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Development and clinical application of a rapid IgM-IgG combined antibody test for SARS-CoV-2 infection diagnosis.

Identifieur interne : 000741 ( PubMed/Corpus ); précédent : 000740; suivant : 000742

Development and clinical application of a rapid IgM-IgG combined antibody test for SARS-CoV-2 infection diagnosis.

Auteurs : Zhengtu Li ; Yongxiang Yi ; Xiaomei Luo ; Nian Xiong ; Yang Liu ; Shaoqiang Li ; Ruilin Sun ; Yanqun Wang ; Bicheng Hu ; Wei Chen ; Yongchen Zhang ; Jing Wang ; Baofu Huang ; Ye Lin ; Jiasheng Yang ; Wensheng Cai ; Xuefeng Wang ; Jing Cheng ; Zhiqiang Chen ; Kangjun Sun ; Weimin Pan ; Zhifei Zhan ; Liyan Chen ; Feng Ye

Source :

Journal of medical virology [ 1096-9071 ] ; 2020.

RBID : pubmed:32104917

Abstract

The outbreak of the novel coronavirus disease (COVID-19) quickly spread all over China and to more than 20 other countries. Although the virus (severe acute respiratory syndrome coronavirus [SARS-Cov-2]) nucleic acid real-time polymerase chain reaction (PCR) test has become the standard method for diagnosis of SARS-CoV-2 infection, these real-time PCR test kits have many limitations. In addition, high false-negative rates were reported. There is an urgent need for an accurate and rapid test method to quickly identify a large number of infected patients and asymptomatic carriers to prevent virus transmission and assure timely treatment of patients. We have developed a rapid and simple point-of-care lateral flow immunoassay that can detect immunoglobulin M (IgM) and IgG antibodies simultaneously against SARS-CoV-2 virus in human blood within 15 minutes which can detect patients at different infection stages. With this test kit, we carried out clinical studies to validate its clinical efficacy uses. The clinical detection sensitivity and specificity of this test were measured using blood samples collected from 397 PCR confirmed COVID-19 patients and 128 negative patients at eight different clinical sites. The overall testing sensitivity was 88.66% and specificity was 90.63%. In addition, we evaluated clinical diagnosis results obtained from different types of venous and fingerstick blood samples. The results indicated great detection consistency among samples from fingerstick blood, serum and plasma of venous blood. The IgM-IgG combined assay has better utility and sensitivity compared with a single IgM or IgG test. It can be used for the rapid screening of SARS-CoV-2 carriers, symptomatic or asymptomatic, in hospitals, clinics, and test laboratories.

