High street health tests give out wrong results
A study by the University of Birmingham concluded that DIY tests for high cholesterol, vitamin deficiency, menopause and prostate problems are not always reliable.
Researchers said the tests, available in supermarkets and pharmacies, risked giving people the wrong result, and could delay diagnosis. And most of them recommend follow-up with a doctor regardless of the result.
The study team added that the self-tests were likely to be fuelling needless anxiety among consumers and heaping extra pressures on GPs.
Medicines watchdog to examine findings
The Medicines and Healthcare products Regulatory Agency (MHRA), which regulates medical products, says it will look at the findings.
Prof Jon Deeks, who led the study, said the research raised 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, there was no evidence to support the accuracy of results, he said.
In one example, he said, the self-tests for prostate-specific antigen (PSA) levels, a marker of prostate health, were fixed at a certain concentration level.
However, he said, a man of 70 needs to have his PSA done at a very different level to a 20-year-old.
Self-testing is becoming increasingly popular, and the UK market for self-tests is expected to reach £660m by 2030.
Thirty self-tests, costing £1.89 to £39.99 and covering 19 conditions, were included in the study, published in the British Medical Journal (BMJ).
Less than half of the test boxes included any statement about test accuracy.
Accuracy claims were made for 24 of the tests, with most claiming a performance of at least 98 per cent accuracy, sensitivity or specificity.
However, the researchers said evidence supporting accuracy claims was largely unavailable or did not provide sufficient information.
Manufacturers 'refused to provide studies'
Prof Deeks said: 'Current regulations for the use of self-testing kits in a commercial setting are not adequately protecting consumers.
'Several of the self-test manufacturers refused to provide us with reports of studies which support their claims, stating that they were 'commercially confidential'.
'Legally, they do not need to share this information. However, for all matters of our health, it really is important that the evidence upon which health decisions are made is available and can be scrutinised.'
In a linked BMJ article, Bernie Croal, the president of the Royal College of Pathologists, said: 'There are significant risks to patients when poor quality tests are carried out inappropriately, with both false reassurance, and unnecessary consequences for the NHS to repeat tests or take additional action.'
While clinical trials and medicines must go through the MHRA, self-test devices are subject to checks by notified bodies.
A spokesman for Suresign, which provides self-tests, said: 'We find this blanket condemnation of a small range of home tests available to be unreasonable and unprofessional, since they admit they are content with many of those examined.
'This is not a clinical approach to a highly scientific subject.
'They also did not confirm that the clinical studies related to our tests were supplied to them, as confirmed to us by the BMJ.
'Our detailed responses to their questions were not fully reflected in their article.
'They have implicitly criticised the professionalism of notified bodies appointed by the MHRA, when we find them to be very exacting in their audits.
'We are content our tests give the public access to healthcare screening not easily available within the NHS at the present time.'
'Seek medical advice if unsure'
Joseph Burt, the MHRA's head of diagnostics and general medical devices, said it would review the evidence and 'consider all allegations about device deficiencies'.
He added: 'We have strengthened post-market surveillance powers to monitor and act on concerns. These require manufacturers to actively monitor their products and report significant incidents to us, including for CE-marked self-tests.
'We're overhauling the medical device regulations to further strengthen standards for safety, usability and clinical performance and 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.'
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