Off-the-shelf medical tests are failing to back up accuracy promises with evidence, study finds
Off-the-shelf medical tests that promise to diagnose conditions ranging from vitamin deficiencies to cancer are lacking evidence to back up their accuracy, a study has found.
Thirty self-testing kits were purchased from a range of mainstream supermarkets, pharmacies and health and wellbeing shops by researchers from the University of Birmingham in 2023.
The kits tested for vitamin deficiency, blood cholesterol, menopause and bowel cancer. These tests are often marketed as tools for empowerment and early detection at a time when the NHS is already over-stretched.
Accuracy claims were made for 24 of these tests however, and nearly six out of 10 (14) promised 98% accuracy. However, evidence supporting these claims was largely unavailable, according to a series of papers published by the British Medical Journal (BMJ).
In addition, 18 of the tests (60%) were found to have errors that could lead to a wrong result. This included 11 that had problems with equipment, 10 showing issues with the sampling process and 15 that had problems with the instructions of interpretation of results.
Where information about what types of accuracy methods were available, about a third of those compared their test with another similar test – not a proper, trusted medical test.
Most of the tests also did not explain who they tested them on to provide the accuracy data.
These types of testing kits are not subject to the same stringent checks that a new medication would have to go through.
The University of Birmingham’s Professor Jon Deeks, a corresponding author of the study, said: “Our findings highlight concerns about the value of these self-tests because the instructions for use for many of them recommended seeing a doctor regardless of the test result (positive or negative).”
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Dr Clare Davenport, co-author of the study, said the benefit of many of these tests “is lacking”.
“This is in contrast to well-established self-tests, such as pregnancy tests,” she said.
“We are worried that consumers concerned about their health and tempted by the convenience of buying a test over the counter may be harmed if they use these tests in the wrong way.”
A false positive on such a test may lead to anxiety, unnecessary investigations and even overtreatment, while a false negative could lead to delays in treatment.
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Pic: University of Birmingham
Researchers are now calling for better regulation and guidance from manufacturers, retailers and healthcare professionals to protect consumers of off-the-shelf health self-tests.
There were some limitations to the test – namely that they were bought two years ago and were not intended to be a sample of what is available across the country.
“But given what they do say about where they got the tests, I’d be surprised if they aren’t pretty much the same anywhere nowadays,” said Professor Kevin McConway, emeritus professor of applied statistics at The Open University.
He said the results were “scary and concerning”.
“I don’t doubt the findings of the researchers, that many of the available tests don’t make it clear who could make good use of them, how accurate the results might be, or what someone should do in the light of their results.”
‘History offers cautionary tales’
“Self-tests should not be dismissed outright though,” wrote Jessica Watson from the Centre for Academic Primary Care, and Margaret McCartney, from the University of St Andrews, in an editorial for the BMJ.
“History offers cautionary tales: when home pregnancy tests were first introduced, some doctors argued that women could not be trusted to use them.
“Clearly that is not the case.
“The use of HIV self-tests has been extensively and carefully evaluated, with decades of research, including large randomised controlled trials.”
However, they say that these examples are of tests that are “binary” with yes or no answers, and are integrated within healthcare systems, “with clear actions to be taken based on the results”.
The study was funded by the National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre.
“I’m incredibly patriotic,” says Ross, “I love our flag.”
He’s pulling a trailer loaded with England flags, otherwise known as the flag of St George, and Union flags, while his friends carry a ladder.
They’re heading out to fly flags from lamp posts in his hometown, Lichfield.
The group carried flags to raise around Lichfield
We’re here to spend an evening with them – keen to understand why flags are appearing on streets across England and what people make of it.
As the flags go up, several passing drivers beep and shout their support.
But it isn’t long before a man and woman walk past, visibly annoyed.
“Shameful behaviour,” the woman tells the group.
One of Ross’s group calls back: “Why can’t you be proud?”
“I am proud, but we’re absolutely tripping over from patriotism to an overt display of nationalism,” the man replies.
“There have been many occasions throughout history where the British flag has been adopted by groups that I don’t agree with”.
It’s a tense moment.
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Octavia raises a flag in Lichfield
I ask Ross, 27, if the flying of the flags is timed to coincide with concerns about immigration.
“Yes,” he replies. “My personal stance on it is, yes, this is us saying ‘you’re in our country’, right?
“This is what we stand for, you bow to this flag how we do, right, and you shouldn’t be doing illegal things, and for example, raping the women and committing crimes, which we don’t agree with.”
Ross says there’s nothing wrong with being patriotic
He tells me some of the handful of people he’s with went to the same school as him. But Octavia, the only woman in their group, only met them recently.
“She bumped into us the other day, and now she’s a full-fledged flagger,” Ross says.
Octavia, 27, lifts her jumper to reveal she’s wearing an England flag dress.
“I saw him putting up the flags and I genuinely wondered why,” she says.
“He kind of explained to me, like, we’re protecting people of Britain, we are spreading awareness, that is literally all, and I was really happy to get involved”.
Octavia says she was happy to get involved
As the next flag is being put up, a man walks past and breaks into song.
“No surrender, no surrender, no surrender to the boats coming over,” he sings.
Ross, filming him, thanks him for his “performance”.
Many opinions but few solutions for debate that crosses dividing lines
Over the course of an evening in Lichfield, we struggled to find anyone who didn’t have an opinion on the flags appearing around the town.
Yet we did find people who were reticent to speak on camera, particularly those opposed to the flags being there.
This is a town where around 93% of residents were born in England, according to the census in 2021.
Unlike many British towns and cities, there is little visible evidence of the mass migration this country has experienced in recent decades.
Octavia, the newest recruit to the group of “flaggers” we met, grew up in Leicester, where just under 58% of people were born in England.
