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Last updated: 2020/8/2

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COVID-19 Human IgM IgG Rapid Test GMP

  • Catalog # : DC0301
  • Visit Frequency :
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  • Specification
  • Product Description:
  • COVID-19 Human IgM IgG Rapid Test provides a fast, convenient, and qualitative testing of human whole blood and plasma for COVID-19 (SARS-CoV-2) IgM and IgG.
  • Supplied Product:
  • Kit content:
    Pouch 1: COVID-19 Testing Strip
     a. Colloidal Gold-Labeled COVID-19 N Protein
     b. Colloidal Gold-Labeled COVID-19 RBD Protein
     c. Colloidal Gold-Labeled Control Antibody
     d. Anti-Human IgM Antibody
     e. Anti-Human IgG Antibody
     f. Anti-Control Antibody
    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 and Plasma
  • 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 or plasma. This product is for professional use only.
  • Regulatory Status:
  • GMP grade
    CE-IVD approved
    Notice: Pre-Emergency Use Authorization (EUA) submission to FDA (PEUA200217).
  • Notification:
  • Clinical laboratories 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
  • 31 known COVID-19 positive and 75 known negative EDTA whole blood samples were collected, confirmed with EUA authorized RT-PCR, and tested for COVID-19 IgM and IgG reactivity following symptom onset with results read by two blinded, independent viewers.
  • Application Image
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