Rapid Capture System Proven Performance

Transcription

1 Rapid Capture System Proven Performance Hybrid Capture 2 For automated human papillomavirus (HPV) testing Sample & Assay Technologies

2 Chaptertitle X.XX The Rapid Capture System (RCS) an automated, CE-marked and FDA-approved system for HPV testing The RCS is an automated, high-throughput robotic pipetting and microplate handling system designed to work with Hybrid Capture 2 (HC2) technology. It replaces modular instrumentation with a reliable and timesaving workflow. The RCS was the first CE-marked and FDA-approved high-throughput system for analyzing cervical samples for high-risk HPV. This system enhances your laboratory s ability to offer clinicians fast and reliable test results for cervical sample processing with less hands-on time. The RCS has software-driven procedures that enforce best practices in integration with Laboratory Information Systems (LIS). Machine design and training are in accordance with ISO 9001/ISO standards, and as a UL-rated instrument, the RCS supports US-OSHA guidelines. Flexible workflow and reliable performance During a single run, the RCS accommodates multiple assays or sample types enabling scheduling flexibility. Laboratories can optimize testing schedules to better meet their daily workload and efficiently allocate laboratory resources (see Table 1). Table 1. Flexible RCS setup options Assay Sample type Characteristics digene HC2 High-Risk HPV DNA Test STM, PreservCyt, BD SurePath A single run can handle STM and PreservCyt or BD SurePath samples on separate plates digene HC2 HPV DNA Test STM, PreservCyt, BD SurePath A single run uses two probe cocktails to detect high-risk HPV and/or low-risk HPV digene HC2 CT-ID DNA Test digene HC2 GC-ID DNA Test STM and PreservCyt A single run uses two probe cocktails to detect CT and/or GC from one sample on separate plates 2 Rapid Capture System Technology 03/2011

3 Chaptertitle X.XX CE-marked for high-risk and low-risk HPV testing The RCS is CE-marked for use with the digene HC2 HPV DNA Test and the digene HC2 High-Risk HPV DNA Test. The system is also FDA-approved as part of the digene HC2 High-Risk HPV DNA Test. The system processes cervical samples collected in Specimen Transport Medium* (STM), in ThinPrep PreservCyt Solution, or in BD SurePath Preservative Fluid. The RCS is also CE-marked for processing STM samples or ThinPrep PreservCyt samples for CT-ID (Chlamydia trachomatis) and GC-ID (Neisseria gonorrhoeae) (see Table 2). The benefits of using CE-marked and FDA-approved system for high-risk HPV automated testing Processing your HPV tests with Hybrid Capture 2 technology on a CE-marked and FDA-approved system assures you that you are using a test that has been extensively and clinically validated in large, randomized trials with almost 1 million women worldwide. It assures that you are using a test that has been determined safe and effective for its intended use when manufacturer s methods are followed assaying up to 352 patient results in a single run. HC2 technology is the proven standard in HPV testing, and over 70% of all HPV tests performed in the world today are tested on a Rapid Capture System. Table 2. HC2 assays compatible with the Rapid Capture System (RCS) Assay Approval status Approved sample type digene HC2 High-Risk HPV DNA Test CE-marked and FDA-approved digene Cervical Sampler*, ThinPrep PreservCyt, BD SurePath Preservative Fluid digene HC2 HPV DNA Test CE-marked digene Cervical Sampler*, ThinPrep PreservCyt, BD SurePath Preservative Fluid digene HC2 CT-ID DNA Test digene HC2 GC-ID DNA Test CE-marked and FDA-approved CE-marked and FDA-approved digene Cervical Sampler*, digene Female Swab Specimen Collection Kit, ThinPrep PreservCyt digene Cervical Sampler*, digene Female Swab Specimen Collection Kit, ThinPrep PreservCyt * Specimen Transport Medium is part of the digene Cervical Sampler. Sample type is CE-marked only. Rapid Capture System Technology 03/2011 Sample & Assay Technologies 3

4 Efficient design for greater throughput n 1 Multi-Specimen Tube (MST) rack holder accommodates STM and PreservCyt sample racks n 2 Pipet tip adaptors for disposable tips n 3 RCS plate grippers n 4 Reagent trough rack n 5 Disposable pipet tips n 6 65 C hybridization incubators n 7 Plate washer n 8 Microplate shakers Automated workflow Automated analytical processes enhance laboratory throughput. Flexible workflow Flexible procedures optimize your laboratory s test schedules, freeing technologists to attend to other tasks. Consider your laboratory s needs. Do you: Require reliable CE-marked and FDA-approved analysis of HPV? Perform batch testing? Anticipate an increase in future volume? Process large testing volumes that cause scheduling issues? Want to reduce the potential for cross-contamination? Seek to minimize employee repetitive motions? Reliable performance Automated pipetting and preset processing times reduce the likelihood of human error. 4 Rapid Capture System Technology 03/2011

