[Evaluation of the role of the HPV test in routine clinical practice: prospective study].
OBJECTIVE: To determine the incidence of papillomavirus and to asses the role a HPV DNA in screening of cervical intraepithelial neoplasia. DESIGN: Czech National Collaborative Trial. SETTING: Department of Gynaecology and Obstetrics, Kladno Hospital, Department of Microbiology, KLINLAB, Prague, outpatient clinics (Kladno, Bruntál, Unhost'). METHODS: The study group includes of 3,264 women, their cervical scrapings were sent to KLINLAB during November 1996 to June 1998, because of abnormal results of primary screening. Patients with ASCUS, AGNUS, LSIL, HSIL and/or abnormal colposcopic findings were eligible for this study. Only completely filled in records of a subgroup of 1,158 patients were assessed for sensitivity and specificity for CIN in screening methods. RESULTS: The overall sensitivity of cytology and basic colposcopy were 84.7% and 64.9% respectively. The overall sensitivity of HPV DNA testing was 66%. The sensitivity of cytology of women with minor cytological abnormities for major cervical disease (CIN 2/3 and microinvasive cancer) in this group of patients was only 35%. Combined cytology with HPV DNA test gave an increased sensitivity for major cervical disease of 83%. CONCLUSION: 153 (66.4%) of the cervical intraepithelial neoplasias grade 2/3 displayed negative and borderline or mild cytological changes. The combined use of cytology with HPV testing increased the sensitivity with a reduction of specificity. However, it is evident from these results that HPV DNA testing alone cannot be used as a diagnostic tool but could usefully improve the level of screening CIN in common clinical practice.