Genital human papillomavirus infection among women recruited for routine cervical cancer screening or for colposcopy determined by hybrid capture II and polymerase chain reaction

The purpose of this study was to evaluate the clinical use of the Hybrid Ca pture (HC)-II system for the detection of human papillomavirus (HPV) DNA to identify women at risk of progression to high grade squamous intraepitheli al lesions (HGSIL) and carcinomas by differentiating low risk (LR) HPV type s (6, 11, 42, 43, 44) and high/intermediate risk (HR) HPV types , 18, 31, 3 3, 35, 39, 45, 51, 52, 56, 58, 59, 68). Five hundred and ninety-six women w ere enrolled in the study. Among them, 466 attended the hospital for routin e cytologic screening and 130 were referred for colposcopy because of an ab normal Pap smear. The presence of HPV DNA was tested in cervical samples co llected with the Digene Cervical Sampler in Digene Specimen Transport Mediu m (Digene Corporation, Silver Spring, MD, U.S.A.) using the HC-II assay. Re sults were compared with those obtained by polymerase chain reaction (PCR) using the MY09-MY11 primers followed by several hybridizations with specifi c probes. The overall HPV positivity was 32.9% by HC-II and 37.8% by PCR. A mong cytologically normal smears, 19.5% were positive by HC-II (14.3% HR) a nd 25.1%, by PCR. Of the atypical squamous cells of undetermined significan ce samples, 52.9% were positive by HC-II (41.1% HR) and 55.9% by PCR. Of th e low grade SIL, 64.5% were positive by HC-II (59.4% HR) and 68.7% by PCR. The HPV positivity rate was found identical by both techniques in high grad e smears (81.6%) and squamous cervical carcinomas (100%). By using PCR as t he reference method, the sensitivity of HC-II was higher among women with a bnormal cytology than with normal cytology (87.3% vs. 70%). Specificity was 80.8% and 97.5%, respectively. In summary, these results indicate that the HC-II method and MY-PCR identified nearly equivalent prevalences of HPV in cervical smear specimens.