Automated Papanicolaou smear analysis as a screening tool for female lower genital tract malignancies

The cervical Papanicolaou (Pap) smear is the most effective and inexpensive cancer screening test in medical history for the identification of premalignant cervicovaginal lesions. Despite this fact, false-negative rates ranging from 6% to 55% have been sporadically reported, resulting in an increase in litigation. With the development of computer-based automated technology, a significant proportion of such false-negative results have been reduced by rescreening of negative smears. This article reviews the automated technology approved by the USA Food and Drug Administration and its use, including performance, accuracy and cost-effectiveness compared with the results of conventional manual screening.