Healthcare firm Abbott has introduced Afinion HbA1c Dx assay for assistance in the diagnosis of diabetes.
Available for use on the Afinion 2 analyser and Afinion AS100 analyser, the Afinion HbA1c Dx assay is claimed to be the first and only rapid point-of-care test secured approval from the US Food and Drug Administration (FDA) to help healthcare professionals diagnose diabetes and assess patients’ risk of developing the condition.
According to the company, the Afinion HbA1c Dx meets FDA’s rigorous requirements for performance testing for diagnostic use claims.
The HbA1c Dx assay provides accurate and precise glycated hemoglobin (HbA1c) results within three minutes, helping clinicians to diagnose patients and formulate individualised care plans during a single doctor’s office visit.
Afinion HbA1c Dx assay is said to complement the Afinion HbA1c assay, a major point-of-care HbA1c test in the UD to monitor long-term glycemic control in diabetes.
Abbott rapid diagnostics, cardiometabolic and informatics divisional vice president Elizabeth Balthrop said: “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.
“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.”
Afinion HbA1c Dx assay is a moderate complexity test for quantitative determination of HbA1c in human whole blood.
It is also approved for use in monitoring long-term glycemic control. In May 2018, the assay secured FDA approval for use on the Afinion AS100 analyser.
Afinion 2 analyser is an advanced multi-assay platform, which streamlines and simplifies the delivery of actionable and precise measurements of HbA1c and ACR results at the point of care.
In May 2018, the platform was introduced for patient management of diabetes through whole blood HbA1c testing and ACR testing in urine.