇文章（38项比较），汇总敏感性和特异性分别为0.92（95%：0.89，0.94）和0.98（95%：0.97，0.99）。亚组分析中患者和标本之间无显著差异。Deeks漏斗图显示检测活动性肺结核可能存在发表偏倚（=0.08），而耐利福平TB不存在发表偏倚（=0.24）。似然比散点图显示，在临床应用中，Xpert MTB/RIF检测活动性肺结核具有良好的诊断能力，在检测耐利福平TB方面具有良好的临床诊断价值。
Xpert MTB/RIF检测中国人TB及耐利福平TB具有良好的敏感性和特异性。特别是在诊断耐利福平TB方面具有良好的临床价值。
