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目的比较高效液相色谱(high performance liquid chromatography,HPLC)法、A1cNOW+TM糖化血红蛋白测试卡测定糖化血红蛋白(glycosylated hemoglobin,HbA1c)的一致性,探讨红细胞压积(hematocrit,HCT)及降糖药物对A1cNOW+TM测试卡准确性的影响。方法确诊糖尿病患者224例,分别应用HPLC法、A1cNOW+TM测试卡测定HbA1c,Spearman相关分析评价2种方法检测结果的一致性,分析HCT、应用降糖药物对2种检测方法相关性的影响。结果 224例患者中24例A1cNOW+TM测试卡显示HbA1c>13%或无法测定而未获得具体值者退出研究,余200例患者HPLC、A1cNOW+TM检测HbA1c结果比较差异无统计学意义(P>0.05);HCT<0.35时,2种方法检测结果无相关性(r=0.365,P=0.165);HCT≥0.35~0.40时,2种方法检测结果相关性强(r=0.942,P=0.000);应用2种方法检测未应用降糖药物者和应用降糖药物者HbA1c水平呈正相关性(r=0.914,P=0.000;r=0.927,P=0.000)。结论A1cNOW+TM测试卡检测HbA1c的准确性和可靠性与“金标准”HPLC法相同,但该方法应用有一定局限性,在HbA1c值>13%、HCT<0.35等情况下,应采用HPLC法测定HbA1c值。
OBJECTIVE To compare the consistency of glycosylated hemoglobin (HbA1c) with high performance liquid chromatography (HPLC) and A1cNOW + TM HbA1c test card, and to investigate the effect of hematocrit (HCT) and hypoglycemic agents Impact of A1cNOW + TM test card accuracy. Methods Confirmed 224 patients with diabetes mellitus, HbA1c was determined by HPLC, A1cNOW + TM test card, Spearman correlation analysis was used to evaluate the consistency of the two methods, HCT was analyzed, and the effect of hypoglycemic agents on the correlation between the two methods was analyzed. Results Of the 224 patients, 24 patients with A1cNOW + TM test card showed that HbA1c> 13% or could not be measured but did not obtain specific value to withdraw from the study. There was no significant difference in HPLC and A1cNOW + TM for HbA1c in the other 200 patients (P> (R = 0.365, P = 0.165). When HCT≥0.35 ~ 0.40, there was a strong correlation between the two methods (r = 0.942, P = 0.000) There was a positive correlation between HbA1c levels and those with hypoglycemic agents (r = 0.914, P = 0.000; r = 0.927, P = 0.000). Conclusion The accuracy and reliability of the A1cNOW + TM test card for detecting HbA1c are the same as that of the “Gold standard” HPLC method. However, there are some limitations in the application of this method. When the HbA1c value is> 13% and HCT <0.35, Determination of HbA1c by HPLC method.