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Evaluation of glycaemic control limits using the Ames DCA 2000 HbA1c analyser
A G Rumley1, E S Kilpatrick, M H Dominiczak
1Department of Clinical Biochemistry, Gartnavel General Hospital, Glasgow, UK.
Diabetic Medicine : a Journal of the British Diabetic Association
|December 1, 1993
Summary
The Ames DCA 2000 accurately measures HbA1c using immunoassay, showing good precision. However, its glycaemic control categorization differs significantly from conventional methods for Type 1 diabetes patients.
Area of Science:
- Clinical Chemistry
- Diabetes Mellitus Diagnostics
- Immunodiagnostics
Background:
- Glycated hemoglobin (HbA1c) is a critical biomarker for diabetes mellitus management.
- Point-of-care testing (POCT) offers potential for immediate clinical decision-making.
- The Ames DCA 2000 is a benchtop analyzer utilizing an immunoassay for HbA1c measurement.
Purpose of the Study:
- To evaluate the performance of the Ames DCA 2000 for on-site HbA1c measurement in Type 1 diabetes patients.
- To compare HbA1c results from the DCA 2000 with established laboratory assays.
- To assess the clinical utility of the DCA 2000 in categorizing glycaemic control.
Main Methods:
- HbA1c was measured on-site using the Ames DCA 2000 in 78 Type 1 diabetes outpatients.
- Results were correlated with two established laboratory HbA1c assays: Corning Glytrac and Novoclone.
- Within- and between-assay coefficients of variation (CV) were determined to assess precision.
Main Results:
- The DCA 2000 demonstrated significant correlations with both reference assays (r = 0.89 and r = 0.95).
- Assay precision was good, with low mean within-assay CVs (1.6% at 5.4% HbA1c, 3.0% at 13.0% HbA1c) and acceptable between-assay CVs (3.8-4.2%).
- A notable discrepancy was observed in glycaemic control categorization: only 22% of patients met good/acceptable control criteria by DCA 2000, versus 46% by conventional methods.
Conclusions:
- The Ames DCA 2000 provides precise and well-correlated HbA1c measurements comparable to laboratory methods.
- Conventional criteria for glycaemic control categorization may not directly apply to results obtained with the DCA 2000.
- Further investigation is needed to establish appropriate reference ranges or interpretation guidelines for the DCA 2000 in specific patient populations.