Some words of caution before you buy a medical self-testing kit
Self-testing is increasingly popular, especially since the Covid-19 epidemic, when lateral flow tests allowed ubiquitous home testing for the infection.
However, two studies published in the
British Medical Journal
have found that many self-tests are unfit for purpose and need greater regulation to ensure they are safe and reliable.
In the first comprehensive studies into the issue, researchers at the University of Birmingham reviewed 30 self-tests bought from local supermarkets, pharmacies and health-and-wellbeing shops. The tests covered 19 different conditions, including vitamin D deficiency, blood sugar, thyroid function, prostate health, HIV,
menopause
and bowel
cancer
.
READ MORE
Of the 30 tests, just 14 made any statement about test accuracy, only eight provided information on the box about who should or should not use the test and only seven indicated what action to take after the result. Only 16 tests explicitly stated they were for screening, diagnosis or monitoring, while nine did not indicate the symptoms or risk factors for their use.
[
Thinking of buying a medical self-test kit? Read this first
Opens in new window
]
However, nearly all tests (27 out of 30) recommended follow-up with a healthcare professional if results were positive or abnormal. Performance claims were made for 24 tests, with more than half claiming 98 per cent accuracy or higher. Yet, much of the evidence to back these claims was not publicly available or was of low quality, which the authors say also raises ethical concerns.
The researchers rated 18 of the tests as 'high risk' over concerns about the testing equipment, sampling process or instructions and interpretation of the results, while use of the tests as advertised was judged contrary to evidence-based guidance for 11 of the 19 conditions studied.
Since collecting their initial sample of tests in 2023, the researchers have continued to track the market – and it's flourishing. A repeat search of the same geographical area in December 2024 identified 63 tests, twice as many as the previous year, many of them clones of existing self-tests, rebranded and sold under different names by a range of distributors. And while the study was UK based, the tests all had CE marks – a certification mark to signify that products have met essential European standards – making the results relevant in an Irish context.
In the Republic, the
Health Products Regulatory Authority
(HPRA) assesses self-testing kits, which are classified as in-vitro diagnostic tests. It advises only purchasing products with a CE mark and for consumers not to rely on the tests alone. No self-testing is 100 per cent reliable, it says, pointing out that a number of factors may interfere with or affect test results, including medicines and dietary supplements.
An example of the problems with the self-testing kits identified by the BMJ is illustrated by one marketed for the diagnosis of 'chronic kidney injury'. The test, which looks for the presence of protein in the urine, had the most usability issues of all the tests examined. There were significant sampling challenges and unclear result interpretation, with faint colour reference charts making results hard to read.
Readers may wonder if there is an element of medical paternalism at play here. After all, when home pregnancy tests were made available, some doctors argued that women should not be trusted to use them. But an accompanying BMJ editorial states that 'giving people access to information and tools to understand their health is not in itself inherently problematic'.
[
Go with the flow: How lateral flow tests are becoming a diagnostic game changer
Opens in new window
]
'Empowering individuals to take an active role in their health is an important goal, but if self-tests are to be sold directly to the public, they must be supported by high quality evidence, robust regulation, trustworthy public information, and clear pathways for interpretation and follow up,' it concludes.
For consumers here, the BMJ studies suggest a need for closer co-operation between the HPRA and the European Commission to ensure the CE marking system is fit for purpose.
