Quality and best practice in medical laboratories: specific requests for autoimmunity testing
Ulrich Sack, Xavier Bossuyt, Hristina Andreeva, Péter Antal‐Szalmás, Nicola Bizzaro, Dimitrios P. Bogdanos, Elena Borzova, Karsten Conrad, Marie‐Agnès Dragon‐Durey, Catharina Eriksson, Katarzyna Fischer, Anna‐Maija Haapala, Ingmar Heijnen, Manfred Herold, Werner Klotz, Ana Kozmar, Andrea Tešija Kuna, Marcos López‐Hoyos, V. Malkov, Lucile Musset, Eszter Nagy, Johan Rönnelid, Yehuda Shoenfeld, Tatjana Sundic, Alexandra Tsirogianni, Raivo Uibo, Maria José Rego de Sousa, Jan Damoiseaux, on behalf of the European Autoimmunity Standardisation Initiative
Abstract
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.