| Establishment of the reference range of glycated albumin of People in GuangzhouObjectiveTo determine the reference range of glyeated albumin(GA)of People in Guangzhou.MethodsWe validated the analysis performance of Asahi Lucica-L GA enzyme method detection kit;We using nested sampling collected 3032 cases of healthy individuals from 18 to 70 year,s old in Guangzhou,all individuals took routine inspection of the project,such as health examination,body mass index(BMI)calculation,ultrasound,ECG,blood and urine routine text,fasting blood glucose(FPG),glycosylated hemoglobin(HbAlc),albumin(ALB),total protein(TP),gamma glutamyl aminopeptidase(GGT),aspartate aminotransferase(AST),alanine aminotransferase(ALT),urea(BUN),creatinine(CREA),triglyceride(TG),high density lipoprotein(HDL)and low density lipoprotein(LDL).We Screened 1918 cases of healthy individuals,then detected every individual’ s GA value,used t test to statistic the normal GA reference range of the local area.1918 healthy individuals were divided into 4 groups according to their ages(41 5 cases in group A,under 30y;478 cases in group B,31-45y;573 in group C,46-60y;452 in group D,above 60y),and the difference of GA value in each age group was analyzed.ResultsThe within-imprecisions of two levels of the GA detected by enzymatic Lucica-L were 1.97%and 1.07%,the total-imprecision were 2.10%and 1.14%;GA concentration recovery rate was 106.4%,ALB concentration recovery rate was 91.9%,GA value is linear in the range of 5.3 to 51.3%;There were no interferences with detection of GA under the total bilirubin(TBIL)<445.50umol/L,TG<10.21mmol/L,cholesterol(CHOL)<10.29mmol/L,TG mix with CHOL<19.10 and 10.90mmol/L,and glucose(GLU)<277.8mmol/L,free hemoglobin<2.4g/L,vitamin C(VitC)<50mg/mL and aspirin<33.3mg/mL.The 95%normal population reference range were 11.3-14.9.GA of different age groups were:A group 12.87±12.92,B group 0.94+1.05,C group 13.41±1.11,D group 13.73 + 1.24.There was no significant difference between the A&B group(P>0.05),differences between C group,D group and other 3 groups were significant(P<0.05).ConclusionThe analysis performance of Lucica-L enzyme method GA test kit is good,it can be used for routine specimens detection;The normal reference range of GA in Guangzhou area is 11-15%.The upper limit of the reference range in people older than 30y have to add about 0.4%by each 15 years.The performance of g I ycated a I bum i n i n d i agnos i s of d i abetes mellitusObjectiveTo evaluate the diagnostic performance of GA in common patients with diabetes mellitus(DM);and to discuss the diagnostic values of GA in special diabetes mellitus(gestational diabetes,thalassemia diabetes).MethodsWe used FPG and HbAlc as the diagnostic criteria of DM,drew ROC curve of GA evaluating DM by 658 sampling individuals,through which we determined the cut-off value in diagnosing DM;we collected serum samples of 58 common patients who was diagnosed DM,51 diabetic patients of pregnancy(GDM)and 22 thalassemia patients who suffered from DM at the same time,and collected 60 cases serum samples of healthy volunteers as control group.FPG,HbAlc and GA value were detected in all the samples,than compared the diagnostic efficiencies of three indicators.ResultsSet 15.35%as the best cut-off value,sensitivity and specificity were 0.613 and 0.998,the maximum AUC is 0.70.Set 16%as the cut-off value which determined by the instructions recommended upper limit,sensitivity and specificity were 0.581 and 1.000.While diagnosing common patients of the 58 DM,FPG,HbAlc and GA values of AUC were 0.893,0822,and 0.792;diagnosing thalassemia in 22 DM patients,FPG,HbAlc and GA values of AUC were 0.941,0.552 and 0.712;diagnosing GDM of 51 patients,FPG,HbA1c and GA values of AUC were 0.614,493 and 0.611.Combined with any of the two indicators,or three indicators combined detection,sensitivity and specificity could reach to 100%.ConclusionThe optimal cut point test of GA diagnosing DM can be set at 15.4%;for ordinary DM patients,the diagnostic efficacy of GA is not better than traditional indicators such as FPG and HbAlc,but for GDM and thalassemia patients,GA efficacy is better than FPG and HbAlc.If intake GA as the diagnostic criteria of DM and combine it with the traditional indicators,there will be conducive to the screening and diagnosis of GDM and thalassemia with diabetes mellitus. |
