| Objective:Glycated albumin is the product of the no-enzymatic glycation of albumin, which can reflects the glycometabolic control in diabetics over 2-3 weeks. We aim to verifying the performance of GA used by enzymatic method, building a reference range and predictive values for detecting IGR and DM in Kunming area. Meanwhile, the correlation of each index and the clinical utility during the monitoring, diagnosis and treatment in diabetics need to be discussed.Methods:1. According to the CLSI EP15-A2,CLSI EP6-A, CLSI EP9-A2, CLSI EP7-A2 and relevant reference books we verified the linearity, imprecision, accuracy and interferences used by enzymatic method.2.1866 healthy adults were enrolled to build a reference range in Kunming area according to the CLSI C28-A2, and analyzed the relationship between GA and physiological, biochemical indexes and diastatic indexes, and explored the influence factors of GA in healthy adults.3. The ROC curve was plotted to examine the predictive values of IGR and DM. Compared GA under different glucose tolerance status and discussed the relationships between GA and physiological, biochemical indexes and diastatic indexes in diabetics.4.377 diabetics were divided into 3 groups according to glucose control:HbAlc< 7%; 7%≤HbAlc≥8%; HbAlc>8%. Compared the differences of GA in each group.5. Diabetics were divided into no-complication group and complications group. Then the complications group was divided into 5 groups further:DN (n=65); DR (n=28); DPN (n=41); DM with AS (n=45); Mix-complications (n=153). Compared the differences of GA in groups.Results:1. Our data indicated a good imprecision, linearity, accuracy and interferences. Repeatability imprecision and middle imprecision CV of GA in the two pool samples were 0.36% and 0.81%,0.82% and 1.37%, respectively; The result of linearity showed that GA and Alb involved in the concentration range (0-33.16 g/1 and 0-88.73 g/1) are linear, with a linear equation:Y= 1.023X-0.049 (R2=0.998) and Y= 1.014X-0.027(R2=0.998); The result of methodology comparison showed that the experimental method and comparison method corrected well and with a linear correlation, the linear regression equation Y= 1.005X-0.353 (R2=0.995); The Interference Test showed that GA was not interfered by chylus; When free bilirubin≤19.7mg/dl and direct bilirubin^ 21mg/dl, there were no interference; When Hb≤97.6mg/dl, there were no interference, and when it gets more, a negative influence was observed in Hb;2. The level of GA in Kunming healthy adults was 11.43%±1.14%, and the reference range was determined to be 9.20%-13.67%; Significant difference was observed between gender, with women was higher (p<0.01). Positive correlation were observed between GA and age (r=0.294, p<0.01) and FPG (r=0.370, p<0.01); Negative correlation were observed between GA and BMI (r=-0.275, p<0.01). Among them, the female, age and obesity is the risk factors of GA.3. The result indicate that the predictive value for detecting IGR and DM were 13.69% and 14.14%, respectively, with a good sensitivity and specificity;4. Significant differences were observed between the NGT, IGR, DM (p<0.01), with GA were 11.43% ± 1.14%,15.44% ± 1.90%,22.31±7.59%, respectively. Positive correlation were found between GA and HbAlc, FPG, fructosamine in diabetics (r=0.509,0.841 and 0.541, respectively, p<0.01); Negative correlation was found between GA and BMI (r=-0.388,p<0.01);5. Significant differences were observed between glucose control status (p<0.01), with GA were 15.70%± 2.02%,17.22% ± 2.43% and 26.36%±7.30 in well-controlled, generally-controlled, poorly-controlled, respectively.6. GA was higher in DM with complications group than that in no-complication group (p<0.05), as well as that in the sub-complication groups (p<0.05), and GA increased with complications appeared.Conclusion:A good analytical performance was found by using enzymatic method, which can meet the demand of clinical. And GA can be used as a early indicator for predicting DM and judging the process of disease. |
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