Refinement of the cutoff values of the HemosIL AcuStar assay for the detection of anticardiolipin and anti‐beta2 glycoprotein‐1 antibodies
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Background The HemosIL AcuStar antiphospholipid assay (Instrumentation Laboratory, Bedford, MA, USA) is a fully automated assay using chemiluminescent technology for the detection of anticardiolipin and anti-beta2 glycoprotein-1 antibodies. This assay showed excellent agreement between results of different laboratories. The cutoff values to define positivity were calculated in 250 healthy blood bank donors but were associated with large confidence intervals (CIs).Objective The objective of this study was to more precisely determine the cutoff values of the HemosIL AcuStar antiphospholipid assay by increasing the number of healthy blood bank donors through a multicenter study and by applying a normalization procedure of the distribution of each antibody.Methods Five laboratories participated to this study, allowing the inclusion of 626 samples. We used a Box-Cox power transformation method to normalize the distribution and calculate the 99th percentile and the corresponding 95%CI for each antibody.Results The revised cutoff values were overall lower than those initially calculated with more stringent CIs and yielded a 4.2% increase in sensitivity with a 2.7% decrease in specificity regarding thrombotic events or obstetric complications.Conclusions We provide refined cutoff values for the detection of anticardiolipin and anti-beta2 glycoprotein-1 antibodies with the HemosIL AcuStar Antiphospholipid assay that should be preferred for routine use.
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Using multiple centers can improve the accuracy of aCL and aβ2GPI cutoff values by testing more healthy donors.
“Previously, it was demonstrated that a multicenter approach can determine the cutoff values of aCL and aβ2GPI antibodies with a higher accuracy by increasing the number of healthy donors.76”
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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
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- Authors
- Fontana, P., Poncet, A., Lindhoff‐Last, E., de Moerloose, P., & Devreese, K. M.
- Affiliations
- University of Geneva (CH)
- University Hospital Frankfurt (DE)
- Ghent University Hospital (BE)
- Corresponding author
- Fontana, P.
- Venue
- Journal of Thrombosis and Haemostasis
- Publisher
- Elsevier BV
- Published
- 2014-12
- Volume
- 12
- Issue
- 12
- Pages
- 2034-2037
- ISSN
- 1538-7836 (ISSN-L)
- OpenAlex
- W1987991996
- Cited by
- 19
- References
- 15
- Citations by year
- 2025: 2 · 2024: 1 · 2023: 4 · 2022: 1 · 2021: 1 · 2020: 2 · 2019: 1 · 2018: 1 · 2017: 1 · 2016: 3 · 2015: 2
- FWCI
- 1.66
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of Thrombosis and Haemostasis (publishedVersion)
- PubMed (publishedVersion)
- Archive ouverte UNIGE (University of Geneva) (publishedVersion)
- Ghent University Academic Bibliography (Ghent University) (submittedVersion)
- Archive ouverte UNIGE (University of Geneva) (submittedVersion, cc-by)
- Topics
- Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
- Health Sciences › Medicine › Hematology › Blood Coagulation and Thrombosis Mechanisms
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Keywords
- antiphospholipid antibodies, anticardiolipin antibodies, cut-off values, chemiluminescence immunoassay, healthy blood donors, assay sensitivity and specificity, thrombotic complications, pregnancy complications
- MeSH terms
- Adult, Algorithms, Antibodies, Automation, Blood Donors, Cardiolipins, Female, Humans, Male, Middle Aged, Reference Values, Sensitivity and Specificity, Thrombosis, Reproducibility of Results, Proportional Hazards Models, Antiphospholipid Syndrome, Antibodies, Anticardiolipin, Clinical Laboratory Techniques, Luminescence, beta 2-Glycoprotein I, Healthy Volunteers
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