Institute for Medical Microbiology and Virology, University Hospital and Medical Faculty, University of Leipzig, Johannisallee 30, Leipzig 04103, Germany.
Institute for Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics, University Hospital and Medical Faculty, University of Leipzig, Germany.
J Clin Virol. 2022 Oct;155:105269. doi: 10.1016/j.jcv.2022.105269. Epub 2022 Aug 19.
The concentration of antibodies against the SARS-CoV-2 spike protein is frequently being measured for clinical and epidemiological purposes. The aim of this study was to examine whether the results of different quantitative SARS-CoV-2 spike antibody assays are comparable.
The Siemens SARS-CoV-2 IgG, Abbott SARS-CoV-2 IgG II Quant, Roche ElecsysT Anti-SARS-CoV-2 S, and Euroimmun Anti-SARS-CoV-2-QuantiVac assay were compared with 110 sera from patients 6-9 months after SARS-CoV-2 infection and the WHO First International SARS-CoV-2 antibody standard 20/136. The antibody values were converted into WHO binding antibody units (BAU)/ml. The diagnostic sensitivity of the assays was determined and the antibody values were compared.
The diagnostic sensitivity ranged from 57.3% (Euroimmun) to 100% (Roche). The antibody concentration values of different assays correlated with Pearson coefficients of correlation between 0.729 and 0.953. The geometric mean antibody values of the Abbott, Siemens and Euroimmun assay varied by a factor of 1.1-1.2. The geometric mean antibody values of the Roche assay were 2.4-2.8 times higher than those from the other assays. The assays yielded varying results with the WHO International antibody standard.
The quantitative SARS-CoV-2 antibody assays from Abbott, Siemens, Roche and Euroimmun correlate strongly but differ in the antibody concentrations. Therefore, the same assay should be used when testing patients repeatedly. In addition, the name of the assay used and the manufacturer should be indicated along with the test results.
目前经常针对 SARS-CoV-2 刺突蛋白的抗体浓度进行临床和流行病学检测。本研究旨在检验不同定量 SARS-CoV-2 刺突抗体检测试剂盒的结果是否具有可比性。
我们比较了西门子 SARS-CoV-2 IgG、雅培 SARS-CoV-2 IgG II Quant、罗氏 ElecsysT Anti-SARS-CoV-2 S 和欧蒙 Anti-SARS-CoV-2-QuantiVac 检测试剂盒与 110 份 SARS-CoV-2 感染 6-9 个月后的患者血清,以及世界卫生组织第一份 SARS-CoV-2 抗体国际标准品 20/136。将抗体值转换为世界卫生组织结合抗体单位(BAU)/ml。确定检测试剂盒的诊断灵敏度并比较抗体值。
诊断灵敏度范围为 57.3%(欧蒙)至 100%(罗氏)。不同检测试剂盒的抗体浓度值与 Pearson 相关系数的相关性在 0.729 到 0.953 之间。雅培、西门子和欧蒙检测试剂盒的抗体几何均数值差异为 1.1-1.2 倍。罗氏检测试剂盒的抗体几何均数值比其他检测试剂盒高 2.4-2.8 倍。检测试剂盒与世界卫生组织国际抗体标准品的检测结果存在差异。
雅培、西门子、罗氏和欧蒙的定量 SARS-CoV-2 抗体检测试剂盒相关性很强,但抗体浓度存在差异。因此,在重复检测患者时应使用相同的检测试剂盒。此外,应在检测结果中注明所使用的检测试剂盒名称和制造商。