CS-5100全自动血凝仪检测抗凝血酶Ⅲ、蛋白C、蛋白S活性的性能验证

Performance verification of CS-5100 automatic blood coagulation analyzer for the determinations of antithrombin Ⅲ,protein C and protein S activities

目的评价CS-5100全自动血凝仪(简称CS-5100)检测抗凝血酶Ⅲ(ATⅢ)、蛋白C(Pc)和蛋白S(Ps)活性的性能。方法参照美国临床实验室标准化协会(CLSI)系列指南文件对CS-5100检测ATⅢ、Pc和Ps活性的不精密度[以变异系数(CV)表示]、准确度、线性、携带污染率、参考区间性能进行验证。结果CS-5100检测ATⅢ、Pc和Ps活性的批内不精密度均<1.9%,日间不精密度均<4.1%,符合厂家说明书给定的标准。准确性验证结果偏移在生物学CV要求内。ATⅢ线性验证试验理论值和实测值的回归方程均符合线性回归方程的斜率在(1±0.05)范围内以及r2≥0.95的要求,携带污染率各参数CV<10%。参考区间验证结果显示各项检测指标的R=1,符合要求(R≥0.9),参考区间验证通过。结论 CS-5100检测抗ATⅢ、Pc和Ps活性项目的精密度、准确度、携带污染率、线性结果均符合质量控制的要求,能够保证检验质量。

Objective To evaluate the performance of CS-5100 automatic blood coagulation analyzer for the determinations of antithrombinⅢ(ATⅢ),protein C(Pc)and protein S(Ps)activities.Methods According to the Clinical and Laboratory Standards Institute(CLSI)guidelines,the imprecision[coefficient of variation(CV)],accuracy,linearity,carry-over rate and reference interval of CS-5100 for the determinations of ATⅢ,Pc and Ps activities were validated.Results The within-run CV of CS-5100 for the determinations of ATⅢ,Pc and Ps activities were<1.9%,and the inter-day CV were<4.1%,meeting manufacturers'requirements.The bias of accuracy verification results was within biology CV requirements.The linear regression equation between ATⅢlinear validation theoretical value and measured values met the slope of 1±0.05,the determination coefficient(r2)≥0.95 and carry-over CV<10%.Reference interval verification results showed that the determination index R was≥0.9.Conclusions The precision,accuracy,linearity,carry-over rate and reference interval of CS-5100 meet the requirements of quality control,which can ensure determination quality.