HIV test kits bought on the internet could be giving users inaccurate results, according to the Medicines and Healthcare products Regulatory Agency. A number of UK-hosted websites were also found to be selling non-compliant testing devices for other sexually transmitted infections, including hepatitis, gonorrhoea, chlamydia and syphilis. Almost 500 people are thought to have already bought the HIV kits, which allow users to test themselves for infection in their own homes.
Why is it important?
The MHRA was made aware of non-CE marked self-test kits to diagnose HIV and sexually transmitted infections being sold online for the UK market.
These devices are not compliant with the Medical Devices Regulations. A medical device cannot be marketed in the UK without carrying a CE Mark of Conformity. The mark is applied by the manufacturer to denote that the device meets the relevant regulatory requirements and performs as intended. The Health Protection Agency has also been involved in contacting individuals known to have purchased home test kits.
The MHRA handled PR and media outreach for the story in-house. A press release was sent out to the UK health media under embargo.
The story was covered extensively in the UK national media on 26 October, including in The Independent and the Daily Mail, on the BBC News and by the Press Association.
22.2k - Estimated number of people living with HIV in the UK who are unaware they have the infection
500 - Number of illegal home test kits thought to have been purchased in the UK.