Search
User Profile
Change
Select your user profile

cobas® HPV

Product image for cobas® 4800 HPV Amplification/Detection Kit and cobas® HPV Qualitative nucleic acid test for use on the cobas® 6800/8800 Systems

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

Powered by PCR

 

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.

Infographic: Testing for mutations in colorectal cancer

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 purposes2,3,4

 

 

Contact Us
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).

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

 

 
  1. cobas® 4800 HPV Test [package insert, CE]. Branchburg, NJ: Roche Molecular Systems, Inc; 2012.
  2. 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.
  3. 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.
  4. 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

Related assays

IVD For in vitro diagnostic use.
MagNA Pure 24 Instrument
MagNA Pure 24 Instrument A fully-automated clinical nucleic acid extraction system that brings you walkaway automation for up to 24 samples. The MagNA Pure 24 System is a fully automated clinical sample extractor. It extracts nucleic acids from various sample types, sample tubes, and volume inputs for multiple downstream applications.The main features of the system are:Scalable purification of 1 to 24 samplesPrimary/secondary tube handlingInventory and sample management via barcodesEfficient order management via host
IVD For in vitro diagnostic use.
MagNA Pure 96 Instrument
MagNA Pure 96 Instrument High-throughput robotic workstation for fully automated purification of nucleic acids from up to 96 samples. Magnetism is the underlying principle of the automated nucleic acid isolation performed by the highthroughput MagNA Pure 96 System. The MagNA Pure 96 Instrument performs automated nucleic acid purification from samples of up to 1000 μl that are pipetted into a 96-well processing cartridge. It comprisesa magnetic glass particles (MGP) based purification process as well as protocols that support isolation of RNA, DNA and tNA from different sample materials. The MagNA Pure 96 System permits automated nucleic acid purification that matches the high standards of speed, accuracy and reliability in PCR/ RT-PCR of the LightCycler® Systems.
IVD For in vitro diagnostic use.
cobas® 6800 System
cobas® 6800 System Embrace the future of molecular testing with proven PCR performance. Learn about the cobas® 6800 System’s broad menu of high-quality assays, including HIV, HPV, CT/NG, Hepatitis, CMV, WNV, respiratory infections, and more!
cobas® SARS-CoV-2
cobas® SARS-CoV-2
Product image for cobas® CT/NG
cobas® CT/NG
cobas® TV/MG box
cobas® ️TV/MG
SARS_Influenza_AB
cobas® SARS-CoV-2 &
Influenza A/B Assay
Product image for cobas® CMV
cobas® CMV
Product image for COBAS® TaqMan® MTB Test
COBAS® TaqMan® MTB Test
Product image for cobas® HIV-1/HIV-2 Qualitative Test
cobas® HIV-1/HIV-2 Qualitative Test
Product image for cobas® HIV-1 Test
cobas® HIV-1 Test
Product image for cobas® HCV Test
cobas® HCV Test
cobas® HBV Test
cobas® HBV Test
Image cobas® MPX assay for the detection of HIV, HCV, and HBV in donated blood
cobas® MPX
cobas® TaqScreen MPX test, v2.0 rapid testing kit for HIV, HCV and HBV
cobas® TaqScreen MPX Test, v2.0
cobas CV DV
cobas® CHIKV/DENV
Image of cobas® HEV assay for the detection of HEV in donated blood
cobas® HEV
Image of cobas® WNV assay for the detection of West Nile Virus in donated blood
cobas® WNV
Image of cobas® DPX assay for the detection of parvovirus B19 and HAV in donated blood
cobas® DPX
IVD For in vitro diagnostic use.
cobas® Liat® System
cobas® Liat® Analyzer Bring accurate and reliable PCR results to the POC, enabling answers patients and clinicians need in 20 minutes or less to support triage and patient management.
IVD For in vitro diagnostic use.
cobas® 5800 System
cobas® 5800 System The cobas® 5800 System makes automation, consolidation, integration and standardization more accessible than ever before.
IVD For in vitro diagnostic use.
LightCycler® PRO System
LightCycler® PRO System LightCycler® PRO integrates innovative technology and Roche manufacturing to deliver accurate real-time PCR results
IVD For in vitro diagnostic use.
digital lightcycler product thumbnail
Digital LightCycler® System Unleash the true power of digital PCR
IVD For in vitro diagnostic use.
cobas omni Utility Channel
cobas omni Utility Channel For use on the cobas® 5800/6800/8800 Systems Consolidate and automate IVD and LDTs on one platform with the cobas omni Utility Channel—maximise laboratory space, minimise capital investment, and decrease operational costs.
IVD For in vitro diagnostic use.
<b>cobas<sup>®</sup> eplex</b> system
cobas® eplex system The cobas eplex system integrates the entire process from order-to-report to better realize the patient and laboratory benefits of rapid, multiplex molecular diagnostics.
IVD For in vitro diagnostic use.
cobas® eplex blood culture identification Fungal Pathogen (BCID-FP) panel
cobas® eplex blood culture identification fungal pathogen (BCID-FP) panel The cobas® eplex blood culture identification (BCID) panels deliver the most comprehensive solution for testing patients suspected of bloodstream infections and sepsis, including patients with COVID-19.
IVD For in vitro diagnostic use.
cobas® eplex blood culture identification Fungal Pathogen panel
cobas® eplex blood culture identification gram-positive (BCID-GP) panel The cobas® eplex blood culture identification (BCID) panels deliver the most comprehensive solution for testing patients suspected of bloodstream infections and sepsis, including patients with COVID-19.
IVD For in vitro diagnostic use.
cobas® eplex blood culture identification Gram-Negative panel
cobas® eplex blood culture identification gram-negative (BCID-GN) panel The cobas® eplex blood culture identification (BCID) panels deliver the most comprehensive solution for testing patients suspected of bloodstream infections and sepsis, including patients with COVID-19.

Related systems

cobas 5800 system

cobas® 5800 System

Based on Roche's Molecular Work Area concept, the cobas® 5800 System comes in a compact size, delivering premium performance and value-added utility from a small footprint.

More
cobas® 6800 System image

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.

More
cobas® 8800 System image

cobas® 8800 System

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

More