两种方法学检测糖化血红蛋白的比对及临床应用

Explore the results of two methods for the analysis of glycated hemoglobin

目的对比高效液相色谱法(high performance liquid chromatography,HPLC)与免疫比浊法(immunoturbidimetry,ITM)检测糖化血红蛋白(glycated hemoglobin,HbA1c)的结果,并考察两种检测方法的参考区间。方法随机收集2019年5月份我院住院及门诊患者样本330例,采取新鲜抗凝全血,使用高效液相色谱法(HPLC)与免疫比浊法(ITM)分别测定糖化血红蛋白(HbA1c),对2组测定结果进行比对分析。结果两种测定方法相关性良好,回归方程Y=0.761X+1.113,相关系数r2=0.963。两种测定方法结果具有显著差异(P<0.01)。结论通过比对分析HPLC(参比方法)检测结果异常率略高于ITM(待评方法),需要分别设置参考区间,两种检测方法均能用于HbA1c检测。而ITM具有较低的试剂成本优势,因此ITM可以作为HPLC的替代方法应用于临床糖化血红蛋白的检测。

Objective To analyze the results of high performance liquid chromatography(HPLC) and immunoturbidimetry(ITM)for detecting glycosylated hemoglobin(HbA1 c),and to investigate the reference intervals of the two detection methods.Methods A total of 330 inpatient and outpatient samples from our hospital in December2018 were randomly collected. Fresh anticoagulated whole blood was taken. High-performance liquid chromatography(HPLC)and immunoturbidimetry(ITM)were used to determine the glycosylated hemoglobin in random samples.HbA1 c),the two groups of results were compared and analyzed. Results The correlation between the two methods was good. The regression equation Y=0.761 x+1.113 and the correlation coefficient R2=0.963. There were significant differences between the two methods(P<0.01). Conclusion The abnormal rate of detection by HPLC(reference method)is slightly higher than that of ITM(method to be evaluated). There are systematic differences between the two,and the reference interval needs to be set separately. Both methods can be used in clinical application for HbA1 c detection. Because of the high reagent cost of HPLC and the low reagent cost advantages of ITM,ITM can be used as an alternative to HPLC for the detection of clinical glycated hemoglobin.