Abbott has launched its Afinion hemoglobin A1c (HbA1c) Dx test for use in diagnosing diabetes and monitoring blood glucose in point-of-care settings. The company said the assay may be used to deliver results in three minutes, informing discussions between physicians and patients during office visits.
The rapid test was cleared by the U.S. Food and Drug Administration (FDA) in May 2018 for use with the company's Afinion AS100 analyzer to measure HbA1c, diagnose diabetes, and assess risk for developing the condition. It received clearance from the agency for use with the company's Afinion 2 multiassay analyzer in November 2018.
Abbott's Afinion HbA1c point-of-care assay for monitoring only was cleared by the FDA in 2005.