纤维结合蛋白透射免疫分析方法学初步评价

Preliminary evaluation of transmission turbidity method for fibronectin

目的初步评价纤维结合蛋白(Fn)透射免疫分析法检测试剂盒的临床应用性能。方法根据美国临床实验室标准化协会(CLSI)2002年10月颁布的《定量临床检验方法的初步评价:批准指南(EP10-A2)》,连续5天按特定顺序测定高、中、低值质控血清中的Fn浓度,记录检验结果,采用Microsoft Excel软件和SPSS16.0统计软件,计算Fn测定的偏差、总不精密度,每天的多元回归分析参数(截距、斜率、非线性、携带污染率、线性漂移)的值。结果线性回归方程为:y=0.99984x-0.22,与y=x参考线几乎重合,表明测定值y与靶值x差很小,r2=0.9999,大于0.95,说明线性范围符合要求;3个浓度偏差分别为-0.40 mg/L、0.07 mg/L、-0.33 mg/L,均低于标定偏差的3.81 mg/L、10.61 mg/L和17.41 mg/L;3个浓度总不精密度分别为2.37%、0.77%、0.24%,均小于最大允许总不精密度。结论纤维结合蛋白(Fn)透射免疫分析法试剂盒达到CLSI EP10-A2文件所规定标准,符合临床应用要求。

Objective To preliminary evaluate transmission turbidity method for Fibronectin（Fn） quantitation.Methods In according with the CLSI Document EP10-A2.Preliminary evaluate Shanghai Beijia Biochemistry Reagents Co.,Ltd.for Fn in Hitachi 7170A.Concentrations of Fn were made by controls and there were assayed for a period of 5 days.Results Three levels of high,middle and low Fn concentrations were 70mg/L,195mg/L,320mg/L,the return equation was y=0.9998x-0.22,with r2= 0.9999,bias was-0.40mg/L,0.07mg/L,-0.33mg/L,with imprecisions at 2.37%,0.77%,0.24% respectively.Conclusion The kits from Shanghai Beijia Biochemistry Reagents Co.,Ltd.were satisfied with the clinical applicable requests under EP10-A2.