Detect HIV (v.4)

analyte

HIV

brief description

Epidemiological evidence indicates that an infectious agent transmitted through intimate contact, intravenous drug use or use of infected blood or blood products leads to Acquired immunodeficiency Syndrome (AIDS). This disease affects T-cell mediated immunity, resulting in severe lymphopenia and a reduce subpopulations of helper T-lymphocytes. Destruction of this T-lymphocyte population by the virus causes an immune defficiency resulting in a reduced or deficient response to subsequent infections. Consequently infections become more severe and may cause death. At present, there is no successful treatment for AIDS.

The etiological agent has been identified as a retrovirus, human immunodeficiency virus type 1 (HIV-1). A closely related, but distinct type of immunodeficiency virus, designated HIV-2, has also been isolated. This virus causes a disease that is indistinguishable from AIDS. Serological cross-reactivity between HIV-1 and HIV-2 has been shown to be highly variable from sample to sample. This variability requires the inclusion of antigens to both HIV-1 and HIV-2 for the screening of antibodies to HIV-1 and HIV-2. In addition, antibodies directed against the HIV-1 p24 antigen are also included for detection of the pre-seroconversion stage of the infection. The presence of anti-HIV-1 and/or anti-HIV-2 in the blood indicates potential infection with HIV-1 and/or HIV-2 and consequently this blood should not be used for transfusion or for manufacture or injectable products.

intended use

The Adaltis DETECT-HIV^TM (v.4) test kit is a solid phase enzyme immunoassay utilizing a mixture of antigens and antibodies for the in vitro diagnostic screening in human serum or plasma (ACD, heparin, EDTA, citrate, lithium) of antibodies to all known subtypes of HIV-1 and to HIV-2, and of the HIV-1 p24 antigen at the early stage of infection. This kit is a combined Ag/Ab assay and is not to be used for the detection of HIV-1 p24 antigen alone. This kit is for in vitro diagnostic use by a health-care professional and will not be sold to the general public.