The FDA has approved the COBAS INTEGRA 800 Tina-quant HbA1cDx assay (Tina-quant HbA1cDx assay) from Roche Diagnostics, Indianapolis, for the diagnosis of diabetes by health care professionals—marking the first HbA1c test the agency has allowed to be marketed for this use.
The HbA1c tests, or A1c tests, currently on the market are FDA-cleared for monitoring a patient's blood glucose (sugar) control, but not for diagnosing diabetes.
A1c tests measure the percentage of hemoglobin A1c that is bound to glucose, giving a patient's average glucose level over a 3-month period.
Diabetes is a serious, chronic metabolic condition where the body is unable to convert glucose into the energy needed to carry out daily activities. An estimated 25.8 million people in the United States have diabetes, including seven million people who remain undiagnosed. If left untreated, high blood glucose levels (hyperglycemia) can lead to serious long-term problems such as stroke, heart disease, and damage to the eyes, kidneys, and nerves.
The diagnostic criteria for diabetes have changed over time. Based on the research and recommendations of international diabetes experts, many health care providers have already been using some A1c tests to diagnose diabetes, in addition to the established diagnostic procedures of a fasting blood glucose test and an oral glucose tolerance test to diagnose diabetes. However, before May 23, A1c tests were not specifically designed or granted permission by FDA to be marketed for diabetes diagnosis, making it difficult to know which A1c tests were accurate enough for this purpose. The Tina-quant HbA1cDx assay, a laboratory-based test, can be used to both accurately diagnose diabetes and monitor blood glucose control.
"Providing health care professionals with another tool to identify undiagnosed cases of diabetes should help them provide patients appropriate guidance on treatment before problems develop," says Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Devices, FDA's Center for Devices and Radiological Health. "As the Tina-quant HbA1cDx assay was designed for diabetes diagnosis and has been reviewed by the FDA, physicians can have confidence that this test is reasonably safe and effective when used for its intended purposes of monitoring and diagnosing diabetes."
In support of marketing clearance, investigators analyzed 141 blood samples and found less than 6% difference in the accuracy of test results from the Tina-quant HbA1cDx assay compared to results from the standard reference for hemoglobin analysis.
Hemoglobin A1c 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.