强生干化学分析仪开放通道检测血清淀粉样蛋白A的性能验证

Performance Verification of the Measurement of Serum Amyloid A Using the Open Channel of Johnson Dry Chemistry Analyzer

目的强生干化学分析仪开放通道搭载国产普瑞柏血清淀粉样蛋白A(serum amyloid A,SAA)试剂盒的分析性能验证。方法根据美国临床和实验室标准化协会(NCCLS)的检测仪器评价标准,并参照卫生部关于分析仪器的性能验证指南,对Vitros 5.1FS检测SAA的精密度、准确度、线性范围、最大稀释度和生物参考区间进行验证。结果 2个水平SAA批内及总精密度分别为S_(批内低)=0.3,S_(总低)=0.45和S_(批内高)=0.6,S_(总高)=1.01,均小于厂家声明的精密度。比对实验决定系数r^2=0.991 2,线性方程Y=0.962 9 X+0.204 6,其线性范围可以验证至5.99～92.59mg/L,最大稀释倍数可验证至10倍。23例健康个体中95.7%的个体SAA检测值处于厂家声明的参考区间之内。结论 Vitros 5.1FS搭载该SAA试剂盒的分析性能验证通过,该检测系统可以用于临床常规标本检测。

Objective To study the performance verification of serum amyloid A （SAA） using the open channel of Johnson dry chemistry analyzer. Methods According to CLSI instruments evaluation standards and referring to the NCCL perform- ance verification guides of the analytical instruments, the precision, accuracy,linear range, maximum dilution degree, biologi- cal reference range of the SAA detected by Vitros 5. 1 FS were verified. Results The intra-batch and total precision experiments were ;sl =0. 3, Stc=0. 45 and Sui=0.6, Stii=1. 01 respectively, and they were all under the statements of manufacturer. Compared with test r2=0.991 2,linear equation Y 0. 962 9X＋0. 204 6,linearity range were reach 5.99~92.59 rag/ L,and the maximum dilution degree was 10 times. The SAA results of 95.7% of the 23 healthy individual were within the reference interval announced by the manufacturer. Conclusion Vitros 5. 1 FS and the SAA reagent have a good performance, this system can be used in routine tests in laboratory.