The U.S. Food and Drug Administration announced that the Cobas Integra 800 Tina-quant HbA1cDx assay can now be used by healthcare professionals as an aid to diagnose diabetes.
The U.S. Food and Drug Administration (FDA) recently announced that the Cobas Integra 800 Tina-quant HbA1cDx assay can now be used by healthcare professionals as an aid to diagnose diabetes. HbA1c is the first test the FDA has allowed to be marketed for diabetes diagnosis. Other HbA1c tests on the market are cleared for monitoring blood glucose control but not for diagnosing diabetes.
The laboratory-based test can be used to diagnose both, providing physicians with another way to identify undiagnosed cases of diabetes and treat patients before problems develop or worsen.
Investigators analyzed 141 blood samples and found less than 6% difference in the accuracy of test results from the new assay compared with results from the standard reference for hemoglobin analysis, according to the FDA.
The assay is available by prescription for use in clinical laboratories. Over-the-counter HbA1c tests should not be used by patients, and only a qualified healthcare professional should make a diagnosis of diabetes.
An estimated 25.8 million people in the United States have diabetes-including 7 million who remain undiagnosed.