AUTOMATED PAP TEST SCREENING FOR QUALITY CONTROL

用于质量控制的自动化巴氏试验筛选

• 批准号: 2106160
• 负责人: DAVID J ZAHNISER
• 金额: $ 6.7万
• 依托单位: CYTYC CORPORATION
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-07-20 至 1995-04-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2106160
• 关键词: biomedical automation; cervical /vaginal smear; cervix neoplasms; computer assisted diagnosis; diagnosis quality /standard; digital imaging; human subject; neoplasm /cancer diagnosis

In this study, the primary goal is to explore the development of an automated cervical analysis system for use after manual screening of thinlayer cervical specimens as a quality control (QC) instrument. We shall test the hypothesis that nuclear features termed "Malignancy Associated Changes" (MACs) measured by the instrument can be employed to identify disease in samples found to be false negative by manual methods. At the current levels of technology and in the present regulatory environment, the development of such a system will play an important role in laboratory quality, and will likely reach the market long before an automated primary screening device. The basic goal of the Phase I feasibility study is to establish the presence of MACs using the preparation, optoelectronics, and features available on a basic Cytyc scanning instrument. New and innovative aspects of this application include the application of MACs in a wide scale screening environment (previous work with MACs has involved manual selection of cells, manual focus, and only limited testing) and, in addition, the use of such an instrument as a low cost QC technique rather than a primary screener. In Phase II a fully automated prototype would be developed and tested, including a user interface.

在这项研究中，主要目标是探索 手动筛选后使用的自动宫颈分析系统 Thinlayer宫颈标本作为质量控制（QC）仪器。我们 应检验以下假设，即核特征称为“恶性肿瘤” 可以使用该仪器测量的相关更改”（Mac） 通过手动方法鉴定样品中发现为假阴性的疾病。 在目前的技术水平以及当前的监管 环境，这种系统的发展将发挥重要作用 在实验室质量上，很可能会在 自动筛选设备。第一阶段的基本目标 可行性研究是使用 基本CYTYC上可用的准备，光电子和功能 扫描工具。本应用程序的新方面 包括在大规模筛选环境中应用Mac的应用 （以前使用Mac的工作涉及手动选择单元格，手动 焦点，只有有限的测试），此外，使用了这样的 仪器作为低成本的QC技术，而不是主要的筛选器。在 第二阶段A将开发和测试全自动的原型 包括用户界面。