The first HIV home testing kit to receive a CE mark may help reduce the number of patients diagnosed late or not at all
Another kit has joined the ever-growing ranks of medical testing people can perform in their own homes – this time, for HIV. But unlike many home testing kits that require samples to be sent away and outcomes interpreted by an expert, the HIV test manufactured by BioSure (Nazeing, UK) provides a clear, easy-to-understand result in about 15 minutes. Not only is it the first home test kit to do this, but it’s also the first of its kind to gain CE mark approval, permitting EU marketing.
The test itself is simple to use – patients pierce one finger with a lancet, touch the tip of the testing device to the drop of blood, then leave the device in an included pot of buffer for 15 minutes. The readout closely resembles those of commonly used pregnancy tests; a single purple control line confirms the test was correctly performed, while a positive result yields a second line below the first. Although the test is highly accurate (negative results are correct 99.9 percent of the time, while positive results are correct 99.7 percent of the time), the manufacturer recommends that all positive home test results be confirmed by a healthcare professional (1). It’s important to note that the test isn’t flawless – it takes up to three months for HIV antibodies to appear in the blood in sufficient quantities for testing, so people who have been exposed more recently won’t be able to get an accurate result until that time period has passed. Another notable concern is that, unlike clinic testing, the home kits cost money – in the case of the BioSure kit, £29.95 (~€40). Despite their cost, tools like these spare people not only the time, inconvenience and discomfort of needing to go to a clinic for HIV evaluation, but also the embarrassment of requesting the test. They ease the pressure on clinics, too; Gary Carpenter, clinical products director at BioSure, says, “We don’t see self-testing as a replacement for testing in clinical settings […] We think that self-testing will provide wider access, getting people to test that would otherwise not have done so.” An estimated quarter of people living with HIV in the UK are unaware of their infection – and even among those who are aware, 42 percent are considered to have been diagnosed late (2). It’s hoped that a rapid, discreet home testing kit will relieve overburdened clinics and encourage reluctant people to be tested for HIV, especially as a late start to treatment can result in as much as 15 years’ loss of life (3). HIV is still considered a major public health challenge, despite the widespread availability of free or low-cost testing, and innovations like easy home test kits provide a welcome new addition to the tools available for fighting the virus.
Newsletters
Receive the latest pathology news, personalities, education, and career development – weekly to your inbox.
References
- BioSure, “HIV Self Test”, (2015). Available at: http://hivselftest.co.uk. Accessed May 14, 2015. Public Health England, “HIV in the United Kingdom: 2014 Report”, (2014). Available at: http://bit.ly/1F9eG4R. Accessed May 14, 2015. M May, et al., “Impact of late diagnosis and treatment on life expectancy in people with HIV-1: UK Collaborative HIV Cohort (UK CHIC) Study”, BMJ, 343, d6016 (2011). PMID: 21990260.
