案例信息
标题：新型冠状病毒抗体检测试剂的评估和应用
【专业学位类别】公共卫生
【专业领域/方向】流行病学
【作者】张军 教授
【单位】厦门大学公共卫生学院
【关键词】新型冠状病毒；抗体；试剂
【适用课程】流行病学、转化医学、生物制品学
【版权说明】真实性案例，仅用于教学目的
【案例摘要】
在新发传染病流行前期, 其关键流行病学和血清学特征并不清晰，往往需要开展血清学研究，以揭示新发传染病的疾病谱（即不同严重程度患者所占比例），解析疾病的真实感染程度、传播能力和致病性等。但在研究开展前，应对抗体检测试剂开展系统的临床评价，以根据不同检测目的和应用场景在不同抗体检测试剂中做出合理的选择。本案例设计了评价新型冠状病毒(SARS-CoV-2)抗体检测试剂盒的详细方案，包括对研究对象、样本量评估、纳入及排除标准、盲法设计、实验标本、伦理、研究管理及质量控制、数据管理与统计分析、结果报告的具体内容和考量。通过解读该案例设计的关键环节，学习方案设计与实施，培养学生开展系统评估检测试剂关键临床性能的能力，探讨新型冠状病毒抗体检测试剂的临床和公共卫生意义。
Title: The Evaluation and Implementation of Antibody Detection Kits
Professional Degree Category: Master of Public Health
Specialized fields: Epidemiology
Authors: Zhang Jun
Affiliation: School of Public Health, Xiamen University
Key words: SARS-CoV-2; Antibody; Serology; Detection kit
Abstract
In the early stages of an emerging infectious disease outbreak, its key epidemiological and serological characteristics are often unclear. It often requires serological studies to reveal the disease spectrum (i.e., the proportion of patients with different levels of severity) and to analyze the true extent of infection, transmission potential, and pathogenicity of the new infectious disease. However, before conducting the research, a systematic clinical evaluation of antibody detection test kits should be carried out to make reasonable selections among different antibody detection test kits based on different testing purposes and application scenarios.
This case outlines a detailed plan for evaluating antibody detection test kits for the novel coronavirus (SARS-CoV-2), including aspects such as the study subjects, sample size assessment, inclusion and exclusion criteria, blind design, experimental specimens, ethics, research management and quality control, data management and statistical analysis, and specific considerations for result reporting. By understanding the key steps in the design of this case, students can learn about the design and implementation of plans, develop the ability to systematically evaluate the key clinical performance of test kits, and explore the clinical and public health significance of novel coronavirus antibody detection test kits.
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