Lab Med Online.  2020 Jan;10(1):25-32. 10.3343/lmo.2020.10.1.25.

Performance Evaluation of the CS-5100 Coagulation Analyzer for Special Coagulation Parameters

• Kim B
• Jang S
• Lee YJ
• Park N
• Cho YU
• Park CJ

• KMID: 2466762
• DOI: http://doi.org/10.3343/lmo.2020.10.1.25

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.

Keyword

CS-5100; FDP; Anticoagulants; Heparin; Low molecular weight heparin; Direct oral anticoagulant; Performance

MeSH Terms

Anticoagulants
Fibrinogen
Heparin
Heparin, Low-Molecular-Weight
Plasma
Reference Values
Anticoagulants
Fibrinogen
Heparin
Heparin, Low-Molecular-Weight

Figure

• 

  Fig. 1 Linearity of (A) FDP, (B) UFH, (C) LMWH, (D) rivaroxaban, and (E) apixaban measured with the CS-5100 coagulometer. Abbreviations: FDP, fibrinogen degradation product; UFH, unfractionated heparin; LMWH, low molecular weight heparin.

• 

  Fig. 2 Comparison of measured FDP levels between STA-R and CS-5100 coagulometers. (A) Result of Passing-Bablok regression analysis and (B) Bland-Altman plot comparisons of FDP levels.

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