MassTrak Vitamin D Kit (IVD)
High-throughput vitamin D analysis made simple
Vitamin D is a key marker of interest given its importance in bone health, cell growth modulation, neuromuscular and immune system function, and inflammation reduction. When evaluating a patient’s overall vitamin D status, it is important to measure 25-hydroxyvitamin D2 ,or 25(OH)D2, and 25-hydroxyvitamin D3 ,or 25(OH)D3, independently for an effective assessment. With Waters MassTrak Vitamin D Kit, your lab can obtain precise results from a liquid chromatography tandem mass spectrometry (LC-MS/MS) based clinical diagnostic solution designed to measure both 25(OH)D3 and 25(OH)D2 independently and accurately.
The MassTrak Vitamin D Kit is CE marked to the IVDR (EU) 2017/746 for the quantitative assessment of vitamin D status in human plasma and serum. As a total solution—inclusive of instrumentation, informatics, reagents and consumables, and service—it provides diagnostics labs with an accurate, precise, and sensitive assay for measuring total 25(OH)D in serum.
MassTrak Vitamin D Kit (IVD)
Specifications
MassTrak Vitamin D Kit is a total solution that includes:
- Instrument: ACQUITY UPLC I-Class/Xevo TQD IVD System
- Reagents and Consumables: MassTrak Vitamin D Kit
- Automation: MassTrak Vitamin D pipetting script for use with the Tecan Freedom EVO 100/4* liquid handler
- Informatics: MassLynx (IVD) Mass Spectrometry Software with TargetLynx Version 4.1
- Service and Support**
*Not available from Waters, must be ordered from Tecan.
**Available for purchase from Waters.
Overview
- Obtain a comprehensive picture of total 25(OH)D by measuring 25(OH)D2 and 25(OH)D3 independently and accurately
- Deliver accurate, linear, and sensitive results with LC-MS/MS specificity and kit robustness
- Achieve excellent precision with a coefficient of variation (CV) of ≤5.7% for total 25(OH)D
- Meet compliance requirements using a solution CE marked to the IVDR (EU) 2017/746
- Minimize costly, time-consuming retests with a wide linear range to accommodate a broad range of patient samples without dilution
- Compare results across different labs with quality control reference materials and calibrators traceable to Standard Reference Material (SRM) 2972
Recommended Use: For the quantitative assessment of vitamin D status in human plasma and serum.
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Obtain independent and accurate measurements of vitamin D2 and D3
There are two clinically significant forms of vitamin D: vitamin D2 and D3. Vitamin D3 is synthesized by the body and can also be obtained through supplementation. Vitamin D2 is obtained primarily by consuming fortified foods and supplements. To achieve a comprehensive picture of total 25(OH)D, it is essential to measure both 25(OH)D2 and 25(OH)D3. Waters MassTrak Vitamin D Kit measures both analytes independently and accurately due to specificity of LC-MS and robustness of the kit.
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Harmonize and achieve confidence in your results
For compliance with ISO 15189 and seamless harmonization, the MassTrak Vitamin D Kit includes quality control reference materials and calibrators that are traceable to SRM 2972.
With a CV of ≤5.7% for total 25(OH)D, the MassTrak Vitamin D Kit exhibits excellent precision so you can have confidence in every result. A mean accuracy of 100.1% was demonstrated by the MassTrak Vitamin D Kit when used to independently quantify total 25(OH)D in materials (traceable to NIST) with known total 25(OH)D.
Improve your laboratory’s efficiency
The MassTrak Vitamin D Kit offers a wide reportable range of between 10 nmol/L and 375 nmol/L for total 25(OH)D. Such a wide linear range can be helpful to accommodate a broad range of patient samples without dilution. This means fewer retests and more predictable costs – leading to laboratory efficiency.
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