Mass Spectrometry Made Simple for Clinical Diagnostic Labs

Transcription

1 Mass Spectrometry Made Simple for Clinical Diagnostic Labs The SCIEX Topaz System with FDA-Cleared Topaz Vitamin D 200M Assay Kit

2 Mass Spectrometry Made Simple SCIEX Topaz System for Clinical Diagnostics Struggling to stay ahead of your clinical testing workload? LC-MS/MS provides a faster path than traditional methods and unquestionable results. Remove months of method development with the SCIEX Topaz System with FDA-cleared Vitamin D Assay. The power of LC-MS/MS technology is now available with the simplicity of the SCIEX Topaz System - a Class l Medical Device, mass spec-based IVD platform designed for the demands of the clinical lab. Introducing the platform into your lab will add valuable capability and capacity, so you can eliminate costly send-out testing and speed-up turnaround times. Bringing the Power of LC-MS/MS into Clinical Labs Acquire the timely, reliable results you need with a mass spec-based IVD system that is incredibly easy to learn, and with an FDA-cleared Vitamin D Assay designed to accelerate adoption. Quantitate multiple compounds in a single run Achieve superior sensitivity and specificity over alternative technologies Capture highly accurate results in weeks, not months Tried-and-True Technology, Adapted For the Clinical Lab The Topaz system delivers the unmatched innovation, performance and dependability that you expect from SCIEX. Our new state-of-the-art software was developed with usability in mind, to have you up and running faster than ever before. Incorporating proprietary Turbo V ion source and Curtain Gas interface, you gain best-in-class reliability, sensitivity and reproducibility while maintaining the highest standards of accuracy demanded by the clinical lab. The Topaz system has 1D/2D LC capability, giving you the option to do online sample clean up to significantly reduce sample prep times. Complete with FDA-cleared (via the de novo pathway) Vitamin D 200M Assay Kit, intuitive ClearCore MD Software, and comprehensive training, the Topaz system is designed for enhanced usability and rapid user adoption. Regardless of your previous experience with LC-MS/MS and the skill level of your team, you will be empowered to do more, save more and set the standard for accurate test results.

3 Have the Ultimate Confidence in Your Results Sensitivity: The Vitamin D Assay Lower Limit of the Measuring Interval (LLMI) was determined to be 2.0 ng/ml for 25-OH-vitamin D3 and 2.0 ng/ml for 25-OH-vitamin D2 and 4.0 ng/ml for total 25-OH vitamin D. Robust performance, minimal maintenance and dedicated customer support ensure high instrument uptime. Analyte LLMI ng/ml Mean Signal to Noise Ratio 25-hydroxyvitamin D hydroxyvitamin D Total 25-hydroxyvitamin D 4.0 N/A Linearity data for 25(OH) Vitamin D3 (top) and 25(OH) Vitamin D2 (bottom) The pooled repeatability estimate was <3% for all data sets. Reproducibility of results for four example analytes of 1500 injections in human plasma shows the stability of the MS system for consistent measurement day after day. See a Return on Your Investment Flexibility to expand the your lab s test menu, with a dedicated LC-MS/MS diagnostic testing platform that you control Empower your lab to do more, significantly improve turn-around times and reduce expensive send-out services By adopting the Topaz system, tests that are currently sent out for a significant fee can be brought back in-house at a lower cost. Starting with Vitamin D, incremental savings are realized annually, expanding as additional assays are adopted on the platform. With increasing testing volume, the payback period is shortened and greater lab profits realized. $ Annual Dollars Increasing savings and profits as additional tests added Vitamin D LDT 1 Vitamin D LDT 2 LDT 1 Vitamin D Year 1 Year 2 Year 3

4 ClearCore MD Software Designed for the New User Setting new standards It has never been easier to introduce LC-MS/MS into your lab. ClearCore MD Software is meticulously designed to simplify adoption for new mass spec users, in a way that isn t possible with other systems. ClearCore MD Software works hand-in-hand with the Topaz system to streamline workflows and method development, bringing the power of SCIEX LC-MS/MS to your lab. Less to learn, more to accomplish ClearCore MD Software is designed to give new users the ultimate confidence in running assays on the Topaz system in no time at all. Ease of viewing and navigation: View any module from the start up panel Streamlined navigation for common tasks Simplify control with component-specific tabs Easy to Navigate An intuitive, tile-based user interface provides easy access to all system modules with a single click. Each module offers simple menus for streamlined navigation to complete tasks. The sample and instrument status panel is visible at all times Method Development Simplified ClearCore MD Software provides enhanced ease of use for rapid method development including automated MRM optimization. Access to complete functionality via a simple tile-based grid Instant view of sample and instrument status Personalized training for success With each system comes comprehensive training through online learning, LC-MS/MS courses, and onsite training and support.

