Vanelli M, De Fanti A, Avantaggiato S, Ziveri M, Cantoni S, Boselli E, Chiari G
Policattedra di Pediatria, Università degli Studi di Parma.
Minerva Pediatr. 1993 Sep;45(9):373-7.
This study compares the results of a new immunoassay method (DCA2000, Ames) used to measure HbAlc concentration in 9 min using 1-microliter capillary blood sample with those obtained with an ion exchange traditional method (HPLC, DIAMAT, Biorad) in both a non-diabetic and a diabetic pediatric population. All HbAlc values were measured in the two methods on the same whole-blood venous aliquot after we had excluded differences in HbAlc values measured by DCA2000 on venous and capillary blood samples (8.5 +/- 1.4 vs 8.6 +/- 1.4%). Data analysis shows an excellent correspondence between the two assays (r = 0.97; p < 0.0001). HbAlc values obtained by DCA2000 method in diabetic patients are related to the mean value of the blood glucose levels collected at home in the last two months (r = 0.74; p < 0.003). The percentile distribution of the HbAlc values is similar both in DCA2000 (3-- = 4.4; 50-- = 5.3; 97-- = 6.0%) and in HPLC method (3-- = 4; 50-- = 5; 97-- = 5.9%). Within-run precision for DCA2000 ranges from 3.7 to 1.9% and between-run precision from 4.5 to 0.9%. The new immunoassay method gives accurate and reliable HbA1c values and compared with HPLC methodology has at least three advantages: it does not require venipuncture, provides HbA1c value within 9 miy and allows both physician and patient to verify in virtually' real time the degree of blood glucose control.
本研究比较了一种新型免疫测定方法（DCA2000，Ames公司）与离子交换传统方法（高效液相色谱法，DIAMAT，伯乐公司）在非糖尿病和糖尿病儿童群体中使用1微升毛细血管血样在9分钟内测量糖化血红蛋白（HbAlc）浓度的结果。在排除DCA2000在静脉血和毛细血管血样上测量的HbAlc值差异后（8.5±1.4%对8.6±1.4%），两种方法在同一静脉全血样本上测量了所有HbAlc值。数据分析显示两种测定方法之间具有极好的相关性（r = 0.97；p < 0.0001）。DCA2000方法在糖尿病患者中获得的HbAlc值与过去两个月在家中采集的血糖水平平均值相关（r = 0.74；p < 0.003）。DCA2000方法（第3百分位数 = 4.4；第50百分位数 = 5.3；第97百分位数 = 6.0%）和高效液相色谱法（第3百分位数 = 4；第50百分位数 = 5；第97百分位数 = 5.9%）中HbAlc值的百分位数分布相似。DCA2000方法批内精密度范围为3.7%至1.9%，批间精密度范围为4.5%至0.9%。这种新型免疫测定方法能给出准确可靠的糖化血红蛋白（HbA1c）值，与高效液相色谱法相比至少有三个优点：无需静脉穿刺，在9分钟内提供HbA1c值，并且使医生和患者几乎能实时核实血糖控制程度。
