SCIEX Diagnostics (Framingham, MA), the in vitro diagnostics division of SCIEX, has launched the only FDA-cleared (via the de novo pathway) LC-MS based Vitamin D assay kit, the Vitamin D 200M Assay, exclusively for the SCIEX Topaz™ System. The Topaz System is a fully integrated LC-MS platform driven by ClearCore™ MD, the new and intuitive software designed specifically for use in clinical labs.

The Office of Inspector General (OIG) recently reported Vitamin D as one of the top five laboratory assays reimbursed by Medicare, accounting for 8.7 million laboratory tests and $337 million in reimbursement dollars. Vitamin D is an important building block for human health, and has been linked in literature to several clinically important diseases. Thus it is necessary to provide physicians with accurate results to allow for confident diagnosis of Vitamin D stores and management of vitamin deficiency-related diseases.

The Centers for Disease Control has established a Vitamin D Standardization-Certification Program (VDSCP) and the SCIEX Topaz Vitamin D 200M Assay Kit has successfully met its rigorous performance criteria. While individually quantitating D2 and D3 isomers, the Topaz System running the Vitamin D 200M Assay Kit, also automatically differentiates between D3 epimers, providing the specificity to deliver highly accurate diagnostic results in a single analysis.

The Vitamin D 200M Assay for the Topaz System is intended for in vitro diagnostic use in the quantitative determination of total 25-hydroxyvitamin D (25-OH-D) through the measurement of 25-hydroxyvitamin D3 (25-OH-D3) and 25-hydroxyvitamin D2 (25-OH-D2) in human serum using LC-MS/MS technology. The Vitamin D 200M Assay for the Topaz System is intended to be used in conjunction with other clinical or laboratory data to assist the clinician in making individual patient management decisions in an adult population in the assessment of Vitamin D sufficiency.