Comparison of the Roche Cobas(®) 4800 HPV assay to Digene Hybrid Capture 2, Roche Linear Array and Roche Amplicor for Detection of High-Risk Human Papillomavirus Genotypes in Women undergoing treatment for cervical dysplasia

Samuel Phillips; Suzanne M Garland; Jeffery H Tan; Michael A Quinn; Sepehr N Tabrizi

doi:10.1016/j.jcv.2014.11.017

Comparison of the Roche Cobas(®) 4800 HPV assay to Digene Hybrid Capture 2, Roche Linear Array and Roche Amplicor for Detection of High-Risk Human Papillomavirus Genotypes in Women undergoing treatment for cervical dysplasia

J Clin Virol. 2015 Jan:62:63-5. doi: 10.1016/j.jcv.2014.11.017. Epub 2014 Nov 18.

Authors

Samuel Phillips¹, Suzanne M Garland², Jeffery H Tan³, Michael A Quinn³, Sepehr N Tabrizi⁴

Affiliations

¹ Regional HPV Lab Net Reference Laboratory, Department of Microbiology and Infectious Diseases, The Royal Women's Hospital, Parkville, Victoria, Australia; Murdoch Childrens Research Institute, Parkville, Victoria 3052, Australia.
² Regional HPV Lab Net Reference Laboratory, Department of Microbiology and Infectious Diseases, The Royal Women's Hospital, Parkville, Victoria, Australia; Department of Obstetrics and Gynecology, University of Melbourne, Victoria, Australia; Murdoch Childrens Research Institute, Parkville, Victoria 3052, Australia.
³ Department of Obstetrics and Gynecology, University of Melbourne, Victoria, Australia; Oncology and Dysplasia Unit, Royal Women's Hospital, Parkville, Victoria, Australia.
⁴ Regional HPV Lab Net Reference Laboratory, Department of Microbiology and Infectious Diseases, The Royal Women's Hospital, Parkville, Victoria, Australia; Department of Obstetrics and Gynecology, University of Melbourne, Victoria, Australia; Murdoch Childrens Research Institute, Parkville, Victoria 3052, Australia. Electronic address: sepehr.tabrizi@thewomens.org.au.

PMID: 25542473
DOI: 10.1016/j.jcv.2014.11.017

Abstract

Background: The recently FDA (U.S. food and drug administration) approved Roche Cobas(®) 4800 (Cobas) human papillomavirus (HPV) has limited performance data compared to current HPV detection methods for test of cure in women undergoing treatment for high grade lesions.

Objective: Evaluation of Cobas HPV assay using historical samples from women undergoing treatment for cervical dysplasia.

Study design: A selection of 407 samples was tested on the Cobas assay and compared to previous results from Hybrid Capture 2, HPV Amplicor and Roche Linear Array.

Results: Overall, a correlation between high-risk HPV positivity and high grade histological diagnosis was 90.6% by the Cobas, 86.1% by Hybrid Capture 2, 92.9% by HPV Amplicor and 91.8% by Roche Linear Array.

Conclusion: The Cobas HPV assay is comparative to both the HPV Amplicor and Roche Linear Array assays and better than Hybrid capture 2 assay in the detection of High-Risk HPV in women undergoing treatment for cervical dysplasia.

Keywords: Amplicor; Diagnostic; Human papillomavirus; Hybrid capture; Linear array; Roche Cobas.

MeSH terms

Antiviral Agents / therapeutic use
DNA, Viral
Female
Genotype
Humans
Papillomaviridae / genetics*
Papillomavirus Infections / diagnosis*
Papillomavirus Infections / drug therapy
Papillomavirus Infections / virology*
Reagent Kits, Diagnostic / standards*
Real-Time Polymerase Chain Reaction / methods
Reproducibility of Results
Sensitivity and Specificity
Uterine Cervical Dysplasia / diagnosis*
Uterine Cervical Dysplasia / drug therapy
Uterine Cervical Dysplasia / pathology
Uterine Cervical Dysplasia / virology*

Substances

Antiviral Agents
DNA, Viral
Reagent Kits, Diagnostic