cobas 4800 HPV Test
® 1
Designed for clinical relevance, reliability, and accuracy
Assay Design and
Sample Options
Multiple Specimen Types
Primary Vial Loading On the
Automated Sample Preparation
Instrument
Minimal Sample Input
Volume Required
State-of-the-Art Sample Prep
High Throughput
Designed as a qualitative single tube multiplex assay that
simultaneously detects 14 high-risk genotypes, identifies
HPV Type 16 & 18, and ß-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)
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 µL 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 µL 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.
1
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.

Clinical Relevance 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

Robust PCR Test Assay designed to correctly identify genotypes important for HPV–HR
panel and not to cross react with low–risk types

Quality Controls • Internal Control ( ß-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

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: 4.5 hours per run – 94 patient samples
Sample prep: 2.5 hours
Detection: 2 hours
Hands-on time: < 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)
3
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

© 2009 Roche Molecular Systems, Inc. All rights reserved.

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Pleasanton, CA USA 94588
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