New HbA1c Test FDA-Approved to Diagnose Diabetes

The FDA announced that it has granted marketing approval for Roche Laboratories' COBAS INTEGRA 800 Tina-quant HbA1cDx assay (Tina-quant HbA1cDx assay) for the diagnosis of diabetes by healthcare professionals. The Tina-quant HbA1cDx assay, a laboratory-based test, can be used to both diagnose diabetes and monitor a patient's blood glucose control. This is the first HbA1c test that FDA has allowed to be marketed for this use.

Current HbA1c tests on the market are approved to monitor a patient's blood glucose level, not for diagnosing diabetes. An A1c test measures the percentage of hemoglobin A1c that is bound to glucose, giving a patient's average glucose level over a three-month period. 

Study investigators analyzed 141 blood samples and found <6% difference in the accuracy of test results from the Tina-quant HbA1c assay compared to results from standard reference for hemoglobin analysis.

HbA1c tests, including the Tina-quant HbA1cDx assay, should not be used to diagnose diabetes during pregnancy and should not be used to monitor diabetes in patients with hemoglobinopathy, hereditary spherocytosis, malignancies, or severe chronic, hepatic and renal disease. This test should not be used to diagnose or monitor diabetes in patients with the hemoglobin variant hemoglobin F.

The Tina-quant HbA1c assay is available by prescription for use in clinical laboratories.

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