Evaluation of a new rapid antibody test based on immunochromatography targeting the S protein of SARS-CoV-2: COVID-19 immunity passport based on immunochromatographic test

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  • SATO Momoko
    Department of Clinical Laboratory, Saitama Medical University Hospital
  • KITAGAWA Yutaro
    Department of Clinical Laboratory, Saitama Medical University Hospital
  • KUBOTA Katsumi
    Department of Clinical Laboratory, Saitama Medical University Hospital
  • TAKADA Tomohito
    Department of Clinical Laboratory, Saitama Medical University Hospital
  • NOGUCHI Sakiko
    Department of Clinical Laboratory, Saitama Medical University Hospital
  • MATSUOKA Masaru
    Department of Clinical Laboratory, Saitama Medical University Hospital
  • TAKEUCHI Shinichi
    Department of Clinical Laboratory, Saitama Medical University Hospital
  • MAEDA Takuya
    Department of Clinical Laboratory, Saitama Medical University Hospital

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  • COVID-19に対するイムノクロマト法による迅速抗体検査の適応と有用性の検討
  • COVID-19 ニ タイスル イムノクロマトホウ ニ ヨル ジンソク コウタイ ケンサ ノ テキオウ ト ユウヨウセイ ノ ケントウ

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Abstract

<p>We evaluated the clinical performance of an immunochromatographic antibody test (ICT), namely, a colloidal gold immunochromatography test “NOZOMI®” for the IgG antibody against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) S protein. We examined 142 serum specimens collected from 92 patients with COVID-19 and also 50 serum specimens collected from febrile non-COVID-19 patients. Additionally, 50 medical staff members who had completed two doses of SARS-CoV-2 vaccines were also included in this study. The sensitivity, specificity, and accuracy for IgG for the S protein were 51.1% (47/92), 96.0% (48/50), and 80.8%, respectively. Among the 50 non-COVID-19 serum specimens, two generated a false-positive result in this ICT “NOZOMI®”. However, IgG for the S protein was satisfactorily detected in 100.0% (17/17) of specimens collected > 22 days after symptom onset. In case of medical staff members, the IgG-S antibody was quantitatively evaluated using the Elecsys® Anti-SARS-CoV-2 S RUO antibody test, and the serum specimens determined to have an antibody titer of 500 U/mL or higher also showed a positive result in the ICT test “NOZOMI®”. Our preliminary data suggest that ICT has potential use in the implementation of the COVID-19 immunity passport.</p>

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