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Press release: MHRA issues guidance on self-test kits

Press release

Date: 19/11/2012
Time: 11:00
Subject: MHRA issues guidance on self-test kits
Contact: Press Office 020 3080 7651
or press.office@mhra.gsi.gov.uk
Out-of-hours 07770 446 189

The Medicines and Healthcare products Regulatory Agency (MHRA) has today issued a new fact sheet with guidance on the use of self-test kits.

Self-test kits are available for a variety of conditions including fertility, sexually transmitted infections and cancer and can have an important role to play in healthcare. They should not, however, be relied upon on their own and the new guidance provides advice what to look out for before buying a kit, before using one and what to do with the results.

When thinking about self-testing remember you can get free access to high quality tests on the NHS. But if you do choose to use a self-test kit it is important to follow up the results and check any concerns you may have with a healthcare professional.

When buying a self-test kit whether from the high street or online, only buy from a source that you trust. You can also seek advice from a healthcare professional such as a pharmacist or practice nurse on the right kit to select. Do not buy the kit if it looks damaged or the seals are broken. You should also make sure the kit has a CE mark which means it meets the relevant regulatory requirements and, when used as intended, works properly and is acceptably safe.

The new guidance provides advice on what to consider before using a self-test kit with a reminder to read the instructions carefully, know how the kit can be stored and know how to read the results. Consumers are also reminded that no test kit is 100% reliable and should never replace a doctor’s diagnosis or a result from a national screening programme.

John Wilkinson, MHRA’s Director of Devices said; ‘Increasingly people are turning to self-test kits to check on a variety of conditions. Whilst they can act as a useful guide to the state of your health they should never replace or be as helpful as a GP consultation. If you do decide to use a self-test kit remember to think about the possible results of the test and what you are going to do, whether it is positive or negative.’

Notes to Editor

1. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone – the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action. www.mhra.gov.uk/selftestkits
Page last modified: 19 November 2012