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HIV/AIDS

MHRA seizes 'unreliable' HIV self-testing kits from UK suppliers

Experts at the MHRA and Public Health England are investigating HIV/AIDS home-testing kits produced by the Chinese Company Qingdao Hightop Biotech Co Ltd.

Packaging of illegal HIV home test seized by the MHRA

Source: Medicines and Healthcare products Regulatory Agency (MHRA)

The Hightop HIV/AIDS Home Test Kits, which were seized by the MHRA, did not carry the CE mark

The Medicines and Healthcare products Regulatory Agency (MHRA) has seized 114 “potentially unreliable” HIV home testing kits from two UK suppliers.

The Hightop HIV/AIDS Home Test Kits, manufactured by the Chinese company Qingdao Hightop Biotech Co Ltd., were confiscated by the MHRA after it emerged they did not bear the CE mark, meaning they did not meet the appropriate regulatory requirements.

Reverse side of the Hightop HIV/AIDS Home Test Kits seized by the MHRA

Source: Medicines and Healthcare products Regulatory Agency (MHRA)

The “unreliable” kits are no longer on sale in the UK market

This meant they could have produced false results, a spokesperson said.

He added: “We are investigating the issue with experts at Public Health England. Those people who may have been affected are being contacted directly. And as our investigation is currently ongoing we are unable to comment further.”

The MHRA said it had now seized all UK based-stock of Hightop HIV/AIDS Home Test Kits, and that the manufacturer had confirmed they would stop all sales into the UK market.

John Wilkinson, director of devices at the MHRA, said: “People who buy a self-test kit online or from the high street should know what they are buying is safe and reliable. If you are concerned you may have used an unreliable test kit, speak to your GP, sexual health clinic, pharmacist or other healthcare professionals.”

Self-testing or home-testing kits for HIV became legal in the UK on 6 April 2014, and the first kit went on sale in April 2015. Unlike postal testing, which has always been legal, self-testing gives an immediate result. The concept of self-testing is supported by HIV charities including the National Aids Trust and the Terrence Higgins Trust (THT). Cary James, head of health promotion at THT, said that self-testing kits “have many benefits, including letting people test in their own space, in their own time, on their terms.”

But the charity was extremely concerned to see unregulated produce on the market and urged anyone considering a test to only use those with a CE mark. “Anyone taking a test without a CE mark risks their own health and that of others,” James added.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20203443

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Supplementary images

  • Packaging of illegal HIV home test seized by the MHRA
  • Reverse side of the Hightop HIV/AIDS Home Test Kits seized by the MHRA

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