Development and Clinical Application of A Rapid IgM-IgG Combined Antibody Test for SARS-CoV-2 Infection Diagnosis.
Identifieur interne : 000446 ( PubMed/Corpus ); précédent : 000445; suivant : 000447Development 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 YeSource :
- Journal of medical virology [ 1096-9071 ] ; 2020.
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 (SARS-Cov-2) nucleic acid RT-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 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 which can detect 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 8 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. This article is protected by copyright. All rights reserved.
DOI: 10.1002/jmv.25727
PubMed: 32104917
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Development and Clinical Application of A Rapid IgM-IgG Combined Antibody Test for SARS-CoV-2 Infection Diagnosis.</title><author><name sortKey="Li, Zhengtu" sort="Li, Zhengtu" uniqKey="Li Z" first="Zhengtu" last="Li">Zhengtu Li</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, 510120, China.</nlm:affiliation></affiliation></author><author><name sortKey="Yi, Yongxiang" sort="Yi, Yongxiang" uniqKey="Yi Y" first="Yongxiang" last="Yi">Yongxiang Yi</name><affiliation><nlm:affiliation>The 2nd Hospital of Nanjing, Nanjing University of Chinese Medicine, Nanjing, 210003, China.</nlm:affiliation></affiliation></author><author><name sortKey="Luo, Xiaomei" sort="Luo, Xiaomei" uniqKey="Luo X" first="Xiaomei" last="Luo">Xiaomei Luo</name><affiliation><nlm:affiliation>Chongqing Public Health Medical Center, Chongqing, 400036, China.</nlm:affiliation></affiliation></author><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 Red Cross Hospital, Wuhan, 430015, 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, 330006, China.</nlm:affiliation></affiliation></author><author><name sortKey="Li, Shaoqiang" sort="Li, Shaoqiang" uniqKey="Li S" first="Shaoqiang" last="Li">Shaoqiang Li</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, 510120, China.</nlm:affiliation></affiliation></author><author><name sortKey="Sun, Ruilin" sort="Sun, Ruilin" uniqKey="Sun R" first="Ruilin" last="Sun">Ruilin Sun</name><affiliation><nlm:affiliation>The 1st Affiliated Hospital of Nanchang University, Nanchang, 330006, China.</nlm:affiliation></affiliation></author><author><name sortKey="Wang, Yanqun" sort="Wang, Yanqun" uniqKey="Wang Y" first="Yanqun" last="Wang">Yanqun Wang</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, 510120, China.</nlm:affiliation></affiliation></author><author><name sortKey="Hu, Bicheng" sort="Hu, Bicheng" uniqKey="Hu B" first="Bicheng" last="Hu">Bicheng Hu</name><affiliation><nlm:affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</nlm:affiliation></affiliation></author><author><name sortKey="Chen, Wei" sort="Chen, Wei" uniqKey="Chen W" first="Wei" last="Chen">Wei Chen</name><affiliation><nlm:affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</nlm:affiliation></affiliation></author><author><name sortKey="Zhang, Yongchen" sort="Zhang, Yongchen" uniqKey="Zhang Y" first="Yongchen" last="Zhang">Yongchen Zhang</name><affiliation><nlm:affiliation>Chongqing Public Health Medical Center, Chongqing, 400036, China.</nlm:affiliation></affiliation></author><author><name sortKey="Wang, Jing" sort="Wang, Jing" uniqKey="Wang J" first="Jing" last="Wang">Jing Wang</name><affiliation><nlm:affiliation>Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; Wuhan Red Cross Hospital, Wuhan, 430015, China.</nlm:affiliation></affiliation></author><author><name sortKey="Huang, Baofu" sort="Huang, Baofu" uniqKey="Huang B" first="Baofu" last="Huang">Baofu Huang</name><affiliation><nlm:affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</nlm:affiliation></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, 510120, China.</nlm:affiliation></affiliation></author><author><name sortKey="Yang, Jiasheng" sort="Yang, Jiasheng" uniqKey="Yang J" first="Jiasheng" last="Yang">Jiasheng Yang</name><affiliation><nlm:affiliation>The 2nd Hospital of Nanjing, Nanjing University of Chinese Medicine, Nanjing, 210003, China.</nlm:affiliation></affiliation></author><author><name sortKey="Cai, Wensheng" sort="Cai, Wensheng" uniqKey="Cai W" first="Wensheng" last="Cai">Wensheng Cai</name><affiliation><nlm:affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</nlm:affiliation></affiliation></author><author><name sortKey="Wang, Xuefeng" sort="Wang, Xuefeng" uniqKey="Wang X" first="Xuefeng" last="Wang">Xuefeng Wang</name><affiliation><nlm:affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</nlm:affiliation></affiliation></author><author><name sortKey="Cheng, Jing" sort="Cheng, Jing" uniqKey="Cheng J" first="Jing" last="Cheng">Jing Cheng</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, 510120, China.