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

Author:

Dragon-Durey Marie-Agnès1,Bizzaro Nicola2,Senant Marie3,Andreeva Hristina4,Bogdanos Dimitrios P.5,Bonroy Carolien6,Bossuyt Xavier7,Eriksson Catharina8,Fabien Nicole9,Heijnen Ingmar10,Herold Manfred11,Musset Lucile12,Kuhi Liisa13,Lopez-Hoyos Marcos14,Berki Tímea15,Roozendaal Caroline16,Sack Ulrich17,Sundic Tatjana18,Taylor Lorna19,Kuna Andrea Tesija20ORCID,Damoiseaux Jan21

Affiliation:

1. Laboratoire d’Immunologie , Hôpital Européen Georges Pompidou, APHP, Université de Paris Cité , Paris , France

2. Laboratory of Clinical Pathology , San Antonio Hospital, Azienda Sanitaria Universitaria Integrata , Udine , Italy

3. Cerballiance , Lisses , France

4. Section of Protein, Allergy and Immunology, Laboratory Medicine Department, Diagnostic Clinic , University Hospital of North Norway , Tromsø , Norway

5. Department of Rheumatology and Clinical Immunology, Faculty of Medicine, School of Health Sciences , University of Thessaly, University General Hospital of Larissa , Larissa , Greece

6. Department of Diagnostic Sciences , Ghent University , Ghent , Belgium ; and Department of Laboratory Medicine , Ghent University Hospital , Ghent , Belgium

7. Department of Microbiology, Immunology and Transplantation , KU Leuven , Belgium and Department of Laboratory Medicine, University Hospitals Leuven , Leuven , Belgium

8. Department of Clinical Microbiology, Division of Infection and Immunology , Umeå University , Umeå , Sweden

9. Immunology department , Hospices Civils de Lyon , Pierre-Bénite , France

10. Medical Immunology, Laboratory Medicine , University Hospital Basel , Basel , Switzerland

11. Rheumatology Laboratory, Department of Internal Medicine II , Medical University of Innsbruck , Innsbruck , Austria

12. Département d’Immunologie, UF immunochimie & autoimmunité , CHU Pitié Salpêtrière-Ch Foix, APHP , Paris , France

13. Central Laboratory , Diagnostic Clinic, East Tallinn Central Hospital , Tallinn , Estonia

14. Servicio de Inmunología , Hospital Universitario Marqués de Valdecilla , Santander , Cantabria , Spain

15. Department of Immunology and Biotechnology , University of Pécs, Medical School , Pécs , Hungary

16. Department of Laboratory Medicine , University Medical Center Groningen, University of Groningen , Groningen , The Netherlands

17. Medical Faculty , Institute of Clinical Immunology, University Leipzig , Leipzig , Germany

18. Immunology and Transfusion Medicine, Department of Laboratory Medicine , Haugesund Hospital , Haugesund , Norway

19. Department of Immunology , Black Country Pathology Services , Wolverhampton , West Midlands , UK

20. Department of Clinical Chemistry , Sestre Milosrdnice University Hospital Center , Zagreb , Croatia

21. Central Diagnostic Laboratory , Maastricht University Medical Center , Maastricht , The Netherlands

Abstract

Abstract Objectives 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. Methods 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). Results 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. Conclusions 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.

Funder

Fondazione IRCCS Policlinico San Matteo

Università degli Studi di Firenze

University of Thessaly

KU Leuven

Vrije Universiteit Amsterdam

Publisher

Walter de Gruyter GmbH

Subject

Biochemistry (medical),Clinical Biochemistry,General Medicine

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