AutoPap System Performance in Screening for Low Prevalence and Small Cell Abnormalities

Performance of the AutoPap Primary Screening System in the Detection of High-Risk Cases in Cervicovaginal Smears

“…This high percentage was, in turn, responsible for the higher incidence of Review cases (78%) with respect to that quoted in the literature (75%). 1 In spite of the alleged detection capability of the device on slides having a low prevalence of abnormal cells, 5 we observed decreased sensitivity when the abnormal cell count was < 10 cells and the inflammatory component was relatively high. It is well known that the presence of inflammation may induce a decrease in nuclear staining intensity.…”

“…3 The accuracy of APSS for initial screening of cervical Pap smears for the diagnosis of HSIL and more serious lesions was proven by the results of two separate two-arm clinical trials 1,4 and confirmed by a biopsy-based trial. 5 In addition, encouraging results of the performance of APSS for primary screening of cervical cytologic smears designated "No Further Review" were recently reported. 6 Below we report on a study performed at a single European institution designed to address APSS performance in cases designated as "Review," independently of any considerations of cost-benefit ratios.…”

Validation of AutoPap® Primary Screening System Sensitivity and High-Risk Performance

“…8 Five of the seven LSIL cases were characterized by the presence of relatively few wellpreserved cells exhibiting features typical of this diagnosis. However, one of the seven LSIL cases contained cells with well-defined koilocytosis and large, dark nuclei.…”

Automation and the Endangered Future of the Pap Test

“…Performance data from clinical trials, sponsored by Neopath, Inc., were included in the submission to the FDA for pre-market approval of AutoPap 300 QC as a rescreening device for quality assurance (38)(39)(40). Another study, performed independently of the manufacturer, has also evaluated the performance of the device.…”