</nlm:affiliation></affiliation></author><author><name sortKey="Chen, Zhiqiang" sort="Chen, Zhiqiang" uniqKey="Chen Z" first="Zhiqiang" last="Chen">Zhiqiang Chen</name><affiliation><nlm:affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</nlm:affiliation></affiliation></author><author><name sortKey="Sun, Kangjun" sort="Sun, Kangjun" uniqKey="Sun K" first="Kangjun" last="Sun">Kangjun Sun</name><affiliation><nlm:affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</nlm:affiliation></affiliation></author><author><name sortKey="Pan, Weimin" sort="Pan, Weimin" uniqKey="Pan W" first="Weimin" last="Pan">Weimin Pan</name><affiliation><nlm:affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</nlm:affiliation></affiliation></author><author><name sortKey="Zhan, Zhifei" sort="Zhan, Zhifei" uniqKey="Zhan Z" first="Zhifei" last="Zhan">Zhifei Zhan</name><affiliation><nlm:affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</nlm:affiliation></affiliation></author><author><name sortKey="Chen, Liyan" sort="Chen, Liyan" uniqKey="Chen L" first="Liyan" last="Chen">Liyan Chen</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, 510120, China.</nlm:affiliation></affiliation></author><author><name sortKey="Ye, Feng" sort="Ye, Feng" uniqKey="Ye F" first="Feng" last="Ye">Feng Ye</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, 510120, China.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2020">2020</date><idno type="RBID">pubmed:32104917</idno><idno type="pmid">32104917</idno><idno type="doi">10.1002/jmv.25727</idno><idno type="wicri:Area/PubMed/Corpus">000446</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000446</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Development and Clinical Application of A Rapid IgM-IgG Combined Antibody Test for SARS-CoV-2 Infection Diagnosis.</title><author><name sortKey="Li, Zhengtu" sort="Li, Zhengtu" uniqKey="Li Z" first="Zhengtu" last="Li">Zhengtu Li</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, 510120, China.</nlm:affiliation></affiliation></author><author><name sortKey="Yi, Yongxiang" sort="Yi, Yongxiang" uniqKey="Yi Y" first="Yongxiang" last="Yi">Yongxiang Yi</name><affiliation><nlm:affiliation>The 2nd Hospital of Nanjing, Nanjing University of Chinese Medicine, Nanjing, 210003, China.</nlm:affiliation></affiliation></author><author><name sortKey="Luo, Xiaomei" sort="Luo, Xiaomei" uniqKey="Luo X" first="Xiaomei" last="Luo">Xiaomei Luo</name><affiliation><nlm:affiliation>Chongqing Public Health Medical Center, Chongqing, 400036, China.</nlm:affiliation></affiliation></author><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 Red Cross Hospital, Wuhan, 430015, 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, 330006, China.</nlm:affiliation></affiliation></author><author><name sortKey="Li, Shaoqiang" sort="Li, Shaoqiang" uniqKey="Li S" first="Shaoqiang" last="Li">Shaoqiang Li</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, 510120, China.</nlm:affiliation></affiliation></author><author><name sortKey="Sun, Ruilin" sort="Sun, Ruilin" uniqKey="Sun R" first="Ruilin" last="Sun">Ruilin Sun</name><affiliation><nlm:affiliation>The 1st Affiliated Hospital of Nanchang University, Nanchang, 330006, China.</nlm:affiliation></affiliation></author><author><name sortKey="Wang, Yanqun" sort="Wang, Yanqun" uniqKey="Wang Y" first="Yanqun" last="Wang">Yanqun Wang</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, 510120, China.</nlm:affiliation></affiliation></author><author><name sortKey="Hu, Bicheng" sort="Hu, Bicheng" uniqKey="Hu B" first="Bicheng" last="Hu">Bicheng Hu</name><affiliation><nlm:affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</nlm:affiliation></affiliation></author><author><name sortKey="Chen, Wei" sort="Chen, Wei" uniqKey="Chen W" first="Wei" last="Chen">Wei Chen</name><affiliation><nlm:affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</nlm:affiliation></affiliation></author><author><name sortKey="Zhang, Yongchen" sort="Zhang, Yongchen" uniqKey="Zhang Y" first="Yongchen" last="Zhang">Yongchen Zhang</name><affiliation><nlm:affiliation>Chongqing Public Health Medical Center, Chongqing, 400036, China.</nlm:affiliation></affiliation></author><author><name sortKey="Wang, Jing" sort="Wang, Jing" uniqKey="Wang J" first="Jing" last="Wang">Jing Wang</name><affiliation><nlm:affiliation>Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; Wuhan Red Cross Hospital, Wuhan, 430015, China.