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. During HIV infection, the p24 antigen is produced during the first few weeks and is detectable 7-9 days earlier than the appearance of HIV antibodies. As a result, the p24 antigen is an ideal marker in aiding early HIV diagnosis. 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 high potential risk for developing AIDS. 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. HIV-1, HIV-2, and Subtype O all elicit immune responses.3 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 crossreactivity. The HIV Ag/Ab Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid test to qualitatively detect the presence of antibodies to HIV type 1, type 2, and/or Subtype O and antigens to HIV P24 in whole blood, serum or plasma specimen.

  The Hysen HIV Ag/Ab Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative, membrane based immunoassay for the detection of antibodies to HIV-1, HIV-2, Subtype O and antigens to HIV P24 in whole blood, serum or plasma. The membrane is pre-coated with recombinant HIV antigens in the test line regions T1. The T1 test line is pre-coated with HIV-1, HIV-2 and Subtype O antigen. The membrane is pre-coated with recombinant HIV antibodies in the test line regions T2. The T2 test line is pre-coated with HIV P24 antibodies. During testing, the whole blood, serum or plasma specimen reacts with HIV antigen and/or antibodies coated particles in the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with recombinant HIV antigen and/or on the membrane in the test line region. If the specimen contains antibodies to HIV-1 and/or Subtype O and/or HIV-2, one colored line will appear in the test line region; if the specimen contains antibodies to HIV-1 and/or Subtype O and/or HIV-2 and antigens to HIV P24, two colored lines will appear in the test line region. Both indicate a positive result. If the specimen does not contain HIV-1, Subtype O, HIV-2 antibodies and/or HIV P24 antigens, no colored line will appear in the test line region indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

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Post time:2024-08-08