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KMID : 1100820200100010025
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Laboratory Medicine Online
2020 Volume.10 No. 1 p.25 ~ p.32
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Performance Evaluation of the CS-5100 Coagulation Analyzer for Special Coagulation Parameters
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Kim Bo-Hyun
Jang Seong-Soo
Lee Yu-Jin
Park Nu-Ree
Cho Young-Uk
Park Chan-Jeong
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Abstract
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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.
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KEYWORD
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CS-5100, FDP, Anticoagulants, Heparin, Low molecular weight heparin, Direct oral anticoagulant, Performance
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