Infectious disease test kit

IgGIgMSARS-COV-2

Through independent research and development, our company has developed a SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold) and determined a set of production processes to ensure product sensitivity and specificity. The company's entire SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold) will be produced strictly in accordance with the following production process to ensure stable product quality. Principles of the test The major principle of this test kit is immunochromatography and SARS-CoV-2 IgM/IgG antibodies in serum, plasma and whole blood samples can be captured by the kit. Antibodies to μ-chain and antibodies to human IgG are coated on the nitrocellulose membrane (NC membrane) and another set of antibodies of SARS-CoV-2 are placed on the surfaces of colloidal gold particles. Blood cells in serum, plasma and whole blood samples will be removed after passing the filter membrane and if SARS-CoV-2 exists in the samples, the virus will bind to the labeled antigenon the colloidal gold particles and captured by the secondary antibodies (anti μ-chain and anti human IgG) in the testing area (T). Then a red line called reaction line is formed to show the positive result. For the negative result the line will not be seen. In normal test conditions, a line in the quality control area will be seen to indicate the validity of the test. Intended Use The test results of this kit can be used as supplemental indexes of negative nucleic acid test results of cases with specific symptoms or nucleic test results of suspected cases. The IgG/IgM test result should not be used as the major proof of SARS-CoV-2diagnoses.