Nanjing Synthgene Medical Technology Co., Ltd

【Product name】 HBsAg Rapid Test Kit (Colloidal gold method) 

【Packaging specification】 1 test/bag, 1/5/10/25/50 Test(s) /Kit  

【Intended use】 This product is used for the qualitative detection of hepatitis B virus antigen  (HBsAg) in human whole blood, serum or plasma samples in vitro. This product is suitable for the auxiliary diagnosis of hepatitis B virus infection.  Hepatitis B is a worldwide infectious disease caused by hepatitis B virus (HBV),  which is mainly transmitted through blood, mother-to-child and sexual contact.  Hepatitis B surface antigen is the coat protein of hepatitis B virus, which appears in  the blood with hepatitis B virus infection and is the main sign of hepatitis B virus  infection. Hepatitis B surface antigen detection is one of the main detection  methods for this disease. 

【Testing principle】 This product is a rapid diagnostic reagent developed based on the colloidal gold  technology and immunochromatography technology. The double antibody  sandwich method was used to qualitatively detect hepatitis B antigen in blood  samples. The test area (T) and the control area (C) on the nitrocellulose membrane  were coated with HBsAg antibody 2 and goat anti-chicken antibody, respectively.  During detection, the sample is chromatographed under capillarity, moving forward  along the test pad. If the sample contains HBsAg, the colloidal gold Au-HBsAg  Ab1-HBsAg complex pass through the test area (T) to form the "Au-HBsAg  Ab1-HBsAg-HBsAg Ab2" complex, a red band appears in the test area (T),  colloidal gold chicken IgY binds to goat anti-chicken antibody in the control area  (C), and a red band appears. Regardless of the presence of HBsAg in the sample, the  control area (C) will show a red band. The red band is the standard for judging  whether the chromatography process is normal, and also serves as the internal  control standard of the reagent. 

【Main components】 

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

2. Disposable plastic straw (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/kit, 1 copy/bag) 

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