New Fully Automated Vitamin D Assay Submitted for FDA Clearance

To help physicians manage growing demand for vitamin D testing, Abbott has announced that it filed a submission for clearance by the U.S. Food and Drug Administration for a fully automated vitamin D assay performed on its widely used ARCHITECT testing system.

4/18/2011 --- According to a recent report from the U.S. Centers for Disease Control and Prevention, a third of Americans have vitamin D levels that are either inadequate or deficient. While many people know that vitamin D is necessary to help the body absorb calcium, which helps create strong bones and muscles, many don’t know that insufficient levels of this important vitamin may lead to other health problems.

"Increasing interest in vitamin D is fueling a surge in orders for tests as more health care professionals and consumers become aware of the rising prevalence of vitamin D deficiencies in otherwise healthy people and the potential health risks," said Sudarshan Hebbar, M.D., senior medical director, Diagnostics, Abbott.

To help physicians manage growing demand for vitamin D testing, Abbott has announced that it filed a submission for clearance by the U.S. Food and Drug Administration for a fully automated vitamin D assay performed on its widely used ARCHITECT testing system.

The ARCHITECT 25-OH Vitamin D assay is a fully automated immunoassay. It is intended to help laboratories manage their increasing vitamin D testing volumes through the quantitative determination of 25-hydroxy vitamin D in human serum and plasma to aid in the assessment of vitamin D sufficiency. 25-hydroxy vitamin D is the body’s repository of vitamin D and is established as the appropriate measurable indicator of vitamin D status.

Low vitamin D also can cause skeletal disorders, such as rickets in children and osteopenia in adults, and has been linked to an increased risk of hip fractures. Although research is still being conducted in this area, some studies have shown that vitamin D deficiency may increase the risk for cardiovascular problems, autoimmune disorders and some infectious diseases.

According to the Institute of Medicine of the National Academy of Science, most adults should get 600 international units (IUs) of vitamin D daily instead of the previously recommended 400 IUs. In addition, higher doses of 800 IUs are better for anyone age 70 and older. While healthcare practitioners agree that vitamin D is essential for bone health, they also believe patients should be tested regularly.

"Research shows that vitamin D levels are a concern for patients with osteoporosis, chronic kidney disease, malabsorption, and anyone with a condition or taking a medication that may impair bone health," said Brian Blaser, senior vice president, Diagnostics, Abbott. "This new fully automated vitamin D assay may help physicians better diagnose and counsel patients with suspected vitamin D deficiency."