Diagnostic Evidence Co-operative
London


MHRA seizes more than 100 unreliable HIV home-testing kits

he Medicines and Healthcare products Regulatory Agency (MHRA) is warning people to not use or buy Hightop HIV/AIDS Home Test Kit after seizing 114 potentially unreliable products from 2 UK based suppliers.

If you believe you have used a Hightop HIV/AIDS Home Test Kit you should seek a further HIV test at your local sexual health clinic or through your GP, because the self-test kits may be unreliable and provide false results.

All UK based stock of Hightop HIV/AIDS Home Test Kit have been seized by MHRA and all sales of the product into the UK market have been stopped by the manufacturer.

The HIV kits, manufactured by Qingdao Hightop Biotech Co Ltd, do not have a valid CE mark which means the product has not met a number of regulatory requirements concerning test performance, labelling and instructions for use for use. MHRA is investigating the issue with experts at Public Health England.

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