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.

中文翻译：

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欧洲专家实验室 SARS-CoV-2 分子检测的可变灵敏度：外部质量评估，2020 年 6 月和 7 月


在 2019 年冠状病毒病 (COVID-19) 持续爆发期间，对严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 的可靠检测是临床管理和中断传播链的关键要素。我们为欧洲专家实验室组织了 SARS-CoV-2 分子检测的外部质量评估 (EQA)。由 12 个样本组成的 EQA 小组已分发给 35 个国家的 68 个实验室，其中包含不同浓度的 SARS-CoV-2 以评估敏感性，或包含其他呼吸道病毒以评估 SARS-CoV-2 测试的特异性。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 以及人类流感病毒 A 和 B。各实验室的灵敏度结果不同，特别是对于低浓度 SARS-CoV-2 样本。结果表明，性能很大程度上与特定提取或 PCR 方法的选择无关。