A clinical trial of the AutoPap 300 QC system for quality control of cervicovaginal cytology in the clinical laboratory.
OBJECTIVE
False-negative reports of cervicovaginal (CV) smears (FNs) due to interpretive errors pose a significant and persistent problem in cytology. Using routinely prepared CV smears, the AutoPap 300 QC System, an automated cytology screening device, can provide an enriched population of slides for manual rescreening. In this clinical trial, the performance of the AutoPap System was assessed and compared to current random quality control (QC) selection techniques.


METHODS
A total of 3,487 "within normal limits" cases were rescreened, both manually and by the AutoPap 300 QC System. Detected FNs were classified by three different methods: cytotechnologist rescreen, internal discrepancy panel and external discrepancy panel. The sensitivity of the AutoPap System to these FNs was established at five QC score thresholds.


RESULTS
By cytotechnologist rescreening, 106 FNs were identified. Subsequent internal and external discrepancy panel reviews confirmed the FNs in 80 cases and 86 cases, respectively. At a 10% review rate, the AutoPap System identified approximately 50% of the squamous intraepithelial lesion FNs.


CONCLUSIONS
The AutoPap 300 QC System is a sensitive automated cytology system that has the potential of yielding five times as many FNs as a 10% random rescreen.
D003365:Costs and Cost Analysis; D003955:Diagnostic Tests, Routine / Q000191:economics; D005188:False Negative Reactions; D005260:Female; D006801:Humans; D012680:Sensitivity and Specificity; D002577:Uterine Cervical Diseases / Q000175:diagnosis*; D014623:Vaginal Diseases / Q000175:diagnosis*; D014626:Vaginal Smears / Q000191:economics / Q000295:instrumentation