Quality and best practice in medical laboratories: specific requests for autoimmunity testingShow others and affiliations
2020 (English)In: Autoimmun Highlights, ISSN 2038-0305, Vol. 11, no 1, article id 12Article in journal (Refereed) Published
Abstract [en]
Special conditions associated with laboratory autoimmune testing are not well compatible with recent developments in regulatory frameworks such as EN/ISO 15189 accreditation or in vitro diagnostic medical device regulation (IVD-R). In addition, international recommendations, guidelines and disease criteria are poorly defined with respect to requirements on autoantibody testing. Laboratory specialists from Austria, Belgium, Croatia, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Norway, Poland, Portugal, South Africa, Spain, Sweden, Switzerland, and The Netherlands collected information, reported national experience, and identified quality issues in relation to autoantibody testing that require consensus on interpretation of the regulatory frameworks and guidelines. This process has been organized by the European Autoimmunity Standardisation Initiative (EASI). By identifying the critical items and looking for a consensus, our objective was to define a framework for, in particular, EN/ISO accreditation purposes. Here, we present a review of current publications and guidelines in this field to unify national guidelines and deliver in this way a European handout on quality control and accreditation for laboratories involved in autoantibody testing. We focus on quality items that can be checked during accreditation visits. Despite various local varieties, we encountered an overwhelming dedication to quality assurance in all contributing countries.
Place, publisher, year, edition, pages
Springer, 2020. Vol. 11, no 1, article id 12
Keywords [en]
Autoimmunity, Autoantibodies, Medical laboratory, Quality, Accreditation
National Category
Clinical Medicine
Identifiers
URN: urn:nbn:se:umu:diva-175130DOI: 10.1186/s13317-020-00134-0ISI: 000565763900001PubMedID: 32883353Scopus ID: 2-s2.0-85088638098OAI: oai:DiVA.org:umu-175130DiVA, id: diva2:1471045
2020-09-282020-09-282025-02-18Bibliographically approved