IgM Elisa Antibody Assay POCT Covid 19 Rapid Test Kit 8 Minutes Reaction

POCT With Blood Result within 8 Minutes SARS-CoV-2 IgG, IgM Antibody Assay Kit

INTENDED USE:

This product is used for the qualitative detection of IgM and IgG antibodies to SARS-CoV-2 in human serum, plasma, whole blood, or fingertip blood in vitro. This product is only a supplementary detection indicator for suspected cases with a 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 COVID-19 and is not suitable for general population screening. It is for use in medical institutions only. A positive test result needs further confirmation. A negative test result cannot rule out the possibility of infection.

TEST PRINCIPLE:

This product is based on 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 IgM antibody to SARS-CoV-2. The G-line is coated with mouse anti-human IgG monoclonal antibody for detecting the IgG antibody to SARS-CoV-2. The C-line is coated with rabbit anti-chicken IgY. When testing, an appropriate amount of sample is added to the sample well of the test card. The sample will move forward along the test card under capillary action. If the sample contains the IgM antibody to SARS-CoV-2, 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 test is positive for IgM antibody to SARS-CoV-2. If the sample contains the IgG antibody to SARS-CoV-2, 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. This suggests that the test is positive for IgG antibody to SARS-CoV-2. 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.

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