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Evaluation of Glycaemic Control Limits Using the Ames DCA 2000 HbA 1c Analyser
Author(s) -
Rumley A.G.,
Kilpatrick E.S.,
Dominiczak M.H.,
Small M.
Publication year - 1993
Publication title -
diabetic medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.474
H-Index - 145
eISSN - 1464-5491
pISSN - 0742-3071
DOI - 10.1111/j.1464-5491.1993.tb00016.x
Subject(s) - medicine , analyser , immunoassay , diabetes mellitus , population , gastroenterology , chromatography , immunology , antibody , endocrinology , environmental health , chemistry
The Ames DCA 2000 is a benchtop analyser that measures HbA 1c by an agglutination inhibition immunoassay using a monoclonal antibody. Laboratory and nursing staff measured HbA 1c on‐site in 78 patients with Type 1 diabetes at the outpatient clinic. Significant correlations were noted with both the Corning Glytrac total HbA 1 assay ( r = 0.89) and the Novoclone assay for HbA 1c ( r = 0.95). Mean within‐assay CV was 1.6% and 3.0% at HbA 1c 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 HbA 1 assay. Locally derived reference population data for HbA 1c 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 HbA 1 in this range. It appears that the convention for derivation of control limits for HbA 1 does not hold for this HbA 1c assay.