Evaluation of Several Screening Approaches for Detection of Cervical Lesions in Rural Shandong, China

Purpose: The study was designed to: (1) investigate the prevalence of high-risk human papillomavirus (HR-HPV) infection and cervical neoplasia; and (2) evaluate clinical performance of visual inspection with acetic acid/ Lugol's iodine (VIA /VILI), Pap smear, high-risk human papillomavirus (HR-HPV) DNA test for detecting cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and (3) explore appropriate screening approach in rural areas of Shandong Province. Materials and Methods: A total of 3,763 eligible women from Yiyuan County in Yimeng mountainous areas of rural Shandong, China, were enrolled and underwent Pap smear, HR-HPV DNA testing by Hybrid Capture 2 (HC2), and VIA /VILI tests. Women positive in any test were referred to colposcopy and biopsy as indicated. Results: The prevalence of HR-HPV infection among all enrolled women was 11.1% and that in healthy women was 9.9%. In total 33 cases of CIN1, 16 cases of CIN2, 6 cases of CIN3 but none of cervical cancer were detected and the crude prevalence of CIN2+ was 0.58%. For detecting CIN2+, the sensitivity of HR-HPV DNA testing, VIA/VILI, Pap smear was 90.9%, 77.3%, 81.8%, respectively. Pap smear had the best specificity of 98.2%, followed by HR-HPV DNA testing with specificity of 89.4%, VIA/VILI had the lowest specificity of 81.2%. Colposcopy referral rate of HR-HPV DNA testing, VIA/VILI, Pap smear was 11.1%, 18.5%, 2.3%, respectively. Conclusions: Our results suggest that HR-HPV DNA testing alone might be appropriate for primary cervical cancer screening in rural low-resource areas of Shandong Province, China.