</nlm:affiliation></affiliation></author><author><name sortKey="Huang, Baofu" sort="Huang, Baofu" uniqKey="Huang B" first="Baofu" last="Huang">Baofu Huang</name><affiliation><nlm:affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</nlm:affiliation></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, 510120, China.</nlm:affiliation></affiliation></author><author><name sortKey="Yang, Jiasheng" sort="Yang, Jiasheng" uniqKey="Yang J" first="Jiasheng" last="Yang">Jiasheng Yang</name><affiliation><nlm:affiliation>The 2nd Hospital of Nanjing, Nanjing University of Chinese Medicine, Nanjing, 210003, China.</nlm:affiliation></affiliation></author><author><name sortKey="Cai, Wensheng" sort="Cai, Wensheng" uniqKey="Cai W" first="Wensheng" last="Cai">Wensheng Cai</name><affiliation><nlm:affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</nlm:affiliation></affiliation></author><author><name sortKey="Wang, Xuefeng" sort="Wang, Xuefeng" uniqKey="Wang X" first="Xuefeng" last="Wang">Xuefeng Wang</name><affiliation><nlm:affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</nlm:affiliation></affiliation></author><author><name sortKey="Cheng, Jing" sort="Cheng, Jing" uniqKey="Cheng J" first="Jing" last="Cheng">Jing Cheng</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, 510120, China.</nlm:affiliation></affiliation></author><author><name sortKey="Chen, Zhiqiang" sort="Chen, Zhiqiang" uniqKey="Chen Z" first="Zhiqiang" last="Chen">Zhiqiang Chen</name><affiliation><nlm:affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</nlm:affiliation></affiliation></author><author><name sortKey="Sun, Kangjun" sort="Sun, Kangjun" uniqKey="Sun K" first="Kangjun" last="Sun">Kangjun Sun</name><affiliation><nlm:affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</nlm:affiliation></affiliation></author><author><name sortKey="Pan, Weimin" sort="Pan, Weimin" uniqKey="Pan W" first="Weimin" last="Pan">Weimin Pan</name><affiliation><nlm:affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</nlm:affiliation></affiliation></author><author><name sortKey="Zhan, Zhifei" sort="Zhan, Zhifei" uniqKey="Zhan Z" first="Zhifei" last="Zhan">Zhifei Zhan</name><affiliation><nlm:affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</nlm:affiliation></affiliation></author><author><name sortKey="Chen, Liyan" sort="Chen, Liyan" uniqKey="Chen L" first="Liyan" last="Chen">Liyan Chen</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, 510120, China.</nlm:affiliation></affiliation></author><author><name sortKey="Ye, Feng" sort="Ye, Feng" uniqKey="Ye F" first="Feng" last="Ye">Feng Ye</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, 510120, China.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Journal of medical virology</title><idno type="eISSN">1096-9071</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><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 (SARS-Cov-2) nucleic acid RT-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 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 which can detect 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 8 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. This article is protected by copyright. All rights reserved.</div></front></TEI><pubmed><MedlineCitation Status="Publisher" Owner="NLM"><PMID Version="1">32104917</PMID><DateRevised><Year>2020</Year><Month>02</Month><Day>27</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1096-9071</ISSN><JournalIssue CitedMedium="Internet"><PubDate><Year>2020</Year><Month>Feb</Month><Day>27</Day></PubDate></JournalIssue><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 (SARS-Cov-2) nucleic acid RT-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 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 which can detect 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 8 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. This article is protected by copyright. All rights reserved.</AbstractText><CopyrightInformation>This article is protected by copyright. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Li</LastName><ForeName>Zhengtu</ForeName><Initials>Z</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, 510120, China.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</Affiliation></AffiliationInfo></Author><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, 210003, China.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Luo</LastName><ForeName>Xiaomei</ForeName><Initials>X</Initials><AffiliationInfo><Affiliation>Chongqing Public Health Medical Center, Chongqing, 400036, China.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</Affiliation></AffiliationInfo></Author><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 Red Cross Hospital, Wuhan, 430015, China.