FDA approves A1c test for diabetes diagnosis

May 29, 2013
FDA approves A1c test for diabetes diagnosis
The U.S. Food and Drug Administration has just cleared a hemoglobin A1c assay to be marketed for the diagnosis of diabetes, according to a May 24 press release issued by the agency.

(HealthDay)—The U.S. Food and Drug Administration has just cleared a hemoglobin A1c assay to be marketed for the diagnosis of diabetes, according to a May 24 press release issued by the agency.

Many already use A1c tests, which are FDA cleared only for monitoring , to diagnose diabetes. In an analysis of 141 blood samples, however, researchers found this particular A1c test, the COBAS INTEGRA 800 Tina-quant HbA1cDx assay, yielded a difference of less than 6 percent compared with the standard reference for hemoglobin analysis.

The agency stressed that over-the-counter A1c assays should not be used to diagnose diabetes. The Tina-quant HbA1cDx assay is available only by prescription for use by in clinical laboratories.

"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," Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Devices in the FDA's Center for Devices and Radiological Health, said in a statement.

Explore further: 2 tests better than 1 to diagnose diabetes in overweight children

More information: More Information

Related Stories

New NIH fact sheet explains test for diabetes, prediabetes

January 27, 2012

A new fact sheet from the National Institutes of Health explains the A1C test, a widely used and important test to diagnose type 2 diabetes and prediabetes, and to monitor blood glucose levels of people with type 1 and type ...

Hemoglobin A1C inadequate for postpartum diabetes screening

June 19, 2012

(HealthDay) -- For postpartum women who have had gestational diabetes mellitus (GDM), the hemoglobin A1c (A1C) test criteria alone or in combination with fasting glucose test criteria does not provide sensitive and specific ...

Self-monitoring of blood glucose protocol cuts hs-CRP

March 7, 2013

(HealthDay)—Among patients with poorly controlled type 2 diabetes, a structured self-monitoring of blood glucose (SMBG) protocol correlates with reductions in the level of high-sensitivity C-reactive protein (hs-CRP), according ...

Recommended for you

New study reveals a novel protein linked to type 2 diabetes

August 16, 2016

Findings from Boston University School of Medicine (BUSM), which appear in eLife, provide a possible explanation as to why most people who are obese develop insulin resistance and type 2 diabetes. A minority of obese individuals, ...

Gene variant explains differences in diabetes drug response

August 9, 2016

The first results from a large international study of patients taking metformin, the world's most commonly used type 2 diabetes drug, reveal genetic differences among patients that may explain why some respond much better ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.