Rumley A G, Kilpatrick E S, Dominiczak M H, Small M
Department of Clinical Biochemistry, Gartnavel General Hospital, Glasgow, UK.
Diabet Med. 1993 Dec;10(10):976-9. doi: 10.1111/j.1464-5491.1993.tb00016.x.
The Ames DCA 2000 is a benchtop analyser that measures HbA1c by an agglutination inhibition immunoassay using a monoclonal antibody. Laboratory and nursing staff measured HbA1c on-site in 78 patients with Type 1 diabetes at the outpatient clinic. Significant correlations were noted with both the Corning Glytrac total HbA1 assay (r = 0.89) and the Novoclone assay for HbA1c (r = 0.95). Mean within-assay CV was 1.6% and 3.0% at HbA1c of 5.4% and 13.0%, respectively, while between-assay CVs were 4.2% and 3.8%. These results are as good as our routine laboratory method based on the Corning HbA1 assay. Locally derived reference population data for HbA1c were produced and patients were assigned to categories of good, acceptable, and poor glycaemic control using conventional recommendations for Type 2 diabetes. There was poor agreement between the methods, with only 22% of patients achieving good/acceptable control using the DCA 2000, while 46% of patients had an HbA1 in this range. It appears that the convention for derivation of control limits for HbA1 does not hold for this HbA1c assay.
Ames DCA 2000是一种台式分析仪，它使用单克隆抗体通过凝集抑制免疫测定法来测量糖化血红蛋白（HbA1c）。实验室和护理人员在门诊为78例1型糖尿病患者现场测量了HbA1c。结果发现，其与康宁Glytrac总HbA1测定法（r = 0.89）和诺沃克隆HbA1c测定法（r = 0.95）均具有显著相关性。当HbA1c分别为5.4%和13.0%时，批内变异系数（CV）均值分别为1.6%和3.0%，而批间CV分别为4.2%和3.8%。这些结果与我们基于康宁HbA1测定法的常规实验室方法一样好。生成了当地的HbA1c参考人群数据，并根据2型糖尿病的常规建议将患者分为血糖控制良好、可接受和较差三类。两种方法之间的一致性较差，使用DCA 2000时只有22%的患者达到良好/可接受的控制水平，而46%的患者HbA1处于该范围内。看来，HbA1控制限值的推导惯例不适用于这种HbA1c测定法。
