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. 2021 Jan;93(1):569-572.
doi: 10.1002/jmv.26363. Epub 2020 Aug 26.

Clinical validation of an immunochromatographic SARS-Cov-2 IgM/IgG antibody assay with Japanese cohort

Shun Kaneko  1 , Yoko Nukui  2 , Takeshi Arashiro  2 , Yoshibumi Aiso  2 , Maya Sugii  2 , Yoshiro Hadano  2 , Kaoru Nagata  3 , Reiko Taki  4 , Ken Ueda  3 , Satoko Hanada  4 , Shinichiro Suzaki  5 , Naoshige Harada  5 , Yoshimi Yamaguchi  6 , Hiroyuki Nakanishi  1 , Masayuki Kurosaki  1 , Masayuki Nagasawa  7 , Namiki Izumi  1
Affiliations

Clinical validation of an immunochromatographic SARS-Cov-2 IgM/IgG antibody assay with Japanese cohort

Shun Kaneko et al. J Med Virol. 2021 Jan.

Abstract

Background: The coronavirus disease 2019 (COVID-19) has become a major health threat. To overcome COVID-19, appropriate diagnosis methods are urgently needed. The aim of this study was to clinically evaluate the colloidal gold immunochromatography assay for SARS-Cov-2 IgM/IgG antibody (Ab).

Methods: Patients confirmed COVID-19 (n = 51) were recruited prospectively from the Musashino Red Cross hospital and Tokyo Medical and Dental University Medical Hospital, between March and May 2020. And the analytical specificity was assessed with serum samples of patients without COVID-19 (n = 100) collected between August to September 2019 before SARS-CoV-2 was first reported in China.

Results: Among COVID-19 patients, a total of 87 serum samples were tested for SARS-Cov-2 IgM/IgG Ab assay. IgM was detected 71.0 %, 86.9 %, and 83.3 % at day8-14, 15-28, >29 after symptom onset and IgG was detected in 81.6 %, 87.0 %, and 94.4 %, respectively. The sensitivity of IgM and IgG Ab after day8 assay was significantly higher than before day7, respectively (p=0.0016, 0.0003). There were no positive results in 100 serum samples from patients without COVID-19.

Conclusion: The SARS-Cov-2 IgM/IgG Ab assay had 79.7% / 86.1% sensitivity (the 8 days after from onset) and 100% specificity in this population.

Keywords: COVID-19; SARS-Cov-2 IgM/IgG antibody; colloidal gold immunochromatography assay.

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