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cobas® HPV

cobas® HPV Test image

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

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

 

 

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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
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 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.

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 (HR) 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 Roche Cell Collection Medium (Roche Molecular Systems, Inc.), cobas® PCR Cell Collection Media (Roche Molecular Systems, Inc.), PreservCyt® Solution (Cytyc Corp.) and SurePath™ Preservative Fluid (BD Diagnostics-TriPath).

Indications for use of the cobas® 4800 HPV Test are:

(a) The cobas® 4800 HPV Test is indicated for use in screening patients 21 years and older with ASC-US (atypical squamous cells of undetermined significance) cervical cytology results to determine the need for referral to colposcopy.

(b) The cobas® 4800 HPV Test is indicated for use in screening patients 21 years and older with ASC-US cervical cytology results, to assess the presence or absence of high-risk HPV genotypes 16 and 18.

(c) The cobas® 4800 HPV Test is indicated for use in patients 30 years and older adjunctively with cervical cytology to assess the presence or absence of high risk HPV types.

(d) The cobas® 4800 HPV Test is indicated for use in patients 30 years and older adjunctively with cervical cytology to assess the presence or absence of HPV genotypes 16 and 18. 

(e) The cobas® 4800 HPV Test is indicated for use as a first-line primary screening test in patients 25 years and older to identify women at increased risk for the development of cervical cancer or presence of high-grade disease. 

(f) The cobas® 4800 HPV Test is indicated for use as a first-line primary screening test in patients 25 years and older to assess the presence or absence of HPV genotypes 16 and 18.  

(g) The results from the cobas® 4800 HPV Test, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of the cobas® HPV Test are not intended to prevent women from proceeding to colposcopy.

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, Roche Cell Collection Medium and SurePath™ Preservative Fluid.

cobas® HPV for use on the cobas® 6800/8800 Systems (cobas® HPV) 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. This test detects the high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68.

cobas® HPV 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. 

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 Roche Cell Collection Medium (Roche Molecular Systems, Inc.), cobas® PCR Cell Collection Media (Roche Molecular Solutions, Inc.), PreservCyt® Solution (Hologic Corp.) and SurePath™ Preservative Fluid (BD Diagnostics-TriPath).

Indications for use of cobas® HPV are:

(a) In women 25 years and older, cobas® HPV is indicated for use in screening patients with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results to determine the need for referral to colposcopy.

(b) In women 25 years and older, cobas® HPV is indicated for use in screening patients with ASC-US cervical cytology results to assess the presence or absence of HR HPV genotypes 16 and 18.

(c) In women 30 years and older, cobas® HPV is indicated for use adjunctively with cervical cytology to assess the presence or absence of HR HPV types.

(d) In women 30 years and older, cobas® HPV is indicated for use adjunctively with cervical cytology to assess the presence or absence of HPV genotypes 16 and 18.

(e) In women 25 years and older, cobas® HPV is indicated for use as a first-line primary screening test to identify women at increased risk for the development of cervical cancer or presence of high-grade disease.

(f) In women 25 years and older, cobas® HPV is indicated for use as a first-line primary screening test to assess the presence or absence of HPV genotypes 16 and 18.

(g) The results from cobas® HPV, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of cobas® HPV are not intended to prevent women from proceeding to colposcopy.

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

cobas® HPV for 5800/6800/8800 Systems, CE-IVD

Package inserts

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

Experience the efficiency of the cobas® 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.

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

Related products

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.

Learn more about cobas® 4800 Systems

Learn more about cobas® 6800 Systems

Learn more about cobas® 8800 Systems

 

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    References

    1. Khan 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.
    2. Bosch FX, de Sanjosé S. Human papillomavirus and cervical cancer — burden and assessment of causality. J Natl Cancer Inst Monogr. 2003;31:3-13.
    3. cobas® 4800 HPV Test [package insert, CE]. Branchburg, NJ: Roche Molecular Systems, Inc; 2012.
    4. 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.
    5. 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.
    6. 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.
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