5 Automated workflow Preparation steps Preanalytical processing 1. Process STM samples: place tubes in STM rack, then denature and vortex. 2. Process samples collected in ThinPrep PreservCyt Solution: perform sample conversion process, then denature and vortex. 3. Process samples collected in BD SurePath Preservative Fluid: perform sample conversion process, place tubes with converted samples in conversion rack, then denature and vortex. RCS processing steps 4. Transfer samples to RCS: place racks directly onto RCS deck. 5. Select RCS script: use Select Script software to choose appropriate protocol. 6. Perform automated analysis: for high-risk HPV, a single run accommodates STM and PreservCyt or BD SurePath sample types on separate plates. Other assays are on individual runs. Detection 7. Transfer plates to luminometer: performs detection interpreted by HC2 System software. 8. Use HC2 System software: transmit results data to Laboratory Information systems (LIS). Validated processing The RCS automates transfer steps that are potentially subject to cross-contamination. The RCS automates sample transfers (from sample tube to hybridization plate and from hybridization plate to Capture Plate), plate handling, precision reagent pipetting with liquid level-sensing tips, incubation at ambient and 65 C temperatures, and washing. Lab technologists run a QIAGEN verified automated maintenance process to clean all fluid lines. The process is logged by the RCS software. Rapid Capture System Technology 03/2011 Sample & Assay Technologies 5

6 Preanalytical process The sample preparation or preanalytical process can also be streamlined for use with the RCS. The Multi-Specimen Tube (MST) Vortexer enables batch processing of samples, reducing hand-on vortexing time. In addition to time savings, batch processing eliminates the repetitive motion and vibration stress associated with individual tube vortexing. MST vortexing reduces liquid-based cytology (LBC) conversion time by as much as 35%. By eliminating individual vortexing and capping, it reduces both STM and LBC processing time 20 50%, based on the number of samples (see Table 3). The MST Vortexer accommodates racks for STM (digene Sample Rack) and LBC (Conversion Rack) samples. Each rack holds up to 88 samples, as well as assay calibrators and controls. Table 3. MST batch vortexing vs. single-tube vortexting Number of samples Time saved (hours) Time saved (percentage) % % % % % Analytical process By automating the sample transfer, hybridization, and capture steps of the HC2 assay workflow, the RCS provides the operator with 3.5 hours of continuous walkaway time and eliminates 12 operator interventions when compared to manual HC2 testing. This frees up laboratory resources to perform other tasks. A single run can process both STM and converted LBC samples on separate plates, enabling multiple protocols to run at the same time. By staggering the steps, the RCS reduces analytical processing time by as much as 49%, based on your number of samples. Robust, auditable software The HC2 System software reports qualitative assay results with a user-friendly interface. The software supports customizable report formats sorted by plate or specimen, with summary or detailed outputs. All results are tracked by the user ID for auditing and QA. This system adheres to Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP). The RCS uses HC2 software, which is compatible with multiple types of bar codes saving time and reducing manual entry errors. HC2 System software fully interfaces with Laboratory Information Systems (LIS), through which designated users can send patient and QC data to the laboratory network. 6 Rapid Capture System Technology 03/2011

7 Complete coverage and cost control Ownership of laboratory equipment is made easy with RCS comprehensive warranty agreements fully covering routine maintenance and rapid-response emergency services. Your laboratory can confidently budget for the RCS operating costs. Table 4. Rapid Capture System (RCS) specifications Physical dimensions Weight Plumbing requirements Bar code compatibility Operating environment Voltage Workflow Processing time Fits on standard bench top: Depth: 116 cm Width: 73 cm Height: 66 cm 112 kg No special plumbing required. Code 3 of 9, Code 128, Interleaved 2 of 5, Codabar System operates in a routine laboratory environment with no concerns of environmental contamination. Relative humidity: 22 85% non-condensing. Temperature: C (68 77 F) 240 V, 120 V switchable. Requires user-supplied uninterrupted power source (UPS). Processes up to 352 patient samples in a single run. 4.5 hours for up to 352 samples 3.75 hours for up to 88 samples Call your QIAGEN sales representative today and find out how RCS technology tests cervical samples with less hands-on time. Ordering Information Product Contents Cat. no. RCS Complete System (For new HC2 customers) RCS Upgrade Package (For existing HC2 customers) Rapid Capture System (RCS), MST Conversion System (vortexer and racks), digene Microplate Luminometer (DML) Startup kit, Validated PC System package (software for RCS and HC2 System monitor; printer; and accessories, such as a mouse and USB/RS232 converter) Rapid Capture System (RCS); MST Conversion System (vortexer and racks); Startup kit; installation of RCS and HC2 System software on existing validated PC System Inquire Inquire Trademarks: QIAGEN, digene, Hybrid Capture, Rapid Capture (QIAGEN Group); PreservCyt, ThinPrep (Cytyc Corporation); BD SurePath (Becton, Dickinson and Company) / QIAGEN, all rights reserved. Rapid Capture System Technology 03/2011 Sample & Assay Technologies 7

8 Australia n Orders n Fax n Technical Austria n Orders n Fax n Technical Belgium n Orders n Fax n Technical France n Orders or n Fax n Technical or Germany n Orders n Fax n Technical Ireland n Orders n Fax n Technical Italy n Orders n Fax n Technical Luxembourg n Orders n Fax n Technical The Netherlands n Orders n Fax n Technical Spain n Orders n Fax n Technical Switzerland n Orders or n Fax n Technical or UK n Orders or n Fax n Technical or /2011 Sample & Assay Technologies