4040半自动生化分析仪检测ALT性能验证及应用

capacity verification of 4040 semi-automatic photometer and its range of applications in the ALT test

目的验证4040半自动生化分析仪检测ALT正确度、精密度、检测可报告范围及正常值参考范围等指标。方法 4040半自动生化分析仪与全自动生化分析仪分别检测ALT平行比对实验;4040半自动生化分析仪分别重复检测ALT低值、高值血清标本,观察精密度;取ALT低值、高值二份血清标本稀释六种不同血清标本分别检测ALT,观察其检测可报告范围。结果 4040半自动生化分析仪与全自动生化分析仪比对实验,线性回归Y=1.003X+0.271,r2=0.998;低值、高值批内不精密度分别2.86%、2.17%,低值、高值批间不精密度分别4.07%、3.51%,6种不同血清标本检测ALT,线性回归Y=570.3X+29.2,r2=0.9996。结纶4040半自动生化分析仪检测ALT正确度、精密度、检测可报告范围及正常值参考范围等指标经性能验证符合血站操作技术规程(2012版)文件要求。

Objective Based on to the blood station regulations （2012 edition）, the aim of this study was to verify the performance of the 4040 semi-automatic photometerfor its accuracy, precision, range of detection and other indicators of the normal reference range for ALT testing. Methods The ALT test results between the 4040 semi-automatic photometer and an automatic photometer were compared. By repeatedly testing the ALT low and high value of the serum sampies respectivelythe precision of the results were examined. Results The comparison of 4040 semiutomatic photometer and automatic photometer was conducted with the linear regression of Y=1.003X＋0.271, r^2 = 0.998. The low value and high value inaccuracy within a batch was 2.86% and 2.17% respectively. The low value and high value inaccuracy between batches were 4.07% and 3.51% respectively. Six different kinds of serum samples were tested on ALT, with the linear regression ofY=570.3X＋29.2, r^2 = 0.9996. Conclusion Using the 4040 semi-automatic photometer to test on ALT, the accuracy, precision, reportable range detection and other indicators of the normal reference range are verified in accordance with the requirements of the blood station regulations （2012 edition）.