NEW YORK (360Dx) – Waters said today that its mass spectrometry-based MassTrak Vitamin D Solution is now CE-marked in accordance with IVD Directive 98/79/EC.
The assay is intended for the quantitative measurement of 25(OH) D2 and D3 (25-OH-VitD) in human plasma and serum and, according to Waters, is the first CE-marked single-vendor system that measures both vitamins in human plasma and serum in a single analysis.
The assay uses Waters Acquity UPLC I-Class liquid chromatography system combined with its Xevo TQD IVD mass spec and the MassTrak Vitamin D Kit and MassLynx (IVD) software. It can also be combined with automated liquid handling systems for high-throughput testing.
Research has implicated vitamin D in biological functions including cell growth, the immune system, and inflammation. According to Waters, growing interest in the vitamin drove an eighty-threefold rise in Medicare reimbursement volumes of vitamin D tests from 2000 to 2010.
The MassTrak Vitamin D Solution is only available for sale in Europe.