According to a report from the Medscape website, Abbott’s Afinion HbA1c Dx point-of-care testing system for HbA1c has received support from the U.S. Food and Drug Administration (FDA).
Afinion HbA1c Dx is largely similar to the previously FDA-cleared test system named Afinion HbA1c, which was cleared in 2005 for moderate complexity testing under the Clinical Laboratory Improvement Amendments (CLIA) for HbA1c monitoring in patients with diagnosed diabetes, and received CLIA waived status in 2006.
Most FDA experts in clinical chemistry and toxicology devices support classifying the Afinion HbA1c Dx as a moderately complex test, meaning its use requires strict proficiency testing, quality control, and professional training. If finally approved, the Afinion HbA1c Dx will become the first point-of-care testing system explicitly indicated for the diagnosis of diabetes, while also being suitable for ongoing monitoring of HbA1c levels in patients with diabetes.
Regarding the Afinion HbA1c Dx, the debate within the FDA advisory panel primarily centered on its accuracy and CLIA waiver status.
The American Diabetes Association (ADA) does not recommend using point-of-care HbA1c testing for the diagnosis of diabetes, as such tests are not subjected to comparative validation. Dr. Ratner, Chief Medical Officer of the ADA, also pointed out that the accuracy of HbA1c testing is particularly critical in diagnosing diabetes, making comparative validation essential; point-of-care testing may yield false-positive and false-negative results.
In response, Dr. George, Vice President of Clinical Affairs at Abbott, stated that there is no need to be concerned about the accuracy and precision of the Afinion HbA1c Dx. Accuracy studies demonstrated that over 97% of results had an error within ±6%, regardless of whether capillary blood or whole blood samples were used. When combining accuracy and precision data, the total test error was below 4.1%.
Regarding the test complexity level, most FDA experts agree that the Afinion HbA1c Dx can be classified as a CLIA moderate-complexity test, but there is disagreement over whether it qualifies for CLIA waiver. Dr. Nipper, Professor of Pathology at Creighton University, stated, “I would not give it (approval for CLIA-waived status) the green light without comparative validation.”
Dr. Burr, an endocrinology expert at the University of Utah, reminds everyone that it is inappropriate to diagnose diabetes based solely on the specific HbA1c threshold (6.5%), because the progression from a normal state to impaired glucose metabolism and finally to diabetes is a continuous process, and HbA1c is only one component of metabolic syndrome.In contrast, Dr. Henderson of Montefiore Medical Center stated that he would support the use of this technology, as it “will enable more patients with diabetes to be diagnosed and prevented.”
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