Nanjing Synthgene Medical Technology Co., Ltd

【Product name】 HCV Antibody 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 C virus (HCV) antibodies in human serum, plasma or whole blood samples. Hepatitis C virus is a single-stranded sense-stranded RNA virus with an envelope. It  is a non-A, non-B hepatitis virus that mainly causes parenteral transmission.  According to reports, more than 90% of parenterally transmitted Non-A, non-B  hepatitis (NANBH) and more than 25% of acute sporadic hepatitis are caused by  HCV infection, and 35-50% of non-A, non-B hepatitis develops into chronic  hepatitis, which is related to the occurrence of liver cancer. HCV is mainly spread  through blood sources, but also through other methods such as vertical transmission  from mother to child, daily family contact, and sexual transmission. 

【Testing principle】 This product adopts the principle of highly specific antibody-antigen reaction and  colloidal gold-labeled immunochromatographic analysis technology. During  detection, the sample is added dropwise to the test pad and it reacts with the gold-labeled HCV recombinant antigen bound to the pre-coated colloidal gold particles,  and then the mixture is chromatographed upward under the capillary effect. If it is  positive, the HCV recombinant antigen gold-labeled particles will bind with the  HCV antibody in the sample during the chromatography process, and then the  complex will be captured by the coated HCV recombinant antigen immobilized on  the membrane, a purple-red band will appear at the detection line (T). This band is  formed by a complex of HCV recombinant antigen-HCV antibody-labeled HCV  recombinant antigen gold-labeled particles bound on the membrane. If negative, the  detection line (T) will have no red band. A purple-red band will appear on the  quality control line (C) regardless of whether HCV antibodies are present in the  blood sample. The purple-red band displayed in the quality control line (C) is the  standard for judging whether there is enough sample and 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.