On World AIDS Day, the Medicines and Healthcare products Regulatory Agency (MHRA) is reminding people to be careful when ordering HIV self-test kits online, encouraging them to always make sure it has a CE mark and is clearly intended for self-testing.
Since April 2014, it has been lawful to sell, and advertise for sale, CE-marked HIV self-testing kits in England, Scotland and Wales. To receive approval for sale in the UK, HIV self-test kits must meet a number of requirements concerning test performance, labelling and directions for use.
The CE mark carried by approved HIV self-testing kits shows they have gone through the proper regulatory processes and, when used in accordance with their instructions, can be used safely.
Whether buying from the high street or online, only buy a self-test kit from a source that you trust. In the UK online pharmacies must be registered with MHRA and display the European Common Logo on every page of their website. You can find out more about where to buy kits at HIV Aware.
Self-test kits can have an important role to play in healthcare but should not be relied upon on their own. If you are worried about your health you should always seek advice from a healthcare professional.
The key things to remember when buying a self-test kit are:
- the test is clearly marked as being for self-testing
- the test has a CE mark and manufacturer details are clearly displayed
- the kit is not damaged and the seal is not broken
Speak to your doctor if you have any concerns about your health or test results. Report any suspected faulty test kits via the Yellow Card Scheme.
Cary James, Head of Health Promotion at Terrence Higgins Trust (THT) said:
After campaigning for years for the availability of self-test kits, we are extremely concerned to see unregulated products on the market and urge anyone considering a test to only use those with a CE mark. Anyone taking a test without a CE mark risks their own health and that of others. Anyone worried about test kits should contact us, as should anyone who needs support after taking a test.
The presence of our logo on a test provider’s website or kit does not mean we endorse the kit. Biosure is the only HIV self-test kit currently approved in the UK, so when going to buy a test look out for this brand and the CE mark. Unfortunately, unscrupulous companies sometimes use the THT logo without permission in order to give their product credibility. If are uncertain about a test, please contact THT for advice.
MHRA’s Director of Devices, John Wilkinson said:
People who buy a self-test kit online or from the high street should buy from a reputable source. Make sure the kit has a CE mark and clearly states that it is intended for home self-testing. Don’t use a test kit if it’s damaged or the seal is broken.
No self-test kit is 100% reliable and if anyone has any questions, speak to your GP, sexual health clinic, pharmacist or other healthcare professional.
- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes NIBSC and CPRD. The Medicines and Healthcare products Regulatory Agency is an executive agency of the Department of Health.
- HIV self-testing is when is when an individual performs an HIV test on themselves, in private, and gets an immediate result. This is not to be confused with Home Sampling which is where individuals order a self-sampling kit, take their own sample in the privacy of their own home and return it to a laboratory for testing and results management.
Terrence Higgins Trust is the UK’s largest HIV and sexual health charity
THT Direct, 0808 802 1221, gives support, advice and information. Their advisers can provide emotional support if people are worried about your sexual health or have concerns about living with HIV. They can help people access services local to you across the UK, whether provided by THT or by someone else.