SURE CHECK® HIV Self-Test – Home Test Kit 99.9% accurate, gives your result in minutes – CE Marked

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The only way to find out if you have HIV is to have an HIV test, as symptoms of HIV may not appear for many years. Anyone who thinks they could have HIV should get tested. Health workers involved in the study received a one-day training session for each test prior to the beginning of the study. However, all nurses were already highly experienced with these tests, as HIV rapid tests and INSTI HIV rapid tests had been used routinely for several years at our centers.

When you have finished you can put everything into this bag and throw it away with your usual household rubbish. Anti-HIV medicine called post-exposure prophylaxis (PEP) may stop you becoming infected if taken within 72 hours of being exposed to the virus.

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All HIV tests need to have reactive (preliminary positive) results confirmed with confirmatory tests. A particular challenge healthcare workers have with rapid tests is how to communicate a reactive result to the person testing (who may be present while the result is being read) and explain that supplementary tests are needed. These problems are less frequently faced with laboratory testing – a large enough blood sample was taken to allow for it to be tested several times and for uncertainties in the diagnosis to be resolved. Window periods of rapid tests There were more invalid results in people using blood-based tests (0.4-9.5%) than studies using oral fluid-based tests (0.2-4.5%). Common errors included incorrect or incomplete specimen collection, spilling or incorrect use of the buffer solution, problems transferring blood samples, and difficulties with the interpretation of results. Following a preliminary positive test result from a self-test, the current clinical workflow for laboratory-based HIV diagnosis is to initially utilize a 4th generation HIV immunoassay that can detect both HIV antibodies and p24 antigen. If a positive indication is obtained, a differentiation immunoassay is performed next to determine the strain of HIV, as treatment plans are different for HIV-1 and HIV-2 [ 10]. Currently, there is only one approved differentiation immunoassay that is approved by the Food and Drug Administration (FDA), Geenius HIV1/2 from Bio-Rad [ 11]. If the differentiation immunoassay is indeterminate, or if an early infection is possible, a HIV-1 nucleic acid test is also performed. This testing algorithm has been recommended by the CDC since 2014, replacing HIV-1 immunofluorescence and western blot assays [ 12]. After diagnosis, viral load and T cell counts will be tested pretreatment, 4–6 weeks after treatment begins, and every 3–6 months thereafter [ 13].

There are three types of HIV tests: nucleic acid tests (NAT), antigen/antibody tests, and antibody tests, and they all have different window periods: Negative (may also be described as ‘non-reactive’). The test did not find any evidence of HIV infection. You probably don’t have HIV (so long as you aren’t testing in one of the situations described in the last section). Some people are at particularly high risk of becoming infected with HIV and may be advised to have regular tests. A) Image of the smartphone dongle for an HIV antibody self-test [ 113]. ( B) Schematic of the immunoassay workflow: (1) Test zone is functionalized with HIV antigens gp41 and gp36. (2) Flow of the blood sample allows binding of the antibody to the surface-coated antigen. (3) Flow of gold-labeled secondary antibodies. (4) Wash buffer removes the unbound antibodies. (5) Flow of the silver reagent with reducing agents to create an optically darkened zone [ 113]. ( C) Schematic of wash-free GMR-based immunoassay workflow: (1) GMR sensors are functionalized with different capture molecules. (2) Test samples are added to the sensor and the target of interest is captured and detected by biotin-labeled detection probes. (3) Sandwich immuno-structures are formed on the sensor surface. (4) Streptavidin-coated MNPs are added and bind to detection probes. (5) Bound MNPs’ local magnetic field will change the sensor resistance, generating an electrical signal correlated with the analyte concentration. (6) MNPs are added again to enable higher signals [ 100]. ( D) Image of the smartphone-based self-testing platform and the GMR nanosensor chip and circuit board with functionalized sensor array for HIV detection. Eight sensors are functionalized with Anti-gp41 capture antibody along with positive controls Biotin-BSA and Human IgG, and BSA as a negative control [ 100]. ( E) Different views of the smart RDT reader connected to a smartphone and renderings of the optical reader. The RDT reader utilizes LEDs to uniformly illuminate the tests through a diffuser. Two of the LED arrays are located beneath the RDT tray and one illuminates from the top to record the reflection and transmission images [ 116].Tests that yield a significant rate of false-negative results in treated HIV patients may lead to dangerous situations. For example, it is possible that a patient who is aware of his HIV-positive status may choose to buy a rapid test and perform it at home. A false “negative” Result could trigger a disbelief in the original diagnosis provided by the physician. Nevertheless, in the Western World, individuals with HIV, receiving HAART and viral load monitoring, are not very likely to buy and use a rapid HIV OF antibody tests.

Do not open the foil pouch containing the self-test device until you are ready to perform the test. It is important to note that there is no current test that can immediately detect HIV infection. Instead, all tests require a time window between exposure and detection [ 2]. Within this window period, an individual with newly acquired HIV can unknowingly spread the disease to others. Thus, early detection of HIV enables individuals to obtain medical treatment early to reduce adverse health effects [ 9]. The early detection window has decreased through advancements in laboratory-based tests with lower limits of detection of HIV antigens in blood or oral fluid. Third and fourth generation HIV tests use synthetic HIV1,2 IgG and IgM antibodies to detect p24 antigens. Most third-generation tests have a window period of approximately 22 days after initial infection [ 2].

Supporting Documents

Livant E et al. The fourth generation Alere™ HIV Combo rapid test improves detection of acute infection in MTN-003 (VOICE) samples. Journal of Clinical Virology 94:15-21, 2017. What is the ‘window period’? The time from when possible exposure to HIV occurs to when a test can correctly give a positive result is called the ‘HIV window period’ or ‘HIV test window period’. During this period, someone who has been exposed to HIV could still get a negative HIV test result because they may not have produced the antibodies needed to generate a positive result. This does not mean the person testing is negative. 4 weeks after exposure about half of people have made the antibodies, by 6 weeks after exposure this goes up to about 95%, however some people don't make these antibodies until up to 12 weeks after exposure. This is why it is so important not to rely on a negative test result until 12 weeks after your most recent possible exposure. Having a sample control line is the only way you can know that your test has been performed and run correctly. It is the only way to be confident in your result.