Latest news with #JonDeeks
Telegraph
5 days ago
- Health
- Telegraph
High street health tests give out wrong results
High street health tests are producing incorrect results, research has found. 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.'
BBC News
5 days ago
- Health
- BBC News
Shop-bought health testing kits 'inaccurate and unsuitable', study says
Home health tests bought by people seeking answers about their conditions could give inaccurate and misleading results and require much greater regulation to ensure they are safe, reliable, and effective, researchers have bowel cancer to the menopause, shop-bought health kits now test for a wide range of conditions and are readily available on high streets and in supermarkets across the two new studies, published in the British Medical Journal (BMJ), say many of the kits lack crucial information, such as who should use them, how to interpret the results, and what steps to take response, the regulator which oversees medical devices in the UK, MHRA, says it is "overhauling" safety standards. Researchers at the University of Birmingham collected and analysed 30 self-test kits, costing between £1.89 and £39.99, in 2023. These included tests for conditions such as bowel cancer, vitamin deficiencies, thyroid issues, HIV, and the researchers concluded that only 14 of the kits they looked at included any statement about accuracy, and fewer than a quarter gave clear guidance on next steps after receiving a also found that nearly half advised users to consult a healthcare professional regardless of the result, something experts warn could place additional pressure on NHS Jon Deeks, who led the research, said current regulations do not go far enough to protect consumers. "Self-tests have a clear potential to improve public health. However, for them to be beneficial and not harmful, they must be proven to be accurate, easy to use, and supported by clear instructions," he said. Self-testing has been around in the UK for more than 50 years in the form of pregnancy tests, first introduced in 1971. During the Covid lockdown, lateral flow tests for Covid became common. Neither was included in the University of Birmingham research, published by the BMJ. "When integrated appropriately into clinical pathways, self-tests have been shown to increase uptake of testing in underserved groups," say the the BMJ warns that offering self-testing based on the ability to pay, rather than clinical need, risks "widening inequalities and the exploitation of vulnerable population groups". Bernie Croal, President of the Royal College of Pathologists, told the BMJ poor-quality testing could lead to both "false reassurance" and "unnecessary consequences" for the UK self-test market is expected to grow significantly, with revenues forecast to reach £660m by 2030."Direct-to-consumer tests may be appealing to the public, as they can provide diagnostic results quickly, offering privacy, confidentiality, and autonomy over healthcare decisions," says the authors classified 60% of the tests they looked at as "high risk".While most kits carried claims of high accuracy, some above 98%, the researchers say supporting evidence was often not made publicly available. Although manufacturers are not currently required by law to publish clinical performance data, the BMJ calls for greater transparency. The Royal College of General Practitioners has also called for more openness in the 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".
Irish Examiner
5 days ago
- Health
- Irish Examiner
Shop-bought health tests not always fit for purpose, researchers warn
Off-the-shelf health tests for issues such as high cholesterol, vitamin deficiency, fertility and prostate problems are not always fit for purpose, experts have warned. A team from the University of Birmingham examined tests that people can buy in supermarkets and shops and which they then use at home. They found the tests risked giving people the wrong result, could delay diagnosis, and most of them recommended follow-up with a doctor anyway, regardless of the result. The researchers called for much tighter regulation of the sector. "In the absence of guidance from healthcare professionals, individuals might use tests inappropriately or without a clear understanding of the implications of the results. "False positive test results can lead to unnecessary anxiety, increased healthcare usage, and additional costs, whereas false negative test results may delay appropriate treatment or engagement with... screening programmes. "Test errors can stem from inherent limitations in the accuracy of the test, as well as user-related issues such as sampling errors, incorrect processing, and difficulties in interpreting the results." However, the team said that in the future, home tests could have great potential for patient care. Professor Jon Deeks, from the University of Birmingham, said: "A plethora of new health self-tests have emerged in recent years and are available to buy from many high street supermarkets and pharmacies in the UK. "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." Prof Deeks said much of the literature contained with tests was "not easy to understand", while some of the results could lead to a "wrong diagnosis". 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, "if you're age 70 you need to have your PSA done at a very different level to when you're 20", he said. Overall, 30 self-tests were included in the study, published in the British Medical Journal (BMJ). The tests covered 19 different conditions, including vitamin deficiency, blood sugar levels, cholesterol, thyroid function, prostate health, HIV, menopause and bowel cancer. Researchers said only eight of the 30 tests provided information about who should or should not use the test, while four specified the presence of symptoms. Less than half of the test boxes (14) included any statement about test accuracy.
Scottish Sun
5 days ago
- Health
- Scottish Sun
Shop-bought health tests not fit for purpose, warn experts – as they present ‘significant risk' for wrong diagnosis
The self-test market is booming in Britain TESTING TIMES Shop-bought health tests not fit for purpose, warn experts – as they present 'significant risk' for wrong diagnosis Click to share on X/Twitter (Opens in new window) Click to share on Facebook (Opens in new window) 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. Sign up for Scottish Sun newsletter Sign up 1 Self-testing became normal during the Covid pandemic Credit: Getty 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.
The Sun
5 days ago
- Health
- The Sun
Shop-bought health tests not fit for purpose, warn experts – as they present ‘significant risk' for wrong diagnosis
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. 1 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. 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. Body checks you can do now Check your semen: It should be a white-grey colour. Red in semen or yellow-green should be assessed Check your testicles: Roll each of them between your finger and thumb to gently feel their surfaces to look for swellling, hardness or lumps. Check your breasts: Both men and women should be aware of the signs of breast cancer, which are lumps, inverted nipples, fluid oozing from the nipple, a sore or rash around the nipple, hard, red skin, swellings or lumps in the armpit. Check your peeing habits: Going more often, straining to go, having a weak flow or feeling like you've not emptied? These could be signs of a prostate problem. Check your blood pressure: You can check your blood pressure at home using an automated digital device, at the GP or pharmacy. Check your heart: Your heart rate should be somewhere between 60 and 100 bpm. You can count using a clock and pressing lightly on the inside of your wrist. Check down the loo: Look for signs of blood in stool or if you've had a persistent change in frequency or type of stool (e.g. diarrhoea or more difficulty). Pain when going should also be checked out. Check your cholesterol: The best way to check your cholesterol levels is by visiting your pharmacist or GP but you can also check it at home with tests including Bupa's at Home. Check your nails: Ridges, dents, brittleness and clubbing of the nails can all indicate an underlying health issue. Check your hair: Hair loss is seen in both men and women from middle age, but iron deficiency can also cause it. Check your BMI: Your body mass index (BMI) is a simple way to check whether you're a healthy weight. Use an online calculator such as that on the NHS. Check for lumps and bumps: Changes to the skin, including around the genitals, moles and marks must be checked.
