Department of Information and Knowledge Engineering, Faculty of Informatics and Statistics, Prague University of Economics and Business, Prague, Czechia.
Institute of Health Information and Statistics of the Czech Republic, Prague, Czechia.
Euro Surveill. 2022 Aug;27(33). doi: 10.2807/1560-7917.ES.2022.27.33.2200070.
BackgroundAnalyses of diagnostic performance of SARS-CoV-2 antigen rapid diagnostic tests (AG-RDTs) based on long-term data, population subgroups and many AG-RDT types are scarce.AimWe aimed to analyse sensitivity and specificity of AG-RDTs for subgroups based on age, incidence, sample type, reason for test, symptoms, vaccination status and the AG-RDT's presence on approved lists.MethodsWe included AG-RDT results registered in Czechia's Information System for Infectious Diseases between August and November 2021. Subpopulations were analysed based on 346,000 test results for which a confirmatory PCR test was recorded ≤ 3 days after the AG-RDT; 38 AG-RDTs with more than 100 PCR-positive and 300 PCR-negative samples were individually evaluated.ResultsAverage sensitivity and specificity were 72.4% and 96.7%, respectively. We recorded lower sensitivity for age groups 0-12 (65.5%) and 13-18 years (65.3%). The sensitivity level rose with increasing SARS-CoV-2 incidence from 66.0% to 76.7%. Nasopharyngeal samples had the highest sensitivity and saliva the lowest. Sensitivity for preventive reasons was 63.6% vs 86.1% when testing for suspected infection. Sensitivity was 84.8% when one or more symptoms were reported compared with 57.1% for no symptoms. Vaccination was associated with a 4.2% higher sensitivity. Significantly higher sensitivity levels pertained to AG-RDTs on the World Health Organization Emergency Use List (WHO EUL), European Union Common List and the list of the United Kingdom's Department of Health and Social Care.ConclusionAG-RDTs from approved lists should be considered, especially in situations associated with lower viral load. Results are limited to SARS-CoV-2 delta variant.
基于长期数据、人群亚组和多种 AG-RDT 类型对 SARS-CoV-2 抗原快速诊断检测（AG-RDT）的诊断性能进行分析的情况较为少见。
我们旨在根据年龄、发病率、样本类型、检测原因、症状、疫苗接种状况以及 AG-RDT 在批准清单上的存在情况，分析 AG-RDT 在亚组中的敏感性和特异性。
我们纳入了 2021 年 8 月至 11 月期间在捷克传染病信息系统中登记的 AG-RDT 结果。基于记录了在 AG-RDT 后 ≤3 天内进行的确认性 PCR 检测结果的 346000 个检测结果，对亚组进行了分析；对 38 种具有超过 100 个 PCR 阳性和 300 个 PCR 阴性样本的 AG-RDT 进行了单独评估。
平均敏感性和特异性分别为 72.4%和 96.7%。我们记录到 0-12 岁（65.5%）和 13-18 岁（65.3%）年龄组的敏感性较低。随着 SARS-CoV-2 发病率从 66.0%增加到 76.7%，敏感性水平也随之上升。鼻咽样本的敏感性最高，唾液样本的敏感性最低。出于预防目的进行检测时的敏感性为 63.6%，而怀疑感染时的敏感性为 86.1%。有一个或多个症状报告时的敏感性为 84.8%，而无症状时的敏感性为 57.1%。接种疫苗与敏感性提高 4.2%有关。在世界卫生组织（WHO）紧急使用清单（EUL）、欧盟共同清单和英国卫生部和社会保障部清单上的 AG-RDT 的敏感性水平更高。
应考虑使用获得批准的清单中的 AG-RDT，尤其是在病毒载量较低的情况下。结果仅限于 SARS-CoV-2 德尔塔变异株。
