Performance of an Imaging System vs. Manual Screening in the Detection of Squamous Intraepithelial Lesions of the Uterine Cervix

To compare the ThinPrep Imaging System (Cytyc Corp., Boxborough Massachusetts, U.S.A) to manual screening in the detection of cervical squamous epithelial lesion (SIL). A total of 27,525 manually screened ThinPrep Pap tests were compared with 27,725 imaged ThinPrep Pap tests for: (1) diagnostic rates of atypical squamous cells of undetermined significance; atypical squamous cells of undetermined significance, cannot rule out high grade SIL (ASC-H); low grade SIL and high grade SIL (HSIL); (2) ASC/SIL ratio; (3) high-risk HPV positivity for ASC; and (4) biopsy follow-up for ASC-H and HSIL. There were significant increases in the percentage of cytologic diagnoses in all categories with the imager. The ASC/SIL ratios of both groups were comparable. There was a significant decrease in HPV positivity in the imager group of ASC. Biopsy results confirmed a significant increase in the detection of HSIL in both the ASC-H and HSIL groups of the imaged cohort. The ThinPrep Imaging System is significantly better than manual screening in the detection of cervical SIL.