March 10, 2020—Thermo Fisher Scientific announced that its Cascadion SM clinical analyzer is commercially available in the U.S. with the Cascadion SM 25-Hydroxy Vitamin D assay.
The Cascadion system analyzes samples directly from qualified primary blood collection tubes, while the Cascadion SM 25-Hydroxy Vitamin D Assay incorporates fully barcoded components, all traceable to a specific result. The vitamin D calibrators and controls are traceable according to the National Institute of Standards and Technology and assay calibration remains stable for up to 30 days. The assay measures 100 percent of the 25-hydroxy vitamin D2 and D3 fractions and excluding the C3 epimers. Total vitamin D is reported, with the D2 and D3 results available to the user and recorded in the instrument software.
“The Centers for Disease Control and Prevention has established LC-MS/MS as the reference method for vitamin D testing,” Bill Östman, vice president and general manager, Thermo Fisher Scientific, said in a press statement. “However, LC-MS/MS has traditionally been a sophisticated technology, requiring specialized knowledge and significant hands-on time for method development. We developed the Cascadion system and the ready-to-use, prevalidated 25-Hydroxy Vitamin D assay to simplify and accelerate the implementation of LC-MS/MS in clinical settings without the need for extensive technical expertise.”
The Cascadion analyzer is listed with the FDA as a class I instrument and the Cascadion SM 25-Hydroxy Vitamin D assay is listed as class II exempt with special controls.