cobas^® HPV

Delivering confidence with every result on cobas^® 4800/5800/6800 Systems

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The cobas^® HPV tests are automated qualitative in vitro tests 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.

Features and benefits

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, Roche Cell Collection Medium and SurePath^™ Preservative 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 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 purposes^2,3,4

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 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).

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

cobas^® HPV for use on the cobas^® 5800/6800/8800 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

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

Package inserts

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

References

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

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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cobas^® 6800 System

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cobas^® 8800 System

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cobas® HPV

Delivering confidence with every result on cobas® 4800/5800/6800 Systems