Microbiology Department, Pathology Division, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK.
Microbiology Department, Bart's Health NHS Trust, London, UK.
Syst Rev. 2017 Oct 25;6(1):215. doi: 10.1186/s13643-017-0608-2.
Rapid and accurate diagnosis of tuberculosis (TB) is key to manage the disease and to control and prevent its transmission. Many established diagnostic methods suffer from low sensitivity or delay of timely results and are inadequate for rapid detection of Mycobacterium tuberculosis (MTB) in pulmonary and extra-pulmonary clinical samples. This study examined whether a real-time polymerase chain reaction (RT-PCR) assay, with a turn-a-round time of 2 h, would prove effective for routine detection of MTB by clinical microbiology laboratories.
A systematic literature search was performed for publications in any language on the detection of MTB in pathological samples by RT-PCR assay. The following sources were used MEDLINE via PubMed, EMBASE, BIOSIS Citation Index, Web of Science, SCOPUS, ISI Web of Knowledge and Cochrane Infectious Diseases Group Specialised Register, grey literature, World Health Organization and Centres for Disease Control and Prevention websites. Forty-six studies met set inclusion criteria. Generated pooled summary estimates (95% CIs) were calculated for overall accuracy and bivariate meta-regression model was used for meta-analysis.
Summary estimates for pulmonary TB (31 studies) were as follows: sensitivity 0.82 (95% CI 0.81-0.83), specificity 0.99 (95% CI 0.99-0.99), positive likelihood ratio 43.00 (28.23-64.81), negative likelihood ratio 0.16 (0.12-0.20), diagnostic odds ratio 324.26 (95% CI 189.08-556.09) and area under curve 0.99. Summary estimates for extra-pulmonary TB (25 studies) were as follows: sensitivity 0.70 (95% CI 0.67-0.72), specificity 0.99 (95% CI 0.99-0.99), positive likelihood ratio 29.82 (17.86-49.78), negative likelihood ratio 0.33 (0.26-0.42), diagnostic odds ratio 125.20 (95% CI 65.75-238.36) and area under curve 0.96.
RT-PCR assay demonstrated a high degree of sensitivity for pulmonary TB and good sensitivity for extra-pulmonary TB. It indicated a high degree of specificity for ruling in TB infection from sampling regimes. This was acceptable, but may better as a rule out add-on diagnostic test. RT-PCR assays demonstrate both a high degree of sensitivity in pulmonary samples and rapidity of detection of 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 CRD42015027534 .
快速准确地诊断结核病（TB）是控制和预防其传播的关键。许多已建立的诊断方法存在敏感性低或结果延迟的问题，不适合快速检测肺部和肺部外临床样本中的结核分枝杆菌（MTB）。本研究旨在检验一种实时聚合酶链反应（RT-PCR）检测方法是否可通过临床微生物学实验室进行 MTB 的常规检测。
对任何语言发表的关于 RT-PCR 检测病理样本中 MTB 的文献进行了系统的文献检索。使用了以下来源：PubMed 中的 MEDLINE、EMBASE、BIOSIS 引文索引、Web of Science、SCOPUS、ISI Web of Knowledge 和 Cochrane 传染病组专业注册处、灰色文献、世界卫生组织和疾病控制与预防中心网站。46 项研究符合设定的纳入标准。对总体准确性进行了汇总摘要估计（95%CI）计算，并采用双变量荟萃回归模型进行荟萃分析。
对 31 项肺部结核病研究的汇总估计值如下：敏感性为 0.82（95%CI 0.81-0.83），特异性为 0.99（95%CI 0.99-0.99），阳性似然比为 43.00（28.23-64.81），阴性似然比为 0.16（0.12-0.20），诊断比值比为 324.26（95%CI 189.08-556.09），曲线下面积为 0.99。对 25 项肺部外结核病研究的汇总估计值如下：敏感性为 0.70（95%CI 0.67-0.72），特异性为 0.99（95%CI 0.99-0.99），阳性似然比为 29.82（17.86-49.78），阴性似然比为 0.33（0.26-0.42），诊断比值比为 125.20（95%CI 65.75-238.36），曲线下面积为 0.96。
RT-PCR 检测法对肺结核具有高度敏感性，对外周结核病也有良好的敏感性。它对 TB 感染的检出具有高度特异性，是从采样方案中排除 TB 感染的一种可行方法。这是可以接受的，但可能更好地作为一种排除附加诊断测试。RT-PCR 检测法在肺部样本中具有高度的敏感性和快速检测 TB 的能力，这是实现有效全球控制和患者管理的重要因素，有助于尽早开始和适当的抗结核治疗。
PROSPERO CRD42015027534。
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