Shop-bought health tests not fit for purpose, warn experts – as they present ‘significant risk' for wrong diagnosis
TESTING TIMES Shop-bought health tests not fit for purpose, warn experts – as they present 'significant risk' for wrong diagnosis
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SHOP-BOUGHT medical tests are unreliable and need tougher regulation, say scientists.
The kits are readily available from supermarkets for checking health factors like high cholesterol, vitamin deficiencies, fertility and prostate problems.
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Self-testing became normal during the Covid pandemic
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But experts warn 'evidence for their benefit is lacking'.
A study by the University of Birmingham found many cannot back up claims about their accuracy.
Testing found many have confusing or unreadable instructions, and customers often do not know what to do with their results.
Scientists said they should go through more stringent quality checks and be regulated like medical products.
Professor Jon Deeks said: 'Current regulations are not adequately protecting consumers.
'For matters of our health, it is important that the evidence upon which health decisions are made is available and can be scrutinised.'
Kits cost as little as £1.89
There is a booming market for the tests, which mostly work like Covid lateral flow tests, and the UK industry is set to be worth half a billion pounds by 2030.
Researchers bought 30 of the kits from shops around Birmingham, costing between £1.89 and £39.99, and evaluated them.
They found at least 18 had 'high risk' problems that might lead to a wrong result or decision.
Eleven had equipment quality issues, 10 did not have a proper sampling process and 15 had issues with the instructions or advice on what to do with the results.
British Heart Foundation video explains what exactly is meant by the risk of high cholesterol
Those with problems included tests for menopause hormones, kidney function, vitamin D and thyroid function.
In one example, Prof Deeks said the self-tests for prostate-specific antigen (PSA) levels, a marker of prostate health, were fixed at a certain concentration level.
However, 'if you're age 70 you need to have your PSA done at a very different level to when you're 20', he said.
False results could put strain on the NHS
Dr Clare Davenport said: 'A good test should be clear about who and when to use it.
'It should be easy to use and easy to interpret.
'We expect it to be accurate and we expect it to be evidence-based if it's going to be sold to the general public, with clear advice of what to do with next steps.
'Unfortunately, what we found is that actually many tests gave unclear or missing guidance.
'On one side, if you get a false positive result that might lead to unnecessary extra testing, unnecessary treatments or just anxiety to patients.
'And on the other side, you may have a false negative and you get this false reassurance, which can lead to missed or delayed diagnosis and delayed treatment with obviously worse outcomes for patients.
'All of this can have an impact on health care demand.
'The wrong test or result can then lead to unnecessary or additional appointments, investigations and treatments and a higher burden on the NHS.'
Dr Bernie Croal, president of the Royal College of Pathologists, said: 'There are significant risks to patients when poor quality tests are carried out inappropriately.'
However, the team said that in the future, home tests could have great potential for patient care.
The Medicines and Healthcare products Regulatory Agency (MHRA), which regulates medical products, said it would look at the findings.
It issued its own warning about the kits in June and said they must not be taken as real medical advice.
The MHRA said: 'Self-tests can provide helpful insights, but they're not a substitute for medical advice or a diagnosis.
'If you're unsure about a result, or have symptoms you're worried about, speak to a GP, pharmacist or other healthcare professional before making any decisions.'
The research was published in the British Medical Journal.
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