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Secondary Screening After Primary Self-Sampling for Human Papillomavirus From SHENCCAST II

Wu, Ruifang MD1; Du, Hui MD1; Belinson, Suzanne Elizabeth MPH, PhD2; Pretorius, Robert Gerald MD3; Zou, Jing MS4; Yang, Bin MD, PhD5; Wang, Chun1; Belinson, Jerome Leslie MD2,6

Journal of Lower Genital Tract Disease: October 2012 - Volume 16 - Issue 4 - p 416–420
doi: 10.1097/LGT.0b013e31824f48c8
Original Articles

Objective We recently demonstrated that a selfcollected sample tested with a high-throughput polymerase chain reaction–based high-risk human papillomavirus (HR-HPV) assay is equal in sensitivity to a physician-obtained direct endocervical sample. We now explore some secondary screening options to improve specificity.

Methods The Shenzhen Cervical Cancer Screening Trial II is a multisite, population-based cross-sectional cervical cancer screening study conducted in Guangdong Province, China. Two HR-HPV assays were used for self-collected specimens, and 3 assays were used for directly collected specimens along with cytology. The polymerase chain reaction–based matrix-assisted laser desorption/ionization time-of-flight mass spectrometry assay reported 14 HR-HPV types. Any patient with a positive lesion on any assay or cytology underwent colposcopy and biopsy.

Results A total of 8,556 women with a mean age of 38.9 years (range = 25–54 years) were included in the analysis. Primary self-collection had a sensitivity of 94.3% and a specificity of 87.5% (for cervical intraepithelial neoplasia grade 3 or cancer). Secondary cervical cytology had a sensitivity and specificity of 83.0% and 95.2%, respectively, which would require a pelvic examination and sacrifice some sensitivity. Secondary genotyping for HPV types 16 or 18 had a sensitivity and specificity of 53.9% and 97.7%, respectively; and HPV types 16, 18, 31, 33, 45, 52, and 58 had a sensitivity and specificity of 92.2% and 90.4%, respectively.

Conclusions Genotyping is efficient if it is part of theprimary test result. It potentially identifies a high percentage of the cancers (types 16/18 = 84.5% in China).

Human papillomavirus genotyping is efficient if it is part of the primary test result. It potentially identifies a high percentage of the cancers.

1Peking University Shenzhen Hospital, Shenzhen, China; 2Preventive Oncology International, Cleveland Heights, OH; 3Kaiser Permanente, Fontana, CA; 4BGI Shenzhen, Shenzhen, China; 5Cleveland Clinic Department of Anatomic Pathology, Cleveland, OH; 6Women’s Health Institute, Cleveland Clinic Lerner College of Medicine, Cleveland, OH

Correspondence to: Jerome Leslie Belinson, MD, Preventive Oncology International/Cleveland Clinic Lerner College of Medicine, Cleveland Heights, OH. E-mail:

Jing Zou is an employee of BGI Shenzhen. The other authors have no conflicts of interest.

©2012The American Society for Colposcopy and Cervical Pathology