mhouston@irishtimes.com
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Irish Times
11 hours ago
- Irish Times
From goats cheese to hummus - why there has been so many listeria recalls
News last month that a person had died with a rare bacterial infection called listeriosis sparked concern among the public. The Food Safety Authority of Ireland (FSAI) described the outbreak of listeriosis, which is caused by the bacteria listeria monocytogenes, as 'extensive', with nine confirmed cases linked to it by the end of July. The outbreak resulted in a 'voluntary, precautionary recall' of 141 ready-meals produced by Ballymaguire Foods . But in the weeks since, products other than ready-meals have been recalled in relation to listeria. READ MORE Over the past three weeks, there have been recalls for various types of goats cheese, potted coriander , hummus, mixed leaves and spinach , and chicken basil pesto pasta. The publicity around the bacteria understandably shook people's confidence in the safety of food. In a bid to reassure consumers, the FSAI issued a statement clarifying that the subsequent recalls were not related to the outbreak in ready-meals and that it carries out inspections of food production facilities. Serious infection with listeriosis is 'very rare', the authority said, with an average of between 14 and 22 cases in Ireland annually. [ What is listeriosis and its symptoms? Opens in new window ] But why are we hearing so much about it? Cormac Gahan, principal investigator at research centre APC Microbiome Ireland, and a professor in University College Cork's schools of microbiology and pharmacy, said listeria was 'ubiquitous' and often found in the environment, including in soil and plant matter. 'It's the prevalence in the environment that's the main concern. So keeping it out of the food chain is a big concern. There can be unintended consequences when processes go awry,' he said. The bacteria is also 'unusual', he said, in that it grows very slowly when refrigerated. 'So you need to use really good hygiene practices to keep it out of the food chain'. But what is driving the increase in food recalls? There is 'no magic answer', according to Prof Séamus Fanning, professor of food safety at University College Dublin (UCD), but there are a number of factors at play. 'We are able to detect it more often because we have an improved surveillance system. That's down to the technological development over the past 20 or 30 years. Now, our toolbox is much better and we have much more accurate ways of identifying it,' he said. It is a 'tricky organism' to deal with, he said, due to the way in which it 'genetically adapts'. 'So you find it in soil and water. It can then move into a situation where it contaminates a food-processing facility. And then there can be cross-contamination,' he explained. 'It can be difficult to get rid of it in a factory. If it raises its head, and there are positive [tests] then you must do a major, major clean.' Prof Gahan believes another reason there has been an increase in recalls is due to the recent publicity around the listeriosis outbreak relating to ready-meals. That, he said, is likely to have resulted in food manufacturers increasing their testing due to public discourse around the topic. 'The more testing there is, the more recalls there will be,' he added. Despite all the recent publicity, the two professors believe consumers can still be confident their food is safe. They highlight the at-risk groups – such as older people , the immunocompromised or those who are pregnant – but said for most people it causes only flu-like symptoms that will resolve by itself. 'We also have strong regulatory and food safety systems. The food recalls could be viewed as a risk-reduction measure,' Prof Fanning said. Prof Gahan agrees: 'Ireland's rates of infection are relatively low. We have good procedures in place.'
Irish Times
11 hours ago
- Irish Times
Does femtech suggest so-called women's troubles might soon be taken as seriously as men's?
No, I tell my iPhone's autocorrect function, I really did mean femtech – not fintech. While one is crypto -focused, the other concerns the cryptic state of women's health , a market projected to be worth $97 billion (€83 billion) by 2030, according to a recent Irish report . The authors want to position Ireland as a leader in gendered health tech. In Ireland, 30 start-ups, many women-led, are innovating in areas such as endometriosis , polycystic ovary syndrome and menopause . We all know the phrase: 'If childbirth/periods/perimenopausal symptoms [insert women's health variable here] were a man's problem, it would have been solved by now.' Does femtech suggest so-called women's troubles might soon be taken as seriously as men's? As things stand, the history of gendered health tech is one of not enough data (and not enough women). Take the contraceptive pill, marketed in the 1960s after a decade of trials in Puerto Rico. Enovid was designed as a 'universal' contraceptive, a one-size-fits-all that ignored women's diverse bodies and needs. And who was the contraceptive pill really designed for? Its 21 days of hormones followed by a seven-day withdrawal bleed were a deliberate choice to mimic 'natural' menstrual cycles, making it more palatable, not just to users, but also to religious institutions. Dr John Rock, a devout Catholic who co-developed