Department of General Medicine, Royal Children's Hospital, Melbourne, Australia;
Clinical Epidemiology and Biostatistics Unit.
Pediatrics. 2014 Oct;134(4):771-81. doi: 10.1542/peds.2014-1094. Epub 2014 Sep 8.
Effective management of group A streptococcal (GAS) pharyngitis is hindered by impracticality of the gold standard diagnostic test: throat culture. Rapid antigen diagnostic tests (RADTs) are a promising alternative, although concerns about their sensitivity and specificity, and variation between test methodologies, have limited their clinical use. The objective of this study was to perform a systematic review with meta-analysis of the diagnostic accuracy of RADTs for GAS pharyngitis.
Medline and Embase from 1996 to 2013 were used as data sources. Of 159 identified studies, 48 studies of diagnostic accuracy of GAS RADTs using throat culture on blood agar as a reference standard were selected. Bivariate random-effects regression was used to estimate sensitivity and specificity with 95% confidence intervals (CIs). Additional meta-analyses were performed for pediatric data.
A total of 60 pairs of sensitivity and specificity from 48 studies were included. Overall summary estimates for sensitivity and specificity of RADTs were 0.86 (95% CI 0.83 to 0.88) and 0.96 (95% CI 0.94 to 0.97), respectively, and estimates for pediatric data were similar. Molecular-based RADTs had the best diagnostic accuracy. Considerable variability exists in methodology between studies. There were insufficient studies to allow meta-regression/subgroup analysis within each test type.
RADTs can be used for accurate diagnosis of GAS pharyngitis to streamline management of sore throat in primary care. RADTs may not require culture backup for negative tests in most low-incidence rheumatic fever settings. Newer molecular tests have the highest sensitivity, but are not true point-of-care tests.
由于金标准诊断试验(咽拭子培养)不切实际,导致 A 组链球菌(GAS)咽炎的管理效果不佳。快速抗原诊断试验(RADT)是一种很有前途的替代方法,尽管人们对其敏感性和特异性以及不同试验方法之间的差异存在担忧,但这限制了它们在临床上的应用。本研究旨在对 RADT 诊断 GAS 咽炎的准确性进行系统评价和荟萃分析。
使用 1996 年至 2013 年的 Medline 和 Embase 作为数据来源。在 159 项已确定的研究中,选择了 48 项使用血琼脂培养作为参考标准的 GAS RADT 诊断准确性研究。使用双变量随机效应回归来估计敏感性和特异性,并计算 95%置信区间(CI)。还对儿科数据进行了额外的荟萃分析。
共纳入 48 项研究中的 60 对敏感性和特异性。RADT 的总体汇总敏感性和特异性估计值分别为 0.86(95%CI 0.83 至 0.88)和 0.96(95%CI 0.94 至 0.97),儿科数据的估计值也相似。基于分子的 RADT 具有最佳的诊断准确性。研究之间的方法学存在很大差异。没有足够的研究允许在每种试验类型内进行 meta 回归/亚组分析。
RADT 可用于准确诊断 GAS 咽炎,从而简化基层医疗保健中咽痛的管理。在大多数风湿热发病率较低的环境中,对于阴性试验,RADT 可能不需要进行培养作为后备。较新的分子检测具有最高的敏感性,但不是真正的即时检测。