Basic evaluation of the CS-5100, a Fully Automated Blood Coagulation Analyzer

• Basic evaluation of the CS-5100, a Fully Automated Blood Coagulation Analyzer

AUTHOR(S)

Masayuki TOKU^*１, Emi TAKEO^*１, Chisa MATSUMOTO^*１, Kanako KISHI^*１, Etsuji SUEHISA^*１ and Hiroshi HIDAKA^*２

*1 Clinical Laboratory, Department of Medical Technology, Osaka University Hospital
*2 Laboratory for Clinical Investigation, Osaka University Hospital

SUMMARY

A blood coagulation/fibrinolytic test is regarded as a clinically useful hemostatic test. This test is conducted to detect hemorrhagic or thrombotic predisposition, clarify pathological conditions in emergency medical care or before/after surgery, or monitor the course of treatment. Medical technologists are expected to quickly provide consistently accurate comprehensive measurement results. Generally, presently available fully automated blood coagulation analyzers adopt a complex system that enables high-speed processing and simultaneous measurement of multiple items required by the coagulation time method, synthetic substrate method and turbidimetric immunoassay. However, only a few models are compatible with the delivery line system that has been introduced to improve work efficiency. Analyzers that allow loading of general-purpose reagents are also limited. Recently, we introduced the CS-5100, a new fully automated blood coagulation analyzer, ( hereinafter referred to as CS-5100 ; Sysmex Corporation, Kobe, Japan ) that is compatible with the delivery line and accepts multiple samples for the evaluation of multiple measurements. The purpose of this integration of measurement systems was to utilize the work space more effectively and to improve work efficiency. We conducted a basic evaluation of the CS-5100 and here report the results.

We evaluated within-run reproducibility by calculating the coefficient of variability ( CV ) of each method, and obtained the following satisfactory results: ≤ 2% ( coagulation method ), ≤ 5% ( synthetic substrate method ) and ≤ 4% ( turbidimetric immunoassay ). In the dilution linearity test, satisfactory linearity was observed up to the following levels: 750 mg/dL ( fibrinogen ), 80 μg/mL [ total fibrin/fibrinogen degradation products ( T-FDP ) ] and 25 μg/mL ( D-dimer ). The minimum detection sensitivity was high in the case of measurements conducted on the same items. Clinical samples were used to compare the CS-5100 with conventional analyzers. Results of the evaluation of various items showed correlation coefficients that consistently exceeded 0.99.

Introduction of the CS-5100, an analyzer possessing the ability of high-speed processing of multiple samples/items, has enabled the integration of measurement systems, which has led to a reduction in hemostatic delivery line space by about 30%. A comparison was made between the CS-5100 and conventional analyzers with respect to TAT. Results showed no reduction in TAT with the CS-5100. Since the TAT required by the CS-5100 was equivalent to that required by conventional analyzers, the comparison results were considered to be satisfactory.

KEY WORDS

Fully Automated Blood Coagulation Analyzer (CS-5100), Multifunction/High-Speed Processing, Compatibility with Delivery Line, Multi-Wave Detection System, Sample Quality Check, Wavelength Switching

NOTE(S)

This article is translated and republished from the Sysmex Journal Web Vol. 14 No. 3, 2013. (Japanese)