cobas® HPV Test

The cobas® HPV Test - for cervical cancer screening and patient risk stratification

A qualitative, multiplex assay, the cobas® HPV Test is the only clinically validated, FDA-approved, CE marked assay that simultaneously provides pooled results on high-risk genotypes and individual results on the highest-risk genotypes, HPV 16 and HPV 18. The cobas® HPV Test is also the only HPV test that is FDA-approved for use with both BD SurePathtm and ThinPrep® Perservcyt® cell collection media.

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

  • First and only test approved by the FDA for HPV primary screening
  • First and only HPV test FDA-approved for use with BD SurePathtm Preservative Fluid
  • No cross-reactivity with low-risk HPV types
  • Results are positive, negative, or invalid with no gray zone
  • ß-globin internal control for sample adequacy; also helps reduce problem of false negatives
  • Reproducible results with real-time PCR
  • AmpErase enzyme to protect against PCR cross-contamination; helps reduce risk of false positives
  • External controls

Confidence with the cobas® HPV Test

The cobas® HPV Test has the potential to set a new standard of testing:

HPV primary screening with the cobas® HPV Test helps identify women at risk for disease, before pre-cancer or cancer develops. Based on the landmark registrational ATHENA study, screening with the cobas® HPV Test detects more high-grade disease than a Pap test alone and maintains screening efficiency. In primary screening, the cobas® HPV Test was proven more sensitive than cytology alone for detecting ≥CIN2 and ≥CIN3.

  • Significantly enhances risk stratification to help manage patient care
  • Lets clinicians focus on the few women who need more aggressive treatment
  • Women who test negative for hrHPV on the cobas® HPV Test can be reassured that they are at very low risk of developing pre-cancer or cancer.

Intended Use: CE-IVD

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 (Hologic Corp) and BD SurePathtm Preservative Fluid (BD Diagnostics-TriPath).

Intended Use: US-IVD

The cobas® HPV Test is a qualitative in vitro test for the detection of Human Papillomavirus in cervical specimens collected by a clinician using an endocervical brush/spatula and placed in the ThinPrep Pap Test PreservCyt® Solution or using a cervical broom and placed in SurePath™ Preservative Fluid. 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 HPV16 and HPV18 while concurrently detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68).

Intended Use: Canada-IVD

The cobas® 4800 Human Papillomavirus (HPV) 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) HPV16 and HPV18 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 (BD Diagnostics-TriPath).