Expected use
This kit is an enzyme-linked immunosorbent assay (ELISA) for the qualitative determination of antibodies against human immunodeficiency virus (HIV) type 1 and / or type 2 in human serum or plasma. It is designed for use in the screening of blood donors and to aid in the diagnosis of clinical conditions related to HIV-1 and / or HIV-2 infection, e.g. Eg acquired immunodeficiency syndrome (AIDS).
Summary and explanation
Human immunodeficiency viruses type 1 and type 2 are etiologic agents of 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. HIV infection is followed by an acute flu-like illness. This phase may go unnoticed and the relationship to HIV infection may not be clear in many cases.
The acute phase is usually followed by an asymptomatic carrier state, which progresses to clinical AIDS in approximately 50% of infected individuals within 10 years of seroconversion. Serological evidence of HIV infection can be obtained by testing the serum of HIV antigens or antibodies from persons suspected of HIV infection. The antigen can generally be detected during the acute phase and the symptomatic phase of AIDS only.
Antibodies to HIV-1 and / or HIV-2 can be detected for virtually the entire period of infection, beginning in the acute phase or shortly thereafter and continuing through the final stage of AIDS. Therefore, the use of highly sensitive antibody assays is the primary focus in serodiagnosis of HIV infection. Apart from sexual transmission, the main route of HIV infection is blood transfusion. HIV can occur in both cellular and cell-free fractions of human blood. Therefore, all blood or plasma donations should be screened for the risk of HIV transmission. This can be effectively accomplished by testing for antibodies to HIV-1 and HIV-2 using a highly sensitive ELISA.
