Global Point of Care
Viewpoints
Until the early 1980s, diagnosis of diabetes was by urine glucose strip screening or a fasting glucose measurement. Both of these diagnostic methodologies added critical data to the use of signs and symptoms (ketone breath, frequent urination complaint, fatigue, and slow healing sores), among others.
But, several issues reduced their effectiveness. The person with diabetes could create a better fasting glucose result than their underlying condition warranted by careful management of their diet before the test was performed. While not in the best interests of the person with diabetes, some took this route to avoid the awkward conversation related to discussions of undesired lifestyle changes.
As such, it avoids any attempts by the person with diabetes to use short-term dietary changes and provides a credible test result to decide whether the person is diabetic, prediabetic or neither.
Many technologies including chromatography, chemistry tests and electrophoresis have been used to determine HbA1c over the years. The most commonly used methods today are performed on small, easy-to-use table top systems using either affinity chromatography or an immunochemical method.
While these methods are suited for use in primary care and are CLIA-waived, there are also high-volume systems in use in major medical centers. One of the most important developments in the measurement of HbA1c was the standardization of results between analytical systems and the implementation of standards of precision requirements to assure that results would be equivalent among analytical systems and that the precision of any system assured an accurate result.
This work was spearheaded by the National Glycohemoglobin Standardization Program (now simply known as NGSP).1 This work was supported by AACC and began in earnest in 1996. Today, this method of standardization has become commonplace and systems in wide use bear the information describing their results as “NGSP certified”.2
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