血清糖化清蛋白检测方法学评价、临床性能验证及其在糖尿病监测的应用研究

Application of Glycated Albumin in Diabetes Monitoring Indicators

目的探讨血清糖化清蛋白(glycated albumin,GA)在糖尿病(diabetes mellius,DM)患者血糖监测和诊疗中的应用价值,并对其进行性能评价。方法选取乌鲁木齐市中医医院2018年11月~2019年11月收治的首次确诊156例DM患者作为观察组,同时选取150例健康人员作为对照组,检测两组GA和糖化血红蛋白(HbA1c)浓度并对酶法测定GA的精密度、准确度、线性范围进行性能评价;使用配对资料χ^2检验,对GA和HbA1c进行一致性分析;使用t检验分析两组GA和HbA1c差异;使用Pearson相关分析评估GA与HbA1c之间关系;采用ROC曲线评价GA对DR的诊断价值。结果酶法测定GA的精密度、准确度均可以接受,GA在125~935μmol/L范围内线性良好;观察组GA(%)和HbA1c的总一致性为90.38%,两种方法差异无统计学意义(P=1.060);观察组GA(%)与HbA1c结果明显高于对照组,差异有统计学意义(t=17.31,9.59,均P<0.05);GA(%)与HbA1c呈正相关(P<0.01);ROC曲线显示GA(%)诊断DM的曲线下面积(AUC)为0.919,敏感度为91.02%,特异度为95.01%,差异均具有统计学意义(P<0.05)。结论酶法测定GA的性能符合方法学评价指标要求,对GM具有较高的诊断价值,可作为糖尿病筛查、诊断、监测、预后的综合评价指标。

Objective To investigate the application value of serum glycated albumin(GA)in blood glucose monitoring and diagnosis and treatment of diabetic patients,and evaluate its performance.Methods 156 patients with DM who were diagnosed for the first time in Urumqi Hospital of traditional Chinese Medicine from November 2018 to November 2019 were selected as the observation group,and 150 healthy people were selected as the control group.The concentrations of GA and glycosylated hemoglobin(HbA1c)in the two groups were detected,and the precision,accuracy and linear range of GA determined by enzyme method were evaluated.The difference of GA and HbA1c between two groupswere analyzed byχ^2 test or t test.The relationship between GA and HbA1c was evaluated by Pearson correlation analysis,and the diagnostic value of GA and HbA1c in DM was evaluated by ROC curve.Results The coefficient of precision and accuracy of GA was accepted.GA had a good linearity in the range of 125~935μmol/L.Chi-square test of paired data was performed,the difference between the two methods was not statistically significant(P=1.060).The result of GA(%)and HbA1c in observation group was significantly higher than that in control group,the difference was statistically significant(t=17.31,9.59,all P<0.05).There was appositive correlation between GA(%)and HbA1c.The area under ROC curve of GA in DM was 0.919,the difference was statistically significant(P<0.05).Conclusion The performance of this method for measuring GA meets the requirements of methodological evaluation indicators.It has high diafnostic value of DM,and it can be used as a comprehensive evaluation index of DM screening,diagnosis,monitoring and prognosis.