Latest news with #selftesting
Irish Times
11-08-2025
- Health
- Irish Times
Some words of caution before you buy a medical self-testing kit
Are you someone who purchases and uses medical self-testing kits? If so, some just-published research suggests caveat emptor may be in order. 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@
Yahoo
25-06-2025
- Business
- Yahoo
Growing Demand for Point-of-Care (POC) Testing and Expanding Applications Beyond Healthcare
The U.S. and Europe lateral flow assay market is expected to reach USD 6.97 billion by 2030, with a 5.48% CAGR from 2025. Growth is driven by the rise in point-of-care testing, advancements in testing technologies, and increased demand during and beyond COVID-19. Emerging trends include digital integration and enhanced assay sensitivity. The report offers insights into major market segments, end-user analysis, and future trends, empowering strategic business decisions. U.S. And European Lateral Flow Assay Market Dublin, June 25, 2025 (GLOBE NEWSWIRE) -- The "U.S. And Europe Lateral Flow Assay Market Size, Share & Trends Analysis Report Product (Kits & Reagents, Lateral Flow Readers), By Application, By Technique, By Test Type, By End Use, By Country, And Segment Forecasts, 2025 - 2030" report has been added to U.S. and Europe lateral flow assay market size is anticipated to reach USD 6.97 billion by 2030 and is projected to grow at a CAGR of 5.48% from 2025 to 2030 This growth is driven by the increasing decentralization of diagnostic services, rapid adoption of point-of-care testing (POCT), advancements in rapid testing technologies, and the positive shift toward self-testing strategies. In addition, the rising prevalence of infectious diseases and heightened awareness of rapid test kits during the COVID-19 pandemic have created favorable conditions for the lateral flow assay market's expansion. The integration of digital technologies into lateral flow devices is another pivotal trend. Smartphone-based readers, as well as highly customized stand-alone LFA readers, have allowed users to obtain semi-quantitative or fully quantitative results from traditionally qualitative assays. These technologies not only have the potential to improve diagnostic accuracy but also enable real-time data sharing for epidemiological tracking and disease management. The increasing prevalence of infectious diseases throughout the world is a key driver fueling the expansion of the lateral flow assay market. These diseases necessitate novel diagnostic techniques for efficient treatment to stop the rising mortality high prevalence of infectious diseases worldwide has been a major driver for the market growth. These diseases necessitate novel diagnostic techniques for efficient treatment to stop the rising mortality rate. The COVID-19 pandemic, in particular, highlighted the need for rapid and accessible diagnostic tools, leading to a surge in demand for LFAs. Beyond COVID-19, other infectious threats have emerged. For instance, in 2025, a highly pathogenic avian influenza A (H5N1) virus infection resulted in a fatality in Louisiana, USA, despite the use of personal protective equipment that was deemed inadequate. According to the Centers for Disease Control and Prevention (CDC), while the general public faces a low risk, individuals working closely with infected animals-such as farmers, veterinarians, and wildlife facility staff-remain highly vulnerable. In 2024, 67 human cases of avian influenza were reported, with 40 linked to exposure to dairy cattle and 23 associated with poultry farms. In response, the UK proactively secured 5 million doses of the H5 vaccine to mitigate potential risks in in LFA technology have significantly improved the sensitivity, specificity, and overall performance of these assays, thereby expanding their applications. In December 2021, Eurofins Technologies introduced the RapidScan ST5-W lateral flow reader, designed for field and in-process testing applications that require qualitative to semi-quantitative test results. Traditionally, commercial LFA test strips utilize the red coloration of gold nanoparticles (GNPs) or colored beads for detection. LFAs have proven highly sensitive in diagnosing diseases like HIV-AIDS, Hepatitis B, and C and assessing immune responses against signal amplification techniques, including silver enhancement and GNP-enzyme conjugation (such as horseradish peroxidase), have significantly improved detection capabilities. Furthermore, integrating electrochemical sensing, Surface-Enhanced Raman Spectroscopy (SERS), fluorescence detection, and nanoparticles have enhanced the specificity of LFAs, allowing for multiplex detection and faster diagnostics. Future advancements, including next-generation chips, DNA amplification, and CRISPR-based technologies, hold the potential to improve LFA performance further. The use of quantum and nanomaterials is also being explored to boost convenience and accessibility of home-based testing have led to