应用NCCLS EP9-A文件评价两种磷试剂

目的探讨在生化分析仪上使用国产试剂替代进口原装试剂检测血清磷(Phosphor)的可行性。方法按照EP9-A文件提供的方法,每天取临床标本8份,分别用两种试剂测定样本磷,共测定5天,记录检测结果,并对两种试剂进行偏差评估。结果采用两种试剂测定的血清磷结果的相关系数为0.996,截距a=0.019,斜率b=0.999,无方法内、间的离群点,测定结果的偏差在允许误差范围内。结论经过方法对比及偏差评估确定在本实验室使用国产试剂替代进口原装试剂是可行的。

Apply EP9- A to Evaluate Two kinds of Phosphor Reagent

ObjectiveTo explore the feasibility of the domestic reagent replacing the foreign imported one by measuring the concentration of the patient's serum Phosphor.Methods According to the file of NCCLS-EP9-A,every day,8 patient samples were analyzed with two kinds of reagent separately for 5 days,and write down the test results in 5 days together,then evaluate deviation of the different reagents.Results The correlation coefficient of using two kinds of Phosphor reagent was 0.996,intercept(a):0.019,slope(b):0.999,without outlier of within-method and between-method,the deviation of results were accepted in the range of the allowable error.Conclusion It is feasible that the domestic reagent replace the foreign imported reagent in our laboratory after method comparison and deviation estimation.