The BioSure HIV Self Test, designed to be used by untrained users at home was has granted a CE mark, making it the first HIV home test which can be legally sold in the UK. The test is simple to perform and tests for the presence of HIV antibodies in a drop of blood. The UK's legal ban on HIV home testing was lifted a year ago, but until now no manufacturer has produced a test with a CE mark for self-testing, indicating that the test conforms to minimum European standards for accuracy and ease of use. In the US, the Food and Drug Administration (FDA) approved a different device, the OraQuick In-Home HIV Test, for home use in 2012. OraQuick's manufacturer is hoping to gain a CE mark later this year.
Taking the BioSure self test involves using a safety lancet to produce a drop of blood from a finger, applying the blood to the tip of the test device, leaving the test to run for 15 minutes and then reading the result. Lines appear on a paper strip inside a plastic tube. The test may not detect recent HIV infection as it can take up to three months for antibodies to become detectable.
BioSure's test is based on a device that is already in widespread use by health professionals. The existing device, marketed either as the Chembio Sure Check HIV 1/2 Assay or as the Clearview Complete HIV 1/2 Assay, was licensed by the FDA in 2006 and granted a European CE mark in 2013 – in both cases, for professional use only.
Several studies have shown that the device, when used by healthcare professionals, is highly accurate. The FDA judged the test's sensitivity (proportion of HIV-positive samples accurately described as such) to be 99.7% and its specificity (proportion of HIV-negative samples accurately described as such) to be 99.9%.
BioSure believes that this is the most suitable device to be adapted for home testing – simple to operate, with an easy-to-read result, accurate, and hard to tamper with. They have paired it with an easy-to-use lancet and have developed specific packaging and clear instructions to guide people through the steps of taking a test.
"The availability of the UK's first home HIV testing kit is a really exciting development," commented Dr Michael Brady of Kings College Hospital Trust and Terrence Higgins Trust. "The single biggest thing that we can do to have a major impact on the HIV epidemic is to dramatically increase HIV testing rates, especially in those most at risk. The availability of HIV self-testing will help us achieve that."
[link url="http://www.aidsmap.com/First-HIV-home-test-approved-for-sale-in-UK/page/2964537/"]Aidsmap material[/link]
[link url="http://hivselftest.co.uk/"]Biosure site[/link]
[link url="http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/UCM091418.pdf"]FDA material[/link]