Date Added: 27/06/2017
Date Updated: 27/06/2017
Point-of-care glycated hemoglobin testing to diagnose type 2 diabetes
Specialties: Endocrine, nutritional and metabolic
Technology Type: Diagnostics
Stage of development: Nearly established
Stage of EAA: Assessment Complete
Glycated hemoglobin (A1C) is a marker in the blood used to monitor glycemic, or blood sugar, control in people with diabetes.
Many point-of-care A1C testing devices have US regulatory approval for use in monitoring glycemic control in people with diabetes, but, as yet, none have been cleared by the FDA for the diagnosis of type 2 diabetes.
In the US, Alere is seeking FDA clearance for their Afinion HbA1c Dx system for the point-of-care diagnosis of type 2 diabetes and as a test to identify people at risk for developing diabetes.
The evidence comparing point-of-care A1C devices to laboratory-based testing shows that point-of-care devices performed as well as laboratory devices. If point-of-care A1C test systems are approved for diagnosing type 2 diabetes, comparative evidence will be needed to inform purchasing decisions. Quality assurance systems and cost analyses will also be needed.
Keywords: HbA1c, Type 2 diabetes, point-of-care diagnostic tests