Laboratorio di Biotecnologie Applicate all'Ortopedia, IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.
Vita-Salute San Raffaele University, Milan, Italy.
J Clin Lab Anal. 2022 May;36(5):e24363. doi: 10.1002/jcla.24363. Epub 2022 Mar 25.
Serological tests can be used to detect antibodies in the serum of subject's after SARS-CoV-2 infection and vaccination. Currently, variability in antibody titers and the availability of a multiplicity of serological tests have made it necessary to highlight their appropriateness and limitations in various diagnostic settings.
This study is part of Covidiagnostix, a multicenter project aimed at the assessment of the health technology used in SARS-CoV-2 serological tests. Based on data gained from the analysis of over 5000 subjects, a selected number of serum samples, representative of different diagnostic settings, were analyzed first by qualitative immunoassays (IgA, M, and G MILLIPLEX SARS-CoV-2 tests based on Luminex ) to define the immunoglobulins serum composition and subsequently by four serological diagnostic tests (Elecsys Anti-SARS-CoV-2 and Elecsys Anti-SARS-CoV-2 S by Roche, SARS-CoV-2 IgG by Siemens Healthcare, and CHORUS SARS-CoV-2 "NEUTRALIZING" Ab by DIESSE). The first WHO International Standard for SARS-CoV-2 was also analyzed using the same methods.
This study evaluated the antibody content and titer of the WHO Standard and serum of subjects with/without previous infection and before/after vaccination for SARS-CoV-2.
The definition of antibodies in the WHO standard and the analysis of serum samples allowed for the identification of the appropriateness of serological tests in each diagnostic setting, increasing the effectiveness of the resulting laboratory data. Furthermore, we found that it would be optimal to produce new international standards against the S1 domain and RBD of the SARS-CoV-2 spike protein for a more effective serological monitoring of vaccination.
血清学检测可用于检测 SARS-CoV-2 感染和接种后受试者血清中的抗体。目前，抗体滴度的变化和多种血清学检测方法的应用，使得有必要强调它们在各种诊断环境中的适宜性和局限性。
本研究是 Covidiagnostix 的一部分，该多中心项目旨在评估 SARS-CoV-2 血清学检测中使用的卫生技术。基于对超过 5000 名受试者的分析数据，首先对来自不同诊断环境的代表性血清样本进行定性免疫分析（基于 Luminex 的 IgA、M 和 G MILLIPLEX SARS-CoV-2 检测），以确定血清中免疫球蛋白的组成，然后用四种血清学诊断检测方法（罗氏的 Elecsys Anti-SARS-CoV-2 和 Elecsys Anti-SARS-CoV-2 S、西门子医疗的 SARS-CoV-2 IgG 和 DIESSE 的 CHORUS SARS-CoV-2 "中和" Ab）进行分析。同时也用相同的方法对第一份世界卫生组织（WHO）的 SARS-CoV-2 国际标准品进行了分析。
本研究评估了 WHO 标准品和有/无既往感染以及接种 SARS-CoV-2 疫苗前后受试者血清中的抗体含量和滴度。
WHO 标准品中抗体的定义和血清样本的分析，有助于确定每种诊断环境中血清学检测的适宜性，从而提高实验室数据的有效性。此外，我们发现，针对 SARS-CoV-2 刺突蛋白的 S1 结构域和 RBD 产生新的国际标准品，将更有利于对疫苗接种进行更有效的血清学监测。
