Evaluation of the Role of the HPV Test in CommonClinical Practice: Prospective Study

Overview

Objective:
To determine the incidence of papillomavirus and to asses the role a HPV DNA inscreening of cervical intraepithelial neoplasia.Design: Czech National Collaborative TrialSetting: Department of Gynaecology and Obstetrics, Kladno Hospital, Department of Microbiolo-gy, KLINLAB, Prague, outpatient clinics (Kladno, Bruntál, Unhošť)Methods: The study group includes of 3 264 women, their cervical scrapings were sent to KLIN-LAB 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 forthis study. Only completely filled in records of a subgroup of 1 158 patients were assessed forsensitivity and specificity for CIN in screening methods.Results: The overall sensitivity of cytology and basic colposcopy were 84.7% and 64.9% respective-ly. The overall sensitivity of HPV DNA testing was 66%. The sensitivity of cytology of women withminor cytological abnormities for major cervical disease (CIN 2/3 and microinvasive cancer) inthis group of patients was only 35%. Combined cytology with HPV DNA test gave an increasedsensitivity for major cervical disease of 83%.Conclusion: 153 (66.4%) of the cervical intraepithelial neoplasias grade 2/3 displayed negative andborderline or mild cytological changes. The combined use of cytology with HPV testing increasedthe sensitivity with a reduction of specificity. However, it is evident from these results that HPVDNA testing alone cannot be used as a diagnostic tool but could usefully improve the level ofscreening CIN in common clinical practice.

Key words:
HPV test, clinical practice