the contraceptive, acted in the misguided hope that the bleed would align the pill more closely with the rhythm method in the eyes of the church. READ MORE Healthcare in general suffers from what Catherine D'Ignazio, the author of Data Feminism, has called the gender data gap. Between the 1970s and the 1990s, an FDA (US Food and Drug Administration) guidance excluded women of childbearing age from early-stage clinical trials. The result is that many drugs were optimised by default for male bodies, with no research into how sex differences might affect drug metabolism, dosage or side effects. [ Femtech is about finally prioritising women's health in a world focused on men Opens in new window ] Then there's the speculum, a gynaecological instrument created with the user in mind – aka, a clinician, not the patient. These are just a few examples in a long history of health technologies designed for women without really considering how women and their bodies respond. Health tech has a habit of treating the user as a genderless everybody, which in practice usually means young, white, able-bodied, well-educated men, reflecting the designer's own demographic group. And it's not just health tech either: VR headsets, PPE, crash-test dummies, even musical instruments are built for male bodies. The problem isn't always a lack of data. Sometimes, it's too much of the wrong kind. The pill was tested in Puerto Rico because population control programmes were already in place, funded by US philanthropy. J Marrion Sims, known as the father of modern gynaecology, developed today's bivalve speculum while undertaking experimental surgeries on enslaved African women without consent or anaesthetic. In the mid-20th century, US venereal disease registries enabled the detention of women under public health laws. Henrietta Lacks, an African-American cancer patient at Johns Hopkins in the 1950s, had her cancer cells taken without her consent. They became the immortal HeLa cell line, used in countless medical breakthroughs. Her family received no compensation. In Ireland, the Magdalene laundries kept records of 'fallen women' for moral surveillance, not maternal care. Today, period and fertility-tracking apps raise similar concerns: in 2021, the Federal Trade Commission in the US charged the Flo app with sharing sensitive data with Facebook, Google and analytics firms, despite promising privacy. In the US, there are now fears such data could be subpoenaed in states where abortion is criminalised. The femtech gold rush promises to undo these wrongs, promising to keep central personalised design, diverse user input, and lived experience in product development. Ireland is already taking steps to ensure women's health innovation isn't left entirely to market forces. As the Femtech in Ireland: The Case for Prioritising Women's Health Research and Innovation report notes, women's health is 'a billion-dollar opportunity,' and 'smart economics', but it's also an area where public support has delivered real results. [ Ireland has potential to become global leader in femtech, report says Opens in new window ] Through programmes such as Femtech @ Health Innovation Hub Ireland, Horizon 2020, and Enterprise Ireland seed funding, dozens of Irish companies have been able to bring early-stage ideas into clinical testing, from Coroflo's real-time breast-milk monitor to IdentifyHer's wearable menopause sensor. This public backing centres women's health in national innovation strategy. It proves the viability of solutions for historically under-researched conditions. But once companies move from research and prototyping to a scaled product, private capital becomes essential. Coroflo raised $2.8 million from private investors; IdentifyHer is currently seeking pre-seed funding. Venture capital can accelerate growth, but as tech writer Edward Ongweso argues, it doesn't necessarily fund what's best, socially or holistically, raising questions about what values get built into women's health tech and who will be able to afford new advances. Privacy is another concern. In 2012, Target made headlines for predicting a teenager's pregnancy based on her purchasing data, sending her baby-product offers before she had told her family. Pregnancy data is extremely lucrative – worth two or three times that of a 'general' consumer – because it signals future spending. Menopause, long under-researched, is another rich data set, flagging future health needs and spending patterns. Much of the data gathered by femtech companies is proprietary, giving whoever collects it a first-mover advantage when it comes to developing drugs, therapies or insurance products. Proprietary data can mean commercial incentives, with no benefit to those being studied, from resale to insurers to invasive advertising (women over 35 are already plagued by ads for mushroom and flax supplements on Instagram). And, as any open-source advocate will tell you, it also means less public benefit; valuable health insights aren't always shared if they form part of a company's intellectual property. Ireland has already shown that sustained, targeted public support can lead to meaningful innovation in women's health. The challenge now is to keep momentum beyond the start-up phase, so that femtech in Ireland doesn't just mirror short-term venture capital cycles, but grows into a genuine revolution in women's care.
