Sole Agent of Covid Antigen Test Kits

Intended Use

Detection of SARS-CoV-2 antigen in nasopharyngeal or nasal swabs (to aid in the diagnosis of SARS-CoV-2 infection)

Measuring principle

This assay is based on immunochromatographic technology using monoclonal antibodies against SARS-CoV-2 antigen. The test stick consists of a sample well, a conjugate pad containing colored nanoparticle-labeled anti-SARS-CoV-2 monoclonal antibody (rabbit) (hereinafter, the colored nanoparticle-antibody), a membrane immobilized with anti-SARS-CoV-2 monoclonal antibody (mouse) (hereinafter, a capture antibody) and an anti-rabbit immunoglobulin polyclonal antibody (goat).

​Sample dropped on the sample well of the test stick will flow into the conjugate pad due to the capillary phenomenon. The colored nanoparticles-labeled antibody in the conjugate pad will dissolve in the specimen and form the antigen-antibody complex with the SARS-CoV-2 antigen in the sample. The formed antigen-antibody complex continuously move to the membrane and is captured with the capture antibody immobilized on the membrane. The colored nanoparticles of the captured antigen-antibody complex will appear as a red line on the [T1] in the test window. In this kit, appearance of this red line can be visually confirmed to determine the presence of SARS-CoV-2 antigen in the specimen. In addition, the non-complexed antibody conjugated with red nanoparticles will move to the [C] in the test window and be captured with polyclonal antibody against rabbit immunoglobulin immobilized on the membrane. The colored nanoparticles of the captured non-complexed antibody will appear as a red line on the [C] in the test window, indicating that the test is performing successfully.