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呼吸道合胞病毒感染快速抗原检测试验的诊断准确性:系统评价与荟萃分析

Diagnostic Accuracy of Rapid Antigen Detection Tests for Respiratory Syncytial Virus Infection: Systematic Review and Meta-analysis.

作者信息

Chartrand Caroline, Tremblay Nicolas, Renaud Christian, Papenburg Jesse

机构信息

Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Montreal, QC, Canada.

Unité d'immunovirologie moléculaire, Centre de recherche du Centre hospitalier de l'Université de Montréal, Montreal, QC, Canada.

出版信息

J Clin Microbiol. 2015 Dec;53(12):3738-49. doi: 10.1128/JCM.01816-15. Epub 2015 Sep 9.

Abstract

Respiratory syncytial virus (RSV) rapid antigen detection tests (RADT) are extensively used in clinical laboratories. We performed a systematic review and meta-analysis to evaluate the accuracy of RADTs for diagnosis of RSV infection and to determine factors associated with accuracy estimates. We searched EMBASE and PubMed for diagnostic-accuracy studies of commercialized RSV RADTs. Studies reporting sensitivity and specificity data compared to a reference standard (reverse transcriptase PCR [RT-PCR], immunofluorescence, or viral culture) were considered. Two reviewers independently extracted data on study characteristics, diagnostic-accuracy estimates, and study quality. Accuracy estimates were pooled using bivariate random-effects regression models. Heterogeneity was investigated with prespecified subgroup analyses. Seventy-one articles met inclusion criteria. Overall, RSV RADT pooled sensitivity and specificity were 80% (95% confidence interval [CI], 76% to 83%) and 97% (95% CI, 96% to 98%), respectively. Positive- and negative-likelihood ratios were 25.5 (95% CI, 18.3 to 35.5) and 0.21 (95% CI, 0.18 to 0.24), respectively. Sensitivity was higher in children (81% [95% CI, 78%, 84%]) than in adults (29% [95% CI, 11% to 48%]). Because of this disparity, further subgroup analyses were restricted to pediatric data (63 studies). Test sensitivity was poorest using RT-PCR as a reference standard and highest using immunofluorescence (74% versus 88%; P < 0.001). Industry-sponsored studies reported significantly higher sensitivity (87% versus 78%; P = 0.01). Our results suggest that the poor sensitivity of RSV RADTs in adults may preclude their use in this population. Furthermore, industry-sponsored studies and those that did not use RT-PCR as a reference standard likely overestimated test sensitivity.

摘要

呼吸道合胞病毒(RSV)快速抗原检测试验(RADT)在临床实验室中被广泛使用。我们进行了一项系统评价和荟萃分析,以评估RADT诊断RSV感染的准确性,并确定与准确性估计相关的因素。我们在EMBASE和PubMed上搜索商业化RSV RADT的诊断准确性研究。纳入那些报告了与参考标准(逆转录聚合酶链反应[RT-PCR]、免疫荧光或病毒培养)相比的敏感性和特异性数据的研究。两名评审员独立提取关于研究特征、诊断准确性估计和研究质量的数据。使用双变量随机效应回归模型汇总准确性估计值。通过预先设定的亚组分析研究异质性。71篇文章符合纳入标准。总体而言,RSV RADT的汇总敏感性和特异性分别为80%(95%置信区间[CI],76%至83%)和97%(95%CI,96%至98%)。阳性似然比和阴性似然比分别为25.5(95%CI,18.3至35.5)和0.21(95%CI,0.18至0.24)。儿童的敏感性(81%[95%CI,78%,84%])高于成人(29%[95%CI,11%至48%])。由于这种差异,进一步的亚组分析仅限于儿科数据(63项研究)。以RT-PCR作为参考标准时,检测敏感性最差,以免疫荧光作为参考标准时最高(74%对88%;P<0.001)。行业资助的研究报告的敏感性显著更高(87%对78%;P=0.01)。我们的结果表明,RSV RADT在成人中的敏感性较差,可能不适合在该人群中使用。此外,行业资助的研究以及那些未将RT-PCR作为参考标准的研究可能高估了检测敏感性。

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