2024 Volume 73 Issue 3 Pages 467-476
In this study, we evaluated the basic performance of S400CF, an automated blood coagulation analyzer newly developed by Sekisui Medical Co. Repeatability and Intermediate Precision, determined using two density control reagents, yielded favorable results. On-board stability was examined using similar samples and found to be significantly superior to that of the existing analyzer, Coapresta 2000 (CP2000, Sekisui Medical Co., Ltd.). We also assessed the effects of coexisting substances (hemoglobin, chyle, free bilirubin, conjugated bilirubin, and rheumatoid factor) using Interference Check A Plus and Interference Check RF Plus (Sysmex Corporation). Up to the permissible limit concentrations specified in the package insert of each measuring reagent, no interference effects were detected for these substances. The correlation between S400CF and CP2000 was good, with correlation coefficients exceeding 0.9 and slopes ranging from 0.9 to 1.1. Dilution linearity was examined using a series of dilutions made by diluting the high-value sample for each measurement item with saline solution. The dilution linearity surpassed the upper limit of the measurement range stated on the package insert of each measurement reagent. The detection limits determined using low-value samples for each measurement item were well-below the lower limit of the measurement range stated on the package insert of each measurement reagent. The processing speed evaluated using control reagents and patient plasma was significantly improved compared with that of CP2000. In conclusion, S400CF exhibits favorable basic performance and is considered to be sufficiently useful for routine tests.
