Skip Navigation LinksHome > January 2013 - Volume 17 - Issue 1 > High-Risk Human Papillomavirus Detection in Women With Low-G...
Journal of Lower Genital Tract Disease:
doi: 10.1097/LGT.0b013e31824ddbe0
Original Articles

High-Risk Human Papillomavirus Detection in Women With Low-Grade Squamous Intraepithelial Lesions or Higher-Grade Cytology Using the Cervista HPV HR Test

Gold, Michael A. MD1; Thomas, Michael A. MD2; Huh, Warner K. MD3; Sarto, Gloria E. MD4; Day, Stephen P. PhD5

Collapse Box

Abstract

Objective: High-risk human papillomavirus (HR-HPV) persistence is thought to be necessary for the development of cervical cancer. Because not all cases of low-grade squamous intraepithelial lesion (LSIL) or higher-grade squamous intraepithelial lesion are associated with HR-HPV, detection of HR-HPV in women with these cervical abnormalities may be clinically useful for management. The aim of this study was to detect HR-HPV in women with LSIL or higher-grade cytology.

Materials and Methods: In a multicenter, prospective clinical study, residual liquid-based cytological specimens from 3,966 US women were analyzed. Women with LSIL or higher-grade cytology underwent colposcopy and cervical biopsy as clinically indicated. The test was used to detect HR-HPV in women with cytologically diagnosed LSIL or higher, with histological confirmation of cervical intraepithelial neoplasia 2 (CIN 2) or worse by a central review panel.

Results: Among subjects with LSIL or higher-grade cytology and complete data sets, 11.8% (41/347) were diagnosed with CIN 2 or worse; 82.1% (285/347) were HR-HPV positive. The prevalence of CIN 2 or worse and CIN 3 or worse was 14.4% (41/285) and 7.0% (20/285), respectively, among subjects who were HR-HPV positive. All subjects diagnosed with CIN 2 or worse (41/41) and CIN 3 or worse (20/20) tested positive for HR-HPV. Sensitivity and negative predictive value calculated for CIN 2 or worse were 100% (95% CI = 91.4%–100.0%) and 100% (95% CI = 94.2%–100.0%), respectively. Specificity and positive predictive value among these subjects were 20.3% (95% CI = 16.1%–25.1%) and 14.4% (95% CI = 10.8%–18.9%), respectively.

Conclusions: Detection of HR-HPV in women with LSIL or higher-grade cytology using the HPV HR test may allow clinicians to further triage women for advanced clinical management.

©2013The American Society for Colposcopy and Cervical Pathology

Login

Article Tools

Share

Search for Similar Articles
You may search for similar articles that contain these same keywords or you may modify the keyword list to augment your search.