Establishment of ABEI-based direct chemiluminescence immunoassays for PIC, TAT, tPAIC, and TM and their preliminary evaluation in thrombotic diseases†

Abstract

Thromboembolism is a leading cause of mortality worldwide. Screening and diagnosis are essential for the prevention and control of thrombotic diseases. This study evaluated four newly developed chemiluminescence assays for the detection of α2-plasmininhibitor-plasmin complex (PIC), thrombin–antithrombin III complex (TAT), tissue plasminogen activator-plasminogen activator inhibitor complex (tPAIC) and thrombomodulin (TM) based on an N-(4-aminobutyl)-N-ethylisoluminol (ABEI)-hydrogen peroxide (H₂O₂) system. Results demonstrated that the proposed MAGLUMI PIC, TAT, tPAIC and TM tests exhibited good analytical performance and were in good concordance with the SYSMEX system. Compared with the controls, patients with thrombotic diseases exhibited significantly elevated levels of TAT, PIC, TM, and tPAIC in disseminated intravascular coagulation (DIC) and elevated levels of TAT, PIC, and tPAIC in ischemic stroke (IS). Logistic regression analysis and receiver operating characteristic (ROC) curve analysis showed that combined PIC and tPAIC contributed to the best area under the curve (AUC) value of 0.915 (95% confidence interval (CI): 0.859–0.959) for DIC diagnosis. The diagnostic system formed using TAT, PIC, and tPAIC could be used for IS diagnosis with an AUC value of 0.839 (95% CI: 0.762–0.899). Our study demonstrates the good performance of MAGLUMI TAT, PIC, tPAIC and TM CLIA tests, suggesting their potential for thrombotic disease diagnosis, and the combination of these thrombosis markers could provide an enhancement in diagnostic efficacy.