The principle and methodology of HIV self-testing should be discussed for both ethical and financial reasons. It is not assumed that pre-test or post-test counseling will be provided, although a study performed in Asia found that 73% of patients were willing to receive a professional consultation [19]. It has also been reported that unskilled individuals are equally able to perform these HIV tests on themselves compared to trained medical staff [19]– [21], with a preference for OF tests [21]. Self-test acceptability was shown to be good [21], [22], although high prices pose a problem even in developed countries [20], with only 28% of patients willing to pay 15 US dollars for a test [19]. Moreover, the vast majority of HIV-infected subjects live in low-resource countries where in-home tests could be an option only if they were affordable for the population. However, the confidentiality of self-test results is a major asset of this approach, which would give more independence to people who are afraid to share their diagnosis while AIDS remains a stigmatizing disease. You can read your test result from 20 minutes after it has run, but do not read your result after 40 minutes as your result may not remain stable after this time. Early diagnosis is crucial for HIV treatment, and self-testing provides a vital role in the prevention of late diagnosis, which remains stubbornly high. Although overall diagnoses are declining, late diagnoses count for about 40% overall with this group facing a tenfold increased risk of early mortality. [2] Anti-HIV medicine called post-exposure prophylaxis (PEP) may stop you becoming infected if taken within 72 hours of being exposed to the virus. Innovations in molecular biology have led to the development of novel nucleic acid amplification technologies for efficient, sensitive, and high-throughput analyses of virus-specific base sequences [ 117]. Detection and quantification of low concentrations of HIV-related RNA in bodily fluids is vital for early detection, clinical care, and controlling the spread of AIDS, particularly for monitoring patients receiving ART. As ART suppresses HIV replication, patients ideally will have undetectable viral load and absence in HIV antibodies, while early detection of ART failure requires detection of the evidence of HIV resurgence at the earliest possible time, necessitating low limits of detection [ 118]. The current laboratory-based gold standard molecular testing method for HIV detection, reverse transcription polymerase chain reaction (RT-PCR), utilizes enzymes and thermal cycling to rapidly amplify a specific region of the viral RNA into millions of copies. The HIV RT-PCR test can detect viral RNA concentrations as low as 20–176 copies/mL [ 119] and as early as 10 days after exposure. However, the assay is only suitable for laboratory environments, as it requires a workflow that utilizes complex sample preparation, precise temperature control, and highly trained personnel [ 120, 121].

A total of 179 HIV-infected patients and 60 HIV non-infected patients were included. Among the HIV-infected patients, 65% were male and 70% were Caucasian. In the HIV non-infected group, 33% were male and 98% were Caucasian. Only 2 patients were HIV-2-positive, and 44% of the HIV-1-positive patients were infected with the subtype B virus. Among the HIV-infected patients, 49% (88/179) had been infected with HIV for over 10 years, and 60% (107/179) were at stage A of the CDC score. Furthermore, 73% (131/179) had received HAART for at least 2 years. The median CD4 value was 533/mm 3, and 53% (95/179) of patients presented CD4 counts above 500/mm 3. Finally, 67% (121/179) of the infected patients had an undetectable viral load (<50 cp/mL). Pant Pai N et al. Head-to-head comparison of accuracy of a rapid point-of-care HIV test with oral versus whole-blood specimens: a systematic review and meta-analysis. Lancet Infectious Diseases 12: 373-380, 2012. You can read more about this study in our news report. Read about The National HIV/AIDS Strategy, our country’s whole-of-society approach to end the HIV epidemic in the United States. 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. Lewis JM et al. Field accuracy of fourth-generation rapid diagnostic tests for acute HIV-1: a systematic review. AIDS 29:2465–2471, 2015.If untreated, HIV can be passed to your baby during pregnancy, birth or breastfeeding. Treatment in pregnancy greatly reduces the risk of passing HIV on to the baby.

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. 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. Delaugerre C et al. Assessment of HIV Screening Tests for Use in Preexposure Prophylaxis Programs. Journal of Infectious Diseases 216:382-386, 2017.

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. Many tests are based on older ‘second-generation’ technology, but a ‘fourth-generation’ test with better performance is available. 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. The study will enrol 400 participants providing 89% power (5% significance level) to demonstrate that the true result is at least 95%, compared to the expected 98%. If 10% decline to undertake part 2 of the study, 360 participants will provide 91% power to demonstrate the overall correct identification is at least 94%, assuming that 98% of tests can be correctly interpreted. The participants will undergo a standard point of care test for HIV in parallel with the study test (but will not be given the result until they have interpreted their own self-test. 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.

When test instructions have not been correctly followed – for example not enough blood has been collected. Some people are at particularly high risk of becoming infected with HIV and may be advised to have regular tests. 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.

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Our research questions include: (1) Do users accept blood-based HIVST, what are their preferences, and what is their WTP for blood-based HIVST; (2) can lay users perform blood-based HIVST correctly; and (3) what is the sensitivity and specificity of blood-based HIVST kits when performed by lay users?

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. This self-test is not intended for use in the context of therapeutic follow-up with patients receiving antiretroviral therapy.If the test finds no sign of infection, your result is "negative". If signs of infection are found, the result is "positive". A GP or a sexual health professional can talk to you about having a test and discuss whether you should take emergency HIV medicine.