Quality and best practice in medical laboratories: Specific requests for autoimmunity testing

Ulrich Sack, Xavier Bossuyt, Hristina Andreeva, Péter Antal-Szalmás, Nicola Bizzaro, Dimitrios Bogdanos, Elena Borzova, Karsten Conrad, Marie Agnes Dragon-Durey, Catharina Eriksson, Katarzyna Fischer, Anna Maija Haapala, Ingmar Heijnen, Manfred Herold, Werner Klotz, Ana Kozmar, Andrea Tesija Kuna, Marcos López Hoyos, Vladimir A. Malkov, Lucile MussetEszter Nagy, Johan Rönnelid, Yehuda Shoenfeld, Tatjana Sundic, Alexandra Tsirogianni, Raivo Uibo, Maria José Rego Sousa, Jan Damoiseaux

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Article number12
JournalAutoimmunity Highlights
Volume11
Issue number1
DOIs
StatePublished - 3 Sep 2020
Externally publishedYes

Keywords

  • Accreditation
  • Autoantibodies
  • Autoimmunity
  • Medical laboratory
  • Quality

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