Evidence map›Paper›PMID 32883353›Full record

ArticleAuto- immunity highlights2020

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

Ulrich Sack, Xavier Bossuyt, Hristina Andreeva, Péter Antal-Szalmás, Nicola Bizzaro, Dimitrios Bogdanos, Elena Borzova, Karsten Conrad, Marie-Agnes Dragon-Durey, Catharina Eriksson and 19 more

Abstract read
In one paragraph

Article in Auto- immunity highlights, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed.

  1. Article
  2. [Quality management in the rheumatology laboratory].Zeitschrift fur Rheumatologie · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

29 authors.

Ulrich SackMedical Faculty, Institute of Clinical Immunology, University Leipzig, Leipzig, Germany. ulrich.sack@medizin.uni-leipzig.de.ORCID http://orcid.org/0000-0002-7813-0492
Xavier BossuytClinical and Diagnostic Immunology, KU Leuven, Louvain, Belgium.
Hristina AndreevaDivision of Immunology and Transfusion Medicine, Department of Laboratory Medicine, University Hospital of North Norway, Tromsoe, Norway.
Péter Antal-SzalmásDepartment of Laboratory Medicine, Faculty of Medicine, University of Debrecen, Debrecen, Hungary.
Nicola BizzaroLaboratorio di Patologia Clinica, Ospedale San Antonio (Tolmezzo), Azienda Sanitaria Universitaria Integrata, Udine, Italy.
Dimitrios BogdanosDepartment of Rheumatology and Clinical Immunology, Faculty of Medicine, University of Thessaly, Larissa, Greece.
Elena BorzovaDepartment of Dermatology and Venereology, I.M. Sechenov First Moscow State Medical University, Moscow, Russia.
Karsten ConradInstitut für Immunologie, Medizinische Fakultät "Carl Gustav Carus" der Technischen Universität Dresden, Dresden, Germany.
Marie-Agnes Dragon-DureyDepartment of Immunology, Georges Pompidou European Hospital, University of Paris, Paris, France.
Catharina ErikssonDepartment of Clinical Microbiology/Clinical Immunology, Umeå University, Umeå, Sweden.
Katarzyna FischerIndividual Laboratory for Rheumatologic Diagnostics, Pomeranian Medical University in Szczecin, Szczecin, Poland.
Anna-Maija HaapalaFimlab Laboratories, Tampere, Finland.
Ingmar HeijnenDivision of Medical Immunology, Laboratory Medicine, University Hospital Basel, Basel, Switzerland.
Manfred HeroldDepartment of Internal Medicine II, Medical University of Innsbruck, Innsbruck, Austria.
Werner KlotzDepartment of Internal Medicine II, Medical University of Innsbruck, Innsbruck, Austria.
Ana KozmarDepartment of Laboratory Diagnostics, University Hospital Centre Zagreb, Zagreb, Croatia.
Andrea Tesija KunaDepartment of Clinical Chemistry, University Hospital Center Sestre Milosrdnice, Zagreb, Croatia.
Marcos López HoyosServicio de Inmunología, Hospital Universitario Marqués de Valdecilla-IDIVAL, Santander, Spain.
Vladimir A MalkovTafi Diagnostica, Vladivostok, Russia.
Lucile MussetDepartment of Immunology, Assistance Publique-Hôpitaux de Paris, Groupe Hospitalier Pitié-Salpêtrière, Paris, France.
Eszter NagyNational Institute of Rheumatology and Physiotherapy, Budapest, Hungary.
Johan RönnelidDepartment of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.
Yehuda ShoenfeldZabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Tel-Hashomer, Israel.
Tatjana SundicDepartment of Immunology and Transfusion Medicine, Stavanger University Hospital, Stavanger, Norway.
Alexandra TsirogianniMedical Biopathologist, Immunology-Histocompatibility Department, "Evangelismos" General Hospital of Athens, Athens, Greece.
Raivo UiboDepartment of Immunology, Institute of Bio- and Translational Medicine, University of Tartu, Tartu, Estonia.
Maria José Rego SousaLaboratório de Imunopatologia e Autoimunidade, UC Medicina Laboratorial, Grupo Germano de Sousa, Lisbon, Portugal.
Jan DamoiseauxMedical Immunology, Maastricht UMC, Maastricht, The Netherlands.
European Autoimmunity Standardisation Initiative

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

AccreditationAutoantibodiesAutoimmunityMedical laboratoryQuality

Identifiers

PMID32883353
PMCPMC7470612

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.