基于各种标本的 Xpert 在结核病诊断中的疗效：系统评价和荟萃分析。

Efficacy of Xpert in tuberculosis diagnosis based on various specimens: a systematic review and meta-analysis.

机构信息

Department of Pediatrics, Ministry of Education Key Laboratory of Women and Children's Diseases and Birth Defects, West China Second University Hospital, Sichuan University, Chengdu, Sichuan, China.

出版信息

Front Cell Infect Microbiol. 2023 May 2;13:1149741. doi: 10.3389/fcimb.2023.1149741. eCollection 2023.

DOI:10.3389/fcimb.2023.1149741

PMID:37201118

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10185844/

Abstract

OBJECTIVE

The GeneXpert MTB/RIF assay (Xpert) is a diagnostic tool that has been shown to significantly improve the accuracy of tuberculosis (TB) detection in clinical settings, with advanced sensitivity and specificity. Early detection of TB can be challenging, but Xpert has improved the efficacy of the diagnostic process. Nevertheless, the accuracy of Xpert varies according to different diagnostic specimens and TB infection sites. Therefore, the selection of adequate specimens is critical when using Xpert to identify suspected TB. As such, we have conducted a meta-analysis to evaluate the effectiveness of Xpert for diagnosis of different TB types using several specimens.

METHODS

We conducted a comprehensive search of several electronic databases, including PubMed, Embase, the Cochrane Central Register of Controlled Trials, and the World Health Organization clinical trials registry center, covering studies published from Jan 2008 to July 2022. Data were extracted using an adapted version of the Checklist for Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modeling Studies. Where appropriate, meta-analysis was performed using random-effects models. The risk of bias and level of evidence was assessed using the Quality in Prognosis Studies tool and a modified version of the Grading of Recommendations Assessment, Development, and Evaluation. RStudio was utilized to analyze the results, employing the , , and packages.

RESULTS

After excluding duplicates, a total of 2163 studies were identified, and ultimately, 144 studies from 107 articles were included in the meta-analysis based on predetermined inclusion and exclusion criteria. Sensitivity, specificity and diagnostic accuracy were estimated for various specimens and TB types. In the case of pulmonary TB, Xpert using sputum (0.95 95%CI 0.91-0.98) and gastric juice (0.94 95%CI 0.84-0.99) demonstrated similarly high sensitivity, surpassing other specimen types. Additionally, Xpert exhibited high specificity for detecting TB across all specimen types. For bone and joint TB, Xpert, based on both biopsy and joint fluid specimens, demonstrated high accuracy in TB detection. Furthermore, Xpert effectively detected unclassified extrapulmonary TB and tuberculosis lymphadenitis. However, the Xpert accuracy was not satisfactory to distinguish TB meningitis, tuberculous pleuritis and unclassified TB.

CONCLUSIONS

Xpert has exhibited satisfactory diagnostic accuracy for most TB infections, but the efficacy of detection may vary depending on the specimens analyzed. Therefore, selecting appropriate specimens for Xpert analysis is essential, as using inadequate specimens can reduce the ability to distinguish TB.

SYSTEMATIC REVIEW REGISTRATION

https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=370111, identifier CRD42022370111.

摘要

目的

GeneXpert MTB/RIF 检测（Xpert）是一种诊断工具，已被证明可显著提高临床环境中结核病（TB）检测的准确性，具有较高的灵敏度和特异性。早期检测 TB 具有挑战性，但 Xpert 提高了诊断过程的效果。然而，Xpert 的准确性因不同的诊断标本和 TB 感染部位而异。因此，在使用 Xpert 识别疑似 TB 时，选择合适的标本至关重要。为此，我们进行了一项荟萃分析，以评估使用多种标本时 Xpert 对不同类型 TB 的诊断效果。

方法

我们全面检索了多个电子数据库，包括 PubMed、Embase、Cochrane 对照试验中心注册库和世界卫生组织临床试验注册中心，涵盖了 2008 年 1 月至 2022 年 7 月发表的研究。使用适应性检查表提取数据，用于系统评价预测模型研究的关键评估和数据提取。在适当的情况下，使用随机效应模型进行荟萃分析。使用预后研究质量工具和改良版推荐评估、制定和评价（GRADE）对偏倚风险和证据水平进行评估。使用 RStudio 分析结果，使用、和包。

结果

排除重复项后，共识别出 2163 项研究，最终根据预先确定的纳入和排除标准，从 107 篇文章中的 144 项研究纳入荟萃分析。为各种标本和 TB 类型估计了敏感性、特异性和诊断准确性。对于肺结核，使用痰（0.95，95%CI：0.91-0.98）和胃液（0.94，95%CI：0.84-0.99）的 Xpert 显示出相似的高灵敏度，超过了其他标本类型。此外，Xpert 对所有标本类型的 TB 检测均具有较高的特异性。对于骨和关节结核，基于活检和关节液标本的 Xpert 显示出对 TB 检测的高准确性。此外，Xpert 可有效检测未分类的肺外 TB 和结核性淋巴结炎。然而，Xpert 对区分结核性脑膜炎、结核性胸膜炎和未分类 TB 的准确性并不理想。