The Medicines and Healthcare products Regulatory Agency (MHRA) has seized 114 “potentially unreliable” HIV home testing kits from two UK suppliers.
The Hightop HIV/AIDS Home Test Kits, manufactured by the Chinese company Qingdao Hightop Biotech Co Ltd., were confiscated by the MHRA after it emerged they did not bear the CE mark, meaning they did not meet the appropriate regulatory requirements.
Source: Medicines and Healthcare products Regulatory Agency (MHRA)
The “unreliable” kits are no longer on sale in the UK market
This meant they could have produced false results, a spokesperson said.
He added: “We are investigating the issue with experts at Public Health England. Those people who may have been affected are being contacted directly. And as our investigation is currently ongoing we are unable to comment further.”
The MHRA said it had now seized all UK based-stock of Hightop HIV/AIDS Home Test Kits, and that the manufacturer had confirmed they would stop all sales into the UK market.
John Wilkinson, director of devices at the MHRA, said: “People who buy a self-test kit online or from the high street should know what they are buying is safe and reliable. If you are concerned you may have used an unreliable test kit, speak to your GP, sexual health clinic, pharmacist or other healthcare professionals.”
Self-testing or home-testing kits for HIV became legal in the UK on 6 April 2014, and the first kit went on sale in April 2015. Unlike postal testing, which has always been legal, self-testing gives an immediate result. The concept of self-testing is supported by HIV charities including the National Aids Trust and the Terrence Higgins Trust (THT). Cary James, head of health promotion at THT, said that self-testing kits “have many benefits, including letting people test in their own space, in their own time, on their terms.”
But the charity was extremely concerned to see unregulated produce on the market and urged 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 added.