In the second part of Pulse’s series on screening, Emma Wilkinson explores the concerns around at-home testing kits
Last week, the RCGP set out its position on self-testing kits in a new position statement. It called on the MHRA to produce regulation and NICE to set out guidelines to protect patients.
The College is calling for a meeting with regulators to discuss concerns around the information patients are given when buying self-testing kits.
Since the pandemic there has been a proliferation of companies offering at-home diagnostic kits to screen for a range of conditions and deficiencies.
This could be a cheap individual test for vitamin D, but is quite often a panel of biomarkers to assess someone’s fertility, general health or marketed for ‘immune health’ or fatigue.
For the online providers, this is usually a kit to take a finger prick sample at home, which is then processed in a lab after which the consumer gets a ‘report’ or ‘dashboard’ to view their results. Some companies offer a GP phone call for an extra fee, others simply advise customers to ask their GP if they have further questions.
And in March, Tesco said it would be selling a range of relatively cheap self-diagnostic products in some of its stores including for thyroid, bowel health, menopause and male fertility.
The rise in these tests hasn’t gone unnoticed by the medical community. In March, the Advertising Standards Agency (ASA) upheld a complaint made by Glasgow GP and evidence-based medicine champion Dr Margaret McCartney, who raised concerns about provider Numan’s promotion of an at-home blood test as ‘free if we don’t find anything’
The website for Numan’s Fear Nothing Blood Test, which offers a £128 check for up to 21 biomarkers on a three-monthly subscription, was found to be misleading because it implied something was medically wrong if a result was outside the ‘normal’ range.
Numan had told the ASA that around 4-10% of people were eligible for that refund to which the regulator responded: ‘We considered that this was a very high proportion of people whose test result indicated that they likely had something medically wrong with them.’
A spokesperson for Numan told Pulse: ‘In response to the ASA’s decision, we updated certain information relating to our Fear Nothing Blood test on our site, so that it’s in line with the ASA’s requirements. We remain committed to helping men take action on their health by providing them with the support they deserve and the treatments they need.’
Dr McCartney claims that the private sector often evades the standards set by the National Screening Committee, which assess the balance of benefit and risks in a transparent way, and operates ‘with poor consent processes, lack of evidence of benefit, and a real potential for harm’.
Self-test kits for menopause have also raised concerns, with the Royal College of Obstetricians and Gynaecologists issuing a statement last year advising women not to buy them. The statement said that the tests are limited by only measuring Follicle Stimulating Hormone (FSH) rather than looking at the wider clinical picture, and do not accurately indicate if a women is in menopause or perimenopause.
Meanwhile, Tesco’s announcement of a partnership with Newfoundland, a provider of diagnostic tests and medical devices, earlier this year said the supermarket giant aimed to ‘empower consumers to take control of their own health’ and could reduce the burden on the strained health service.
RCGP chair Professor Kamila Hawthorne says there is a risk that patients may not know how to properly interpret results, or safely and appropriately act on them and for something like cancer, may not have the appropriate support in place deal with a result.
‘Some tests are also quite general, not testing for a specific condition, carrying the risk that some of the results will be unimportant or of dubious value and could leave people unnecessarily confused and distressed,’ she adds,
Professor Jon Deeks who heads up the biostatistics, evidence synthesis and test evaluation research group at Birmingham University, is looking into the tests further. He sent his team out to purchase whatever high street test kits they could find including those from Tesco and Superdrug.
The team are currently assessing what information is provided to patients, and who has approved the tests for use. These are essentially ‘lateral flow’ tests but for PSA, bowel cancer, fertility, vitamin and thyroid levels, microalbuminuria, and menopause to give some examples.
Professor Deeks says that because of Brexit and changes at the MHRA it is very unclear how such tests, which in theory fall under medical devices legislation, are regulated in the UK at the moment. But based on what his team has seen so far, he suspects that the regulation is weak. He adds that many of these types of tests make claims such as being ‘98% accurate’ and his team is in the process of tracking down the evidence behind these.
‘There are other questions like how do we decide this is a good thing to do, that people should be able to buy these tests and who is it that makes that decision. We really don’t know at the moment,’ he says.
‘Also, what information are people given with the tests both in terms of how you use the test and how well it works but also what are the risks and what do the results mean and does it tell me what I should do. Most of them don’t tell you that.’
In a digital world, where many things are already at our fingertips it is perhaps not a surprise that such tests have found their way onto the market. But as East London GP Dr Selvaseelan Selvarajah notes, these tests need to be fully validated, within UK guidelines, and evidence-based for the condition being tested or screened.
He adds that there is also a common misconception that an abnormal test means illness and a normal test means illness, whereas the reality is much more complex – so patients need access to the right medical information before and after a test, so they can make an informed decision.
‘Just selling test kits with little to no medical support will lead to more anxiety for patients, may not help them, and [will] increase workload for the health system without improving outcomes for patients.’