Performance of the AutoPap Primary Screening System in the detection of high-risk cases in cervicovaginal smears

OBJECTIVE: To assess the performance of the AutoPap Primary Screening Syste m (APSS) (TriPath Imaging, Inc., Burlington, North Carolina, U.S.A.) for th e detection of high grade cervical squamous intraepithelial lesions and inv asive cervical cancer. STUDY DESIGN: A total of 14,779 consecutive conventional Pap smears mere pr ocessed by the APSS. All slides designated as "Review" by the device were m anually screened according to the Bethesda System. The ranking scores obtai ned from the device were compared with the cytologic interpretations in all cases and with the final histologic diagnoses in the cases with cytologic severe abnormalities. RESULTS: The device classified 10,349 slides as Review (78%) and 2,912 (22% ) as "No Further Review." In the 78% Review, cases, the samples were mixed in descending order of potential abnormality' broken into quintiles. The co rrelation between the slide quintile and the manual cytologic diagnosis ind icated that 90% of abnormal smears were categorized by the device as in the first and second quintile rank, and the correlation between the rank repor t of the device and the histologic diagnosis showed that all cases of HSIL or invasive carcinoma were in the top two ranks. No significant abnormaliti es were observed in any of the smears categorized as No Further Review. CONCLUSION: This study confirmed the effectiveness of APSS for the detectio n of Pap smears with severe abnormalities.