Human papillomavirus detection by the hybrid capture II assay: A reliable test to select women with normal cervical smears at risk for developing cervical lesions

The reliability of the Hybrid Capture II (HC-LI; Digene, Silver Spring, MD, U.S.A.) assay was tested in detecting 18 human Papillomavirus (HPV) types for the screening of cervical lesions. Cytology, HPV testing, colposcopy, a nd biopsy were used to monitor 204 women with normal smears at the first en try. The median follow-up was 15 months (range, 4-27 months). The primary e ndpoint was clinical progression defined as the presence of a cervical intr aepithelial lesion at the biopsy. In the patient population of 204 HPV-infe cted women, 81 (39.7%) had a persistent HPV infection at two or three exami nations with a final histologic diagnosis of 14 high-grade and 13 low-grade squamous intraepithelial lesions (SIL) within 4 to 22 months. Women with r egressive HPV infection did not develop any lesion during the same period. The evaluation of the viral load of high-risk HPV by the HC-II did not repr esent a sensitive approach to predict the persistence or the apparition of high-grade lesions. Thus, persistent high-risk HPV infection detected with HC-II represents a reliable tool to select populations at risk for the deve lopment of high-grade cervical lesions.