title: Evaluation of HPV-16 and HPV-18 genotyping for the triage of women with high-risk HPV+ cytology-negative results.
abstract: The ATHENA (Addressing THE Need for Advanced HPV Diagnostics) HPV study evaluated the clinical usefulness of the cobas HPV Test (Roche Molecular Systems, Pleasanton, CA) for high-risk human papillomavirus (HR-HPV) testing (14 HR types) and individual HPV-16/HPV-18 genotyping in women undergoing routine cervical cytology screening in the United States. For the study, 47,208 women were recruited, including 32,260 women 30 years or older with negative cytology. All women with positive results for HR-HPV (n = 4,219) plus a subset of HR-HPV- women (n = 886) were referred for colposcopy and biopsy. The overall prevalence of HR-HPV was 6.7% and of HPV-16/HPV-18 was 1.5%. Cervical intraepithelial neoplasia grade 2 (CIN 2) or worse was found in 1.2% of women examined. The estimated absolute risk of CIN 2 or worse in HPV-16+ and/or HPV-18+ women was 11.4% (95% confidence interval [CI], 8.4%-14.8%) compared with 6.1% (95% CI, 4.9%-7.2%) in HR-HPV+ and 0.8% (95% CI, 0.3%-1.5%) in HR-HPV- women. These analyses validate the 2006 American Society of Colposcopy and Cervical Pathology guidelines for HPV-16/HPV-18 genotyping, which recommend referral to colposcopy of HPV-16/HPV-18+ women with negative cytology.
authors.affiliation: Department of Pathology, Columbia University School of Medicine, New York, NY, USA.
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Wright
authors.forename: Mark H
authors.initials: MH
authors.lastname: Stoler
authors.forename: Abha
authors.initials: A
authors.lastname: Sharma
authors.forename: Guili
authors.initials: G
authors.lastname: Zhang
authors.forename: Catherine
authors.initials: C
authors.lastname: Behrens
authors.forename: Teresa L
authors.initials: TL
authors.lastname: Wright
mesh_terms: D000328:Adult; D003127:Colposcopy; D003430:Cross-Sectional Studies; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D005838:Genotype; D052162:Human papillomavirus 16 / Q000235:genetics; D052161:Human papillomavirus 18 / Q000235:genetics; D006801:Humans; D008403:Mass Screening / Q000379:methods; D030361:Papillomavirus Infections / Q000150:complications / Q000453:epidemiology / Q000821:virology*; D016133:Polymerase Chain Reaction; D015995:Prevalence; D002583:Uterine Cervical Neoplasms / Q000473:pathology / Q000821:virology*; D014626:Vaginal Smears; D002578:Uterine Cervical Dysplasia / Q000473:pathology / Q000821:virology*