SELFCheck is manufactured in the UK by biotech company JR Biomedical who supply routine clinical diagnostics for use by the NHS, hospital laboratories and ICU as well as diagnostics for medical research.
Our aim with SELFCheck is to ensure that you can access self test kits that are based on the same clinically proven principles found in our hospital laboratory tests and used by your doctor.
Medical tests, whether used at home or in the hospital lab are regulated in the UK and EU in exactly the same way, ensuring that your tests are safe, easy to use to use and give reliable results. As such, all SELFCheck medical tests are CE certified for self test use according to the In Vitro Diagnostics Directive/Regulations (IVDD/R).
This certification is only granted following external independent review of each test by an independent Notified Body, where the manufacturer has to demonstrate that each test;
- is of appropriate sensitivity and specificity
- components such as the device, lancets and swabs are the same high quality as those used in clinics and hospital labs
- has instructions that are clear enough for lay-persons to easily use the test and interpret their results
- contains advice on what to do with your result once you have completed the test
- contains information on how to contact the manufacturer for help
- encourages you to speak with your doctor regarding your health concerns
Self test kits aren't meant to replace traditional healthcare pathways but whether you get a positive or negative result, self tests can help prompt you to seek help from your pharmacist or doctor sooner than you might have done.
SELFCheck self test kits are manufactured in ISO13485:2016 certified UK laboratories.
Find out more about the SELFCheck range click here