Chinese Multi-center Screening Trial that will take place in five sites in China, which are 1) Beijing, 2) Shanghai, 3) Shijiazhuang, Hebei Province, 4) Wuhan, Hubei Province, and 5) Wushen County, Erdose, Inner Mongolia.
The primary objective of the project will be to evaluate the Cobas 4800 HPV Assay, the Aptima HPV Assay, and the SEQHPV Assay for the detection of high grade pre-cancer of the uterine cervix, in population based screening samples obtained using self-collection.
Secondary Objectives:
1) To evaluate differences in assay performance using solid and liquid based specimen transport media for the self-collected specimens. 2) To evaluate cytology and genotyping as secondary screens after primary HPV screening using Cobas 4800, Aptima, and SEQHPV. 3) A cost-effectiveness analysis of several potential screening algorithms based on our study design. 4) A 3-year follow-up of women testing HPV+ (by direct testing) and <=CIN1