Department of Laboratory Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Korea.
Department of Laboratory Medicine, Soonchunhyang University Seoul Hospital, Seoul, Korea.
Ann Clin Lab Sci. 2021 Jan;51(1):112-119.
CP3000 coagulation analyzer is a high-throughput, fully automated coagulation analyzer. The objective of this study was to evaluate the analytical performance of CP3000 coagulation system for general and special coagulation analyses. Quality control materials and patient samples were used to evaluate the analytical performance of CP3000 coagulation system. Precision, carryover, linearity, comparability with ACL-TOP 700 coagulation system, and verification of reference range were evaluated or performed according to Clinical and Laboratory Standards Institute guidelines. Within-run and between-run precisions were below 5% for both normal and abnormal ranges. There was no detectable carryover. The linearity of antithrombin and fibrinogen were excellent. The comparability between CP3000 and ACL-TOP 700 coagulation systems was acceptable except for activated partial thromboplastin time and thrombin time due to differences in reagent composition. Reference ranges proposed by the manufacturer were verified to be acceptable. CP3000 coagulation system is a reliable system that can be used to perform routine and special coagulation tests rapidly and accurately. Because of its small footprint as an additional advantage, the implementation of CP3000 coagulation system can be efficient in hospital laboratories of various sizes.
CP3000 凝血分析仪是一种高通量、全自动的凝血分析仪。本研究旨在评估 CP3000 凝血系统在一般和特殊凝血分析中的分析性能。使用质控材料和患者样本评估 CP3000 凝血系统的分析性能。根据临床和实验室标准协会的指南评估或进行精密度、携带污染、线性、与 ACL-TOP 700 凝血系统的可比性以及参考范围的验证。正常和异常范围内的批内和批间精密度均低于 5%。未检测到携带污染。抗凝血酶和纤维蛋白原的线性度良好。CP3000 和 ACL-TOP 700 凝血系统之间的可比性除了由于试剂组成不同导致的活化部分凝血活酶时间和凝血酶时间外，其余均可以接受。制造商提出的参考范围经过验证是可以接受的。CP3000 凝血系统是一种可靠的系统，可用于快速准确地进行常规和特殊凝血检测。由于其占地面积小，作为额外的优势，CP3000 凝血系统的实施可以在各种规模的医院实验室中高效进行。
