Latest news with #healthtests
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.'
BBC News
24-07-2025
- 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".
Gulf Business
07-05-2025
- Health
- Gulf Business
Major workforce shift: Saudi Arabia plans new test for employees
Image credit: Getty Images The Read- The ministry has published the National Regulations for Occupational Fitness Tests on the Istitlaa Public Survey platform to gather feedback from the public and stakeholders before enforcing the regulations. Types of tests There will be three types of tests for employees: general medical testing, specialised additional testing, and psychological testing. These tests aim to monitor individual health and promote occupational well-being through pre-employment and periodic employee evaluations. The initiative seeks to reduce work-related accidents and diseases and improve workplace environments in Saudi Arabia. Framework for health assessment The regulations are designed to establish a comprehensive framework for assessing employees' physical and psychological fitness, ensuring they can perform their duties safely and effectively. The testing framework aligns with national standards and international best practices. It aims to reduce occupational injuries and diseases, enhance worker fitness, and ensure job performance safety. Who the regulations apply to The regulations apply to all employees in the public, private, and non-profit sectors. This includes: New hires before appointment Current employees under specific conditions, including: After an occupational injury Upon return from extended medical leave When there are doubts about the employee's ability to perform duties When the job requires periodic medical examinations When an employee changes roles or professions If the work environment changes When new equipment or machinery is introduced Upon retirement, if the worker was exposed to hazardous substances such as asbestos These regulations do not apply to medical examinations unrelated to job duties. Pre-employment medical examinations The regulations outline procedures for medical examinations for those in high-risk roles, standardise examination forms, and define periodic and exceptional examinations suitable for each profession. They also provide a comprehensive health database for all workers and promote compliance with local and international occupational safety standards. Who conducts the medical examinations? Occupational fitness assessments must be carried out by a specialized team, supervised by a certified occupational medicine specialist accredited by the Saudi Commission for Health Specialties and registered with the National Council for Occupational Safety and Health. Employment categories after medical testing Following the pre-employment examination, candidates will be classified as: Medically fit and permitted to practice the job Medically fit with restrictions or considerations, including time limitations Medically unfit, with restrictions or considerations, including time limitations If a worker fails to meet fitness requirements in a periodic test, they will be prohibited from continuing in their current role, and management must take steps to reassign them. Objection to test results Employees have the right to object to test results within 30 days of notification. An independent review committee comprising specialists in occupational medicine and related fields will issue a decision within 15 days of receiving the objection.
Zawya
07-05-2025
- Health
- Zawya
Saudi: MHRSD plans to introduce mandatory occupational fitness testing for employees
RIYADH — The Ministry of Human Resources and Social Development (MHRSD) plans to introduce mandatory occupational fitness testing for employees in the government, private and non-profit sectors as well as for those who take up new jobs in these sectors. These tests will be carried out under certain specific occasions. The ministry published the National Regulations for Occupational Fitness Tests on the Istitlaa Public Survey platform seeking the viewpoints and opinions of the public and the stakeholders before enforcing these regulations. There will be three types of tests: general medical testing, additional specialized testing, and psychological testing. These tests aim to monitor and follow up on individual health and promote occupational health through pre-employment testing and periodic employee testing. This contributes to reducing work-related accidents and occupational diseases and improving work environments in the Kingdom. The regulations aim to provide a comprehensive framework for assessing the health and psychological fitness of employees and workers to ensure their ability to perform their duties efficiently and safely. The testing framework will be aligned with national standards and international best practices. These include reducing work-related injuries, accidents, and occupational diseases, enhancing the physical and psychological fitness of workers, and ensuring their ability to perform their duties safely and efficiently. The provisions of the regulations apply to all employees and workers in public entities, private sector establishments, and the non-profit sector, including all new candidates prior to appointment, and all workers and employees currently employed. This test applies to employees under certain occasions and these include tests following an occupational injury; upon returning from extended medical leave; when there are doubts about the worker's or employee's ability to perform their work; if the job or profession requires a periodic medical examination; if the worker or employee changes his or her profession; if there is a change in the work environment; if new equipment, machinery, or devices are used, and upon retirement from work if exposed to substances with a long latency period during employment such as asbestos. These regulations do not apply to medical examinations outside the scope of the job or profession. The regulations define the mechanism for pre-employment medical examinations for those working in high-risk professions, standardizes medical examination forms, periodic examinations, and exceptional examinations appropriate to each profession, provides comprehensive databases on the health status of all workers, and improves compliance with local standards, regulations, and international agreements in the field of occupational safety and health. The medical examination for occupational fitness must be conducted by a specialized team under the supervision of an occupational medicine specialist certified by the Saudi Commission for Health Specialties and registered with the Secretariat of the National Council for Occupational Safety and Health. Upon completion of the pre-employment medical examination, the result will be as follows: medically fit and permitted to practice the profession or job for which the candidate is applying; medically fit, with the restrictions or considerations required when practicing the profession for which the candidate is applying, including the duration; and medically unfit, with the restrictions or considerations required when practicing the profession for which the candidate is applying, including the duration. If the occupational fitness requirements are not met after the periodic examination, the workers will be prohibited from continuing to practice their profession, and the supervising management must take the necessary measures to change their profession. The worker or employee has the right to object to the test results within 30 days of notification. An independent review committee, consisting of specialists in occupational medicine and related specialties, will be formed to consider the objections, with a decision to be issued within 15 days. © Copyright 2022 The Saudi Gazette. All Rights Reserved. Provided by SyndiGate Media Inc. (
