Beckman Coulter is a trusted partner in clinical diagnostics, offering a wide range of innovative diagnostic instruments, tests and information systems to help labs improve productivity, processes and performance. The company recently launched a next generation Hemoglobin A1c (HbA1c) assay with improved performance for its UniCel DxC and AU chemistry analyzers. The new test can be used on the company’s AU clinical chemistry systems for offline sample preparation use as well as for online sample preparation on the company’s UniCel DxC analyzers. Beckman Coulter Diagnostics has received FDA 510(k) clearance for this HbA1c assay on its DxC and AU clinical chemistry systems.
Hemoglobin A1c (HbA1c) is used routinely to track long-term glycemic control in people with diabetes mellitus. Compared with glucose measurements, the use of HbA1c as a diagnostic test offers advantages such as convenience, less day-to-day variability, greater preanalytical stability, and international standardization.
The World Health Organization (WHO) recommends: “HbA1c can be used as a diagnostic test for diabetes providing that stringent quality assurance tests are in place and assays are standardized to criteria aligned to the international reference values, and there are no conditions present which preclude its accurate measurement”.
Beckman Coulter’s press release announcing the launch of the new HbA1c assay describes it as an enhanced reagent formulation designed to improve accuracy and precision so as 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).
According to the Centers for Disease Control and Prevention (CDC), about 8.1 million people in the United States have undiagnosed diabetes. Assays such as the new Hemoglobin A1c from Beckman Coulter play a critical role in the diagnosis of diabetes, which is the first step in implementing appropriate lifestyle, glycemic, and nonglycemic interventions.
“Availability of the next generation HbA1c assay on the AU clinical chemistry product line is a demonstration of Beckman Coulter’s commitment to providing laboratories with the latest solutions to manage patient care”, said Kathleen Orland, vice president, Clinical Chemistry/Immunoassay Product Management, Beckman Coulter Diagnostics. “The new assay and the Canterbury Scientific control will allow physicians to maintain diabetic patients under better glycemic control and better manage complications of the disease”.
Beckman Coulter has also teamed up with Canterbury Scientific, Ltd. For the distribution of the extendSURE liquid ready-to-use control for both the AU and UniCel DxC HbA1c assays. These liquid controls come 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.