Korean J Cytopathol.  1998 Jun;9(1):37-44.

Clinical Experience and Sensitivity of the AutoPap 300 QC System in Cervicovaginal Cytology

• Hong SR
• Park JS
• Jang HS
• Kim YJ
• Kim HS
• Park CT
• Park IS

Abstract

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.

Keyword

Cervicovaginal cytology; False negatives; AutoPap 300 QC System

MeSH Terms

Mass Screening
Quality Control
Vaginal Smears