SARS-CoV-2 IgM/IgG Antibody Assay Kit (Immunochromatography)
Intend Use
This product is used for the qualitative detection of IgM and IgG antibodies of SARS-CoV-2 in human serum, plasma or whole blood in vitro.
This product is only used as a supplementary detection indicator for suspected cases with negative detection of SARS-CoV-2 nucleic acid or used in conjunction with nucleic acid detection in the diagnosis of suspected cases. It cannot be used as a basis for diagnosis and exclusion of SARS-CoV-2 pneumonia, and is not suitable for general population screening.
For medical institutions only. A positive test result needs further confirmation. A negative test result cannot rule out the possibility of infection.
In the process of pathogenic microorganism infection, IgG and IgM are the most commonly used antibody markers of infectious diseases. IgM, as the first antibody in the process of infection, is usually used as a marker of acute infection. With the development of infection, IgM concentration gradually decreased and disappeared after the appearance of IgG. IgG usually exists in the body for a long time, even if the virus has been completely eliminated. Positive blood can be used as an indicator of infection and previous infection. Therefore, detecting SARS-CoV-2 IgM antibody and IgG antibody is of great clinical significance and is of great significance for effective control of the large-scale transmission of the SARS-CoV-2.
Test Principle
This product adopts colloidal gold immune technology, spraying SARS-CoV-2 recombinant antigen labeled with colloidal gold and chicken IgY on the gold pad; two detection lines (G-line and M-line) and a control line (C-line) are coated on the nitrocellulose membrane. The M-line is coated with mouse anti-human IgM monoclonal antibody, which is used to detect the SARS-CoV-2 IgM antibody. The G-line is coated with mouse anti-human IgG monoclonal antibody for detecting the SARS-CoV-2 IgG antibody. The C-line is coated with rabbit anti-chicken IgY When testing, an appropriate amount of sample to be tested is added to the sample well of the test card, and the sample will move forward along the test card under capillary action. If the sample contains the SARS-CoV-2 IgM antibody, the antibody binds to the colloidal gold-labeled SARS-CoV-2 recombinant antigen, the immune complex will form a complex with the coated mouse anti-human IgM monoclonal antibody at the M-line, showing a purple-red M-line, suggesting that the SARS-CoV-2 IgM antibody is positive. If the sample contains the SARS-CoV-2 IgG antibody, the antibody binds to the colloidal gold-labeled SARS-CoV-2 recombinant antigen, and the immune complex will form a complex with the coated mouse anti-human IgG monoclonal antibody at the G-line, showing a purple-red G-line, suggesting that the SARS-CoV2 IgG antibody is positive. If the test G-line and M-line are not colored, a negative result is displayed. The test card also contains a control C-line. The purple-red control C-line should appear regardless of whether a test line appears. If the control C-line does not appear, the test result is invalid, and the sample needs to be tested again.
more details please contact us.
