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Interpretive discrepancies caused by target values inter‐batch variations in chemiluminescence immunoassay for SARS‐CoV‐2 IgM/IgG by MAGLUMI
Author(s) -
Selingerova Iveta,
Valik Dalibor,
Gescheidtova Lenka,
Sramek Vladimir,
Cermakova Zdenka,
ZdrazilovaDubska Lenka
Publication year - 2021
Publication title -
journal of medical virology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.782
H-Index - 121
eISSN - 1096-9071
pISSN - 0146-6615
DOI - 10.1002/jmv.26612
Subject(s) - immunoassay , antibody , virology , chemiluminescence , immunoglobulin g , immunoglobulin m , covid-19 , chemiluminescent immunoassay , coronavirus , immunology , chemistry , biology , medicine , chromatography , infectious disease (medical specialty) , disease
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.