cobas^® 4800 HPV Test, a real-time polymerase chain reaction assay for the detection of human papillomavirus in cervical specimens

Abstract

Cervical cancer screening incorporating high-risk human papillomavirus (HPV) detection has become the preferred screening strategy in some countries and is increasingly more widespread in other countries with organized or opportunistic screening programs. Given knowledge that high-risk HPV genotypes differ in their oncogenic potential, commercial HPV assays with genotyping capabilities have been developed and have garnered attention in the recent literature. The cobas^® 4800 HPV Test is a qualitative multiplex assay that provides specific genotyping information for HPV types 16 and 18, while concurrently detecting 12 other high-risk HPV genotypes as a pooled result. It is currently the only clinically validated, US FDA-approved assay with this capability. Since HPV types 16 and 18 have been designated as conferring the greatest risk for cervical disease, their detection may prove useful in guiding patient management.

Keywords::

• cervical cancer
• cobas^® 4800 HPV Test
• diagnostic test
• genotyping
• HPV testing
• HPV DNA
• human papillomavirus
• PCR
• screening

Financial & competing interests disclosure

F Coutlée has received grants through his institution from Merck Sharp & Dohme and Roche Diagnostics, as well as honoraria from Merck and Roche for lectures. EL Franco has served as occasional consultant or advisory board member to Merck and GSK on HPV vaccines, to Qiagen, Roche, GenProbe and Becton & Dickinson on HPV diagnostics, to Cytyc and Ikonisys on cytology and to Innovus and Scimetrika on health economic modeling. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending or royalties.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Persistent infection with high-risk human papillomaviruses (HPVs) causes over 99% of cervical cancers worldwide.

• HPV testing has demonstrated greater reliability and sensitivity for detecting cervical disease than cytology-based testing, and has been recommended for use in cervical cancer screening in several industrialized countries.

• Over 100 distinct tests for the detection of oncogenic HPVs are now commercially available.

• The introduction of HPV testing raises concerns regarding how best to manage women who are HPV-positive while cytology-negative.

• Given the exceptional oncogenic potential of HPV types 16 and 18, HPV tests with partial concurrent or reflex genotyping capabilities to detect these types have been developed as a means to further stratify HPV-positive women according to risk, and avoid over-screening and over-treatment.

• The cobas^® 4800 HPV Test is one such HPV test that provides specific genotyping results for HPV types 16 and 18, along with a pooled result for 12 other oncogenic types.

• The cobas 4800 HPV Test is an in vitro qualitative real-time PCR assay that is performed using the cobas 4800 System, which includes fully automated specimen preparation, amplification and detection of viral nucleic acid, and automated reportable test results.

• The test has demonstrated favorable clinical performance in a large, prospective trial (the ATHENA Study), as well as in numerous comparative studies. It is the first test of its kind to be US FDA-approved.

• The benefits of incorporating HPV testing and genotyping into practice will require a well-organized screening program with optimal compliance.

Notes