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.
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。