参照EP方案在不同检测系统评价尿微量白蛋白试剂的分析性能

The evaluation of michoalbuminuria analytical performance by CLSI EP protocols in two different detection system

目的 通过不同检测系统测定尿微量白蛋白的分析性能评价,以探讨新成生物公司尿微量白蛋白测定试剂盒与英国朗道测定试剂盒在分析性能上的差异.方法 在同一台全自动生化分析仪上,同时对两个检测系统的正确度、精密度、最低检测限、测定范围、方法学比对共五项性能指标进行评价.结果 在正确度实验,新成和朗道试剂的相对偏差分别都小于10%.精密度试验,两种试剂的批内CV分别都小于5%.两种试剂的检测低限分别为：0.87mg/L、0.27mg/L.线性试验结果,新成试剂的回归方程和相关系数分别为：Y＝0.9827X＋0.5455,R2＝0.9987（浓度范围0～400mg/L）,朗道试剂的回归方程和相关系数分别为：Y＝1.0356X-0.9091,R2＝0.9996（浓度范围0.0～202.8mg/L）,新成试剂的测定范围更广.方法 比对试验,试验结果表明两种试剂相关性良好,回归方程和相关系数分别为：Y＝1.2555X-1.6888,R2＝0.9976.结论 两种检测系统对尿微量白蛋白的测定能得到一致的结果,其性能指标均能满足临床使用要求,无明显差异.

Objective Purpose Through evaluate the analytical performance between two different detection systems of microalbuminuria, to probe the analytical performance of siehuan xincheng eonpany＇ s detecting system, and find the differences between the xincheng detecting system and the England RANDOX detecting system. Methods On the same automatic biochemical analyzer, evaluate the two detecnon system s five indicators such as accuracy, precision, minimum detection limit, linear range and the method comparison. Results In the accuracy test, the two reagents＇ relative deviation are less than 10%. In the precision test, the within run coefficient of variation are less than 5%. The two reagents＇ minimum detection hmit respectively are 1.03mg/L and 0.27mg/L. In the linear test, the linear regression equation and correlation coefficient of xineheng＇ s reagent： Y = 0. 9827X ＋ 0. 5455, R2 = 0. 9987（the linear range is 0～400mg/L） ; The linear regression equation and Correlation coefficient of RANDOX＇ s reagent： Y = 1. 0356X - 0. 9091, R2 = 0. 9996 （ the linear range is0.0 - 202.8mg/L） ; the xineheng reagent＇ s linear range is wider than the RANDOX＇ s. In the method comparison test, the test results show that the two reagents＇ correlation is good, the linear regression equation and correlation coefficient Y = 1. 2555X - 1. 6888, R2 = 0. 9976. The Conclusion The detemaination of the microalbuminuria within xineheng＇s reagent and RANDOX＇s reagent can get the consistent result, all the performance indexs can meet the re- quest of the chnieal, there＇s no significant difference between the two kands of reagents.