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

Autori
Sack, Ulrich ; Bossuyt, Xavier ; Andreeva, Hristina ; Antal-Szalmás, Péter ; Bizzaro, Nicola ; Bogdanos, Dimitrios ; Borzova, Elena ; Conrad, Karsten ; Dragon-Durey, Marie‑Agnes ; Eriksson, Catharina ; Fischer, Katarzyna ; Haapala, Anna‑Maija ; Heijnen, Ingmar ; Herold, Manfred ; Klotz, Werner ; Kozmar, Ana ; Tešija Kuna, Andrea et al.

Izvornik
Autoimmunity Highlights (2038-0305) 11 (2020), 12; 1-9

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, stručni

Ključne riječi
Autoimmunity ; Autoantibodies ; Medical laboratory ; Quality ; Accreditation

Sažetak
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 defned 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 identifed 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 defne a framework for, in particular, EN/ISO accreditation purposes. Here, we present a review of current publications and guidelines in this feld 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.

Izvorni jezik
Engleski

Znanstvena područja
Kliničke medicinske znanosti, Farmacija, Biotehnologija u biomedicini (prirodno područje, biomedicina i zdravstvo, biotehničko područje)

POVEZANOST RADA