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Quality and best pr...
Quality and best practice in medical laboratories : specific requests for autoimmunity testing
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- Sack, Ulrich (författare)
- Univ Leipzig, Med Fac, Inst Clin Immunol, Leipzig, Germany.
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- Bossuyt, Xavier (författare)
- Katholieke Univ Leuven, Clin & Diagnost Immunol, Louvain, Belgium.
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- Andreeva, Hristina (författare)
- Univ Hosp North Norway, Dept Lab Med, Div Immunol & Transfus Med, Tromso, Norway.
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- Antal-Szalmas, Peter (författare)
- Univ Debrecen, Fac Med, Dept Lab Med, Debrecen, Hungary.
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- Bizzaro, Nicola (författare)
- Azienda Sanit Univ Integrata, Lab Patol Clin, Osped San Antonio Tolmezzo, Udine, Italy.
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- Bogdanos, Dimitrios (författare)
- Univ Thessaly, Fac Med, Dept Rheumatol & Clin Immunol, Larisa, Greece.
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- Borzova, Elena (författare)
- IM Sechenov First Moscow State Med Univ, Dept Dermatol & Venereol, Moscow, Russia.
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- Conrad, Karsten (författare)
- Tech Univ Dresden, Med Fak Carl Gustav Carus, Inst Immunol, Dresden, Germany.
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- Dragon-Durey, Marie-Agnes (författare)
- Univ Paris, Georges Pompidou European Hosp, Dept Immunol, Paris, France.
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- Eriksson, Catharina, 1955- (författare)
- Umeå universitet,Klinisk immunologi,Umeå Univ, Dept Clin Microbiol Clin Immunol, Umeå, Sweden.
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- Fischer, Katarzyna (författare)
- Pomeranian Med Univ, Individual Lab Rheumatol Diagnost, Szczecin, Poland.
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- Haapala, Anna-Maija (författare)
- Fimlab Labs, Tampere, Finland.
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- Heijnen, Ingmar (författare)
- Univ Hosp Basel, Div Med Immunol, Lab Med, Basel, Switzerland.
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- Herold, Manfred (författare)
- Med Univ Innsbruck, Dept Internal Med 2, Innsbruck, Austria.
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- Klotz, Werner (författare)
- Med Univ Innsbruck, Dept Internal Med 2, Innsbruck, Austria.
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- Kozmar, Ana (författare)
- Univ Hosp Ctr Zagreb, Dept Lab Diagnost, Zagreb, Croatia.
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- Kuna, Andrea Tesija (författare)
- Univ Hosp Ctr Sestre Milosrdnice, Dept Clin Chem, Zagreb, Croatia.
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- Hoyos, Marcos Lopez (författare)
- Hosp Univ Marques de Valdecilla IDIVAL, Serv Inmunol, Santander, Spain.
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- Malkov, Vladimir A. (författare)
- Tafi Diagnost, Vladivostok, Russia.
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- Musset, Lucile (författare)
- Grp Hosp Pitie Salpetriere, AP HP, Dept Immunol, Paris, France.
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- Nagy, Eszter (författare)
- Natl Inst Rheumatism & Physiotherapy, Budapest, Hungary.
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- Rönnelid, Johan (författare)
- Uppsala universitet,Klinisk immunologi
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- Shoenfeld, Yehuda (författare)
- Sheba Med Ctr, Zabludowicz Ctr Autoimmune Dis, Tel Hashomer, Israel.
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- Sundic, Tatjana (författare)
- Stavanger Univ Hosp, Dept Immunol & Transfus Med, Stavanger, Norway.
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- Tsirogianni, Alexandra (författare)
- Evangelismos Gen Hosp Athens, Immunol Histocompatibil Dept, Athens, Greece.
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- Uibo, Raivo (författare)
- Univ Tartu, Inst Bio & Translat Med, Dept Immunol, Tartu, Estonia.
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- Rego Sousa, Maria Jose (författare)
- Grp Germano Sousa, UC Med Lab, Lab Imunopatol & Autoimunidade, Lisbon, Portugal.
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- Damoiseaux, Jan (författare)
- Maastricht UMC, Med Immunol, Maastricht, Netherlands.
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Univ Leipzig, Med Fac, Inst Clin Immunol, Leipzig, Germany Katholieke Univ Leuven, Clin & Diagnost Immunol, Louvain, Belgium. (creator_code:org_t)
- 2020-09-03
- 2020
- Engelska.
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Ingår i: Autoimmun Highlights. - : Springer. - 2038-0305 .- 2038-3274. ; 11:1
- Relaterad länk:
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https://doi.org/10.1...
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https://umu.diva-por... (primary) (Raw object)
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https://autoimmunhig...
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https://uu.diva-port... (primary) (Raw object)
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https://urn.kb.se/re...
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https://doi.org/10.1...
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https://urn.kb.se/re...
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Abstract
Ämnesord
Stäng
- 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.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Reumatologi och inflammation (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Rheumatology and Autoimmunity (hsv//eng)
Nyckelord
- Autoimmunity
- Autoantibodies
- Medical laboratory
- Quality
- Accreditation
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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Till lärosätets databas
- Av författaren/redakt...
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Sack, Ulrich
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Bossuyt, Xavier
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Andreeva, Hristi ...
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Antal-Szalmas, P ...
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Bizzaro, Nicola
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Bogdanos, Dimitr ...
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visa fler...
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Borzova, Elena
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Conrad, Karsten
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Dragon-Durey, Ma ...
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Eriksson, Cathar ...
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Fischer, Katarzy ...
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Haapala, Anna-Ma ...
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Heijnen, Ingmar
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Herold, Manfred
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Klotz, Werner
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Kozmar, Ana
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Kuna, Andrea Tes ...
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Hoyos, Marcos Lo ...
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Malkov, Vladimir ...
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Musset, Lucile
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Nagy, Eszter
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Rönnelid, Johan
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Shoenfeld, Yehud ...
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Sundic, Tatjana
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Tsirogianni, Ale ...
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Uibo, Raivo
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Rego Sousa, Mari ...
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Damoiseaux, Jan
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- Om ämnet
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Reumatologi och ...
- Artiklar i publikationen
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Autoimmun Highli ...
- Av lärosätet
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Umeå universitet
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Uppsala universitet