5 Power for the Experienced LC-MS/MS User ClearCore MD Software puts you in control to develop and expand your in-house lab tests. Method Development Flexibility of discrete LC and MS method modules Automatic optimization with minimal user input Direct compound detection for multiple analyte panels Review and Results Report and review functionality Quantitation module for quickly spotting outliers Automatic optimization report generation Managing Your Laboratory Multi-level user access Bidirectional LIS communication Import and export of sample information and results

6 Vitamin D Tests in Weeks Not Months In conjunction with the first FDA-cleared, SCIEX Vitamin D Assay Kits, the Topaz system saves months of method development time empowering your lab to deliver test results with less complexity for the benefit of better patient care. Simple, pre-developed, locked method enables your lab to get up and running quickly Chromatographic separation of the D3 epimer to eliminate bias Extensive interference testing with 58 compounds to ensure analyte specificity FDA-cleared assay to reduce risk compared to running LDTs Vitamin D Assay Kit is CDC reference standard certified Accuracy of Data A method comparison study was performed following standard CLSI guidelines. The study tested the Vitamin D 200M Assay for the Topaz system using the CDC and University of Ghent Vitamin D2 and D3 reference method. Description Value # of unique patients 120 (including 12% modified) Concentration range of total 25-OH Vitamin D 5.6 ng/ml to 153 ng/ml Pierson correlation coefficient Passing Bablok analysis Line with slope of and intercept of ng/ml The results indicate a high correlation between the candidate device method and reference method recognized as the gold standard Reference Method Procedure (RMP) across the measuring range of the candidate device. Passing Bablok Fit for Total 25 OH Vitamin D The Topaz system provides highly accurate and specific quantitative measurements, even for similarly structured compounds in biological fluids 25-OH-Vitamin D3 25-OH-Vitamin D3 25-OH-Vitamin D2 3-epi-25-OH- Vitamin D3 The kit contains all reagents required to run the assay including calibrators, QC s, standards, mobile phases, LC analytical column, trap column, system suitability mix, rinsing solution, precipitation reagent, reaction vials and instructions. The Topaz Vitamin D Assay removes interference from the 3-epi-25-OH-Vitamin D3 epimer, preventing overestimation of total Vitamin D levels. The Topaz Vitamin D Assay directly measures both 25-OH-Vitamin D2 and D3 forms individually, to ensure accurate quantitation of total Vitamin D.

7 5 Steps to Results with the Topaz Vitamin D Assay Batch Setup Import or Create Sample List (LIS or Excel) Equilibrate Topaz System Run System Suitability 5 Load and Run Assay Analysis Sample Prep (vials or 96-well plates) Review Report Results

8 Your Success is Our Success We take it personally As a SCIEX user you have access to a world-class customer support organization in the SCIEX Success Network. Wherever you are, we re there with you as a trusted partner to answer questions, provide solutions, and maximize lab productivity. Superior patient care is a click away. Learn more at sciex.com/massspecmadesimple Personalized Support Everything you need, anytime you need it. Comprehensive Training Your online access to courses on LC-MS/MS basics, maintenance and more, with full certification tracking. Productivity, Maximized From service plans to application support and consulting, we re here to help you get the most from your SCIEX Topaz System. Connect and Collaborate Learn about what s trending in the industry and get support questions answers. Same Mass Spec, Better Data The support plans that keep your software up to date for better system performance and quality AB Sciex is doing business as SCIEX AB Sciex. For in vitro Diagnostic Use. Not available in all countries. The trademarks mentioned herein are the property of AB Sciex Pte. Ltd. or their resp ective owners. AB SCIEX is being used under license. IVD-MKT B Headquarters 500 Old Connecticut Path Framingham, MA USA Phone sciex.com International Sales For our office locations please call the division headquarters or refer to our website at sciex.com/offices Answers for Science. Knowledge for Life.