全自动电化学发光分析仪检测系统性能验证

Performance Verification on Automatic Electrochemical Luminescence Analyzer

目的对新的检测系统罗氏Cobas 6000 E602全自动电化学发光分析仪的分析性能做规范验证。方法依据美国临床实验室标准化协会(CLSI)指南文件EP-15A3、EP-9A2、EP-6A的要求,对罗氏Cobas 6000 E602全自动电化学发光分析仪开展的总共15个项目的精密度、准确度、线性范围等3个性能进行验证,并与厂商声明的性能或公认的质量标准进行比较。结果该全自动电化学发光分析仪检测的15个项目批内精密度分布为(1.66±1.10)%,批间精密度分布为(2.50±1.51)%,均小于厂家声明的不精密度;所有项目对卫计委20份室间质控品检测结果与靶值进行比对,结果全部满分,显示准确度良好;所有15个项目实测相关系数r^2在0.989 2~0.999 8,证明在厂商声明的线性范围之内的实测值线性良好。结论罗氏Cobas 6000 E602全自动电化学发光分析仪检测系统参与验证的15个项目精密度、准确度及线性范围等主要性能在本实验室均达到了相关标准的要求。

Objective To investigate analytical Performance of the Roche cobas 6000 E602 automatic electrochemical luminescence analyzer. Methods The intra-batch and inter-batch precisions, accuracy and linearity of the analyzer were validated according to the Clinical and Laboratory Standards Institute（CLSI） documents（EP-15A3, EP-9A2, EP〈06）,and compared 3 performance indicators with announced quality standard by manufacturer. Results The intra-batch precisions were （1.66±1.10）%, the inter-batch precisions were（ 2.50±1.51）%,which were all less than the value provided by the specifcation; the accuracy tests were was quite consistent with the external quality assessment（EQA） results, which showed favorable accuracy;the linear range of various detected items were in line with the range provided by the specifcation （r^2 ：0.989 2~0.999 8）,which showed good linearity in announced linearity range by manufacturer. Conclusion The precisions, accuracy and linearity of 15 test in the Roche cobas 6000 E602 automatic electrochemical luminescence analyzer conform to the quality requirement of the lab and this analyzer can be used in clinical biochemical detection work.