Wilgenbusch Heather, Mueller Gail, Neal Margaret, Renshaw Andrew A
Ketchum Wood and Burgert, Pathology Associates, Tallahassee, Florida.
Diagn Cytopathol. 2011 Nov;39(11):818-21. doi: 10.1002/dc.21469. Epub 2010 Oct 14.
Both manual (rapid prescreening) and automated methods have been devised to reduce screening error compared with routine review of 10% of negative gynecologic cases. To date these two methods have not been compared. A total of 5,139 liquid-based (SurePath Pap Test, BD Diagnostics) cases were subjected to 100% rapid prescreening and routine manual screening. All cases diagnosed as negative on routine screening were placed on the FocalPoint (BD Diagnostics, Franklin Lakes, NJ) automated screening device. All cases that were negative on routine screening and abnormal on rapid prescreening or in the top 15% of cases by FocalPoint were rescreened and a final diagnosis obtained. Cases were blinded during rapid prescreening and routine manual screening. Abnormal was defined as any diagnosis of atypical squamous cells (ASC) or worse. A total of 427 (8%) of cases were abnormal on routine screening. The sensitivity of rapid prescreening was 44.6%. Rapid prescreening identified an additional 14 abnormal cases (13 ASC and 1 LSIL) and FocalPoint identified nine cases (eight ASC, one LSIL) that were not detected by routine screening. Three of these cases were detected by both methods. The sensitivity of routine screening was 93.1%. Rapid prescreening increased the overall sensitivity significantly (96.0%, P = 0.04); FocalPoint increased the sensitivity but this change was not significant (95.0%, P = 0.21). Estimated screening time was 30 seconds for rapid prescreening and 6 minutes for routine screening with the result that rapid prescreening required 2,570 minutes while review of the FocalPoint Slides required 2,694 minutes. The sensitivity of routine screening in the second half of the study (95.3%) was higher than that in the first half of the study (91.6%) but the difference was not significant (P = 0.11). Rapid prescreening is as effective as directed review using FocalPoint at reducing screening errors and requires no additional screening time. Continued use of these methods may improve the sensitivity of routine screening
与对10%的阴性妇科病例进行常规复查相比,已经设计出了手动(快速预筛查)和自动化方法来减少筛查误差。到目前为止,这两种方法尚未进行比较。共有5139例液基(SurePath巴氏试验,BD诊断公司)病例接受了100%的快速预筛查和常规手动筛查。所有在常规筛查中被诊断为阴性的病例都被放置在FocalPoint(BD诊断公司,新泽西州富兰克林湖)自动化筛查设备上。所有在常规筛查中为阴性且在快速预筛查中异常或在FocalPoint筛查中处于前15%的病例都进行了重新筛查并得出最终诊断。在快速预筛查和常规手动筛查过程中,病例是盲态的。异常定义为任何非典型鳞状细胞(ASC)或更严重的诊断。共有427例(8%)病例在常规筛查中异常。快速预筛查的敏感性为44.6%。快速预筛查发现了另外14例异常病例(13例ASC和1例低度鳞状上皮内病变[LSIL]),FocalPoint发现了9例(8例ASC,1例LSIL)常规筛查未检测到的病例。其中3例病例两种方法都检测到了。常规筛查的敏感性为93.1%。快速预筛查显著提高了总体敏感性(96.0%,P = 0.04);FocalPoint提高了敏感性,但这种变化不显著(95.0%,P = 0.21)。快速预筛查的估计筛查时间为30秒,常规筛查为6分钟,结果是快速预筛查需要2570分钟,而复查FocalPoint玻片需要2694分钟。研究后半段常规筛查的敏感性(95.3%)高于前半段(91.6%),但差异不显著(P = 0.11)。快速预筛查在减少筛查误差方面与使用FocalPoint进行定向复查一样有效,并且不需要额外的筛查时间。持续使用这些方法可能会提高常规筛查的敏感性