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  • Lab technician running the cobas 4800 HPV Test

    cobas®  4800 HPV Test

    Risk matters. Deliver 3 results in 1 test for accuracy that your clinical partners expect and that patients deserve      

The progression of cervical cancer disease

The HPV infection process typically occurs in the transformation zone of the cervix.

Human papillomaviruses (HPV) are small, double-stranded DNA viruses. More than 100 HPV types have been identified and they are differentiated by the genetic sequence of the major capsid protein (L1). Of the HPV types, about 40 types of HPV infect the mucosal epithelium and are categorized accordingly to their association with cervical cancer. The typical site of an HPV infection is the transformation zone of the cervix.

Watch this educational video that explains the HPV genome and how HPV infection can progress to cervical cancer.

HPV & CERVICAL CANCER
This video is intended to provide educational information.

The cobas® 4800 HPV Test offers 3 results in 1 test.

Simultaneous HPV 16/18 genotyping enables clinicians to make more informed patient management decisions. 

cobas HPV Test 3 in 1

The cobas® 4800 HPV Test’s “3-in-1” results allow for screening and risk stratification in a single test, eliminating need for reflex genotyping.  

The cobas® 4800 HPV Test is the only assay which meets all of the following criteria:

  • FDA-approved 
  • CE-marked 
  • Clinically validated to international HPV screening guidelines2 
  • Simultaneously provides individual results for HPV 16 and 18 and a pooled result for the twelve other high-risk HPV genotypes, all in one run from one patient sample

HPV 16 and 18 confer a higher risk of having precancerous lesions and cervical cancer than other genotypes, so focusing on HPV 16 and 18 gives clinicians the useful details upon which to make effective treatment decisions.1

By choosing the right HPV test, labs can provide the accurate hrHPV information that clinical partners expect and patients deserve. Learn how the cobas® 4800 HPV Test also provides testing efficiency


The cobas® 4800 HPV Test design provides assurance against false results.  

 

The cobas® 4800 HPV Test mitigates the reporting of false positives and false negatives that can do harm to patients. A false positive result may cause a patient to go through unnecessary treatment, needless emotional burden, and undue financial costs.4,5,6,7 A false negative result may cause a patient to have a false sense of security, which may result in the patient going up to 5 years before being screened again.8

The cobas® 4800 HPV Test is designed to increase patient safety by protecting against false negative and false positive results with several features:

ß-globin internal control: The ß-globin internal control helps prevent false negatives. Each sample is tested for the human ß-globin gene. 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, helping to eliminate false positive results from carry-over contamination by differentiating amplification products from target molecules.

No cross-reactivity: The cobas® 4800 HPV Test demonstrates no cross-reactivity with non-high risk (hr) HPV genotypes, helping to ensure that positive results are clinically meaningful. The cobas® 4800 HPV Test was evaluated against 25 non-targeted HPV genotypes with no false positivity. 

No grey zones, indeterminate results, or need for repeat testing: The cobas® 4800 HPV Test is processed on the cobas® 4800 System, which applies a proprietary kinetic algorithm to each sample to remove outliers and increase the number of true positive test results. This algorithm, based on 15 years of clinical experience, manages result calculations, eliminates the need for manual interpretation and gives precise answers, reporting only positive, negative, or invalid result options.


Help guide clinical decision making with confidence.

 

The cobas® 4800 HPV Test gives laboratories confidence in the test results they report and enables clinicians to rely on the precise and accurate information provided to make critical patient care decisions. 

2 controls per run: Only 1 positive and 1 negative control is required per run of the cobas® 4800 HPV Test, which provides confidence in results, while maximizing the number of patient reportables generated for clinicians.9 Other tests require as many as 8 calibrators and controls. 

Detection of HPV DNA: The cobas® 4800 HPV Test detects DNA, leveraging the proven longitudinal safety and protective benefit of a negative HPV DNA result. Screening guidelines and algorithms have been designed based on the risk levels conveyed by the presence or absence of HPV DNA. In the absence of HPV DNA, there is a very low risk of disease, with ≤1% of women with a negative HPV DNA result developing ≥CIN3 over 10 years.1 Other non-DNA markers have not been demonstrated to convey reduced longitudinal risk of disease. 

Polymerase chain reaction (PCR) technology: The real-time PCR technology used by the cobas® 4800 HPV Test is most proven technology. PCR was used to establish the causal link between HPV and cervical cancer and its performance was clinically validated by the landmark ATHENA trial

L1 gene target: The cobas® 4800 HPV Test targets the L1 region because the L1 gene is well conserved across widely divergent papillomaviruses. In addition, the L1 region has been chosen historically for clinical and research HPV tests as well as HPV vaccines.  

Learn how the cobas® 4800 HPV Test was validated in the ATHENA HPV Clinical Trial

10-year Cumulative Incidence Rate of CIN3 by hrHPV Status


The clearest path to the most meaningful results

Download the brochure to see how the cobas® HPV Test delivers clinical value with workflow efficiencies every step of the way.

Download brochure ›

  • Acronyms:

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. 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. McCaffery K, Waller J, Nazroo J, Wardle J. Social and psychological impact of HPV testing in cervical screening. Sex Transm Infect. 2006; 82(2):169-174.

5. Kinney W, Stoler MH, Castle PE. Special commentary: Patient Safety and the Next Generation of HPV DNA Tests. Am J Clin Pathol. 2010; 134(2):193–199.

6. Price of Procedures and Patient Responsibility. Virginia Mason Patient & Visitor Information.  https://www.virginiamason.org/PriceofProceduresandPatientResponsibility#1. Accessed April 8, 2013.

7. Centers for Medicare and Medicaid Services Website.  http://www.cms.gov/Medicare/Medicare.html. Accessed April 24, 2013.

8. Saslow D, Solomon D, Lawson HW et al. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. Am J Clin Pathol. 2012; 137:516-542. 

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