HIV/AIDS home test kits seized over potential false results

The Medicines and Healthcare products Regulatory Agency (MHRA) has seized 114 Hightop HIV/AIDS Home Test Kits which may be unreliable and provide false results.

The agency advises anyone who has used the kit to seek a further HIV test at a local sexual health clinic or through a GP.

“All UK based stock of Hightop HIV/AIDS Home Test Kit have been seized by MHRA and all sales of the product into the UK market have been stopped by the manufacturer”, a statement issued by MHRA revealed.

“The HIV kits, manufactured by Qingdao Hightop Biotech Co Ltd, do not have a valid CE mark which means the product has not met a number of regulatory requirements concerning test performance, labelling and instructions for use for use.”

MHRA is currently investigating the issue with experts at Public Health England.

Self testing kits for HIV became legal in the UK from 6 April, 2014. But buyers are warned to carefully check the CE mark before purchasing any kit.

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

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

“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.”

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

MHRA says emphasises consumers should 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.

Cary James, head of health promotion at Terrence Higgins Trust said while home self-test kits for HIV and STIs have many benefits, including letting people test in their own space and on their own terms, there’s equal concerns surrounding their use.

“…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”, James said.

According to Terrence Higgins Trust, there are more than 100,000 people living with HIV in the UK and around a quarter of them don’t know they’re HIV positive.