The Multispot HIV-1/HIV-2 Rapid Test is a single use qualitative immunoassay to detect and differentiate circulating antibodies to Human Immunodefi ciency Virus Types 1 and 2 (HIV-1, HIV-2) in fresh or frozen human serum and plasma. This rapid HIV-1/HIV-2 test kit is intended as an aid in the diagnosis of infection with HIV-1 and/or HIV-2 in fresh or frozen human serum or plasma. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results or as part of an HIV-1/HIV-2 diagnostic testing algorithm that includes differentiation of HIV-1 and HIV-2 antibodies.
The human immunodeficiency virus (HIV) is a lentivirus (a subgroup of retrovirus) that causes the acquired immunodeficiency syndrome (AIDS), a condition in humans in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive. Without treatment, average survival time after infection with HIV is estimated to be 9 to 11 years, depending on the HIV subtype. Infection with HIV occurs by the transfer of blood, semen, vaginal fluid, pre-ejaculate, or breast milk. Within these bodily fluids, HIV is present as both free virus particles and virus within infected immune cells.
HIV can be divided into two major types, HIV type 1 (HIV-1) and HIV type 2 (HIV-2). HIV-1 is related to viruses found in chimpanzees and gorillas living in western Africa, while HIV-2 viruses are related to viruses found in the endangered west African primate sooty mangabey. HIV-1 viruses may be further divided into groups. The HIV-1 group M viruses predominate and are responsible for the AIDS pandemic. Group M can be further subdivided into subtypes based on genetic sequence data. Some of the subtypes are known to be more virulent or are resistant to different medications. Likewise, HIV-2 viruses are thought to be less virulent and transmissible than HIV-1 M group viruses, although HIV-2 is known to cause AIDS.