系统评价线探针检测在结核病和耐药结核病诊断中的应用。
Systematic evaluation of line probe assays for the diagnosis of tuberculosis and drug-resistant tuberculosis.
机构信息
Department of Clinical Laboratory Medicine, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou 510150, China; Department of Chinese and Western Medicine in Clinical Medicine, The Clinical School of Chinese and Western Medicine of Guangzhou Medical University, Guangzhou 511436, China.
Department of Chinese and Western Medicine in Clinical Medicine, The Clinical School of Chinese and Western Medicine of Guangzhou Medical University, Guangzhou 511436, China.
出版信息
Clin Chim Acta. 2022 Aug 1;533:183-218. doi: 10.1016/j.cca.2022.06.020. Epub 2022 Jul 2.
BACKGROUND
Line probe assays (LPAs) are PCR-based assays used for the rapid diagnosis of Mycobacterium tuberculosis (MTB) and drug-resistant tuberculosis (DR-TB). But studies on its performance are insufficient. Thus, in this study, we conducted a systematic review and meta-analysis to evaluate the effect of LPAs in the detection of MTB and drug-resistant TB in comparison with the traditional culture and DST methods.
METHODS
A systemic literature search was conducted on the Web of Science, Embase, PubMed, the Cochrane Library, Scopus, and OVID databases. All the included studies were classified according to different detecting objects. Sensitivity, specificity, Positive Likely Ratio (PLR), Negative Likely Ratio (NLR), Diagnostic Odds Ratio (DOR), corresponding 95% confidence interval, Area Under Curve (AUC), Deeks' funnel plot, and Bivariate Boxplot was used to do the evaluation.
RESULTS
147 studies included 491 datasets, with 182,448 samples, were incorporated into our analysis. The sensitivity (95% CI), specificity (95% CI), PLR, NLR, DOR and AUC for MTB were 0.89 (0.86 to 0.92), 0.94 (0.90 to 0.97), 15.70, 0.11, 139 and 0.96, respectively; for rifampicin-resistant TB were 0.96 (0.95 to 0.97), 0.99 (0.98 to 0.99), 82.9, 0.04, 1994 and 1.00, respectively; for isoniazid-resistant TB were 0.91 (0.89 to 0.93), 0.99 (0.98 to 0.99), 83.4, 0.09, (0.99 to 1.00), 195.7, 0.07, 2783 and 1.00, respectively; for Multi-drug resistant TB (MDR-TB) were 0.93 (0.90 to 0.95), 1.00 (0.99 to 1.00), 195.7, 0.07, 2783 and 1.00, respectively; for extensively drug-resistant TB (XDR-TB) were 0.60 (0.33 to 0.82), 1.00 (0.95 to 1.00), 291.3, 0.4, 726 and 0.95, respectively; for (second-line drug-resistant TB) SLID-TB were 0.83 (0.78 to 0.87), 0.98 (0.97 to 0.99), 44.6, 0.17, 262 and 0.98, respectively. Sensitivity in pre-extensively drug-resistant TB (Pre-XDR-TB) was 0.67, specificity was 0.91. No publication bias existed according to Deeks' funnel plot.
CONCLUSION
High diagnosis performance was confirmed in LPAs for the diagnosis of MTB and drug-resistant TB. LPAs might be a good alternative to culture and DST in detecting MTB, RR-TB, INH-TB, XDR-TB, SLID-TB, and MDR-TB. While more studies were still needed to explore the diagnosis performance of LPAs for Pre-XDR TB.
背景
线探针分析（LPA）是一种基于 PCR 的快速诊断方法，用于检测结核分枝杆菌（MTB）和耐药结核病（DR-TB）。但是，关于其性能的研究还不够充分。因此，在本研究中，我们进行了系统综述和荟萃分析，以评估 LPA 与传统培养和 DST 方法相比在检测 MTB 和耐药性结核病方面的效果。
方法
在 Web of Science、Embase、PubMed、Cochrane 图书馆、Scopus 和 OVID 数据库中进行了系统性文献检索。所有纳入的研究均根据不同的检测对象进行分类。使用敏感性、特异性、阳性似然比（PLR）、阴性似然比（NLR）、诊断优势比（DOR）、相应的 95%置信区间、曲线下面积（AUC）、Deeks 漏斗图和双变量 Boxplot 进行评估。
结果
共纳入 147 项研究，包含 491 个数据集，共 182448 个样本。MTB 的敏感性（95%CI）、特异性（95%CI）、PLR、NLR、DOR 和 AUC 分别为 0.89（0.86 至 0.92）、0.94（0.90 至 0.97）、15.70、0.11、139 和 0.96；利福平耐药性结核病（RR-TB）的敏感性（95%CI）、特异性（95%CI）、PLR、NLR、DOR 和 AUC 分别为 0.96（0.95 至 0.97）、0.99（0.98 至 0.99）、82.9、0.04、1994 和 1.00；异烟肼耐药性结核病（INH-TB）的敏感性（95%CI）、特异性（95%CI）、PLR、NLR、DOR 和 AUC 分别为 0.91（0.89 至 0.93）、0.99（0.98 至 0.99）、83.4、0.09、（0.99 至 1.00）、195.7、0.07、2783 和 1.00；耐多药结核病（MDR-TB）的敏感性（95%CI）、特异性（95%CI）、PLR、NLR、DOR 和 AUC 分别为 0.93（0.90 至 0.95）、1.00（0.99 至 1.00）、195.7、0.07、2783 和 1.00；广泛耐药结核病（XDR-TB）的敏感性（95%CI）、特异性（95%CI）、PLR、NLR、DOR 和 AUC 分别为 0.60（0.33 至 0.82）、1.00（0.95 至 1.00）、291.3、0.4、726 和 0.95；二线药物耐药结核病（SLID-TB）的敏感性（95%CI）、特异性（95%CI）、PLR、NLR、DOR 和 AUC 分别为 0.83（0.78 至 0.87）、0.98（0.97 至 0.99）、44.6、0.17、262 和 0.98。在耐多药结核病前阶段（Pre-XDR-TB）的敏感性为 0.67，特异性为 0.91。Deeks 漏斗图未显示存在发表偏倚。
结论
LPA 对 MTB 和耐药性结核病的诊断具有较高的诊断性能。LPA 可能是培养和 DST 检测 MTB、RR-TB、INH-TB、XDR-TB、SLID-TB 和 MDR-TB 的良好替代方法。但是，仍然需要更多的研究来探索 LPA 在检测 Pre-XDR-TB 方面的诊断性能。
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