MHRA warn patients not to purchase unreliable “Hightop” HIV testing kits

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a warning to the public not to use or buy Hightop HIV Home Testing Kits because they may be unreliable and produce false results.

The MHRA has seized 114 potentially unreliable products from suppliers in the UK and all sales of the product 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. Members of the public are advised to:

  • Always make sure the HIV test kit has a CE mark and is clearly intended for self-testing. Only approved HIV self-testing kits that have met the appropriate regulatory requirements concerning test performance, labelling and directions for use carry a CE mark.
  • Whether buying from the high street or online, only buy a self-test kit from a reputable source, such as an online pharmacy registered with MHRA. In the UK online pharmacies must be registered with MHRA and display the European Common Logo on every page of their website.
  • Seek a further test through their GP or local sexual health clinic if you have used this product.

Suspected faulty test kits can be reported via the Yellow Card Scheme.

MHRA’s director of devices, John Wilkinson, said: “People who buy a self-test kit online or from the high street should know what they are buying is safe and reliable. Make sure the kit has a CE mark and clearly states that it is intended for home self-testing. Don’t use a test kit if it’s damaged or the seal is broken.

“If you are concerned you may have used an unreliable test kit, speak to your GP, sexual health clinic, pharmacist or other healthcare professional.”

Local support

Spectrum works with partners in Wakefield and Barnsley to provide HIV testing and support.

For HIV support in Wakefield, contact Trinity Walk Clinic on 01924 846628 or email Wakefield.SHARP@Spectrum-cic.nhs.uk

For HIV support in Barnsley, contact Gateway Clinic on 0800 055 6442 or email Barnsley.SHARP@Spectrum-cic.nhs.uk

You can also find out more about Spectrum’s sexual health service on our sexual health webpage.