Hemoglobin A1c test approved for diagnosis

The FDA recently approved the first hemoglobin A1c (HbA1c) test specifically labeled for diagnosing diabetes.


The FDA recently approved the first hemoglobin A1c (HbA1c) test specifically labeled for diagnosing diabetes (COBAS INTEGRA 800 Tina-quant HbA1cDx assay). Many clinicians have already been using HbA1c tests to diagnose diabetes, but they were not specifically designed or approved for this use, making it difficult to know which tests were sufficiently accurate. In support of marketing clearance for the new assay, investigators analyzed 141 blood samples and found less than 6% difference in the accuracy of test results from the new test compared to the standard reference for hemoglobin analysis.