DOI: 10.1002/jmv.25727
PubMed: 32104917

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pubmed:32104917

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<author><name sortKey="Lin, Ye" sort="Lin, Ye" uniqKey="Lin Y" first="Ye" last="Lin">Ye Lin</name>
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<author><name sortKey="Yang, Jiasheng" sort="Yang, Jiasheng" uniqKey="Yang J" first="Jiasheng" last="Yang">Jiasheng Yang</name>
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<author><name sortKey="Cai, Wensheng" sort="Cai, Wensheng" uniqKey="Cai W" first="Wensheng" last="Cai">Wensheng Cai</name>
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<author><name sortKey="Cheng, Jing" sort="Cheng, Jing" uniqKey="Cheng J" first="Jing" last="Cheng">Jing Cheng</name>
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<author><name sortKey="Zhan, Zhifei" sort="Zhan, Zhifei" uniqKey="Zhan Z" first="Zhifei" last="Zhan">Zhifei Zhan</name>
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<author><name sortKey="Chen, Liyan" sort="Chen, Liyan" uniqKey="Chen L" first="Liyan" last="Chen">Liyan Chen</name>
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</affiliation>
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<author><name sortKey="Luo, Xiaomei" sort="Luo, Xiaomei" uniqKey="Luo X" first="Xiaomei" last="Luo">Xiaomei Luo</name>
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</affiliation>
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<author><name sortKey="Xiong, Nian" sort="Xiong, Nian" uniqKey="Xiong N" first="Nian" last="Xiong">Nian Xiong</name>
<affiliation><nlm:affiliation>Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Liu, Yang" sort="Liu, Yang" uniqKey="Liu Y" first="Yang" last="Liu">Yang Liu</name>
<affiliation><nlm:affiliation>The 1st Affiliated Hospital of Nanchang University, Nanchang, China.</nlm:affiliation>
</affiliation>
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<author><name sortKey="Li, Shaoqiang" sort="Li, Shaoqiang" uniqKey="Li S" first="Shaoqiang" last="Li">Shaoqiang Li</name>
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<author><name sortKey="Sun, Ruilin" sort="Sun, Ruilin" uniqKey="Sun R" first="Ruilin" last="Sun">Ruilin Sun</name>
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<author><name sortKey="Zhang, Yongchen" sort="Zhang, Yongchen" uniqKey="Zhang Y" first="Yongchen" last="Zhang">Yongchen Zhang</name>
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<author><name sortKey="Wang, Jing" sort="Wang, Jing" uniqKey="Wang J" first="Jing" last="Wang">Jing Wang</name>
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</affiliation>
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<author><name sortKey="Huang, Baofu" sort="Huang, Baofu" uniqKey="Huang B" first="Baofu" last="Huang">Baofu Huang</name>
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</affiliation>
</author>
<author><name sortKey="Lin, Ye" sort="Lin, Ye" uniqKey="Lin Y" first="Ye" last="Lin">Ye Lin</name>
<affiliation><nlm:affiliation>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.</nlm:affiliation>
</affiliation>
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<author><name sortKey="Yang, Jiasheng" sort="Yang, Jiasheng" uniqKey="Yang J" first="Jiasheng" last="Yang">Jiasheng Yang</name>
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</affiliation>
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<author><name sortKey="Cheng, Jing" sort="Cheng, Jing" uniqKey="Cheng J" first="Jing" last="Cheng">Jing Cheng</name>
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<author><name sortKey="Chen, Zhiqiang" sort="Chen, Zhiqiang" uniqKey="Chen Z" first="Zhiqiang" last="Chen">Zhiqiang Chen</name>
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<author><name sortKey="Sun, Kangjun" sort="Sun, Kangjun" uniqKey="Sun K" first="Kangjun" last="Sun">Kangjun Sun</name>
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</affiliation>
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<author><name sortKey="Pan, Weimin" sort="Pan, Weimin" uniqKey="Pan W" first="Weimin" last="Pan">Weimin Pan</name>
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</affiliation>
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<author><name sortKey="Zhan, Zhifei" sort="Zhan, Zhifei" uniqKey="Zhan Z" first="Zhifei" last="Zhan">Zhifei Zhan</name>
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</affiliation>
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<author><name sortKey="Chen, Liyan" sort="Chen, Liyan" uniqKey="Chen L" first="Liyan" last="Chen">Liyan Chen</name>
