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cobas® HPV

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cobas® HPV Test: Delivering confidence with 3-in-1 HPV test results

The link between cervical cancer and Human Papillomavirus (HPV) has become clear over the past few decades — today we know that persistent infection with specific types of HPV account for nearly all cases of cervical cancer.

Cervical cancer rarely causes overt symptoms in its early stages — when treatment is most effective — so screening for the types of HPV infection at the greatest risk of progressing to cervical pre-cancer and cancer is imperative.

The cobas® HPV test is clinically validated and FDA-approved to provide individual results for HPV 16 and HPV 18, along with a simultaneous, pooled result for other high-risk genotypes, all in one run, from one patient sample. By providing 3-in-1 results, clinicians are able to better risk stratify patients, and make patient management decisions with confidence.

Individual results for HPV 16 and HPV 18 along with a pooled result for other high-risk HPV types

Benefits and Features

Both cobas® 4800 HPV test and the cobas® HPV test for use on cobas® 68/8800 systems are clinically validated and FDA approved. They 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. HPV DNA tests have extensive longitudinal data to support the safety of a negative result and to ensure confidence in a negative result, each cobas® HPV test also includes appropriate controls to verify human cells are present in the sample.

 

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.

 

Peace of mind patients deserve

  • All Roche assays are validated in large, clinical studies that evaluate specific product performance in various screening strategies (e.g., cobas® HPV and cobas® 4800 Systems in the ATHENA trial, and cobas® HPV for use on the cobas® 6800/8800 Systems and triage with CINtec® PLUS Cytology in the IMPACT trial).
  • 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 purposes2,3,4,5,6

Learn more about Roche’s cobas® HPV test and how it can help you identify women at greatest risk for cervical cancer.

Download the cobas® HPV performance specification sheet

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cobas 6800 and 8800 systems

Offering highly efficient workflows from sample processing to result interpretation, the cobas® Systems put the future of molecular testing in your hands. Our broad assay menu is held to the rigorous performance standards you expect from Roche, and our real-time PCR technology delivers reliable results every time.

Intended use

Intended use

The cobas® 4800 Human Papillomavirus (HPV) Test is a qualitative in vitro test for the detection of Human Papillomavirus in patient specimens. The test utilises amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridisation 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 Cell Collection Medium, PreservCyt® Solution (Hologic Corp) and BD SurePath™ Preservative Fluid (BD Diagnostics-TriPath).

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 utilises amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridisation 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 in PreservCyt® Solution, cobas® PCR Cell Collection Media, Roche Cell Collection Medium and SurePath™ Preservative Fluid.

 

Registration status

cobas® HPV for 4800 System, CE-IVD, US-IVD, Canada-IVD 

cobas® HPV for 6800/8800 Systems, CE-IVD, US-IVD, Canada-IVD


 

Package inserts

Access package inserts through your country’s Roche Diagnostics website.

References

 

 

1Khan MJ, Castle PE, Lorincz AT, et al. The elevated 10-year risk of cervical precancer and cancer in women with human papillomavirus (HPV) type 16 or 18 and the possible utility of type-specific HPV testing in clinical practice. J Natl Cancer Inst. 2005;97(14):1072-1079.

2Bosch FX, de Sanjosé S. Human papillomavirus and cervical cancer — burden and assessment of causality. J Natl Cancer Inst Monogr. 2003;31:3-13.

3cobas® 4800 HPV Test [package insert, CE]. Branchburg, NJ: Roche Molecular Systems, Inc; 2012.

4Heideman 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.

5Meijer 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.

6Saville 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.

Roche offers comprehensive options for workflow automation and pre-analytics in the molecular lab. Productivity is increased by streamlining or reducing touchpoints so staff can focus on more complex testing demands.

Designed to provide users with minimal and intuitive interactions, cobas® 6800/8800 Systems, for example, turn walk away time into true “work-away” time with just three touchpoints.

*Depending on workflow, up to eight hours of “work-away” time for the cobas® 6800 System and four hours for the cobas® 8800 System respectively.

Other solutions, such as the cobas® 4800 System, offer automation where it’s needed most.

  • Assay preparation and sample transfer for PCR amplification and detection
  • Result analysis for clear and precise answers, with a reduced need for retesting or interpretation

cobas® HPV product summary

  • Sample type

    PreservCyt® Solution, SurePath™ Preservative Fluid and Roche Cell Collection Medium

  • 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
 

Discover Roche’s Systems portfolio

 

Through unrivaled investment in innovation, Roche offers a wide range of platforms and workflow solutions designed to improve your lab’s efficiency and ensure you get the quality results you expect.

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Cervical Screening Sample Collection

 

Learn more about sample collection for screening and triage tests in the Roche Cervical Cancer Portfolio.

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