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The cobas® HPV test

Simultaneously detects 14 high-risk HPV types and provides specific genotyping information for HPV Type 16 and 18
A qualitative multiplex assay that provides specific genotyping information for HPV Types 16 and 18, while concurrently detecting the other 12 high-risk HPV types in a pooled result. ß-globin from cellular input is used as an internal control to assess specimen quality and identify specimens containing factors that inhibit the amplification process. This assay is automated on the cobas® 4800 System.

Features and Benefits

  • Easy to learn, easy to use
  • Reduces labor costs and training time
  • Intuitive software walks the user through the entire set up process
  • Bi-directional LIS connection protects results integrity and reduces repetitive tasks
  • Automated result algorithm provides clear positive, negative or invalid results with no gray zone
  • Quality control in every step
  • A total process internal control utilizing the ß-globin identifies samples with low cellularity that could lead to false negative results
  • Contamination control
  • The AmpErase enzyme degrades previously amplified target, allowing sample prep and detection in the same lab Intended.

This test is a qualitative in vitro test for the detection of Human Papillomavirus in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis.

The test specifically identifies (types) HPV 16 and HPV 18 while concurrently detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) at clinically relevant infection levels. Specimens are limited to cervical cells collected in cobas® PCR Cell Collection Media (Roche Molecular Systems, Inc.), PreservCyt® Solution (Cytyc Corp.) and SurePath® Preservative Fluid (not approved in the US) (BD Diagnostics-TriPath).

The cobas® 4800 system

Fully automated sample preparation with real-time polymerase chain reaction (PCR) technology for amplification and detection

Best combination of technologies available:

cobas x 480 Instrument

  • Fully automated sample preparation from primary vials
  • Ready-to-use, load-and-go reagents
  • No thawing or mixing required
  • Less than 20-minute set-up for full run of 94 samples

cobas z 480 Analyzer

  • Real-time PCR with digital data capture provides accurate qualitative results with no gray zone
  • Eliminates the need for equivocal sample retesting
  • Advanced results algorithm eliminates the need for manual curve analysis

Features and Benefits

Easy-to-learn and easy-to-use software

  • Intuitive user interface
  • Requires only a few hours training at all levels of laboratory personnel
  • Seamlessly integrates both system components

Streamlines workflow

  • Fully automated sample preparation
  • High quality nucleic acid extraction technology
  • Robust engineering reduces maintenance and downtime
  • Bi-directional connectivity with an LIS for automated results reporting reduces labor and potential for error

Promotes lab efficiency

  • Processes up to 384 samples a day
  • Efficient for labs with lower throughput requirements
  • Load primary collection tubes and liquid cytology vials directly on the system
  • Minimal input volumes allow multiple tests from the same patient specimen

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