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Liu</LastName><ForeName>Yang</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>The 1st Affiliated Hospital of Nanchang University, Nanchang, 330006, China.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Li</LastName><ForeName>Shaoqiang</ForeName><Initials>S</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, 510120, China.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sun</LastName><ForeName>Ruilin</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>The 1st Affiliated Hospital of Nanchang University, Nanchang, 330006, China.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</Affiliation></AffiliationInfo></Author><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, 510120, China.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hu</LastName><ForeName>Bicheng</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Wuhan No. 1 Hospital, Wuhan, 430022, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chen</LastName><ForeName>Wei</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>The 1st Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zhang</LastName><ForeName>Yongchen</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>Chongqing Public Health Medical Center, Chongqing, 400036, China.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wang</LastName><ForeName>Jing</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; Wuhan Red Cross Hospital, Wuhan, 430015, China.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Huang</LastName><ForeName>Baofu</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, 210061, China.</Affiliation></AffiliationInfo></Author><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, 510120, China.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Yang</LastName><ForeName>Jiasheng</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>The 2nd Hospital of Nanjing, Nanjing University of Chinese Medicine, Nanjing, 210003, China.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cai</LastName><ForeName>Wensheng</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, 210061, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wang</LastName><ForeName>Xuefeng</ForeName><Initials>X</Initials><Identifier Source="ORCID">http://orcid.org/0000-0001-8854-275X</Identifier><AffiliationInfo><Affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, 210061, China.</Affiliation></AffiliationInfo></Author><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, 510120, China.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chen</LastName><ForeName>Zhiqiang</ForeName><Initials>Z</Initials><AffiliationInfo><Affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, 210061, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sun</LastName><ForeName>Kangjun</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, 210061, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pan</LastName><ForeName>Weimin</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, 210061, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zhan</LastName><ForeName>Zhifei</ForeName><Initials>Z</Initials><AffiliationInfo><Affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Hunan Provincial Center For Disease Control and Prevention, Changsha, 410000, 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, 510120, China.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</Affiliation></AffiliationInfo></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, 510120, China.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou Guangdong, 510317, China.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>02</Month><Day>27</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>J Med Virol</MedlineTA><NlmUniqueID>7705876</NlmUniqueID><ISSNLinking>0146-6615</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">COVID-19</Keyword><Keyword MajorTopicYN="N">Lateral flow immunoassay</Keyword><Keyword MajorTopicYN="N">Point-of-Care Testing</Keyword><Keyword MajorTopicYN="N">SARS-CoV-2 Virus Infection</Keyword><Keyword MajorTopicYN="N">fingerstick blood</Keyword><Keyword MajorTopicYN="N">rapid IgM-IgG Combined test</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2020</Year><Month>2</Month><Day>28</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2020</Year><Month>2</Month><Day>28</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2020</Year><Month>2</Month><Day>28</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>aheadofprint</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">32104917</ArticleId><ArticleId IdType="doi">10.1002/jmv.25727</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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