Beckman Coulter, Brea, Calif, has received FDA clearance for its next-generation hemoglobin A1c (HbA1c) assay for use on its AU and DxC series of chemistry analyzers. The assay has been standardized for offline sample preparation use on all platforms of the company’s AU clinical chemistry systems, in addition to online sample preparation use on the company’s UniCel DxC systems. The assay’s enhanced reagent formulation has been developed to improve accuracy and precision in order to continue meeting the latest accuracy grading from the College of American Pathologists and the recommendations of the National Glycohemoglobin Standardization Program (NGSP) and International Federation of Clinical Chemistry. The HbA1c assay is standardized and holds a certificate of traceability to NGSP standards. When used in conjunction with Beckman Coulter’s Synchron/AU hemolyzing reagent or HbDil, the HbA1c assay is intended for the quantitative determination of hemoglobin A1c concentration in human whole blood. For more information, visit Beckman Coulter.
January 5, 2012
October 20, 2004