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Serology assessment of antibody response to SARS-CoV-2 in patients with COVID-19 by rapid IgM/IgG antibody test

De Marinis, Yang LU ; Sunnerhagen, Torgny LU ; Bompada, Pradeep LU ; Bläckberg, Anna LU ; Yang, Runtao ; Svensson, Joel LU ; Ekström, Ola LU ; Eriksson, Karl-Fredrik LU ; Hansson, Ola LU and Groop, Leif LU , et al. (2020) In medRxiv
Abstract
The coronavirus disease 2019 (COVID-19) pandemic has created a global health- and economic crisis. Lifting confinement restriction and resuming to normality depends greatly on COVID-19 immunity screening. Detection of antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which causes COVID-19 by serological methods is important to diagnose a current or resolved infection. In this study, we applied a rapid COVID-19 IgM/IgG antibody test and performed serology assessment of antibody response to SARS-CoV-2. In PCR-confirmed COVID-19 patients (n=45), the total antibody detection rate is 92% in hospitalized patients and 79% in non-hospitalized patients. We also studied antibody response in relation to time after symptom... (More)
The coronavirus disease 2019 (COVID-19) pandemic has created a global health- and economic crisis. Lifting confinement restriction and resuming to normality depends greatly on COVID-19 immunity screening. Detection of antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which causes COVID-19 by serological methods is important to diagnose a current or resolved infection. In this study, we applied a rapid COVID-19 IgM/IgG antibody test and performed serology assessment of antibody response to SARS-CoV-2. In PCR-confirmed COVID-19 patients (n=45), the total antibody detection rate is 92% in hospitalized patients and 79% in non-hospitalized patients. We also studied antibody response in relation to time after symptom onset and disease severity, and observed an increase in antibody reactivity and distinct distribution patterns of IgM and IgG following disease progression. The total IgM and IgG detection is 63% in patients with < 2 weeks from disease onset; 85% in non-hospitalized patients with > 2 weeks disease duration; and 91% in hospitalized patients with > 2 weeks disease duration. We also compared different blood sample types and suggest a potentially higher sensitivity by serum/plasma comparing with whole blood measurement. To study the specificity of the test, we used 69 sera/plasma samples collected between 2016-2018 prior to the COVID-19 pandemic, and obtained a test specificity of 97%. In summary, our study provides a comprehensive validation of the rapid COVID-19 IgM/IgG serology test, and mapped antibody detection patterns in association with disease progress and hospitalization. Our study supports that the rapid COVID-19 IgM/IgG test may be applied to assess the COVID-19 status both at the individual and at a population level.Competing Interest StatementTS, PB, AB, RY, JS, OE, KFE, OH, LG, IG and MR declare no conflict of interest. YDM is the founder of and has an equity interest in ZetaGene Ltd. (Sweden), a company that is developing microfluidic technologies for point-of-care diagnostic solutions.Funding StatementThis study was supported by the Swedish Research Council, Strategic Research Area Exodiab, Dnr 2009-1039; and the Swedish Foundation for Strategic Research Dnr IRC15-0067, the Swedish Research Council (OH), the Crafoord foundation (OH), Governmental funding of clinical research within the NHS (National Health Services) (to MR, AB and OH), the Novo Nordisk foundation (OH) and the Pahlsson foundation (OH). The CPIP study was supported by grants to IG from the Swedish Research Council, Swedish Heart and Lung Foundation, Skane University Hospital, Stroke Foundation, ALF grants Region Skane. Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:ETHICS The study was performed in accordance with the Declaration of Helsinki. Patients in all study cohorts included gave informed consent to serum donation and study participation. All studies were approved by the ethical review board: the COVID-19 prospective study (2020-01747); CPIP (472/2005); and MSAT (2015/593). All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesThe authors confirm th t the data supporting the findings of this study are available within the article. (Less)
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@misc{145dd7d5-a208-4d1e-a130-e92a55441c7a,
  abstract     = {The coronavirus disease 2019 (COVID-19) pandemic has created a global health- and economic crisis. Lifting confinement restriction and resuming to normality depends greatly on COVID-19 immunity screening. Detection of antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which causes COVID-19 by serological methods is important to diagnose a current or resolved infection. In this study, we applied a rapid COVID-19 IgM/IgG antibody test and performed serology assessment of antibody response to SARS-CoV-2. In PCR-confirmed COVID-19 patients (n=45), the total antibody detection rate is 92% in hospitalized patients and 79% in non-hospitalized patients. We also studied antibody response in relation to time after symptom onset and disease severity, and observed an increase in antibody reactivity and distinct distribution patterns of IgM and IgG following disease progression. The total IgM and IgG detection is 63% in patients with &lt; 2 weeks from disease onset; 85% in non-hospitalized patients with &gt; 2 weeks disease duration; and 91% in hospitalized patients with &gt; 2 weeks disease duration. We also compared different blood sample types and suggest a potentially higher sensitivity by serum/plasma comparing with whole blood measurement. To study the specificity of the test, we used 69 sera/plasma samples collected between 2016-2018 prior to the COVID-19 pandemic, and obtained a test specificity of 97%. In summary, our study provides a comprehensive validation of the rapid COVID-19 IgM/IgG serology test, and mapped antibody detection patterns in association with disease progress and hospitalization. Our study supports that the rapid COVID-19 IgM/IgG test may be applied to assess the COVID-19 status both at the individual and at a population level.Competing Interest StatementTS, PB, AB, RY, JS, OE, KFE, OH, LG, IG and MR declare no conflict of interest. YDM is the founder of and has an equity interest in ZetaGene Ltd. (Sweden), a company that is developing microfluidic technologies for point-of-care diagnostic solutions.Funding StatementThis study was supported by the Swedish Research Council, Strategic Research Area Exodiab, Dnr 2009-1039; and the Swedish Foundation for Strategic Research Dnr IRC15-0067, the Swedish Research Council (OH), the Crafoord foundation (OH), Governmental funding of clinical research within the NHS (National Health Services) (to MR, AB and OH), the Novo Nordisk foundation (OH) and the Pahlsson foundation (OH). The CPIP study was supported by grants to IG from the Swedish Research Council, Swedish Heart and Lung Foundation, Skane University Hospital, Stroke Foundation, ALF grants Region Skane. Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:ETHICS The study was performed in accordance with the Declaration of Helsinki. Patients in all study cohorts included gave informed consent to serum donation and study participation. All studies were approved by the ethical review board: the COVID-19 prospective study (2020-01747); CPIP (472/2005); and MSAT (2015/593). All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesThe authors confirm th t the data supporting the findings of this study are available within the article.},
  author       = {De Marinis, Yang and Sunnerhagen, Torgny and Bompada, Pradeep and Bläckberg, Anna and Yang, Runtao and Svensson, Joel and Ekström, Ola and Eriksson, Karl-Fredrik and Hansson, Ola and Groop, Leif and Goncalves, Isabel and Rasmussen, Magnus},
  language     = {eng},
  series       = {medRxiv},
  title        = {Serology assessment of antibody response to SARS-CoV-2 in patients with COVID-19 by rapid IgM/IgG antibody test},
  url          = {http://dx.doi.org/10.1101/2020.08.05.20168815},
  doi          = {10.1101/2020.08.05.20168815},
  year         = {2020},
}