Regulator seizes almost 10,000 unsafe STI and HIV test kits

23 October 2018

Article: 52/4209

Almost 10,000 sexually transmitted infection (STI) and HIV test kits, which could give unreliable and false results, have been seized by the Medicines and Healthcare products Regulatory Agency (MHRA) since 2015.

The MHRA are warning people to make sure that they are purchasing test kits from legitimate sources to avoid unreliable and false results. Fake test kits could potentially give false negatives and lead to an increase in diseases such as chlamydia, syphilis and gonorrhoea as well as HIV. A false negative test result occurs when the test shows negative and the person is instead positive.

Online marketplaces are a known avenue where potentially unsafe test kits are being sold. While MHRA works with companies to remove these types of products from sale, the next stage of the #FakeMeds campaign intends to educate people buying STI and HIV test kits online.

Approved self-testing kits carry a CE mark, illustrating that they have gone through the proper regulatory processes and, when used in accordance with their instructions, are safe to use. Approved kits should also clearly state they are intended for use as self-tests.

Separate MHRA research has revealed people are prepared to buy risky products over the internet. Approximately 25% of young people have bought medical products online in the past 12 months and around 9% admitted to buying products they knew, or strongly suspected, to be falsified. Around 63% of those surveyed bought STI test kits after reading articles about home testing kits on a website, forum or blog and 64% wanted to avoid the embarrassment of buying the kits in a shop or pharmacy.

Source: MHRA, 17 October 2018