cobas 4800 HPV Test

Designed for clinical relevance, reliability, and accuracy

Assay Design and Sample Options Designed as a qualitative single tube multiplex assay that simultaneously detects 14 high-risk genotypes, identifies HPV Type 16 & 18, and -globin is used as an internal control. Test options include: HPV-HR only (which provides qualitative result) HPV-HR + Genotype (GT) 16/18 (which provides HPV-HR result and separate qualitative result for Type 16 and Type 18) Multiple Specimen Types Plans include validation in both PreservCyt and SurePathTM Liquid Based Cytology (LBC) vials. A Roche labeled specimen collection kit is also planned for stand-alone DNA tests for samples run separately or cases where conventional PAP smears are common. Sample carriers are available to load primary LBC vials directly onboard the sample prep system, minimizing hands on time for transfer of sample. Only 400 L input volume is required for each test. Depending on residual volume remaining from PAP process, options include: loading primary vial or transferring to a secondary tube (requires 800 L total volume). Ideal when residual samples are below 4 mL. Sample preparation is based on the state-of-the-art magnetic glass particles chemistry. Onboard heating and mixing of media and cervical cells provides superior sample preparation product. Specialized pipetting technology combined with AmpErase enzymes reduces cross contamination risk. The cobas 4800 System is designed to process up to 280 samples in one day. One test can provide up to 3 results: (HPV-HR, GT 16, GT 18) to enhance testing efficiency.
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Primary Vial Loading On the Automated Sample Preparation Instrument Minimal Sample Input Volume Required

State-of-the-Art Sample Prep

High Throughput

System and assay in development; Not available for in vitro diagnostic use at this time

Less Hands-On 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

Robust PCR Test

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

Clear and Definitive Results

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*

Total run time to result: Sample prep: Detection: Hands-on time:

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.
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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