Intended Use:

Test for subtyping of antibody to HIV 1 and/or 2 in human serum and plasma samples.

Introduction:

HIV is the etiologic agent of Acquired immune Deficiency Syndrome (AIDS). The virion is surrounded by a lipid envelope. Each virus contains two copies of positive-sense genomic RNAs. HIV-1 has been isolated from patients with AIDS and AIDS-related complex, and from healthy people with a high potential of risk for developing AIDS. HIV-2 has been isolated from West African AIDS patients and from seropositive asymptomatic individuals. Both HIV-1 and -2 elicit an immune response. Detection of HIV antibodies in serum or plasma is the most efficient and common way to determine whether an individual has been exposed to HIV and to screen blood and blood products for HIV. Despite the differences in their biological characteristics, serological activities and genome sequences of HIV-1 and -2 show strong antigenic cross-reactivity. Most HIV-2 positive sera can be identified by using HIV-1 based serological tests.

Method Principal:

The HIV ½, a 3-line Test Device (serum/plasma) is a qualitative, membrane-based immunoassay for the detection of antibody HIV in serum or plasma. The membrane coated with recombinant HIV antigens on the test line region of the device. When a serum or plasma specimen is applied at one end of the membrane, it reacts with recombinant HIV antigen coated particle that has already been applied to the specimen pad at the same end. The mixture then migrates chromatographically towards the other end of the membrane and reacts with the recombinant HIV antigens on the membrane in the test line region. If the serum or plasma contains antibodies to HIV-1 or HIV-2, a coloured line will appear in the test line regions for either HIV-1 and/or HIV-2, showing a positive result. The absence of the coloured line indicates that the serum or plasma does not contain the anti-HIV antibodies, showing a negative result. To serve as a procedural control, a coloured line will always appear at the control line region if the test has been performed properly.