The COVID-19 Rapid Test Cassette is a qualitative membrane-based immunoassay for the detection of IgG and IgM antibodies to SARS-CoV-2 in whole blood, serum or plasma specimens. This test consists of two components, an IgG component and an IgM component.
In the IgG component, anti-human IgG is coated in the IgG test line region. During testing, the specimen reacts with SARS-CoV-2 antigen-coated particles in the test cassette. The mixture then migrates laterally along the membrane chromatographically by capillary action and, if the specimen contains IgG antibodies to SARS-CoV-2, reacts with the anti-human IgG in the IgG test line region. A coloured line will appear in the IgG test line region as a result of this. Similarly, anti-human IgM is coated in the IgM test line region and a specimen containing IgM antibodies to SARS-CoV-2 will cause a coloured line to appear in the IgM test line region.
If the specimen does not contain SARS-CoV-2 antibodies, no coloured line will appear in either of the test line regions, indicating a negative result. To serve as a procedural control, a coloured line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
The median incubation period is estimated to be 5.1 days.
Specific IgM antibodies to SARS-CoV-2 become detectable 3-5 days after onset of symptoms.
Therefore, this COVID-19 Rapid Test should not be used until symptoms have been present for at least 3 days.