99% Lab Accuracy - NGSP Certified

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Bayer’s A1CNow+® is annually certified by the National Glycohemoglobin Standardization Program (NGSP).

The purpose of the NGSP is to standardize glycated hemoglobin test results so that A1C results are comparable to those reported in the Diabetes Control and Complications Trial (DCCT) where relationships to mean blood glucose and risk for vascular complications have been established.
In order to achieve NGSP certification, an A1C testing method must successfully complete rigorous testing requirements annually.
A key component of the certification process is the Reference Laboratory Network. The network interacts with manufacturers of glycohemoglobin methods to assist them first in standardizing their methods and then in providing comparison data for certification of traceability to the DCCT.
A1C test methods are awarded a ‘certificate of traceability to the DCCT reference method’ if they pass rigorous accuracy-testing criteria.[1]
Certificate of NGSP (pdf)

About IFCC

The relationship between the National Glycohemoglobin Standardization Program (NGSP) A1C calibration (expressed as % A1C) and the International Federation of Clinical Chemistry (IFCC) network calibration (expressed as mmol/mol) has been shown to be stable and is given by the master equation: (NGSP = [0.0915 * IFCC] + 2.15). For further details and additional references see the NGSP website at http://www.ngsp.org/prog/index.html.

The A1CNow+® is NGSP certified (DCCT-traceable) and results can be converted to IFCC units with the master equation. Demonstrating IFCC traceability is a formal process during which A1C blood samples are assigned values by the IFCC network. Manufacturers use these samples to verify alignment of their assay with the IFCC network. In accordance with IFCC expectations, Bayer expects A1CNow+ to be formally IFCC-traceable by the end of 2009, while continuing to maintain NGSP certification (DCCT-traceable). In the meantime, you can be assured that NGSP-based results are clinically equivalent to the corresponding IFCC values through the master equation.

Real-time results. Better outcomes.

The ADA recommends that healthcare professionals use A1C point-of-care testing for timely decisions on therapy changes [2]
Giving diabetes patients on-the- spot feedback on their A1C number may result in a 1% point reduction in their A1C [3]
A 1% point reduction lowers the risk of serious complications by 40% [1]

Centers for Disease Control and Prevention. National diabetes fact sheet: general information and national estimates on diabetes in the United States, 2002. Atlanta, GA:
U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2003.
Standards of Medical Care in Diabetes - 2008. Diabetes Care, Volume 31, Supplement 1, January 2008.
Daniels, E. et al, Point of Care Testing to Improve Glycemic Control.Intl J or Health Care Quality Assurance 2008; 21 (3): pp. 325-335.
Data on file; Evaluation of the A1CNow SELFCHECK with lay-users. August 2008.
* Study results with healthcare professionals showed that the accuracy of A1CNow+ with fingerstick samples was, on average, 99%. This means that, on average, a true 7.0% 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.
Miller CD et al., Rapid A1C availability improves clinical decision-making in an urban primary care clinic. Diabetes Care 2003; 26:1158-1163.
Cagliero E et al., Immediate feedback of HbA1C levels improves glycemic control in type 1 and insulin-treated type 2 diabetic patients.
Diabetes Care 1999; 22: 1785-1789.