糖化清蛋白酶法快速检测及其临床意义评价

Primary assessment of enzymatic measurement of glycated albumin

目的评价糖化清蛋白(GA)的酶法快速检测及其临床应用的意义。方法检测147例2型糖尿病(T2DM)患者及78例健康者的空腹血糖(FPG)、餐后2h血糖(2hBG)、糖化血红蛋白(HbAlc)等指标;同时应用液态酶法测定GA,用GA高值血清和低值血清评估试剂盒的精密度及其线性,建立GA参考范围;分析GA与各检测指标的相关性。结果健康人群GA值为(14.48±2.12)%;对147例患者的相关性分析显示,GA与HbA1c具有良好的相关性(r=0.868 7,P<0.01);GA与FPG、2hBG呈正相关(r=0.854、0.836,P<0.01);HbA1c>7.0%、4.0%≤HbA1c≤7.0%以及HbA1c<4.0%患者GA与HbA1c的相关系数分别为0.823(P<0.01)、0.756(P<0.05)和0.187(P>0.05);健康者、临界者和T2DM患者间GA差异有统计学意义(P<0.001)。结论该法批内变异系数(CV)<2%,批间CV<5%,线性测定r=0.998 7。GA与HbA1c具有良好的相关性,尤其表现于长期血糖控制欠佳的患者。酶法检测GA有良好的精密度和线性。

Objective To evaluate the clinical significance of fast enzymatic measurement of glycated albumin（GA）.Methods 143 cases of patients with type 2 diabetes mellitus（DM） and 78 cases of healthy controls were enrolled,for whom the fasting plasma glucose（FPG）,postprandial 2 hours blood glucose（2hBG） and glycated hemoglobin（HbA1c） were measured.At the same time,the levels of GA were detected by using enzymatic measurement,the precision and linear rage of the detection kits were analyzed by the detection of samples with high and low levels of GA,and the reference range of GA was constructed and the correlation between GA and other indexes was evaluated.Results The level of GA in healthy controls was（14.48±2.12）%.In patients group,there was fine correlation between GA and HbA1C,FPG and 2hBG（r=0.868 7,0.854,0.836,P0.01）.In patients with HbAlc7.0%,4.0%≤HbA1c≤7.0% or HbA1c4.0%,the correlation coefficients between GA and HbA1C were 0.823（P0.01）,0.756（P0.05） and 0.187（P0.05）,respectively.There was statistical difference of the level of GA between healthy controls,individual at criticality and patients with DM（P0.001）.The enzymatic measurement of GA was with the coefficients of variability of within-run and between-run less than 2% and 5% respectively and the correlation coefficient of linear range was 0.998 7.Conclusion GA could be well correlated with HbA1c,especially in patients with poor control of blood glucose for a long time.The enzymatic measurement of GA was with fine precision and linearity.