Mattia Elena, Ruffatti Amelia, Meneghel Lauro, Tonello Marta, Faggian Diego, Hoxha Ariela, Fedrigo Marny, Punzi Leonardo, Plebani Mario
Rheumatology Unit, Department of Medicine, University of Padova, Via Giustiniani 2, 35128 Padova, Italy.
Rheumatology Unit, Department of Medicine, University of Padova, Via Giustiniani 2, 35128 Padova, Italy.
Clin Chim Acta. 2015 Jun 15;446:93-6. doi: 10.1016/j.cca.2015.04.012. Epub 2015 Apr 17.
Currently, ELISA for detection of anticardiolipin (aCL) and anti-β2glycoprotein I (anti-β2GPI) antibodies is not standardized. Recently, few studies have compared the performance of ELISA with that of fluorescence enzyme immunoassay (FEIA), but they have produced debatable results. The aim of this investigation was to compare ELISA with FEIA results in detecting aCL and anti-β2GPI antibodies.
The study cohort included 94 primary antiphospholipid syndrome (PAPS) patients, 65 subjects with the clinical criteria for PAPS classification but ELISA negative for the laboratory criteria and 165 control subjects. Serum IgG/IgM aCL/anti-β2GPI antibodies were determined using FEIA-EliA™ and a home-made ELISA.
The sensitivities of the two methods were similar with the exception of IgM aCL which was found to be significantly higher in the PAPS patients using the ELISA method, even if IgM aCL was detected at a low level by both techniques. The two assays had a comparable specificity, a high/significant agreement and a significant correlation between the antibody levels. FEIA testing uncovered no significant prevalence of any antiphospholipid (aPL) antibody in the ELISA negative patients.
Our results suggest that FEIA is comparable to a home-made ELISA.
目前，用于检测抗心磷脂（aCL）和抗β2糖蛋白I（抗β2GPI）抗体的酶联免疫吸附测定（ELISA）尚未标准化。最近，很少有研究比较ELISA与荧光酶免疫测定（FEIA）的性能，但得出了有争议的结果。本研究的目的是比较ELISA与FEIA检测aCL和抗β2GPI抗体的结果。
研究队列包括94例原发性抗磷脂综合征（PAPS）患者、65例符合PAPS分类临床标准但ELISA实验室标准阴性的受试者以及165例对照受试者。使用FEIA-EliA™和自制ELISA测定血清IgG/IgM aCL/抗β2GPI抗体。
两种方法的敏感性相似，但IgM aCL除外，ELISA法检测PAPS患者的IgM aCL显著更高，即使两种技术检测到的IgM aCL水平都很低。两种检测方法具有相当的特异性、高度/显著的一致性以及抗体水平之间的显著相关性。FEIA检测未发现ELISA阴性患者中任何抗磷脂（aPL）抗体的显著流行。
我们的结果表明，FEIA与自制ELISA相当。
