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cobas® HPV Test

Qualitative nucleic acid test for use on the cobas® 4800/5800/6800/8800 Systems

IVD For in vitro diagnostic use.
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 utilize amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization 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.*

Results you can trust by our built-in quality & 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 patients deserve

  • 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,*.

* SurePath only available on cobas® 4800 System

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

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cobas® HPV product specifications

  • Sample type

    ThinPrep PreservCyt® Solution and SurePath™ Preservative Fluid

     

  • 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

  • Test duration

    <3.5 hours for first HPV result
Intended use

Intended use

The cobas® HPV Test for use on the cobas® 4800 System cobas® HPV Test) is a qualitative in vitro test for the detection of Human Papillomavirus in clinician-collected cervical specimens using an endocervical brush/spatula or broom and placed in the ThinPrep® Pap Test™ PreservCyt® Solution or using a cervical broom and placed in SurePath™ Preservative Fluid. This test detects the high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.

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]. Branchburg, NJ: Roche Molecular Systems, Inc; 2022.
  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. Saville et al. (2018). “Clinical validation of the cobas HPV test on the cobas 6800 system for the purpose of cervical screening” J. Clin. Microbiol. doi:10.1128/JCM.01239-18.
  5. cobas®  HPV test [package insert]. Branchburg, NJ: Roche Molecular Systems, Inc; 2023.

Overview

Detailed Specifications

Ordering Information

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