cobas® HPV Test 

 
Registration Status

Canada-IVD
CE-IVD
US-IVD
Now FDA Approved
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 Use


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).
More Information
 
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