Clinical evaluation of a new model of self-obtained method for the assessment of genital human papilloma virus infection in an underserved population.

BACKGROUND We designed a self-sampling method to collect exfoliated genital cells for human papilloma virus (HPV) detection. The aim was to assess whether it was suitable as an assistant tool for the early detection of cervical pre-cancer and cancer in a special category of the women who are not frequently screened for cervical cancer. METHODS We compared the results of HPV detection that were self-obtained and physician-obtained cervical swabs from the same patient that were analyzed using hybrid capture II assay. The diagnostic rate of cervical pre-cancer and cancer between self-obtained method and physician-obtained method were analyzed. RESULTS A total of 1194 women were prospectively registered from September 1997 through September 1999. Among them, 144 (12.1%) of self-test samples and 155 (13%) of physician-obtained samples were oncogenetic associated-HPV positive. Statistically, no significant differences existed in the screening rate for cervical cancer using either the self-collected samples or the physician-obtained samples (p > .05). The sensitivity of cervical precancer or cancer detection using self-obtained HPV testing was higher (96.3%) as compared with the Pap smear (79.2%) (p < .02). CONCLUSION The detection correlation of the HPV test between the self-obtained method and physician-obtained method was 93%. Our results indicated that self-sampling was a reliable method for testing for HPV. The identification of HPV infection through the self-obtained method can be used in early identification of high-risk women with cervical precancer and cancer especially in underserved populations.