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

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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.

The delay to obtain a positive result following fluid collection was measured using a chronometer and recorded for each patient. The result was always read at the time recommended by the manufacturer. There are two lines that can appear on your test - the 'T' which is the Test Line and the 'C' which is the Control Line. 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]. Don't put yourself or others at risk based on your test result. Using condoms is an effective and easy way to protect your own and others sexual health.Anti-HIV medicine called post-exposure prophylaxis (PEP) may stop you becoming infected if taken within 72 hours of being exposed to the virus. By making the test widely available, Boots UK helps accessibility of self-testing reach a ‘turning point’ on the UK high street and helps support the Joint United Nations Programme on HIV and AIDS (UNAIDS) and partners to meet the ‘90-90-90 targets’ to beat AIDS by 2030. [3] 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. 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]. A positive test result can always be relied upon but a negative result within the first 12 weeks following possible exposure may not be accurate because you haven't produced antibodies yet. If you have any doubts about your result or have any symptoms, you should visit your local healthcare professional. If you are not sure of the exact timing of possible exposure, you should test again after 12 weeks.

I’m worried I have been exposed to HIV within the past 72 hours. You need to visit a specialist HIV clinic or A&E department as soon as possible, where you may be able to access a course of PEP (anti HIV medication). Our test will not give you an accurate result only 72 hours after potential exposure.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. 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. Nucleic Acid Test (NAT)—A NAT can usually tell if you have HIV infection 10 to 33 days after exposure. It is performed by a lab on blood from your vein.

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. 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. DO NOT eat or drink for at least 15 minutes before you start the test or use mouth cleaning products 30 minutes before you start the test. 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].

Screening for HIV in pregnancy

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: For all these tests, a blood test should be carried out to confirm the result if the first test is positive. The Centers for Disease Control (CDC) recommends HIV screening as part of general routine healthcare for everyone between 13 and 64 years old regardless of risk. For those in higher risk groups, the CDC recommends getting tested at least once a year [ 7]. The World Health Organization (WHO) recommends that three consecutive positive tests are needed for a conclusive HIV diagnosis for underdeveloped countries, which is expected to further drive the need for inexpensive and accurate self-testing and self-sampling approaches [ 8].