Department of Pediatrics, Severance Children's Hospital, Yonsei University College of Medicine, Seoul, Korea.
Biostatistics Collaboration Unit, Department of Biomedical Systems Informatics, Yonsei University College of Medicine, Seoul, Korea.
PLoS One. 2020 Mar 17;15(3):e0230338. doi: 10.1371/journal.pone.0230338. eCollection 2020.
The aim of this study was to evaluate the diagnostic performance of immunochromatographic tests (ICTs) for the detection of Mycoplasma pneumoniae. Medline/Pubmed, Embase, the Cochrane Library, and ISI Web of Science were searched through June 12, 2019 for relevant studies that used ICTs for the detection of M. pneumoniae infection with polymerase chain reaction (PCR) or microbial culturing as reference standards. Pooled diagnostic accuracy with 95% confidence interval (CI) was calculated using a bivariate random effects model. We also constructed summary receiver operating characteristic curves and calculated the area under the curve (AUC). Statistical heterogeneity was evaluated by χ2 test or Cochrane's Q test. Thirteen studies including 2,235 samples were included in the meta-analysis. The pooled sensitivity and specificity for diagnosing M. pneumoniae infection were 0.70 (95% CI: 0.59-0.79) and 0.92 (95% CI: 0.87-0.95), respectively. The positive likelihood ratio (LR) was 8.94 (95% CI: 4.90-14.80), negative LR 0.33 (95% CI: 0.22-0.46), diagnostic odds ratio 29.20 (95% CI: 10.70-64.20), and AUC 0.904. In subgroup analysis, ICTs demonstrated similar pooled sensitivities and specificities in populations of children only and mixed populations (children + adults). Specimens obtained from oropharyngeal swabs exhibited a higher sensitivity and specificity than those of nasopharyngeal swab. Moreover, pooled estimates of sensitivity and accuracy for studies using PCR as a reference standard were higher than those using culture. The pooled sensitivity and specificity of Ribotest Mycoplasma®, the commercial kit most commonly used in the included studies, were 0.66 and 0.89, respectively. Overall, ICT is a rapid user-friendly method for diagnosing M. pneumoniae infection with moderate sensitivity, high specificity, and high accuracy. This suggests that ICT may be useful in the diagnostic workup of M. pneumoniae infection; however, additional studies are needed for evaluating the potential impact of ICT in clinical practice.
本研究旨在评估免疫层析试验(ICTs)检测肺炎支原体的诊断性能。通过 2019 年 6 月 12 日之前的 Medline/Pubmed、Embase、Cochrane 图书馆和 ISI Web of Science 搜索,使用 ICTs 检测肺炎支原体感染的相关研究,以聚合酶链反应(PCR)或微生物培养作为参考标准。使用双变量随机效应模型计算具有 95%置信区间(CI)的汇总诊断准确性。我们还构建了汇总受试者工作特征曲线并计算曲线下面积(AUC)。使用 χ2 检验或 Cochrane 的 Q 检验评估统计异质性。纳入的 13 项研究共包括 2235 个样本。诊断肺炎支原体感染的汇总敏感性和特异性分别为 0.70(95%CI:0.59-0.79)和 0.92(95%CI:0.87-0.95)。阳性似然比(LR)为 8.94(95%CI:4.90-14.80),阴性 LR 为 0.33(95%CI:0.22-0.46),诊断比值比为 29.20(95%CI:10.70-64.20),AUC 为 0.904。在亚组分析中,仅儿童人群和混合人群(儿童+成人)的 ICT 显示出相似的汇总敏感性和特异性。从口咽拭子获得的标本比鼻咽拭子的敏感性和特异性更高。此外,使用 PCR 作为参考标准的研究的汇总敏感性和准确性估计值高于使用培养的研究。在纳入的研究中最常用的商业试剂盒 Ribotest Mycoplasma®的汇总敏感性和特异性分别为 0.66 和 0.89。总体而言,ICT 是一种快速易用的方法,用于诊断肺炎支原体感染,具有中等敏感性、高特异性和高准确性。这表明 ICT 可能对肺炎支原体感染的诊断有帮助;但是,需要进一步的研究来评估 ICT 在临床实践中的潜在影响。