LC-MS system for clinical diagnostics

LC-MS system for clinical diagnostics

The SCIEX Topaz System is designed specifically to meet the unique needs of the clinical diagnostic lab, lowering the barriers to adoption of LC-MS and making it accessible to the entire clinical lab staff....

Supplied by Sciex


The SCIEX Topaz System is designed specifically to meet the unique needs of the clinical diagnostic lab, lowering the barriers to adoption of LC-MS and making it accessible to the entire clinical lab staff. The heart of the system lies within the innovative ClearCore MD software, a platform which simplifies and streamlines workflows and method development and incorporates features that enhance usability to help new users build proficiency quickly. In addition, the first FDA-cleared (via the de novo pathway) LC-MS based Vitamin D assay kit, the SCIEX Vitamin D 200M Assay, is for use on the SCIEX Topaz System. According to the Centered for Disease Control (CDC), LC-MS technology is the gold standard method for testing vitamin D, as it offers greater specificity and less cross-reactivity over immunoassay methods. The Vitamin D 200M Assay Kit has successfully met the rigorous performance criteria established by the CDC’s Vitamin D Standardization-Certification Program (VDSCP). The assay individually quantitates both vitamin D2 and D3 while also separating out the D3 epimer, providing the specificity to deliver an accurate measurement of vitamin D status. The Topaz System offers both an open system for lab-developed tests (LDTs) and a closed system for running locked, pre-validated assays.


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