Abbott has announced the availability of its Afinion HbA1c Dx assay for use on the Afinion 2 Analyzer and the Afinion AS100 Analyzer in the diagnosis of diabetes.
The Afinion HbA1c Dx point-of-care test has secured clearance from the US Food and Drug Administration (FDA) as a moderate complexity test to determine HbA1c in human whole blood.
The test delivers accurate and precise glycated hemoglobin (HbA1c) results in a short span of time. This enables clinicians to diagnose patients and develop informed, individualised care plans during a patient consultation.
Abbott Cardiometabolic and Informatics, Rapid Diagnostics 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.”
Approved for monitoring and diagnosis, the Afinion HbA1c Dx complements the Afinion HbA1c assay, which is approved only for monitoring.
The multi-assay Afinion 2 Analyzer streamlines and simplifies the delivery of actionable, accurate measurements of HbA1c and albumin-to-creatinine ratio (ACR) results at the point of care.
Launched in May last year, the Afinion 2 platform offers all-in-one connectivity to laboratory and hospital information systems.
It was launched for patient management of diabetes through whole blood HbA1c testing and ACR testing in urine.