A unique antiphospholipid assay recognizing phospholipid mixture compared with criteria antiphospholipid immunoassays in lupus patients

作者：Zuo Y; Willis R; Papalardo E; Petri M; Harris E N; Schleh A; DeCeulaer K; Smikle M; Vila L M; Reveille J D; Alarcon G S; Gonzalez E B^*

来源：Lupus, 2017, 26(6): 606-615.

DOI：10.1177/0961203316671812

• Anticardiolipin antibodies
• antiphospholipid syndrome
• classification
• pregnancy morbidity
• thrombosis

Background While essential for the classification of antiphospholipid syndrome (APS), anticardiolipin (aCL) assays lack specificity and anti-2glycoproteinI (anti-2GPI) assays lack sensitivity in this regard. Our aim was to perform a comparative analysis of the APhL ELISA assay (IgG/IgM) and criteria antiphospholipid (aPL) immunoassays in identifying APS-related clinical manifestations in a large group of patients with systemic lupus erythematosus (SLE).
Methods Serum samples from 1178 patients from the Hopkins (n=543), LUMINA (n=588) and Jamaican SLE cohorts (n=47) were examined for IgG/IgM positivity in aCL (in-house), anti-2GPI (two commercial kits) and APhL (Louisville APL) ELISA assays. Correlation of assay positivity with clinical manifestations and sensitivity, specificity, positive and negative predictive values and likelihood ratios were evaluated. A case series analysis was also performed in patients for whom there was isolated positivity in the specific aPL assays.
Results The prevalence of aCL positivity was 34.9%, anti-2GPI kit A was 22.6%, APhL was 11.5% and anti-2GPI kit B was 7.6% in the study population. Anti-2GPI kit B, aCL and APhL assays were correlated with venous thrombosis, while only APhL was significantly correlated with arterial thrombosis and consistently correlated with pregnancy-related morbidity. No significant correlations were noted for anti-2GPI kit A. Sensitivity was greatest for aCL assays followed by anti-2GPI kit A, APhL and anti-2GPI kit B, while specificity was greatest and equal for anti-2GPI kit B and APhL assays.
Conclusions Overall, APhL antibodies, especially IgG, represent a promising biomarker for the classification of APS patients in the context of autoimmunity and in risk assessment with regards to pregnancy morbidity and thrombotic manifestations.

• 出版日期2017-5