Testing Laboratory for In-vitro Diagnostic Medical Devices, Paul-Ehrlich-Institute, Langen, Germany.
Robert Koch Institute, Highly Pathogenic Viruses, Centre for Biological Threats and Special Pathogens, WHO Reference Laboratory for SARS-CoV-2 and WHO Collaborating Centre for Emerging Infections and Biological Threats, Robert Koch Institute, Berlin, Germany.
Euro Surveill. 2021 Nov;26(44). doi: 10.2807/1560-7917.ES.2021.26.44.2100441.
IntroductionNumerous CE-marked SARS-CoV-2 antigen rapid diagnostic tests (Ag RDT) are offered in Europe, several of them with unconfirmed quality claims.AimWe performed an independent head-to-head evaluation of the sensitivity of SARS-CoV-2 Ag RDT offered in Germany.MethodsWe addressed the sensitivity of 122 Ag RDT in direct comparison using a common evaluation panel comprised of 50 specimens. Minimum sensitivity of 75% for panel specimens with a PCR quantification cycle (Cq) ≤ 25 was used to identify Ag RDT eligible for reimbursement in the German healthcare system.ResultsThe sensitivity of different SARS-CoV-2 Ag RDT varied over a wide range. The sensitivity limit of 75% for panel members with Cq ≤ 25 was met by 96 of the 122 tests evaluated; 26 tests exhibited lower sensitivity, few of which failed completely. Some RDT exhibited high sensitivity, e.g. 97.5 % for Cq < 30.ConclusionsThis comparative evaluation succeeded in distinguishing less sensitive from better performing Ag RDT. Most of the evaluated Ag RDT appeared to be suitable for fast identification of acute infections associated with high viral loads. Market access of SARS-CoV-2 Ag RDT should be based on minimal requirements for sensitivity and specificity.
介绍
欧洲有许多获得 CE 标志的 SARS-CoV-2 抗原快速诊断检测（Ag RDT），其中有几个未经证实的质量声明。
目的
我们对德国提供的 SARS-CoV-2 Ag RDT 的敏感性进行了独立的头对头评估。
方法
我们使用由 50 个标本组成的共同评估面板，直接比较了 122 种 Ag RDT 的敏感性。对于 PCR 定量循环（Cq）≤25 的组内标本，最低敏感性为 75%，用于确定有资格在德国医疗保健系统中报销的 Ag RDT。
结果
不同 SARS-CoV-2 Ag RDT 的敏感性差异很大。在评估的 122 种检测方法中，有 96 种符合组内 Cq≤25 的成员的 75%敏感性限制；26 种检测方法敏感性较低，其中少数完全失败。一些 RDT 表现出很高的敏感性，例如对于 Cq<30 的样本，敏感性为 97.5%。
结论
这项比较评估成功地区分了敏感性较低和性能较好的 Ag RDT。评估的大多数 Ag RDT 似乎适用于快速识别与高病毒载量相关的急性感染。SARS-CoV-2 Ag RDT 的市场准入应基于敏感性和特异性的最低要求。
