New Abbott Vitamin D Test Available for Use in the European Union

Abbott Park, Illinois - Abbott has announced CE marking (Conformité Européenne) for the ARCHITECT 25-OH Vitamin D assay, a new diagnostic test to measure levels of vitamin D in blood using Abbott’s ARCHITECT automated instrument system.

According to the International Osteoporosis Foundation, vitamin D deficiency is a global health issue. The percentage of the European population that is vitamin D insufficient is high, with some countries exceeding 75 percent. Global demand for patient testing is estimated to be growing at 50 percent per year due to increasing medical knowledge of the adverse health implications associated with vitamin D deficiency.

The ARCHITECT 25-OH Vitamin D assay is a fully-automated immunoassay that can help laboratories manage the expected increase in vitamin D testing volumes. It is intended for the quantitative determination of 25-hydroxy vitamin D in human serum and plasma to aid in the assessment of vitamin D sufficiency. The 25-hydroxy vitamin D test provides an accurate gauge of vitamin D status, and its measurement in patients provides opportunities for preventive and therapeutic interventions.

“As a major diagnostic lab, serum 25-OH vitamin D has become an increasingly important diagnostic marker to us,” said Dr. Frans AL van der Horst, Reinier de Graaf Group, Diagnostic Center SSDZ, Delft, The Netherlands. “There has been a great need for a reliable and cost effective assay. With the introduction of the Abbott test, we can fulfill these needs and significantly improve the efficiency of the workflow in our routine lab.”

Low concentrations of vitamin D can cause secondary hyperparathyroidism (high levels of parathyroid hormone or PTH) and diseases related to impaired bone metabolism. When PTH is abnormally high, a person loses calcium from his/her bones and has an elevated risk for bone density loss.

Consequently, low vitamin D levels can cause skeletal disorders, such as rickets in children and osteopenia in adults, and have been linked to an increased risk of hip fracture and falls. Studies have also shown that vitamin D deficiency may increase risk for some cancers, cardiovascular problems, autoimmune disorders and infectious diseases.

"Vitamin D deficiency is recognized as a global health problem, and vitamin D supplementation should be considered for all people at risk of vitamin D deficiency,” said Jean-Claude Souberbielle, Ph.D., Hopital Necker-Enfants Malades, Université Paris. He added that determination of the serum vitamin D concentration and supplementation according to the measured level is important for patients with osteoporosis, chronic kidney disease, abnormalities in absorbing food nutrients, and more generally, in those with a disease or a treatment that may impair bone health.

“The new vitamin D assay is a valuable and convenient addition for Abbott ARCHITECT customers, who now have an automated test to use on samples that previously might have been sent to outside reference labs,” said Brian Blaser, senior vice president, diagnostic operations, Abbott. “This will save labs time and money as they work to manage increases in the volume of vitamin D tests they perform"

The ARCHITECT 25-OH Vitamin D assay is not approved for use in the United States.
About Abbott ARCHITECT

The ARCHITECT family of analyzers delivers the first truly integrated portfolio of immunoassay and clinical chemistry instruments. Since the introduction of the ARCHITECT i2000 a decade ago, Abbott has developed and launched a series of ARCHITECT analyzers that are delivering unprecedented flexibility, automation and convenience to today’s clinical laboratory. With its extensive menu of more than 170 assays, ARCHITECT enables laboratories facing increasing cost pressures to reduce labor, optimize throughput and enhance overall productivity, while standardizing data management processes and optimizing inventory control. The ARCHITECT family provides features that minimize training and reduce inventory costs and sample contamination potential, which results in improved performance and outcomes for laboratories, physicians and patients.
About Abbott Diagnostics

Abbott is a global leader in in vitro diagnostics and offers a broad range of innovative instrument systems and tests for hospitals, reference labs, molecular labs, blood banks, physician offices and clinics. With more than 69,000 customers in more than 100 countries, Abbott’s diagnostic products offer customers automation, convenience, bedside testing, cost-effectiveness and flexibility. Abbott has helped transform the practice of medical diagnosis from an art to a science through the company’s commitment to improving patient care and lowering costs.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and markets its products in more than 130 countries.