Self testing - on the verge of a new normal
Wednesday 21st October 2020
JR Biomedical Ltd
As we enter the second wave of COVID-19 in the UK, increased pressures will once again be placed on NHS health screening programmes as well as primary and secondary care. Providing that the safety and reliability of self tests can be guaranteed, could greater access to medical self testing kits contribute to a 'new normal' in healthcare?
The advantages of self testing are clear; results at home within minutes with appropriate follow-up advice, empowering individuals to make proactive decisions for their health. Self test kits also provide an additional route towards traditional NHS pathways for patients who may be too embarrassed to speak with their doctor in the first place or are unable to arrange an appointment due to work or carer responsibilities.
The range of self testing kits available to the public continues to grow, including;
- pregnancy tests
- ovulation tests
- blood glucose tests for diabetes monitoring
- bowel and prostate cancer screening
- coeliac disease (gluten sensitivity)
- drugs of abuse testing
- urine infection
Currently, all diagnostic tests, whether intended for self testing or laboratory tests for professional use sold in the UK, have to comply with strict requirements of the EU IVD Regulations and obtain CE approval and certification.
There are additional regulatory requirements for self test devices, where all information provided in the instruction leaflets and on the packaging of self tests must be approved by doctors and scientists working for an independent Notified Body, for example; mdc, BSi or TUV. This is to ensure that the information gives appropriate advice on what individuals should do following a positive or negative result in a way that can be easily understood. Similarly, lay-person user trials have to be performed to show that people without any medical or laboratory qualifications can perform the tests as intended.
One of the major objections of clinicians is that no diagnostic test by itself, whether it be a hospital laboratory test or a self test will diagnose a medical condition. The current regulations address these concerns as it is also a requirement that the information provided with self test kits must also state that users should take medical advice before acting on any self test result. This means speaking with your doctor or pharmacist if your result is positive or, if you have a negative result but still have persisting symptoms that are causing concern. Of course, in a perfect world it would be more convenient for self test users to be able to contact the manufacturer for follow up medical advice but it is not legally possible for manufacturers to do this.
In summary, we now know that self test kits currently sold in the UK are tightly regulated and must meet rigorous standards for ease of use and reliability of test result. The outstanding questions are whether self test kits will be used in a context that will add value to the health of individuals and society or will extra testing cause an increased burden on an already stretched health service.
Perhaps the key future role of self testing will be directing patients to a better quality of life through an additional pathway leading to their GP or pharmacist, that could potentially offer a speedier diagnosis and reduce the subsequent cost to the NHS of diseases being diagnosed late.
For further information about the SELFCheck range of self test kits please visit www.selfchecktests.com