【摘要】 目的对挪威NycoCard ReaderⅡ多功能金标定量检测仪测定糖化血红蛋白A1c(HbA1c)进行方法学评价。方法按仪器及试剂说明书操作规程检测HbA1c,对其精密度、准确性、线性和抗干扰能力进行测定,并与高效液相色谱法作比较测定,观察其相关性。结果金标法检测HbA1c批内CV值为2.12%,批间CV值为3.67%;平均回收率为94.4%;线性回归方程y=1.0135x-0.0547;高浓度的黄疸、脂血及不同种类的抗凝剂对其测定无明显干扰;与高效液相色谱法测定结果比较具有良好的相关性,差异无统计学意义(r=0.9667,P>0.05)。结论NycoCardReaderⅡ金标定量法测定HbA1c,精密度、准确度较高,线性好,受干扰影响小,具有简便、快速、仪器维护简单等优点,其测定结果符合临床对糖尿病患者的治疗监测要求,有较大实用价值。更多还原

【Abstract】 Objective To evaluate the colloidal gold device in glycosylated hemoglobin A1c (HbA1c) measurements.Methods Used the colloidal gold device to detect the HbA1c and also evaluate the precision, accuracy, linearity, the interference element test,and the relativity test with the high-performance liquid chromatography (HPLC) method on it.Results The inter-CV of HbA1c was 2.12 %.The intra-CV for them was 3.67 %. The average recovery rates were 94.4% respectively.linear equation:y=1.0135x-0.0547. The jaundice, lipemia and different anticoagulant had rarely interfered with it. The result of HbA1c measured by the colloidal gold device and the HPLC has good relativity and no significant difference (r=0.9667,P>0.05).Conclusion Colloidal gold device in HbA1c measurements have a good precision,accuracy and linearity.It is a rapid,sensitive and reliable method,which can act as a clinical routine method for measuring HbA1c.更多还原