FDA has cleared the Access 25(OH) Vitamin D Total assay from Beckman Coulter Diagnostics, now available for use on the company’s Access 2 and UniCel DxI series of immunoassay systems. The assay comes with innovative packaging designed to prevent light-induced reagent degradation, while offering high stability, greater ease of use, and convenient storage.
“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,” says Arnd Kaldowski, president of 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 Ghent RMP is the reference procedure used by the Vitamin D Standardization Program, an international collaboration established by the Office of Dietary Supplements at the National Institutes of Health. The program aims to promote standardized laboratory measurements of 25(OH) vitamin D around the world.
“Alignment with this internationally recognized reference measurement procedure provides increased confidence that patients will be correctly assessed for vitamin D deficiency or insufficiency,” says Michael Samoszuk, MD, chief medical officer at Beckman Coulter Diagnostics.
For more information, visit Beckman Coulter Diagnostics.