Irish Times
11 hours ago
- Irish Times
In pictures: The winning photographs of Ireland's night skies
To infinity and beyond ... This year's winners of the Dublin Institute for Advanced Studies (DIAS) photography competition, Reach for the Stars, show us images of space that take us all across the galaxy. There were five categories open to the public for submissions and entrants could submit images taken in Ireland between April 26th last year and June 2nd this year. For the first time, under-18s were eligible to enter the competition as they could submit photos to the Night Sky in Your Hand category, in which the judges asked for images taken using a smartphone. This year the competition saw more than 170 entries from photographers across Ireland. Mark McCormack won the Out of this World – Deep Sky category for the second year in a row. READ MORE The judging panel included: Pro Peter Gallagher, head of astrophysics at DIAS; Michael McCreary, president of the Irish Astronomical Society; Dr Lisa McNamee co-founder Space Medicine Ireland; and Alan Betson, Irish Times photographer and multiple winner of the Press Photographer of the Year award. Winter Nebula in Full Bloom, photographed by Martin McCormack, Dublin, the winning image in the Out of the World – Deep Sky category. An active star-forming region of ionised hydrogen about 130 light-years in diameter, the Rosette Nebula is located in the constellation Monoceros, about 5,200 light-years from Earth The competition is run in partnership with The Irish Times and is sponsored by MKC Communications and the Astronomical Observatories of Ireland, with The Irish Astronomical Observatories Society serving as 'initiative supporters'. There will be a prize ceremony for the winners at DIAS on Wednesday, August 20th and an exhibition of winning and shortlisted photographs will be open to the public from Thursday, August 21st. The Lone Tree, by Enda O'Loughlin, shortlisted in Out of this World – Planetary. 'It was a full moon in September and I wanted to capture a photo of the moon over this iconic lone tree in the Burren limestone pavement,' says Enda. 'The image is really two images taken within a couple of seconds of each other; one is exposed and focused for the Moon and one is is focused on the lone tree; both images are edited on Lightroom Classic and merged into Photoshop to show the focus on both the Lone Tree and Moon' Crescent Nebula and Soap Bubble Nebula by John Walsh, shortlisted in Out of the World – Deep Sky. 'The floating space brain, aka the Crescent Nebula ... 17.5 hours captured over five nights. I have always been intrigued by this weird object and have dreamed of imaging it since I started the hobby last year,' says John. It is the result of a stellar explosion that occurred more than 250,000 years ago Skellig Michael Under the Harvest Full Moon, by Goran Loncar, shortlisted in Out of this World – Planetary. 'This is a result of multiple exposures blended together in Photoshop. Most of the blend was done on a sky around the Moon from same location. I didn't touch the size and position of the Moon' Winning image in the Public Vote category: Symmetry, by Anthony Lynch, Dublin. 'The train tracks are a new feature in this sculpture park in Boora,' says Anthony. 'I used an astro modified Canon 6D with a 20mm lens at f/2 and ISO 800 to capture this sweeping panorama of the milky way across the top with the tracks. It's about a 20-shot pano with each shot being 15 seconds exposure' Aurora above the Golden Fields, by Raluca Lica, Kildare, the winning image in the Back on Earth – Landscape category. 'The image was captured during the impressive geomagnetic storm on the night between May 10th and 11th, 2024. I was a little sceptic about the forecast and I was quite late getting on the move,' says Raluca. 'However, as I was loading my gear into the car, the sky suddenly brightened up and the beams started dancing. It was an unbelievable experience. The photo was taken with my Sony A7iii camera and my Sony 20mm lens, at ISO 1250, at f/1.8, three seconds exposure' Comet Tsuchinshan, ATLAS In All Its Glory, photographed by Brian O'Halloran, Waterford, the winning image in Out of the World – Planetary. The comet passed into our evening skies in mid-October 2024. 'It was an easy naked eye sight, and displayed not only a lovely tail but also an anti-tail, an apparent spike projecting from a comet's coma which seems to go towards the Sun and consists of larger dust particles left behind by the comet. This is rarely seen, and it was a privilege to capture' The Voyager, by Liam Reddall, Dublin, the winning image in Back on Earth – Landmark. 'I had seen the Voyager Statue by Linda Brunker while scouting locations online and knew it would make a captivating foreground subject. This bronze stature looks out over the coast to the sea, allowing for an uninterrupted view of the night sky. Lit by the surrounding streetlamps, it takes on a golden glow under long-exposure photography' Winning image, Night Sky in Your Hand: Comet Catcher, by Anthony Lynch, Dublin. 'Myself standing under a tree in Phoenix Park, reaching out to comet 12P Ponns Brooks when it was low on the horizon in twilight' Sunflower Galaxy by Mark Gribbin, shortlisted in Out of this World – Deep Sky. 'The image was taken from the heart of Carlow town. This is my second real attempt at focusing on a galaxy for multiple nights,' says Mark. 'I was confident when beginning this session that I would be able to do this galaxy justice and I feel I've done that here' Waterford's Crowning Glory, by Adrian Hendroff, shortlisted in Back on Earth – Landscape. 'Coumshingaun is a colossal glacial wonder; there is nothing in Ireland quite like it,' says Adrian. 'At over 2,500 feet, it boasts a stupendous view from its cliff-top, with a large pear-shaped lake sitting at the bottom of a rocky coum. Ever since taking up astrophotography, it's been a yearning ambition of mine to shoot the Milky Way from up here. Having waited for five years, a weather window finally presented itself in early April. The temperature was just below freezing but it was just amazing to see the millions of stars twinkling in the night sky'
