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Waters CE-Marks In Vitro Diagnostic MassTrak Vitamin D Solution
Waters Corporation (NYSE:WAT) 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*. 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, 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.”
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.
Due, in part, to mounting evidence of the importance of vitamin D to human health and to news media coverage, Medicare reimbursement volumes of vitamin D laboratory tests rose 83-fold from 2000 – 20101.
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.
LC-MS/MS in the Clinical Laboratory
In pursuit of better accuracy and precision for clinical laboratory analyses, liquid chromatography tandem mass spectrometry (LC-MS/MS) is rapidly becoming the analytical technique of choice. Waters IVD LC-MS/MS medical devices provide clinical laboratories access to technologies delivering selectivity, sensitivity and versatility – performance characteristics that traditional methods, such as immunoassays, often struggle to meet.
Designed to optimize workflow from pre-analytics to post-analytics, our system portfolio offers a wide variety of options for the routine use of LC-MS/MS in the clinical laboratory.
Waters Corporation (NYSE:WAT) develops and manufactures advanced analytical and material science technologies for laboratory dependent organizations. For more than 50 years, the company has pioneered a connected portfolio of separations science, laboratory information management, mass spectrometry and thermal analysis systems.
*For in vitro diagnostic use. Not available for sale in all countries.
1. Arch Pathol Lab Med. 2014 February ; 138(2): 189–203. doi:10.5858/arpa.2013-0149-OA
Waters, UPLC, ACQUITY, ACQUITY UPLC, Xevo, MassLynx and MassTrak are trademarks of Waters Corporation.