Saint-Petersburg State University Hospital, 154, Fontanka river embankment, Saint-Petersburg, 198103, Russian Federation; Almazov National Medical Research Centre, Saint-Petersburg, 2 Akkuratova str., 197341, Russian Federation; North-West Centre for Evidence-Based Medicine JSC, 28A Pulkovskoe shosse, Saint-Petersburg, 196247, Russian Federation.
Petersburg Nuclear Physics Institute named by B.P. Konstantinov of National Research Centre «Kurchatov Institute», Gatchina, 188300, Russian Federation.
J Clin Virol. 2023 Jul;164:105448. doi: 10.1016/j.jcv.2023.105448. Epub 2023 Apr 20.
There are significant number of tests used to determine the level of antibodies to SARS-CoV-2 which differ both in the methods underlying testing and in the antigenic targets used and classes of measured immunoglobulins. Comparison of the results obtained using various tests reveals their significant discrepancy when converted to the WHO recommended standard unit for measuring the level of specific immunoglobulins BAU/mL. The aim of this study is a comparison of anty-SARS-CoV-2 IgG levels, measured using test systems based on different methodological platforms - EuroImmun assay and Abbott assay.
Abbott uses the immunochemiluminescence method CLIA, EuroImmun uses the enzyme immunoassay method ELISA. The dependences of the measurement error on the level of antibodies for the two test systems were approximated by power functions using the least squares method. The nonlinear relation of antibody levels values measured by Abbott assay and Euroimmun assay was approximated by an asymptotic function.
The study involved 112 people. Our results confirm the fallacy of using a single conversion coefficient in BAU/mL for anti-SARS-CoV-2 IgG levels measured by Abbott and EuroImmun. To describe the interdependence of anti-SARS-CoV-2 IgG Abbott and EuroImmun levels, we offer the function y = 18/π arctan(0.0009x) and a calculator that allows to easily recalculate the results obtained using these tests.
The non-linear nature of the interdependence of the measured anti-SARS-CoV-2 antibodies levels on the levels magnitude is one of the main reasons for the discrepancy between the tests results when converted to BAU/mL using a single conversion coefficient.
有大量用于确定 SARS-CoV-2 抗体水平的检测方法，这些方法在检测原理、抗原靶点和所测量的免疫球蛋白类别上均存在差异。使用不同检测方法获得的结果进行比较时，将其转换为世界卫生组织（WHO）推荐的用于测量特定免疫球蛋白 BAU/mL 水平的标准单位时，会发现其差异非常显著。本研究旨在比较基于不同方法学平台（EuroImmun 检测和 Abbott 检测）的检测系统所测量的抗 SARS-CoV-2 IgG 水平。
Abbott 使用免疫化学发光法 CLIA，EuroImmun 使用酶联免疫吸附试验 ELISA。使用最小二乘法，通过幂函数对两种检测系统的测量误差与抗体水平之间的关系进行了近似。Abbott 检测和 EuroImmun 检测所测量的抗体水平值之间的非线性关系通过渐近函数进行了近似。
该研究共纳入 112 人。我们的结果证实，在使用 Abbott 和 EuroImmun 测量的抗 SARS-CoV-2 IgG 水平的 BAU/mL 中，使用单一转换系数是错误的。为了描述 Abbott 和 EuroImmun 抗 SARS-CoV-2 IgG 水平之间的相互关系，我们提供了函数 y=18/π arctan(0.0009x)和一个计算器，可方便地重新计算使用这些检测方法获得的结果。
所测量的抗 SARS-CoV-2 抗体水平与水平幅度之间的相互关系的非线性性质是使用单一转换系数将测试结果转换为 BAU/mL 时产生差异的主要原因之一。
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