[1]宗曾艳,熊丹,武薇,等.一种国产新型冠状病毒核酸检测试剂盒的性能验证[J].现代检验医学杂志,2020,35(05):113-117.[doi:10.3969/j.issn.1671-7414.2020.05.029]
 ZONG Zeng-yang,XIONG Dan,WU Wei,et al.Performance Evaluation of A Domestic New Coronavirus Detection Kit[J].Journal of Modern Laboratory Medicine,2020,35(05):113-117.[doi:10.3969/j.issn.1671-7414.2020.05.029]
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一种国产新型冠状病毒核酸检测试剂盒的性能验证()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第35卷
期数:
2020年05期
页码:
113-117
栏目:
新型冠状病毒肺炎检验专题
出版日期:
2020-11-01

文章信息/Info

Title:
Performance Evaluation of A Domestic New Coronavirus Detection Kit
文章编号:
1671-7414(2020)05-113-05
作者:
宗曾艳12熊丹12武薇1汤花梅1陈大洋1豆小文1王萌萌2张秀明12
1. 深圳市罗湖医院集团医学检验实验室,广东深圳 518001;2. 安徽理工大学医学院,安徽淮南 232001
Author(s):
ZONG Zeng-yang12 XIONG Dan12 WU Wei1 TANG Hua-mei1 CHEN Da-yang1 DOU Xiao-wen1 WANG Meng-meng1 ZHANG Xiu-ming12
1. Department of Central Laboratory, Shenzhen Luohu Hospital Group, Guangdong Shenzhen 518001,China;2. Anhui University of Science and Technology, Anhui Huainan 232001,China
关键词:
新型冠状病毒核酸检测性能评价
分类号:
R373.19;R446
DOI:
10.3969/j.issn.1671-7414.2020.05.029
文献标志码:
A
摘要:
目的 评估一种国产新型冠状病毒(SARS-CoV-2)核酸检测试剂盒是否满足临床SARS-CoV-2 核酸检测要求。 方法 采用15 例SARS-CoV-2 核酸阳性和15 例SARS-CoV-2 核酸阴性的临床样本,1 支SARS-CoV-2 RNA 干粉标准 品,5 支阳性定值参考品和5 支阴性定值参考品,对该试剂盒检测SARS-CoV-2 阴性和阳性符合率、精密度、检出限和 交叉反应进行验证。结果 20 例阴性和20 例阳性样本的N 基因和ORF1ab 基因阴阳符合率均为100%。2 例阳性样本 ORF1ab 基因重复性CV 为0.41%~0.56%,优于N 基因重复性,N 基因和ORF1ab 基因重复性、实验室总不精密度CV 均< 5%。检出限重复20 次的检出率为100%,SARS-CoV-2 与常见呼吸道病原体、与SARS-CoV-2 同种属病毒(人副 流感病毒1 型、鼻病毒、MERS,SARS,甲型流感病毒、乙型流感病毒、冠状病毒HKU1,NL63,229E 和OC43)之间不 产生交叉反应。 结论 该试剂盒阴阳性符合率一致,重复性好。SARS-CoV-2 与常见呼吸道病原体,与SARS-CoV-2 同 种属病毒不会产生交叉反应,适用于临床实验室和检测机构进行SARS-CoV-2 核酸筛查。
Abstract:
Objective To evaluate whether a domestic novel coronavirus (SARS-CoV-2) nucleic acid detection kit meets the requirements of clinical new coronavirus nucleic acid detection. Methods Fifteen positive and negative clinical samples, one SARS-CoV-2 RNA dry powder standard, and five positive and negative reference samples were collected to verify the negative and positive coincidence rate, precision, detection limit, and cross-reactivity for SARS-CoV-2. Results The negative and positive coincidence rate of both N gene and ORF1ab gene were 100% (20 negative and positive samples). CV of ORF1ab gene repeatability was 0.41%~0.56% and better than that of N gene. The CV of repeatability and total laboratory imprecision of both N gene and ORF1ab gene were all less than 5%. The detection rate was 100% with 20 repeats. Common respiratory pathogens and viruses of the same genus as the new coronavirus (human parainfluenza virus type 1, rhinovirus, MERS, SARS, influenza a virus, influenza b virus, coronavirus HKU1, NL63, 229E, OC43) were no cross-reaction with the SARS-CoV-2. Conclusion  The kit had the same negative and positive coincidence rate, and good reproducibility. SARS-CoV-2 did not have cross-reaction with common respiratory pathogens and viruses of the same species as the SARS-CoV-2. It is suitable for clinical laboratory and testing institutions for SARS-CoV-2 nucleic acid screening.

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备注/Memo

备注/Memo:
基金项目:国家自然科学基金面上项目(81772921), 深圳市基础研究自由探索项目(JCYJ20180306172209668),深圳市卫生计生委学      科建设能力提升项目(SZXJ2017018),深圳市医疗卫生三名工程(SZSM201601062)。
作者简介:宗曾艳(1992-),女,在读研究生,主要研究分子诊断和肿瘤标志物方向,E-mail:1445385411@qq.com。
通讯作者:张秀明, 教授,主任技师,E-mail:zxm0760@163.com。
更新日期/Last Update: 2020-10-30