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

The result's identifiers

  • Result code in IS VaVaI

    <a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00209805%3A_____%2F21%3A00078471" target="_blank" >RIV/00209805:_____/21:00078471 - isvavai.cz</a>

  • Alternative codes found

    RIV/00159816:_____/20:00073377 RIV/65269705:_____/21:00074236

  • Result on the web

    <a href="https://onlinelibrary.wiley.com/doi/epdf/10.1002/jmv.26612" target="_blank" >https://onlinelibrary.wiley.com/doi/epdf/10.1002/jmv.26612</a>

  • DOI - Digital Object Identifier

    <a href="http://dx.doi.org/10.1002/jmv.26612" target="_blank" >10.1002/jmv.26612</a>

Alternative languages

  • Result language

    angličtina

  • Original language name

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

  • Original language description

    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/immunoglobulinG (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.

  • Czech name

  • Czech description

Classification

  • Type

    J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database

  • CEP classification

  • OECD FORD branch

    30102 - Immunology

Result continuities

  • Project

    <a href="/en/project/LM2018125" target="_blank" >LM2018125: Bank of Clinical Samples</a><br>

  • Continuities

    P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)

Others

  • Publication year

    2021

  • Confidentiality

    S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Data specific for result type

  • Name of the periodical

    Journal of medical virology

  • ISSN

    0146-6615

  • e-ISSN

  • Volume of the periodical

    93

  • Issue of the periodical within the volume

    3

  • Country of publishing house

    US - UNITED STATES

  • Number of pages

    5

  • Pages from-to

    1805-1809

  • UT code for WoS article

    000583206600001

  • EID of the result in the Scopus database

    2-s2.0-85094640715