Test HIV-1/2 + Test Sifilide Ab – Product code: 90-1028
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 human immunodeficiency virus type 1/type 2 and Treponema pallidum in human whole blood. with EDTA, fingertip blood, serum or EDTA plasma. The test is intended for use by qualified personnel in medical facilities, clinical laboratories, in emergency situations and in doctors’ offices as an in vitro diagnostic device capable of providing results in less than a minute. It is suitable for near-patient or point-of-care (POC) testing. All pre- and post-testing counseling guidelines should be followed in the context in which the Insti Multiplex Antibody Test is used. The INSTI MULTIPLEX HIV-1/2 Syphilis Ab Test is a qualitative in vitro, single use, rapid, flow-through immunoassay for the detection of antibodies against human immunodeficiency virus type 1 / type 2 and Treponema pallidum in human blood. whole with EDTA, fingertip blood, serum or EDTA plasma. The test is intended for use by qualified personnel in medical facilities, clinical laboratories, emergency situations and medical offices as an in vitro diagnostic device capable of providing results in less than a minute. It is suitable for near-patient or point-of-care (POC) testing and is not currently approved for self-testing. All guidelines required for pre- and post-testing counseling should be followed in any setting where the INSTI Multiplex Antibody Test is used. The INSTI MULTIPLEX HIV-1/2 Syphilis Ab Test will be referred to as the INSTI Multiplex Test throughout the remainder of these Instructions for Use. 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.2-5 Specific antibodies to HIV pericapsid proteins are prevalent in serum 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 required to determine if syphilis is active or if the reactive result is caused by the patient’s previous infection.
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