We conducted a population-based cohort study to evaluate the complementary value of HPV testing to Papanicolaou (Pap) smear and the prevalence and genotype distribution of HPV in Taiwan. In this report, we described the design of the whole study and analyzed the cross-sectional results. Female residents (age 30 years) of Taoyuan, Taiwan were invited. After signing informed consent, every participant had a Pap smear and a HPV testing. Patients with Pap atypical squamous cell of undetermined significance (Group I) or those with HPV-positive but normal cytology (Group II) were referred for a colposcopic examination. A total of 10,014 women were eligible. The overall HPV prevalence was 10.8% (95% confidence interval 10.5%-11.4%) in the study population. A total of 37 types of HPV were identified and the leading three were HPV-52, -18 and -58. There was a significant positive correlation of HPV prevalence with older age, postmenopausal status, current-user of oral contraceptives and never-user of hormone replacement therapy. Past users of oral contraceptives and never users of Pap were associated with higher risk of abnormal Pap, while age 40-49 strata had lower risk. Fifty-nine cases of cervical intraepithelial neoplasia (CIN) 2 from Group I and additional 11 from Group II were identified. The improvement of sensitivity with additional HPV testing was 15.3%. Besides, no specific subgroup was found to most benefit from the combined strategy. The value of adding HPV test to conventional Pap smear has to be evaluated after longer-term follow-up of this population-based cohort. ' 2008 Wiley-Liss, Inc.Key words: cervical cancer screening; Pap smear; human papillomavirus; polymerase chain reaction (PCR); prevalence Cervical cancer continues to be one of the leading female genital cancers worldwide. 1 The cervical cancer burden in Taiwan is still heavy with the incidence of invasive cancer being 24.5/ 100,000, which ranked the fifth place of cancer death in women. 2 Traditionally, primary screening of cancer precursors remains based on cytological classification of cervical smears. Conventional Papanicolaou (Pap) test or monolayer cytology provided sensitivity rates ranged from 30% to 87% and specificity rates from 86% to 100%. 3 Since human papillomavirus (HPV) has been established as a well-recognized etiologic agent of cervical neoplasia, HPV DNA testing is a promising alternative or complementary test to improve the efficacy of cervical screening and probably cost-effective, depending on screening interval. 4,5 Cervical cancer screening programs integrating HPV testing have been advocated in United Kingdom, United States, South Africa, Thailand and Germany. [6][7][8][9][10] Hybrid Capture assay (HCII) (Digene Corporation, Gaithersburg, MD) is the most widely used method of HPV DNA testing. HCII utilizes liquid hybridization of RNA probes against HPV DNA followed by signal amplification, has been validated for its reproducibility. 11 Methods using PCR is more sensitive and quality assays were generally consistent for...