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.

New Test Launched in European HIV Testing Week

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In its fourth year, and the second time hepatitis testing has been included, European HIV Testing Week is currently in action. Starting on 18th November, and finishing a week later, testing week is spanning the length and breadth of the continent with partners participating from over 50 European countries.

Prior to this, the world’s fastest HIV self-test kit went on sale last week in order to relieve pressure on overcrowded sexual health clinics.

bioLytical Laboratories, renowned for their production of rapid infectious disease tests, has developed the INSTI HIV Self Test, following research revealing that over 103,000 people are living with HIV in the UK and an estimated 18,100 remain unaware of their positive status.

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It was reported recently that funding cuts have resulted in clinic closures across the country meaning the pressure is on for remaining clinics. Failure to fund routine testing in GP surgeries is leading to late diagnosis when early treatment of the disease is highly beneficial.

With one prick to a finger and a droplet of blood, the INSTI HIV Self Test provides immediate results and is over 99% accurate. Other home testing kits can take up to 20 minutes to produce a result, and in some cases laboratory test results can take several days or weeks.

The INSTI HIV Self Test kit also includes a resource card on where to seek help or for those who have general questions on HIV screening.

The test is available now online at www.INSTI-HIVSelfTest.com and costs €29.95 (£25.95) per kit.