Boz M, Gérard P, Scheen A J, Lefèbvre P J, Castillo M J
Département de médecine, CHU Sart-Tilman, Liége, Belgique.
Ann Biol Clin (Paris). 1997 Mar-Apr;55(2):139-44.
Measurement of glycosylated haemoglobin has become an essential tool in the management of diabetic patients. A recently developed device allows the rapid immuno-assay of HbA1c in 1 microliter capillary blood obtained by a finger prick. In 100 ambulatory diabetic patients, we compared the results obtained with this method to those obtained in venous blood using a standard affinity chromatography laboratory method. Although both methods correlated (r = 0.88, p < 0.001), the mean +/- SD levels respectively obtained differed slightly (7.6 +/- 1.5 vs 79 +/- 1.4% p < 0.001). The 95% confidence interval of the difference was [-0.41. -0.14]. Considering a cut-off HbA1c value of 8%, as indicative of the need for treatment adjustment, 33 patients with the capillary blood immuno-assay method and 42 with the venous-blood affinity chromatography method were above that limit (Mc Nemar test, p < 0.05). In conclusion, the rapid assay of HbA1c in capillary blood can be useful for the management of some diabetic patients but the results are not readily exchangeable with those obtained from other standardized laboratory methods. Consequently, specific ranges and clinical decision limits must be determined.
糖化血红蛋白的测定已成为糖尿病患者管理中的一项重要工具。一种最近开发的设备能够对通过手指针刺采集的1微升毛细血管血中的糖化血红蛋白(HbA1c)进行快速免疫测定。在100名门诊糖尿病患者中,我们将该方法得到的结果与使用标准亲和色谱实验室方法从静脉血中获得的结果进行了比较。尽管两种方法具有相关性(r = 0.88,p < 0.001),但分别获得的平均±标准差水平略有不同(7.6±1.5对7.9±1.4%,p < 0.001)。差异的95%置信区间为[-0.41,-0.14]。将糖化血红蛋白(HbA1c)临界值设定为8%,作为需要调整治疗的指标,采用毛细血管血免疫测定法有33名患者、采用静脉血亲和色谱法有42名患者高于该限值(Mc Nemar检验,p < 0.05)。总之,毛细血管血中糖化血红蛋白(HbA1c)的快速测定对某些糖尿病患者的管理可能有用,但结果与其他标准化实验室方法获得的结果不能轻易互换。因此,必须确定特定的范围和临床决策限值。