Recent reports predicted that the world Vitamin D testing market would grow at a CAGR of 32.36 percent over the period 2013-2018. According to the Research and Markets report, a key factors contributing to this market growth is the increase in aging and chronically ill populations worldwide.
In the past, a test for vitamin D, popularly called the sunshine vitamin, was performed in cases of unusual bone fracturing, to determine risk for osteoporosis, or as part of routine laboratory tests. The recent increase in demand for vitamin D testing comes from the identification of links by researchers between vitamin D and conditions such as heart disease, cancer, diabetes, multiple sclerosis, Parkinson’s disease, and some other chronic and infectious diseases.
Vitamin D is a fat-soluble hormone that the body can produce. There are two major types: vitamin D2 which is manufactured by plants, and vitamin D3 which is produced by the human body when bare skin is exposed to sunlight. Adequate levels of this vitamin are important for maintaining strong bones and muscular movement, and to help the immune system ward off disease.
The two methods commonly used for vitamin D testing are immunoassays that use antibodies to detect vitamin D and a complex, more expensive, chromatographic method that separates vitamin D based on chemical properties. Major issues in laboratory testing relate to the considerable variability in the available assays as well as lack of standardization. It is to address this issue that the NIH Office of Dietary Supplements established the Vitamin D Standardization Program (VDPS) in collaboration with the Centers for Disease Control and Prevention, the National Institute for Standards and Technology (NIST) and Ghent University. This program aims to standardize the laboratory measurement of vitamin D status in national health surveys in different countries by linking them to the NIST reference measurement procedure (RMP).
To meet the increased demand for measuring vitamin D, in vitro diagnostic manufacturers have come up with new immunoassays. U.S. Food and Drug Administration (FDA) clearance is mandatory for marketing a new vitamin D immunoassay. Beckman Coulter Diagnostics made headlines recently when the FDA granted 510(k) clearance for its Access 25(OH) Vitamin D Total Assay for use on the Access 2 and UniCel DxI immunoassay systems. Standardized to the reference measurement procedure from Ghent University in Belgium, this new assay ensures accurate and convenient clinical assessment of vitamin D status.