title: High-risk human papillomavirus testing in women with ASC-US cytology: results from the ATHENA HPV study.
abstract: This study evaluated the clinical performance of the cobas 4800 HPV Test (Roche Molecular Systems, Pleasanton, CA) for high-risk human papillomavirus (HR-HPV) testing with individual HPV-16/HPV-18 genotyping in women 21 years or older with atypical squamous cells of undetermined significance (ASC-US). Women (N = 47,208) were recruited in the United States during routine screening, and liquid-based cytology and HPV testing were performed. The ASC-US prevalence was 4.1% (1,923/47,208), and 1,578 women underwent colposcopy with valid results. The cobas 4800 HPV Test demonstrated performance comparable to the Hybrid Capture 2 test (QIAGEN, Gaithersburg, MD) for the detection of cervical intraepithelial neoplasia (CIN) grade 2 or worse and grade 3 or worse. HPV-16/HPV-18+ women had a greater absolute risk of CIN 2 or worse compared with pooled HR-HPV+ and HR-HPV- women (24.4%, 14.0%, and 0.8%, respectively). The cobas 4800 HPV Test is clinically validated for ASC-US triage. HPV-16/HPV-18 genotyping can identify women at highest risk for high-grade cervical disease, and this additional risk stratification may be used in formulating patient management decisions.
authors.affiliation: University of Virginia Health System, Charlottesville, USA.
authors.forename: Mark H
authors.initials: MH
authors.lastname: Stoler
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Wright
authors.forename: Abha
authors.initials: A
authors.lastname: Sharma
authors.forename: Raymond
authors.initials: R
authors.lastname: Apple
authors.forename: Karen
authors.initials: K
authors.lastname: Gutekunst
authors.forename: Teresa L
authors.initials: TL
authors.lastname: Wright
mesh_terms: D000328:Adult; D000368:Aged; D002584:Cervix Uteri / Q000473:pathology / Q000821:virology; D003127:Colposcopy; D004279:DNA, Viral / Q000032:analysis; D005260:Female; D052162:Human papillomavirus 16 / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D052161:Human papillomavirus 18 / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D008403:Mass Screening / Q000379:methods; D008875:Middle Aged; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology; D018570:Risk Assessment; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000821:virology; D014626:Vaginal Smears; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000821:virology
chemical_list: D004279:DNA, Viral