by Off-the-shelf health tests for problems such as cholesterol, lack of vitamins, fertility and prostate problems may not be suitable for the purpose, warned researchers.
A team from the University of Birmingham examined tests that people can buy in British supermarkets, pharmacies and shops and which they then use at home.
They found that the tests risked to give people the wrong result, to delay the diagnosis, and most of them still recommended with a doctor, regardless of the result.
The researchers called for a much closer regulation of the sector and added that the NHS can meet additional demand after the self -test of the people.
They said: “In the absence of instructions from relatives of the health professions, individuals could use tests inappropriately or without a clear understanding of the effects of the results.
“False positive test results can lead to unnecessary anxiety, increased healthcare and additional costs, while false negative test results can delay adequate treatment or commitment with … screening programs.
“Test errors can be attributed to inherent restrictions on the accuracy of the test and user -related problems such as sample errors, false processing and difficulties in interpreting the results.”
However, the team said that homing tests could have great potential for patient care in the future.
The regulatory authority for Medicines and Healthcare Products (MHRA), which regulated medical products, stated that they examined the results.
Professor Jon Deeks from the University of Birmingham said: “A wealth of new health -day self -tests have appeared in recent years and can be bought in many high street supermarkets and patoses in Great Britain.
“While these kits have been approved for sale, they are not subject to the same strict regulations as pharmaceutical products.
“Our latest research results raise concerns about the suitability, accuracy and usability of many of the available self -test products in which users have to test, test and interpret the results themselves.
“In some cases, it is unclear how accuracy claims are supported, and there is no requirement for manufacturers to share evidence of these claims.”
Prof. Deeks said Great Britain has a “new world” in terms of self -examination, but there is more work to show that claims were robust.
He said a large part of the literature with tests was “not easy to understand”, while some of the results could lead to a “wrong diagnosis”.
In an example, he said that the self-tests for prostate-specific antigen (PSA), a marker for the health of the prostate, were fixed at a certain level of concentration.
“If you are 70 years old, you have to make your PSA at a completely different level when you are 20,” he said.
Self -test is becoming increasingly popular, and the British market for self -tests is expected to reach £ 660 million by 2030.
A total of 30 self -tests, which cost £ 1.89 to 39.99 GBP, were included in the study, which was published in the British Medical Journal (BMJ).
The tests included 19 different diseases, including vitamin deficiency, blood sugar levels, cholesterol, thyroid function, prostate health, HIV, menopause and colon cancer.
Researchers said only eight of the 30 tests provided information about who should use the test or not, while four specified the presence of symptoms.
The external packaging at less than half of the tests (14) contained an explanation of its accuracy.
In the meantime, 90% of the tests recommended the follow -up examination with a health profession if the test results were positive or abnormal, while 47% recommended this if the test results were negative.
For 24 of the tests, including in brochures, accuracy claims were raised, and most (58%) stated an output of at least 98% accuracy, sensitivity or specificity.
However, the researchers said that the evidence of the accuracy claims were largely not available or did not provide sufficient information for people who are likely to acquire the tests.
Prof. Deeks said: “The current regulations for the use of self -test kits in a commercial environment do not adequately protect consumers.
“Some of the manufacturers of self -tests refused to provide us with reports of their studies that support their claims and explained that they were” commercially confidential “.
“You do not have to pass this information legally. For all questions of our health, however, it is really important that the evidence of which health decisions are made and can be checked.”
Dr. Clare Davenport, professor of clinical staff at the University of Birmingham, said: “The wide range of tests now available to the public, which are now available to the public, are not approved by the NHS, and evidence of their benefits are missing.
“In contrast to well -established self -tests such as pregnancy tests, this is in contrast.
“We are concerned that consumers who are concerned about their health and are tempted by the convenience of buying a test via the counter if they use these tests incorrectly.”
Dr. Davenport said the recommendation that people seek a doctor anyway, regardless of the result “asks the question”, what is the point of doing the test at all? “.
Sue Davies, which one? Head of consumer rights and food policy said: “Consumers should be careful with self-tests, they can be expensive, difficult to interpret and are not always associated with expert advice to help them understand their results.
“It is also likely that you have to track your family doctor. We therefore always recommend that you include you from the start if you have certain health concerns.
“Most tests you need are available free of charge on the NHS, and your family doctor can also talk to you about how you feel and discover symptoms that may not appear during a test.”
While clinical studies and medication have to go through the MHRA, self -test devices are subject to notification bodies.
A spokesman for Suresign, who delivers three of the self -tests examined, said: “We find this flat -rate condemnation of a small selection of hometowns that are inappropriate and unprofessional because they admit that they are satisfied with many of the examined.
“This is not a clinical approach to a very scientific topic.
“You have also not confirmed that the clinical studies related to our tests were delivered to them, as we confirmed by the BMJ.
“Our detailed answers to your questions were not completely reflected in your article.
“You implicitly criticized the professionalism of the reported bodies defined by the MHRA when we find it very demanding in your audits.
“We are satisfied with our tests that are accessible to public access to the screening of the healthcare system, which is currently not easily available with the NHS.”
Joseph Burt, Mhra director of diagnostics and general medical devices, said that it would check the evidence and “consider all allegations about device defects”.
He added: “We have strengthened the surveillance powers after the market for monitoring and acting.
“These require manufacturers to actively monitor their products and report significant incidents, including for CE-marked self-tests.
“We overtake the regulations for medical devices to further strengthen the standards for security, user -friendliness and clinical performance, and we examine new transparency measures such as the requirement of published summaries.
“In the meantime, we all encourage everyone to use a self-test to search for a CE or UKCA brand, to carefully read the instructions and to receive medical advice if they are not sure whether they are not sure of their result.”
