描述
- 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.
Specification CertificateCE + ISO 13485:2016 Product NameWiz Biotech COVID-19 IgM/IgG Rapid Test Test PrincipleColloidal gold Sample TypeWhole blood (from vein or fingertip), serum or plasma Sample Volume10 μL Test Time15 min Operation Temperature2-30ºC Production DateFeb 17, 2020 Shelf Life (Unopened)12 months Note: 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.
