COBAS® HPV TEST

cobas® HPV Test image

COBAS® HPV TEST: DELIVERING CONFIDENCE WITH 3-IN-1 HPV TEST RESULTS

HPV 16 and 18 are the two most prevalent oncogenic HPV types in both squamous cell carcinoma and adenocarcinoma; these two high-risk HPV (hrHPV)types are responsible for more than two-thirds of all cervical cancer cases.1,2 The cobas® HPV Test is FDA-approved to simultaneously provide individual results on HPV 16, HPV 18, and a pooled result on the twelve other high-risk HPV genotypes, all in one run from one patient sample. By providing three results in one test, clinicians are able to better risk stratify patients and help guide patient management decisions with confidence.

By choosing the right HPV test, labs can provide the accurate hrHPV information that clinical partners expect and patients deserve.

Infographic: Testing for mutations in colorectal cancer

BENEFITS AND FEATURES: COBAS® 4800/6800/8800 SYSTEMS

Only cobas® HPV Test is clinically validated and FDA-approved for use in both PreservCyt and SurePath, and only HPV DNA has the longitudinal data to support the safety of a negative result. 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 (hrHPV) types in a single analysis.

 

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)3
  • 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

 

 

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 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 Cell Collection Medium, PreservCyt®Solution (Hologic Corp) and BD SurePath™ Preservative Fluid (BD Diagnostics-TriPath).

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).

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 Cell Collection Medium, PreservCyt®Solution (Cytyc Corp.) and 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 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 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, Canada-IVD; US-IVD 

cobas® HPV for 6800/8800 Systems, CE-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.

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

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