Evaluation of latex agglutination turbidimetric method for measuring glycosylated hemoglobin

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.