Siemens Announces FDA Clearance for ADVIA Centaur Vitamin D Total Assay

Siemens has announced that its new Vitamin D Total assay has been given FDA clearance. This will enable laboratories to consolidate vitamin D testing with routine testing, on a single, fully automated immunoassay platform.

Vitamin D rates have been increasing globally as people limit their sun exposure due to the risk of skin cancer. In the U.S., approximately 77 percent of adults are either insufficient or deficient in vitamin D, according to the National Health and Nutrition Examination Survey (NHANES) III from 2001 to 2004.

Rising deficiency rates and increasing evidence of vitamin D sufficiency as a general health indicator have driven demand for more vitamin D testing. However, not all vitamin D tests are the same. A number of studies have reported discrepancies between assays used to measure vitamin D, calling into question the ability of some assays to accurately identify individuals affected by vitamin D deficiency.

To ensure accuracy, the Siemens’ ADVIA Centaur Vitamin D Total assay measures a patient’s total 25(OH) vitamin D level – ~100% of 25 (OH) vitamin D₂ and D₃, metabolites of the two major forms of vitamin D. Because circulating 25(OH)D can arise from hydroxylation of either vitamin D₂ or D₃, measurement of total 25(OH)D (both D₂ and D₃) is essential for accurate assessment of vitamin D status.²

FDA clearance means that U.S laboratories can now meet increasing demand for vitamin D testing and assay consolidation on a high efficiency analyzer with access to precise, accurate results in as little as 18 minutes. The assay, which is traceable to LC/MS/MS (liquid chromatography-mass spectrometry), measures the total level of 25-hydroxyvitamin D [25(OH)D] in serum and plasma to aid in the assessment of vitamin D sufficiency. Measurement of [25(OH)D], the most widely used indicator of vitamin D status, ensures accurate evaluation of patients for deficiency, sufficiency, or toxicity.

“In order to meet the demand for vitamin D testing, laboratories are under increasing pressure to enhance efficiency while providing reliable results,” said David Hickey, CEO, Chemistry, Immunoassay, Automation & Diagnostics IT Business Unit, Siemens Healthcare Diagnostics. “With the ADVIA Centaur Vitamin D Total assay, laboratories can now consolidate vitamin D testing into their existing workflow, saving time and money, while meeting clinicians’ expectations for fast and accurate results."