cobas s 201 system The first multi-dye NAT screening system

Transcription

1 cobas s 201 system The first multi-dye NAT screening system

2 cobas s 201 system Making NAT screening easy A complete NAT system with state-of-the-art components: Automated real-time PCR, with multi-dye technology, and a unique modular design offers a world of possibilities to meet current and future demands. Automated Pooling Testing in pools has never been so easy with the advanced Hamilton MICROLAB STAR Pipettor and Roche s proprietary Pooling Wizard Software. Roche has been the global leader in NAT screening of donated blood since More donations are tested on Roche systems than any other system. Roche s cobas s 201 system uses a multi-dye technology and offers a reliable, operator-friendly system with fast and easy daily start-up and minimal maintenance. The cobas s 201 system can be implemented easily with few environmental requirements. The modularity of the system allows it to be configured for specific throughput, laboratory space and staffing. The assays that run on the cobas s 201 system are developed with safety in mind; all assays have the most comprehensive viral genotype coverage to ensure viral detection in donations, no matter where the donors reside or where they have visited. The cobas s 201 system is enabled for the future application of its 4-channel, multi-dye detection technology for real-time virus discrimination in a single test. The majority of donations screened worldwide, using NAT testing, are screened in pools with comparable clinical sensitivity to single unit testing. By testing in pools, more donors and blood products are retained because false reactive results are minimized. The cobas s 201 system utilizes a high-performance pooling instrument that makes the pooling algorithm easy to manage, uses labor efficiently, reduces equipment and laboratory space needed, and increases the throughput of the system. cobas s 201 Assays Test cobas TaqScreen MPX Test HIV-1 (Groups M and O), HIV-2, HCV HBV cobas TaqScreen WNV Test cobas TaqScreen DPX Test B19V, HAV cobas TaqScreen MPX Test, v2.0 HIV-1 (Groups M and O), HIV-2, HCV, HBV Status CE-IVD, US-IVD CE-IVD, US-IVD CE-IVD, US* In development *Not an FDA-licensed product; available to US laboratories with appropriate FDA authorization

3 Automated Sample Preparation & Real-Time PCR Nucleic acid extraction, amplification, and detection are easily managed to allow operators to focus on essential tasks elsewhere in the laboratory. Pooling & Data Management Server A single server accommodates multiple instrument configurations and provides the added security of built-in redundancy. The Most Comprehensive System Full process control Entire process is monitored and data is stored for future access One-room operation All instruments can be in the same room for operational efficiency Quiet operation Ensures safe and pleasant operating environment Minimal environmental requirements Few laboratory enhancements are needed for NAT screening implementation System guided workflow Reduces error and increases efficiency Pooling Minimize aerosols Proprietary tip technology minimizes contamination by preventing the creation of aerosols Advanced aspiration and dispense monitoring Software monitors the pipetting process to ensure accurate pipetting and sample integrity so no pre- and post- weighing of samples is necessary Amplification and Detection Built-in contamination control The Roche AmpErase enzyme helps prevent carry-over of amplified products No freezers required Reagents do not require freezer storage, reducing operating cost Real-time PCR: the time-proven technology The real-time PCR technology instills confidence in the results Gold Standard Service and Support Local, regional and global support A multi-tiered support structure ensures operation with minimal downtime Manufactured and supported by Roche All aspects of the system and assays are covered by Roche s world-class service and support Manufacturing Redundancy Multiple manufacturing locations to ensure continuous product supply

4 The NAT Screening Platform Powerful and modular The cobas s 201 system is the platform that reliably delivers accurate, on-time results with donor ID captured directly by the system. The single-server design provides flexibility to meet throughput needs while maintaining donor and reagent traceability. Leading-Edge Technology System Modularity Safer Blood Supply For Today and Tomorrow Most comprehensive assays Multi-dye nucleic acid technology Complete system-guided workflow Offers flexibility for specific staffing, throughput and laboratory needs Simultaneous processing of multiple assays Integrated backup and redundancy in routine system Full Automation NAT Screening Made Easy Minimal Environmental Requirements Easy-to-Implement Technology Fast daily startup Ready-to-use reagents Minimal hands-on time Reduced human errors Minimal end-of-day cleanup One-room operation No special air handling No instrument-related biohazardous waste Ease of Use System Performance Minimal Operator Learning Curve Confidence in Implementing NAT Screening Full system reliability Built-in server and instrument redundancy Quiet operation Gold Standard multi-tiered customer support Fully computerized, guided workflow Minimal maintenance and daily startup No reagent preparation required No caustic chemicals used for daily cleanup Reliable Test Results Full Traceability Confidence in Releasing Blood Products Reliable Documentation Donor ID with results Reagent lot number Date and time of testing All data managed by server Computerized, guided workflow The most comprehensive genotype coverage Unsurpassed system and assay performance Monitoring of each run by external control Monitoring of each tube by internal control Ability to run additional external controls No calibration required Full traceability from donor sample ID to result

