Vitamin D Assay Development

Total 25-OH Vitamin D Immunoassay Development

Vitamin D

Vitamin D research has expanded greatly over the last 10 years. Annual publications listed in PubMed with the key word 'Vitamin D' increased with more than two-fold from 1675 in 2005 to 3953 in 2014. Part of this increase is due to research showing that Vitamin D deficiency is associated with a wide range of diseases and health outcomes. Until the 1980s, the primary focus of Vitamin D research (in combination with calcium supplementation) was on bone diseases. Since then, observational studies have linked Vitamin D deficiency with increased risk of many diseases: both acute and chronic.
The market for Vitamin D is projected to reach about $2.5 Billion by 2020 at a Compound Annual Growth Rate (CAGR) of 11%.*

Adequate level of Vitamin D for human health

Vitamin D, the sunshine Vitamin, has received a lot of attention recently as a result of a meteoric rise in the number of publications. They show that Vitamin D plays a crucial role in a plethora of physiological functions. Vitamin D deficiency is associated with many acute and chronic illnesses. These include disorders of calcium metabolism, autoimmune diseases, some cancers, type 2 diabetes mellitus, cardiovascular disease and infectious diseases.

Vitamin D deficiency is now recognized as a global pandemic. The major cause for Vitamin D deficiency is the lack of appreciation that sun exposure has been. This continues to be the major source of Vitamin D for children and adults of all ages. Vitamin D plays a crucial role in the development and maintenance of a healthy skeleton throughout life. There remains some controversy regarding what blood level of 25-hydroxy Vitamin D should be attained for both bone health and reducing risk for Vitamin D deficiency. What is associated with acute and chronic diseases and how much Vitamin D should be supplemented?

25-hydroxy (25-OH) Vitamin D

Vitamin D in the circulation is bound to the Vitamin D binding protein. This is transported to the liver where Vitamin D is converted by the Vitamin D-25-hydroxylase to 25-hydroxy Vitamin D [25(OH)D]. This is the major circulating form of Vitamin D that is used by clinicians to measure Vitamin D status. It is biologically inactive and must be converted in the kidneys by the 25-hydroxyl Vitamin D-1Į-hydroxylase (1-OHase) to its biologically active form 1,25-dihydroxy Vitamin D [1,25(OH)2D].

Free 25-hydroxy (25-OH) Vitamin D

Currently, Free T4 (thyroid hormone) measurements are well established in clinical diagnostics. Free T4 measurements, which reflect both total T4 levels and binding protein capacity, have become the recognized standard for determining thyroid status in conjunction with a TSH measurement.
Similarly, in several conditions such as pregnancy, renal disease or liver disease the level of Vitamin D binding proteins may be elevated or decreased. Recent literature suggests that free 25OH Vitamin D might be a better indicator of Vitamin D status. It provides more relevant diagnostic information than measurement of Total 25OH Vitamin D.

Patent release reagent for Vitamin D

Future Diagnostics holds a patent in the field of conducting an immunoassay of 25-OH Vitamin D in blood or blood components, notably serum or plasma. The invention pertains to an immunoassay method, including point-of-care tests. Samples of blood or blood components are tested for total Vitamin D or Vitamin D metabolites. In particular 25-OH Vitamin D is tested using an agent to release Vitamin D from endogenous binding proteins.

Do you miss a Vitamin D assay in your product range?

Future Diagnostics is your partner when you require an immunoassay to detect total 25-OH Vitamin D.
We developed Vitamin D assays on automated immunoassay platforms showing the highest grades of specificity, sensitivity and precision found in the market for large multinational IVD companies.

Three key take-aways in outsourcing the development of your 25-OH Vitamin D assay:
1) Fast to market: feasibility and optimization is already done for you
2) Best specs in the market: highest grades of specificity, sensitivity and precision
3) Success guaranteed: work with an experienced partner

Feel free to contact us and explore the possibility to have your company’s name on a total 25-OH Vitamin D.

2) Vitamin D and Human Health by Simon Spedding (ed)

Have your Company’s Name on a Total 25-OH Vitamin D Assay

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