College calls for greater transparency around self-testing kits

The Royal College of GPs is calling on UK regulators to ensure self-testing kits are independently validated, and approved with a quality mark, so that patients are protected from tests that are not proven to have benefits for them.

The College also says that manufacturers of self-tests should hold responsibility for patient aftercare - and not simply promote general practice as the default provider for this.

Availability of self-testing kits has expanded in recent years especially since the universal use of lateral flow testing for Covid-19. But also for long-term health concerns such as high cholesterol and high blood sugar, and serious conditions such as bowel cancer.

The College recognises that self-testing kits can have value when evidence-based and used appropriately. Good examples of this are with pregnancy tests.

However, it is concerned that patients may use them without full knowledge of risks and benefits, or know how to properly interpret the results.  

This may lead to anxiety about their health, lead to unnecessary tests following a false positive result, or even falsely reassure them that everything is alright if the test is not accurate.

The College has published a position statement, setting out concerns about the potential impact on patients and GPs if self-testing kits are not fully regulated. This states that:

• Self-testing kits should have an evidence base, and proven benefits for patients: Currently the accuracy of self-testing kits cannot be guaranteed. They should be evidence-based, properly evaluated and potentially labelled with a 'quality mark' if found to be reliable.
• Patients must be provided with clear information on the risks of self-testing: Independent guidance about the benefits and harms of each self-testing kit should be clearly outlined, as well as the potential for inaccurate results. Before buying a self-testing kit, patients should have access to clear information on whether the self-testing kit they are purchasing would be approved by NICE and used in the NHS, and if not, why this is the case.
• Manufacturers must be responsible for after care - not GPs: It is not acceptable for manufacturers to expect GPs to interpret, explain or discuss the results of self-tests, unless the test was initiated in primary care, especially if they are not in routine use in general practice in the NHS.

The College will move these calls forward by working with:

• NHS England,
• The Department for Health and Social Care,
• The UK National Screening Committee,
• NICE,
• the UK Medicines and Healthcare products Regulatory Agency.

Professor Kamila Hawthorne, Chair of the Royal College of GPs said:

"Manufacturers can market self-testing kits as medical 'check-ups'. Irrespective of the evidence base behind the product, and regardless of a patient's symptoms.

"We are seeing patients in our surgeries, who are distressed because of misleading or inaccurate results from self-testing, which they could have been spared if unevidenced tests were properly regulated.

"GPs and our teams are expertly trained to deliver high-quality, complex care for patients, taking into account an individual's circumstances. We actively encourage patients to take an interest in their health. But if they need a test for something, we'll tell them.

"Taking a test can provide peace of mind for a patient. But it can also cause worry, if they're not sure about how to interpret the result - or if they get a positive result that they weren't necessarily expecting. For some conditions, this could be really distressing, and people may not have the appropriate support in place.

"We are providing 6% more appointments than before the pandemic, but with 852 fewer full-time GPs. General practice is already stretched to the limit. It isn't a good use of our time to be explaining the results of unnecessary tests with patients.

"Manufacturers of self-testing kits should be responsible for providing patient aftercare, they are making money from selling these tests, the NHS must not be left to pick up the pieces."

In 2019, the College published a separate position statement on medical screening, such as genetic screening for the risks of serious illness. This raised concerns that unevidenced screening for diseases may cause more harm than good.

Further information

RCGP Press office: 0203 188 7659
press@rcgp.org.uk

Notes to editor

The Royal College of General Practitioners is a network of more than 54,000 family doctors working to improve care for patients. We work to encourage and maintain the highest standards of general medical practice and act as the voice of GPs on education, training, research and clinical standards.