Nanjing Synthgene Medical Technology Co., Ltd

【Product Name】 COVID-19 IgM/IgG Antibody Rapid Detection Kit (Colloidal gold method) 

【Packaging specifification】 1 test/bag, 1/5/10/25/50 test(s)/kit 

【Intended use】 This product is used for in vitro qualitative detection of novel coronavirus  (2019-nCoV) IgG/IgM antibodies in human serum/plasma/whole blood. IgG antibody detection is suitable for screening suspected patients, tracking the  treatment effect of patients, and judging whether recovered patients have the risk of  secondary infection. Compared with IgG, IgM has an earlier increasing and  decreasing trend and higher content in the early stage, which is convenient for early  screening and judgment of treatment effect. 

【Testing principle】 This product adopts the principle of indirect method and colloidal gold immunochromatography. Using gold-labeled novel coronavirus recombinant antigen and  chicken IgY as indicator markers, the M line, G line and C line on the nitrocellulose  membrane are coated with anti-human IgM antibody 2, anti-human IgG antibody 2  and goat anti-chicken IgY, respectively. During detection, the sample is chromatographed under the capillary effect. If the tested sample contains anti-2019-nCoV  IgG antibody, the gold-labeled 2019-nCoV recombinant antigen 1 binds with  2019-nCoV IgG antibody to form a complex, which binds to the anti-human IgG  antibody immobilized at the detection area G to form a sandwich of "Au-novel  coronavirus recombinant antigen 1-novel coronavirus IgG antibody-anti-human  IgG antibody 2" during the chromatography process, and a purple-red band appears  in the detection area (G line). In the case of coronavirus IgM antibody, the gold-labeled novel coronavirus recombinant antigen combines with the novel coronavirus  IgM antibody to form a complex, which combines with the anti-human IgM  antibody 2 immobilized at the detection area M during the chromatography process  to form "Au-novel coronavirus recombinant antigen 1-novel coronavirus IgM  antibody-anti-human IgM antibody 2" sandwich, and a purple-red band appears in  the detection area (M line). Otherwise, there is no purple-red band in the detection  area (G line, M line). Regardless of whether there are novel coronavirus antibodies  in the tested sample, the complexes will continue to be chromatographed upward to  the quality control area (C line), and a purple-red band will appear when the  complexes react with goat anti-chicken IgY. The purple-red band presented in the  quality control area (C line) is the standard for judging whether the chromatography  process is normal or not, and also serves as the internal control standard of the  reagent. 

【Main components】 

1. Test pad, individually packed in aluminum foil bag(1 piece/bag, 1/5/10/25/50  piece(s)/kit) 

 2. Sample diluent(1 piece/bag, 1/5/10/25/50 piece(s)/kit)

3. Medical waste bag(1 piece/bag, 1/5/10/25/50 piece(s)/kit) 

4. Instruction manual(1 copy/bag, 1 copy/kit) 

Note: The components in different batch numbers of kits are not interchangeable.