Vitamin D Test Available for Use in EU

The new vitamin D assay is a fully automated immunoassay, which can help laboratories manage the expected increase in vitamin D testing volumes.

The assay is intended for quantitative determination of 25-hydroxy (25-OH) vitamin D in human serum and plasma to aid in the assessment of vitamin D sufficiency. The 25-OH vitamin D test provides an accurate gauge of vitamin D status, and its measurement in patients provides opportunities for preventive and therapeutic interventions.

The Abbott (Abbott Park IL, USA) diagnostic 25-OH vitamin D assay has received CE marking. The assay will measure levels of vitamin D in blood on the company'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, in some countries exceeding 75 %. Global demand for patient testing is estimated to be growing at 50 % per year due to increasing medical knowledge of the adverse health implications associated with vitamin D deficiency.

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.

"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."

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

Related Links:
Abbott
Reinier de Graaf Group, Diagnostic Center SSDZ