Next generation Hb A1c test
Beckman Coulter Diagnostics has launched its next generation Hemoglobin A1c (HbA1c) assay with improved performance across all of its chemistry systems. The assay, with CE Mark approval, has been standardized for use on all platforms of the company’s AU clinical chemistry systems for offline sample preparation use, in addition to online sample preparation use on the company’s UniCel DxC systems. U.S. Food and Drug Administration (FDA) 510(k) clearance has been received for this assay on both the AU and DxC series of chemistry analysers. The next generation HbA1c assay is an enhanced reagent formulation, developed to improve accuracy and precision in order to continue to meet the latest accuracy grading from the College of American Pathologists (CAP) and the recommendations of the National Glycohemoglobin Standardization Program (NGSP) and International Federation of Clinical Chemistry (IFCC). HbA1c is standardized and holds a certificate from the NGSP. Additionally, Beckman Coulter has partnered with Canterbury Scientific, Ltd. to distribute the extendSURE liquid ready-to-use control for both the AU and UniCel DxC HbA1c assays. The extendSURE liquid controls are value-assigned specifically for Beckman Coulter’s AU and UniCel DxC clinical systems. The extendSURE control is available in two kit sizes, one of which represents a one-year supply of the same lot. The control has open-bottle stability of 30 days and a long shelf life of 30 months.
