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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