Repository of intra-and inter-run variations of quantitative autoantibody assays: A European multicenter study

Marie Agnès Dragon-Durey*, Nicola Bizzaro, Marie Senant, Hristina Andreeva, Dimitrios P. Bogdanos, Carolien Bonroy, Xavier Bossuyt, Catharina Eriksson, Nicole Fabien, Ingmar Heijnen, Manfred Herold, Lucile Musset, Liisa Kuhi, Marcos Lopez-Hoyos, Tímea Berki, Caroline Roozendaal, Ulrich Sack, Tatjana Sundic, Lorna Taylor, Andrea Tesija KunaJan Damoiseaux

*Bijbehorende auteur voor dit werk

    OnderzoeksoutputAcademicpeer review


    No reference data are available on repositories to measure precision of autoantibody assays. The scope of this study was to document inter-and intra-run variations of quantitative autoantibody assays based on a real-world large international data set. Members of the European Autoimmunity Standardisation Initiative (EASI) group collected the data of intra-and inter-run variability obtained with assays quantifying 15 different autoantibodies in voluntary participating laboratories from their country. We analyzed the impact on the assay performances of the type of immunoassay, the number of measurements used to calculate the coefficient of variation (CVs), the nature and the autoantibody level of the internal quality control (IQC). Data were obtained from 64 laboratories from 15 European countries between February and October 2021. We analyzed 686 and 1,331 values of intra-and inter-run CVs, respectively. Both CVs were significantly dependent on: The method of immunoassay, the level of IQC with higher imprecision observed when the antibody levels were lower than 2-fold the threshold for positivity, and the nature of the IQC with commercial IQCs having lower CVs than patients-derived IQCs. Our analyses also show that the type of autoantibody has low impact on the assay' performances and that 15 measurements are sufficient to establish reliable intra-and inter-run variations. This study provides for the first time an international repository yielding values of intra-and inter-run variation for quantitative autoantibody assays. These data could be useful for ISO 15189 accreditation requirements and will allow clinical diagnostic laboratories to assure quality of patient results.

    Originele taal-2English
    Pagina's (van-tot)1373-1384
    Aantal pagina's11
    TijdschriftClinical chemistry and laboratory medicine
    Nummer van het tijdschrift9
    Vroegere onlinedatum24-jun-2022
    StatusPublished - 26-aug-2022

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