cobas^® HPV

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 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.

Benefits and Features

Only the cobas^® HPV Test is clinically validated for use in both ThinPrep® PreservCyt® and SurePath™ sample collection media, and HPV DNA tests have extensive longitudinal data to support the safety of a negative result. 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 (hrHPV) types in a single analysis. To ensure confidence in a negative result, each 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.
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 HPV²
Validated to the standards set forth in international guidelines for HPV testing for cervical screening purposes^1,3,4

Intended use

CE-IVD (cobas^® 4800 System)

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).

CE-IVD (cobas^® 5800/6800/8800 Systems)

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-IVDR

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

Package inserts

Access package inserts through Roche DiaLog.

References

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

²Khan 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.

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

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.

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^® 5800/6800/8800 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, 6h for the cobas 5800 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

Related systems

cobas^® 6800 System

Transform your testing experience for IVD applications—just 2 simple user interactions per run and up to 8 hours of walk-away time.

cobas^® 8800 System

Unparalleled performance with minimal operator interaction revolutionises the future of high-throughput applications.

cobas^® 5800 System

Making molecular diagnostics accessible to more labs, even where space is limited.

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.

Learn more about Roche’s Molecular Work Area

Transform your lab with the simplicity, efficiency and flexibility of the Molecular Work Area from Roche–proven performance with a clear path to success.

cobas® HPV

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