The Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) is an in vitro diagnostic test for the qualitative detection of novel coronavirus antigens in Nasopharyngeal swab, using the rapid immunochromatographic method. The identification is based on the monoclonal antibodies specific for the novel coronavirus antigen. The easy to use and rapid point of care application of the test facilitates deployment of large-scale screening in environments where rapid, on-site testing is vital to ensure public health safety. Instructions for Use
HOW IT WORKS
The Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (swab) is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to Novel coronavirus. The test strip is composed of the following three parts, namely sample pad, reagent pad and reaction membrane. The reagent membrane contains the colloidal-gold conjugated with the monoclonal antibodies against Novel coronavirus; the reaction membrane contains the secondary antibodies for Novel coronavirus, and the polyclonal antibodies against the mouse globulin, which are pre-immobilized on the membrane. When the sample is received by the test, the conjugated solution from the reagent pad gets dissolved and migrates along with the nasal sample. When the Novel coronavirus is present in the sample, a complex is formed between the anti-Novel coronavirus conjugate and the virus will be caught / detected by the specific anti Novel coronavirus monoclonal coated on the T region. Whether the sample contains the virus or not, the solution continues to migrate to encounter another reagent (an anti-mouse IgG antibody) that binds the remaining conjugates, thereby producing a red line on the region C.
ALWAYS REFER TO THE INSTRUCTIONS FOR USE – Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing should be considered to rule out infection in these individuals. Results from rapid antigen testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection. Not for at home use.
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