Clinical characteristics and antibody response to SARS-CoV-2 spike 1 protein using the VITROS Anti-SARS-CoV-2 antibody tests in COVID-19 patients in Japan

Nagura-Ikeda, Mayu; Imai, Kazuo; Kubota, Katsumi; Noguchi, Sakiko; Kitagawa, Yutaro; Matsuoka, Masaru; Tabata, Sakiko; Miyoshi, Kazuyasu; Ito, Toshimitsu; Tamura, Kaku; Maeda, Takuya

Abstract Background: We evaluated clinical characteristics and the clinical utility of VITROS SARS-CoV-2 antibody tests according to COVID-19 severity in patients in Japan. Methods: We analyzed 255 serum specimens from 130 COVID-19 patients and examined clinical records and laboratory data. Presence of total (IgA, IgM, and IgG) and specific IgG antibody for the spike 1 antigen of SARS-CoV2 was determined using VITROS Anti-SARS-CoV-2 antibody tests. Findings: Overall, 98 (75.4%) and 32 (24.6%) patients had mild and severe COVID-19, respectively. On admission, 76 (58.5%) and 45 (34.6%) patients were positive for total and IgG antibody assays. Among 91 patients at discharge, 90 (98.9%) and 81 (89.0%) patients were positive for total and IgG antibody, respectively. Clinical background and laboratory findings on admission, but not the prevalence or concentration of total or IgG antibody, were associated with disease prognosis. Total and IgG antibody intensity were significantly higher in severe cases than in mild cases in serum collected after 11 days from onset, but not within 10 days. Conclusion: VITROS Anti-SARS-CoV-2 Total and IgG assays will be useful as supporting diagnostic and surveillance tools and for evaluation of humoral immune response to COVID-19. Clinical background and laboratory findings are preferable predictors of disease prognosis.