Performance evaluation of thrombomodulin, thrombin‐antithrombin complex, plasmin‐α2‐antiplasmin complex, and t‐PA: PAI‐1 complex

Abstract

BACKGROUND: To conduct a comprehensive performance evaluation of a fully automated analyzer for measuring thrombomodulin (TM), thrombin-antithrombin complex (TAT), plasmin-α2-antiplasmin complex (PAP), and t-PA: PAI-1 complex (tPAI-C). METHODS: According to the Clinical and Laboratory Standards Institute (CLSI) EP05-A2, EP06-A specifications, TM, TAT, PAP, and tPAI-C were analyzed to evaluate intraassay variability and interassay variability, linear range, carryover rate, reference range, sample stability, and interferences. RESULTS: The intraassay variability and interassay variability of the four factors were all below 5%. The carryover rates were below 1%. Linear verification analysis revealed correlation coefficients of 0.998-0.999. The recommended reference ranges of TM, TAT, and PAP were appropriate for our laboratory, whereas the reference of tPAI-C should be established by each laboratory. Stability assessment revealed that TM is stable for 2 days at room temperature but lacks stability at colder temperatures. In contrast, TAT is stable for 5 days at 4°C and -20°C but has poor stability at room temperature. PAP and tPAI-C are stable for 3 days at all three temperatures. The measurement of TM, TAT, PAP, and tPAI-C is not altered by the presence of 510 mg/dL hemoglobin, 1490 FTU triglycerides, or 21.1 mg/dL conjugated and free bilirubin. CONCLUSION: The determination of TM, TAT, PAP, and tPAI-C using a high-sensitivity chemiluminescence analyzer performs well in terms of precision, carryover rate, linear range, and interference. Thus, this method is suitable for the detection of these substances in clinical specimens.