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.

 

 

Contact for journalists:

Susan Drew
Siemens Healthcare, Media Relations
Phone: +1 914-524-2844; E-mail: susan.drew@siemens.com

For further information on the ADVIA Centaur Vitamin D Total assay, please visit: www.siemens.com/vitamindtotal

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The Siemens Healthcare Sector is one of the world's largest suppliers to the healthcare industry and a trendsetter in medical imaging, laboratory diagnostics, medical information technology and hearing aids. Siemens offers its customers products and solutions for the entire range of patient care from a single source – from prevention and early detection to diagnosis, and on to treatment and aftercare. By optimizing clinical workflows for the most common diseases, Siemens also makes healthcare faster, better and more cost-effective. Siemens Healthcare employs some 52,000 employees worldwide and operates around the world. In fiscal year 2013 (to September 30), the Sector posted revenue of 13.6 billion euros and profit of 2.0 billion euros. For further information please visit: www.siemens.com/healthcare.

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.

2http://www.cdc.gov/labstandards/hs_standardization.html

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.