This TGA Approved COVID-19 Antigen Rapid Test is a lateral flow immunoassay based on the principle of double antibody sandwich technology. The SARS-CoV-2 nucleocapsid protein monoclonal antibody conjugated with colored microparticles is used as a detector and sprayed onto the ...This TGA Approved COVID-19 Antigen Rapid Test is a lateral flow immunoassay based on the principle of double antibody sandwich technology. The SARS-CoV-2 nucleocapsid protein monoclonal antibody conjugated with colored microparticles is used as a detector and sprayed onto the conjugation pad.
During the test, the SARS-CoV-2 antigen in the sample interacts with the SARS-CoV-2 antibody, which is conjugated with colored microparticles, creating an antigen-antibody-labeled complex. This complex migrates via capillary action on the membrane to the test line, where it is captured by the pre-coated monoclonal SARS-CoV-2 nucleocapsid protein antibody. A colored test line (T) would be visible in the result window if SARS-CoV-2 antigens are present in the sample.
The absence of the T-line indicates a negative result. The control line is used as a procedural control and should always be displayed when the test procedure is being carried out properly. Until lay approval from the BfArM is available, the test is only approved for medical or trained personnel.