Purpose: The study was designed to: (1) investigate the prevalence of high-risk human papillomavirus (HRHPV)infection and cervical neoplasia; and (2) evaluate clinical performance of visual inspection with aceticacid/ Lugol’s iodine (VIA /VILI), Pap smear, high-risk human papillomavirus (HR-HPV) DNA test for detectingcervical intraepithelial neoplasia grade 2 or worse (CIN2+) and (3) explore appropriate screening approach inrural areas of Shandong Province. Materials and
Methods: A total of 3,763 eligible women from Yiyuan Countyin Yimeng mountainous areas of rural Shandong, China, were enrolled and underwent Pap smear, HR-HPVDNA testing by Hybrid Capture 2 (HC2), and VIA /VILI tests. Women positive in any test were referred tocolposcopy and biopsy as indicated.
Results: The prevalence of HR-HPV infection among all enrolled womenwas 11.1% and that in healthy women was 9.9%. In total 33 cases of CIN1, 16 cases of CIN2, 6 cases of CIN3 butnone of cervical cancer were detected and the crude prevalence of CIN2+ was 0.58%. For detecting CIN2+, thesensitivity of HR-HPV DNA testing, VIA/VILI, Pap smear was 90.9%, 77.3%, 81.8%, respectively. Pap smearhad the best specificity of 98.2%, followed by HR-HPV DNA testing with specificity of 89.4%, VIA/VILI hadthe lowest specificity of 81.2%. Colposcopy referral rate of HR-HPV DNA testing, VIA/VILI, Pap smear was11.1%, 18.5%, 2.3%, respectively.
Conclusions: Our results suggest that HR-HPV DNA testing alone might beappropriate for primary cervical cancer screening in rural low-resource areas of Shandong Province, China.