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<front><div type="abstract" xml:lang="en">The outbreak of the novel coronavirus disease (COVID-19) quickly spread all over China and to more than 20 other countries. Although the virus (severe acute respiratory syndrome coronavirus [SARS-Cov-2]) nucleic acid real-time polymerase chain reaction (PCR) test has become the standard method for diagnosis of SARS-CoV-2 infection, these real-time PCR test kits have many limitations. In addition, high false-negative rates were reported. There is an urgent need for an accurate and rapid test method to quickly identify a large number of infected patients and asymptomatic carriers to prevent virus transmission and assure timely treatment of patients. We have developed a rapid and simple point-of-care lateral flow immunoassay that can detect immunoglobulin M (IgM) and IgG antibodies simultaneously against SARS-CoV-2 virus in human blood within 15 minutes which can detect patients at different infection stages. With this test kit, we carried out clinical studies to validate its clinical efficacy uses. The clinical detection sensitivity and specificity of this test were measured using blood samples collected from 397 PCR confirmed COVID-19 patients and 128 negative patients at eight different clinical sites. The overall testing sensitivity was 88.66% and specificity was 90.63%. In addition, we evaluated clinical diagnosis results obtained from different types of venous and fingerstick blood samples. The results indicated great detection consistency among samples from fingerstick blood, serum and plasma of venous blood. The IgM-IgG combined assay has better utility and sensitivity compared with a single IgM or IgG test. It can be used for the rapid screening of SARS-CoV-2 carriers, symptomatic or asymptomatic, in hospitals, clinics, and test laboratories.</div>
</front>
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<DateRevised><Year>2020</Year>
<Month>04</Month>
<Day>13</Day>
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<JournalIssue CitedMedium="Internet"><PubDate><Year>2020</Year>
<Month>Feb</Month>
<Day>27</Day>
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<Title>Journal of medical virology</Title>
<ISOAbbreviation>J. Med. Virol.</ISOAbbreviation>
</Journal>
<ArticleTitle>Development and clinical application of a rapid IgM-IgG combined antibody test for SARS-CoV-2 infection diagnosis.</ArticleTitle>
<ELocationID EIdType="doi" ValidYN="Y">10.1002/jmv.25727</ELocationID>
<Abstract><AbstractText>The outbreak of the novel coronavirus disease (COVID-19) quickly spread all over China and to more than 20 other countries. Although the virus (severe acute respiratory syndrome coronavirus [SARS-Cov-2]) nucleic acid real-time polymerase chain reaction (PCR) test has become the standard method for diagnosis of SARS-CoV-2 infection, these real-time PCR test kits have many limitations. In addition, high false-negative rates were reported. There is an urgent need for an accurate and rapid test method to quickly identify a large number of infected patients and asymptomatic carriers to prevent virus transmission and assure timely treatment of patients. We have developed a rapid and simple point-of-care lateral flow immunoassay that can detect immunoglobulin M (IgM) and IgG antibodies simultaneously against SARS-CoV-2 virus in human blood within 15 minutes which can detect patients at different infection stages. With this test kit, we carried out clinical studies to validate its clinical efficacy uses. The clinical detection sensitivity and specificity of this test were measured using blood samples collected from 397 PCR confirmed COVID-19 patients and 128 negative patients at eight different clinical sites. The overall testing sensitivity was 88.66% and specificity was 90.63%. In addition, we evaluated clinical diagnosis results obtained from different types of venous and fingerstick blood samples. The results indicated great detection consistency among samples from fingerstick blood, serum and plasma of venous blood. The IgM-IgG combined assay has better utility and sensitivity compared with a single IgM or IgG test. It can be used for the rapid screening of SARS-CoV-2 carriers, symptomatic or asymptomatic, in hospitals, clinics, and test laboratories.</AbstractText>
<CopyrightInformation>© 2020 The Authors. Journal of Medical Virology Published by Wiley Periodicals, Inc.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Li</LastName>
<ForeName>Zhengtu</ForeName>
<Initials>Z</Initials>
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</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Yi</LastName>
<ForeName>Yongxiang</ForeName>
<Initials>Y</Initials>
<AffiliationInfo><Affiliation>The 2nd Hospital of Nanjing, Nanjing University of Chinese Medicine, Nanjing, China.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Luo</LastName>
<ForeName>Xiaomei</ForeName>
<Initials>X</Initials>
<AffiliationInfo><Affiliation>Chongqing Public Health Medical Center, Chongqing, China.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Xiong</LastName>
<ForeName>Nian</ForeName>
<Initials>N</Initials>
<AffiliationInfo><Affiliation>Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Liu</LastName>
<ForeName>Yang</ForeName>
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<ForeName>Shaoqiang</ForeName>
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</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Sun</LastName>
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<Initials>R</Initials>
