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The perspective on standardisation and harmonisation: the viewpoint of the EASI president
Open accessAbstract
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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Classification criteria for a disease should be rather robust in order to enable widespread usage, but as far as autoantibodies are concerned, detection of autoantibodies is not standardized and only poorly harmonized.
“Altogether, it is obvious that classification criteria for a disease should be rather robust in order to enable widespread usage, but as far as autoantibodies are concerned, it should be realized that detection of autoantibodies is not standardized and only poorly harmonized [33].”
From Anti-dsDNA antibodies in the classification criteria of systemic lupus erythematosus (2022) · cites this paper as [33]
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Cited by
Sorted by citations
Anti-dsDNA antibodies in the classification criteria of systemic lupus erythematosus
Infantino, M., Nagy, E., Bizzaro, N., Fischer, K., Bossuyt, X., & Damoiseaux, J. (2022) · Journal of Translational Autoimmunity · doi:10.1016/j.jtauto.2021.100139 · Cited by 38
“Altogether, it is obvious that classification criteria for a disease should be rather robust in order to enable widespread usage, but as far as autoantibodies are concerned, it should be realized that detection of autoantibodies is not standardized and only poorly harmonized [33].”
BackgroundSelf-citation
Metadata
- Authors
- Damoiseaux, J.
- Affiliations
- Maastricht University Medical Centre (NL)
- Corresponding author
- Damoiseaux, Jan
- ORCID
- Damoiseaux, Jan
- Venue
- Autoimmunity Highlights
- Published
- 2020-02-06
- Volume
- 11
- Issue
- 1
- Pages
- 4-4
- ISSN
- 2038-0305 (ISSN-L)
- 2038-3274
- PMC
- PMC7065346
- OpenAlex
- W3012219282
- Cited by
- 34
- References
- 2
- Citations by year
- 2026: 2 · 2025: 6 · 2024: 5 · 2023: 4 · 2022: 6 · 2021: 9 · 2020: 2
- FWCI
- 0.67
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Autoimmunity Highlights (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Research Publications (Maastricht University) (publishedVersion, cc-by)
- Research Publications (Maastricht University) (submittedVersion, other-oa)
- Topics
- Health Sciences › Health Professions › Medical Laboratory Technology › Clinical Laboratory Practices and Quality Control
- Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Advanced Biosensing Techniques and Applications
- Keywords
- assay standardization, harmonization, international reference standards
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