タイトルまたは説明

INTENDED USE

GenBody COVID-19 IgM/IgG device is a chromatographic immunoassay kit for the rapid and differential detection of immunoglobulin M (lgM) and immunoglobulin G (IgG) against COVID-19 using serum, plasma and whole blood.

EXPLANATION OF THE TEST

The recombinant COVID-19 antigen was coated on the membrane and anti-human IgM and IgG monoclonal antibody was conjugated the gold particles, respectively. When the specimen existing anti-COVID-19 antibodies is loaded into a sample well (S), the antibodies are complexed with anti- human IgM (or IgG) gold conjugate. And this complex migrates and captured by the immobilized recombinant COVID-19 antigens to make a visible band in the test line regions, M and G. The solution continues to migrate to the control line (C) region that binds a control conjugate, thereby producing another red line. GenBody COVID-19 IgM/IgG can detect the antibodies against COVID-19, so that the device is suitable for the diagnosis of COVID-19 infections.

MATERIALS PROVIDED

GenBody COVID-19 IgM/IgG kit contains the following components:

1. Test device individually foil-pouched with a desiccant

2. Assay solution in dropping bottle

3. Capillary tube for sample loading

4. Instructions for UseINTENDED USE

GenBody COVID-19 IgM/IgG device is a chromatographic immunoassay kit for the rapid and differential detection of immunoglobulin M (lgM) and immunoglobulin G (IgG) against COVID-19 using serum, plasma and whole blood.

4. Instructions for Use