Department of Hematology, Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University, Linhai, Zhejiang, China.
Department of Emergency, Taizhou First People's Hospital, Huangyan, Zhejiang, China.
Expert Rev Anti Infect Ther. 2022 Jul;20(7):1005-1013. doi: 10.1080/14787210.2022.2070152. Epub 2022 Apr 29.
The rapid antigen detection tests (RADTs) for SARS-CoV-2 infection could contribute to the clinical and public health strategies for managing COVID-19. This umbrella review aimed to explore the accuracy and sensitivity of RADTs for SARS-CoV-2 by assessing the incidence of false positivity associated with them.
Meta-analyses and systematic reviews on the sensitivity and specificity of commercially available RADTs with data on false-positive results were identified by searching the PubMed, EMBASE, Cochrane Library, and Web of Science databases from inception to 31 March 2022. All meta-analyses and systematic reviews on the sensitivity and specificity of rapid antigen tests were included. Data on the author and year, included studies, index tests, sample size, false negatives, false positives, and study quality based on AMSTAR 2 (Assessing the Methodological Quality of Systematic Reviews) rating were extracted from the included meta-analyses and systematic reviews.
The false positivity rates in the included studies ranged from 0.0% - 4.0%. This study summarizes the available evidence on the incidence of false positivity in RADTs and shows it is less than 4.0%. Therefore, our findings imply that RADTs can be an appropriate, economic, and rapid detection method for mass screening of COVID-19.
用于 SARS-CoV-2 感染的快速抗原检测(RADT)可以为 COVID-19 的临床和公共卫生策略提供帮助。本综述旨在通过评估与 RADT 相关的假阳性率,探讨 RADT 检测 SARS-CoV-2 的准确性和敏感性。
从研究开始到 2022 年 3 月 31 日,通过检索 PubMed、EMBASE、Cochrane 图书馆和 Web of Science 数据库,确定了具有假阳性结果数据的商业 RADT 的敏感性和特异性的荟萃分析和系统评价。所有关于快速抗原检测敏感性和特异性的荟萃分析和系统评价均被纳入。从纳入的荟萃分析和系统评价中提取了关于作者和年份、纳入研究、索引测试、样本量、假阴性、假阳性以及基于 AMSTAR 2(评估系统评价方法学质量)评分的研究质量的数据。
纳入研究中的假阳性率范围为 0.0%至 4.0%。本研究总结了 RADT 假阳性发生率的现有证据,表明其发生率低于 4.0%。因此,我们的研究结果表明,RADT 可以作为 COVID-19 大规模筛查的一种合适、经济和快速的检测方法。