Endometrial cells and the AutoPap System for primary screening of cervicovaginal Pap smears

In 1998, the AutoPap 300 received FDA approval for primary screening of conventional cervical smears. As approved, smears categorized as "no further review" and comprising up to 25% of the smears screened by the AutoPap 300 can be reported as negative for malignant and dysplastic cells without screening by a cytotechnologist. We studied 106 conventional cervical smears in which glandular endometrial cells had been identified by manual screening to assess the ability of the AutoPap System (TriPath Imaging, Inc., Burlington, NC) to (1) designate conventional Papanicolaou smears that contain endometrial cells for "review," and (2) stratify smears that contain endometrial cells as more or less likely to be abnormal. Although the number of cases in our study was small, our findings indicate that (1) the AutoPap System is slightly less sensitive than manual screening by experienced cytotechnologists for the detection of endometrial cells in conventional smears, as the System designated for "review" 94.3% of all smears containing endometrial cells, 92.9% of smears reported as atypical glandular cells of undetermined significance (AGUS) or endometrial adenocarcinoma, and 100% of the four smears with subsequently confirmed endometrial adenocarcinomas, (2) ranking of smears into quintiles by the AutoPap System did not provide additional diagnostically useful information with respect to endometrial pathology, (3) the number of endometrial cells in the smears did not correlate with quintile assignment, and (4) for most patients, routine use of the AutoPap System for primary screening of conventional cervical smears is unlikely to contribute to delay in the diagnosis of clinically significant endometrial lesions.