The SCIEX clinical diagnostic portfolio is For In Vitro Diagnostic Use. Rx Only. Product(s) not available in all countries. For information on availability, please contact your local sales representative or refer to https://sciex.com/diagnostics. All other products are For Research Use Only. Not for use in Diagnostic Procedures.
Trademarks and/or registered trademarks mentioned herein, including associated logos, are the property of AB Sciex Pte. Ltd. or their respective owners in the United States and/or certain other countries.
© 2020 DH Tech. Dev. Pte. Ltd.
SCIEX Vitamin D 200M Assay for the TopazTM System designed to measure Vitamin D with greater accuracy and simplicity for In Vitro Diagnostic (IVD) analysis in clinical diagnostic labs
Framingham, MA — SCIEX Diagnostics, the in vitro diagnostics division of SCIEX, a global leader in mass spectrometry in the life sciences industry, announced today the first and 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 Vitamin D 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 D deficiency-related diseases.
According to the CDC, LC-MS technology is the gold standard method for testing Vitamin D, offering greater specificity and less cross-reactivity over immunoassay methods. The CDC has established a Vitamin D Standardization-Certification Program (VDSCP) and the SCIEX Topaz Vitamin D 200M Assay Kit has successfully met the 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 by a trained laboratory professional in a clinical laboratory. The Assay is intended for use with the Topaz System. 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.
“Clinical diagnostic labs are challenged every day to deliver highly accurate and reliable test results in order to make critical treatment decisions,” said Dr. Aaron Hudson, Sr. Director and GM of SCIEX Diagnostics. “Through the Topaz System, SCIEX offers a LC-MS-based IVD system that is easy to learn and validate in the clinical lab. It will enable clinical labs to expand their in-house testing services through the SCIEX Vitamin D Assay Kit, as well as add to their own laboratory developed tests (LDTs), thus empowering the lab to do more, save more and deliver more confident results to support clinicians and physicians. The Topaz System from SCIEX Diagnostics is “Mass Spectrometry Made Simple”, and primed to set the new standard for delivering superior patient care.”
To learn more about the SCIEX Vitamin D Assay Kit SCIEX Topaz System and the SCIEX Vitamin D 200M Assay Kit, available in the United States only from SCIEX: sciex.com/massspecmadesimple
SCIEX helps to improve the world we live in by enabling scientists and laboratory analysts to find answers to the complex analytical challenges they face. The company's global leadership and world-class service and support in the capillary electrophoresis and liquid chromatography-mass spectrometry industry have made it a trusted partner to thousands of the scientists and lab analysts worldwide who are focused on basic research, drug discovery and development, food and environmental testing, forensics and clinical research.
With over 40 years of proven innovation, SCIEX excels by listening to and understanding the ever-evolving needs of its customers to develop reliable, sensitive and intuitive solutions that continue to redefine what is achievable in routine and complex analysis. For more information, please visit sciexdiagnostics.com.
AB Sciex is operating as SCIEX.
©2017 AB Sciex. The trademarks mentioned herein are the property of the AB Sciex Pte. Ltd. or their respective owners. AB Sciex™ is being used under license.
For in vitro diagnostic use. Rx Only. IVD-MKT-12- 5686-A
Manager Global Public Relations and Brand, SCIEX
NSniper Public Relations on Behalf of SCIEX
A new password has been sent to your email.
You have added a user.
Unfortunately the serial number you provided shows as inactive in our database. Would you like to submit the case anyway?
This serial number could not be found. Would you like to submit the case anyway?
Your password has been updated.
Your account is now created.
A verification link has been sent to your email.
A new password has been sent to your email.
Your insturment has been removed.
Your privacy settings are now updated.
Unfortunately the serial number you provided shows as inactive in our database. Please open a support case here if you require more assistance.
Software has already been registered to another instrument. Please check your AID and try again.
If you want to change the License Key to another instrument, please submit a new case.
Software has already been registered to the instrument selected.
Please check your instrument's software by going to the Instruments page and selecting the instrument in your "My Instruments" section. Here you will see a Software tab where you can view your instrument's software information.
You can also go to the Registered Software page to view software associated with your instrument(s).
If you are not finding what you are looking for, please submit a new case.