Interpretive discrepancies caused by target values inter-batch variations in chemiluminescence immunoassay for SARS-CoV-2 IgM/IgG by MAGLUMI
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu časopisecké články, práce podpořená grantem
Grantová podpora
LM2018125
Ministerstvo Školství, Mládeže a Telovýchovy
LM2018128
Ministerstvo Školství, Mládeže a Telovýchovy
DRO 00209805
Ministerstvo Zdravotnictví Ceské Republiky
PubMed
33079389
DOI
10.1002/jmv.26612
Knihovny.cz E-zdroje
- Klíčová slova
- CLIA, anti-SARS-CoV-2 IgG, anti-SARS-CoV-2 IgM, inter-assay batch variation, interpretative inconsistency,
- MeSH
- COVID-19 krev imunologie MeSH
- imunoanalýza metody MeSH
- imunoglobulin G krev imunologie MeSH
- imunoglobulin M krev imunologie MeSH
- lidé MeSH
- luminiscence MeSH
- luminiscenční měření metody MeSH
- protilátky virové imunologie MeSH
- SARS-CoV-2 imunologie MeSH
- senzitivita a specificita MeSH
- testování na COVID-19 metody MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- Názvy látek
- imunoglobulin G MeSH
- imunoglobulin M MeSH
- protilátky virové MeSH
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.
Department of Anaesthesiology St Anne's University Hospital Brno Czech Republic
Department of Clinical Biochemistry University Hospital Brno Brno Czech Republic
Department of Clinical Microbiology and Immunology University Hospital Brno Brno Czech Republic
Department of Laboratory Medicine Masaryk Memorial Cancer Institute Brno Czech Republic
Zobrazit více v PubMed
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