Walts Ann E, Thomas Premi
Department of Pathology and Laboratory Medicine, Cedars-Sinai Medical Center, Los Angeles, California 90048, USA.
Diagn Cytopathol. 2002 Oct;27(4):232-7. doi: 10.1002/dc.10175.
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.
1998年，AutoPap 300获得美国食品药品监督管理局（FDA）批准，用于传统宫颈涂片的初次筛查。按照批准的内容，归类为“无需进一步检查”且占AutoPap 300筛查涂片总数不超过25%的涂片，无需细胞技术人员筛查，即可报告为无恶性和发育异常细胞。我们研究了106份传统宫颈涂片，这些涂片经人工筛查已鉴定出存在子宫内膜腺细胞，以评估AutoPap系统（TriPath Imaging公司，北卡罗来纳州伯灵顿）的能力：（1）将含有子宫内膜细胞的传统巴氏涂片指定为“需检查”；（2）将含有子宫内膜细胞的涂片按异常可能性高低进行分层。尽管我们研究中的病例数量较少，但我们的研究结果表明：（1）在传统涂片中检测子宫内膜细胞时，AutoPap系统的敏感性略低于经验丰富的细胞技术人员进行的人工筛查，因为该系统将所有含有子宫内膜细胞的涂片的94.3%、报告为意义不明确的非典型腺细胞（AGUS）或子宫内膜腺癌的涂片的92.9%以及随后确诊为子宫内膜腺癌的4份涂片中的100%指定为“需检查”；（2）AutoPap系统将涂片分为五等分，对于子宫内膜病理学而言，并未提供额外的诊断有用信息；（3）涂片中子宫内膜细胞的数量与五等分分类无关；（4）对于大多数患者，常规使用AutoPap系统对传统宫颈涂片进行初次筛查不太可能导致临床上有意义的子宫内膜病变诊断延迟。