After meeting people opposed to the flags in Lichfield, she told me “they’re wealthy, they live in a nice area, they don’t actually have to go through the struggles that everybody else does”.
She then revealed her opposition to migrant hotels is in part because she was once at risk of homelessness and didn’t get state support.
But from what we saw, it would be wrong to conclude that there are obvious dividing lines in this debate.
On both sides, there were people from a range of different backgrounds, young and old.
Some see a display of pure patriotism. To others, it’s blatant nationalism that has to stop.
But in these uneasy times, the removal of any flags has been seized on as a political act that has sparked anger in communities.
A woman sees it all happen and tells us her husband has written to the council to ask for the flags to be removed.
She’s unhappy about how it may make the town feel for some people.
But she doesn’t want to go on camera – or even have her words recorded.
Bob says the number of flags going up has become ‘extreme’
I ask Ross about his political views.
He says he doesn’t belong to any party, but he tells me he supports Tommy Robinson – and had been with him the previous evening.
He got the flags they’re putting up from him.
Further down the street, we meet Bob. He’s just out for dinner. We get talking about the flags.
“It’s not a racist thing just to be wanting to look after your people,” Ross tells him.
Bob agrees, but is concerned about why flags are going up now.
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“It’s become quite extreme,” he says. I ask if he thinks the flag is being used as a racist symbol. “100% yeah, I do,” he says.
But an elderly couple over the road completely disagrees with him. “Of course, we support St George’s flag, we’re British,” the woman says.
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“There’s nothing wrong with showing the English flag,” her husband agrees.
It’s hard to find anyone who doesn’t have a view on the flags appearing around the town. We leave Lichfield with a sense that they’re provoking strong feelings on both sides of a very live national debate.
Sir Keir Starmer has defended welcoming the Israeli president to Downing Street as MPs raised concerns about allowing him into the UK.
Sir Keir started Prime Minister’s Questions (PMQs) by saying “however difficult, the UK must not walk away from a diplomatic solution” to the war in Gaza.
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“We will negotiate and we will strain every sinew, because that is the only way to get the hostages out, to get aid in and to stop the killing,” he told MPs.
The PM said he will be “absolutely clear that we condemn Israel’s action” in bombing Hamas leaders in Qatar, during his meeting with Israeli President Isaac Herzog on Wednesday afternoon.
His visit comes just a day after Israel carried out the strike in Qatar.
The PM added that it would be the “politics of students” not to meet Mr Herzog after the SNP’s Westminster leader Stephen Flynn gave an impassioned speech against the Israeli president’s visit.
Mr Flynn said: “Would he invite Vladimir Putin into No 10? Would he invite Benjamin Netanyahu into No 10?
“What does it say of this prime minister that he will harbour this man whilst children starve?”
Isaac Herzog is in the UK. File pic
Following Mr Herzog’s visit to Number 10, the Israeli president said: “Britain and Israel are friends, but among friends there are sometimes disagreements.”
He said he “made clear” the UK’s intention to recognise a Palestinian state would “in no way help bring the hostages home, help the Palestinians, or help bring an end to the conflict” – but would instead “embolden extremists”.
The president also told Sir Keir it was “dangerous” to “echo Hamas’s propaganda campaign of starvation in Gaza”.
MPs question Herzog visit
Dozens of MPs from all parties, including Labour, questioned the legal standing of Sir Keir welcoming Mr Herzog.
The Israeli president previously said there are “no innocent civilians in Gaza” and “it is an entire nation that is responsible”.
He was also pictured signing an artillery shell before it was fired towards Gaza in December.
The prime minister’s spokesman said the attack in Qatar is a “clearly unacceptable act” and said it “of course” would be one of the subjects raised with Mr Herzog.
He added Sir Keir will be “clear” with Mr Herzog about the risk of Israel escalating its actions.
Handcuffs not handshakes
New Green Party leader Zack Polanski called for “handcuffs not handshakes” as he said Scotland Yard’s war crimes unit should be waiting inside Number 10 to handcuff Mr Herzog “and take him away for questioning”.
Mr Polanski, who won the Greens leadership election last week and is Jewish, accused Mr Herzog of being “complicit while the Israeli government has engaged in committing genocide in Gaza”.
Zack Polanski. Pic: PA
Israel has continually denied it is carrying out a genocide in Gaza, but last week, the world’s leading association of genocide scholars declared it is. Earlier this week, the UK government concluded Israel is not committing genocide in Gaza.
Herzog is a conduit
The Liberal Democrats tabled an urgent question following PMQs, calling on the foreign secretary to make a statement on the implications of Israel’s strike in Qatar.
Foreign Office minister Hamish Falconer took to the despatch box to defend Mr Herzog’s visit, saying: “President Herzog is on a private visit to the UK.
“He is not a functional part of the government; he is an important conduit to raise these concerns.”
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In full: Wednesday’s PMQs
Mr Falconer said the UK is supporting a motion for an emergency meeting of the UN Security Council on Wednesday evening and revealed Foreign Secretary Yvette Cooper is speaking to the E3 (UK, France and Germany) and G7 allies, including the US about Israel’s attack on Qatar.
He added that Ms Cooper met Mr Herzog in the morning and “amongst other things” asked him to ensure greater support from the Israeli government to get children with injuries and students out of Gaza.
As PMQs was taking place, union members at the Trades Union Congress (TUC) conference unanimously passed a motion to oppose Mr Herzog’s visit.
On Tuesday evening, 60 cross-party MPs and Lords gathered outside parliament to condemn Mr Herzog’s visit after they sent a letter to Sir Keir asking what legal advice the government has received about Mr Herzog’s visit and whether his entry to the UK “is compatible with our obligations under the Genocide Convention”.
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