Beckman Coulter AU5800全自动生化分析仪检测血清淀粉样蛋白A的性能验证分析

Performance study of Beckman Coulter AU5800 automatic biochemical analyzer for detecting serum amyloid A

目的对血清淀粉样蛋白A(SAA)试剂盒在Beckman Coulter AU5800全自动生化分析仪(以下简称"AU5800全自动生化分析仪")上的检测性能进行评价。方法通过实验计算AU5800全自动生化分析仪检测SAA的精密度、准确度、线性范围、临床可报告范围、参考区间,与厂家说明书提供的参考值比较,评估SAA试剂在AU5800生化分析仪上的检测性能。结果 SAA的高、低水平质控品的批内精密度、批间精密度的变异系数(CV)分别为1.3%、3.3%,1.3%、3.4%,均满足厂家说明书的要求;与参考方法比较:线性回归方程Y=0.985 X+1.259 5,决定系数(r2)=0.993 9,t=-0.01,P=0.992;在SAA范围为0～202.87mg/L,r2=0.998 9,符合试剂说明书r2≥0.990的要求;检验结果的最大可报告范围可扩展至1 622.96 mg/L。结论 SAA试剂盒在AU5800生化分析仪上检测性能能满足厂家和卫生行业标准要求,且其准确度好、重复性好,结果可靠,能较好地满足临床工作。

Objective To evaluate the performance of Beckman Coulter AU5800 automatic biochemical analyzer(abbreviated as AU5800 biochemical analyzer)for detecting serum amyloid A(SAA).Methods The precision,accuracy,linearity,clinical report range and reference intervals of SAA were verified by AU5800 biochemical analyzer with instructions to evaluate SAA reagent produced by Chongqing Zhongyuan Biotechnology Co,Ltd.Results The CV of high and low SAA quality control products were 1.3%,3.3%,and 1.3%,3.4%respectively,which met the requirements of manufacturer′s specifications.Compared with the reference method:linear regression equation Y=0.985 X+1.259 5,r 2=0.993 9,t=-0.01,P=0.992.The linearity range was 0-202.87 mg/L.The maximum reportable range of test results can be extended to 1 622.96 mg/L.Conclusion The performance of SAA kit on AU5800 biochemical analyzer can meet the requirements of manufacturers and health industry standards,and its accuracy is good,repeatability is good,the results are reliable,can better meet the clinical work.