IVD LC-MS/MS System for Precise and Accurate Vitamin D Analysis
for the Clinical Laboratory
MILFORD, Mass.--(BUSINESS WIRE)--Jan. 4, 2017--
Waters Corporation (NYSE:WAT) announced today 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.
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Waters CE-Marks In Vitro Diagnostic MassTrak Vitamin D Solution (Photo: Business Wire)
“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.
For more information: www.waters.com/vitamind
About Waters Corporation (www.waters.com)
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170104005422/en/
Source: Waters Corporation
Waters Corporation:
Brian J. Murphy, +1 508-482-2614
Public
Relations
brian_j_murphy@waters.com