Prevalence of human papillomavirus in 5,072 consecutive cervical SurePath samples evaluated with the Roche cobas HPV real-time PCR assay

PLoS One. 2013;8(3):e59765. doi: 10.1371/journal.pone.0059765. Epub 2013 Mar 22.

Abstract

New commercially available Human Papillomavirus (HPV) assays need to be evaluated in a variety of cervical screening settings. Cobas HPV Test (cobas) is a real-time PCR-based assay allowing for separate detection of HPV genotypes 16 and 18 and a bulk of 12 other high-risk genotypes. The aim of the present study, Horizon, was to assess the prevalence of high-risk HPV infections in an area with a high background risk of cervical cancer, where women aged 23-65 years are targeted for cervical screening. We collected 6,258 consecutive cervical samples from the largest cervical screening laboratory in Denmark serving the whole of Copenhagen. All samples were stored in SurePath media. In total, 5,072 samples were tested with cobas, Hybrid Capture 2 High Risk HPV DNA test (HC2) and liquid-based cytology. Of these, 27% tested positive on cobas. This proportion decreased by age, being 43% in women aged 23-29 years and 10% in women aged 60-65 years. HC2 assay was positive in 20% of samples, and cytology was abnormal (≥ atypical squamous cells of undetermined significance) for 7% samples. When only samples without recent abnormalities were taken into account, 24% tested positive on cobas, 19% on HC2, and 5% had abnormal cytology. The proportion of positive cobas samples was higher than in the ATHENA trial. The age-standardized cobas positivity vs. cytology abnormality was 3.9 in our study and 1.7 in ATHENA. If in Copenhagen the presently used cytology would be replaced by cobas in women above age 30 years, an extra 11% of women would based on historical data be expected to have a positive cobas test without an underlying cervical intraepithelial lesion grade 3 or worse. Countries with a high prevalence of HPV infections should therefore proceed to primary HPV-based cervical screening with caution.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Cervix Uteri / pathology*
  • Cervix Uteri / virology*
  • Female
  • Humans
  • Middle Aged
  • Papillomaviridae / genetics*
  • Papillomaviridae / pathogenicity
  • Real-Time Polymerase Chain Reaction
  • Uterine Cervical Neoplasms / diagnosis
  • Uterine Cervical Neoplasms / prevention & control

Grant support

Sarah Preisler and Matejka Rebolj: Danish Strategic Research Council. Elsebeth Lynge: University of Copenhagen and Olga and Esper Boel’s Fund. Roche Diagnostics, the manufacturer of the cobas HPV Test and the cobas®4800 HPV test instrumentation, and Qiagen, the manufacturer of the Hybrid Capture 2 assay, provided assays and instrumentations for the study. None of the funders had any role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The researchers worked independently of the funders.