Liverpool John Moores University-City Campus, Liverpool, Merseyside, UK.
Syst Rev. 2021 Oct 27;10(1):278. doi: 10.1186/s13643-021-01836-w.
Rapid and accurate diagnosis of paediatric tuberculosis (TB) is key to manage the disease and to control and prevent its transmission. Collection of quality sputum samples without invasion methods from paediatrics (age < 16 years) with presumptive pulmonary tuberculosis (PTB) remains a challenge. Thus, the aim of this meta-analysis was to assess the overall accuracy of a real-time polymerase chain reaction (RT-PCR)-based assay, for routine diagnosis of MTB in different samples from paediatrics with active pulmonary and extra-pulmonary tuberculosis using mycobacterial culture as the gold standard in clinical microbiology laboratories.
We conducted a systematic review and meta-analysis to examine the diagnostic test accuracy of RT-PCR based assay for the detection of MTB in paediatric clinical samples. A systematic literature search was performed for publications in any language. MEDLINE via PubMed, EMBASE, and Web of Science were among 9 bibliographic databases searched from August 2019 until November 2020. Bivariate random-effects model of meta-analysis were performed to generate pooled summary estimates (95% CIs) for overall accuracy of RT-PCR based assay compared to mycobacterial culture as the reference standard.
Of the 1592 candidate studies, twenty-one eligible studies met our inclusion criteria. In total, the review and meta-analysis included 5536 (3209 PTB and 2327 EPTB). Summary estimates for pulmonary TB (11 studies) were as follows: sensitivity 56 (95% CI 51-62), specificity 97 (95% CI 96-98) and summary estimates for extra-pulmonary TB (10 studies) were as follows: sensitivity 87 (95% CI 82-91)) specificity 100 (95% CI 99-100). There was significant heterogeneity in sensitivity and specificity among the enrolled studies (p < 0.001).
Our results suggested that the RT-PCR based assay could be a useful test for the diagnosis of paediatrics TB with high sensitivity and specificity in low-income/high-burden and upper medium income/low-burden settings. From the study, RT-PCR assay demonstrated a high degree of sensitivity for extra-pulmonary TB and good sensitivity for pulmonary TB which is an important factor in achieving effective global control and for patient management in terms of initiating early and appropriate anti-tubercular therapy.
PROSPERO CRD42018104052.
快速准确地诊断儿童结核病（TB）是管理该疾病以及控制和预防其传播的关键。从疑似肺结核（PTB）的儿科患者（年龄<16 岁）中采集无侵入性方法的高质量痰液样本仍然是一个挑战。因此，本荟萃分析的目的是评估实时聚合酶链反应（RT-PCR）检测基于 MTB 在儿科患者的肺部和肺外活动性肺结核中的不同样本中的总体准确性，使用分枝杆菌培养作为临床微生物学实验室的金标准。
我们进行了系统评价和荟萃分析，以检查 RT-PCR 检测基于 MTB 在儿科临床样本中的检测的诊断测试准确性。以任何语言发表的出版物均进行了系统的文献检索。MEDLINE 通过 PubMed、EMBASE 和 Web of Science 等 9 个书目数据库进行了搜索，从 2019 年 8 月至 2020 年 11 月进行了搜索。采用双变量随机效应模型荟萃分析，生成 RT-PCR 检测基于 MTB 与分枝杆菌培养作为参考标准的总体准确性的汇总估计值（95%CI）。
在 1592 个候选研究中，有 21 项符合纳入标准的研究。共有 5536 例（3209 例 PTB 和 2327 例 EPTB）纳入综述和荟萃分析。11 项研究对肺结核（TB）的汇总估计值如下：敏感性 56（95%CI 51-62），特异性 97（95%CI 96-98），10 项研究对肺外结核（EPTB）的汇总估计值如下：敏感性 87（95%CI 82-91），特异性 100（95%CI 99-100）。纳入研究的敏感性和特异性存在显著异质性（p<0.001）。
我们的研究结果表明，RT-PCR 检测在中低收入/高负担和中上收入/低负担环境中，可用于儿科结核病的诊断，具有较高的敏感性和特异性。从研究中可以看出，RT-PCR 检测对肺外结核病具有很高的敏感性，对肺结核也具有良好的敏感性，这是实现有效全球控制和启动早期、适当抗结核治疗的重要因素。
PROSPERO CRD42018104052。
