REF:

E4102 (Microwell Plate)

INTENDED USE:

This HIV Type I/Type II Total Antibody ELISA Test is an enzyme-linked immunosorbent assay (ELISA) for qualitative determination of antibodies to Human Immunodeficiency Virus (HIV) type 1 and/or type 2 in human serum or plasma. It is intended for screening of blood donors and as an aid for the diagnosis of clinical conditions related to infection with HIV-1 and/or HIV-2, e.g. the acquired immunodeficiency syndrome (AIDS).

SUMMARY:

The human immunodeficiency viruses type 1 and type 2 are the etiological agents of the acquired immunodeficiency syndrome (AIDS) and related conditions. HIV has been isolated from patients with AIDS, AIDS related complex (ARC) and from healthy individuals at high risk for AIDS. Infection with HIV is followed by an acute flu-like illness. This phase may remain unnoticed and the relationship to HIV infection may not be clear in many cases. The acute phase is typically followed by an asymptomatic carrier state, which progresses to clinical AIDS in about 50% of infected individuals within 10 years after seroconversion.

Serological evidence of infection with HIV may be obtained by testing for presence of HIV antigens or antibodies in serum of individuals suspected for HIV infection. Antigens can generally be detected during both acute phase and the symptomaticm phase of AIDS only. The Antibodies to HIV-1 and/or HIV-2 can be detected throughout virtually the whole infection period, starting at, or shortly after the acute phase and lasting till the end stage of AIDS. Therefore, the use of highly sensitive antibody assays is the primary approach in serodiagnosis of HIV infection. Apart from sexual transmission, the principal route of infection with HIV is blood transfusion. HIV can present both in cellular and cell-free fractions of human blood. Therefore, all donations of blood or plasma should be tested due to the risk of HIV transmission through contaminated blood. This can be effectively achieved by testing for antibodies to HIV-1 and HIV-2 by using a highly sensitive ELISA tests.