Comparison of the Diagnostic Value of Immunochromatography Kits in Corona Virus Disease 2019 Patients: A Prospective Pilot Study

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  • Mitsunaga Toshiya
    Department of Emergency Medicine, Association of EISEIKAI Medical and Healthcare Corporation Minamitama Hospital, Tokyo, Japan Department of Emergency Medicine, Jikei University School of Medicine, Tokyo, Japan Center for Preventive Medical Sciences, Chiba University, Chiba, Japan
  • Seki Yutaka
    Department of Emergency Medicine, Association of EISEIKAI Medical and Healthcare Corporation Minamitama Hospital, Tokyo, Japan Department of Cardiology, Association of EISEIKAI Medical and Healthcare Corporation Minamitama Hospital, Tokyo, Japan Department of Internal Medicine, Association of EISEIKAI Medical and Healthcare Corporation Minamitama Hospital, Tokyo, Japan
  • Yoshioka Masakata
    Department of Internal Medicine, Association of EISEIKAI Medical and Healthcare Corporation Minamitama Hospital, Tokyo, Japan
  • Suzuki Ippei
    Department of Internal Medicine, Association of EISEIKAI Medical and Healthcare Corporation Minamitama Hospital, Tokyo, Japan
  • Akita Kumi
    Department of Emergency Medicine, Association of EISEIKAI Medical and Healthcare Corporation Minamitama Hospital, Tokyo, Japan
  • Mashiko Syunsuke
    Department of Emergency Medicine, Jikei University School of Medicine, Tokyo, Japan
  • Uzura Masahiko
    Department of Emergency Medicine, Jikei University School of Medicine, Tokyo, Japan
  • Takeda Satoshi
    Department of Emergency Medicine, Jikei University School of Medicine, Tokyo, Japan
  • Sekine Akihiro
    Department of Emergency and Critical Care Medicine, Chiba University, Chiba, Japan
  • Mashiko Kunihiro
    Department of Emergency Medicine, Association of EISEIKAI Medical and Healthcare Corporation Minamitama Hospital, Tokyo, Japan

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Abstract

<p>Introduction: The spread of coronavirus 2019 (COVID-19) is a serious problem all over the world. Several immunochromatography kits of the antibody for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have been developed, but it is still unclear which kits have high diagnostic value. This study aims to evaluate the accuracy rate for antibody detection of each immunochromatography kit and reveal which kit has a high diagnostic value for antibody detection.</p><p>Methods: This study was carried out between 1 August 2020 and 14 October 2020 at the Association of EISEIKAI Medical and Healthcare Corporation Minamitama Hospital. Patients diagnosed with COVID-19 and approximately 30 days after symptom onset were included as the positive group. The serum SARS-CoV-2 antibodies were analysed using seven immunochromatography kits.</p><p>Results: Twenty samples (Positive group: 10 patients, Negative group: 10 healthy medical workers) were included in this study. The median age of the patients was 44 years, and the median duration from symptom onset was 30.5 days in the positive group. The accuracy rates for IgM/IgG detection were: 90.0%/100% in Kit A; 50.0%/95.0% in Kit B; 55.0%/65.0% in Kit C; 60.0%/55.0% in Kit D; 50.0%/80.0% in Kit E; 80.0%/90.0% in Kit F; and 90.0%/100% in Kit G.</p><p>Conclusions: Our study showed that there is a variation of accuracy rates between immunochromatography kits for antibodies of SARS-CoV-2. COVID-19 IgG/IgM RAPID TEST CASSETTE (Hangzhou Biotest Biotech Co., Ltd., China) and Nadal COVID-19 IgG/IgM Rapid Test (BioServUK Ltd., UK: United Kingdom) have high accuracy rates for both IgM and IgG detection. Evidence from large population studies of immunochromatography kits is needed to clarify the details of diagnostic value for SARS-CoV-2.</p>

Journal

  • JMA Journal

    JMA Journal 4 (1), 32-40, 2021-01-29

    Japan Medical Association / The Japanese Associaiton of Medical Sciences

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