Commercial self-test kits ‘unfit for purpose’ and increase GP workload, finds study

A study of 30 self-test health kits available on the high street has raised concerns over regulation after many were found to be ‘unfit for purpose’.

The analysis showed a range of issues with test kits bought from supermarkets or pharmacies including poor or no information on when and why to do the tests as well as how to interpret the results.

Writing in two papers in the BMJ, the team from the University of Birmingham also found a lack of transparency and evidence on the effectiveness of the tests.

In all 60% of the tests looked at were classified as ‘high risk’ because of concerns about the testing equipment, sampling process, or instructions and interpretation of the results.

Almost all the tests (27 out of 30) recommended follow-up with a healthcare professional if results were positive or abnormal, and 14 of them advised this whatever the result, which puts more work on the NHS, the team noted.

The self-tests – most of them lateral flow type devices – are marketed as checking for things like vitamin deficiency, cholesterol, menopause, PSA, thyroid function, kidney disease, fertility and bowel cancer.

But they could lead to erroneous or misleading results, the researchers found with use of the tests as advertised contrary to evidence-based guidance for 11 of the 19 conditions studied.

In a linked editorial, two GPs concluded that the NHS should not be expected to provide a free follow-up service for companies offering ‘inappropriate, oversold, and low value tests’.

As well as looking at the information provided in the test kits and how easy they were to use, the researchers asked manufacturers for evidence of effectiveness which is required to get a CE mark from a Notified Body but is not publicly available.

Consumer demand which has led to the growth of the market expected to be worth £660 million by 2030.

If introduced in the right way and within clear NHS pathways they could be useful as had been shown with pregnancy tests, HIV self tests and Covid tests, the researchers said.

But the market seems to have moved faster than legislation or regulators have been able to keep up, they added.

The RCGP called for more transparency over self-testing kits two years ago also pointing out that manufacturers should be responsible for patient aftercare.

Co-author Professor Jon Deeks, professor of biostatistics at the University of Birmingham said a ‘plethora’ of new health self-tests had appeared on the high street in recent years.

‘While these kits have been approved for sale, they are not subject to the same stringent regulations as pharmaceutical products.

‘Our recent research raises concerns about the suitability, accuracy and usability of many of the self-testing products available that require users to sample, test and interpret results themselves.

‘In some cases, it is unclear how accuracy claims are supported, and there is no requirement of manufacturers to share the evidence behind these claims.

He added their value was questionable when so many of them advised seeing a doctor whatever the result. 

Dr Clare Davenport, clinical associate professor at the University of Birmingham added: ‘The wide range of off-the-shelf tests now available to the public are not endorsed by the NHS and evidence for their benefit is lacking.

‘We are worried that consumers concerned about their health and tempted by the convenience of buying a test over the counter may be harmed if they use these tests in the wrong way.’

In a linked editorial Dr Jessica Watson, a GP and researcher at the University of Bristol and Dr Margaret McCartney, a GP in Scotland and long-time advocate of evidence-based medicine warned there was ‘considerable potential for harm’.

‘As well as the impact on individuals, healthcare systems are likely to be affected by the downstream consequences of interpreting and acting on dubious test results.

‘False positive results may lead to anxiety, unnecessary investigations, overdiagnosis, and overtreatment.

‘False negative results can offer erroneous reassurance, which could potentially lead to delays in seeking appropriate medical care, with risks of delayed diagnosis and treatment,’ they said.

Joseph Burt, head of diagnostics and general medical devices at MHRA, said it is examining the research.

‘We’re exploring new transparency measures such as requiring published summaries of clinical evidence.

‘In the meantime, we strongly encourage anyone using a self-test to check for a CE or UKCA mark, read the instructions carefully, and seek medical advice if they’re unsure about their result.’