五种国产甘胆酸均相酶免疫法检测试剂的分析性能验证

Performance Verification of Five Domestic Glycocholic Acid Reagents by Homogeneous Enzyme Immunoassay

目的对五种国产均相酶免疫法甘胆酸(CG)试剂进行分析性能验证,评价其临床应用价值。方法在HITACHI7600全自动生化分析仪上对苏州博源(A)、安徽(B)、浙江(C)、重庆(D)和贵州(E)公司的CG试剂(标为A,B,C,D和E)进行性能验证,参考美国临床实验室标准化协会(CLSI)EP15-A,EP6-A和EP9-A2方案,对5种CG试剂的精密度、线性范围进行评价,并比对判定CG异常的一致率。结果 A^E试剂的批内变异系数(CV)分别为1.10%~5.23%,2.14%~5.73%,2.92%~8.74%,2.33%~8.23%和1.54%~3.70%,总CV分别为4.94%~7.02%,4.95%~6.90%,7.21%~18.75%,4.86%~11.32%和3.28%~5.90%。C试剂精密度大于试剂盒标注的不精密度。各试剂线性范围拟合方程斜率b分别为1.038,0.964,0.908,0.984和1.040,C试剂线性范围验证未通过。B^E试剂与A试剂结果比对,线性良好,相关系数(r^2)为0.924~0.990,平均绝对偏倚分别为6.67%,36.3%,9.80%和16.45%,C,E试剂与A试剂结果不等效。CG异常一致率分别为90%(Kappa=0.80,P=0.000),82.5%(Kappa=0.65,P=0.000),82.5%(Kappa=0.65,P=0.000),90%(Kappa=0.75,P=0.000),B,E试剂与A试剂一致性优。结论经过验证认为,不同厂家CG试剂各项性能略有不同,部分试剂参考范围有待进一步验证,建议选择适合自己实验室的CG试剂使用。

Objective To validate the analytical performance of five domestic glycocholic acid reagents by homogeneous enzyme immunoassay and evaluate their clinical application.Methods The performance of five glycocholic acid reagents(labeled as A,B,C,D and E) from Suzhou EVERMED Co.,Anhui B Co.,Zhejiang C Co.,Chongqing D Co.and Guizhou E Co.on HITACHI 7600 automatic biochemistry analyzer were assessed.According to the Clinical and Laboratory Standards Institute(CLSI) EP15-A,EP6-A and EP9-A2,the precision and linearity range were assessed.Compared five glycocholic acid reagents and determine the consistency of glycocholic acid abnormalities.Results The within-run coefficient of variation(CV) of five reagents(A^E) were 1.10%~5.23%,2.14%~5.73%,2.92%~8.74%,2.33%~8.23% and 1.54%~3.70% respectively.The total CV of reagents in A^E were 4.94%~7.02%,4.95%~6.90%,7.21%~18.75%,4.86%~11.32% and 3.28%~5.90% respectively.The precision of reagent C was higher than the stated.Slope b of fitting equation were 1.038,0.964,0.908,0.984 and 1.040,respectively,and the linear range verification of reagent C failed.In method comparison tests,the reagent B^E compared showed good linearities with reagent A,coefficient of correlation(r^2) were 0.924~0.990,and the average absolute bias were 6.67%,36.3%,9.80% and 16.45%,respectively.Results of reagent C,E were not effective with reagent A.Agreement rates of the high glycocholic acid in reagent B^E and reagent A were 90%(Kappa=0.80,P=0.000),82.5%(Kappa=0.65,P=0.000),82.5%(Kappa=0.65,P=0.000) and 90%(Kappa=0.75,P=0.000),respectively.Reagent B,E had good consistency with reagent A.Conclusion The validation of different glycocholic acid reagents was different and the reference range should be further validated.So the laboratory should select suitable glycocholic acid reagent.