新型冠状病毒抗体检测试剂的临床性能评估方案  

Protocol for the Clinical Performance Assessment of SARS⁃CoV⁃2 Antibody Testing Reagent

作　　者：黄悦 吴婷[1] 杜珩 葛胜祥[1] 陈毅歆[1] 夏宁邵[1] 龚文峰 张军[1] HUANG Yue;WU Ting;DU Heng;GE Shengxiang;CHEN Yixin;XIA Ningshao;GONG Wenfeng;ZHANG Jun(National Institute of Diagnostics and Vaccine Development in Infectious Diseases,State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics,Collaborative Innovation Center of Biologic Products,School of Public Health,Xiamen University,Xiamen 361102,China;Bill&Melinda Gates Foundation,Beijing 100027,China)

机构地区：[1]厦门大学公共卫生学院,国家传染病诊断试剂与疫苗工程技术研究中心,分子疫苗学和分子诊断学国家重点实验室,医用生物制品省部共建协同创新中心,厦门361102 [2]比尔及梅琳达•盖茨基金会,北京100027

出　　处：《病毒学报》2020年第4期541-548,共8页Chinese Journal of Virology

基　　金：福建省科技重大专项(2020YZ014001),题目:新型冠状病毒候选疫苗及质量控制方法研究;厦门市科技重大专项(3502Z2020YJ01),题目:新冠状病毒快速诊断试剂的研制。

摘　　要：新型冠状病毒肺炎(COVID-19)已在全球形成大流行,目前其确诊主要依靠病毒核酸检测,但核酸检测存在漏诊及对检测条件要求较高等不足。与核酸检测相比,抗体检测通常具有普及面广、样品采集便捷、容易实现高通量、成本低等优点,与核酸检测联合应用可有效弥补核酸检测的缺陷。本研究设计了评价新型冠状病毒(SARSCoV-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,旨在帮助使用者在大规模应用抗体检测试剂前系统地评估抗体检测试剂的灵敏度、特异度等关键临床性能,以根据各自的检测目的在不同抗体检测试剂中做出合理的选择提供参考。To date,the coronavirus disease 2019(COVID-19)pandemic is impacting globally.COVID-19 is mainly diagnosed via viral nucleic acid testing,but with the disadvantages of unsatisfactory sensitivity and high requirements for expensive equipment and facility the operating settings.Compared with nucleic acid testing,antibody testing usually has advantages as wide popularization,convenient sample collection,easy to achieve high throughput,less workload,high reproducibility,and low cost,therefore it will be an efficient supplement for nucleic acid detection to confirm COVID-19.This protocol providesd detailed design for the assessment of antibody testing reagent,including consideration for the study objectives,calculation of sample size,inclusion and exclusion criteria,blinding method,experimental specimen,ethical issues,study management and quality control,data management and statistical analysis,and results report and so on,aiming to assist the researchers to systematically assess the critical performance of antibody testing reagent prior to large-scale application of the antibody testing reagent,so that researchers could make reasonable choices among different antibody testing reagents according to their respective purposes.

关 键 词：新型冠状病毒SARS-CoV-2 COVID-19 抗体 血清学 试剂 临床评估 

分 类 号：R373.1[医药卫生—病原生物学] R446.61[医药卫生—基础医学]