迈瑞CX-9000全自动凝血分析仪性能评估

Performance evaluation of Mindray CX-9000 automatic coagulation analyzer

目的:对迈瑞CX-9000全自动凝血分析仪的性能进行验证评估。方法:参照行业标准和国家标准,通过凝血酶原时间(prothrombin time,PT)、活化部分凝血活酶时间(activated partial thromboplastin time,APTT)、纤维蛋白原(fibrinogen,FIB)、凝血酶时间(thrombin time,TT)、D-二聚体5个凝血常规检查项目对迈瑞CX-9000全自动凝血分析仪进行性能验证,评估该仪器的精密度、准确度、线性范围、携带污染率及参考区间能否满足临床需求。结果:5个凝血常规检查项目的批内精密度变异系数(coefficient of variation,CV)均<3%,日间精密度CV均<5%,准确度相对偏差在±10%以内。FIB的线性回归方程斜率k为1.0060,相关系数r为0.9993,D-二聚体的线性回归方程k为1.0132,r为0.9975,线性良好。样本浓度携带污染率CR1为4.6%,项目携带污染率CR2均<2%,参考区间R值均为100%,均符合行业标准要求,验证通过。结论:迈瑞CX-9000全自动凝血分析仪是一款精密度好、准确度高、线性范围宽、携带污染率低的检测系统,能够满足临床需求。

Objective To verify and evaluate the performance of Mindray CX-9000 automatic coagulation analyzer.Methods Myriad CX-9000 automatic coagulation analyzer had its performance validated and evaluated by five routine coagulation tests with reference to the industry including standard prothrombin time(PT),activated partial thromboplastin time(APTT),fibrino-gen(FIB),thrombin time(TT)and D-dimer,so as to clarity whether the analyzer meets the clinical requirements in terms of precision,accuracy,linear range,carry-over and reference interval.Results The five routine coagulation tests had the intra-batch precision CVs lower than 3%,the inter-day precision CVs lower than 5%and the relative deviations of the accuracies within±10%.The slope k of the linear regression equation was 1.0060 for FIB and 1.0132 for D-dimer,and the correlation coefficient r was 0.9993 for FIB and 0.9975 for D-dimer,which showed high linearity.The carry-over rate of sample concen-tration(CR1)was 4.6%,and the carry-over rate between test items(CR2)was lower than 2%;the R value of the reference interval was 100%;the requirements of industrial standards were met.Conclusion Mindray CX-9000 automatic coagulation analyzer gains advantages in precision,accuracy,linear range and carry-over,and is worthy promoting clinically.