AACE: Assessment of Accuracy and Precision of A New Simple Method for Office-Based A1c Measurement
The results of this study confirm the accuracy and reliability of the InViewTM capillary monitor for HhA 1c measurement. Glycohemoglobin Ale (HbAlc) is a universally-accepted tool for monitoring glycemic control in patients with diabetes. Recently-introduced portable HbAlc devices for use in physicians’ offices are desirable because they are easy for clinical staff to use, and they pro-vide immediate results that physicians can share with their patients. We undertook this study to evaluate the accuracy and precision of a recently-introduced device, the AleNow @ InViewTM capillary monitor.
Thirty-five EDTA-preserved whole blood samples were obtained from our laboratory, selected based on the results of HbAlc to cover a range from 4 to 13%. HbAlc was then measured using an AlcNow OO InViewTM device by a representative of the device manufacturer, under the observation of our lab-oratory director. Blinded aliquots of these samples were then sent to a certified National Glycohemoglobin Standardization Program (NGSP) reference laboratory for comparison. One sample with a laboratory result of 9.2% HbAlc was measured with the InViewTM device 9 successive times to assess the precision of the device. The consistency between the measurement of HbA lc measured by the reference laboratory and the InViewTM device were analyzed via linear regression.
The HbA1c measurements using the InViewTM device correlated well with the results of the reference laboratory, as well as with the results of our own laboratory. The precision study showed excellent reproducibility. These results indicate good accuracy and reliability of this new device, respectively.
The results of this study confirm the accuracy and reliability of the InViewTM capillary monitor for HhA 1 c measurement.
Presented at the AACE Meeting in Chicago on April 27, 2006. Abstract #253 Ainarbir Mattewal, MD, Saleh A. Aldasougi, MD, FACE, David Solomon, PhD, Ved Gossain, MD, and Anthony Koller, PhD