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

I. Selingerova, D. Valik, L. Gescheidtova, V. Sramek, Z. Cermakova, L. Zdrazilova-Dubska

. 2021 ; 93 (3) : 1805-1809. [pub] 20201101

Jazyk angličtina Země Spojené státy americké

Typ dokumentu časopisecké články, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/bmc21011463

Grantová podpora
LM2018125 Ministerstvo Školství, Mládeže a Telovýchovy
LM2018128 Ministerstvo Školství, Mládeže a Telovýchovy
DRO 00209805 Ministerstvo Zdravotnictví Ceské Republiky

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.

Citace poskytuje Crossref.org

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