The SARS-CoV-2 Antigen RapidTest Kit is a colloidal gold enhanced double antibody san dwich immunoassay forthe qualitative determination of SARS-CoV-2 antigen.The test region (T) ofnitrocellulose membrane was immobilized with mouse anti SARS-CoV-2 antibody 1(Ab1), a nd the control region (C) was immobilized with Goat anti chicken IgYantibody (GAC). At the same time, the binding pad of the test card was fixedwith mouse anti SARS-CoV-2 antibody 2 (Ab2) a nd chicken IgY (CIgY) which wereboth labeled by colloidal gold.
When the sample contains SARS-CoV-2 antigen is added to the samplewell of the detection card, it will react with Ab2 to form complexes“antigen-Ab2-colloidal gold”. When the complexes migrates along the membrane,it can be captured by the Ab1 immobilized in the test region to form complexes“Ab1-antigen- Ab2-colloidal gold”, a nd a purple ban d appeared in the testregion. The absence of this colored ban d in the test region suggests a negativeresult. A colored ban d always appears in the control region serving asprocedural control regardless of the sample contains SARS-CoV-2 o r not.
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license number：Fujian Food and Drug Administration Production No. 20110184