用于测量糖化血红蛋白HbA1c的快速桌面方法

Rapid desktop method for the measurement of glycated haemoglobin HbA1c.

作者信息

Thai A C, Ng W Y, Lui K F, Cheah J S

机构信息

Department of Medicine, National University Hospital, Singapore.

出版信息

Singapore Med J. 1993 Dec;34(6):493-5.

PMID:8153708

Abstract

A new desktop monoclonal antibody-based test system (Bayer Diagnostics DCA 2000) for quantitation of glycated haemoglobin HbA1c is described and evaluated. This method involves a monoclonal antibody to HbA1c which defines its specificity. It requires 9 minutes to complete, and shows good intra- and inter-run precisions (1.3%-3.7%), at 5 HbA1c levels tested--4.1%, 5.7%, 6.1%, 9.2% and 12.4%. Results from 81 blood samples obtained from diabetic patients (3.9%-13.2% HbA1c) showed excellent correlation with a laboratory-based ion-exchange HPLC technique (y = 1.03 [Lab] + 0.103%; Pearson coefficient, r = 0.99). The test can be performed either with a capillary fingerprick or venous blood sample. Only 1 microliter of blood volume is required. Comparison of HbA1c levels of 43 paired capillary and venous samples showed excellent correlation (y = 1.00 [venous] + 0.042%; r = 0.99). The HbA1c values obtained from a cohort of 37 healthy adults, mean (+/- SD) age 33 +/- 9.01 years, gave a value of 5.5 +/- 0.42%. The calculated 95% confidence limits are 4.7%-6.3%. This quick method provides 'stat' HbA1c results, which were hitherto not possible with the laboratory-based methods.

摘要

本文描述并评估了一种基于单克隆抗体的新型台式糖化血红蛋白HbA1c定量检测系统（拜耳诊断DCA 2000）。该方法采用针对HbA1c的单克隆抗体来确定其特异性。检测过程需9分钟完成，在检测的5个HbA1c水平（4.1%、5.7%、6.1%、9.2%和12.4%）下，批内和批间精密度良好（1.3%-3.7%）。从糖尿病患者采集的81份血样（HbA1c为3.9%-13.2%）的检测结果与基于实验室的离子交换高效液相色谱技术具有极佳的相关性（y = 1.03[实验室检测结果]+0.103%；皮尔逊系数，r = 0.99）。该检测既可用毛细血管血针刺采血，也可用静脉血样进行。仅需1微升血样。对43对配对的毛细血管血样和静脉血样的HbA1c水平进行比较，显示出极佳的相关性（y = 1.00[静脉血样结果]+0.042%；r = 0.99）。对37名健康成年人（平均年龄（±标准差）为33±9.01岁）进行检测，所得HbA1c值为5.5±0.42%。计算得出的95%置信区间为4.7%-6.3%。这种快速检测方法可提供即时的HbA1c检测结果，而这是基于实验室的方法此前无法做到的。