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Cited by 66Systemic Lupus Erythematosus ResearchClinical Laboratory Practices and Quality ControlBlood Coagulation and Thrombosis Mechanisms

Semiquantitative interpretation of anticardiolipin and antiβ2glycoprotein I antibodies measured with various analytical platforms: Communication from the ISTH SSC Subcommittee on Lupus Anticoagulant/Antiphospholipid Antibodies

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Vandevelde, Arne, Chayoua, Walid, de Laat, Bas, Gris, Jean‐Christophe, Moore, Gary W., Musiał, Jacek, Zuily, Stéphane, Wahl, Denis +1 more·2022·Journal of Thrombosis and Haemostasis
DOI 10.1111/jth.15585
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Abstract

Background Antiβ2glycoprotein I (aβ2GPI) and anticardiolipin (aCL) IgG/IgM show differences in positive/negative agreement and titers between solid phase platforms. Method-specific semiquantitative categorization of titers could improve and harmonize the interpretation across platforms. Aim To evaluate the traditional 40/80-unit thresholds used for aCL and aβ2GPI for categorization into moderate/high positivity with different analytical systems, and to compare with alternative thresholds. Material and methods aCL and aβ2GPI thresholds were calculated for two automated systems (chemiluminescent immunoassay [CLIA] and multiplex flow immunoassay [MFI]) by receiver operating characteristic curve analysis on 1108 patient samples, including patients with and without antiphospholipid syndrome (APS), and confirmed on a second population (n = 279). Alternatively, regression analysis on diluted standard material was applied to identify thresholds. Thresholds were compared to 40/80 threshold measured by an enzyme-linked immunosorbent assay (ELISA). Additionally, likelihood ratios (LR) were calculated. Results Threshold levels of 40/80 units show poor agreement between ELISA and automated platforms for classification into low/moderate/high positivity, especially for aCL/aβ2GPI IgG. Agreement for semiquantitative interpretation of antiphospholipid antibodies (aPL) IgG between ELISA and CLIA/MFI improves with alternative thresholds. LR for aPL IgG increase for thrombotic and obstetric APS based on 40/80 thresholds for ELISA and adapted thresholds for the other systems, but not for IgM. Conclusion Use of 40/80 units as medium/high thresholds is acceptable for aCL/aβ2GPI IgG ELISA, but not for CLIA and MFI. Alternative semiquantitative thresholds for non-ELISA platforms can be determined by a clinical approach or by using monoclonal antibodies. Semiquantitative reporting of aPL IgM has less impact on increasing probability for APS.

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  • No data support the use of fixed cut-off values.

    “although no data support the use of fixed cut-off values [6, 7].”

    From Insights into the 2023 ACR/EULAR antiphospholipid syndrome classification criteria: findings from a cohort of 205 patients with primary APS (2025) · cites this paper as [6]

    The conclusion (Additional information; page not provided) says the study demonstrated that fixed thresholds of 40 and 80 units are acceptable for aCL IgG and anti-β2GPI IgG measured by ELISA. It cautions that those thresholds cannot be applied to CLIA or MFI platforms, but that is narrower than the claim that no data support fixed cut-offs at all. (LLM, conf=0.88)

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Authors
Vandevelde, A., Chayoua, W., de Laat, B., Gris, J., Moore, G. W., Musiał, J., Zuily, S., Wahl, D., & Devreese, K. M. J.
Affiliations
  • Ghent University Hospital (BE)
  • Inserm (FR)
  • St Thomas' Hospital (GB)
  • Jagiellonian University (PL)
Corresponding author
Devreese, Katrien M.J.
ORCID
Venue
Journal of Thrombosis and Haemostasis
Publisher
Elsevier BV
Published
2022-02
Volume
20
Issue
2
Pages
508-524
ISSN
1538-7836 (ISSN-L)
DOI
10.1111/jth.15585
OpenAlex
W3211562983
Cited by
66
References
5
Citations by year
2026: 10 · 2025: 14 · 2024: 20 · 2023: 15 · 2022: 7
FWCI
7.78
Type
journal article
Language
en
Open access
Licence
Locations
  • Journal of Thrombosis and Haemostasis (publishedVersion)
  • PubMed (publishedVersion)
  • Middlesex University Research Repository (Middlesex University Of London) (acceptedVersion)
  • Research Publications (Maastricht University) (submittedVersion, other-oa)
  • Jagiellonian University Repository (Jagiellonian University) (submittedVersion, other-oa)
  • Jagiellonian University Repository (Jagiellonian University) (submittedVersion, cc-by-nc-nd)
  • Homo Politicus (Academy of Humanities and Economics in Lodz) (submittedVersion, cc-by-nc-nd)
  • HAL (submittedVersion)
  • Ghent University Academic Bibliography (Ghent University) (submittedVersion)
  • Research Publications (Maastricht University) (submittedVersion)
Topics
  • Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
  • Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
  • Health Sciences › Medicine › Hematology › Blood Coagulation and Thrombosis Mechanisms
Keywords
anticardiolipin antibodies, antiphospholipid syndrome, chemiluminescence immunoassay, ELISA, likelihood ratios
MeSH terms
Female, Humans, Pregnancy, Lupus Coagulation Inhibitor, Antibodies, Antiphospholipid, Antibodies, Anticardiolipin, beta 2-Glycoprotein I

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