Getty imagesHome health tests purchased by people seeking answers to their terms can give incorrect and misleading results and require much regulation to ensure that they are safe, reliable and effective, the researchers have warned.
From intestinal cancer to menopause, shop-borne health kits now test for a variety of conditions and are easily available on high roads and supermarkets in the UK.
But two new studies published in the British Medical Journal (BMJ) say that many kits lack important information, such as who they should use, how to interpret the results, and what steps to take further.
In response, the regulator, who maintains medical equipment in the UK, MHRA, says it is of “overhaling” security standards.
Researchers at the University of Birmingham analyzed the 30 self-test kit in 2023, £ 1.89 and £ 39.99.
Researchers concluded that only 14 kits saw any statement about accuracy, and less than a quarter gave clear guidance in the next stages after achieving results.
He also found that about half of users advised to consult a healthcare professional regardless of the result, some experts warning that they could put additional pressure on NHS services.
Prof. John Dex, who led the research, said the current rules do not go far to protect consumers.
He said, “Self-testing has a clear ability to improve public health. However, to not be beneficial and harmful for them, they must be accurate, supported by easy and clear instructions,” he said.
Pregnancy tests have been around self-testing in the UK for more than 50 years, first introduced in 1971. During the covid lockdown, lateral flow tests became common for Kovid. Neither was included at the Birmingham Research University published by BMJ.
“When properly integrated into clinical routes, self-testers have been shown to increase the uplift of testing in underscribed groups,” the researchers say.
But BMJ has warned that offering self-testing based on the ability to pay instead of clinical requirement, “increases the exploitation of inequality and weak population groups”.
Royal College of Pathologist President Berney Calli reported that BMJ poorly testing can lead to both “false assurance” and “unnecessary results” for NHS.
The UK self-test market is expected to increase significantly, the revenue forecast to reach £ 660m by 2030.
Says BMJ, “Direct-to-consumer testing can appeal to the public, as they can provide clinical results quickly, offering autonomy on privacy, privacy and health decisions,” BMJ says.
The authors classified 60% of the tests, which they saw as a “high risk”.
While most kits carried out claims of high accuracy, some above 98%, researchers say support evidence was often not publicly available.
Although it is not necessary by law to publish clinical performance data to manufacturers, BMJ asks for more transparency.
Royal college of general practitioners More openness has also been called in the industry.
Joseph Burt, the head of diagnostics and general medical devices in MHRA, said it is investigating research, “We are searching for new transparency measures such as a published summary of clinical evidence requires a summary.
“Meanwhile, we strongly encourage anyone using self-testing to examine the CE or UKCA mark, read the instructions carefully, and if they are uncertain about their results, seek medical advice”.
