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%-13.7% HbA1c). The Afinion AS100 Analyzer (0.9%-1.8% coefficient of variation [CV]) displayed laboratory comparable precision (Variant II Turbo = 1.1%-1.9% CV) that was superior to the DCA2000+ (2.9%-3.3% CV) with minimal bias to the National Glycated Hemoglobin Standardization Program target concentrations (<0.2% HbA1c average unit bias or 3.1%). The Afinion AS100 Analyzer had good agreement with both the Variant II Turbo and DCA2000+ with r of greater than 0.9837 and Sy.x of ±0.22% and ±0.29% HbA1c, respectively. Staff found the analyzer easy to train and use, providing faster results than the DCA2000+ (3 minutes vs 6 minutes). The Afinion AS100 Analyzer will be recommended over the DCA2000+ when requests for future point-of-care HbA1c are made in our health system.
From the Baystate Health, Springfield, MA.
Reprints: James H. Nichols, PhD, DABCC, FACB, Tufts University School of Medicine, Clinical Chemistry, Baystate Health, 759 Chestnut St, Springfield, MA 01199. E-mail: email@example.com.