Abbott Announces FDA Clearance for Vitamin D Assay

Abbott has announced that it has received FDA clearance for its fully-automated 25-OH Vitamin D assay. The assay is designed for use on its ARCHITECT® laboratory testing platform.

Low vitamin D levels can be caused by reduced dietary intake, sun avoidance, geographic location, age and ethnicity. Vitamin D deficiency can cause skeletal disorders, such as rickets in children and bone loss in adults. Some studies have shown that people suffering from vitamin D deficiency may also be at increased risk for cardiovascular problems, autoimmune disorders and some infectious diseases. Research into this area is still being conducted.

The ARCHITECT 25-OH Vitamin D assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 25-hydroxyvitamin D in human serum and plasma. This stable form of vitamin D is established as the appropriate measurable indicator of vitamin D status. 25-OH vitamin D is converted into the active form of the vitamin in the kidneys, which helps to regulate the body’s calcium and phosphate levels.

"As health care professionals and patients become aware of the potential health risks associated with low vitamin D, labs have seen a surge in test orders," said Brian Blaser, senior vice president, Diagnostics, Abbott. "The new ARCHITECT 25-OHVitamin D assay has shown excellent precision and offers a fully-automated solution that may help laboratories cope with escalating demand for vitamin D testing and help get results to physicians and their patients much sooner."