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cobas® HPV

Delivering confidence with every result on cobas® 4800/6800/8800 Systems

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The cobas® HPV tests are an automated qualitative in vitro test 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.

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 PreservCyt® Solution, cobas® PCR Cell Collection Media and SurePathPreservative 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*

*Note: cobas® HPV for use on cobas® 6800/8800 Systems is currently under validation.

cobas® HPV product summary

Description Summary
Sample type PreservCyt® Solution, SurePath™ Preservative Fluid, cobas® PCR Cell Collection media
Minimum amount of sample required (µl) 1,000
Sample processing value (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

Summary of Intended Use

cobas® HPV for use on the cobas® 4800 System cobas® HPV for use on the cobas® 6800/8800 Systems
CE-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 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 SurePath™ Preservative Fluid (BD Diagnostics-TriPath).

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 and nucleic acid hybridization for the detection of 14 high-risk 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).

Canada-IVD

The cobas® Human Papillomavirus 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 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).

CE-IVD

cobas® HPV for use on the cobas® 6800/8800 Systems (cobas® HPV) is an automated qualitative in vitro test for the detection of human papillomavirus (HPV) DNA 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 HPV16 and HPV18 while concurrently detecting the other 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 PreservCyt® Solution, cobas® PCR Cell Collection Media and SurePath™ Preservative Fluid.

References:

  1. cobas® 4800 HPV Test [package insert, CE]. Branchburg, NJ: Roche Molecular Systems, Inc; 2012.
  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.