Testing for Antiphospholipid antibodies with Solid Phase Assays: guidance from the SSC of the ISTH
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Transference of manufacturer cutoff values after verification with 20 or 40 normal donors was found reliable by more than 80% of survey respondents.
“More practical, is the transference of the manufacturer's cutoff values after verification using a small number (20 or 40) of normal donors, 68 as often applied for the solid phase assays, 75 and found reliable by more than 80% of the survey”
From Guidance from the Scientific and Standardization Committee for lupus anticoagulant/antiphospholipid antibodies of the International Society on Thrombosis and Haemostasis (2020) · cites this paper as [75]
The Cut-off values calculation section says manufacturers’ cutoffs may be accepted if measurements on 20 or more healthy subjects yield similar results. The Results interpretation table also permits transfer under specified conditions. Neither passage reports a survey or says that more than 80% of respondents found the approach reliable; no page number is available in our copy. (LLM, conf=0.87)
Experimental — accuracy not yet measuredSolid-phase assays for IgG and IgM aCL and aβ2GPI were performed according to international guidelines.
“Solid-phase assays for immunoglobulin (Ig) G and IgM aCL and aβ2GPI were performed according to international guidelines [36].”
From Triple-positive antiphospholipid syndrome does not guarantee positivity in each lupus anticoagulant assay (2023) · cites this paper as [36]
Cut-off values from manufacturers were transferred after confirmation in 20 healthy individuals according to guidelines.
“The cut-off values from the manufacturers were transferred after confirmation in 20 healthy individuals according to the guidelines. 17”
From Clinical Relevance of Isolated Lupus Anticoagulant Positivity in Patients with Thrombotic Antiphospholipid Syndrome (2021) · cites this paper as [17]
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Cites
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- Authors
- Devreese, K. M. J., Pierangeli, S. S., de Laat, B., Tripodi, A., Atsumi, T., & Ortel, T. L.
- Affiliations
- Ghent University Hospital (BE)
- The University of Texas Medical Branch at Galveston (US)
- University of Milan (IT)
- Hokkaido University (JP)
- Duke Medical Center (US)
- Corresponding author
- Devreese, K.M.J.
- Venue
- Journal of Thrombosis and Haemostasis
- Publisher
- Elsevier BV
- Published
- 2014-05
- Volume
- 12
- Issue
- 5
- Pages
- 792-795
- ISSN
- 1538-7836 (ISSN-L)
- OpenAlex
- W2017573410
- Cited by
- 224
- References
- 20
- Citations by year
- 2026: 12 · 2025: 13 · 2024: 20 · 2023: 20 · 2022: 14 · 2021: 17 · 2020: 30 · 2019: 22 · 2018: 27 · 2017: 20 · 2016: 16 · 2015: 10 · 2014: 3
- FWCI
- 13.57
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of Thrombosis and Haemostasis (publishedVersion)
- PubMed (publishedVersion)
- Research Publications (Maastricht University) (publishedVersion, other-oa)
- Ghent University Academic Bibliography (Ghent University) (submittedVersion)
- Research Publications (Maastricht University) (submittedVersion)
- Funders
- Japan Society for the Promotion of Science (26293230, 25670455)
- 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 antibodies, antiphospholipid syndrome, solid-phase immunoassay, anticardiolipin antibodies, anti-beta2-glycoprotein I antibodies, lupus anticoagulant, assay standardization
- MeSH terms
- Calibration, Cardiolipins, Cardiology, Hemostasis, Humans, Immunoassay, International Cooperation, Societies, Medical, Thrombosis, Reproducibility of Results, Lupus Coagulation Inhibitor, Antiphospholipid Syndrome, Antibodies, Antiphospholipid, Guidelines as Topic, Clinical Chemistry Tests, beta 2-Glycoprotein I
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