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Repository of intra...
Repository of intra-and inter-run variations of quantitative autoantibody assays: A European multicenter study
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- Dragon-Durey, Marie-Agnès (author)
- Laboratoire d'Immunologie, Hôpital Européen Georges Pompidou, APHP, Université de Paris Cité, Paris, France
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- Bizzaro, Nicola (author)
- Laboratory of Clinical Pathology, San Antonio Hospital, Azienda Sanitaria Universitaria Integrata, Udine, Italy
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- Senant, Marie (author)
- Cerballiance, Lisses, France
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- Andreeva, Hristina (author)
- Section of Protein Allergy and Immunology, Laboratory Medicine Department, Diagnostic Clinic, University Hospital of North Norway, Tromsø, Norway
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- Bogdanos, Dimitrios P. (author)
- Department of Rheumatology and Clinical Immunology, Fac. of Med., Sch. of Hlth. Sciences, University of Thessaly, University General Hospital of Larissa, Larissa, Greece
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- Bonroy, Carolien (author)
- Department of Diagnostic Sciences, Ghent University, Ghent, Belgium
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- Bossuyt, Xavier (author)
- Department of Microbiology, Immunology and Transplantation, Ku Leuven, Belgium
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- Eriksson, Catharina, 1955- (author)
- Umeå universitet,Klinisk immunologi
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- Fabien, Nicole (author)
- Immunology Department, Hospices Civils de Lyon, Pierre-Bénite, France
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- Heijnen, Ingmar (author)
- Medical Immunology, Laboratory Medicine, University Hospital Basel, Basel, Switzerland
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- Herold, Manfred (author)
- Rheumatology Laboratory, Department of Internal Medicine Ii, Medical University of Innsbruck, Innsbruck, Austria
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- Musset, Lucile (author)
- Département d'Immunologie, Uf Immunochimie and Autoimmunité, Chu Pitié Salpêtrière-Ch Foix, Aphp, Paris, France
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- Kuhi, Liisa (author)
- Central Laboratory, Diagnostic Clinic, East Tallinn Central Hospital, Tallinn, Estonia
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- Lopez-Hoyos, Marcos (author)
- Servicio de Inmunología, Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain
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- Berki, Tímea (author)
- Department of Immunology and Biotechnology, University of Pécs, Medical School, Pécs, Hungary
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- Roozendaal, Caroline (author)
- Department of Laboratory Medicine, University Medical Center Groningen, University of Groningen, Groningen, Netherlands
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- Sack, Ulrich (author)
- Medical Faculty, Institute of Clinical Immunology, University Leipzig, Leipzig, Germany
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- Sundic, Tatjana (author)
- Immunology and Transfusion Medicine, Department of Laboratory Medicine, Haugesund Hospital, Haugesund, Norway
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- Taylor, Lorna (author)
- Department of Immunology, Black Country Pathology Services, Wolverhampton, West Midlands, United Kingdom
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- Kuna, Andrea Tesija (author)
- Department of Clinical Chemistry, Sestre Milosrdnice University Hospital Center, Zagreb, Croatia
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- Damoiseaux, Jan (author)
- Central Diagnostic Laboratory, Maastricht University Medical Center, Maastricht, Netherlands
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(creator_code:org_t)
- 2022-06-24
- 2022
- English.
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In: Clinical Chemistry and Laboratory Medicine. - : De Gruyter Open. - 1434-6621 .- 1437-4331. ; 60:9, s. 1373-1383
- Related links:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Subject headings
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Klinisk laboratoriemedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Clinical Laboratory Medicine (hsv//eng)
Keyword
- immunoassay
- inter-run variation
- internal quality control
- intra-run variation
- laboratory accreditation
- precision
- quality assurance
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Dragon-Durey, Ma ...
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Bizzaro, Nicola
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Senant, Marie
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Andreeva, Hristi ...
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Bogdanos, Dimitr ...
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Bonroy, Carolien
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Bossuyt, Xavier
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Eriksson, Cathar ...
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Fabien, Nicole
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Heijnen, Ingmar
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Herold, Manfred
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Musset, Lucile
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Kuhi, Liisa
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Lopez-Hoyos, Mar ...
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Berki, Tímea
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Roozendaal, Caro ...
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Sack, Ulrich
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Sundic, Tatjana
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Taylor, Lorna
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Kuna, Andrea Tes ...
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Damoiseaux, Jan
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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Clinical Chemist ...
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Umeå University