Waters CE-Marks In Vitro Diagnostic MassTrak Vitamin D Solution

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, enabling 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.

Vitamin D, the main source of which is 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. The 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.

“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, Ph.D., Director of Health Sciences, Global Marketing Operations, Waters Corporation. “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.”

Waters 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 solution 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.

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