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Primary Vial Loading On the Automated Sample Preparation Instrument Minimal Sample Input Volume Required
High Throughput
System and assay in development; Not available for in vitro diagnostic use at this time
Collection tubes are placed directly onto the sample preparation instrument, eliminating the need for manual handling of samples, reducing time and the potential for cross contamination. Manual processing intervention is limited to the transfer of the plate to the cobas z 480 analyzer for amplification and detection. Newly designed primers and probes target a well defined L1 region for DNA Expect to correlate to detect medically relevant pre-cancer CIN2+ Medical decision point to balance clinical specificity and clinical sensitivity to ensure application is suitable for screening and to achieve guidelines and benchmarks 2 Information on infection with genotypes 16 and 18, which have been shown to increase risk for cervical disease and provide actionable data for immediate follow-up 3
Clinical Relevance
Assay designed to correctly identify genotypes important for HPVHR panel and not to cross react with lowrisk types Internal Control ( -globin) for full process monitoring from extraction to detection, ensuring effective sample preparation, amplification, and target detection Positive and Negative Controls are included in every run to validate the results obtained AmpErase enzymes helps control contamination from amplicon carry over
Quality Controls
Results can be Positive, Negative, or Invalid.* No indeterminate results are expected; reduces need for retesting.
* Invalid results identify specimen inhibition detected by the Internal Control as means to prevent false negative results.
Workflow Timeline*
4.5 hours per run 94 patient samples 2.5 hours 2 hours < 20 minutes (estimated)**
Next run can start as soon as the PCR plate is transferred from cobas x 480 instrument. No centrifugation or incubation required.
*Each laboratory may have a different workflow that may result in a somewhat different outcome. ** Limited to loading of samples and reagents and transfer of microwell plate from cobas x 480 instrument to cobas z 480 analyzer.
2
Meijer Chris JLM, Berkhof, J, Castle PE et al. Guidelines for human papillomavirus DNA test requirements for primary cervical screening in women over 30 years and older. Int J of Cancer 124, 516-520 (2009) Khan MJ, Castle PE, Lorincz AT et al. Elevated 10 year risk of cervical precancer and cancer in women with human papillomavirus (HPV) Type 16 or 18 and the possible utility of type specific HPV testing in clinical practive. J Natl Cancer Inst. 2005:97:1072-1079
ROCHE, COBAS, LIFE NEEDS ANSWERS, and AMPERASE are trademarks of Roche. PreservCyt is a registered trademark of Hologic, Inc. SurePath is a registered trademark of Becton, Dickinson and Company 05540330001 2009 Roche Molecular Systems, Inc. All rights reserved. Roche Molecular Diagnostics 4300 Hacienda Drive Pleasanton, CA USA 94588 http://molecular.roche.com