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.’


Posted on the UK MHRA wesbite on 19 November 2012