Abbott Receives FDA Clearance for New Test to Detect Vitamin D Levels

Abbott has received clearance from the FDA for a fully automated 25-OH Vitamin D assay performed on its widely used ARCHITECT® laboratory testing platform.

Low vitamin D can cause skeletal disorders, such as rickets in children and bone loss 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 people with a low level of vitamin D may have elevated risk for cardiovascular problems, autoimmune disorders and some infectious diseases.

“As healthcare professionals and patients become aware of the potential health risks associated with low vitamin D, labs have seen a surge in test orders,” says Brian Blaser, senior vice president, Diagnostics, Abbott. “The new ARCHITECT 25-OH Vitamin 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.”

With a simple blood test, the ARCHITECT 25-OH Vitamin D assay can measure the stable form of vitamin D, 25-hydroxyvitamin D (25-OH vitamin D), the body’s repository of vitamin D. In the kidneys, 25-OH vitamin D converts into the active form of the vitamin that helps regulate calcium and phosphate levels. 25-OH vitamin D is established as the appropriate measurable indicator of vitamin D status because it is stable and easily measured.

“Regular vitamin D testing can be important for people who may have risk factors that could contribute to vitamin D deficiencies” says Beth Schodin, PhD, scientific affairs manager, Diagnostics, Abbott. “The availability of a highly accurate and reliable vitamin D assay can give physicians timely information about their patients and help them identify appropriate treatment options.”

The ARCHITECT 25-OH Vitamin D assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 25-hydroxyvitamin D (25-OH vitamin D) in human serum and plasma. The assay is to be used as an aid in the assessment of vitamin D sufficiency.

For diagnostic purposes, results should be used in conjunction with other data, e.g., symptoms, results of other tests, clinical impressions, etc. It is recommended that each laboratory establish its own reference range, which may be unique to the population it serves depending upon geographical, season, patient, dietary or environmental factors. This product contains human sourced and/or potentially infectious components. It is recommended that these reagents and human specimens be handled in accordance with the OSHA Standard on Bloodborne Pathogens. This material contains sodium azide; The material and its container must be disposed of in a safe way.

U.S. federal law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory.