Waters’ vitamin D analysis system receives CE mark

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  • Published: Jan 4, 2017
  • Author: Jon Evans
  • Source: Waters
  • Suppliers: Waters Corporation
  • Channels: HPLC / Base Peak
thumbnail image: Waters’ vitamin D analysis system receives CE mark

Waters Corporation has announced that its fully-validated Waters MassTrak Vitamin D Solution is now CE-marked in accordance with IVD Directive 98/79/EC for the quantitative measurement of 25(OH) D2 and D3 (25-OH-VitD) from human plasma and serum. The IVD LC-MS/MS system is a complete solution consisting of reagents and consumables, instrumentation, and software and support services for clinical laboratories routinely measuring vitamin D in patient samples. The Vitamin D solution is currently only available for sale in Europe.

“Our MassTrak Vitamin D Solution is the first, CE-marked, single-vendor system to measure both vitamins 25(OH) D2 and D3 independently and accurately from human plasma and serum in a single analysis,” said Jose Castro-Perez, director of health sciences, global marketing operations, at Waters. “It’s the ideal solution for clinical laboratories performing (25-OH-VitD) analysis on a routine basis and which may want to standardize (25-OH-VitD) analysis on a single-vendor platform.”

Vitamin D, the main source of which comes from dietary intake, is part of a family of fat-soluble secosteroids and has two major forms ergocalciferol (plant-derived Vitamin D2) and cholecalciferol (animal-derived Vitamin D3). Vitamin D is also derived from the conversion of 7-dihydrocholesterol to Vitamin D3 following exposure of skin to sunlight.

Increasingly, research is revealing the importance of vitamin D in protecting against a host of health problems. In the absence of vitamin D, bones can become brittle and thin. Research also suggests that vitamin D plays a role in modulating cell growth, the function of neuromuscular and immune systems, and reducing inflammation. It also indicates that those most at risk of a vitamin D deficiency are those who shun the sun, have milk allergies, adhere to a strict vegan diet, or suffer from certain diseases.

The MassTrak Vitamin D Solution is configured with the Waters ACQUITY UPLC I-Class/Xevo TQD IVD System, the MassTrak Vitamin D Kit and MassLynx (IVD) mass spectrometry software. The MassTrak Vitamin D Kit provides metrological traceability to the National Institute of Standards and Technology (NIST) Standard Reference Material (SRM) 2972, allowing standardization and lot-to-lot consistency for an easy comparison of results from multiple laboratories. For high-volume vitamin D testing, the system is designed for use with an automated liquid handler and custom pipetting script provided with the kit.

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