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Last updated: 2021/5/18

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COVID-19 Viral Antigen Rapid Test (CE IVD) GMPCoronavirus

  • Catalog # : DC0302
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  • Specification
  • Product Description:
  • COVID-19 Viral Antigen Rapid Test provides a fast, convenient, and qualitative testing of SARS nucleocapsid antigens from nasal swabs in individuals who are suspected of COVID-19 (SARS-CoV-2) within first 12 days of symptom onset.
  • Supplied Product:
  • 25 Test Kit:
    COVID-19 Antigen Testing Strips (25)
     - Colloidal gold-labeled COVID-19 nucleocapsid murine monoclonal antibody
     - COVID-19 nucleocapsid human monoclonal antibody
     - Goat anti-murine polyclonal antibody
    Extraction Buffers (25)
     - Extraction reagent
    Droppers (25)
     - 100 uL Dropper for drawing sample mixture
    Positive Control Swab (1)
     - Non-infectious, recombinant viral nucleocapsid protein with less than 0.1% sodium azide
    Negative Control Swab (1)
     - Buffer with less than 0.1% sodium azide
    Assay Documentation (1)
     - Instructions for Use
  • Storage Instruction:
  • Store product at 15°C-30°C (59°F-86°F) and avoid direct exposure to sunlight.
    Do not freeze or store the product outside the temperature range described above.
    Do not open until ready to use.
    Do not use it after the expiration date.
  • Note:
  • Product Image


  • Fresh Specimen Sampling Procedure and Test


  • Suitable Sample:
  • Nasal Swab Specimen (not Nasopharyngeal or Oropharyngeal)
  • Features:
  • Fast result in 15 minutes
    Easy to operate
    Highly sensitive via visual inspection
  • Intended Use:
  • This product is a chromatographic immunoassay for the rapid and qualitative detection of SARS nucleocapsid antigens from nasal swabs in individuals who are suspected of COVID-19 within first 12 days of symptom onset.
  • Video:
  • Applications
  • Lateral Flow Immunoassay
  • Lateral Flow Immunoassay
  • Result Zone of the COVID-19 Antigen Testing Strip indicates Test line (T line) Control line (C line). C line must appear to ensure the quality of sample processing.

    Note: Report all positive results to the appropriate public health authorities. For invalid results, review the procedure and repeat the procedure with a new test. If the problem persists, discontinue using the test kit and contact local distributors and Abnova.
  • Lateral Flow Immunoassay
  • Lateral Flow Immunoassay
  • PPA: 100% (C.I. 84%-100%)
    NPA: 95% (C.I. 87%-98%)
    OPA: 96% (C.I. 90%-99%)

    81 direct nasal swabs were prospectively collected and enrolled from individual symptomatic patients (within 12 days of onset) who were suspected of COVID-19. The performance of the Abnova COVID-19 Viral Antigen Rapid Test was compared to results of a nasopharyngeal swab tested with an Emergency Use Authorized molecular (RT-PCR) test for detection of SARS-CoV-2.
  • Application Image
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