5 cobas s 201 system Makes pooling fast and simple With today s latest Nucleic Acid Amplification Technology (NAT), a balance needs to be reached between sensitivity (ability to detect and remove products containing the targeted pathogens) and specificity (ability to retain donors and save products that do not contain the targeted pathogens). Mini-pool testing allows you to achieve that balance. By utilizing Roche s pooling algorithm and highly sensitive cobas TaqScreen assays to screen donations, a high level of blood safety is achieved. Mini-pool testing also helps reduce unnecessary loss of products and donor deferrals due to false positive results. Testing in mini pools provides better workflow and turnaround time as compared to single unit testing. The highly sensitive cobas TaqScreen assays combined with the fully computerized guided workflow of the cobas s 201 system make creating and deconstructing pools easy. Time 14:24 12:00 09:36 07:12 04:48 00:24 00:00 5:30 6:00 7:00 7:15 7:00 8:15 8:37 11:20 9:38 11:55 9: Number of donations Fig. 1. Throughput comparisons of donations in Tigris ( ) and s 201 ( ) screened in IDs and MPs of six, respectively. 1 As the graph illustrates, the cobas s 201 system has a faster turnaround with pooled testing than the TIGRIS Instrument with single unit testing. Multiple laboratory studies around the world have shown that the cobas TaqScreen MPX Test performed in a pool of 6 has comparable clinical sensitivity to the Procleix Ultrio Test performed in single unit. 1,2,3 The added benefit of pooled testing is that an initially reactive result can be ruled out as a false positive or confirmed as a true positive. Ready-to-use reagents Automated real-time PCR 1 Assal, A., et al., Transfusion, Volume 49, February 2009, Margaritis, A.R., et al., Transfusion, Volume 47, October 2007, Phikulsod, S., et al., Transfusion, Volume 49, June 2009,

6 Take Control of Your NAT Laboratory One system to manage your NAT screening Whether your laboratory currently performs blood screening or you are considering implementing a new laboratory, Roche and the cobas s 201 system are here to simplify the implementation and screening. Starting a NAT screening laboratory can be challenging, with many considerations that do not apply to traditional serological testing. The Roche team and the cobas s 201 system uniquely address these challenges to help you ensure a safer blood supply. Key benefits of the cobas s 201 system identified by our customers around the world include: Full Process Control Confidence in the test results with accurate pipetting of donor samples, donor-to-result traceability, reagent ID traceability, internal controls for each reaction and external controls for each batch. System and Assay Performance Ensure a continuous and safe blood supply with world-class system reliability and the most comprehensive assays on the market. Due to increasing globalization, it is now more important than ever that a comprehensive NAT test and a reliable system be used to keep the blood supply safe. Leading-Edge Technology This system is built for menu expansion using multi-dye technology which allows for real-time viral discrimination in a single test. Full Automation Minimal total hands-on time for the entire testing process. With the cobas s 201 system, not only are the pooling, extraction, amplification, detection and final results reporting fully automated, reagents are ready-to-use, daily startup is fast, and end-of-day cleanup is easy. Roche s Multi-Tier Service and Support Rest assured that if any issues on the cobas s 201 system arise, the Roche team, local and global, will get you up and testing again quickly and with minimal interruption. Make the right choice by implementing the cobas s 201 system and cobas TaqScreen assays. No matter what your throughput needs are, the system will manage the workflow, donor traceability, and reagent ID tracking throughout the testing process and allow you to focus on tasks elsewhere in your laboratory. cobas TaqScreen MPX Test, v2.0,* the most comprehensive NAT test for blood safety *Test in development

7 Roche Service and Support Local support in over 140 countries Rotkreuz Branchburg Shanghai Bangkok Global Support Centers Global Training Centers Singapore

8 COBAS, COBAS S, TAQSCREEN, AMPERASE and ROCHE are trademarks of Roche. All other product names and trademarks are the property of their respective owners Roche Molecular Systems, Inc. All rights reserved. Roche Molecular Diagnostics 4300 Hacienda Drive Pleasanton, CA USA xxxxxxxxxxxx➀ WW