Azienda USL-IRCCS di Reggio Emilia; V.le Amendola n.2 - 42122 RE; Servizio di Prevenzione e Sicurezza negli Ambienti di Lavoro (SPSAL)Dip. di Prevenzione.
University of Parma, Department of Medicine and Surgery, School of Occupational Medicine, I-43123 Parma (PR), Italy.
Acta Biomed. 2022 May 11;93(2):e2022036. doi: 10.23750/abm.v93i2.11031.
Background and aim Rapid antigen detection (RAD) tests on nasopharyngeal specimens have been recently made available for SARS-CoV-2 infections, and early studies suggested their potential utilization as rapid screening and diagnostic testing. The present systematic review and meta-analysis was aimed to assess available evidence and to explore the reliability of antigenic tests in the management of the SARS-CoV-2 pandemic.
We reported our meta-analysis according to the PRISMA statement. We searched Pubmed, Embase, and pre-print archive medRxiv.og for eligible studies published up to November 5th, 2020. Raw data included true/false positive and negative tests, and the total number of tests. Sensitivity and specificity data were calculated for every study, and then pooled in a random-effects model. Heterogeneity was assessed using the I2 measure. Reporting bias was assessed by means of funnel plots and regression analysis.
Based on 25 studies, we computed a pooled sensitivity of 72.8% (95%CI 62.4-81.3), a specificity of 99.4% (95%CI 99.0-99.7), with high heterogeneity and risk of reporting bias. More precisely, RAD tests exhibited higher sensitivity on samples with high viral load (i.e. <25 Cycle Threshold; 97.6%; 95%CI 94.1-99.0), compared to those with low viral load (≥25 Cycle Threshold; 43.6%; 95% 27.6-61.1).
As the majority of collected reports were either cohort or case-control studies, deprived of preventive power analysis and often oversampling positive tests, overall performances may have been overestimated. Therefore, the massive referral to antigenic tests in place of RT-qPCR is currently questionable, and also their deployment as mass screening test may lead to intolerable share of missing diagnoses. On the other hand, RAD tests may find a significant role in primary care and in front-line settings (e.g. Emergency Departments). (www.actabiomedica.it).
最近，针对鼻咽标本的快速抗原检测（RAD）已可用于 SARS-CoV-2 感染，早期研究表明其具有作为快速筛查和诊断检测的潜力。本系统评价和荟萃分析旨在评估现有证据，并探讨抗原检测在 SARS-CoV-2 大流行管理中的可靠性。
我们根据 PRISMA 声明报告了我们的荟萃分析。我们在 Pubmed、Embase 和预印本存档 medRxiv.og 中搜索了截至 2020 年 11 月 5 日发表的合格研究。原始数据包括真/假阳性和阴性检测以及总检测数量。为每一项研究计算了敏感性和特异性数据，并在随机效应模型中进行了汇总。使用 I2 测量评估异质性。通过漏斗图和回归分析评估报告偏倚。
基于 25 项研究，我们计算出合并敏感性为 72.8%（95%CI 62.4-81.3），特异性为 99.4%（95%CI 99.0-99.7），存在高度异质性和报告偏倚风险。更确切地说，RAD 检测在高病毒载量（即 <25 个循环阈值；97.6%；95%CI 94.1-99.0）的样本中表现出更高的敏感性，而在低病毒载量（≥25 个循环阈值；43.6%；95%CI 27.6-61.1）的样本中表现出较低的敏感性。
由于大多数收集的报告要么是队列研究，要么是病例对照研究，缺乏预防效力分析，并且经常过度采样阳性检测，因此总体表现可能被高估了。因此，目前抗原检测大规模替代 RT-qPCR 的做法值得商榷，将其作为大规模筛查检测的应用可能会导致无法承受的漏诊率。另一方面，RAD 检测可能在初级保健和一线环境（如急诊部门）中发挥重要作用。（www.actabiomedica.it）。
