Age-stratified performance of the Cervista HPV 16/18 genotyping test in women with ASC-US cytology

Cancer Epidemiol Biomarkers Prev. 2011 Jun;20(6):1185-9. doi: 10.1158/1055-9965.EPI-11-0116. Epub 2011 Apr 28.

Abstract

Background: The objective of this study was to evaluate the clinical performance of the Cervista HPV 16/18 genotyping test for detection of human papilloma virus (HPV) 16 and 18 in cervical cytology specimens in women stratified by age.

Methods: In a multicenter, prospective clinical study, ThinPrep specimens were tested for the presence of HPV 16 and 18 using the HPV 16/18 genotyping test. Genotyping results from women with atypical squamous cells of undetermined significance or greater cytology were compared with local colposcopy and/or histology results. Sensitivity, specificity, and negative and positive predictive values (NPV and PPV) were determined.

Results: The prevalence of cervical intraepithelial neoplasia (CIN) 2(+) in subjects positive for HPV 16/18 was 6.6% and 4.1% for women <30 and ≥30 years of age, respectively. The sensitivity of the test was 70.0% (95% CI: 54.6-81.9) and 66.7% (95% CI: 46.7-82.0) in women <30 and ≥30 years, respectively. The NPV was 95.5% (95% CI: 93.4-97.6) in women <30 years and 96.6% (95% CI: 94.8-98.5) in women ≥30 years. Specificity was higher in women ≥30 years (79.9%; 95% CI: 74.9-84.2) than women <30 years (61.9%; 95% CI: 57.1-66.4). The PPV was 15.2% (95% CI: 12.7-19.1) in women <30 years and 21.9% (95% CI: 17.0-30.7) in women ≥30 years.

Conclusions: The performance of the Cervista HPV 16/18 genotyping test for predicting ≥CIN 2 is what would be expected across the key ≥CIN 2 age strata.

Impact: HPV 16/18 genotyping may help further stratify women with a greater potential to develop cervical cancer.

Publication types

  • Comparative Study
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Age Factors
  • Aged
  • Aged, 80 and over
  • Carcinoma, Squamous Cell / diagnosis
  • Carcinoma, Squamous Cell / genetics
  • Carcinoma, Squamous Cell / virology*
  • Case-Control Studies
  • Cervix Uteri / pathology*
  • Cohort Studies
  • Colposcopy
  • Cytodiagnosis*
  • DNA, Viral / genetics
  • Female
  • Follow-Up Studies
  • Human papillomavirus 16 / genetics
  • Human papillomavirus 16 / isolation & purification
  • Human papillomavirus 18 / genetics
  • Human papillomavirus 18 / isolation & purification
  • Humans
  • Middle Aged
  • Papillomavirus Infections / diagnosis
  • Papillomavirus Infections / genetics
  • Papillomavirus Infections / virology*
  • Prognosis
  • Prospective Studies
  • Uterine Cervical Dysplasia / diagnosis
  • Uterine Cervical Dysplasia / genetics
  • Uterine Cervical Dysplasia / virology*
  • Uterine Cervical Neoplasms / diagnosis
  • Uterine Cervical Neoplasms / genetics
  • Uterine Cervical Neoplasms / virology*
  • Vaginal Smears

Substances

  • DNA, Viral