[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1; 2; 熊丹1; 2; 武薇1; 汤花梅1; 陈大洋1; 豆小文1; 王萌萌2; 张秀明1; 2
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-yang1; 2;  XIONG Dan1; 2;  WU Wei1;  TANG Hua-mei1;  CHEN Da-yang1;  DOU Xiao-wen1;  WANG Meng-meng1;  ZHANG Xiu-ming1; 2
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