More than 100 HIV home-testing kits have been seized by the UK Medicines and Healthcare products Regulatory Agency (MHRA) amid fears over their reliability.
The agency believes it has seized all stock of the Hightop HIV/Aids home-test kit from UK suppliers but is warning consumers against purchasing the product online or using it, if already purchased, because of the potential for false results.
People are advised to always check before using a HIV kit that it carries a CE mark, which indicates that it complies with EU safety, health and environmental requirements.
The Hightop tests, manufactured by Qingdao Hightop Biotech Co Ltd, do not have a valid CE mark, meaning they have not met a number of regulatory requirements concerning test performance, labelling and instructions for use.
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.”
The MHRA seized 114 of the products in question from two UK-based suppliers and all sales of the tests into the UK market have been stopped by the manufacturer.
It says 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.
Qingdao Hightop Biotech, which specialises in medical tests and equipment, stopped supplying its HIV kit to the UK market after being contacted by the MHRA. According to the Chinese company’s website, its annual revenues amount to between $5m and $10m (£4m-£8m).
The UK and Europe would not appear to be key markets for Qingdao Hightop Biotech: it states that 88% of its business is domestic, with its next biggest markets the Middle East (4%) and Africa (2.5%)
It is unclear why the HIV test did not carry a CE mark as many of its other kits, including tests for pregnancy, fertility, malaria, other sexually transmitted diseases and recreational drugs, do carry the standard.
HIV self-testing kits sold and advertised for sale in England Scotland and Wales must be CE-marked.
Cary James, the head of health promotion at the 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.”
The first legally approved HIV self-testing kit, the BioSure HIV Self Test, went on sale in the UK in 2015. It has a 99.7% accuracy rate. Home kits have been hailed as a way of increasing early diagnosis. In the UK, 39% of people living with HIV are diagnosed late, leaving them with shorter life expectancies, according to the National Aids Trust.
The THT says there are more than 100,000 people living with HIV in the UK and about a quarter of them do not know they are HIV positive, meaning they are not receiving treatment.
Dr Kirsty Foster, a consultant in STIs and blood-borne viruses at Public Health England, 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.”