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Clin Chim Acta. 2018 Oct;485:7-13. doi: 10.1016/j.cca.2018.06.008. Epub 2018 Jun 5.

Assessment of diagnostic methods for the detection of anticardiolipin and anti-βeta2 glycoprotein I antibodies in patients under routine evaluation for antiphospholipid syndrome.

Author information

1
ARUP Institute of Clinical and Experimental Pathology, Salt Lake City, UT, USA.
2
ARUP Institute of Clinical and Experimental Pathology, Salt Lake City, UT, USA; Department of Pathology, University of Utah School of Medicine, Salt Lake City, UT, USA.
3
ARUP Laboratories, Salt Lake City, UT, USA.
4
Rheumatology/Internal Medicine, University of Texas Medical Branch, Galveston, TX, USA.
5
ARUP Institute of Clinical and Experimental Pathology, Salt Lake City, UT, USA; Department of Pathology, University of Utah School of Medicine, Salt Lake City, UT, USA. Electronic address: anne.tebo@hsc.utah.edu.

Abstract

BACKGROUND:

We assessed the performance characteristics and correlations of the traditional enzyme-linked immunosorbent assay (ELISA) and chemiluminescence immunoassay (CIA) for detecting IgG and IgM antibodies to cardiolipin (aCL) and beta2 glycoprotein (anti-β2GPI) antibodies in patients under routine evaluation for APS.

METHODS:

Patients (n = 216) referred to ARUP Laboratories for lupus anticoagulant (LAC) and/or aCL or anti-β2GPI IgG/IgM antibodies evaluation were assessed by ELISA and CIA methods. Diagnostic accuracies, correlations between methods and specific clinical manifestations in APS were investigated.

RESULTS:

The areas under the curve (%) for APS using LAC with CIA (74, 95% CI: 65-82) or ELISA (70, 95% CI: 61-79) aPLs were comparable. The overall agreements and linear regression correlations between methods for aPL antibody of the same specificity were variable: aCL IgG 87.3%; R2 = 0.7491, aCL IgM 71.6%; R2 = 0.2656, anti-β2GPI IgG 77.2%; R2 = 0.7688 and anti-β2GPI IgM 81.7%; R2 = 0.3305.

CONCLUSIONS:

With inclusion of LAC, the ELISA and CIA show comparable performance for the diagnosis of APS. However, correlations of APS-specific manifestations were dependent on method of detecting the aPL antibodies suggesting platforms may not be used interchangeable.

KEYWORDS:

Antibodies; Antiphospholipid syndrome; Beta2 glycoprotein I; Cardiolipin; Performance characteristics

PMID:
29883633
DOI:
10.1016/j.cca.2018.06.008
[Indexed for MEDLINE]

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