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Last updated: 2020/5/17

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COVID-19 Human IgM IgG Rapid Test GMP

  • 目錄號 # : DC0301
  • 訪問頻率 :
  • 目前國家 :
  • Specification
  • Product Description:
  • COVID-19 Human IgM IgG Rapid Test provides a fast, convenient, and qualitative testing of human whole blood, plasma, and serum for COVID-19 IgM and IgG.
  • Supplied Product:
  • Kit content:
    Pouch 1: COVID-19 Testing Strip
    Pouch 2: Sample Buffer
  • Storage Instruction:
  • Store product at 15-30°C and avoid direct exposure to sunlight.
    Do not open until ready to use.
    Do not freeze or store the product outside the temperature range described above.
    Do not use after the expiration date.
  • Note:
  • Product Image


  • Product Procedure


  • Suitable Sample:
  • Human whole blood, Plasma, and Serum
  • Features:
  • Fast result in 15 minutes
    Easy to operate
    Highly sensitive via visual inspection
  • Intended Use:
  • This product is a lateral flow immunoassay for the rapid detection of human IgM and IgG antibodies against COVID-19 virus in human whole blood, plasma, or serum. This product is for professional use only.
  • Regulatory Status:
  • GMP grade
    Notice: Pre-Emergency Use Authorization (EUA) submission to FDA (PEUA200217).
  • Notification:
  • Laboratories and healthcare providers must include this information in their patient test report as specified in FDA guidance:

    This test has not been reviewed by the FDA.
    Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
    Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
    Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
  • Applications
  • Lateral Flow Immunoassay
  • Lateral Flow Immunoassay
  • Result zone of the Testing Strip indicates human IgM line (T1 line), IgG line (T2 line) and control line (C line). C line must appear to ensure the quality of sample processing.
  • Lateral Flow Immunoassay
  • Lateral Flow Immunoassay
  • A total of 167 cases were tested: 37 (positive) clinically confirmed (including PCR test) COVID-19-infected patients and 130 non-COVID-19-infected patients (negative).

    Cross Reactivity: In testing, this test did not cross-react with FLuA, FLuB or RSV antibodies. SARS-COV1 has not yet been tested.
  • Application Image
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