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covid-19 sars-cov-2 corona virus antibody test IgG IgM

Infectious Disease Series

COVID-19 test kits

covid-19 sars-cov-2 corona virus antibody test IgG IgM

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covid-19 sars-cov-2 corona virus antibody test IgG IgM

COVID-19(SARS-CoV-2)IgG/IgM Antibody Test Kit
(Colloidal Gold)    

COVID-19(SARS-CoV-2)IgG/IgM Antibody Test Kit (Colloidal Gold)             

                  
Intended use
COVID-19(SARS-CoV-2)IgG/IgM Test is used for qualitative detection of novel coronavirus IgG/IgM antibodies in human serum, plasma and whole blood. After infection with the novel coronavirus, the common signs include respiratory symptoms, fever, cough, wheezing and dyspnea, etc. In more severe cases, the infection can lead to pneumonia, severe acute respiratory syndrome, kidney failure and even death. Coronaviruses can be expelled from the body through respiratory secretions, transmitted by oral fluids, sneezing, contact, and by airborne droplets.


Principle
COVID-19(SARS-CoV-2)IgG/IgM Test is the detection principle of colloidal gold marked recombinant novel coronavirus (COVID-19) antigen, while nitrocellulose membrane is coated with rat anti-human IgM, rat anti-human IgG and sheep  anti-mouse polyclonal antibodies, when specimens containing IgM antibody with colloidal gold marked a novel coronavirus antigen form compounds, the compounds in rat anti-human IgM antibody was captured, presents the colored lines, if the specimen contains IgG antibody,And colloidal gold marked a novel coronavirus antigen form compounds, the compounds was caught the rat anti-human IgG antibody, presents the colored line, when specimens containing IgG and IgM at the same time, form 2 lines at T1 and T2, extra colloidal gold complexes and sheep anti-rat polyclonal antibody to form a line, as quality control line.When there is no IgG and IgM antibody in the sample, only the quality control line presents the color, which is negative.

Certification

1. Regarding FDA, you can search https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=654808&lpcd=QKO

2. ISO13485

3. Declaration of Conformity

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