High street self-tests for bowel cancer and menopause may be unfit for purpose, researchers warn
Researchers, vitamin deficiencies, menopause and intestinal cancer high street self tests may not be suitable for the purpose, he said.
There are many products for UK customers without the need for a doctor’s appointment. However, concerns about the quality, suitability and safety of these kits were expressed, doctors said that they may be “dangerous ve and may cause“ wrong assurance ..
Researchers, NHS’nin self -tested after the NHS can see additional demand, he said.
To put this easily existing health checks Test, researchers He examined 30 Öz Tests purchased from local supermarkets, pharmacies and health and welfare shops at the University of Birmingham.
Findings Posted on Wednesday in UNJ Show that most of the tests of self -tests do not have basic information about who should use them, how the results will be interpreted and what the next action should be done.
Researchers looked at tests covering 19 conditions such as vitamin D deficiency, blood sugar, thyroid function, prostate health, HIV, menopause and bowel cancer.
However, less than half of the 30 tests made any explanation about accuracy, and only eight had information about who should or should not use the test. Only seven of the tests in the house told users what to do after receiving their results.
Only 16 tests, scanning, diagnosis or monitoring clearly stated that they were for, and nine did not show symptoms or risk factors for their use. However, almost all tests (27 out of 30) suggested that the results were positive or abnormal and 14 with a healthcare professional, regardless of the result.
Approximately half (14) claimed a 98 percent accuracy, but the work writers said that the evidence that supports these claims was not either public or low quality and increased ethical concerns.
Researchers also said that 18 of the tests were “high risk ı due to the quality of the test equipment, the sampling process or the instructions and interpretation of the results.
The authors acknowledge that the study example is limited to the Birmingham region and that its assessments are limited to lack of access and the weak reporting of the documents provided by the producers. However, they say that this is a solid and reliable assessment of self -tests for the British people.
“I think it is dangerous. I want a central arrangement that prevents these things from being released. I think that the biggest potential damage of these things is that it is not positive, I think it is a wrong assurance that these things are good.
Joseph Burt, Head of Diagnosis and General Medical Devices in the Drugs and Health Products Regulatory Agency (MHRA), said that he would review the evidence and “take into account all the allegations about device deficiencies”.
“We strengthened the post -market surveillance forces to monitor and activate.
“To further strengthen safety, usability and clinical performance standards, we overcome medical device arrangements and investigate new transparency measures, such as requiring published summaries of clinical evidence.
“In the meantime, we encourage a CE or UKCA sign, to read the instructions carefully and to receive medical advice if they are not sure of their consequences.”
Bernie Croal, President of the Royal Pathologists College, warned about the impact of hitting for NHS: “There are important risks for patients when NHS is performed in an inappropriate way when both misrepresented and unnecessary assurance and unnecessary results are performed in an inappropriate way.”
Since the first example of 2023, researchers have continued to monitor the exploding self -test market. In December 2024, the repetition of the same geographical area detected 63 tests as twice the previous year.
“There is a need for consistent guidance and better regulation to protect both individuals and health systems from misuse and misunderstanding,” the researchers said.
Irwin Armstreng, the founder and CEO of Ciga Healthcare and Surahign, who criticized the UNJ work
He said: ız We find the condemnation of this blanket of a small home test that is not unreasonable and professional, because they admit that they are satisfied with most of the studies. This is not a clinical approach to a very scientific issue.
“They did not confirm that clinical studies related to our tests were given to them as confirmed by the UNJ. Our detailed answers to their questions were not fully reflected in their articles.
“When we think that they were very meticulous in their audits, they indirectly criticized the professionalism of the organs reported by MHRA. [that] Our tests cannot easily be found with NHS at the moment. “
Mr. Armstrong added: “Sur design tests are not intended to make medical decisions, but as scanning tests.
