Test HIV 1.2

Product code: 90-1015

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Test HIV 1.2 – Product code: 90-1015

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 whole blood from lancing device. Insti Hiv Test for self-diagnostic use is intended to be used as a test to aid in the diagnosis of HIV-1 and HIV-2 infection using a small drop of blood (50μL) obtained by finger prick. Extensive research studies have shown that this test is extremely accurate when done correctly. It has a proven sensitivity (measure of reliability that the test will be positive for those with HIV infection) of 99.8%. The INSTI HIV-1 / HIV-2 Antibody Test is a qualitative, fast-scrolling, single-use in vitro test for the detection of Human Immunodeficiency Virus Type 1 and Type 2 antibodies on human whole blood collected in EDTA, blood from finger pricker, serum or EDTA plasma. The test is designed for use by trained personnel in medical facilities, clinical laboratories, emergency care situations and medical clinics as a diagnostic test capable of providing results in less than a minute. Although it is suitable for testing in care centers (POCs) or in patients, the INSTI HIV-1/HIV-2 antibody test is not suitable for home self-diagnosis. All pre- and post-test counseling guidelines should be followed in any setting where the INSTI HIV-1/HIV-2 Antibody Test is used. The test is packaged as a kit containing the INSTI Membrane Unit, Sample Diluent (Solution 1), Color Developer (Solution 2) and Lightening Solution (Solution 3) with or without support materials (lancet, pipette and alcohol swab). 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 the ability to cause AIDS. HIV is mainly transmitted through sexual contact, exposure to blood or blood products or through an infected mother to her fetus. Among those at highest risk of HIV infection are hemophiliacs, intravenous drug users and men who have sex with other men (MSM). HIV has been isolated from patients with AIDS, the AIDS-related complex (ARC) and people at high risk of contracting AIDS. Specific antibodies to HIV envelope proteins are prevalent in the serum of subjects at high risk of contracting AIDS, as well as people with AIDS or ARC. The presence of antibodies to HIV indicates previous exposure to the virus, but does not necessarily constitute a diagnosis of AIDS. The prevalence of HIV antibodies in people whose HIV risk is unknown is unknown but significantly lower. The absence of HIV antibodies does not indicate that an individual is completely free of HIV-1 or HIV-2; HIV was isolated in seronegative individuals prior to seroconversion. The specificity and sensitivity of the test depend, among other factors, on: a) the selection of HIV antigens used for the detection of antibodies, b) the classes of antibodies recognized by the detection conjugate, and c) the complexity of the protocol used to perform the test. Non-specific reactions may be observed in some samples. A reactive result of the INSTI test should be considered a preliminary result, with the appropriate advice provided by the service centers. Following a result of the rapid reactive test, a blood sample should be collected via an EDTA tube (for whole blood or plasma) or a tube without anticoagulants (for serum) and forwarded to the laboratory for a confirmatory HIV test. The INSTI HIV-1/HIV-2 antibody test is a manual, visually-readable, vertical-scrolling immunoassay for the detection of HIV-1/HIV-2 antibodies in human blood, serum or plasma. The test consists of a synthetic filter membrane placed on top of the absorbent material inside a plastic case, known as the INSTI membrane unit. The membrane was specifically treated with HIV-1 and HIV-2 recombinant proteins that react with HIV-1 / HIV-2 antibodies in the sample producing a distinctive visual signal on the membrane. The membrane also contains a procedural control. The procedural control consists of a point treated with protein-A capable of capturing the IgG antibodies normally present in the blood and its components. IgG antibodies react with a proprietary color agent producing a visual signal on the membrane. Since IgG antibodies are present in the blood of normal or HIV positive samples, the control point provides a visual cue when the test is performed to indicate that it was performed correctly. If the control point does not appear, the test is considered null. In the case of the test point, the recombinant HIV-1 and HIV 2 proteins contained in the membrane capture the specific antibodies for HIV, if present in the sample. The antibodies captured at the test site react with a patented chromatic agent producing a visible signal on the membrane. The membrane unit is designed to filter, absorb and retain the test sample and all reagents in order to limit the loss and exposure of personnel to potential infectious agents. Reagents needed to run a test include Sample Diluent (Solution 1), Color Developer (Solution 2), and Lightening Solution (Solution 3). The test is done by pouring the blood, serum or plasma sample into the Sample Diluent vial, which dissolves the red blood cells. This sample / diluent solution is then poured into the well of the membrane unit. HIV-1 / HIV-2 antibodies, if present in the sample, are captured by the proteins on the filter membrane. The color developer is then added to the membrane unit. The color developer reacts with the captured antibodies by generating a clearly visible blue dot at the control point and, if HIV-1 / HIV-2 antibodies are present in the sample, another blue dot appears in the test area on the membrane . In the last step, the lightening solution is added to the membrane to decrease the background color and make the blue control and test dots more visible. Antigen Selection: The INSTI HIV-1/HIV-2 Test uses a combination of HIV-1 (gp41) and HIV-2 (gp36) recombinant transmembrane proteins. The use of these proteins prevents sensitivity and specificity problems associated with tests based on viral lysates in a combination of core antigen and other viral proteins. Antibody Detection: The INSTI HIV-1/HIV-2 Test uses a unique reagent to detect HIV-1/HIV-2 antibodies. Although initially designed to detect the IgG class of specific antibodies, the INSTI HIV-1/HIV-2 test has been shown to detect antibodies in samples obtained in the early stages of infection, during seroconversion and samples with low anti-titer. -HIV-1 obtained in the later stages of infection (see Tables # 1, 2 and 3). Test Complexity: The INSTI HIV-1/HIV-2 Test was designed to reduce protocol complexity. The INSTI HIV-1/HIV-2 Test requires no sample preparation, accurate timing, or multiple steps, such as multiple washes and reagents. These requirements increase the complexity of a test and lead to procedural errors that can adversely affect sensitivity and specificity. Total test time may vary slightly depending on sample type, but valid test results are always clearly legible within a minute or two.


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