June 21, 2019—Abbott announced that its Afinion HbA1c Dx assay, the first rapid point-of-care test cleared by the U.S. Food and Drug Administration to aid in the diagnosis of diabetes and the assessment of patients’ risk of developing the disease, is available for use on the Afinion 2 Analyzer.
The assay is FDA-cleared as a moderate complexity test for the quantitative determination of HbA1c in human whole blood and delivers results in three minutes. It is also cleared for use in monitoring long-term glycemic control.
“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 of cardiometabolic and informatics, Rapid Diagnostics, Abbott, said in a press release.
The Afinion HbA1c Dx assay received FDA clearance for use on the Afinion AS100 Analyzer in May 2018. The next-generation Afinion 2 Analyzer is a multi-assay platform that delivers measurements of HbA1c and ACR results at the point of care and offers connectivity to laboratory and hospital information systems.