Mohammadie Zahra Eslami, Akhlaghi Saeed, Samaeinasab Saeed, Shaterzadeh-Bojd Shakiba, Jamialahmadi Tannaz, Sahebkar Amirhossein
Student Research Committee, Faculty of Paramedical Sciences, Mashhad University of Medical Sciences, Mashhad, Iran.
Department of Biostatistics, School of Health, Mashhad University of Medical Sciences, Mashhad, Iran.
Rev Med Virol. 2023 Mar;33(2):e2428. doi: 10.1002/rmv.2428. Epub 2023 Feb 15.
The Omicron variant of concern has a high level of mutations in different genes that has raised awareness about the performance of immunological products such as vaccines and antigen detection kits. In this systematic review and meta-analysis, we investigated whether Omicron had a significant influence on rapid antigen test (RAT) performance in comparison to PCR. We registered this systematic review and meta-analysis in PROSPERO with the registration number CRD42022355510. We searched PubMed, Scopus, Embase, and Web of Science databases systematically to 1 August 2022. After article screening, we assessed the quality of the included studies based on the JBI checklist. Following data extraction, we performed a meta-analysis using R software. We included 18 qualified articles presenting sufficient data about RATs performance in comparison to RT-PCR in Omicron infections. The pooled specificity and sensitivity of RATs were 1.000 (0.997-1.000) and 0.671 (0.595-0.721), respectively. The FDA-approved kits showed a better performance than WHO-approved ones with a sensitivity of 0.728 (0.620-0.815). The use of RATs with nasal swabs showed a higher sensitivity compared with nasopharyngeal swabs. The sensitivity for samples with a CT-value >25 was 0.108 (0.048-0.227). Rapid antigen tests show impaired performance for COVID-19 diagnosis when the Omicron variant is circulating, particularly in samples with low viral loads.
值得关注的奥密克戎变异株在不同基因中有大量突变，这引发了人们对疫苗和抗原检测试剂盒等免疫产品性能的关注。在这项系统评价和荟萃分析中，我们调查了与聚合酶链反应（PCR）相比，奥密克戎对快速抗原检测（RAT）性能是否有显著影响。我们在国际前瞻性系统评价注册库（PROSPERO）中注册了这项系统评价和荟萃分析，注册号为CRD42022355510。我们系统检索了PubMed、Scopus、Embase和科学网数据库至2022年8月1日。在文章筛选后，我们根据澳大利亚 Joanna Briggs 循证卫生保健中心（JBI）检查表评估纳入研究的质量。在数据提取后，我们使用R软件进行荟萃分析。我们纳入了18篇合格文章，这些文章提供了与奥密克戎感染中逆转录聚合酶链反应（RT-PCR）相比RAT性能的充分数据。RAT的合并特异性和敏感性分别为1.000（0.997 - 1.000）和0.671（0.595 - 0.721）。美国食品药品监督管理局（FDA）批准的试剂盒表现优于世界卫生组织（WHO）批准的试剂盒，敏感性为0.728（0.620 - 0.815）。使用鼻拭子进行RAT检测的敏感性高于鼻咽拭子。CT值>25的样本的敏感性为0.108（0.048 - 0.227）。当奥密克戎变异株传播时，快速抗原检测在新冠病毒疾病诊断中的性能受损，尤其是在病毒载量低的样本中。
