TY - JOUR
T1 - Quality and best practice in medical laboratories
T2 - specific requests for autoimmunity testing
AU - Sack, Ulrich
AU - Bossuyt, Xavier
AU - Andreeva, Hristina
AU - Antal-Szalmas, Peter
AU - Bizzaro, Nicola
AU - Bogdanos, Dimitrios
AU - Borzova, Elena
AU - Conrad, Karsten
AU - Dragon-Durey, Marie-Agnes
AU - Eriksson, Catharina
AU - Fischer, Katarzyna
AU - Haapala, Anna-Maija
AU - Heijnen, Ingmar
AU - Herold, Manfred
AU - Klotz, Werner
AU - Kozmar, Ana
AU - Kuna, Andrea Tesija
AU - Hoyos, Marcos Lopez
AU - Malkov, Vladimir A.
AU - Musset, Lucile
AU - Nagy, Eszter
AU - Roennelid, Johan
AU - Shoenfeld, Yehuda
AU - Sundic, Tatjana
AU - Tsirogianni, Alexandra
AU - Uibo, Raivo
AU - Rego Sousa, Maria Jose
AU - Damoiseaux, Jan
AU - European Autoimmunity Standardisation Initiative
N1 - Publisher Copyright:
© 2020 The Author(s).
PY - 2020/9/3
Y1 - 2020/9/3
N2 - 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.
AB - 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.
KW - Autoimmunity
KW - Autoantibodies
KW - Medical laboratory
KW - Quality
KW - Accreditation
KW - INTERNATIONAL CONSENSUS
KW - INDIRECT IMMUNOFLUORESCENCE
KW - EASI-SURVEY
KW - ANTIBODIES
KW - ANA
KW - RECOMMENDATIONS
U2 - 10.1186/s13317-020-00134-0
DO - 10.1186/s13317-020-00134-0
M3 - Article
C2 - 32883353
SN - 2038-0305
VL - 11
JO - Autoimmunity Highlights
JF - Autoimmunity Highlights
IS - 1
M1 - 12
ER -