Expert warns against HIV self-test kits

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Expert warns against HIV self-test kits

31st October 2011

A defective product expert has echoed warnings issued by the Government health watchdog, the Medicines and Healthcare products Regulatory Agency (MHRA), against non-compliant HIV self-test kits.

Sam Harmel, a partner at Fentons Solicitors LLP, said there were a number of self-test kits currently available online. “The advertising, selling and supplying of HIV self-test kits is illegal in the UK under the HIV Testing Kits and Services Regulations 1992,” he said. “These tests are not compliant with the Medical Devices Regulations and should not be placed on the UK market as there is a significant risk they could be providing users with false results.”

The MHRA is investigating a number of UK-hosted websites currently selling HIV self-test kits imported from China which haven’t been subject to the necessary quality checks. In addition, the agency said there were concerns with a number of non-compliant but legal self-test kits used for diagnosing other sexually transmitted infections including hepatitis, chlamydia, syphilis and gonorrhoea.

Almost 500 people - who were identified through sales records during the MHRA investigation as having already purchased illegal HIV tests online in the UK - have been contacted by the Health Protection Agency (HPA) to inform them that the kits do not comply with UK guidelines and any results could be unreliable.

The MHRA, who regularly scan the internet looking for websites selling illegal testing devices, say that people have been browsing online to buy these products as an anonymous alternative to being tested in a clinic.

“It is very important that people avoid considering the internet as a method of anonymous testing,” said Sam. “They need to remember that it is illegal to supply these products in this way and that in order to comply with EU rules, self-test kits must bear the name and address of the manufacturer or an EU-based representative, as well as crucially, the CE quality kite mark which denotes conformity with the relevant European legislation.”

Some of the self-test kits examined by the MHRA were found to have no instructions whatsoever while others came with instructions that were incorrect, confusing or simply inadequate for someone trying to use the kits at home.

“Rapid and confidential tests, as well as sexual health advice, are readily available for free through the NHS,” said Sam. “It is a disgrace that those worried about something as serious as HIV are being sold wholly unreliable kits that are giving them results which may be totally inaccurate.

“If anyone is concerned about results obtained from online-purchased self-test kits,” added Sam, “it is vital they contact their local GP or go to their nearest sexual health clinic where they can receive advice and be screened for all sexually transmitted diseases including HIV, without charge.”

How can Fentons help?

Fentons has a specialist department experienced in handling claims for victims of accidents and injury caused by defective products.

If you think that you have a case or require further information contact Fentons on 0800 0191 297 or fill in the online claims questionnaire.

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