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: 2106161
• 负责人: DAVID J ZAHNISER
• 金额: $ 37.23万
• 依托单位: CYTYC CORPORATION
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-09-30 至 1997-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2106161
• 关键词: cervical /vaginal smear; computer assisted diagnosis; computer program /software; computer system design /evaluation; diagnosis quality /standard; digital imaging; human tissue; image processing; neoplasm /cancer classification /staging; stainings

In this research, the primary goal is to develop an automated cervical smear analysis system for use after manual screening of thinlayer cervical specimens as a quality control (QC) instrument. The device will measure nuclear features termed "Malignancy Associated Changes" (MACs) to identify disease in samples that are falsely 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 use of MACs is new and innovative in that it allows fast and accurate processing at a very reasonable system cost. In Phase II a fully automated prototype would be developed and tested. Specific research areas are 1) the optimization of the stain, 2) the use of multiple focal planes, 3) optimization of classifiers, and 4) completion and testing of a completely automated prototype. Specification and design of a commercial instrument will begin at the end of Phase II and continue into Phase III. PROPOSED COMMERCIAL APPLICATION: This device would provide enhanced quality control for Pap test analysis in all cytology laboratories worldwide. The current practice of rescreening 10% of negative smears is not adequate. Implementation of a fast and inexpensive automated system used after manual screening would result in increased accuracy and improved healthcare.

在这项研究中，主要目标是开发一种自动化宫颈 薄层宫颈手动筛查后使用的涂片分析系统 样品作为质量控制 (QC) 仪器。 该设备将测量 称为“恶性相关变化”（MAC）的核特征来识别 手动方法假阴性的样本中存在疾病。 在 当前的技术水平和当前的监管环境， 这种系统的开发将在实验室中发挥重要作用 质量，并且很可能早在自动化初级产品之前就进入市场 筛选装置。 MAC 的使用是新颖且创新的，因为它允许 以非常合理的系统成本进行快速、准确的处理。 同相 II 将开发和测试全自动原型。 具体的 研究领域是 1) 染色剂的优化，2) 使用 多个焦平面，3）分类器优化，4）完成 以及完全自动化原型的测试。 规格及设计 商业工具的开发将在第二阶段结束时开始并继续 进入第三阶段。 拟议的商业应用：该设备将提供增强的 所有细胞学实验室巴氏试验分析的质量控制 全世界。 目前的做法是重新筛查 10% 的阴性涂片 不够。 实施快速且廉价的自动化系统 手动筛选后使用会提高准确性和 改善医疗保健。