Point-of-Care Test Could Aid in Diagnosis of Diabetes

Abbott announced this week that its Afinion HbA1C Dx assay, which can deliver a result in 3 minutes, is now available for use. According to a statement from Abbott, the test is “the first and only rapid point-of-care test” with FDA clearance to help clinicians diagnose diabetes or assess their risk of developing the condition.

It will allow clinicians to diagnose diabetes within a single office visit, according to the company’s statement. Abbott makes a separate assay for monitoring glycemic control, called Afinion HbA1C. The new assay can be used on the Afinion 2 Analyzer as well as the Afinion AS100 Analyzer, according to the statement.

In statement, an Abbott official said the new test fits with the trend of moving diagnostics into point-of-care settings.

“In addition to giving physicians the certainty of diagnosis they need to make informed decisions during a patient visit, the HbA1C Dx assay gives people living with diabetes near real-time results, so that in consultation with their doctor they can make adjustments to their lifestyle and better manage their condition,” Elizabeth Balthrop, divisional vice president, Cardiometabolic and Informatics, Rapid Diagnostics, Abbott, said in a statement.

A former official with the American Diabetes Association (ADA) said the availability of a rapid test could immediately connect patient care they need for the disease.

Said Richard Kahn, PhD, former ADA chief scientific officer and medical officer, “In addition, point-of-care diagnosis can enhance clinical efficiencies for busy practices and, at a population level, help stem the massive economic and societal impacts of diabetes in the United States.”