基于宫颈液基细胞的智能病理辅助诊断系统临床试验规范研究.pdfVIP

中文科技期刊数据库（全文版）医药卫生 基于宫颈液基细胞的智能病理辅助诊断系统临床试验规 范研究 1 3 3 2 4 陈建勤 王晓丹 陈传文 陈超敏 李作家 1.东莞市长安医院设备科，广东 东莞 523000 2.南方医科大学生物医学工程学院，广东 广州 510515 3.广州华银医学检验中心有限公司，广东 广州 510515 4.南方医科大学南方医院设备科，广东 广州 510515 摘要：基于医疗大数据的人工智能（AI）辅助诊断技术近年来日趋成熟，宫颈液基细胞的智能病理辅助诊断系统 在宫颈癌的筛查中展现了良好的灵敏度和特异度。本文拟探究科学有效的病理辅助诊断系统临床试验规范。规范 包括临床前准备、临床试验、临床试验结果输出规范等。期望填补目前国内对宫颈液基细胞人工智能病理辅助诊 断系统产品标准的空白，推动宫颈液基细胞病理人工智能辅助诊断系统持续发展。 关键词：人工智能；宫颈液基细胞筛查；病理诊断；临床试验规范 中图分类号：R445 Study on Clinical trial Specification and method of Intelligent pathological Auxiliary diagnosis system based on Cervical liquid-based cells CHEN Jianqin 1 WANG Xiaodan 3 CHEN Chuanwen 3 CHEN Chaomin 2 LI Writer 4 1.Dongguan Chang’an Hospital ， Equipment Section， Guangdong Dongguan 523000 2.School of Biomedical Engineering, Southern Medical University, Guangdong Guangzhou 510515 3.Limited to Guangzhou Huayin Medical Laboratory Center, equipment Department, Guangdong Guangzhou 510515 4.Equipment Department of Nanfang Hospital, Guangdong Guangzhou 510515 Abstract: The artificial intelligence (AI) assisted diagnosis technology based on medical big data has become increasingly mature in recent years. The intelligent pathology assisted diagnosis system of cervical liquid-based cells has shown good sensitivity and specificity in the screening of cervical cancer. This article intends to explore the scientific and effective clinical trial specifications of the pathological-assisted diagnosis system. The specifications include preclinical preparation, clinical trial, and output specifications of clinical trial results. It