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

Identifieur interne : 000737 ( 2020/Analysis ); précédent : 000736; suivant : 000738

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

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

Source :

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

Le document en format XML

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<name sortKey="Hu, Bicheng" sort="Hu, Bicheng" uniqKey="Hu B" first="Bicheng" last="Hu">Bicheng Hu</name>
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<nlm:affiliation>Wuhan No. 1 Hospital, Wuhan, China.</nlm:affiliation>
<country xml:lang="fr">République populaire de Chine</country>
<wicri:regionArea>Wuhan No. 1 Hospital, Wuhan</wicri:regionArea>
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<settlement type="city">Wuhan</settlement>
<region type="région">Hubei</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Chen, Wei" sort="Chen, Wei" uniqKey="Chen W" first="Wei" last="Chen">Wei Chen</name>
<affiliation wicri:level="1">
<nlm:affiliation>The 1st Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.</nlm:affiliation>
<country xml:lang="fr">République populaire de Chine</country>
<wicri:regionArea>The 1st Affiliated Hospital of Xi'an Jiaotong University, Xi'an</wicri:regionArea>
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<name sortKey="Zhang, Yongchen" sort="Zhang, Yongchen" uniqKey="Zhang Y" first="Yongchen" last="Zhang">Yongchen Zhang</name>
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<nlm:affiliation>The 2nd Hospital of Nanjing, Nanjing University of Chinese Medicine, Nanjing, China.</nlm:affiliation>
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<wicri:regionArea>The 2nd Hospital of Nanjing, Nanjing University of Chinese Medicine, Nanjing</wicri:regionArea>
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<name sortKey="Wang, Jing" sort="Wang, Jing" uniqKey="Wang J" first="Jing" last="Wang">Jing Wang</name>
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<nlm:affiliation>Chongqing Public Health Medical Center, Chongqing, China.</nlm:affiliation>
<country xml:lang="fr">République populaire de Chine</country>
<wicri:regionArea>Chongqing Public Health Medical Center, Chongqing</wicri:regionArea>
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<nlm:affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.</nlm:affiliation>
<country xml:lang="fr">République populaire de Chine</country>
<wicri:regionArea>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing</wicri:regionArea>
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<name sortKey="Lin, Ye" sort="Lin, Ye" uniqKey="Lin Y" first="Ye" last="Lin">Ye Lin</name>
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<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>
<country xml:lang="fr">République populaire de Chine</country>
<wicri:regionArea>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</wicri:regionArea>
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<settlement type="city">Jiangmen</settlement>
<region type="province">Guangdong</region>
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<name sortKey="Yang, Jiasheng" sort="Yang, Jiasheng" uniqKey="Yang J" first="Jiasheng" last="Yang">Jiasheng Yang</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou, Guangdong, China.</nlm:affiliation>
<country xml:lang="fr">République populaire de Chine</country>
<wicri:regionArea>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou, Guangdong</wicri:regionArea>
<wicri:noRegion>Guangdong</wicri:noRegion>
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</author>
<author>
<name sortKey="Cai, Wensheng" sort="Cai, Wensheng" uniqKey="Cai W" first="Wensheng" last="Cai">Wensheng Cai</name>
<affiliation wicri:level="1">
<nlm:affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.</nlm:affiliation>
<country xml:lang="fr">République populaire de Chine</country>
<wicri:regionArea>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing</wicri:regionArea>
<wicri:noRegion>Nanjing</wicri:noRegion>
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<author>
<name sortKey="Wang, Xuefeng" sort="Wang, Xuefeng" uniqKey="Wang X" first="Xuefeng" last="Wang">Xuefeng Wang</name>
<affiliation wicri:level="1">
<nlm:affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.</nlm:affiliation>
<country xml:lang="fr">République populaire de Chine</country>
<wicri:regionArea>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing</wicri:regionArea>
<wicri:noRegion>Nanjing</wicri:noRegion>
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<author>
<name sortKey="Cheng, Jing" sort="Cheng, Jing" uniqKey="Cheng J" first="Jing" last="Cheng">Jing Cheng</name>
<affiliation wicri:level="3">
<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>
<country xml:lang="fr">République populaire de Chine</country>
<wicri:regionArea>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</wicri:regionArea>
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<settlement type="city">Jiangmen</settlement>
<region type="province">Guangdong</region>
</placeName>
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<author>
<name sortKey="Chen, Zhiqiang" sort="Chen, Zhiqiang" uniqKey="Chen Z" first="Zhiqiang" last="Chen">Zhiqiang Chen</name>
<affiliation wicri:level="1">
<nlm:affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.</nlm:affiliation>
<country xml:lang="fr">République populaire de Chine</country>
<wicri:regionArea>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing</wicri:regionArea>
