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

Product Information

Rapid tests are usually reliable for long-standing infections, but are sometimes unable to detect recent HIV infections acquired in the past few weeks. 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. In people who are taking pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP). If you acquire HIV, you may have a delayed antibody response, extending the window period. If you get an HIV test after a potential HIV exposure and the result is negative, get tested again after the window period. Remember, you can only be sure you are HIV-negative if: In an effort to provide nucleic acid-based diagnostics that are more suitable for point of care and self-testing scenarios, several alternatives offer less stringent requirements for sample preparation and remove the need for thermal cycling equipment, while still providing enzymatic amplification of a specific RNA or DNA sequence. Approaches that have gained considerable attention include loop-mediated isothermal amplification (LAMP), recombinase polymerase amplification (RPA), nucleic acid sequence-based amplification (NASBA), Rolling Circle Amplification (RCA), helicase dependent amplification (HDA), and Strand Displacement Amplification (SDA). Compared to RT-PCR, these methods provide advantages that include simplified sample preparation, less stringent temperature control, high amplification efficiency, reduced sensitivity to amplification inhibitors, and greater tolerance for detecting a target sequence within unprocessed samples, making these assays simpler to translate to POC self-testing environments. Moreover, isothermal amplification techniques can incorporate reverse transcription, expanding the detection to RNA targets such as HIV genomes [ 122].

You haven’t had a potential HIV exposure during the window period. If you have had a new potential exposure, then you will need to be retested. After 20 minutes your test will be completed, and you will be able to read your result. DO NOT read the result after 40 minutes. The INSTI HIV Self Test is adapted from the INSTI HIV-1/HIV-2 Antibody Test for personal use. This is one of the most accurate third-generation tests available, with a superior sensitivity to recent infection. When used by health professionals, the test’s sensitivity and specificity were both calculated to be 99.8%. Are people able to understand test instructions and use self-tests reliably? If your test result is positive, you should go to a health care provider or clinic for follow-up testing. Counselors providing the initial test should be able to answer your questions and provide referrals for follow-up testing. You can use the HIV.gov locator to find a health center near you.Due to their simplicity and low cost, lateral flow assay (LFA)-based diagnostic devices have been widely adopted for diagnostic scenarios where rapid results are required [ 27]. LFA-based tests can be performed on a variety of biological samples, including sweat, saliva, plasma, serum, and whole blood. The testing does not require expensive laboratory equipment and the results are available in 5–30 min. Moreover, sample quantity required for detection is less than needed for conventional confirmatory HIV diagnostic assays, such as enzyme linked immunoassay (ELISA), thereby allowing affordable, sensitive, specific, user friendly, rapid, equipment free, and deliverable (ASSURED) detection of HIV infections. The researchers found that most people could reliably and accurately use rapid tests. Using a statistical approach known as Cohen’s kappa in which 1 represents perfect agreement between the results of a self-tester and a trained health worker and less than 1 represents less than perfect agreement, results were highly concordant. The Cohen’s kappa was 0.98 in studies in which users first received a demonstration of how to do the self-test or to interpret its result. In studies in which this was not provided, it was 0.97. This means that in only a small minority of cases the self-tester and the healthcare worker got results that were different from each other. In people with diagnosed HIV who are taking HIV treatment. These tests are not a reliable way to confirm that you still have HIV infection. Reactive (often incorrectly described as ‘positive’ by manufacturers). The test assay has reacted to a substance in your blood. This does not necessarily mean that you are HIV positive. It means you need to take more tests to confirm the result. These extra tests are best done at a healthcare facility where they have access to the most accurate HIV testing technologies. Because of the possibility that a positive result from a single HIV test is, in fact, a false positive, the result is described as 'reactive' rather than 'positive'. If the result is reactive, this indicates that the test has reacted to something in the blood and needs to be investigated with follow-up tests.

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.

Indicates products intended for use by both professional healthcare and untrained lay users at POC setting. ** Indicates products intended for use by healthcare professionals at POC setting. -Indicates products under development or research purposes only. Want to stay abreast of changes in prevention, care, treatment or research or other public health arenas that affect our collective response to the HIV epidemic? Or are you new to this field?

A wide range of point-of-care tests have been manufactured in many countries, but only a few of them have been subject to rigorous, independent evaluations, and even fewer are marketed in the UK. Research on HIV tests is only occasionally published in medical journals. Informally, laboratory professionals may have insights into which tests perform best.If the test finds no sign of infection, your result is "negative". If signs of infection are found, the result is "positive". If your test result is negative, and you haven’t had a possible exposure during the previous three months, you can be confident you don’t have HIV. When test instructions have not been correctly followed – for example not enough blood has been collected. Enter your ZIP code to find HIV testing, PrEP, care and treatment, and other HIV-related services near you.

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. We conducted a cross-sectional study to assess the usability and performance of blood-based HIVST. The primary outcomes of interest were the usability, acceptability, feasibility, and accuracy of blood-based HIVST kits in the hands of unassisted lay users. Usability was defined as the number and percentage of participants who completed all testing steps correctly without assistance and interpreted the results correctly. Acceptability was measured through acceptance of HIVST, willingness to recommend the test, desire to use the test in the future, preference for use of the test, and WTP for HIVST. Feasibility was measured by the ability of lay users to correctly use the self-test, succeed in obtaining an interpretable result, and correctly interpret the results. Accuracy was estimated by the sensitivity and specificity of HIVST kits compared to the gold standard enzyme immunoassay (EIA) or enzyme-linked immunosorbent assay (ELISA) test (i.e., Murex HIV Ag/Ab Combination). This review of existing technologies describes HIV self-testing that can be conducted at home or through POC, similar to those authorized by the FDA for OTC/at-home use for COVID-19. There are several hurdles to overcome that extend beyond the technological aspects. For example, research innovations face a funding gap between early-stage technology development and commercialization that can be filled by government, or private venture, or philanthropic investments. For a technology to gain clinical adoption it must gain support [ 167] from various components of the healthcare system, including insurance/reimbursement coverage before it becomes established as part of the standard-of-care or part of routine infectious disease monitoring tool for the general public. Hence, there must be willingness to change current medical practices, insurance coverage, the habits of healthcare professionals, improvements in logistical access of the at-risk populations to testing devices, easing of approval processes of such devices by the regulatory agencies, and encouragement of adoption of those devices by the end users.blood test – where a sample of blood is taken in a clinic and sent for testing in a laboratory. Results are usually available on the same day or within a few days 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.