Abbott has announced CE marking for the Architect 25-OH vitamin D assay, a diagnostic test to measure levels of vitamin D in blood using the company's Architect automated instrument system.
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 preventative and therapeutic interventions.
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.
The Architect 25-OH vitamin D assay is not approved for use in the US.