酶法糖化血红蛋白试剂盒方法学比对评价

目的评估一种酶法测定糖化血红蛋白（HbAlc）试剂盒的性能。方法酶法测定HbAlc，评价的方法学指标为试剂盒的线性范围、不精密度、抗干扰性、回收率，并分别与免疫法和高效液相（HPLC）法进行相关及偏倚分析。结果该试剂盒的检测在4．3-12．9％呈线性；不精密度测定低、中、高值批内及批间CV在0．89％～1．43％之间，总CV在1．77-2．16％；HbAlc标准为5．5％和10．5％其回收率分别为99．0％、102．1％；干扰实验：维生素C〈500mg／L、胆红素〈400mg／L、溶血素〈5000mg／L、乳糜〈2％时，对结果无明显干扰（干扰率（±5％）。酶法HbAlc与免疫法和HPLC法的测定结果比较其回归方程分别是：Y=1．0417X-0．7187和Y=0．9881X-0．0944，相关系数均为r=0．99，P〈0．05，检验方法之间具有显著的统计学意义，经验证酶法测定HbAlc与免疫法和高效液相法的偏倚都在允许范围内。结论酶法HbAlc试剂盒在不精密度、抗干扰性、线性范围均符合临床要求，与常规方法比较相关良好偏差较小，可完全满足临床对HbAlc检测需求。

To evaluate an enzymatic method for detecting glycated hemoglobin(GHb)

Objective To evaluate the analytical performance of the new enzymatic method for detecting glycated hemoglobin. Methods By means of the linearity test, the precision test, the interference test and the method comparison and bias estimation test to evaluate the analytical performance of the enzymatic method for detecting glycated hemoglobin. Results The linearity range of the new method was 4. 3- 12.9 %. The imprecision of intra-assay was 1.43 % （ HbA1c5.56 % ） ,0.96 % （8.33 % ） ,0.89 % （ 10.12 % ）. The total imprecision was 1.77 % （5.56 % ）, 2.16 % （ 8.33 % ）, 2.07 % （ 10.12 % ）. The recovery was 99.00 % （5.5 % ）, 102.1% （10.5 % ）. The interference test showed the result had no significant interference in the assay（interference 〈 ±5 % ） when Vitamin C 〈 500 mg/L, bilirubin 〈 400 mg/L, hemolysin 〈 5 000 mg/L and chylous 〈 2%. The comparison test showed the correlation between the new enzamatic method and the method of the immunochemistry for measurement of the hemoglobin Alc （HbAlc）was excellent （ Y = 1.0417X- 0.7187, R2= 0. 98, N =40, P 〈 0.05）; and between the new enmatic method and the method of the high performance liquid chromatography（HPLC） for measurement of the hemoglobin Alc was excellent （ Y= 0. 9881X ＋ 0.0944, R2 = 0.98, N = 40, P 〈 0.05 ）. Conclusion The precision, interference, linearity, correlation and accuracy test were suitable for routine HbA1c measurement on automated biochemistry analyzer, and can be used in clinic.