Evaluation of the Afinion AS100 Point-of-Care Analyzer for Hemoglobin A1c

Abstract: An evaluation of a new Afinion AS100 Analyzer was conducted to assess analytical performance. Precision was estimated by analyzing 2 control and 3 patient samples twice a day for 10 days. Accuracy was established by analysis of 6 samples from the National Glycated Hemoglobin Standardization Program for a 3-day period. Agreement was correlated to a laboratory method, the Variant II Turbo Hemoglobin Testing System, and a point-of-care method, the DCA2000+ Hemoglobin A1c System, using leftover EDTA samples from laboratory analysis (n = 110, range of results = 4.6%Y13.7% HbA1c). The Afinion AS100 Analyzer (0.9%Y1.8 % coefficient of variation [CV]) displayed laboratory comparable precision (Variant II Turbo = 1.1%Y1.9 % CV) that was superior to the DCA2000+ (2.9%Y3.3 % CV) with minimal bias to the National Glycated Hemo-globin Standardization Program target concentrations (G0.2 % HbA1c average unit bias or 3.1%). The Afinion AS100 Analyzer had goo