high Street Self-testing for vitamin deficiency, Menopause And bowel cancer The purpose may not fit, the researchers have warned.
There are many products available for UK customers, without requirement Appointment of doctorBut concerns about their quality, suitability and safety have been increased. Kit, with doctors warnings they can be “dangerous” and can cause “false assurance”.
Researchers called for very strict regulation of the region, warning NHS and people may face additional demand after self-testing.
Market for self-suggestions There is a boom and expected to reach an estimated revenue of £ 660m by 2030 in the UK.
To do these easily available health checkways Testing, researcher But University of birmingham Local supermarkets, pharmacies and 30 self-testers purchased from health and good shops reviewed.
conclusion Published in BMJ on Wednesday Show that most self-scrutiny lacks the required information of who they should use, how to explain the results, and what action should be taken further.
Researchers saw tests that covered 19 conditions including vitamin D deficiency, blood sugar, thyroid function, prostate health, HIV, menopause and bowel cancer.
However, out of 30 tests, less than half made any statement about accuracy, and only eight were aware of the box about who should use the test or not. Only seven tests in the house told users what to do after getting their results.
Only 16 tests clearly stated that they were for screening, diagnosis or monitoring, while nine did not indicate symptoms or risk factors for their use. However, almost all tests (27 out of 30) made follow -up recommendations with a healthcare professional, if the results were positive or unusual, and regardless of 14 results.
About half (14) claimed an accuracy of 98 percent, but the study authors highlighted that the evidence of returning these claims was either not publicly available or of low quality, which he raised moral concerns.
Researchers also stated that 18 tests were “high risk” due to the quality, sampling process, or interpretation of the testing equipment, or the interpretation of instructions and results.
The authors admitted that the study sample was limited to the Birmingham region and was limited by the reach of documentation provided by their assessment manufacturers and lack of poor reporting. However, they say that this is a strong, reliable evaluation of self-suggestions available to the UK public.
Professor of Endocrinology, Christian Bolert and an advisor Endocrinologist at Birmingham University said: “I really feel that it is dangerous. I would like to support the UK-Wide regulation … which prevents these things from coming to the market.
Joseph Burt, head of diagnostics and general medical devices at the Medicine and Healthcare Products Regulatory Agency (MHRA), said it would review the evidence and “consider all the allegations about the deficiencies of the device”.
He said: “We have strengthened post-mortem monitoring powers to monitor and work on concerns. In these, manufacturers need to actively monitor their products and report important events for us including CE-Choic self-prisoners.
“We are overhale to the medical equipment rules to further strengthen the standards for safety, purpose and clinical performance, and we are searching for new transparency measures such as a published summary of clinical evidence requires a summary.
“Meanwhile, we encourage anyone using self-testing to check CE or UKCA Mark, read the instructions carefully, and if they are uncertain about their results, seek medical advice.”
The Royal College of Pathologist President Berney Call warned of knock-on effects for NHS: “There are significant risks for patients when poor quality tests are done improperly, both false assurances and additional action with unnecessary consequences for NHS and to take additional action.”
Since the initial sample in 2023, researchers have continued to track rapidly growing self-testing market. A repetition discovery of the same geographical area in December 2024 identified 63 trials, which is double the previous year.
Researchers concluded, “There is an urgent need for coherent guidance and better regulation, both individuals and health care systems to misuse and protect against misinformation,” researchers concluded.
Irwin Armstrong, the founder and CEO of Ciga Healthcare and SURESING, who provides three of the several self-protections studied, criticized the BMJ study.
He said: “We find this blanket of a small series of home tests available for being inappropriate and unprofessional, as they believe that they are satisfied with many people. It is not a clinical approach to a highly scientific subject.
“He did not even confirm that the clinical study related to our tests was supplied to him, as confirmed to us by BMJ. Our detailed reactions about his questions were not completely reflected in his article.
“They have clearly criticized the professionalism of the notified bodies appointed by MHRA, when we find them very accurately in our audit. We are the materials [that] Our tests are not easily available with NHS at the present time.
Mr. Armstrong said: “Susign tests are used as screening tests and not to make medical decisions. They are not to replace the tests conducted by professionals. Currently, it is difficult to get an appointment with GP and therefore, these tests provide users to actively enable to take a medical opinion.”
