Automated Pap Test Screening for Quality Control

In this study, we will explore the development of an automated cervical analysis system for useafter manual screening of thinlayer cervical specimens as a quality control (QC) instrument. We shall testthe hypothesis that nuclear features termed "Malignancy Associated Changes" (MACs) measured by theinstrument can be employed to identify disease in samples found to be false negative by manualmethods. At the current levels of technology and in the present regulatory environment, thedevelopment of such a system will play an important role in laboratory quality, and will likely reach themarket long before an automated primary screening device. The basic goal of the Phase I feasibilitystudy is to establish the presence of MACs using the preparation, optoelectronics, and features availableon a basic Cytyc scanning instrument. New and innovative aspects of this application include theapplication of MACs in a wide scale screening environment (previous work with MACs has involvedmanual selection of cells, manual focus, and only limited testing) and, in addition, the use of such aninstrument as a low cost QC technique rather than a primary screener. In Phase II a fully automatedprototype would be developed and tested, including a user interface.