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Clinical validation of an immunochromatographic SARS‐Cov‐2 IgM/IgG antibody assay with Japanese cohort
Author(s) -
Kaneko Shun,
Nukui Yoko,
Arashiro Takeshi,
Aiso Yoshibumi,
Sugii Maya,
Hadano Yoshiro,
Nagata Kaoru,
Taki Reiko,
Ueda Ken,
Hanada Satoko,
Suzaki Shinichiro,
Harada Naoshige,
Yamaguchi Yoshimi,
Nakanishi Hiroyuki,
Kurosaki Masayuki,
Nagasawa Masayuki,
Izumi Namiki
Publication year - 2021
Publication title -
journal of medical virology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.782
H-Index - 121
eISSN - 1096-9071
pISSN - 0146-6615
DOI - 10.1002/jmv.26363
Subject(s) - medicine , covid-19 , antibody , immunoglobulin m , virology , immunoglobulin g , immunology , gastroenterology , disease , infectious disease (medical specialty)
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.