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Cited by 53Systemic Lupus Erythematosus ResearchClinical Laboratory Practices and Quality ControlVasculitis and related conditions

Evaluation of a new set of automated chemiluminescense assays for anticardiolipin and anti-beta2-glycoprotein I antibodies in the laboratory diagnosis of the antiphospholipid syndrome

Persijn, Lies, Decavele, An-Sofie, Schouwers, Sofie, Devreese, Katrien·2011·Thrombosis Research
DOI 10.1016/j.thromres.2011.04.004
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Abstract

Introduction The laboratory diagnosis of antiphospholipid syndrome (APS) requires the demonstration of antiphospholipid antibodies (aPL): lupus anticoagulant (LAC) measured through coagulation assays, anticardiolipin IgG or IgM antibodies (aCL) and/or anti-β2glycoprotein I IgG or IgM antibodies (aβ2GPI), usually detected by ELISA.Materials and methods We evaluated the diagnostic value of aCL and aβ2GPI measured by a new automated system using the chemiluminescence principle, the immunoanalyzer Zenit RA (Menarini).Results Results of aCL and aβ2GPI were correlated with the clinical background of the patients and with results of ELISA (n=314). Correlated to the clinical background sensitivity/specificity ranged for aCL IgG between 7.5-45.2% / 54.2-98.8%, for aCL IgM 3.4-5.5% / 89.9-94%, for aβ2GPI IgG 5.5-25.3% / 75.6-100% and aβ2GPI IgM 3.4-4.8% / 89.9-92.3%, depending on the cut-off used. Sensitivity with manufacturer's cut-offs was comparable to ELISA, except for aβ2GPI IgG with a significantly lower sensitivity compared to ELISA (5.5% vs 11.6%). In the APS patient population (n=30) sensitivity of aCL IgG and aβ2GPI IgG was higher measured by ELISA compared to Zenit RA (46.7% vs 30.0%, and 46.7% vs 26.7%, respectively). Agreement between Zenit RA results and ELISA results for the four parameters was moderate (Kappa-values ranging 0.509-0.565). Sensitivity was 38.5%, 53.3%, 40% and 69.2% for aCL IgG, aCL IgM, aβ2GPI IgG and aβ2GPI IgM, respectively, applying the highest cut-off value for Zenit RA, raising towards 64.3%, 100%, 57.1%, for aCL IgG, aCL IgM, aβ2GPI IgG, respectively, in a APS patient population.Conclusions The new technology of chemiluminescense for measuring aPL showed good performance characteristics. Interpretation of results with a cut-off value associated with a good discrimination for disease, resulted in a lower sensitivity for the diagnosis of APS for aβ2GPI IgG measured by Zenit RA assays compared to ELISA; sensitivity for aCL IgG was comparable to ELISA. Specificity for all parameters was high and comparable for aCL and aβ2GPI.

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Authors
Persijn, L., Decavele, A.-S., Schouwers, S., & Devreese, K.
Affiliations
Ghent University Hospital (BE)
Corresponding author
Devreese, Katrien
ORCID
Venue
Thrombosis Research
Publisher
Elsevier BV
Published
2011-12
Volume
128
Issue
6
Pages
565-569
ISSN
0049-3848 (ISSN-L)
DOI
10.1016/j.thromres.2011.04.004
OpenAlex
W2051067744
Cited by
53
References
24
Citations by year
2025: 2 · 2024: 1 · 2023: 1 · 2022: 2 · 2021: 3 · 2020: 5 · 2019: 4 · 2018: 5 · 2017: 3 · 2016: 7 · 2015: 5 · 2014: 2 · 2013: 4 · 2012: 8
FWCI
3.49
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Thrombosis Research (publishedVersion)
  • PubMed (publishedVersion)
  • Ghent University Academic Bibliography (Ghent University) (submittedVersion)
Topics
  • Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
  • Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Vasculitis and related conditions
Keywords
antiphospholipid syndrome, anticardiolipin antibodies, anti-beta2-glycoprotein I antibodies, chemiluminescence immunoassay, ELISA comparison, sensitivity and specificity, lupus anticoagulant, cut-off values, assay agreement
MeSH terms
Enzyme-Linked Immunosorbent Assay, Humans, Immunoglobulin G, Immunoglobulin M, Luminescent Measurements, Predictive Value of Tests, Reagent Kits, Diagnostic, Retrospective Studies, Antiphospholipid Syndrome, Antibodies, Anticardiolipin, beta 2-Glycoprotein I

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