HIV home tests seized from market over potential risk

pharmafile | August 24, 2017 | News story | Sales and Marketing HIV, MHRA, biotech, drugs, pharma, pharmaceutical 

The MHRA has removed over 100 HIV home testing kits from two UK based suppliers, after they were found not to contain a valid CE mark. The CE mark indicates that the product has met regulatory requirements and any products that do not feature this could potentially be defective.

The MHRA has warned that anybody who self-tested with the kit produced by Qingdao Hightop Biotech Co Ltd should immediately get themselves re-tested at a local sexual health clinic or through their GP.

Further than this, the authority has recommended that consumers always check to ensure the CE mark is present on any products they use. It also recommends to only purchase products from reputable sources, such as online pharmacies registered with the MHRA.

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. We continue to encourage people to report any issues involving medical devices to MHRA via our Yellow Card Scheme.”

Qingdao is a company based in Shandong, China, and largely produces products for the domestic Chinese market – with Western Europe only accounting for 0.5% of its total revenue.

HIV testing kits only became legal in the UK in April of 2014, with the first products going on sales a year later. The kits give an immediate result and it is hoped that having such products on the market can ensure people who could potentially be at risk of the infection are able receive a quick diagnosis. Complications from HIV usually arise if the disease is not identified early and fast diagnosis can ensure it can be effectively managed.

Ben Hargreaves

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