Hybrid Capture II-based human papillomavirus detection, a sensitive test to detect in routine high-grade cervical lesions: a preliminary study on 1518 women

Hybrid Capture II (HC-II) is a commercial human papillomavirus (HPV) detect ion test designed to detect 18 HPV types divided into high-risk and low-ris k groups. We have tested 1647 scrapes from 1518 unselected women attending routine cytological screening by this assay for the detection of histologic ally proven high-grade lesions. The reliability of this test was also evalu ated on 117 fresh cone biopsy samples. HPV DNA has been detected in 400 scr apes (24.3%), 296 containing a high-risk HPV (18.0%). All the smears evocat ive of high-grade lesions were positive for high-risk HPV, and high-risk HP V were detected in all the 34 cases presenting a histologically proven high -grade lesion and in 68 (97.1%) of the 70 cone biopsy samples showing a hig h-grade lesion or an invasive carcinoma. Thus, the sensitivity was superior to the sensitivity of cytology (85.3%). Nevertheless, the quantitative app roach provided by the HC-II assay for the assessment of the viral load coul d not clearly distinguish among cases with or without high-grade lesions. T hus this assay is recommended for the screening of high-grade lesions on a large scale, in association with classic cytology.