胶乳凝集比浊法测定糖化血红蛋白的分析性能评价

Evaluation of latex agglutination turbidimetric method for measuring glycosylated hemoglobin

目的对胶乳凝集比浊法测定糖化血红蛋白(HbA1c)的分析性能进行评价。方法用日立7600-120全自动生化分析仪对胶乳凝集比浊法测定HbA1c的分析性能进行检测。结果试剂稳定性结果表明,新配制的试剂测定低值时到第3天才保持稳定,测定高值时试剂以每天平均0.1%的速度下降;胶乳凝集比浊法测定HbA1c批内CV为1.56%,批间CV为0.0%,天间CV为0.86%,总CV为1.59%;比对实验胶乳凝集比浊法和高效液相色谱(HPLC)法测定HbA1c呈良好的线性关系,Y=0.904 X+0.239,r=0.9915;当胎儿血红蛋白F(HbF)≤16.2%时,对胶乳凝集比浊法和HPLC法测定的结果均无影响;线性范围为2%～15.8%;健康人HbA1c95%参考区间4.04%～5.69%,不同性别组比较差异无统计学意义(P>0.05),年龄方面,以45岁为界,45岁以上中老年人的参考范围略高于45岁以下人群的参考范围(P<0.05)。结论胶乳凝集比浊法测定HbA1c是一种适用于临床实验室开展的经济、有效、简单可行的方法。

Objective To evaluate the analytical performance of latex agglutination turbidimetry for determination of glycated hemoglobin（HbA1c）.Methods Hitachi 7600-120 automatic biochemical analyzer was used to evaluate the analytical performance of latex agglutination turbidimetric method for testing HbA1c.Results The reagents′stability results showed that,freshly prepared reagent was not stable until 3 d in testing low value of HbA1c,while in measuring high value,the reagent was declined at the average daily rate of 0.1%.Precision test results showed that within-run coefficient of variation（CV） was 1.56%,inter-run CV was 0.0 and between-day CV was 0.86%,thus total CV was 1.59%.Two methods had a good linear relationship between latex agglutination turbidimetry and HPLC,Y=0.904X＋0.239,r=0.9915;and there were no effects on the results of those two methods when fetal hemoglobin（HbF） ≤16.2%.The linear range was 2%-15.8%.95% of normal reference range of HbA1c was 4.04%-5.69%,there were no significant differences between male and female groups（P0.05）;with age of 45 years as boundary,the reference range in elderly people over the age of 45 years was obviously higher than that in elderly people under 45 years old（P0.05）.Conclusion Latex agglutination turbidimetric method is an economic,effective,simple and feasible method for testing HbA1c in the clinical laboratory.