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MULTI-TEST A1C SYSTEM

Practitioner Direct

99% Lab Accuracy - NGSP Certified

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

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.

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  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.
  2. Standards of Medical Care in Diabetes - 2008. Diabetes Care, Volume 31, Supplement 1, January 2008.
  3. 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.
  4. 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.
  5. Miller CD et al., Rapid A1C availability improves clinical decision-making in an urban primary care clinic. Diabetes Care 2003; 26:1158-1163.
  6. 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.