Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humbolt-Universität zu Berlin and Berlin Institute of Health, Institute of Virology, Berlin, Germany.
Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands.
J Clin Microbiol. 2021 Feb 18;59(3). doi: 10.1128/JCM.02676-20.
During the ongoing coronavirus disease 2019 (COVID-19) outbreak, robust detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a key element for clinical management and to interrupt transmission chains. We organized an external quality assessment (EQA) of molecular detection of SARS-CoV-2 for European expert laboratories. An EQA panel composed of 12 samples, containing either SARS-CoV-2 at different concentrations to evaluate sensitivity or other respiratory viruses to evaluate specificity of SARS-CoV-2 testing, was distributed to 68 laboratories in 35 countries. Specificity samples included seasonal human coronaviruses hCoV-229E, hCoV-NL63, and hCoV-OC43, as well as Middle East respiratory syndrome coronavirus (MERS-CoV), SARS-CoV, and human influenza viruses A and B. Sensitivity results differed among laboratories, particularly for low-concentration SARS-CoV-2 samples. Results indicated that performance was mostly independent of the selection of specific extraction or PCR methods.
在持续的 2019 冠状病毒病（COVID-19）疫情期间，对严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）的强有力检测是临床管理和阻断传播链的关键要素。我们为欧洲专家实验室组织了一项针对 SARS-CoV-2 的分子检测外部质量评估（EQA）。一个由 12 个样本组成的 EQA 小组，包含不同浓度的 SARS-CoV-2 以评估灵敏度，或其他呼吸道病毒以评估 SARS-CoV-2 检测的特异性，分发给 35 个国家的 68 个实验室。特异性样本包括季节性人类冠状病毒 hCoV-229E、hCoV-NL63 和 hCoV-OC43，以及中东呼吸综合征冠状病毒（MERS-CoV）、SARS-CoV 和人流感病毒 A 和 B。实验室之间的灵敏度结果存在差异，特别是对于低浓度的 SARS-CoV-2 样本。结果表明，性能主要与特定提取或 PCR 方法的选择无关。
