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New Standard of National Glycohemoglobin Standardization Program

Tue, 07/20/2010 - 5:34am
Bio-Medicine.Org

TARRYTOWN, N.Y., July 20 /PRNewswire/ -- As of January 1, 2010 the new performance certification standards applicable to devices that measure A1C (or glycated hemoglobin) as set by the National Glycohemoglobin Standardization Program (NGSP) changed to +/-0.75% A1C, 95% CI, 4-10.0% A1C range.  Bayer Diabetes Care, manufacturer of A1CNow+® and A1CNow® SELFCHECK devices, submits for annual NGSP certification each June and has now successfully completed certification under this new tighter criteria.  The company has received a new NGSP certificate valid from July 1, 2010 to July 1, 2011.  The previous criteria for last year's NGSP certification was +/-0.85% A1C, 95% CI, 4-12.0% A1C range.

Background:

The purpose of the NGSP is to standardize glycated hemoglobin test results. Standardization allows A1C results to be 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.(1) In order to achieve NGSP certification, an A1C testing method must successfully complete rigorous testing requirements annually.  Each year, Bayer's A1CNow+ and A1CNow SELFCHECK devices meters must complete NGSP certification requirements.  Bayer's NGSP certificate expires annually on July 1.  

Bayer's new A1CNow+ and A1CNow SELFCHECK NGSP Certificate of Traceability is available online at

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