Quality and best practice in medical laboratories: specific requests for autoimmunity testing
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Autoimmunity Highlights Open Access
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Quality and best practice in medical laboratories: specific requests for autoimmunity testing Ulrich Sack1* , Xavier Bossuyt2, Hristina Andreeva3, Péter Antal‑Szalmás4, Nicola Bizzaro5, Dimitrios Bogdanos6, Elena Borzova7, Karsten Conrad8, Marie‑Agnes Dragon‑Durey9, Catharina Eriksson10, Katarzyna Fischer11, Anna‑Maija Haapala12, Ingmar Heijnen13, Manfred Herold14, Werner Klotz14, Ana Kozmar15, Andrea Tesija Kuna16, Marcos López Hoyos17, Vladimir A. Malkov18, Lucile Musset19, Eszter Nagy20, Johan Rönnelid21, Yehuda Shoenfeld22, Tatjana Sundic23, Alexandra Tsirogianni24, Raivo Uibo25, Maria José Rego Sousa26, Jan Damoiseaux27 and on behalf of the European Autoimmunity Standardisation Initiative
Abstract Special conditions associated with laboratory autoimmune testing are not well compatible with recent develop‑ ments 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 Neth‑ erlands 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 look‑ ing 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. Keywords: Autoimmunity, Autoantibodies, Medical laboratory, Quality, Accreditation Introduction Quality management is an important task for medical laboratories involved in patient care and translational research. It guarantees correct and meaningful laboratory results supporting medical care and innovation. *Correspondence: [email protected]‑leipzig.de 1 Medical Faculty, Institute of Clinical Immunology, University Leipzig, Leipzig, Germany Full list of author information is available at the end of the article
New in vitro diagnostic regulations (IVD-R) in the European Union [1], and comparable regulations worldwide, define high standards for diagnostic test kits. If available, medical laboratories are obliged to use test kits that have been registered by the authorities. This market authorization will b
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