关于FDA批准的巴氏涂片图像识别系统


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送交者: blackbox 于 2008-02-18, 15:43:54:


FDA于2003年6月6日批准巴氏涂片图像识别系统(ThinPrep™ Imaging System)的临床使用。全美可提供这套系统服务的机构可查阅以下网址。

另外,美国医师经常查阅的网站[UpToDate (2008)]对计算机图像识别系统有如下的描述:

Computerized screening or rescreening — Computerized automated screening has been developed, but the role for this technology has not been definitively determined. Available technologies include Autopap, PapNet, and ThinPrep. Proposals for use include initial screening to identify slides for manual screening that are high risk for abnormalities, or quality control for rescreening slides initially read as negative. Automated testing improves sensitivity at the expense of specificity

Automated slide interpretation is also used as an initial procedure to enable laboratories to manually screen only the subgroup of slides designated high risk by the automated process, and thus improve the rate at which the slides can be screened. The ThinPrep Imaging System is FDA approved for primary screening. This system uses programmed algorithms to review each slide for areas of most concern. If abnormalities are found, the whole slide is reviewed. In one study, use of this device increased detection of HSIL by 38 percent and LSIL by 46 percent compared to manual screening [46]. In another study, use of the imager resulted in fewer unsatisfactory slides than with conventional cytology (1.8 versus 3.1 percent) and better detection of high grade squamous lesions [34]."

http://www.fda.gov/cdrh/mda/docs/p020002.html

http://www.thinprep.com/find-an-imager/map.cfm





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