Medakit Antigen Rapid test device is an in vitro immunoassay. This assay is for the direct and qualitative detection of SARS- CoV-2 viral nucleoprotein antigens from nasopharyngeal and oropharyngeal secretions.
It effectively detects an active Covid-19 infection.
The immune colloidal gold technique is used in the assay to detect antigens of COVID-19. The reagent binding pad is coated with anti-SARS-CoV-2 monoclonal antibodies which is labeled with colloidal gold marker, respectively. A nitrocellulose membrane in test area of a strip is coated with anti-SARS-CoV-2 antibodies. The quality control area within the nitrocellulose membrane is coated with goat anti-mouse IgG antibodies. When testing, the antibodies against COVID-19 form immuno-complexes with the antigen protein of the virus in the specimen to be tested. As a result of chromatography, immuno-complexes move along the membrane and will be captured by the anti-SARS-CoV-2 antibodies coated in the test area to form a visible line with red color (T line). The free colloidal gold marker or immune complexes continue to move forward and specifically bind to the goat anti-mouse antibody coated in the quality control area to form a visible line (C line). If the specimen does not contain the antigen of COVID-19, no test line will show, only quality control line(C line) will appear.
Results are valid 15 minutes after the sample is inserted in the cassette sample well.
A total of two detection lines are possible, with the control (C) line appearing when sample has been flowed through the cassette.
POSITIVE:Two colored lines appear on the membrane. One line appears in the control region (C) and the other line appears in the test
NEGATIVE: Only one colored line appears in the control region (C). No apparent colored line appears in the test region (T).
INVALID: Control line fails to appear. Results from any test which has not produced a control line at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
1. The color intensity in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control line failure.
Medakit new rapid test provides highly accurate COVID-19 infection diagnosis within 15 minutes.
SARS-CoV-2, the virus that causes COVID-19, has several known antigens, including its nucleocapsid phosphoprotein and spike glycoprotein, which are the visible protrusions on its surface.
This test detects the SARS-CoV-2 viral nucleoprotein antigen, and effectively detects an active Covid-19 infection.