Intended Use
This product is a lateral flow immunoassay for the rapid detection of
human IgM and IgG antibodies against COVID-19 virus in human
whole blood, plasma, or serum. This product is for professional use
only.
Background
In 2019, a novel coronavirus was identified as the cause of an
outbreak of severe respiratory disease in China. On February 11, 2020,
the disease was officially named “Coronavirus Disease 2019” (COVID19). As the first line of defense against viral infection, human IgM
antibody is generated when one becomes infected with the COVID-19
virus. The level of IgM will rise within 2 weeks and then drop;
accordingly, a second antibody IgG, which is more protective than IgM
antibody, develops within 4 weeks. Therefore, the detection of human
IgM/IgG antibodies in blood not only serves as an evidence of viral
exposure, but also provides the stage of infection and antibody
protection.
Principle
COVID-19 Human IgM/IgG Rapid Test utilizes the technique of
chromatography and qualitative immunoassay to detect the presence
of IgM and IgG antibodies against COVID-19 virus in human whole
blood, plasma or serum. During testing, the blood sample firstly
interacts with COVID-19 protein antigen labeled gold nanoparticles in
the sample zone. By capillary action, the mixed sample flows across
the membrane strip. Human IgM antibodies interact with the antihuman IgM antibody coated in the IgM result zone showing a visible
colored line. Similarly, a colored line in the IgG test zone demonstrates
the presence of human IgG antibodies. Control line must appear every
time to ensure the quality of the sample processing.