The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Beckman Coulter’s Access 25(OH) Vitamin D Total assay. An important addition to the company’s bone metabolism assay menu, this new assay is meant for use on the Access 2 and UniCel DxI immunoassay systems. It provides diagnostic confidence for vitamin D measurement, which is becoming increasingly important due to the links that researchers have discovered between vitamin D deficiency and increased risk for cardiovascular disease, cancer, diabetes, rheumatoid arthritis, multiple sclerosis, Parkinson’s, and some infectious diseases.
“FDA clearance of our 25(OH) Vitamin D Total assay allows us to provide laboratories with the tools needed to confidently diagnose and manage vitamin D deficiency-related diseases,” said Arnd Kaldowski, president, Beckman Coulter Diagnostics. “The new assay delivers increased accuracy in patient results through traceability to the gold standard 25(OH) vitamin D reference measurement procedure (RMP) from Ghent University and equimolar detection of 25(OH) vitamin D2 and 25(OH) vitamin D3.”
The Access 25(OH) Vitamin D Total assay is standardized to the reference measurement procedure from Ghent University in Belgium. Ghent University collaborates with the National Institutes of Health, the Centers for Disease Control and Prevention (CDC), and the National Institute for Standards and Technology (NIST) in the Vitamin D Standardization Program (VDSP) initiated by the National Institutes of Health Office of Dietary Supplements (NIH ODS) with the goal of promoting standardized laboratory measurements of 25(OH) vitamin D around the world.
The new assay can enhance lab productivity in many ways:
- Confidence in patient results through standardization to the NIST-Ghent ID-LC-MS/MS Reference Method Procedure (RMP)
- Accurate and convenient clinical assessment of vitamin D status
- Excellent stability and reproducibility
- Greater storage convenience from a unique, opaque reagent pack designed to prevent light-induced reagent degradation
Clinical laboratories can also benefit from speed and flexibility that the UniCel DxI 800 and Access 2 systems offer. With exceptional throughput and proven technology, these systems are designed to deliver new levels of laboratory efficiency, standardization and cost effectiveness.