An HIV/AIDS home test kit being sold in the UK may be producing false results, leading to warnings that people who have used the product should get checked at a sexual health clinic or GP practice.
People are being told not to use or buy the Hightop HIV/AIDS Home Test Kit, after the body that regulates healthcare products in the UK found the kit did not have a valid “CE” mark.
“If you are concerned, speak to your GP, sexual health clinic, pharmacist or other healthcare professional”
This means it had not met a number of regulatory requirements, including for test performance, labelling and instructions for use.
The Medicines and Healthcare products Regulatory Agency (MHRA) has seized 114 of the ”potentially unreliable” Hightop kits – manufactured by Qingdao Hightop Biotech Co Ltd – from two UK-based suppliers.
In addition, all sales of the product into the UK market have been stopped by the manufacturer. The MHRA is now investigating the issue with experts at government arms-length body Public Health England.
People who have used a Hightop HIV/AIDS Home Test Kit should seek a further HIV test at a local sexual health clinic or through their GP practice, said the regulatory body.
“We would encourage anyone who thinks they may have been at risk of HIV to get tested as soon as possible”
Dr Kirsty Foster
“People who buy a self-test kit online or from the high street should know what they are buying is safe and reliable,” said MHRA director of devices John Wilkinson.
“Make sure the kit has a CE mark and clearly states that it is intended for home self-testing,” he said. “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,” he added in advice for patients.
Since April 2014, it has been lawful to sell, and advertise for sale CE-marked HIV self-testing kits in England, Scotland and Wales.
However, Dr Kirsty Foster, consultant in sexually transmitted infections 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,” she added.