Abstract
Abstract Background Coagulation and fibrinolytic tests are widely used as screening of abnormalities on hemostatic mechanisms, and for thrombosis. Our laboratory routinely receives large number of orders for coagulation and fibrinolytic tests. The monthly average of order is 9700, and these orders are reported as emergency tests. To address the demands, fully automated blood coagulation analyzers that offer a variety of measuring principles such as coagulation time method and photometric method. We have operated three units of the automated blood coagulation CP3000 for eight years. In this eight years, the number of samples in our hospital has been increased. On the other hand, our preparation time before daily set-up has been extended because of the stricter management on quality control to comply with ISO 15189. As a result, we need to do the same procedure on three units and our turnaround time (TAT) has been extended. In November 2021, the blood coagulation analyzer S400CF that offers high throughput and performance was launched. We evaluated basic performance of S400CF and TAT and compared with the CP3000. Methods In the evaluation of basic performance, S400CF (Sekisui Medical) and was used. Correlation was compared with CP3000 (Sekisui Medical). In the comparison of TAT, three units of CP3000 and one unit of S400CF were used and the orders corresponding for the 243 samples that were requested by 7:45 AM–10:08 AM on July 11, 2022 were demonstrated on both analyzers. Results Repeatability:C.V.% 2% or less for all items. Between-day precision: C.V. 8% or less for all items. Correlations were PT-% (N = 135): Y = 1.0477 X − 6.40, PT-INR (N = 135): Y = 0.9612 X + 0.046, APTT (N = 124): Y = 1.0150 X + 0.42, Fbg (N = 112): Y = 1.0284 X + 2.4, AT (N = 52): Y = 0.9700 X, FDP (N = 49): Y = 0.9326 X + 0.06, DD (N = 80): Y = 1.0322 X + 0.279, SF (N = 50): Y = 1.0423 X − 1.73. TAT of CP3000 and S400CF were MIN 1 minutes(min.) 41 seconds(sec.), MAX 14 min. 45 sec. and MIN 1 min. 20 sec., MAX 12 min. 27 sec., respectively. Conclusion It was indicated that one S400CF has three times or more productivity of CP3000. Therefore, the number of blood coagulation analyzers can be reduced from the current three units. And the total time for quality related process such as calibration and control can be saved.Results were equivalent to current CP3000 or better. It indicates that the quality of our current test can be maintained. S400CF has a capability to connect laboratory automation system that saves the time for placing specimen and improves the working efficiency of laboratory technicians. We concluded S400CF can solve the problems in our current operation in blood coagulation test and can contribute to faster report of high-quality test results.
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