Combiquic HIV & HCV

INTENDED USE:  

COMBIQUIC is rapid, qualitative, immunoconcentration (flow through) assay for the simultaneous and differential detection of antibodies to HIV1&2 and HCV in human serum/plasma. For Professional use. HIV - Acquired Immuno Deficiency Syndrome (AIDS) is caused by at least two retroviruses, the HIV-1 and the HIV-2, collectively referred to as HIV-1/2. Antibodies to HIV-1 envelope protein (gp120), transmembrane protein (gp 41) and HIV-2 transmembrane protein (gp36) are prevalent in sera of individuals with AIDS or AIDS related complex (ARC) or who are at high risk of contracting AIDS. Detection of these antibodies indicates exposure to the HIV-1/2 virus. HCV HCV is as single-stranded RNAvirus containing a linear genome with a length of about 9,600 nucleotides with positive polarity. It is now recognized that HCV infection is the major ethiological agent of post transfusion hepatitis type non-A, non-B, HCV infection frequently progresses to chronic liver disease. On the basis of phylogenetic analysis. HCV has been grouped into six major genotypes, each of which contains one or more subtypes. The distribution of HCV genotypes varies in different geographical areas. For the detection of HIV, synthetic peptides representing the highly immunodominant regions of HIV-1 &2 are coated on the membrane of COMBIQUIC . Combination of these peptides in a new generation assay format (advanced flow-through) affords specific and early detection of seroconversion following exposure to HIV. For the detection of HCV, COMBIQUIC employs recombinant protein derived from Core, NS3, NS4 and NS5 regions of the HCV genome. For its HCV- detection module, COMBIQUIC is a third generation assay the uses a cocktail of recombinant antigens derived from multiple HCV genotypes. COMBIQUIC utilizes the principle of agglutination of antibodies/ antisera with respective antigen in immuno-chromatography format along with use of nano gold particles as agglutination revealing agent. It comprises of a test device striped with distinct bands or purified gp120, gp41 and gp36 synthetic peptides specific to HIV at a test region ‘HIV’ and recombinant antigens derived from the Core, NS3, NS4 and NS5 regions of the HCV genome (from multiple HCV-genotypes) specific to HCV at test region ‘HCV’. The third band striped at region ‘CNT’ corresponds to the assay performance control and contains purified Protein -A . At first the membrane assembly is hydrated with wash buffer and then the specimen is added. Antibodies to HIV and /or HCV, if present, are captured by the respective antigens. After washing with wash buffer. Protein-A conjugates gold sole reagent is added to reveal the presence/absence of bound antibodies. Post final wash, a positive reaction is visualized by the appearance of purple colored bands at the test regions. The absence of bands at the test regions is a negative test result . The appearance of control band serves to validate device functionally, sample addition, reagent and assay performance. Each kit of COMBIQUIC contains the following component Device Stripped with HIV-1&2, HCV specific antigens and procedural control, individually pouched with a desiccant Disposable sample applicator Inside each individual pouch, for single use only Dropper bottle for wash buffer Buffer containing surfactant and preservatives, ready to use Dropper bottle for conjugate Protein-A conjugated to colloidal gold in a stabilizing solution, ready to use Package Insert One package insert provided in each kit 50 Tests COMBIQUIC should be stored between 2-8°C for the duration of shelf life as indicated on the outer carton. Once the pouch is opened, the device must be used immediately. 1. Disinfectant. 2. Disposable gloves. 3. Biohazard waste containers.