Abbott Launches Rapid Point-of-Care HbA1c Test to Aid in the Diagnosis of Diabetes

Abbott, a global healthcare leader with a portfolio of technologies spanning the spectrum of healthcare, announced today that its Afinion HbAlc Dx Assay is now available for use on the Afinion 2 Analyzer, as well as the Afinion AS100 Analyzer. The Afinion HbA1c Dx assay is the first and only rapid point-of-care test cleared by the U.S. Food and Drug Administration (FDA) to aid healthcare professionals in the diagnosis of diabetes and the assessment of patients’ risk of developing the condition.
 
The Afinion HbA1c Dx assay, which is a moderate complexity test for quantitative determination of HbA1c in human whole blood, meets the FDA’s stringent requirements for performance testing for diagnostic use claims. The test delivers accurate and precise^1,2 glycated hemoglobin (HbA1c) results in only three minutes, enabling clinicians to diagnose patients and help them formulate individualized care plans during a single doctor’s office visit. The Afinion HbA1c Dx assay (approved for monitoring and diagnosis) complements the Afinion HbA1c assay (approved for monitoring only), the number one point-of-care HbA1c test in the U.S. for monitoring long-term glycemic control in diabetes.³
 
“As diagnostics continue to move to point-of-care settings such as physician office labs, the Afinion HbA1c Dx rapid assay shows how Abbott is once again setting new standards for innovation in the diagnosis and monitoring of diabetes,” said Elizabeth Balthrop, divisional vice president, Cardiometabolic and Informatics, Rapid Diagnostics, Abbott. “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.”

 
“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. “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 U.S.”
 
References:
¹ Arnold, W et. al. Fingerstick Precision and Total Error of a Point-of-Care HbA1c Test.  J Diab Sci Technol 2019; Mar [Epub ahead of print]. https://doi.org/10.1177/1932296819831273 
² Arnold, W et. al. Accuracy and Precision of a Point-of-Care HbA1c Test. J Diab Sci Technol 2019; Mar [Epub ahead of print]. https://journals.sagepub.com/doi/full/10.1177/1932296819831292
³ Market share data reflects Q1-4 2018 & Q1-2019 GHX data for distributor product sales in US.