Methodological evaluation on enzymatic method for detecting HbA1c and influence of sample pre-processing on detection result
10.3969/j.issn.1671-8348.2015.10.027
- VernacularTitle:酶法测定糖化血红蛋白的方法评价及标本前处理对结果的影响
- Author:
Tongqing CHEN
;
Chun ZHOU
;
Wenqing CHEN
;
Zhenxing LI
;
Bing LUO
;
Qian TANG
;
Wenming ZHANG
- Publication Type:Journal Article
- Keywords:
enzymatic method;
hemoglobin A,glycosylated;
methodology;
performance evaluation
- From:
Chongqing Medicine
2015;(10):1374-1377
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the methodological performance of the new enzymatic method for detecting glycated hemo-globin(HbAIc)and its influencing factors.Methods HbAIc was detected by the enzymatic method.The precision,anti-interfer-ence,recovery rate,accuracy and the influence of pre-processing(anti-coagulation,preservation,centrifugation)on the detection re-sults were evaluated,its correlation with HPLC and the bias degree were analyzed.Results The within-run coefficients of variation (CVs)for high,middle and low value QC samples in the enzymatic assay were 1.04%,1.26% and 1.37% respectively and the be-tween-run CVs were 1.83%,2.24% and 2.64%,respectively;the enzymatic method showed the linear correlation with HPLC(r=0.996,P <0.01);the HbA1c target value concentrations were 5.20%,6.40%,7.60%,8.80%,10.00% and 11.20% respectively, the recovery rates were 100.15%,98.91%,98.84%,98.20%,103.62% and 99.82% respectively;the interference test showed that this method had no significant interference on the detection results when glucose <15.50 mmol/L,UA<516.00 μmol/L,bili-rubin <217.00 μmol/L,triglyceride<10.20 mmol/L,urea<11.50 mmol/L,albumin<50 g/L and globulin <50 g/L.The HbA1c detection results in the samples with anti-coagulation by heparin sodium,EDTA-2K and sodium citrate stored for 3 d under -20-20 ℃ had no obvious change (P >0.05);the sample was centrifuged at 500,1 000 r/min(R=15 cm)for different time(1,2,5,10 min)and at 2 000 r/min for 1 min,their detection results had statistical differences compared with the sample centrifuged=3 000 r/min for 5 min (P <0.05).Conclusion The precision,anti-interference,accuracy and linearity range of the enzymatic method all conform to the clinical requirement.Compared with the conventional method,its correlation is good with small deviation,which can entirely satisfy the demand of the HbAIc detection in clinic.
