Clinicians can officially use the Tina-quant HbA1cDx assay (Roche) to diagnose diabetes, the FDA has announced.
This is the first HbA1c test the agency is allowing to be marketed for diabetes diagnosis. Other HbA1c tests currently on the market have only received clearance for blood glucose control, but not diagnosis.
Although many health care providers already use HbA1c test to diagnose diabetes based on research and recommendations from international diabetes experts, non were designed or indicated specifically for diagnosis. This made it difficult for health care providers to know which A1c tests were accurate enough to use for this purpose, the FDA said in a press release.
“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,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Devices at 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.”
The FDA’s decision is based on results from an analysis of 141 blood samples, in which there was a less than 6% difference in the accuracy of the Cobas Integra 800 Tina-quant HbA1cDx assay and the standard reference for hemoglobin analysis.
The test is available by prescription for use in clinical laboratories. Only qualified healthcare professionals should diagnose diabetes; patients should not use OTC HbA1c tests for this purpose, the FDA warned.
The Tina-quant HbA1cDx assay should not be used to diagnose diabetes in certain patients, such as those who are pregnant, those 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.