Latest news with #DIYtests
Telegraph
29-07-2025
- Health
- Telegraph
Women unlikely to do DIY cancer tests unless told by GP
Women are unlikely to do DIY cervical cancer tests unless they are told to by a GP, a study suggests. From January next year, at-home kits will be offered to women who have rarely or have never attended their cervical screening. The tests look for the human papillomavirus (HPV), the infection which is linked to the majority of cases of cervical cancer. A new study examined the most effective ways women can be approached about performing the tests themselves at home. Researchers from Queen Mary University of London and King's College London performed a study across 13 GP surgeries in west London. They found that under-screened women were more likely to take up the offer of a self-sample test if they were 'opportunistically' approached when they were visiting a GP for another reason. More work needed for tests to be returned Fewer tests were returned when under-screened women were sent a test in the post, or were sent a letter inviting them to get a self-sampling kit. Of 449 women opportunistically offered a self-sample kit, 333 (74 per cent) accepted the offer and 234 (52 per cent) returned a sample within six months. Meanwhile, 198 of the 1,616 women sent a kit in the post (12 per cent) and 76 of the 1,587 women sent a letter inviting them to order a kit (5 per cent) returned a self-sample within six months. 'We showed that the uptake of self-sampling was by far the highest among women who were opportunistically offered kits in primary care,' the researchers wrote in the journal eClinicalMedicine. But the researchers said that more work was needed to ensure women who took up the offer returned their sample. 'Substantial numbers accepted (an opportunistic offer) or ordered (sent a letter) a kit but did not return a sample and over a quarter of those whose self-sample was HPV positive did not follow through with a clinician sample,' the authors added. Suggestion of 'valuable' text or phone reminders They suggested that text or phone reminders 'could be valuable'. Professor Peter Sasieni, a senior researcher from Queen Mary University of London, said: 'Our study showed that offering a self-sample kit in person was the most effective method of encouraging women to complete their cervical cancer screening tests. But he said that a 'combination of approaches may be best for enabling more women to participate in cervical screening'. The NHS offers cervical screening tests, previously known as smear tests, to all women aged 25-64 every three years. But many people do not take up the offer, with a number citing a lack of time, discomfort or embarrassment.
Daily Mail
24-07-2025
- Health
- Daily Mail
DIY health tests relied on by thousands could be delivering false results and putting lives at risk, major study reveals
Many DIY tests for the likes of high cholesterol, vitamin deficiency, fertility and prostate cancer are not fit for purpose, a study suggests. Researchers examined tests that patients can buy in supermarkets, pharmacies and shops which they then use at home. They found the checks risked giving users the wrong result and could delay diagnosis. Most of them recommended following-up with a doctor regardless of the result, prompting experts to question the point of using them in the first place. Scientists from the University of Birmingham are now calling for much tighter regulation of the sector, adding that the NHS may face additional demand after patients self-test. They said: '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. The Medicines and Healthcare products Regulatory Agency (MHRA) said it would look at the findings. Self-testing is becoming increasingly popular and the UK market for self-tests is expected to reach £660million by 2030. Overall 30 self-tests costing £1.89 to £39.99 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. External packaging on fewer than half of the tests (14) included any statement about their accuracy. Meanwhile, 90 per cent of the tests recommended following up with a healthcare professional if results were positive or abnormal, while 47 per cent recommended this if the outcome was negative. Accuracy claims were made for 24 of the tests, including in pamphlets, and most (58 per cent) claimed 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 for people likely to purchase the tests. 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.' Professor Deeks said the UK is looking at a 'new world' when it comes to self-testing, but there is more work to do to show claims made were robust. He 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, he said this depended on how old the patient was, adding 'if you're age 70 you need to have your PSA done at a very different level to when you're 20'. Professor Deeks added: 'Current regulations for the use of self-testing kits in a commercial setting are not adequately protecting consumers.' Dr Clare Davenport, clinical associate professor at the University of Birmingham, said: '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. 'This is in contrast to well-established self-tests, such as pregnancy tests. '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.' A spokesman for Suresign, which provides three of the self-tests studied, 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. 'We are content our tests give the public access to healthcare screening not easily available with the NHS at the present time.' Joseph Burt, head of diagnostics and general medical devices at the MHRA, said the regulator is 'overhauling the medical device regulations to further strengthen standards'. He added: '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.'
Telegraph
24-07-2025
- 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.'
