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

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Another study used a microfluidic chip to capture multiple HIV subtypes (A, B, and C) using protein G-based anti-gp120 antibody immobilization ( Figure 3C), where the different HIV subtypes were derived from viral culture supernatant and spiked in whole blood. The capture efficiency was 75.73% for subtype A, 73.67% for subtype B, and 74.67% for subtype C across 103–105 viral copies/mL [ 88]. The COVID-19 pandemic underscored the imperative need to develop diagnostic devices that can be rapidly deployed en masse to the general population to stop the spread of highly transmissible pathogens. It also highlighted the need to improve upon large-scale manufacturability, test sensitivity, sample-to-answer time, biological sample matrix (e.g., saliva, blood, nasopharyngeal fluid) independence in detection, simplicity of the entire testing process, and testing costs. Inspired by these aspects, we also propose recommendations to bring forth the next generation of HIV self-testing and viral load self-monitoring approaches, integrated devices and miniaturized instrumentation and highlight some of these as below. The first part of the study will assess the ability of the participant to follow the instructions provided, complete the self-test procedure and obtain and interpret the result correctly. The outcome will be assessed by a researcher who will observe, but not assist, the participant. Fitzgerald N et al. Diagnosing acute HIV infection at point of care: a retrospective analysis of the sensitivity and specificity of a fourth-generation point-of-care test for detection of HIV core protein p24. Sexually Transmitted Infections 93(2):100-101, 2017. A GP or a sexual health professional can talk to you about having a test and discuss whether you should take emergency HIV medicine.

You must remember that from initial HIV exposure it can take up to 12 weeks for your body to produce enough antibodies for your test to give a positive result. 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. Lewis JM et al. Field accuracy of fourth-generation rapid diagnostic tests for acute HIV-1: a systematic review. AIDS 29:2465–2471, 2015. A "T' line, even if the line is faint, and no "C" line means the test is not working and you will need to get a new test.In people who are taking pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP). If they acquire HIV, they may have a delayed antibody response, extending the window period. It has a proven clinical specificity (if a person doesn’t have HIV how often will the test be negative) of >99.8%, this means that on average 998 in every 1,000 negative results will be correct.

Rapid tests are often referred to as point-of-care tests because rather than sending a blood sample to a laboratory, the test can be conducted and the result read in a doctor’s office or a community setting, without specialised laboratory equipment. The window period refers to the time after infection and before seroconversion, during which markers of infection (p24 antigen and antibodies) are still absent or too scarce to be detectable. Tests cannot reliably detect HIV infection until after the window period has passed. All tests have a window period, which varies from test to test. Is an HIV Self Test the right choice for me? HIV self-testing is another testing choice and puts you in control. You may want to talk to someone before performing your HIV test or have someone with you while you do. Also consider what you are going to do when you get your result - whether positive or negative. It is always your choice.

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]. The number of steps required for HIV self-testing varied from 4 to 14, including sampling and reading. All tests were read twice, first by the investigator who administered the test and then by a second investigator who was blinded to the serological status of the patient. The results were recorded as positive (including weakly positive), negative, invalid (no control band), or impossible to perform (in the case of test B) due to difficulty with sample collection. As a result, the window period of commonly used rapid tests such as the Determine HIV Early Detect and the INSTI HIV-1/HIV-2 Antibody Test may be one to two weeks longer than for fourth-generation laboratory tests. Other rapid tests, based on older technology, may have longer window periods than this.

RPA is an isothermal amplification method that uses recombinase enzymes to rapidly amplify nucleic acids without needing an annealing stage as in PCR [ 150]. Proviral DNA or RNA from multiple subtypes of HIV-1 has been detected via RPA in less than twenty minutes without complex equipment [ 149]. This RT-RPA HIV-1 assay had a LOD of 10–30 copies of HIV-1. Beyond detecting HIV-1, the assay detected 97.7% (171/175) of HIV-1 major subtypes and recombinant sequence variants, suggesting that RT-RPA application for viral RNA and proviral DNA of HIV-1 may be a highly sensitive at home testing tool for HIV diagnosis. point of care test – where a sample of saliva from your mouth or a small spot of blood from your finger is taken in a clinic. This sample does not need to be sent to a laboratory and the result is available within a few minutes If this test is also positive, you'll be referred to a specialist HIV clinic for some more tests and a discussion about your treatment options.The BioSURE HIV Self Test is extremely simple to use – it needs only a fraction of a drop of blood to give an easy to read and accurate result in just 15 minutes. In HIV testing, refers to moisture obtained by swabbing an absorbent pad around the outer gums. Some tests require a sample of oral fluid, which in a person living with HIV is likely to contain HIV antibodies. The other tests tend to be less accurate and may not give a reliable result for a longer period after exposure to the infection. This is known as the window period. 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).

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