Comparison of SARS-CoV-2 antigen test kit “Quick Navi<sup>TM</sup>-COVID19 Ag” with nucleic acid amplification test and presentation of mismatched cases: Retrospective study using one-year field clinical data

  • YAMAMOTO Hajime
    Department of Clinical Laboratory, Takeda General Hospital, The Takeda Healthcare Foundation
  • SATOH Manami
    Department of Clinical Laboratory, Takeda General Hospital, The Takeda Healthcare Foundation
  • SAIKAWA Takeshi
    Department of Clinical Laboratory, Takeda General Hospital, The Takeda Healthcare Foundation
  • MIROKU Sayaka
    Department of Clinical Laboratory, Takeda General Hospital, The Takeda Healthcare Foundation
  • SEKIMOTO Masahiro
    Department of Clinical Laboratory, Takeda General Hospital, The Takeda Healthcare Foundation
  • NIHONYANAGI Hiroshi
    Department of Clinical Laboratory, Takeda General Hospital, The Takeda Healthcare Foundation
  • ISHIHATA Tetsuya
    Department of Clinical Laboratory, Takeda General Hospital, The Takeda Healthcare Foundation
  • TAKADA Naoki
    Department of Clinical Laboratory, Takeda General Hospital, The Takeda Healthcare Foundation

Bibliographic Information

Other Title
  • SARS-CoV-2抗原定性検査キット「クイックナビ<sup>TM</sup>-COVID19 Ag」における核酸増幅検査との判定比較と不一致症例の提示
  • Comparison of SARS-CoV-2 antigen test kit “Quick NaviTM-COVID19 Ag” with nucleic acid amplification test and presentation of mismatched cases: Retrospective study using one-year field clinical data (Article in Japanese)

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Description

<p>Rapid diagnostic tests by antigen detection for diagnosing COVID-19 are widely used because they can be conducted easily and inexpensively. In this study, we compared the diagnostic performance of the SARS-CoV-2 antigen qualitative test kit “Quick NaviTM-COVID19 Ag” compared with that of the nucleic acid amplification test. As a result, both tests showed a concordance rate of 99.3%. Thirty cases showed both negative antigen qualitative and positive nucleic acid amplification test results. In many of the 30 cases, the Ct value tends to be high, and the amount of virus may be lower than the minimum detection sensitivity of the antigen qualitative test, and thus the results of the nucleic acid amplification test may not match those of the antigen qualitative test. On the other hand, seven cases showed both positive antigen qualitative and negative nucleic acid amplification test results. In all these seven cases, COVID-19 was confirmed to be negative, but a false positive result of the antigen qualitative test was obtained, the cause of which was not identified. From the above, it was clarified that “Quick NaviTM-COVID19 Ag” has sufficient performance as a SARS-CoV-2 antigen qualitative test. However, since false negative and positive results, which depend on the performance limits of the immunochromatography method, cannot be avoided, we should use it with sufficient attention to the characteristics of the test method.</p>

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Details 詳細情報について

  • CRID
    1390573407595207936
  • DOI
    10.14932/jamt.21-96
  • ISSN
    21885346
    09158669
  • Text Lang
    ja
  • Data Source
    • JaLC
    • Crossref
  • Abstract License Flag
    Disallowed

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