Abbott submits fully automated vitamin D assay for FDA clearance
Abbott has submitted a fully automated vitamin D assay performed on its ARCHITECT testing system for clearance by the US Food and Drug Administration (FDA).
The ARCHITECT 25-OH Vitamin D fully automated immunoassay is intended to help laboratories manage their increasing vitamin D testing volumes through the quantitative determination of 25-hydroxy vitamin D in human serum and plasma to aid in the assessment of vitamin D sufficiency.
25-hydroxy vitamin D is the body's repository of vitamin D and is established as the appropriate measurable indicator of vitamin D status.
Abbott Diagnostics senior medical director Sudarshan Hebbar said increasing interest in vitamin D is fueling a surge in orders for tests as more health care professionals and consumers become aware of the rising prevalence of vitamin D deficiencies in otherwise healthy people and the potential health risks.
Abbott Diagnostics senior vice president Brian Blaser said research shows that vitamin D levels are a concern for patients with osteoporosis, chronic kidney disease, malabsorption, and anyone with a condition or taking a medication that may impair bone health.
"This new fully automated vitamin D assay may help physicians better diagnose and counsel patients with suspected vitamin D deficiency," Blaser said.