Performance Verification of High Sensitivity Analyzer for TAT, PIC, TM, and t-PAIC.

Background: Thrombin-antithrombin complex (TAT), a2-plasmininhibitor-plasmin complex (PIC), thrombomodulin (TM), tissue plasminogen activator-plasminogen activator inhibitor complex (t-PAIC) has been increasingly applied in clinical practice in recent years, especially in the diagnosis and treatment of diseases associated with thrombosis and hemorrhage. However, there is no universally accepted evaluation standard for the performance verification of these four indicators currently. Therefore, we designed experiments to verify the precision, trueness, carryover, linearity, and reference intervals of these four indicators. This study is expected to provide references for subsequent research in terms of data and experimental methods. Methods: According to the Clinical and Laboratory Standards Institute (CLSI) guidelines EP15-A2, EP06-A, and C28-A, the precision, trueness, carryover, linearity, and reference intervals were evaluated. Results: The within-laboratory CVs of TAT, PIC, TM, and t-PAIC were 3.67, 6.51, 3.64, and 2.46% on Control L and 4.68, 4.67, 5.08, and 3.87% on Control H. The assigned value of calibrations of TAT, PIC, TM, and t-PAIC were all included in the verification intervals. The biases of the four items of Calibration 1 were -6.67, -0.90, -3.58, and -6.78% and biases on Calibration 2 were -2.70, 1.63, 2.66, and -1.16%, respectively, compared with the assigned value provided by the manufacturer. The carryover rate of each indicator was less than 1%. Within the range that meets clinical use, the best fit curves of the four indicators were linear, and the correlation coefficients of all indicators were greater than 0.99. The reference intervals provided by the manufacturer were appropriate in our laboratory. Conclusion: The performance of HISCL-5000 analyzer for TAT, PIC, TM, and t-PAIC analysis were acceptable and the systems were suitable for clinical analysis.