均相免疫法甘胆酸试剂的分析性能验证

Homogeneous Immunoassay Cholylglycine Reagent Performance Verification

目的：对应用于全自动生化分析仪的均相免疫法甘胆酸（Cholylglycine,CG）试剂进行分析性能验证。方法：实验性能验证。采用制造商提供的主校准品、质控品及我院门诊患者血清标本,参考美国临床和实验室标准协会（CLSI）EP15-A、EP17-A、EP6-A、EP7-P方案,于生化分析仪对该项目的正确度、精密度、定量检测下限（LoQ）、线性范围、干扰因素进行验证,同时与放射免疫法（RIA）CG试剂进行比较。结果：正确度验证显示测定值与标示值偏倚分别为-3.4%、1.33%。自动生化分析仪的LoQ为0.30mg/L;线性范围为0.30~56.86mg/L（R2=0.992 3）;重复精密度为4.3%、3.4%;中间精密度为5.3%、4.8%,均小于厂家声明的不精密度。3种干扰物在试验浓度内（胆红素≤39.2mg/dl,血红蛋白≤194mg/dl及甘油三酯≤285mg/dl）的偏差分别为7.2%、5.9%、-8.51%。该方法与放射免疫法比较回归方程为Y=0.964 3X＋0.025 3,R2=0.996 6,两种方法偏倚小于总允许误差。结论：均相免疫法测定CG,重复性好,线性范围宽,抗干扰能力强,与放射免疫分析法甘胆酸试剂具有高度相关性,适合在生化分析仪上进行自动分析,可满足临床测试要求。

Objective：To do performance verification for full automatic biochemical analyzer of cholyglycine（CG）reagent analysis.Methods：Performance verification test.According to the CLSI EP15-A EP17-A,EP6-A,EP7-A protocol,this verification study validated accuracy,imprecision,the limit of quantitation,linearity,interferences of CG assay by using manufacturer＇s secondary atandard material,control and serum samples of outpatient.Meanwhile,to evaluate the correlation of assay,60 fresh serum samples of outpatient were tested using this kit and commercial RIA CG kit,respectively.Results：For the accuracy based tests,the bias of homogeneous immunoassay were-3.4%,1.33%,when compared to the marked value.The limit of quantitation was 0.30mg/L,the linearity was 0.30~56.86mg/L（R2=0.992 3）,the within-day CVs were 4.3%,3.4% and the between-day CVs were 5.3%,4.8%.The imprecision were lower than that declared by assay producer.When bilirubin≤39.2mg/dl,hemoglobin≤194mg/dl and triglyceride≤285mg/dl,the deviation was 7.2%,5.9%,-8.51%respectively.Linear regression analysis between homogeneous immunoassay and RIA,produced a regression equation of Y=0.964 3X＋0.025 3（R2=0.996 6）,the relative bias wasTEa（target value±10%）.Conclusion：Assessment of the homogeneous immunoassay CG reagents on automatic biochemistry analyzer show good repeatability,wide linear range,and good anti-interference capability.Moreover,there is a significant correlation between homogeneous immunoassay and RIA.Which meet the clinical needs.