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Medical devices regulator issues warning on unreliable HIV home-testing kit

 

The Medicines and Healthcare Regulatory Agency (MHRA) is warning people not to purchase or use Hightop HIV/AIDS home test kit as they may be unreliable and produce inaccurate results.  If you or someone you know has used a Hightop HIV/AIDS home test kit please seek a further test at your local sexual clinic or GP.

The HIV self-test kit, manufactured by Qingdao Biotech Co Ltd, does not have a valid CE marking which means the product has not met EU safety, health or environmental requirements and several other regulatory requirements. MHRA is investigating the issues with experts at Public Health England.

When purchasing from the high street or online always make sure a HIV self-test kit has a CE marking to show that it has gone through regulatory processes and is safe to use. These kits should clearly state that they are for self-testing. Online pharmacies must be registered with MHRA and the display of the European Common Logo must be on every page of their website.

For more information read MHRA’S #FakeMeds top tips information on buying medicines and medical devices, including HIV home-testing kits, safely online. If you or someone you know have concerns about their health or test results. Suspected faulty test kits can be reported via the Yellow Card Scheme.

 

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