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

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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. Many tests are based on older ‘second-generation’ technology, but a ‘fourth-generation’ test with better performance is available. 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].

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. 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. There are many HIV self-tests that do not have this special in-built feature and will produce a clear control line even if no sample has been added. You will see this as a negative result which may actually be incorrect. The HIV Self Test kit was created by BioSURE, a specialist diagnostic company who developed the world’s first approved HIV self-test to use blood and is now the market leading HIV self-test provider in the UK. The privately owned business has also already launched across South Africa, has launches underway in Kenya and Brazil, with many more countries in the pipeline.

When you have finished you can put everything into this bag and throw it away with your usual household rubbish. 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. 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]. 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]. If that confirmatory blood sample test result is positive, the lab will conduct follow-up tests. If you receive a positive test result, you can take medicine to treat HIV (called antiretroviral therapy or ART), which protects your health and prevents transmission to others. You may be able to start treatment the same day you get your test result.

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 promise of having a ‘fourth-generation’ point of care test that detects p24 antigen is that the window period should be shortened. However, several studies found that although the older version of this test performed well in respect of established HIV infection, its ability to detect recent HIV infection did not match that of laboratory antibody/antigen tests. The test was quite insensitive to p24 antigen, making it only marginally better than antibody-only tests in detecting acute (recent) infection. Yes. HIV self-testing allows people to take an HIV test and find out their result in their home or other private location. There are two kinds: 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. Do not open the foil pouch containing the self-test device until you are ready to perform the test.Lewis JM et al. Field accuracy of fourth-generation rapid diagnostic tests for acute HIV-1: a systematic review. AIDS 29:2465–2471, 2015. Read about The National HIV/AIDS Strategy, our country’s whole-of-society approach to end the HIV epidemic in the United States.

As discussed previously, the most commonly used virus detection methods for SARS-CoV-2 and HIV-1 can be classified into three overarching categories, namely (i) direct virus capture (immunofluorescence) or viral protein detection (antigen detection), (ii) indirect detection of antibodies against the viral proteins using serological approaches (ELISA and LFA) after an exposure, and (iii) detection of the viral nucleic acids by RNA/cDNA hybridization and amplification technologies such as isothermal amplification previously discussed; LAMP [ 147], NASBA [ 148], RPA [ 149, 150], or RT-PCR amplification. Currently, all of the FDA approved in vitro diagnostics for COVID-19 detection are either antigen tests or molecular assays; for definitive confirmatory diagnosis of recent exposure or active infection is always achieved by RT-PCR. This case also holds true for detection of HIV, in that serological findings are exclusively validated by viral load testing through RT-PCR. 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].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. 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. Inci et al. presented a detection technique utilizing the immobilization of intact HIV virus specific antibodies on a plasmonic biosensor surface for capture and quantitative detection of whole blood samples due to antibody selectivity and specificity at clinically relevant concentrations ( Figure 7C) [ 136]. Spectral analysis was analyzed and upon intact HIV virus binding, peak shifts were recorded. The platform can be used on unprocessed whole blood samples with high detection efficiency and short detection time (1 h for intact virus capture and 10 min for detection and data analysis), with detection of multiple HIV subtypes to a LOD of 98 ± 39 viral copies/mL [ 136]. Molecularly Imprinted Polymers (MIPs) integrated with various sensing technologies such as electrochemical, electroluminescence, fluorescence, cyclic voltammetry is emerging as a promising biodetection technology that is highly suitable as a POC or at-home virus detection tool [ 155, 156, 157, 158]. MIPs are structural mimics of antibodies and other similar bioanalyte recognition elements. They are also referred to as plastic antibodies since they are formed from functional polymers, can capture analytes with high affinity, but are highly stable, easy to fabricate, and readily integrate into portable device schemes. Recently, MIPs-based electrochemical nanosensors were successfully used to detect SAR-CoV-2 and HIV through a POC diagnostic approach [ 159].

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]. All HIV tests need to have reactive results (a preliminary positive result) confirmed with further tests."More than a decade ago, the biomedical framework “HIV treatment as prevention” began in earnest. It is a highly effective method of HIV prevention, wherein individuals living with HIV who are engaged in care can reduce their HIV viral load to levels undetectable by current laboratory testing standards and eliminate sexual HIV transmission risk to partners [ 171]. This evidence-based framework has led to public health campaigns promoting “undetectable equals untransmittable,” or “U=U”, to help reduce HIV stigma and promote HIV testing and treatment [ 172]. Nonetheless, fewer than half of MSM living with HIV are engaged in treatment care, and the U.S. continues to experience more than 35,000 HIV infections yearly [ 173], requiring combined biomedical and behavioral HIV prevention approaches to be inclusive of HIV-negative individuals. The window period is very important when relying on a negative result. A negative reualt within 12 weeks of possible explosure is encouraging but should not be relied upon. This is because your test detects antibodies to HIV (not the virus itself) and it may take your body up to 12 weeks to make these antibodies. You should always test again at 12 weeks after possible exposure. The second part of the study will assess the ability of the participant to interpret the results of 3 contrived devices which will mimic the real device, but enable different potential readouts to the interpreted (against an expert assessor). The devices to be interpreted will selected at random from a panel of 12 devices with differing result appearances. Enter your ZIP code to find HIV testing, PrEP, care and treatment, and other HIV-related services near you.