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. 2021 Mar;93(3):1805-1809.
doi: 10.1002/jmv.26612. Epub 2020 Nov 1.

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

Iveta Selingerova  1 , Dalibor Valik  1   2 , Lenka Gescheidtova  1 , Vladimir Sramek  3 , Zdenka Cermakova  2 , Lenka Zdrazilova-Dubska  1   4
Affiliations

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

Iveta Selingerova et al. J Med Virol. 2021 Mar.

Abstract

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.

Keywords: CLIA; anti-SARS-CoV-2 IgG; anti-SARS-CoV-2 IgM; inter-assay batch variation; interpretative inconsistency.

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References

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