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</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Wang</LastName>
<ForeName>Yanqun</ForeName>
<Initials>Y</Initials>
<AffiliationInfo><Affiliation>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Hu</LastName>
<ForeName>Bicheng</ForeName>
<Initials>B</Initials>
<AffiliationInfo><Affiliation>Wuhan No. 1 Hospital, Wuhan, China.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Chen</LastName>
<ForeName>Wei</ForeName>
<Initials>W</Initials>
<AffiliationInfo><Affiliation>The 1st Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Zhang</LastName>
<ForeName>Yongchen</ForeName>
<Initials>Y</Initials>
<AffiliationInfo><Affiliation>The 2nd Hospital of Nanjing, Nanjing University of Chinese Medicine, Nanjing, China.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Wang</LastName>
<ForeName>Jing</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Chongqing Public Health Medical Center, Chongqing, China.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Huang</LastName>
<ForeName>Baofu</ForeName>
<Initials>B</Initials>
<AffiliationInfo><Affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Lin</LastName>
<ForeName>Ye</ForeName>
<Initials>Y</Initials>
<AffiliationInfo><Affiliation>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Yang</LastName>
<ForeName>Jiasheng</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou, Guangdong, China.</Affiliation>
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<Author ValidYN="Y"><LastName>Cai</LastName>
<ForeName>Wensheng</ForeName>
<Initials>W</Initials>
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<ForeName>Xuefeng</ForeName>
<Initials>X</Initials>
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<AffiliationInfo><Affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Cheng</LastName>
<ForeName>Jing</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.</Affiliation>
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<Author ValidYN="Y"><LastName>Chen</LastName>
<ForeName>Zhiqiang</ForeName>
<Initials>Z</Initials>
<AffiliationInfo><Affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.</Affiliation>
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<ForeName>Kangjun</ForeName>
<Initials>K</Initials>
<AffiliationInfo><Affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.</Affiliation>
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<ForeName>Weimin</ForeName>
<Initials>W</Initials>
<AffiliationInfo><Affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.</Affiliation>
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<Author ValidYN="Y"><LastName>Zhan</LastName>
<ForeName>Zhifei</ForeName>
<Initials>Z</Initials>
<AffiliationInfo><Affiliation>Hunan Provincial Center for Disease Control and Prevention, Changsha, China.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Chen</LastName>
<ForeName>Liyan</ForeName>
<Initials>L</Initials>
<AffiliationInfo><Affiliation>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.</Affiliation>
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</Author>
<Author ValidYN="Y"><LastName>Ye</LastName>
<ForeName>Feng</ForeName>
<Initials>F</Initials>
<AffiliationInfo><Affiliation>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.</Affiliation>
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<Language>eng</Language>
<PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType>
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<ArticleDate DateType="Electronic"><Year>2020</Year>
<Month>02</Month>
<Day>27</Day>
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<MedlineJournalInfo><Country>United States</Country>
<MedlineTA>J Med Virol</MedlineTA>
<NlmUniqueID>7705876</NlmUniqueID>
<ISSNLinking>0146-6615</ISSNLinking>
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<Keyword MajorTopicYN="N">SARS-CoV-2 virus infection</Keyword>
<Keyword MajorTopicYN="N">fingerstick blood</Keyword>
<Keyword MajorTopicYN="N">lateral flow immunoassay</Keyword>
<Keyword MajorTopicYN="N">point-of-care testing</Keyword>
<Keyword MajorTopicYN="N">rapid IgM-IgG combined test</Keyword>
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<PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year>
<Month>02</Month>
<Day>24</Day>
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<PubMedPubDate PubStatus="accepted"><Year>2020</Year>
<Month>02</Month>
<Day>26</Day>
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<Month>2</Month>
<Day>28</Day>
<Hour>6</Hour>
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<Day>28</Day>
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<ArticleIdList><ArticleId IdType="pubmed">32104917</ArticleId>
<ArticleId IdType="doi">10.1002/jmv.25727</ArticleId>
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</ReferenceList>
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Development and clinical application of a rapid IgM-IgG combined antibody test for SARS-CoV-2 infection diagnosis.

Development and clinical application of a rapid IgM-IgG combined antibody test for SARS-CoV-2 infection diagnosis.

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