NEW YORK (360Dx) – Quidel announced Wednesday that it has received the CE Mark for a fluorescence immunoassay that gauges vitamin D levels from patient blood samples. It is the first quantitative test for the firm's flagship Sofia immunoassay reader.
The test specifically quantifies 25-OH vitamin D from serum samples. Total 25-OH vitamin D is a liver metabolite that reflects vitamin D produced in skin as well as vitamin D obtained from food and supplements, and has a circulating half-life of 15 days, Quidel said in a statement.
Quidel President and CEO Doug Bryant said the test provides an opportunity to expand Sofia's international footprint. It also shows that the firm can develop quantitative assays on the Sofia platform, as well as the firm's next-generation Sofia 2 system, Bryant said, "greatly expanding the potential pipeline and market opportunity for both products."
Vitamin D deficiency is correlated with a number of health problems and adequate levels depend on age and other factors. In general, the fat-soluble vitamin serves many biological functions, such as maintaining serum calcium and phosphate concentrations, and playing a role in bone mineralization, cell growth, neuromuscular and immune function, and inflammation, the company noted.