Nanjing Synthgene Medical Technology Co., Ltd

【PRODUCT NAME】 HIV 1/2 Antibody Rapid Test Kit (Colloidal gold method) 

【PACKING SPECIFICATIONS】 1 test/bag, 1/5/10/25/50 test(s)/kit 

【INTENDED USE】  This product is used for in vitro qualitative detection of human immunodeficiency  virus antibodies (HIV 1/2) in human whole blood/serum/plasma, including type 1 and  type 2 antibodies. The pathogen of Acquired Immune Deficiency Syndrome (AIDS) is human immunodeficiency virus (HIV), belongs to the genus Lentivirus of the Retroviridae family.  AIDS is caused by HIV, and it can damage the body's immune system. Globally, HIV-1  has the highest prevalence, especially HIV-1 M group is the leading cause of AIDS  worldwide. The HIV-2 infected population is mainly distributed in western African  countries. Combined with clinical and other laboratory indicators, this product is used  for the auxiliary diagnosis of human immunodeficiency virus infection. This product  is suitable not only for professional medical personnel to test in medical units, but also  for consumer self- test. HIV-1/2 antibody detection includes enzyme-linked immunosorbent assay, chemiluminescence or immunofluorescence, immunochromatography, and western blotting. 

【TEST PRINCIPLE】 The product adopts the principle of double antigen sandwich. If HIV1/2 antibody is  present in the sample, the HIV1/2 antibody in the sample reacts with HIV1+2 antigen  3 in the colloidal gold-labeled antigen on the binding pad to form a labeled antigen-antibody complex. The complex moves upward through capillary action, and is captured  by the test line (T line) antigens (recombinant HIV1 antigen 1, HIV2 antigen 2) coated  on nitrocellulose membrane, and a red band appear. The complex continued to be  chromatographed upward, and the chicken IgY in the colloidal gold label was captured  by the quality control line (C line) antibody (goat anti-chicken IgY antibody) coated on  the nitrocellulose membrane, and a red band appears. When the content of the analyte  in the sample is lower than the minimum detection limit, the test line (T line) does not  develop color.

【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 (1copy/bag, 1copy/kit) 

Note: Components in different batches of kits are not interchangeable.