Abstract
Background:
Glycohemoglobin A1c (HbAlc) is a universally accepted tool for glycemic control. Portable HbAlc devices for use in physicians' offices are desirable because they provide immediate results that physicians can share with their patients. This has been shown to enhance self-management in patients with diabetes. We undertook this study to evaluate the accuracy and precision of a recently introduced device, the AlcNow® InView™ capillary monitor.
Method:
Previously tested EDTA-preserved whole blood samples from our laboratory pool were preselected based on the results of HbAlc to cover a range from 4 to 13%. HbAlc was then measured using an AlcNow InView capillary monitor. Blinded aliquots of these samples were then sent to a National Glycohemoglobin Standardization Program (NGSP)-certified reference laboratory for comparison. One sample with a laboratory HbAlc result of 9.2% was measured with the InView device nine successive times to assess the device precision. The consistency between the measurement of HbAlc measured by the reference laboratory and the AlcNow InView device was analyzed via linear regression.
Results:
Thirty-five samples were tested. The correlation between HbAlc measured by the InView device and the reference laboratory, as well as our own laboratory, was 0.96. The coefficient of variation was 2.7l°%.
Conclusions:
Results of this study confirm the accuracy and precision of the InView capillary HbAlc monitor. However, the feasibility, reproducibility, and cost-effectiveness of this promising device in the real-life settings of physicians' offices must be verified by prospective clinical studies.