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

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.