increased adoption of LFAs among consumers. In September 2024, InBios International Inc., a leading developer of diagnostic tests for emerging infectious diseases, obtained 510(k) clearance from the USFDA for its SCoV-2 Ag Detect Rapid Test. Featuring a patent-pending design, this user-friendly rapid antigen test requires no additional equipment or mixing, can be stored at room temperature, and delivers results in just 20 minutes-offering a simple and accessible COVID-19 testing solution for home use. Beyond COVID-19, InBios International Inc. has secured a USD 16.5 million project aimed at enhancing the design of its Active Melioidosis Detect Plus (AMD Plus) device. The funding will support performance validation and regulatory approvals, demonstrating the growing investment in LFA-based diagnostics for infectious diseases beyond the pandemic. In December 2024, the USFDA approved the OraQuick HIV Self-Test, a qualitative immunoassay designed to detect antibodies to HIV-1 and HIV-2 in oral fluid samples. Intended for over-the-counter (OTC) use, this test offers individuals a discreet and reliable way to screen for HIV at home, contributing to early diagnosis and timely medical intervention.U.S. And Europe Lateral Flow Assay Market Report Highlights The kits & reagents segment led the market with the largest revenue share of 68.48% in 2024, driven by technological advancements and rising demand for rapid diagnostics. Innovations in assay sensitivity, specificity, and ease of use have significantly contributed to market expansion. Based on application, the clinical testing segment led the market with the largest revenue share of 77.18% in 2024. This growth is fueled by the increasing prevalence of infectious diseases and chronic conditions, along with the rising demand for rapid diagnostic solutions. Based on technique, the sandwich assay segment led the market with the largest revenue share of 39.66% in 2024, driven by its accuracy, affordability, and ease of use. These assays are particularly valuable in low-resource healthcare settings, as they do not require trained personnel. Sandwich assays are commonly used to detect larger analytes that contain two epitopes or binding sites. Based on test type, the lateral flow immunoassay (LFIA) segment led the market with the largest revenue share of 65.10% in 2024, solidifying its position as a widely used platform for rapid diagnostics since its introduction in the mid-1980s. Due to their ease of use, cost efficiency, and quick results, LFIA tests are highly adaptable, allowing for administration by healthcare professionals and patients at home. Based on end use, the hospitals & clinics segment led the market with the largest revenue share of 35.99% in 2024. As primary diagnostic and treatment centers, hospitals and clinics play a crucial role in driving LFA adoption across the U.S. and Europe. The U.S. market is experiencing robust growth, driven by continuous product innovation, strategic investments, and strong government support. Advances in LFA technology have significantly enhanced sensitivity and broadened applications, fueling market expansion. Key Attributes: Report Attribute Details No. of Pages 100 Forecast Period 2024 - 2030 Estimated Market Value (USD) in 2024 $5.19 Billion Forecasted Market Value (USD) by 2030 $6.97 Billion Compound Annual Growth Rate 5.4% Regions Covered Europe, United States Market Dynamics Market Drivers Analysis Increasing prevalence of infectious diseases Technological advancements in lateral flow Growing adoption in homecare settings Market Restraints Analysis Stringent Regulations Market Opportunities Analysis Growing demand for Point-of-Care (POC) Testing Expanding applications beyond healthcare Market Challenges Analysis Product Recalls U.S. and Europe Lateral Flow Assay Market Analysis Tools Porter's Analysis Bargaining power of the suppliers Bargaining power of the buyers Threats of substitution Threats from new entrants Competitive rivalry PESTEL Analysis Political landscape Economic and Social landscape Technological landscape Environmental landscape Legal landscape Companies Featured Abbott Bio-Rad Laboratories, Inc Siemens Healthineers AG BIOMERIEUX BD QIAGEN QuidelOrtho Corporation F. Hoffmann-La Roche DH Life Sciences, LLC. Quest Diagnostics For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Attachment U.S. And European Lateral Flow Assay Market CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Sky News
24-06-2025
- Health
- Sky News
Women who don't come forward for cervical cancer screening to be offered home tests
