Shop-bought health tests not always fit for purpose, researchers warn

Standard health tests for problems such as high cholesterol, vitamin deficiency, fertility and prostate problems may not be adapted to use, have warned the researchers.

A team from the University of Birmingham has examined tests that people can buy in British supermarkets, pharmacies and stores and which they then use at home.

They found that the tests were likely to give people the bad result, could delay the diagnosis, and most of them recommended a follow -up with a doctor, whatever the result.

Researchers called for much closer regulation in the sector, adding the NHS Can face an additional request after the self-test of people.

They said: “In the absence of advice from health professionals, individuals can use tests inappropriately or without a clear understanding of the implications of the results.

“The results of false positive tests can cause unnecessary anxiety, increased use of health care and additional costs, while the results of false negative tests can delay the appropriate treatment or engagement with … screening programs.

“Test errors can arise from limitations inherent in the precision of the test, as well as problems related to the user such as sampling errors, incorrect treatment and difficulties to interpret the results.”

However, the team said that in the future, home tests may have great potential for patient care.

The regulatory agency for drugs and health products (MHRA), which regulates medical products, said that it would examine the results.

Professor Jon Deeks, from the University of Birmingham, said: “A plethora of new health self-tests has emerged in recent years and are available for the purchase of many street supermarkets and pharmacies in the United Kingdom.

“Although these kits have been approved for sale, they are not subject to the same strict regulations as pharmaceutical products.

“Our recent research raises concerns about the relevance, precision and conviviality of many available auto-test products that force users to sample, test and interpret the results themselves.

“In some cases, it is not clear how precision complaints are supported, and there is no requirement for manufacturers to share the evidence of these complaints.”

Professor Deeks said that the United Kingdom is considering a “new world” with regard to the self-test, but there is more work to do to show that the assertions rendered were robust.

He said that a large part of the literature contained with tests was “not easy to understand”, while some of the results could lead to a “bad diagnosis”.

In an example, he said that auto-tests for specific prostate antigen levels (PSA), a prostate health marker have been set at a certain level of concentration.

However, “If you are 70 years old, you must have your Psa Done at a very different level in your 20, ”he said.

The auto-test is becoming more and more popular and the British auto-test market is expected to reach 660 million pounds sterling by 2030.

Overall, 30 auto-tests costing £ 1.89 at £ 39.99 were included in the study, published in the British Medical Journal (BMJ).

The tests covered 19 different conditions, including a vitamin deficiency, blood sugar, cholesterol, thyroid function, prostate health, prostate, prostate health, HIVMenopause and intestine cancer.

The researchers said that only eight of the 30 tests provided information on which or not to use the test, while four specified the presence of symptoms.

The external packaging on less than half of the tests (14) included any declaration on their precision.

Meanwhile, 90% of the tests recommended follow -up with a health professional if the test results were positive or abnormal, while 47% recommended that the test results were negative.

Precision complaints have been made for 24 tests, including brochures, and most (58%) requested a performance of at least 98% precision, sensitivity or specificity.

However, the researchers said that evidence to support allegations were not largely available or had not provided sufficient information for people likely to buy the tests.

Professor Deeks said: “Current regulations for the use of self-test kits in a commercial setting do not adequately protect consumers.

“Several auto-test manufacturers have refused to provide us with reports on their studies, which support their claims, declaring that they were” commercially confidential “.

“Legally, they do not need to share this information. However, for all questions of our health, it is really important that the evidence on which the health decisions are made are available and can be examined.”

Dr. Clare Davenport, associate professor of clinic at the University of Birmingham, said: “The wide range of standard tests now available to the public is not approved by the NHS and the proofs of their advantage are lacking.

“This contrasts with well-established auto-tests, such as pregnancy tests.

“We fear that consumers concerned about their health and attempted by the convenience of buying an over -the -counter test can be injured if they use these tests in a mistake.”

Dr. Davenport said that the recommendation that people see a doctor anyway, whatever the result “folds the question” What is the point of taking the test in the first place? ” “”.

Sue Davies, which one? Head of Consumer Rights and Food Policy, said: “Consumers Must be careful with auto -tests – they can be expensive, difficult to interpret and are not always delivered with an expert consultation to help you understand your results.

“It is also likely that you will have to follow your general practitioner, so we always recommend involving them from the start if you have special health problems.

“Most of the tests you will need will be available for free on the NHS and your general practitioner can also tell you about how you feel and locate the symptoms that may not appear during a test.”

While clinical trials and drugs must go through MHRA, self-test devices are subject to verifications by notified organizations.

A Susign spokesperson, who provides three of the auto-tests studied, said: “We find this conviction to cover a small range of home tests available to be unreasonable and non-professional, because they admit that they are content with many of those examined.

“It is not a clinical approach to a highly scientific subject.

“They also did not confirm that clinical studies linked to our tests were provided to them, as confirmed by the BMJ.

“Our detailed answers to their questions were not fully reflected in their article.

“They implicitly criticized the professionalism of the notified organs appointed by the MHRA, when we find them very demanding in their audits.

“We are satisfied with our tests giving the public access to health care screening which is not easily available with the NHS at present.”

Joseph Burt, head of the MHRA for diagnostics and general medical devices, said that he would examine the evidence and “would consider all the allegations concerning the gaps in the devices”.

He added: “We have strengthened post-commerce surveillance powers to monitor and act on concerns.

“They force manufacturers to actively monitor their products and bring us significant incidents, including for auto-tests marked by this.

“We revise the regulations of medical devices to strengthen standards for safety, conviviality and clinical performance and we explore new transparency measures such as published summary of clinical evidence.

“In the meantime, we strongly encourage anyone who uses a self-test to check a brand CE or UKCA, read instructions carefully and consult medical advice if they are not sure of their result.”