Accreditation in autoimmune diagnostic laboratories. A position paper of the European Autoimmunity Standardisation Initiative (EASI).
Reliable autoantibody detection is important for early diagnosis and appropriate treatment of autoimmune disorders. However, in contrast to testing for classical clinical chemistry analytes, autoantibody testing is complex and evolving. Moreover, there is a lack of standardization. Nevertheless, it is important that laboratories that provide autoimmune tests comply with the requirements set forward by general international accreditation bodies. In the present manuscript, an ad hoc committee of the European Autoimmunity Standardisation Initiative (EASI) group provides background information on accreditation and identifies the minimum requirements needed to set up an accredited autoimmunity lab and to ensure that high-quality results are provided (in terms of personnel, procedures, validation, quality control, and reporting). Areas in which additional work needs to be done are identified.
Laboratorio di Patologia Clinica, Ospedale San Antonio, Tolmezzo, Italy. Electronic address: nicola.bizzaro@asuiud.sanita.fvg.it.
Nicola
N
Bizzaro
Laboratory Medicine, University Hospitals Leuven, Department of Microbiology and Immunology, KU Leuven, Belgium. Electronic address: xavier.bossuyt@uzleuven.be.
Xavier
X
Bossuyt
Department of Clinical Microbiology, Fimlab Laboratory, Tampere, Finland. Electronic address: Anna-Maija.Haapala@fimlab.fi.
Anna-Maija
AM
Haapala
Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Tel Hashomer, Israel. Electronic address: Yehuda.Shoenfeld@sheba.health.gov.il.
Yehuda
Y
Shoenfeld
Universitätsklinikum Leipzig, Department für Diagnostik, Institut für Klinische Immunologie, Leipzig, Germany. Electronic address: Ulrich.Sack@medizin.uni-leipzig.de.
Ulrich
U
Sack
D000068:Accreditation; D001323:Autoantibodies / Q000097:blood; D001327:Autoimmune Diseases / Q000097:blood / Q000175:diagnosis*; D015551:Autoimmunity; D005060:Europe; D006801:Humans; D059232:Laboratory Personnel; D017410:Practice Guidelines as Topic; D011786:Quality Control; D012015:Reference Standards
D001323:Autoantibodies
Accreditation; Autoantibodies; Laboratory diagnosis; Quality management; Validation