The Insti HIV Test for self-diagnostic use is a single-use, vertical scrolling qualitative immunoassay for the detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV -2) in fingerstick whole blood. The Insti Multiplex HIV-1/2 Syphilis Ab Test is a single use in vitro rapid single-use qualitative flow immunoassay for the detection of antibodies against the virus. human immunodeficiency type 1 / type 2 and Treponema pallidum in human whole blood with EDTA, fingertip blood, serum or EDTA plasma. Acquired Immunodeficiency Syndrome (AIDS) is caused by at least two retroviruses, HIV-1 and HIV-2. HIV-1 and HIV-2 are similar in genomic structure, morphology and ability to cause AIDS. HIV is mainly transmitted through sexual contact, exposure to blood or blood products, or from an infected mother to her fetus. People at greatest risk of HIV infection are hemophiliacs, intravenous drug addicts, and men who have sex with other men (MSM). HIV has been isolated from patients with AIDS, AIDS-related complex (ARC), and from people at high risk of contracting AIDS. Antibodies specific to HIV pericapsid proteins are prevalent in the sera of people at high risk of contracting AIDS and in people with AIDS or ARC. The presence of HIV antibodies indicates previous exposure to the virus, but does not necessarily constitute a diagnosis of AIDS. The prevalence of HIV antibodies in people not known to be at risk for HIV infection is unknown, but significantly lower. The absence of HIV antibodies does not indicate that an individual is HIV-1 or HIV-2 free; HIV was isolated from seronegative individuals prior to seroconversion. The specificity and sensitivity of the test depend, among other factors: a) on the selection of HIV antigens used for antibody detection, b) on the classes of antibodies recognized by the detection conjugate, and c) on the complexity of the protocol used to perform the test. Nonspecific reactions may occur in some samples. A reactive INSTI test result should be viewed as a preliminary result, with appropriate advice given in the POC setting.
Following a reactive HIV rapid test result, a venous blood sample should be drawn into an EDTA collection tube (for whole blood or plasma) and forwarded to an HIV confirmatory testing laboratory. Treponema pallidum is the causative agent of syphilis. Some of the proteins in this organism are highly immunoreactive, and infected people develop antibodies soon after infection. These antibodies are unaffected by treatment and once induced remain detectable for years. It is possible that a person is positive for antibodies to T. pallidum but has been cured of the infection. Following a reactive result for T. pallidum antibodies, a venous blood sample should be drawn into an EDTA collection tube (for whole blood or plasma) or a red cap tube (for serum) and forwarded to a laboratory to carry out the confirmation test for syphilis. A confirmatory test is needed to determine if syphilis is active or if the reactive result is caused by the patient’s previous infection.
