Standardization of antiphospholipid antibody assays. Where do we stand?
Abstract
The laboratory criteria (lupus anticoagulants (LA), and/or anti-cardiolipin (aCL) antibodies and/or anti-β2-glycoprotein I antibodies (aβ2GPI)) that define patients with antiphospholipid syndrome (APS) were set in the Sapporo and Sydney criteria published in 1999 and 2006, respectively, and led to a substantial improvement in the recognition of APS. In addition, guidelines for LA detection were published by the Scientific Standardisation Subcommittee (SSC) of the International Society of Thrombosis and Haemostasis (ISTH) in 2009. However, a number of questions on this respect remain unresolved. Recommendations for the aCL and aβ2GPI assays intended to ameliorate the performance of these solid-phase assays. Despite efforts over the years, standardization has not been reached. This review will focus on methodological issues of the three antiphospholipid antibody (aPL) subtypes that are the subject of debate. The use of an international standard for aPL detection might help solve many of the problems caused by a lack of standardization of these assays.
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There is currently no established gold standard assay or reference plasma for LA detection.
“As a result, there are currently no established gold standard assays or reference plasmas for LA detection [[6], [7], [8], [9], [10]].”
From Comparison of different algorithms for lupus anticoagulant detection: a single-center experience (2024) · cites this paper as [10]
International External Quality Assessment programs have shown significant inter-laboratory variation, especially for weaker LAC samples.
“International External Quality Assessment programs have shown significant inter-laboratory variation, especially for weaker LAC samples. 2,4,7”
From Clinical Relevance of Isolated Lupus Anticoagulant Positivity in Patients with Thrombotic Antiphospholipid Syndrome (2021) · cites this paper as [2]
Cites
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Update of the guidelines for lupus anticoagulant detection
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Devreese, K. M. J., de Groot, P. G., de Laat, B., Erkan, D., Favaloro, E. J., Mackie, I., Martinuzzo, M., Ortel, T. L., Pengo, V., Rand, J. H., et al. (2020) · Journal of Thrombosis and Haemostasis · doi:10.1111/jth.15047 · Cited by 439 · see citing works
Self-citationTesting for Antiphospholipid antibodies with Solid Phase Assays: guidance from the SSC of the ISTH
Devreese, K. M. J., Pierangeli, S. S., de Laat, B., Tripodi, A., Atsumi, T., & Ortel, T. L. (2014) · Journal of Thrombosis and Haemostasis · doi:10.1111/jth.12537 · Cited by 224 · see citing works
Self-citationAntiphospholipid antibody testing and standardization
Devreese, K. M. J. (2014) · International Journal of Laboratory Hematology · doi:10.1111/ijlh.12234 · Cited by 98 · see citing works
Self-citationMoore, G. W., Culhane, A. P., Daw, C. R., Noronha, C. P., & Kumano, O. (2016) · Thrombosis Research · doi:10.1016/j.thromres.2016.01.019 · Cited by 42 · see citing works
Yin, D., de Groot, P. G., Ninivaggi, M., Devreese, K. M. J., & de Laat, B. (2021) · Thrombosis and Haemostasis · doi:10.1055/a-1344-4271 · Cited by 36 · see citing works
Self-citationCurrent Controversies in Lupus Anticoagulant Detection
Moore, G. (2016) · Antibodies · doi:10.3390/antib5040022 · Cited by 36 · see citing works
Kumano, O., & Moore, G. W. (2018) · Research and Practice in Thrombosis and Haemostasis · doi:10.1002/rth2.12069 · Cited by 26 · see citing works
Fontana, P., Poncet, A., Lindhoff‐Last, E., de Moerloose, P., & Devreese, K. M. (2014) · Journal of Thrombosis and Haemostasis · doi:10.1111/jth.12732 · Cited by 19 · see citing works
Self-citationEvaluation of an automated algorithm for interpretation of lupus anticoagulant testing
Florin, L., Desloovere, M., & Devreese, K. M. J. (2019) · International Journal of Laboratory Hematology · doi:10.1111/ijlh.13001 · Cited by 12 · see citing works
Self-citationComparison of different algorithms for lupus anticoagulant detection: a single-center experience
Apipongrat, D., Lamool, R., Arnutti, P., Ruangpratheep, C., & Chantkran, W. (2024) · Research and Practice in Thrombosis and Haemostasis · doi:10.1016/j.rpth.2024.102333 · Cited by 4 · see citing works
- Authors
- Devreese, K.
- Affiliations
- Coagulation Laboratory, Department of Clinical Chemistry, Microbiology and Immunology, Ghent University Hospital, Gent, Belgium
- Venue
- Lupus
- Publisher
- SAGE Publications
- Published
- 2012-05-25
- Volume
- 21
- Issue
- 7
- Pages
- 718-721
- ISSN
- 0961-2033 (ISSN-L)
- 1477-0962
- OpenAlex
- W2123051496
- Cited by
- 76
- References
- 2
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 5 · 2023: 1 · 2021: 4 · 2020: 6 · 2019: 10 · 2018: 8 · 2017: 6 · 2016: 11 · 2015: 5 · 2014: 9 · 2013: 4 · 2012: 3
- FWCI
- 5.14
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Lupus (publishedVersion)
- PubMed (publishedVersion)
- Ghent University Academic Bibliography (Ghent University) (submittedVersion)
- Topics
- Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
- Health Sciences › Medicine › Hematology › Blood Coagulation and Thrombosis Mechanisms
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Vasculitis and related conditions
- Keywords
- antiphospholipid syndrome, antiphospholipid antibodies, lupus anticoagulant, anticardiolipin antibodies, anti-beta2-glycoprotein I antibodies, assay standardization, international standards, solid-phase immunoassay
- MeSH terms
- Blood Coagulation Tests, Humans, Reference Standards, Antiphospholipid Syndrome, Antibodies, Antiphospholipid
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