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. 2020 Sep 20;10(1):1821513.
doi: 10.1080/20008686.2020.1821513.

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

Yang De Marinis  1   2 , Torgny Sunnerhagen  3 , Pradeep Bompada  1 , Anna Bläckberg  3 , Runtao Yang  4 , Joel Svensson  5 , Ola Ekström  1 , Karl-Fredrik Eriksson  6 , Ola Hansson  1   7 , Leif Groop  1   7 , Isabel Gonçalves  8 , Magnus Rasmussen  3
Affiliations

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

Yang De Marinis et al. Infect Ecol Epidemiol. .

Abstract

The coronavirus disease 2019 (COVID-19) pandemic has created a global health- and economic crisis. 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. 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 higher sensitivity by serum/plasma over whole blood. Test specificity was determined to be 97% on 69 sera/plasma samples collected between 2016-2018. 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 results support 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.

Keywords: COVID-19; IgM and IgG; SARS-CoV-2; antibody test; disease severity and duration; serology assessment.

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Conflict of interest statement

TS, 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.

Figures

Figure 1.
Figure 1.
Serum SARS-Cov-2 IgM and IgG antibody detection in response to hospitalization in COVID-19 patients. IgM and IgG reactivity to SARS-CoV-2 was measured in sera in patients with PCR-confirmed COVID-19 (n = 45) by lateral flow test COVID-19 Antibody test IgM/IgG (ZetaGene, Sweden). Total IgM, IgG and total antibody detection percentage (%) are presented for the hospitalized (red bars, n = 12) and non-hospitalized patients (black bars, n = 33).
Figure 2.
Figure 2.
The distribution of COVID-19 IgM and IgG detection in hospitalized vs. non-hospitalized patients. Qualitative detection of IgM and IgG to SARS-CoV-2 was assessed in sera of hospitalized (n = 12) and non-hospitalized (n = 33) COVID-19 patients. IgG and IgM positivity and distribution (%) in the COVID-19 patients are presented in respective color as indicated in the figure.
Figure 3.
Figure 3.
The distribution of antibody detection in response to time from onset and hospitalization. Total IgM, IgG and total antibody detection percentage (%) are presented for PCR-confirmed COVID-19 patients divided into the following groups: (1) acute patients with < 2 weeks (w) after onset (n = 8); (2) convalescent patients with > 2 weeks after onset, non-hospitalized (n = 26); (3) convalescent patients with > 2 weeks after onset, hospitalized (n = 11). Different groups are presented in respective colors as indicated in the figure.
Figure 4.
Figure 4.
The dynamics of COVID-19 IgM/IgG detection in response to time from onset and hospitalization. Qualitative detection of IgM and IgG to SARS-CoV-2 is mapped in COVID-19 cohort patients from the following groups: (1) acute patients with < 2 weeks (w) after onset (n = 8); (2) convalescent patients with > 2 weeks after onset, non-hospitalized (n = 26); (3) convalescent patients with > 2 weeks after onset, hospitalized (n = 11). IgM and IgG detection percentage (%) is presented in respective color as indicated in the figure.
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Grants and funding

This 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 (2018-02635, OH), the Crafoord foundation (20200928, OH), Governmental funding of clinical research within the NHS (National Health Services, 2018-0253) (to MR, AB and OH), the Novo Nordisk foundation (NNF18OC0033572, OH) and the Påhlsson foundation (OH). The CPIP study was supported by grants to IG from the Swedish Research Council (2019-01260), Swedish Heart and Lung Foundation (20170333), Skåne University Hospital (2019-o000032), Stroke Foundation, ALF grants Region Skåne (2019: 1 207 000). Governmental Avtal om Läkarutbildning och Forskning (ST-ALF 2017-ST0003) (to JS).

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