The Shenzhen cervical cancer screening program was initiated as a collaborative effort between the government of China, Shenzhen University Peking University Hospital and private donors. The goal was to provide cervical cancer screening to women in the Southern Chinese province of Guangdong who had not been screened in the past 3 years. Dr. Jerome Belinson and Preventive Oncology International, Inc. were invited to include a research opportunity for those women choosing to participate. The study goal was to evaluate the sensitivity and specificity of the Gen-Probe APTIMA High Risk HPV assay as compared to the Hybird Capture II assay applied as a direct sample along with liquid based cytology.
The cervical cancer screening program was initiated November of 2008. Women choosing to be screened were offered the opportunity to participate in the research study. Approximately 2000 women agreed to participate. After obtaining consent, women entered the examining area. A physician collected a direct cervical sample. That sample was placed in Sure Path liquid, and shaken to distribute cells. 4cc’s were place in a separate vial for HCII processing, and the remaining sample was sent for automated cytology. Next, the physician collected a 2nd direct cervical sample and placed it in PreservCyt liquid. Again, the sample was shaken to distribute cells. 1cc was placed in Gen-Probe STM and the remaining sample was stored under controlled conditions. Any woman positive on automated cytology, HC2 or GenProbe APTIMA HPV assay was colposcoped and biopsied using the POI microbiopsy protocol. De-identified data was sent to the POI center for Epidemiology and Biostistics in Chicago, Illinois.
Results showed a significant advantage for the APTIMA assay for the detection of >= CIN 2 based on ROC curve comparison. (see link for abstract). The data has been presented at EUROGIN 2010 and AOGIN 2010.