Abstract：
During the last two years, a variety of assays for the serological detection of antibodies to the new SARS-CoV-2 virus have been launched and used as part of standard care in many laboratories. The pace with which these tests have been introduced into routine care emphasizes the importance of quality measures for analytical methods, particularly with regard to the implications of results for clinical and epidemiologic decisions. Accuracy, reliability and comparability of analytical test results are thus essential, and here external quality assessment (EQA) is the most important quality assurance tool. It allows us to achieve harmonization of test methods as a prerequisite for a high standard of performance for laboratory and analytical techniques and their interpretation.
This EQA scheme consisted of pre-characterized clinical biospecimens dedicated to the analysis of anti-SARS-CoV-2 IgG total antibodies and differentiation into spike protein-specific IgG antibodies against SARS-CoV-2 (anti-S-SARS-CoV-2) and nucleocapsid-specific IgG antibodies against SARS-CoV-2 (anti-N-SARS-CoV-2).
A total of 239 laboratories across Europe participated in this scheme, called CoVimm. In detail, 536 results for anti-SARS-CoV-2 IgG, 431 results for anti-S-SARS-CoV-2 IgG, and 200 results for anti-N-SARS-CoV-2 IgG were reported. Based on the pre-defined thresholds, the success rates for the determination of anti-S-SARS-CoV-2 IgG and anti-N-SARS-CoV-2 IgG were 96% and 90%, respectively. Interestingly, only 64% of the participating laboratories successfully passed the EQA scheme for the determination of total anti-SARS-CoV-2 IgG.
This EQA revealed serious concerns regarding the reliability and appropriate use of anti-SARS-CoV-2 antibody assays in routine care. In addition to the wide heterogeneity of different assays used by participating laboratories, a lack of standardization and harmonization is also evident. This is of particular importance for reliable and clinically meaningful interpretation of test results.
This EQA scheme consisted of pre-characterized clinical biospecimens dedicated to the analysis of anti-SARS-CoV-2 IgG total antibodies and differentiation into spike protein-specific IgG antibodies against SARS-CoV-2 (anti-S-SARS-CoV-2) and nucleocapsid-specific IgG antibodies against SARS-CoV-2 (anti-N-SARS-CoV-2).
A total of 239 laboratories across Europe participated in this scheme, called CoVimm. In detail, 536 results for anti-SARS-CoV-2 IgG, 431 results for anti-S-SARS-CoV-2 IgG, and 200 results for anti-N-SARS-CoV-2 IgG were reported. Based on the pre-defined thresholds, the success rates for the determination of anti-S-SARS-CoV-2 IgG and anti-N-SARS-CoV-2 IgG were 96% and 90%, respectively. Interestingly, only 64% of the participating laboratories successfully passed the EQA scheme for the determination of total anti-SARS-CoV-2 IgG.
This EQA revealed serious concerns regarding the reliability and appropriate use of anti-SARS-CoV-2 antibody assays in routine care. In addition to the wide heterogeneity of different assays used by participating laboratories, a lack of standardization and harmonization is also evident. This is of particular importance for reliable and clinically meaningful interpretation of test results.
摘要：
在过去的两年里,针对新型SARS-CoV-2病毒的抗体的血清学检测的各种试验已经启动,并在许多实验室中用作标准治疗的一部分。这些测试引入常规护理的步伐强调了质量措施对分析方法的重要性，特别是关于结果对临床和流行病学决策的影响。准确性,因此，分析测试结果的可靠性和可比性至关重要，在这里，外部质量评估(EQA)是最重要的质量保证工具。它使我们能够实现测试方法的统一，作为实验室和分析技术及其解释的高标准性能的先决条件。
该EQA方案由预先表征的临床生物样本组成，该样本专门用于分析抗SARS-CoV-2IgG总抗体并分化为抗SARS-CoV-2的刺突蛋白特异性IgG抗体（抗S-SARS-CoV-2）和抗SARS-CoV-2的核衣壳特异性IgG抗体（抗N-SARS-CoV-2）。
欧洲共有239个实验室参与了这个计划，叫做CoVimm.详细来说,针对抗SARS-CoV-2IgG的536个结果，抗S-SARS-CoV-2IgG的431个结果，报道了200例抗N-SARS-CoV-2IgG的结果。根据预定义的阈值，抗S-SARS-CoV-2IgG和抗N-SARS-CoV-2IgG的检测成功率分别为96%和90%,分别。有趣的是,只有64％的参与实验室成功通过了EQA方案，用于测定总的抗SARS-CoV-2IgG。
该EQA揭示了在常规护理中对抗SARS-CoV-2抗体测定的可靠性和适当使用的严重关切。除了参与实验室使用的不同测定法的广泛异质性之外，缺乏标准化和协调也很明显。这对于测试结果的可靠和临床上有意义的解释特别重要。
该EQA方案由预先表征的临床生物样本组成，该样本专门用于分析抗SARS-CoV-2IgG总抗体并分化为抗SARS-CoV-2的刺突蛋白特异性IgG抗体（抗S-SARS-CoV-2）和抗SARS-CoV-2的核衣壳特异性IgG抗体（抗N-SARS-CoV-2）。
欧洲共有239个实验室参与了这个计划，叫做CoVimm.详细来说,针对抗SARS-CoV-2IgG的536个结果，抗S-SARS-CoV-2IgG的431个结果，报道了200例抗N-SARS-CoV-2IgG的结果。根据预定义的阈值，抗S-SARS-CoV-2IgG和抗N-SARS-CoV-2IgG的检测成功率分别为96%和90%,分别。有趣的是,只有64％的参与实验室成功通过了EQA方案，用于测定总的抗SARS-CoV-2IgG。
该EQA揭示了在常规护理中对抗SARS-CoV-2抗体测定的可靠性和适当使用的严重关切。除了参与实验室使用的不同测定法的广泛异质性之外，缺乏标准化和协调也很明显。这对于测试结果的可靠和临床上有意义的解释特别重要。
