GSD receives FDA Clearance for 25-OH Vitamin D Total ELISA test

Jul 24 2013

Gold Standard Diagnostics, Corp. (GSD, www.gsdx.us), a leading manufacturer and marketer of clinical laboratory instrumentation and assays for the in vitro diagnostics market, announced 510k FDA Clearance of its 25-OH Vitamin D, Total ELISA. The competitive assay strongly correlates with established LC/MS, EIA and Chemiluminescence methods, and offers high sensitivity and specificity over a wide dynamic range. The assay can be automated on a variety of instruments, providing a cost-effective Vitamin D testing option, even at lower volumes.

"As Vitamin D levels have become an important indicator of overall health, testing volume has risen but assay choices have remained limited. Especially for labs or physicians with smaller volumes, the prohibitive cost and volume requirements of a high-throughput system can make running Vitamin D in-house difficult to justify financially. GSD has created an ELISA that can be fully-automated and cost-effective even if a lab only runs a few samples a week," says Gerrit Mueller, Product Manager for Gold Standard Diagnostics.

DIAsource Collaboration

The Vitamin D assay was developed by Belgium-based DIAsource ImmunoAssays S.A. Gold Standard Diagnostics and DIAsource have enjoyed a successful relationship for many years. GSD is the exclusive distributor of the Vitamin D assay in the U.S. market. In turn, DIAsource also distributes the GSD ThunderBolt® automated instrument worldwide.

"This approval is a milestone for our company. It not only proves the quality of our assay but it also allows us via GSD to enter into the US market with this exciting product that has been highly appreciated by our customers and made the assay a huge success in Europe and Asia immediately after launching in 2012," says Dr. Jef Vangenechten, CEO of DIAsource.

Automation Options

The GSD Vitamin D assay features a unique pre-treatment step that allows for complete automation on virtually any open ELISA processor. Because of the simple pre-treatment step and automation capability, GSD's 25-OH Vitamin D provides fast and consistent results. All assay protocol steps are completed in a standard microtiter plate, without the need for labor-intensive, time-consuming and complicated pre-treatment done manually outside of the analyzer.

Clinical Significance of Vitamin D Testing

Vitamin D testing offers important information for general physicians and specialists alike. Long-established as an important factor for bone metabolism, new research indicates Vitamin D also plays an important role in immune function, cardiovascular disease, autoimmune conditions, diabetes, depression and cancer prevention. Many reports estimate that up to 75% of the U.S. population has a deficiency of 25-Hyrdoxyvitamin D.

SOURCE Gold Standard Diagnostics, Corp.