Making the Grade
Meets Important Criteria
On June 3, 2002, Metrika, Inc., of Sunnyvale, California, announced that its disposable A1cNow diabetes
monitor, which can provide an A1C test result in a doctor's office or a patient's home, has obtained certification from the National Glyco-hemoglobin Standardization Program (NGSP).
This means the A1cNow has an NGSP-certified coefficient of variation (CV)-an estimate of the monitor's precision, or repeatability-of 5%.
Last year, the A1cNow's CV was around 8%.
"[Metrika's] precision data showed that the CV is not statistically greater than 5%," thus meeting the NGSP criteria, says Randie Little, PhD, of the University of Missouri, who is the network coordinator for the NGSP.
Little adds, however, that the NGSP precision criteria were tightened to 4% as of July 1, 2002. "All methods certified after July 1 will have to meet these new precision criteria," she points out.
In its press release, Metrika says it "plans to pursue clearance for over-the-counter use without a prescription."
The purpose of the NGSP is to standardize A1C test results and ensure that they are traceable to the reference method used in the Diabetes Control and Complications Trial.
For more information, log on to www.metrika.com.