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

Area of Science:

• Clinical Chemistry
• Hematology
• Laboratory Medicine

Background:

• Thrombin-antithrombin complex (TAT), α2-plasmin inhibitor-plasmin complex (PIC), thrombomodulin (TM), and tissue plasminogen activator-plasminogen activator inhibitor complex (t-PAIC) are crucial in diagnosing thrombosis and hemorrhage.
• Current clinical practice lacks standardized performance verification methods for these four hemostasis markers.

Purpose of the Study:

• To evaluate the precision, trueness, carryover, linearity, and reference intervals of TAT, PIC, TM, and t-PAIC.
• To establish reliable performance standards for these indicators in clinical settings.
• To provide data and methodological references for future research.

Main Methods:

• Evaluation of precision, trueness, carryover, linearity, and reference intervals following CLSI guidelines (EP15-A2, EP06-A, C28-A).
• Analysis conducted on the HISCL-5000 analyzer.
• Verification intervals and manufacturer-assigned values were used for bias assessment.

Main Results:

• Within-laboratory coefficients of variation (CVs) were low for all four markers (e.g., TAT: 3.67-4.68%).
• Biases were within acceptable limits, and carryover rates were below 1%.
• Linearity was confirmed with correlation coefficients > 0.99, and manufacturer-provided reference intervals were appropriate.

Conclusions:

• The HISCL-5000 analyzer demonstrates acceptable performance for TAT, PIC, TM, and t-PAIC analysis.
• The system is suitable for clinical diagnostic applications, ensuring reliable hemostasis marker testing.