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

Arabadjief, Melissa MD; Nichols, James H. PhD, DABCC, FACB

Point of Care: The Journal of Near-Patient Testing & Technology: March 2009 - Volume 8 - Issue 1 - p 11-15
doi: 10.1097/POC.0b013e3181971cef
Original Articles

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: james.nichols@bhs.org.

© 2009 Lippincott Williams & Wilkins, Inc.