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. 2020 Sep 10;6(9):e04929.
doi: 10.1016/j.heliyon.2020.e04929. eCollection 2020 Sep.

Reliability of serological tests for COVID-19: comparison of three immunochromatography test kits for SARS-CoV-2 antibodies

Hidetsugu Fujigaki  1 , Masao Takemura  1 , Michiko Osawa  2 , Aki Sakurai  3 , Kentaro Nakamoto  1 , Koichi Seto  4 , Takashi Fujita  2 , Tadayoshi Hata  2 , Hidehiko Akiyama  5 , Yohei Doi  3 , Kuniaki Saito  1
Affiliations

Reliability of serological tests for COVID-19: comparison of three immunochromatography test kits for SARS-CoV-2 antibodies

Hidetsugu Fujigaki et al. Heliyon. .

Abstract

Background: Several immunochromatographic serological test kits have been developed to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific antibodies, but their relative performance and potential clinical utility is unclear.

Methods: Three commercially available serological test kits were evaluated using 99 serum samples collected from 29 patients diagnosed with coronavirus disease 2019 (COVID-19) and 100 serum samples collected from 100 healthy volunteers in 2017 as negative controls.

Results: The specificity of the IgM and IgG antibodies showed comparable results among the three immunochromatographic serological test kits. The specificity for IgM antibody was 98.0%, 98.0%, and 97.0%, and the specificity for IgG antibody was identical among the three kits (99.0%). The IgM antibody-positive rates of the three test kits for samples taken at the early stage of the disease (0-4 days after onset) were consistent with all three kits (18.2%); however, the IgM antibody-positive rates thereafter showed considerable differences among the kits, making it difficult to interpret the kinetics of IgM response against SARS-CoV-2. The IgG antibody-positive rates for samples taken after 13 days of onset were 100.0%, 97.6%, and 97.6%, respectively.

Conclusion: There were large differences among the results of the three test kits. Only few cases showed positive results for IgM, suggesting that at least 2 of these kits used in this study were unsuitable for diagnosis of COVID-19. The IgG antibody was positive in almost all samples after 13 days of onset, suggesting that it may be useful for determining infections in the recent past.

Keywords: Antibody; COVID-19; Diagnostics; Immunochromatography; Immunology; Infectious disease; Laboratory medicine; SARS-CoV-2; Virology.

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Figures

Figure 1
Figure 1
Kinetics of anti-SARS-CoV-2 IgM antibody of serum samples from 29 COVID-19 patients. The positive or negative result of the antibody in each serum sample is expressed as + or −, respectively. A, Hangzhou AllTest; B, SD BIOSENSOR; C, Vazyme.
Figure 2
Figure 2
Kinetics of anti-SARS-CoV-2 IgG antibody of serum samples from 29 COVID-19 patients. The positive or negative result of the antibody in each serum sample is expressed as + or −, respectively. A, Hangzhou AllTest; B, SD BIOSENSOR; C, Vazyme.
See this image and copyright information in PMC

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