Abbott launches Afinion HbA1c Dx assay the first-ever rapid point-of-care HbA1c Test to aid in the diagnosis of diabetes

Abbott announced that its Afinion HbA1c Dx assay is now available for use on the Afinion 2 Analyzer, as well as the Afinion AS100 Analyzer. The Afinion HbA1c Dx assay is the first and only rapid point-of-care test cleared by the FDA to aid healthcare professionals in the diagnosis of diabetes and the assessment of patients' risk of developing the condition.

The Afinion HbA1c Dx meets FDA's stringent requirements for performance testing for diagnostic use claims. The test delivers accurate and precise, glycated hemoglobin (HbA1c) results in only three minutes, enabling clinicians to diagnose patients and help them formulate individualized care plans during a single doctor's office visit. The Afinion HbA1c Dx assay (approved for monitoring and diagnosis) complements the Afinion HbA1c assay (approved for monitoring only), the number one point-of-care HbA1c test in the U.S. for monitoring long-term glycemic control in diabetes.

Comment: The assay received FDA clearance for use on the Afinion AS100 Analyzer in May 2018 . The assay is the first-ever rapid point-of-care test approved to help diagnose diabetes and assess patients’ risk of developing the disease by offering precise and reliable results comparable to those of central laboratory systems.

Comment: Until now, the only HbA1c assays cleared for diagnosing diabetes and assessing the risk of developing diabetes were those that run on central laboratory instruments. In analytical and clinical studies, the Afinion HbA1c Dx assay demonstrated accurate, precise and reliable results comparable to those of central laboratory systems.

Comment: The Afinion HbA1c assay on the Afinion AS100 Analyzer was previously cleared in 2005 for rapid delivery of hemoglobin A1c (HbA1c) results for patient management of diabetes at the point of care. The FDA granted CLIA (Clinical Laboratory Improvements Amendments) waiver for the system in 2006, enabling broader use in qualified healthcare settings. The recent clearance for the expanded diagnostic indication is specific to laboratories with CLIA certification to perform tests that are moderate complexity or higher and does not extend to those that can only perform CLIA waived tests.