Siemens receives FDA clearance for re-standardized Vitamin D Total assay
Aug 08, 2014
The FDA has cleared the Siemens Healthcare Diagnostics re-standardized ADVIA Centaur Vitamin D Total assay1, which has also recently become a certified procedure of the Centers for Disease Control (CDC) Vitamin D Standardization Certification Program (VDSCP)2. The Siemens assay, which the company voluntarily re-standardized to align with a reference measurement procedure used in the Vitamin D Standardization Program (VDSP) for vitamin D measurement3, is the first such assay to receive FDA clearance. The re-standardized assay enhances accuracy and reliability in vitamin D testing and enables clinicians to generate reproducible and comparable results.
The recent increased demand for vitamin D testing has led to more commercially available vitamin D assays. However, without a universal vitamin D standard, different assays and testing methods produced varying results. In an effort to standardize the laboratory measurement of vitamin D status measurement worldwide, the National Institutes of Health’s Office of Dietary Supplements (NIH ODS) introduced the VDSP in 2010.
The re-standardized ADVIA Centaur Vitamin D Total assay is also now available with pediatric observed values for ages 12 months to up to 21 years old. Studies have shown that vitamin D deficiency in children is widespread, and can lead to such issues as skeletal deformities, brittle bones, frequent fractures and even premature osteoporosis later in life4.
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For further information on the ADVIA Centaur Vitamin D Total assay, please visit: www.siemens.com/vitamindtotal
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1The products/features (here mentioned) are not commercially available in all countries. Due to regulatory reasons their future availability cannot be guaranteed. Further details are available from the local Siemens organizations.
3VDSP is a collaboration with the National Institute of Standards and Technology (NIST), the Centers for Disease Control (CDC) and Ghent University in Belgium. The NIST and Ghent reference measurement procedures are the reference methods for the measurement of total 25(OH)vitamin D, i.e. 25(OH)vitamin D2, 25(OH)vitamin D3
4John Hopkins Children’s Center. Memo to Pediatricians: Screen all kids for vitamin D deficiency, test those at high risk. Available at: http://www.hopkinschildrens.org/Screen-All-Kids-for-Vitamin-D-Deficiency.aspx. Accessed 6/14/13.