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