HIV / AIDS home test kits seized over potential false results

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has seized 114 Hightop HIV/AIDS Home Test Kits, which could be potentially misleading in providing false results. The agency has advised that anyone who has used the kit should seek a further HIV test at a local sexual health clinic or through a GP.

A statement issued by the MHRA stated: “All UK based stock of Hightop HIV/AIDS Home Test Kit have been seized by MHRA and all sales of the product into the UK market have been stopped by the manufacturer”

The statement continued: “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.”

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Self-testing kits for HIV became legal in the UK from 6 April 2014, but buyers have always been warned to carefully check the CE mark before purchasing any kit. Self-test kit users who purchase kits online or from the high street should know what they are buying is safe and reliable. MHRA is currently investigating the issue with experts at Public Health England.

John Wilkinson, MHRA’s director of devices commented: “If you are concerned you may have used an unreliable test kit, speak to your GP, sexual health clinic, pharmacist or other healthcare professional”. He further added: “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.”

MHRA strongly suggests consumers should only buy a self-test kit from a reputable source, such as an online pharmacy registered with the MHRA. In the UK, online pharmacies must be registered with the MHRA and display the European common logo on every page of their website. While home self-test kits for HIV and STIs have many benefits, including letting people test in their own space and on their own terms, there’s equal concern surrounding their use.

According to recent surveys there are more than 100,000 people living with HIV in the UK and around a quarter of them don’t know they’re HIV positive.

OTCs in Action Episode 8: Procreate & Protect

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Did you hear the story of the Egyptian bus driver who tried to avoid a random drugs test by using his wife’s urine? According to the Al-Yawm al-Sabi website, after the driver confirmed that he had submitted his own urine, officials said: “Congratulations, you’re pregnant.”

While the bus driver likely greeted this news with mixed emotions, achieving a positive pregnancy test can be a frustrating and heartbreaking journey for many people. This week, OTCs in Action are the new home tests kits that can help prospective parents to conceive. Each year 11mn couples will try to have a baby and about 7mn of those couples will have fertility issues. Yet while male infertility accounts for half of all infertility problems, mainly owing to low sperm count, only 20% of men have their sperm levels tested. The new SpermCheck home test kits, currently rolling out in the UK and US, identify whether men have normal or low sperm counts. The problem can often be reversed with lifestyle changes such as eating a healthy diet and avoiding smoking and alcohol. The availability of a simple, convenient and cost-effective home test can allow a couple to easily identify, and possibly remedy, a possible roadblock to pregnancy at an early stage.

2014 has been a watershed year in the expansion of at-home testing. The French Parliament adopted a bill allowing the mass market sale of pregnancy and ovulation tests, ending the pharmacy monopoly on those products. In Japan, The Council for Regulatory Reform has proposed the Rx-to-OTC switch of 49 types of diagnostic tests, among them colorectal cancer screening kits, which can give consumers life-saving information. The Australian Government has also taken an important step in protecting public health this year by removing a restriction preventing the manufacture and sale of HIV home self-tests.

OTC.NewDirections keeps Nicholas Hall & Company clients up to date on scientific and regulatory news. Visit www.nicholashall.com/otc-newdirections to set up your free 30-day trial.