Quality Control for Molecular Diagnostics (QCMD), Glasgow, United Kingdom.
Institute of Virology, Charité-Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, Berlin, Germany, and German Center for Infection Research (DZIF), Berlin, Germany; Labor Berlin-Charité Vivantes GmbH, Berlin, Germany.
J Clin Virol. 2022 Sep;154:105222. doi: 10.1016/j.jcv.2022.105222. Epub 2022 Jun 27.
Antigen testing has become an essential part of fighting the ongoing COVID-19 pandemic. With the continual increase in available tests, independent and extensive comparative evaluations using data from external quality assessment (EQA) studies to evaluate test performance between different users are required.
An EQA scheme was established to assess the sensitivity of antigen tests and the potential impact of circulating SARS-CoV-2 strains on their performance.
Panels were prepared for three challenges in 2021 containing inactivated SARS-CoV-2-positive samples of various genetic strains (including variants of concern, VOCs) at different concentrations, and negative samples. Data was analysed based on qualitative testing results in relation to the antigen test used.
Participants registered for each individual challenge in any combination. In total, 258 respondents from 27 countries worldwide were counted submitting 472 datasets. All core samples were correctly reported by 76.7 to 83.1% at participant level and by 73.5 to 83.8% at dataset level. Sensitivity differences could be shown in viral loads and SARS-CoV-2 strains/variants including the impact on performance by a B.1.1.7-like mutant strain with a deletion in the nucleoprotein gene. Lateral flow rapid antigen tests showed a higher rate of false negatives in general compared with automated point-of-care tests and laboratory ELISA/immunoassays.
EQA schemes can provide valuable data to inform participants about weaknesses in their testing process or methods and support ongoing assay evaluations for regulatory approval or post-market surveillance.
抗原检测已成为抗击持续的 COVID-19 大流行的重要手段。随着可利用检测数量的不断增加，需要利用外部质量评估（EQA）研究的数据，对不同使用者之间的检测性能进行独立且广泛的比较评估。
建立 EQA 方案，以评估抗原检测的敏感性，以及循环 SARS-CoV-2 株对其性能的潜在影响。
2021 年，我们为三个挑战准备了包含不同浓度的各种遗传株（包括关注变异株，VOCs）灭活 SARS-CoV-2 阳性样本以及阴性样本的检测板。根据与使用的抗原检测相关的定性检测结果分析数据。
参与者可以选择组合注册参加各个挑战。共有来自全球 27 个国家的 258 名参与者，共提交了 472 组数据集。在参与者层面，所有核心样本的正确报告率为 76.7%至 83.1%，在数据集层面为 73.5%至 83.8%。可以显示病毒载量和 SARS-CoV-2 株/变异株之间的敏感性差异，包括对核蛋白基因缺失的 B.1.1.7 样突变株的性能影响。侧向流动快速抗原检测通常比自动化即时检测和实验室 ELISA/免疫测定显示出更高的假阴性率。
EQA 方案可以为参与者提供有价值的数据，使其了解自身检测过程或方法的弱点，并支持正在进行的用于监管批准或上市后监测的检测评估。
