Abbott has launched the Afinion HbA1c Dx assay, a point of care (POC) glycated hemoglobin (HbA1c) test that provides results in 3 minutes. The test can be used to aid in the diagnosis of diabetes or to assess the risk of developing the disease.
Approved by the Food and Drug Administration (FDA), the assay has been cleared for use with the Afinion 2 Analyzer and the Afinion AS100 Analyzer. The FDA approval was based on 2 trials that collected fingerstick and venous whole blood samples at POC sites. Results showed that testing with the Afinion HbA1c Dx assay was found to be accurate and precise. Moreover, the calculated total error was under the accepted quality requirement of ≤6%.
The assay is also cleared for use in monitoring long-term glycemic control. The Afinion HbA1c Dx assay complements the Company’s Afinion HbA1c assay, which is approved for monitoring only.
“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, PhD, former chief scientific and medical officer of the American Diabetes Association.
For more information visit Abbott.com.