贝克曼库尔特AU680生化分析系统肌酸激酶可报告范围的评价

Evaluate the reportable range of CK by Beckman Coulter AU680 biochemical measurement system

目的用贝克曼库尔特AU680全自动生化分析系统对肌酸激酶（CK）的分析测量范围（AMR）进行验证，根据实验结果确定该检测系统的临床可报告范围（CRR）。方法参考美国临床实验室标准化协会（ClinicalandLaboratoryStandardsIn—stitute，CLSI）EP6一A文件和相关文献，在贝克曼库尔特AU680全自动生化分析仪上进行CK的相关实验（最大稀释度实验、功能灵敏度实验及分析测量范围实验），并由此确定其临床可报告范围。结果肌酸激酶（CK）的最大允许稀释度为1：16；功能灵敏度为2．0U／L；在分析测量范围（2．O～1000U／L）内呈线性（r^2=0．9993），与厂商声明基本一致，故其临床可报告范围为2．0～16000U／L。结论贝克曼库尔特AU680全自动生化分析系统检测CK在厂家声明的分析测量范围内线性良好，所建立的临床可报告范围可以满足临床需要。

Objective To test the analytical measurement range（AMR） of creat the kinase with backman coulter AU680 auto- matic biochemical analysis system,and analyze the measuring range according to the result of the experiment to determine the clini- cal reportable range. Methods Referring to clinical and laboratory standards institute（CLSI） EP6-A evaluation protocols and perti- nent literature,we performed the CK validate experiments of max dilution limit, functional sensitivity and analytical measurement range（AMR）, and established clinical report range（CRR） for Beckman Coulter AU680 automatic analyzer. Results All experi- mental dates according the setting requires,the max dilution limit was 1 ： 16, functional sensitivity was 2.0 U/L, and CK showed good linearity（r= 0. 999 3） in AMR（2.0--1 000 U/L）. According with the declaration of the manufacture, the CRR was 2.0-16 000 U/L. Conclusion There is fine linearity within the AMR claimed by manufacture of Beckman Coulter AU680 biochemical measurement system in the detection of CK and CRR established in this research can meet the needs of clinical laboratory.