Women who don't come forward for cervical cancer screening will be offered home-testing kits as part of the government's new 10-year health plan. The Department of Health and Social Care has said the initiative aims to "revolutionise" cervical cancer prevention rates by helping overcome barriers that prevent some women from having potentially life-saving screenings. This can include a fear of discomfort, embarrassment, cultural sensitives and the struggle to find time for medical appointments. Cervical screening, sometimes referred to as a smear test, is a test to check the health of the cervix and help prevent cervical cancer. The NHS offers it to women and people with a cervix aged 25 to 64 - with those aged between 25 to 49 invited for the checks every three years, and 50 to 64-year-olds every five years. However, the government has said participation in cervical cancer screening currently sits at just 68.8% - well below the NHS England target of 80%. This means more than five million women in England are not up to date with their routine check-up. Experts have now said sending home-testing kits to those who don't attend their check-ups could increase participation in the screening programme that saves approximately 5,000 lives a year across England. The self-sample kits will be offered to women who have rarely or never attended their cervical screening. It will then be sent out in "discreet packaging" that can be returned via prepaid mail. The self-sample method tests only for the presence of the human papillomavirus (HPV), a group of viruses that can lead to cervical cancer. Anyone testing positive for HPV through self-sampling will be encouraged to attend a clinician-taken follow-up cervical screening test to check for cervical cell changes. The initiative is part of the government's "10-year health plan", which is due to be published in the coming weeks. A woman named only as Gem, who was diagnosed with cervical cancer in 2015, said: "I've been cancer-free for years now, but I still live with the aftermath of my diagnosis. I hope that one day we live in a world where cervical cancer is eliminated. With advances in vaccines and screening, I believe that day is getting ever closer. "For many, though, there are barriers to attending screening. Our everyday lives are busy juggling jobs, family life, and more, which can make attending appointments difficult. But feelings of embarrassment, fear, or unease can also prevent people from going. "Making it easier for people to access screening they can do at home removes some of those barriers and will, I'm sure, save lives." 2:23 Health Secretary Wes Streeting said: "These self-sampling kits represent healthcare that works around people's lives, not the other way around. They put women firmly in control of their own health, ensuring we catch more cancers at their earliest, most treatable stages. "Our 10-year health plan will fundamentally reform the NHS, shifting focus from treating illness to preventing it before it starts. "We know the earlier cancer is diagnosed the better the chances are of survival. By making screening more convenient, we're tackling the barriers that keep millions of women from potentially life-saving tests." Michelle Mitchell, chief executive of Cancer Research UK, said: "Screening is a powerful tool to prevent cervical cancer and save lives, but we know it isn't always easy for everyone to take part. "For some, the test may seem uncomfortable, embarrassing, or simply hard to fit into their lives. That's why we welcome the UK government's decision to roll out cervical cancer home screening kits in England - to help remove barriers and make cervical screening more accessible."
Telegraph
11-06-2025
- Health
- Telegraph
The £12 at-home prostate cancer test that could save you weeks of waiting for a GP
It's a slightly odd moment when I fire the little spring-loaded lancet into my own hand and, despite my attempts to bleed neatly, the kitchen table takes on a crime-scene feel. I've waited until family members are out and I'm able to process results alone, decide on next steps, and set my face if needed. I'm taking a prostate health blood test that I bought in Sainsbury's. It uses the little white plastic result tray familiar from Covid, capturing a drop of blood. The makers of the test I'm using say take up has increased 69 per cent since launch, two years ago. More and more of us are checking ourselves in this way, but what does it entail and what do you need to know? There is something satisfying about taking some control of your own health, and that's how it feels to take a prostate health test in your kitchen. It requires some self-education and a little caution, but I'm a fan. There are two kinds currently available – the pin-prick quick response that I am trying, and those that require a larger sample to be sent to a lab. Other commercial screenings exist, but have not been rolled out for home use yet. The commercial laboratory tests are much the same as an NHS blood test, only without the doctor to interpret results and place them in context (many provide this as an optional extra). Both measure PSA, a naturally occurring protein that can be an indicator of cancer. Testing at home for medical conditions is a booming business, with the global at-home medical testing market estimated at $7.4 million (£5.5m) in 2024. I have to confess, the idea of peering into