Automation of the Papanicolaou smear: a technology assessment perspective.

Abstract

Cytology automation has captured the attention of industry, the public, and the pathology community as a potential solution to false negatives and other limitations of the conventional Papanicolaou smear. However, cytology automation includes a mixed group of technologies, including cytology rescreening, prescreening, independent screening, automated preparation technologies, and screening process control. While certain of these technologies may prove valuable to improving the quality of the Papanicolaou test, a structured analysis approach, such as is offered by technology assessment, is required to determine whether the technology is safe, effective under conditions of actual use, cost-effective, and whether it adds value and improves outcomes in patient care. Such studies must be carefully constructed to eliminate bias so that proper decisions can be made. The implications of these devices on individual screening standards are yet to be determined; sufficient peer-reviewed literature studies must accumulate to document their value, and the cytology community must participate with other interested parties in establishing the standard for care.