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27 October 2011
Non-compliant home test kits being bought over the internet to diagnose HIV and other sexually transmitted infections could be giving users inaccurate results, the Medicines and Healthcare products Regulatory Agency (MHRA) has warned.
The MHRA has recently been made aware of a UK-hosted website selling non-CE marked self-test kits to diagnose HIV and sexually transmitted infections. These devices are not compliant with the Medical Devices Regulations and should not be placed on the UK market.
Additionally, in the case of HIV kits, advertising, selling or supplying a home test kit for HIV is illegal under the HIV Testing Kits and Services Regulations 1992.
MHRA Clinical Director of Devices, Susanne Ludgate, said: “People may consider using the internet to purchase HIV self-test kits but they need to be aware that it is illegal to supply such devices in this way.
“As far as self-test kits for sexually transmitted infections are concerned purchasers should check that any kits purchased from internet sites are CE marked which should denote conformity with the relevant European legislation.
“We’re concerned that there may be a number of self-test kits being sold online that may not be compliant with the relevant piece of legislation and we’re urging people not to consider the internet as a method of anonymous testing.
“These kits may be unreliable and there is a significant risk they could be providing the user with a false result. The instructions for use might also be incorrect or confusing and not adequate for someone trying to use the kit in their home. In fact, many of the kits we have assessed as part of this investigation have come with no instructions for use at all.”
The MHRA advises people who wish to use home test kits purchased over the internet to ensure that they are compliant with the Regulations before they use them. If they have any concerns over the results obtained from an internet purchased self-test kit they should seek advice from their GP or sexual health clinic.
In addition if they have concerns as to the legality of any self-test kit purchased over the internet they should report it to the MHRA device compliance hotline on: devices.compliance@mhra.gsi.gov.uk