혈액응고장비 CS-5100의 특수혈액응고 항목 성능 평가

Abstract

Background: The CS-5100 high-throughput automated coagulometer (Sysmex, Japan) can perform general and special coagulation assays. We evaluated the performance of the CS-5100 coagulometer to measure fibrinogen degradation product (FDP), plasma level of unfractionated heparin (UFH), low molecular weight heparin (LMWH), and direct oral anticoagulants (DOACs). Methods: Precision, linearity, and carryover rate of the CS-5100 while measuring FDP, UFH, and LMWH were validated. Precision and linearity were validated for measurements of DOACs. Results of FDP measurement using CS-5100 were compared to those using the currently used STA-R coagulometer (Diagnostica Stago, France). The reference range of FDP was established. All evaluation procedures were in accordance with Clinical and Laboratory Standards Institute guidelines. Results: CS-5100 displayed good precision, linearity, and carryover rate for measuring FDP, UFH, LMWH, and DOACs. The FDP level measured with the CS-5100 and STA-R coagulometers correlated well. The reference range of FDP with CS-5100 was 0.0 to 3.48 µg/mL. Conclusions: The CS-5100 coagulometer has acceptable analytical performance in measuring special coagulation parameters. It is suitable for the reliable measurement of plasma FDP and anticoagulant levels in clinical laboratories.