The primary screening clinical trials of the TriPath AutoPap System

The AutoPap Primary Screening System has been approved recently by the United States Food and Drug Administration for the initial screening and quality control of non-"high-risk" conventional cervical cytology slides. A prospective clinical trial using the device compared its performance in terms of sensitivity and specificity for abnormality detection with the current standard of practice, which is represented by initial manual screening and 10% random quality control rescreening. The study showed statistically superior abnormality detection sensitivity by the AutoPap System. In addition, specificity of diagnosis was also improved. Equivalent performance was noted for categorization of slide adequacy and detection of infectious organisms and benign cellular changes. Use of the AutoPap System therefore has the potential to improve the accuracy of cervical cytologic examinations as well as to make a positive impact on the productivity of cytology laboratory personnel.