Respiratory Syncytial Virus IgM Detection Kit is intended for in vitro qualitative detection of IgM antibody in human serum, plasma or whole blood from individuals suspected of Respiratory Syncytial Virus by their healthcare point of care provider.This test is only provided for use by clinical laboratories or to health care workers for point of care testing. Results from antibody testing should not be used as the sole basis to diagnose or exclude Respiratory Syncytial Virus infection or to inform infection status. The diagnosis should be confirmed in combination with clinical symptoms or other conventional testing methods.
【TEST PRINCIPLE】
This kit adopts colloidal gold-immunochromatography assay (GICA).The test card contains:
1. Colloidal gold-labeled antigen and quality control antibody complex.
2. Nitrocellulose membranes immobilized with one test line (T line ) and one quality control line (C line).When 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 an IgM antibody of Respiratory Syncytial Virus, the antibody will bind to the colloidal gold-labeled Respiratory Syncytial Virus antigen, and the immune complex will be captured by the monoclonal anti-human IgM antibody immobilized on the nitrocellulose membrane to form a purple/red T line , showing that the sample is positive for IgM antibody. If the C line does not appear, the test result is invalid and the specimen must be retested with another device.