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HIV home-testing kits seized over false result fears

Nick Duffy August 23, 2017

More than 100 HIV home-testing kits have been seized by the the UK’s medicines watchdog due to fears that they are giving false results.

The Medicines and Healthcare products Regulatory Agency (MHRA), which monitors the supply of products in the UK, confirmed this week that it had seized 114 of the testing kits from suppliers.

They kits are designed to allow people to test themselves for HIV in their home and obtain a fast result, but the tests sold under the brand name Hightop have not been subjected to regulator testing.

People who have already purchased the tests, manufactured by Qingdao Hightop Biotech Co Ltd, are being urged not to use them due to the potential for false results.

The seizure does not affect the most common HIV self-testing kit used in the UK, which is sold by BioSure and is regulator-approved. Tests which bear the ‘CE’ mark are considered safe to use.

Only approved HIV self-testing kits that have met the appropriate regulatory requirements concerning test performance, labelling and directions for use are permitted to carry a CE mark.

John Wilkinson

MHRA’s Director of Devices, John Wilkinson, said: “People who buy a self-test kit online or from the high street should know what they are buying is safe and reliable.

“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.

“If you are concerned you may have used an unreliable test kit, speak to your GP, sexual health clinic, pharmacist or other healthcare professional.

“We continue to encourage people to report any issues involving medical devices to MHRA via our Yellow Card Scheme.”

Cary James, Head of Health Promotion at Terrence Higgins Trust (THT), said: “Home self-test kits for HIV and STIs have many benefits, including letting people test in their own space, in their own time, on their terms.

“However we are extremely concerned to see unregulated produce 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.”

Dr Kirsty Foster, Consultant in STIs and Blood Borne Viruses at PHE, said: “HIV tests are free and testing through a sexual health clinic is strictly confidential.

“We would encourage anyone who thinks they may have been at risk of HIV to get tested as soon as possible, as early diagnosis and treatment are highly effective in helping people with HIV remain in good health long term and reduce the risk of passing the virus on.”

MHRA added: “Whether buying from the high street or online, only buy a self-test kit from a reputable source, such as an online pharmacy registered with MHRA.

“In the UK online pharmacies must be registered with MHRA and display the European Common Logo on every page of their website.”

Next: UK’s first HIV test vending machine unveiled at gay sauna

More: AIDS, Gay, HIV, LGBT, self test, testing

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