Follow us...


Search News Archives

News Channels


Coronavirus (COVID-19)


View Channel

New Laboratory Products


View Channel

Lab News


View Channel

Research & Case Studies


View Channel

Microscopy | Image Analysis


View Channel

Separation Science


View Channel



View Channel

Events | Webinars


View Channel

Conferences | Events

Waters CE-Marks In Vitro Diagnostic MassTrak Vitamin D Solution

publication date: Jan 30, 2017
author/source: Waters Corporation


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.

Find out more

About Waters Corporation

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.





Popular this Month...

Our Top 10 most popular articles this month


Today's Picks...




Looking for a Supplier?

Search by company or by product


Company Name:




Please note Lab Bulletin does not sell, supply any of the products featured on this website. If you have an enquiry, please use the contact form below the article or company profile and we will send your request to the supplier so that they can contact you directly.

Lab Bulletin is published by newleaf marketing communications ltd



Media Partners