A1CNow Selfcheck monitor with 2 test strips provides a fast and easy way of obtaining accurate HbA1c results in the home to help you better manage (or avoid) diabetes. Results in 5 minutes.
Manufacturer does not sell test strips separately from monitor.
The A1CNow system is certified by the NGSP (National Glycohemoglobin Standardization Program), CLIA Waived, and FDA approved for home and professional use.
The results of clinical tests showed that the accuracy of A1CNow, with fingerstick samples was, on average, 99%. This means that, on average, a true 7 %A1c could read approximately 6.9 %A1c. An individual A1CNow, with a venous sample, result may differ by as much as -1.0 %A1c to +0.8 %A1c from the true result. The results showed that the accuracy with venous sampling was, on average, 99.7%. An individual result may differ by -0.8 %A1c to +0.7 %A1c from the true result.
Accuracy studies were conducted with 189 diabetic and non-diabetic subjects across three US sites. Fingerstick sampling was performed on each subject for testing with the A1CNow+ system, and venous blood was collected from each subject for comparative testing using an NGSP-certified method. A1CNow+ results were compared to the NGSP reference results. The A1C results ranged from 5.0% A1C to 12.8% A1C, with a mean of 7.3% A1C (reference results). Data analysis consisted of least squares linear regression (x = reference results), bias calculation, and Bland Altman limits.
The results showed that the accuracy of the A1CNow+ system, with fingerstick samples was, on average, 99%. This means that, on average, a true 7% A1C could read approximately 6.9% A1C. An individual A1CNow+ result may differ by as much as -1.0% A1C to +0.8% A1C from the true result. This represents the 95% confidence limits of a Bland-Altman plot.
Venous blood was collected from 110 diabetic subjects, and each sample was tested on one of three different lots. Aliquots of the venous samples were also tested by the NGSP-certified method, providing comparative results. Data analysis again consisted of least squares linear regression (x = reference results), bias calculation and Bland-Altman limits. The results showed that the accuracy with venous sampling was, on average, 99.7%. An individual result may differ by -0.8% A1C to +0.7% A1C from the true result. This represents the 95% confidence limits of the Bland-Altman plot. The A1CNow+ system may be used with either fingerstick (capillary) or venous (heparin-anticoagulated) whole blood samples.
Clinical studies were performed at three US sites with over 180 untrained people (most with diabetes). These study subjects read the instructions and then performed one A1CNow+ test on themselves. A venous blood sample was collected from each subject, and this sample was tested by an NGSP-certified laboratory method for % A1C. The two results were then compared.