Quality and best practice in medical laboratories : specific requests for autoimmunity testing
| Autor: | Tatjana Sundic, Lucile Musset, Yehuda Shoenfeld, Ana Kozmar, Vladimir A. Malkov, Katarzyna Fischer, Anna-Maija Haapala, Werner Klotz, Catharina Eriksson, Hristina Andreeva, Ulrich Sack, Maria José Rego Sousa, Péter Antal-Szalmás, Dimitrios P. Bogdanos, Johan Rönnelid, Alexandra Tsirogianni, Ingmar Heijnen, Raivo Uibo, Nicola Bizzaro, Jan Damoiseaux, Karsten Conrad, Eszter Nagy, Andrea Tešija Kuna, Marie-Agnès Dragon-Durey, Marcos López Hoyos, Xavier Bossuyt, Elena Borzova, Manfred Herold |
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| Přispěvatelé: | Faculteit FHML Centraal, RS: NUTRIM - R3 - Respiratory & Age-related Health, MUMC+: DA CDL Algemeen (9) |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Autoimmunity
Autoantibodies Medical laboratory Quality Accreditation Medical device Best practice media_common.quotation_subject INDIRECT IMMUNOFLUORESCENCE Immunology Guideline In vitro diagnostic RECOMMENDATIONS Rheumatology Political science Quality (business) media_common Rheumatology and Autoimmunity Medical education Reumatologi och inflammation Indirect immunofluorescence business.industry INTERNATIONAL CONSENSUS ANA ANTIBODIES EASI-SURVEY business Quality assurance |
| Zdroj: | Autoimmunity Highlights, 11(1):12. Springer Verlag Autoimmunity Highlights |
| ISSN: | 2038-0305 |
| Popis: | 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. ispartof: AUTOIMMUNITY HIGHLIGHTS vol:11 issue:1 ispartof: location:England status: published |
| Databáze: | OpenAIRE |
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