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.
The cobas® HPV Test is FDA-approved to simultaneously provide individual results on the highest-risk genotypes – HPV 16 and HPV 18 – and a pooled result on the twelve other high-risk HPV (hrHPV) 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 the physician useful details upon which to make effective treatment decisions.1
By identifying hrHPV genotypes 16 and 18 with the cobas® HPV Test, labs can provide the information that physicians need to manage their patients with greater precision and efficiency for cervical cancer prevention.
The cobas® HPV Test gives labs the confidence to deliver reliable hrHPV test results—mitigating 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.2,3,4,5 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.6
The cobas® HPV Test is designed to increase patient safety by reducing the risk of false negative and false positive results with several test features:
No cross-reactivity: The cobas® HPV Test is a FDA-approved test that demonstrates no cross-reactivity with low-risk HPV genotypes, helping ensure that a positive result is a true positive. Cross-reactivity with low-risk HPV genotypes can produce false-positive results, which could lead to unnecessary colposcopy.7
Internal cellular control: A true negative result using the cobas® HPV Test will show a negative result for HPV, but will always show the presence of human ß-globin from the patient’s cells. The internal cellular control monitors the presence of human cells and the completion of the entire test process. According to the ASCCP management guidelines released in March 2013, HPV tests that lack internal controls to detect cellularity cannot be relied upon as the HPV test may by falsely negative because of an insufficient sample.8
Proprietary kinetic algorithm: The cobas® HPV Test is processed on the cobas® 4800 System, which applies an advanced algorithm to each sample to remove outliers and increase the number of true positive test results. This proprietary algorithm is based upon 15 years of proven clinical experience and eliminates the need for manual interpretations.
No bleaching or alcohol: The AmpErase® enzyme protects against cross-contamination, and provides full confidence in results, which eliminates laborious and time-consuming decontamination processes requiring the use of hazardous substances that can harm skin and clothing, and require special handling for disposal.7,9,10,11
Small 1 mL sample size: Using a test with a small sample requirement helps eliminate the inconvenience of patient call-backs due to Quantity Not Sufficient (QNS) results from the laboratory.7
2 controls per run: Only 1 positive and 1 negative control is required per run of 96 samples of the cobas® HPV Test, which provides confidence in results, while maximizing the number of patient reportables generated for clinicians.7
Detection of HPV DNA: The cobas® HPV Test detects DNA. Guideline-creating organizations, such as ACOG, ACS, ASCCP, and NCCN, base their screening guidelines on results obtained from an HPV DNA test.6,7
L1 Gene Target: The cobas® HPV Test targets an L1 region for DNA because L1 genes are 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.
No grey zones, indeterminate results, or repeats required: The cobas® 4800 System expert software manages result calculations and provides only positive, negative, or invalid patient result options without the need for a repeat testing algorithm.7
Polymerase Chain Reaction (PCR) technology: The PCR technology used by the cobas® HPV Test is clinically validated by the ATHENA study. PCR has a proven track record as the right technology for molecular screening tests and has been utilized to establish the causal link between HPV and cervical cancer.
No manual adjustment of clinical cutoffs: The cobas® 4800 System software does not allow manual adjustment of clinical cutoffs.7 Therefore, labs do not have to accept unnecessary risk by adjusting clinical cutoffs and deviating from FDA-approved test performance.
The cobas® HPV Test meets the preferred hrHPV testing options from the current clinical guidelines in one single test. Learn more about U.S. cervical cancer screening guidelines.
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. 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.
3. 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.
4. Price of Procedures and Patient Responsibility. Virginia Mason Patient & Visitor Information.https://www.virginiamason.org/PriceofProceduresandPatientResponsibility#1. Accessed April 8, 2013.
5. Centers for Medicare and Medicaid Services Website. http://www.cms.gov/Medicare/Medicare.html. Accessed April 24, 2013.
6. 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.
7. cobas® HPV Test [package insert, US]. Branchburg, NJ: Roche Molecular Systems, Inc; 2016.
8. Massad, L et al. 2012 Updated Consensus Guidelines for the Management of Abnormal Cervical Cancer Screening Tests and Cancer Precursors. Journal of Lower Genital Tract Disease. 2013;17(5):S1-S27.
9. Cervista HPV HR [package insert, US]. Madison, WI: Third Wave Technologies, Inc; 2009.
10. Hybrid Capture 2 High-Risk HPV DNA Test [package insert, US]. Gaithersburg, MD: Digene Corporation; 2004.
11. APTIMA HPV Assay [package insert, US]. San Diego, CA: Gen-Probe Incorporated; 2016.