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  • Sack, UlrichUniv Leipzig, Med Fac, Inst Clin Immunol, Leipzig, Germany. (author)

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

  • Article/chapterEnglish2020

Publisher, publication year, extent ...

  • 2020-09-03
  • Springer,2020
  • electronicrdacarrier

Numbers

  • LIBRIS-ID:oai:DiVA.org:umu-175130
  • https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-175130URI
  • https://doi.org/10.1186/s13317-020-00134-0DOI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-421317URI

Supplementary language notes

  • Language:English
  • Summary in:English

Part of subdatabase

Classification

  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • 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.

Subject headings and genre

Added entries (persons, corporate bodies, meetings, titles ...)

  • Bossuyt, XavierKatholieke Univ Leuven, Clin & Diagnost Immunol, Louvain, Belgium. (author)
  • Andreeva, HristinaUniv Hosp North Norway, Dept Lab Med, Div Immunol & Transfus Med, Tromso, Norway. (author)
  • Antal-Szalmas, PeterUniv Debrecen, Fac Med, Dept Lab Med, Debrecen, Hungary. (author)
  • Bizzaro, NicolaAzienda Sanit Univ Integrata, Lab Patol Clin, Osped San Antonio Tolmezzo, Udine, Italy. (author)
  • Bogdanos, DimitriosUniv Thessaly, Fac Med, Dept Rheumatol & Clin Immunol, Larisa, Greece. (author)
  • Borzova, ElenaIM Sechenov First Moscow State Med Univ, Dept Dermatol & Venereol, Moscow, Russia. (author)
  • Conrad, KarstenTech Univ Dresden, Med Fak Carl Gustav Carus, Inst Immunol, Dresden, Germany. (author)
  • Dragon-Durey, Marie-AgnesUniv Paris, Georges Pompidou European Hosp, Dept Immunol, Paris, France. (author)
  • Eriksson, Catharina,1955-Umeå universitet,Klinisk immunologi,Umeå Univ, Dept Clin Microbiol Clin Immunol, Umeå, Sweden.(Swepub:umu)caaern74 (author)
  • Fischer, KatarzynaPomeranian Med Univ, Individual Lab Rheumatol Diagnost, Szczecin, Poland. (author)
  • Haapala, Anna-MaijaFimlab Labs, Tampere, Finland. (author)
  • Heijnen, IngmarUniv Hosp Basel, Div Med Immunol, Lab Med, Basel, Switzerland. (author)
  • Herold, ManfredMed Univ Innsbruck, Dept Internal Med 2, Innsbruck, Austria. (author)
  • Klotz, WernerMed Univ Innsbruck, Dept Internal Med 2, Innsbruck, Austria. (author)
  • Kozmar, AnaUniv Hosp Ctr Zagreb, Dept Lab Diagnost, Zagreb, Croatia. (author)
  • Kuna, Andrea TesijaUniv Hosp Ctr Sestre Milosrdnice, Dept Clin Chem, Zagreb, Croatia. (author)
  • Hoyos, Marcos LopezHosp Univ Marques de Valdecilla IDIVAL, Serv Inmunol, Santander, Spain. (author)
  • Malkov, Vladimir A.Tafi Diagnost, Vladivostok, Russia. (author)
  • Musset, LucileGrp Hosp Pitie Salpetriere, AP HP, Dept Immunol, Paris, France. (author)
  • Nagy, EszterNatl Inst Rheumatism & Physiotherapy, Budapest, Hungary. (author)
  • Rönnelid, JohanUppsala universitet,Klinisk immunologi(Swepub:uu)joharonn (author)
  • Shoenfeld, YehudaSheba Med Ctr, Zabludowicz Ctr Autoimmune Dis, Tel Hashomer, Israel. (author)
  • Sundic, TatjanaStavanger Univ Hosp, Dept Immunol & Transfus Med, Stavanger, Norway. (author)
  • Tsirogianni, AlexandraEvangelismos Gen Hosp Athens, Immunol Histocompatibil Dept, Athens, Greece. (author)
  • Uibo, RaivoUniv Tartu, Inst Bio & Translat Med, Dept Immunol, Tartu, Estonia. (author)
  • Rego Sousa, Maria JoseGrp Germano Sousa, UC Med Lab, Lab Imunopatol & Autoimunidade, Lisbon, Portugal. (author)
  • Damoiseaux, JanMaastricht UMC, Med Immunol, Maastricht, Netherlands. (author)
  • Univ Leipzig, Med Fac, Inst Clin Immunol, Leipzig, Germany.Katholieke Univ Leuven, Clin & Diagnost Immunol, Louvain, Belgium. (creator_code:org_t)

Related titles

  • In:Autoimmun Highlights: Springer11:12038-03052038-3274

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