OBJECTIVE: False negatives of cervical smears due to screening errors pose a significant and persistent problem.
AutoPap 300 QC System, an automated screening device, is designed to rescreen conventionally prepared Pap smears initially screened by cytotechnologists as normal. Clinical experience and sensitivity of the AutoPap 300 QC System were assessed and compared with current 10% random quality control technique.
MATERIALS AND METHODS: In clinical practice, a total of 18,592 "within normal limits" or "benign cellular changes" cases classified by The Bethesda System were rescreened by the AutoPap System. In study for sensitivity of The AutoPap System to detect false negatives, a total of 1,680 "within normal limits" or "benign cellular changes" cases were rescreened both manually and by the AutoPap System. The sensitivity of the AutoPap System to these false negatives was assessed at 10% review rate to compare 10% random manual rescreen. RESULTS In clinical practice, 38 false negatives were identified by the AutoPap System and we had achieved 0.2% reduction in the false negative rate of screening error. In study for sensitivity, 37 false negatives were identified by manual rescreening, and 23 cases(62.2%) of the abnormal squamous cytology were detected by the AutoPap System at 10% review rate.
CONCLUSONS: The AutoPap 300 QC System is a sensitive automated rescreening device that can detect potential false negatives prior to reporting and can reduce false negative rates in the laboratory. The device is confirmed to be about eight times superior to the 10% random rescreen in detecting false negatives.
The AutoPap 300 QC System is an automated device for the analysis and classification of conventional cervical cytology slides for quality control purpose. These studies evaluated the sensitivity of the AutoPap 300 QC System, and estimated morphologic features other than epithelial abnormality to identify a high quality control(QC) score with the AutoPap 300 QC System. The sensitivity of the AutoPap 300 QC System at 10% review rate for 210 cases of cervicovaginal cytology with low grade squamous intraepithelial lesion(LSIL) and higher grade lesion was assessed, and compared with a 10% random rescreening. The morphologic features, such as presence of endocervical component, dirty background, atrophy, abnormal cell size, and cellularity of single atypical cells were estimated in 45 cases of no review and 30 cases of QC review cases. The AutoPap 300 QC System identified 119(56.7%) out of 210 cases with LSIL and higher grade lesion at 10% review rate. It was more sensitive to squamous cell lesions(50-62%) than to glandular lesions(10%). The dirty background and the scanty cellularity of single atypical cells were significantly related to low QC score. Conclusively, AutoPap 300 QC System is superior to human random rescreen for the identification of false negative smears. The upgrading of this device is required to enhance the detection of glandular lesion and certain inadequate conditions of the slides.