日立7600检测血清淀粉样蛋白A的实验室性能验证

The Performance of SAA was Detected with the Hitachi 7600 Automatic Biochemistry Analyzer to Observe Its Verification

目的:日立7600型全自动生化分析仪检测血清淀粉样蛋白A的性能验证。方法:参照CLSI及CNAS有关检测系统性能验证文件方法通过实验对血清淀粉样蛋白A的精密度、正确度、线性范围、临床可报告范围、参考区间进行评价。结果:批间精密度变异系数分别为5.38%,2.29%,小于规定声称值10%;批内精密度变异系数分别为4.87%、1.82%,均小于规定声称值8%。正确度偏倚为-2.1%,<10%;临床可报告范围上限为3072mg/L;厂家说明书的线性范围、参考范围符合要求。结论:日立7600全自动生化分析仪搭载重庆中元生物技术有限公司血清淀粉样蛋白A试剂盒检测血清淀粉样蛋白A符合质量要求,能够为临床提供可靠的依据。

Objectives:In order to clarify the accurate and reliable clinical test results,the performance of serum amyloid A(SAA)detection by Hitachi 7600 automatic biochemical analyzer was performed.Methods:The precision,accuracy,linear range,clinical reporting range and reference interval of serum amyloid A(SAA)were evaluated according to the performance verification method of the detection system in CLSI and CNAS specifications.Results:The inter-batch precision coefficients of variation(CV)were:5.38%,2.29%,which were less than the claim value of 10%;The intra-batch precision coefficients of variation(CV)were 4.87%and 1.82%,less than the claimed value of 8%;The accuracy bias were-2.1%,not more than 10%;The upper limit of clinical reportable range was 3072mg/L;The linear range and reference range of manufacturer instructions were acceptable.Conclusion:The detection of serum amyloid A by Hitachi 7600 automatic biochemical analyzer equipped with serum amyloid A kit from Chongqing Zhongyuan Biotechnology Co.,Ltd.conform to quality requirements which can provide reliable basis for clinical diagnosis.