Intended Use

HIV Ag/Ab Rapid Test Kit is a tri-line, serological, lateral flow chromatographic immunoassay for the simultaneous and qualitative detection of human immunodeficiency virus type 1 (HIV-1) p24 antigen, human immunodeficiency virus type 1 antibody and type 2 antibody in human whole blood, serum, or plasma specimens to aid in the diagnosis of infection with HIV. The test only provides preliminary analysis results but not critical diagnosis criteria. Any reactive specimen with the HIV Ag/Ab Rapid Test Kit must be analyzed and confirmed with alternative testing method(s) and clinical findings. The test is intended for healthcare professional use. Applications of the test including, screening test for sex transmitted diseases (STD’s) among high-risk group of people, regular health examinations, and field screen test for blood bank

Summary

Human Immunodeficiency Virus type-1 (HIV-1) and type-2 (HIV-2) are enveloped single strand RNA virus that cause acquired immunodeficiency syndrome (AIDS). Current data indicate that the HIV is transmitted through sexual contact, exposure to blood (including sharing contaminated needle and syringe) or certain blood products or from an infected mother to her child during the prenatal period. People with increased risk of HIV infection include intravenous drug users, homosexuals, and hemophiliacs. The presence of HIV-1 p24 antigen indicates fresh infection with HIV-1 virus, and presence of antibodies to HIV- 1/HIV-2 indicates previous exposures to HIV-1/HIV-2 virus. HIV Ag/Ab Rapid Test Kit utilizes anti-HIV-1 p24 antibody and recombinant HIV antigen immobilized on a membrane to detect HIV-1 p24 antigen, HIV type 1 and HIV type 2 antibodies qualitatively and selectively in human whole blood, serum,or plasma specimens.

MATERIALS PROVIDED

1.Test device individually foil pouched with a desiccant

2. Sample diluent

3. Dropper

4. Sterile lancets

5.Alcohol pad

6. Instructions for use