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目的:对酶法测定糖化血红蛋白(HbAIc)进行方法学评价,探讨其在妊娠期糖尿病(GDM)诊断中的临床意义。方法:系统研究酶法测定HbAIc的灵敏度、精密度及干扰因素。并将正常妊娠组和GDM组进行比较。结果:酶法测定HbAIc批内平均变异系数(CV)为3.36%,批间平均CV为3.51%,平均回收率99.40%。抗坏血酸低于4 mg/dl时对结果无干扰,血红蛋白(Hb)在2.0 g/L以下对测定结果无干扰,三酰甘油4.5 mmol/L以下对测定结果无干扰,与DS5糖化血红蛋白仪比较有良好的相关性,Y=0.895X+0.29,r=0.924(P<0.01),GDM组结果高于正常妊娠组,差异具有统计学意义(P<0.01)。结论:酶法测定HbAIc具有较高的灵敏度和精密度,适于大批量及临床常规使用。
Objective: To evaluate the clinical significance of enzymatic determination of glycosylated hemoglobin (HbAIc) and its clinical significance in the diagnosis of gestational diabetes mellitus (GDM). Methods: The enzymatic method was used to determine the sensitivity, precision and interference factors of HbAIc. The normal pregnancy group and GDM group were compared. Results: The average coefficient of variation (CV) of HbAIc by enzyme method was 3.36%, the average CV between batches was 3.51% and the average recovery was 99.40%. Ascorbic acid was lower than 4 mg / dl without any interference with the results, hemoglobin (Hb) was below 2.0 g / L without any interference with the determination results, and no significant difference was observed when the concentration of triacylglycerol was less than 4.5 mmol / L as compared with DS5 glycated hemoglobin There was a good correlation between the two groups (Y = 0.895X + 0.29, r = 0.924, P <0.01), and the difference between the GDM group and the normal pregnancy group was statistically significant (P <0.01). Conclusion: Enzymatic determination of HbAIc with high sensitivity and precision, suitable for large quantities and clinical routine use.