High-risk HPV DNA detection by hybrid capture II - An adjunctive test for mildly abnormal cytologic smears in women >= 50 years of age

OBJECTIVE: To determine whether high-risk human papillomavirus (HPV) DNA te sting could improve the detection of cervical intraepithelial neoplasia (CI N) and cancer in older women (greater than or equal to 50 years old) with m ildly abnormal results on conventional cytology. STUDY DESIGN: The study was based an 119 patients aged over 50 (median, 62; range, 50-78) referred for colposcopy with Pap smears reported as atypical squamous cells of undetermined significance (ASCUS) or low grade squamous intraepithelial lesion (LSIL) from February 1997 to September 1998. The pre sence of high-risk HPV DNA (including HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68) was determined with the Hybrid Capture II (Dige ne, Inc., Silver Spring, Maryland) microplate method. Cytologic examination by Pap smear was based on the Bethesda System and, cervical biopsy was non e via colposcopy. RESULTS: High-risk HPV DNA was demonstrated in 75.6% (34/45) of patients wi th LSIL and 52.7% (39/74) with ASCUS. Those who were HPV positive were sign ificantly move likely to have CIN or cancer (odds ratio, 33.40; 95% confide nce interval, 11.89-93.97; P<.0001). The sensitivity of HPV assay for detec tion of lesions more severe than CIN 2 was 100%, specificity 64.8%, positiv e predictive value 66.7% and negative predictive value 100%. CONCLUSION: The addition of a high-risk HPV DNA assay to cytologic examinat ion appears to provide excellent sensitivity and negative predictive value for early detection of high grade CIN or cancer in older women with minimal ly abnormal Pap smears.