A slew of at-home medical tests have flooded supermarkets, pharmacies, and wellness shops in recent years, claiming they can identify everything from gluten sensitivity to male fertility without the need for a doctor’s visit.
But most self-tests sold do not provide clear information about who should use them, how to interpret the results, or what to do next, according to a new pair of studies.
Many also contradict formal health guidance, which could be confusing and prompt people to make “inappropriate” decisions about their health care, the researchers warned.
“We expect [a self-test] to be accurate and we expect it to be evidence-based if it's going to be sold to the general public,” Dr Alex Richter, one of the studies’ authors and a professor of clinical immunology at the University of Birmingham, said during a press briefing.
“Unfortunately, we found that many tests gave unclear or at least missing guidance”.
Independent experts said the results were alarming, particularly given the booming market for at-home tests, predicted to be valued at hundreds of millions of euros by 2030.
But with the abundance of choice, it can be difficult for consumers to pick out high-quality tests from the pack.
For the new reports, Richter’s team examined 30 self-tests for 19 health issues, including vitamin D deficiency, menopause, blood sugar levels, HIV, bowel cancer, and prostate health.
Only 14 tests made statements about their accuracy, eight offered information on the box about who should or should not use the test, and seven told consumers what they should do after taking the test.
Sixteen tests explicitly said they were for screening, diagnosis, or monitoring, while another nine did not provide information about the symptoms or risk factors for their use.
Nearly all of the tests recommended following up with a doctor if the results were positive or abnormal, the studies found.
Two dozen tests claimed they were highly accurate, but the evidence to back up those assertions was either of poor quality or not publicly available, prompting the researchers to raise ethical concerns.
Two companies – Newfoundland and Suresign – had the most problematic tests, the research found. They make rapid tests for menopause, vitamin D deficiency, the diagnosis of chronic kidney injury, and to detect thyroid problems.
Independent experts said the results should serve as a reminder that at-home tests can be useful, but they should not replace traditional, evidence-based medical care.
“Sometimes people use self-tests because they ‘feel it is better to know’ and they are trying to inform their health and healthcare decisions,” Dr Amitava Banerjee, a cardiologist and professor of clinical data science at University College London, said in a statement.
“This research shows that these self-tests are often not providing relevant knowledge or information and they are not informing decisions in the right way,” added Banerjee, who was not involved with the studies.
The study authors called for more regulation of self-tests, saying they should be thoroughly evaluated before reaching the supermarket or pharmacy shelves to protect consumers and the healthcare system from “misuse and misinformation”.
Richter said the findings should not cause people to cast doubt on all self-tests.
At-home pregnancy tests, for example, have been available for many years and are highly reliable when used correctly. And during the COVID-19 pandemic, self-tests were a cheaper, faster way for people to identify infections, easing some of the burden on the health system.
“We think there is a real place for this. … We just need to work out how they can be properly used and assessed,” Richter said.
“We don’t want bad tests on the market, we want good tests on the market”.
