Interpretive discrepancies caused by target values inter-batch variations in chemiluminescence immunoassay for SARS-CoV-2 IgM/IgG by MAGLUMI.

Iveta Selingerova, Dalibor Valik, Lenka Gescheidtova, Vladimir Sramek, Zdenka Cermakova, Lenka Zdrazilova-Dubska

Journal of medical virology 2021 Mar

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Plasma specimens from coronavirus disease 2019 patients were double-tested for anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies by two different batches of MAGLUMI 2019-nCov immunoglobulin M/immunoglobulin G (IgM/IgG) assays to evaluate IgM/IgG levels, qualitative interpretation, antibody kinetics, and linearity of diluted specimen. Here we show that (i) high-level IgM specimens need to be diluted with negative human plasma but not kit diluents and (ii) measured anti-SARS-CoV-2 IgM/IgG concentrations are substantially higher with later marketed immunoassay batch leading to (iii) the change of qualitative interpretation (positive vs. negative) in 12.3% of specimens measured for IgM, (iv) the informative time-course pattern of antibody production only when data from different immunoassay batches are not combined. © 2020 Wiley Periodicals LLC.

Citation

Iveta Selingerova, Dalibor Valik, Lenka Gescheidtova, Vladimir Sramek, Zdenka Cermakova, Lenka Zdrazilova-Dubska. Interpretive discrepancies caused by target values inter-batch variations in chemiluminescence immunoassay for SARS-CoV-2 IgM/IgG by MAGLUMI. Journal of medical virology. 2021 Mar;93(3):1805-1809