Products

cobas® HPV Test

cobas hpv
Delivering confidence with every result on cobas® 4800 / 5800 / 6800 / 8800 systems

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The cobas® HPV tests are automated qualitative in vitro tests for the detection of human papillomavirus (HPV) DNA in patient specimens. The tests utilise amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridisation for the detection of 14 high-risk HPV (hrHPV) types in a single analysis.

Infographic: Testing for mutations in colorectal cancer

Features and benefits

The tests simultaneously provide pooled results on high-risk genotypes and individual results on the highest-risk genotypes, HPV 16 and HPV 18, at clinically relevant infection levels. Cervical cell specimens can be collected in ThinPrep PreservCyt® Solution and SurePath™ Preservative Fluid.*

Now introducing Roche HPV Self-Collection Solution

The test is CE-IVD validated for use in collected vaginal specimens in a healthcare setting. Women and people with a cervix can collect their own vaginal specimen in a healthcare worker-instructed when a cervical specimen can not be obtained.

This solution

  • Allows women to take greater controlof their health
  • Reduces cultural, religious, and socioeconomic barriers to in-clinic screening.
  • Improves cervical cancer screening attendance.4

Learn more: Expanding access to cervical cancer screening with HPV self-collection

Would you like to know more about the cobas® HPV Test?

Please submit your information in the following form to be contacted by a Roche representative with more details.

Results you can trust by our built-in quality and safety features

  • Internal control: The ß-globin internal cellular control helps prevent false negatives. HPV negative specimens with a negative ß-globin result are flagged as invalid, helping to prevent reporting of false negative results
  • Use of AmpErase Enzyme: Each reaction contains AmpErase Enzyme, reducing the risk of false positive results from carry-over contamination by differentiating amplification products from target molecules
  • No cross reactivity: Demonstrates no cross-reactivity with non-high risk HPV genotypes, ensuring that positive results are clinically meaningful


Peace of mind

  • Assays are validated in clinical performance studies (e.g. cobas® 4800 HPV test was validated in the ATHENA Trial)1
  • Validated for detection of >CIN2 lesions and not simply presence of HPV1
  • Validated to the standards set forth in international guidelines for HPV testing for cervical screening purposes2,3,*.


References

  1. cobas® 4800 HPV Test [package insert].
  2. Heideman DA, Hesselink AT, Berkhof J, et al. Clinical validation of the cobas® 4800 HPV Test for cervical screening purposes. J Clin Microbiol. 2011;49(11):3983-3985. doi: 10.1128/JCM.05552-11.
  3. Meijer CJ, Berkhof J, Castle PE, et al. Guidelines for human papillomavirus DNA test requirements for primary cervical cancer screening in women 30 years and older. Int J Cancer. 2009;124(3):516-20. doi: 10.1002/ijc.24010.
  4. Elfström KM, et al. Increasing participation in cervical screening by targeting long-term nonattenders: Randomised health services study. Int J Cancer.  2019 Dec.
  5. cobas®  HPV test [package insert].

cobas® HPV product specifications

  • Sample type

    Clinician-collected cervical specimens placed in ThinPrep PreservCyt® Solution and SurePath™ Preservative Fluid. Self-collected vaginal specimens obtained in a healthcare setting.

  • Minimum amount of sample required (µL)

    1,000

  • Specimen processing volume (µL)

    400

  • Internal cellular control

    ß-globin

  • Simultaneous 16/18 genotyping

    Yes; HPV 16, HPV 18 and 12 hrHPV

  • Genotypes

    16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68
Intended use

Intended use

The cobas® HPV Test is indicated for use for routine cervical cancer screening as per professional medical guidelines, including triage of ASC-US cytology, co-testing (or adjunctive screen) with cytology, and HPV primary screening of women to assess the risk for cervical precancer and cancer. Patients should be followed-up in accordance with professional medical guidelines, results from prior screening, medical history, and other risk factors.


References

  1. cobas® 4800 HPV Test [package insert].
  2. Heideman DA, Hesselink AT, Berkhof J, et al. Clinical validation of the cobas® 4800 HPV Test for cervical screening purposes. J Clin Microbiol. 2011;49(11):3983-3985. doi: 10.1128/JCM.05552-11.
  3. Meijer CJ, Berkhof J, Castle PE, et al. Guidelines for human papillomavirus DNA test requirements for primary cervical cancer screening in women 30 years and older. Int J Cancer. 2009;124(3):516-20. doi: 10.1002/ijc.24010.
  4. Opportunistic offering of self-sampling to non-attenders within the English cervical screening programme: a pragmatic, multicentre, implementation feasibility trial with randomly allocated cluster intervention start dates (YouScreen). Lim, Anita W.W.Lawrence, Alexandra et al. eClinicalMedicine, Volume 73, 102672
  5. cobas®  HPV test [package insert].
  6. Elfström KM, et al. Increasing participation in cervical screening by targeting long-term nonattenders: Randomised health services study. Int J Cancer.  2019 Dec.
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