Sysmex CS2000i全自动凝血分析仪性能评价

Evaluation on performance of Sysmex CS2000i Automatic Blood Coagulation Analysis System

目的对Sysmex CS2000i全自动凝血分析仪(以下简称"CS2000i仪")的性能进行系统评价。方法根据美国临床和实验室标准化协会(CLSI)相关标准对CS2000i仪进行精密度、准确度、线性、生物参考区间、携带污染率评价,同时用CS2000i仪与Sysmex CA1500全自动凝血分析仪检测5份临床标本,并进行比较。结果 CS2000i仪检测凝血酶原时间、活化部分凝血活酶时间、凝血酶时间、纤维蛋白原、D-二聚体等主要参数的批内、日间不精密度变异系数、携带污染、准确度、线性等均符合该室质量目标。结论 CS2000i仪各方面性能良好,检测结果可用于临床诊治相关疾病。

Objective To systematically evaluate the performance of the Sysmex CS2000i Automatic Blood Coagulation Analysis System. Methods According to the standards of the Clinical and Laboratory Standards Institute（CLSI） ,the precision,accuracy,linearity, biological reference interval and carry-over rates of the Sysmex CS2000i Automatic Blood Coagulation Analysis System were detected,meanwhile the detections of 5 clinical specimens were compared between this system and the Sysmex CA1500 Automatic Blood Coagulation Analysis System. Results The intra-assay precision coefficient of variation （CV） ,inter-day precisions CV carry- over rate, accuracy and linearity of plasma prothrombin time, activated partial thromboplastin time, fibrinogen and D-dimmer detected by the Sysmex CS2000i Automatic Blood Coagulation Analysis System were all consistent with the quality target requirements of our laboratory. Conclusion The Sysmex CS2000i Automatic Blood Coagulation Analysis System has better performance in various aspects, the detection results could be used for the clinical diagnosis and treatment of related diseases.