The development and evaluation of glycated albumin enzymatic determination reagent
LIAN Guojun1, PAN Liqin2, LI Baoqing3, CHEN Qingsong4.
1.School of Environmental Science and Public Health, Wenzhou Medical University, Wenzhou, 325035; 2.Department of Laboratory Tests, the Wenzhou People’s Hospitol, Wenzhou, 325000; 3.Department of Laboratory Tests, the Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, 325027; 4.Zhejiang Kuake Bioscience Co.Ltd, Shaoxing, 312500
LIAN Guojun,PAN Liqin,LI Baoqing, et al. The development and evaluation of glycated albumin enzymatic determination reagent[J]. JOURNAL OF WEZHOU MEDICAL UNIVERSITY, 2016, 46(7): 526-529.
Abstract：Objective: To develop and evaluate the serum glycated albumin enzymatic determination reagent. Methods: The analysis was based on the fact that the glycated albumin glycated albumin was hydrolyzed to glycated amino acids by special proteinase digestion, and glycated amino acids were oxidized to produce hydrogen peroxide, which was quantitatively measured through the Trinder’s chromogenic reaction, compared with the same treatment of the standard solution. Results: The within-run and between-run CVs of this reagent were 0.84%～1.88% and 1.14%～2.35%, respectively; the method was liner in the range of 1.3～1 200 μmol•L-1, percent deviation of the measured results of diluted serum samples diluted by 2 to 16 times compared to the results of the original samples ranged from 99.3%～108.6%, the average rate of recovery was 101.8%; No significant interference (bias%≤±5%) was found in the test of 550 μmol•L-1 GA analysis when bilirubin <35 mg•dL-1, triglyceride<750 mg•dL-1, hemoglobin <200 mg•dL-1, bile acid <8 mg•dL-1, uric acid <33 mg•dL-1, glucose <1800 mg•dL-1, Vitamin C <15 mg•dL-1, EDTA•K2 <2.5 mg•mL-1, Heparin Sodium <80 U•L-1, Sodium citrate <8.0 mg•mL-1. Comparing this methods (Y) with the ASAHI method (X), the regression equations is Y=0.9991X+0.0809, r=0.9958. The reagent was stable at least 30 days when it was open cover stored and at least 12 months when it was sealed stored at 4 ℃. Conclusion: This reagent shows high precision, wide linear range, and the dilution accuracy can meet the clinical needs. It also shows high recovery, good anti-interference capability, good correlation with imported reagent, and suitable for clinical application.
