Investigation of anti-phospholipid syndrome detection system using multiplex EIA

Abstract

Anti-phospholipid syndrome (APS) is an autoimmune thrombosis that appears in association with various anti-phospholipid antibodies (aPLs) in a patient’s blood. The presence of aPLs is associated with clinical events, such as arterial and/or venous thrombosis and recurrent fetal loss. Therefore, it is important to simultaneously measure many aPLs of every patient and identify the types of aPL to determine the condition of APS patients appropriately. In the diagnosis of APS, the presence of aPLs is proved by direct detection using enzyme-linked immunosorbent assay (ELISA). However, while ELISA can determine the quantity of aPLs, it is difficult to measure many samples simultaneously. We have established an analytical system that enables the simultaneous measurement of aPLs, namely, the enzyme immunoassay system (aPLs-EIA) using “ACL AcuStar^®”, and examined the clinical usefulness of measuring the aPL concentration with this system. In this study, we established a diagnostic method that can predict thrombotic complications by measuring aPLs in patients with high thrombosis risk. Multivariate logistic regression analysis revealed that the presence of aDomain1-IgG was most closely associated with arterial thromboembolic complications. In contrast, the presence of aβ₂GPI-IgG was most closely related to venous thromboembolic complications. Moreover, ROC analysis revealed that the accuracy of predicting thrombotic complications based on the results of the multiplex EIA system was higher than that based on the results of aCL/β₂GPI-ELISA. Therefore, in the differential diagnosis of APS, it is essential to detect various aPL subclasses simultaneously, which can be done using this new automated EIA system.