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The perspective on standardisation and harmonisation: the viewpoint of the EASI president

Authors
  • Damoiseaux, Jan1
  • 1 Maastricht University Medical Center, P. Debyelaan 25, Maastricht, 6229 HX, The Netherlands , Maastricht (Netherlands)
Type
Published Article
Journal
Autoimmunity Highlights
Publisher
BioMed Central
Publication Date
Feb 06, 2020
Volume
11
Issue
1
Identifiers
DOI: 10.1186/s13317-020-0127-3
Source
Springer Nature
Keywords
License
Green

Abstract

Standardisation of immuno-assays for autoantibodies is a major challenge. Although multiple organisations participate in the generation of internationally accepted standards, adequate standardisation of assays has not yet been achieved. Harmonisation may offer an alternative approach to better align requesting, testing, reporting and interpretation of autoimmune diagnostics. The European Autoimmunity Standardisation Initiative (EASI) was founded to facilitate both standardisation as well as harmonisation of autoantibody tests, but over the years the focus has drifted away from standardisation in favour of harmonisation. In the current paper the options for harmonisation are highlighted.

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