RCGP Position Statement on Non-Symptomatic Self-Tests

Self-testing kits have expanded in availability and disease areas in recent years. Manufacturers may offer testing of suspected conditions or 'check-ups' regardless of symptoms or evidence for screening. This may reassure patients when the test returns a negative result or confirm suspicions where there is a positive result. However, these tests' efficacy, validity and accuracy are not guaranteed. This means false positives and negatives have to be mitigated. Many of these tests also do not come with clear and supported informed choice, interpretation of results, and aftercare and can lead to stress and anxiety as well as patients seeking guidance from their GP to interpret the result. In many cases, testing is not warranted under NHS guidance, potentially increasing the overwhelming workload of overstretched GPs.

The RCGP insists on independent validation of these tests and their use in line with national guidance. They should not promote general practice as the default provider for aftercare. Independent information on the pros and cons of testing should also be provided. We are collaborating with other organisations to clarify and develop a more transparent and robust policy for using self-testing kits.

Key RCGP position

  1. Tests should be evidence-based and have proven benefits to patients. Self-testing kits are useful when used appropriately and correctly. However, they must be reliable, evidence-based and performed to benefit patients. They should be evaluated per guidelines from the Royal Statistical Society1. Test evaluation results should be publicly available, and there should be independent checks on the labs performing these tests. Tests fully supported by evidence could receive a ‘quality mark’ to demonstrate reliability.
  2. The use of tests should follow national guidelines. Self-testing kits should only be used if they have been quality assured and their use is in line with national guidelines. For example, the use of rapid antigen throat swabs for Streptococcus A is not included in NICE guidance on sore throats, as it was found to have no added benefit over using a FeverPAIN score and should, therefore, not be routinely used2.
  3. Tests must have clear interpretations and results. Self-testing kits can lead to anxiety, unwarranted use of health services or false reassurance. The test used may be unnecessary, inappropriate or lack clear interpretation instructions. Results from self-testing kits must be patient-focused, specific and clear.
  4. Tests should include complete information. Undertaking testing without considering disease risk, benefits of testing, risks of false positives and negatives, and how to interpret the result could be better quality medicine. This can lead to understanding and interpretation. Information about the potential for the test for benefit and harm should be explained and produced by independent experts, made available before a test is purchased and included with tests. The rationale should be presented to patients where the NHS does not offer such testing. Access to appropriate aftercare, as organised by manufacturers, should be explained.
  5. Patients need to have clear information about when self-testing is recommended and when it's not. This is especially important in places like pharmacies that offer NHS services, where patients might be confused about whether they should be getting tested. It's important for the NHS to provide more guidance on this and make sure patients aren't getting mixed messages about testing.
  6. Tests should come with aftercare. Providers of self-testing kits should be responsible for providing fully informed consent and a full explanation of the risks and benefits of testing. They should ensure aftercare is provided or signposted once the result is available. This should explicitly reference what is available on the NHS and, if not available, why. This information should be independently produced to minimise bias.
  7. Tests must not increase GP workload. GP services should only be used for aftercare if the self-testing kit was initiated in primary care or if clear pathways of care are commissioned. Providers of self-testing kits should offer expert interpretation advice and monitor the impact of their tests on GP workload. GPs should only be expected to interpret, explain, discuss, or give feedback on non-evidenced screening tests, mainly if they are routinely used in general practice.
  8. There should be more patient information on self-tests. NHS.net should have a dedicated information site to explain why the NHS does and does not offer specific point-of-care symptomatic or screening tests. What the evidence is, what the harms are, and what the responsibility of the NHS and the private sector is. This should have input from:
    • the UK National Screening Committee
    • the National Institute of Health and Care Excellence
    • the Medicines and Healthcare products Regulatory Authority
    • the Royal Pharmaceutical Society
    • the Royal College of General Practitioners.

Work so far

The RCGP has raised this issue with NICE. They have agreed that a national policy would be helpful. However, NICE require central commissioning from NHSE, DHSC or the UK National Screening Committee. This is to undertake a complete and comprehensive review of the evidence available for self-testing kits.

Next steps

The RCGP will share this statement with key stakeholders and request to meet with the MHRA to highlight our concerns, particularly regarding patient information and the need for independent advice to be made available before purchase.