Sensitivity studies of AutoPap System Location-Guided Screening of cervical-vaginal cytologic smears.

OBJECTIVE: To present the results of a study that assessed the efficacy of a cervical cytology screening method utilizing the AutoPap System with Location-Guided Screening (AutoPap LGS) software for detecting abnormal Papanicolaou smear slides. STUDY DESIGN: Two hundred cases of abnormal cervical and vaginal smears were selected from the recent archives of the Taipei Institute of Pathology. For each abnormal slide, a matched "within normal limit" slide was included in the study. The slides were processed on the AutoPap Primary Screening System to select slides for Review or No Review and identify areas of the Review slides for human review and diagnosis (AutoPap LGS). The effectiveness of AutoPap LGS for detecting abnormal Papanicolaou smear slides was evaluated at multiple No Review rates. RESULTS: The AutoPap LGS demonstrated statistically superior sensitivity over current laboratory practice for the identification of abnormal slides. Assessing the potential benefit of the AutoPap LGS using a projection method, it is expected that the AutoPap LGS would detect an additional 52 low grade squamous intraepithelial lesion and 13 high grade squamous intraepithelial lesion cases missed by current laboratory practice in a population of 2,860 cases. CONCLUSION: The effectiveness of AutoPap LGS was demonstrated by its statistically superior performance in the detection of missed abnormal slides as compared to current laboratory practice at the Taipei Institute of Pathology.