Abbott said its Afinion™ HbA1c Dx assay is now available for use on the Afinion 2 Analyzer, as well as the Afinion AS100 Analyzer. 

The product is the first and only rapid point-of-care test cleared by the U.S. Food and Drug Administration to aid healthcare professionals in the assessment and diagnosis of diabetes.

It delivers accurate and precise1,2 glycated hemoglobin (HbA1c) results in three minutes.

The Afinion HbA1c Dx assay, which is approved for monitoring and diagnosis, complements the Afinion HbA1c assay, which is approved for monitoring only, the company said. It can help move diagnostics to point-of-care settings, Abbot executives said. Historically, only HbA1c assays cleared for diagnosing diabetes and assessing diabetes risk were those running on central laboratory instruments

“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,” said Elizabeth Balthrop, divisional vice president, Cardiometabolic and Informatics, Rapid Diagnostics, Abbott.

Accurate and quick diabetes screening is increasingly needed, the American Diabetes Association said.

“Rapid, reliable diabetes screening at the point of care enables healthcare providers to immediately link patients to comprehensive care that can help prevent the serious consequences of the disease,” said Richard Kahn, Ph.D., former chief scientific and medical officer of the American Diabetes Association. 

Point-of care diagnosis can enhance clinical efficiencies when geriatricians or other physicians are busy, he added. Plus, at a population level, the tests can “stem the massive economic and societal impacts of diabetes in the U.S.”