A rapid test for the diagnosis of Human Immunodeficiency Virus to detect antibodies to HIV type 1, type 2 and Subtype O qualitatively in whole blood, serum or plasma. For professional in vitro diagnostic use only.
HIV (Human Immunodeficiency Virus) is the etiologic agent of Acquired Immune Deficiency Syndrome (AIDS). The virion is surrounded by a lipid envelope that is derived from the host cell membrane. Several viral glycoproteins are on the envelope. Each virus contains two copies of positive-sense genomic RNAs. Human immunodeficiency virus type 1 (HIV-1) infection occurs throughout the body and can have dramatic physical effects, such as neurocognitive impairment in the central nervous system.1 HIV-1 has been isolated from patients with AIDS and AIDS-related complex, and from healthy people with high potential risk for developing AIDS.2 HIV-1 consists of Subtype M and Subtype O. Highly divergent strains of HIV-1 were first recognized in 1990 and grouped provisionally as Subtype O as this variation has similar glycoprotein markers to HIV-1 but a slight variation to the protein marker. Although rarely compared to HIV-1 and HIV-2, infections caused by Subtype O have so far been identified in Africa (Cameroon), France and Germany. HIV-2 has been isolated from West African AIDS patients and from seropositive asymptomatic individuals.3 HIV-1, HIV-2, and Subtype O all elicit immune responses.4 Detection of HIV antibodies in serum, plasma or whole blood 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 characters, serological activities and genome sequences, HIV-1, HIV-2, and Subtype O show strong antigenic cross-reactivity. The HIV 1.2.O Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid test to qualitatively detect the presence of antibodies to HIV type1, type 2, and/or Subtype O in whole blood, serum or plasma specimen.
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