Evaluation of HPV-16 and HPV-18 Genotyping for the Triage of Women With High-Risk HPV+ Cytology- Negative Results

• Published in: American journal of clinical pathology Vol. 136; no. 4; pp. 578 - 586
• Main Authors: WRIGHT, Thomas C, STOLER, Mark H, SHARMA, Abha, GUILI ZHANG, BEHRENS, Catherine, WRIGHT, Teresa L
• Format: Journal Article
• Language: English
• Published: Chicago, IL American Society of Clinical Pathologists 01.10.2011; Oxford University Press
• Subjects: Adult; Biological and medical sciences; Cervical Intraepithelial Neoplasia - pathology; Cervical Intraepithelial Neoplasia - virology; Colposcopy; Cross-Sectional Studies; Early Detection of Cancer - methods; Female; Female genital diseases; Genotype; Gynecology. Andrology. Obstetrics; Human papillomavirus 16 - genetics; Human papillomavirus 18 - genetics; Humans; Investigative techniques, diagnostic techniques (general aspects); Mass Screening - methods; Medical sciences; Papillomavirus Infections - complications; Papillomavirus Infections - epidemiology; Papillomavirus Infections - virology; Pathology. Cytology. Biochemistry. Spectrometry. Miscellaneous investigative techniques; Polymerase Chain Reaction; Prevalence; Tumors; Uterine Cervical Neoplasms - pathology; Uterine Cervical Neoplasms - virology; Vaginal Smears; High risk; Cytology; Malignancy; Papovaviridae; Human papillomavirus 18; HPV DNA testing; Papillomavirus; Human papillomavirus 16; Negative result; Human papillomavirus; Cervical dysplasia; Adjunct testing; Cervical intraepithelial neoplasia; NILM; Adult; Female; Woman; Human; Evaluation; Premalignant lesion; Typing; Genotype; Malignant tumor; Medical screening; Female genital diseases; Virus; Cervical cancer screening; Negative for intraepithelial lesions or malignancy; DNA; Intraepithelial neoplasia; Uterine cervix diseases; Cervical cancer; Cancer
• ISSN: 0002-9173; 1943-7722
• DOI: 10.1309/AJCPTUS5EXAS6DKZ

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.