Internet-Based Cervical Cytology Screening Program
Internet-Based Cervical Cytology Screening Program
The purpose of this study is to assess whether a system that couples automated screening of
 Pap Tests with transmission of machine selected digital images, and review by cytologists at
 a remote location, performs to a clinically effective standard of accuracy.
This clinical study uses the automated screening capabilities of the FocalPoint Primary
 Screening System (BD) for gynecologic cytology specimens (Pap tests) to allow for automated
 field of view (FOV) selection, digital image capture, and subsequent Internet-based
 transmission to a custom designed computer-based image reading station. The system utilizes
 liquid-based cytology preparations (ThinPrep, SurePath). In such a system, no skilled
 cytology human resources are necessary at the scanning site, and all expertise can be
 centralized. Pilot studies showed that the task was feasible to a clinically relevant
 standard of care. Phase 1 trials on preselected and seeded specimens confirmed this clinical
 standard. The phase 2 trials extend the concept to a prospectively enrolled population of
 patients from 2 sites (Walter Reed, Mass General) thereby testing the concept in a population
 of normal disease prevalence. The final phase 3 will be a larger study with intended use
 design, siting a screening device at the 121st Army Hospital in Korea and interpreting the
 specimen images in the US. In addition to the reading of the specimens, the system is
 designed to give immediate "loop closing" results back to each specimen's originating point
 immediate upon completion of the test.
Inclusion Criteria:

 -  Female presenting to clinic for a Pap test for any reason

 Exclusion Criteria:

 -  Pregnant

 -  Prisoners

 -  Mentally unable to provide informed consent