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

J 2021

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

SELINGEROVÁ, Iveta, Dalibor VALÍK, Lenka GESCHEIDTOVÁ, Vladimír ŠRÁMEK, Z. CERMAKOVA et. al.

Basic information

Original name

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

Authors

SELINGEROVÁ, Iveta, Dalibor VALÍK, Lenka GESCHEIDTOVÁ, Vladimír ŠRÁMEK, Z. CERMAKOVA and Lenka ZDRAŽILOVÁ DUBSKÁ

Edition

Journal of Medical Virology, Hoboken, Wiley, 2021, 0146-6615

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30230 Other clinical medicine subjects

Country of publisher

Czech Republic

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 20.693

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1002/jmv.26612

UT WoS

000583206600001

Keywords (in Czech)

anti‐ SARS‐ CoV‐ 2 IgG; anti‐ SARS‐ CoV‐ 2 IgM; CLIA; inter‐ assay batch variation; interpretative inconsistency

Keywords in English

anti‐ SARS‐ CoV‐ 2 IgG; anti‐ SARS‐ CoV‐ 2 IgM; CLIA; inter‐ assay batch variation; interpretative inconsistency

Abstract

V originále

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.

Links

90128, large research infrastructures

Name: CZECRIN III

Citovat

SELINGEROVÁ, Iveta, Dalibor VALÍK, Lenka GESCHEIDTOVÁ, Vladimír ŠRÁMEK, Z. CERMAKOVA and Lenka ZDRAŽILOVÁ DUBSKÁ. Interpretive discrepancies caused by target values inter-batch variations in chemiluminescence immunoassay for SARS-CoV-2 IgM/IgG by MAGLUMI. Journal of Medical Virology. Hoboken: Wiley, 2021, vol. 93, No 3, p. 1805-1809. ISSN 0146-6615. Available from: https://dx.doi.org/10.1002/jmv.26612.

@article{1807083,
   author = {Selingerová, Iveta and Valík, Dalibor and Gescheidtová, Lenka and Šrámek, Vladimír and Cermakova, Z. and Zdražilová Dubská, Lenka},
   article_location = {Hoboken},
   article_number = {3},
   doi = {http://dx.doi.org/10.1002/jmv.26612},
   keywords = {anti‐ SARS‐ CoV‐ 2 IgG; anti‐ SARS‐ CoV‐ 2 IgM; CLIA; inter‐ assay batch variation; interpretative inconsistency},
   language = {eng},
   issn = {0146-6615},
   journal = {Journal of Medical Virology},
   note = {Bez afiliace k MU.},
   title = {Interpretive discrepancies caused by target values inter-batch variations in chemiluminescence immunoassay for SARS-CoV-2 IgM/IgG by MAGLUMI},
   url = {https://onlinelibrary.wiley.com/doi/10.1002/jmv.26612},
   volume = {93},
   year = {2021}
}

TY  - JOUR
ID  - 1807083
AU  - Selingerová, Iveta - Valík, Dalibor - Gescheidtová, Lenka - Šrámek, Vladimír - Cermakova, Z. - Zdražilová Dubská, Lenka
PY  - 2021
TI  - Interpretive discrepancies caused by target values inter-batch variations in chemiluminescence immunoassay for SARS-CoV-2 IgM/IgG by MAGLUMI
JF  - Journal of Medical Virology
VL  - 93
IS  - 3
SP  - 1805-1809
EP  - 1805-1809
PB  - Wiley
SN  - 01466615
N1  - Bez afiliace k MU.
KW  - anti‐ SARS‐ CoV‐ 2 IgG
KW  - anti‐ SARS‐ CoV‐ 2 IgM
KW  - CLIA
KW  - inter‐ assay batch variation
KW  - interpretative inconsistency
UR  - https://onlinelibrary.wiley.com/doi/10.1002/jmv.26612
N2  - 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.
ER  -

SELINGEROVÁ, Iveta, Dalibor VALÍK, Lenka GESCHEIDTOVÁ, Vladimír ŠRÁMEK, Z. CERMAKOVA and Lenka ZDRAŽILOVÁ DUBSKÁ. Interpretive discrepancies caused by target values inter-batch variations in chemiluminescence immunoassay for SARS-CoV-2 IgM/IgG by MAGLUMI. \textit{Journal of Medical Virology}. Hoboken: Wiley, 2021, vol.~93, No~3, p.~1805-1809. ISSN~0146-6615. Available from: https://dx.doi.org/10.1002/jmv.26612.

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