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<author>
<name sortKey="Sun, Kangjun" sort="Sun, Kangjun" uniqKey="Sun K" first="Kangjun" last="Sun">Kangjun Sun</name>
<affiliation wicri:level="1">
<nlm:affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.</nlm:affiliation>
<country xml:lang="fr">République populaire de Chine</country>
<wicri:regionArea>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing</wicri:regionArea>
<wicri:noRegion>Nanjing</wicri:noRegion>
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</author>
<author>
<name sortKey="Pan, Weimin" sort="Pan, Weimin" uniqKey="Pan W" first="Weimin" last="Pan">Weimin Pan</name>
<affiliation wicri:level="1">
<nlm:affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.</nlm:affiliation>
<country xml:lang="fr">République populaire de Chine</country>
<wicri:regionArea>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing</wicri:regionArea>
<wicri:noRegion>Nanjing</wicri:noRegion>
</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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<nlm:affiliation>Hunan Provincial Center for Disease Control and Prevention, Changsha, China.</nlm:affiliation>
<country xml:lang="fr">République populaire de Chine</country>
<wicri:regionArea>Hunan Provincial Center for Disease Control and Prevention, Changsha</wicri:regionArea>
<wicri:noRegion>Changsha</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Chen, Liyan" sort="Chen, Liyan" uniqKey="Chen L" first="Liyan" last="Chen">Liyan Chen</name>
<affiliation wicri:level="3">
<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>
<country xml:lang="fr">République populaire de Chine</country>
<wicri:regionArea>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</wicri:regionArea>
<placeName>
<settlement type="city">Jiangmen</settlement>
<region type="province">Guangdong</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Ye, Feng" sort="Ye, Feng" uniqKey="Ye F" first="Feng" last="Ye">Feng Ye</name>
<affiliation wicri:level="3">
<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>
<country xml:lang="fr">République populaire de Chine</country>
<wicri:regionArea>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</wicri:regionArea>
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<settlement type="city">Jiangmen</settlement>
<region type="province">Guangdong</region>
</placeName>
</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>
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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>
</TEI>
<affiliations>
<list>
<country>
<li>République populaire de Chine</li>
</country>
<region>
<li>Guangdong</li>
<li>Hubei</li>
<li>Jiangxi</li>
</region>
<settlement>
<li>Jiangmen</li>
<li>Nanchang</li>
<li>Wuhan</li>
</settlement>
</list>
<tree>
<country name="République populaire de Chine">
<region name="Guangdong">
<name sortKey="Li, Zhengtu" sort="Li, Zhengtu" uniqKey="Li Z" first="Zhengtu" last="Li">Zhengtu Li</name>
</region>
<name sortKey="Cai, Wensheng" sort="Cai, Wensheng" uniqKey="Cai W" first="Wensheng" last="Cai">Wensheng Cai</name>
<name sortKey="Chen, Liyan" sort="Chen, Liyan" uniqKey="Chen L" first="Liyan" last="Chen">Liyan Chen</name>
<name sortKey="Chen, Wei" sort="Chen, Wei" uniqKey="Chen W" first="Wei" last="Chen">Wei Chen</name>
<name sortKey="Chen, Zhiqiang" sort="Chen, Zhiqiang" uniqKey="Chen Z" first="Zhiqiang" last="Chen">Zhiqiang Chen</name>
<name sortKey="Cheng, Jing" sort="Cheng, Jing" uniqKey="Cheng J" first="Jing" last="Cheng">Jing Cheng</name>
<name sortKey="Hu, Bicheng" sort="Hu, Bicheng" uniqKey="Hu B" first="Bicheng" last="Hu">Bicheng Hu</name>
<name sortKey="Huang, Baofu" sort="Huang, Baofu" uniqKey="Huang B" first="Baofu" last="Huang">Baofu Huang</name>
<name sortKey="Li, Shaoqiang" sort="Li, Shaoqiang" uniqKey="Li S" first="Shaoqiang" last="Li">Shaoqiang Li</name>
<name sortKey="Lin, Ye" sort="Lin, Ye" uniqKey="Lin Y" first="Ye" last="Lin">Ye Lin</name>
<name sortKey="Liu, Yang" sort="Liu, Yang" uniqKey="Liu Y" first="Yang" last="Liu">Yang Liu</name>
<name sortKey="Luo, Xiaomei" sort="Luo, Xiaomei" uniqKey="Luo X" first="Xiaomei" last="Luo">Xiaomei Luo</name>
<name sortKey="Pan, Weimin" sort="Pan, Weimin" uniqKey="Pan W" first="Weimin" last="Pan">Weimin Pan</name>
<name sortKey="Sun, Kangjun" sort="Sun, Kangjun" uniqKey="Sun K" first="Kangjun" last="Sun">Kangjun Sun</name>
<name sortKey="Sun, Ruilin" sort="Sun, Ruilin" uniqKey="Sun R" first="Ruilin" last="Sun">Ruilin Sun</name>
<name sortKey="Wang, Jing" sort="Wang, Jing" uniqKey="Wang J" first="Jing" last="Wang">Jing Wang</name>
<name sortKey="Wang, Xuefeng" sort="Wang, Xuefeng" uniqKey="Wang X" first="Xuefeng" last="Wang">Xuefeng Wang</name>
<name sortKey="Wang, Yanqun" sort="Wang, Yanqun" uniqKey="Wang Y" first="Yanqun" last="Wang">Yanqun Wang</name>
<name sortKey="Xiong, Nian" sort="Xiong, Nian" uniqKey="Xiong N" first="Nian" last="Xiong">Nian Xiong</name>
<name sortKey="Yang, Jiasheng" sort="Yang, Jiasheng" uniqKey="Yang J" first="Jiasheng" last="Yang">Jiasheng Yang</name>
<name sortKey="Ye, Feng" sort="Ye, Feng" uniqKey="Ye F" first="Feng" last="Ye">Feng Ye</name>
<name sortKey="Yi, Yongxiang" sort="Yi, Yongxiang" uniqKey="Yi Y" first="Yongxiang" last="Yi">Yongxiang Yi</name>
<name sortKey="Zhan, Zhifei" sort="Zhan, Zhifei" uniqKey="Zhan Z" first="Zhifei" last="Zhan">Zhifei Zhan</name>
<name sortKey="Zhang, Yongchen" sort="Zhang, Yongchen" uniqKey="Zhang Y" first="Yongchen" last="Zhang">Yongchen Zhang</name>
</country>
</tree>
</affiliations>
</record>

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