my health in the privacy of my own home is very appealing – especially while there is no national screening programme. The faff of arranging appointments, the vulnerable feeling that overtakes you as you walk through the door of the surgery, and the worry about managing feelings: all of this makes lightly stabbing myself at the kitchen table feel more than worth it. Pros of self-test kits They are (reasonably) accurate Nick James, professor of prostate and bladder cancer research at the Institute of Cancer Research, and the Royal Marsden Hospital in London says, 'We did a bit of research on tests of this type and they weren't bad, to be honest. We dual-tested 50-100 [patients], comparing our lab results with their results – there was some inaccuracy at the borderline between normal and abnormal, but did that matter? Probably not. Once you have a properly abnormal PSA they will be accurate'. They are quick Prof James says: 'It is quite a good way of circumventing the initial chat with the GP. Most things in life you have control of, you want a pizza you pick up the phone and it arrives. It's only in medicine where you have to be grateful for what the NHS gives you, which might be great or it might be rubbish.' They are a useful start 'There's not much you can do wrong with them really,' says Prof James. 'If you have the test and it's normal, probably the NHS test would be normal too, if it's abnormal that should allow you to drive a referral. I tried to get an NHS PSA just to see the process, and it took me weeks and weeks.' They are cheap and easy Frederick Manduca is a director of Newfoundland Diagnostics, which makes the lateral flow PSA test I used. He says: 'There's a convenience factor, you can buy the test in Sainsbury's with your shopping and the result is there within ten minutes. It retails at £12, so you can screen regularly. It's easy to use. You only need a few droplets of blood and you can put it through the lateral flow test.' They are set up for the most at-risk group Newfoundland tests record any PSA score up to four as normal. 'We chose four as the dividing line,' says Manduca. 'It's all based on what we see as the most helpful cut-off for age. If we were screening 20-40 year olds the cut off would be much lower, but because that group is at such low risk, we weren't focused on them. At 70-plus, an abnormal result comes in between 4 and 5 PSA, between 50 and 70, anything from 4.00 upwards is definitely raised. It's the mid-point for that age range.' Cons of self-test kits Interpreting the results It's about self-education. PSA is not a cancer indicator in itself. Manduca says: 'The key is people understanding when they should test and what the results mean – this is a test for a protein the body produces, it's not a test for prostate cancer.' The Newfoundland tests come with a leaflet produced in conjunction with a cancer charity. How do the self-test kits compare to a clinical screening? There has been some controversy about this. A BBC report into the rapid response tests (no brands were specified) said: 'Of the five kits analysed by the BBC, one did not produce a readable result; three came back all clear; but one did show a solid dark line, indicating a PSA level above 4.0 ug/l. A private blood test taken the same day and sent to a laboratory, showed a much lower reading of 0.27 ug/l.' Manduca says the Newfoundland kits are tested against approved independent lab results: '92 per cent of the time the lab tests and the rapid tests were agreeing. There are slight deviations and cut-offs, if you were right on a boundary number, say 3.9.' He warns, however, that there are less reliable tests sold online and consumers need to check for official approvals before buying. The Prostate Cancer UK site says: 'We recommend that if you're worried about prostate cancer and want a PSA blood test, you should speak to your GP. It's crucial that, before you have a PSA blood test, you get balanced information or counselling from a healthcare professional, and that you get professional follow-up about your result and what to do next.' How to read your self-test kit results Any PSA is far from conclusive. Using a cheap and reasonably accurate home test can allow you to track your number and spot any changes. An NHS PSA test is also not definitive, and a high number should mark the start of an investigation. Figures for 'normal' PSA scores by age are available online, but any worries need full investigation with MRI scans via the doctor. Fredrick Manduca says: 'It's a tool in an overall toolkit. A lot of men don't know that if do they have a raised PSA only one-in-four of them will have prostate cancer. The general concept is for someone to test every year or every two years depending on how at risk they are, and see if there's a change.' My test, by the way, was normal, matching my most recent PSA which came in under 4.00. But I shall continue to monitor myself, looking for tell-tale changes.
Washington Post
02-06-2025
- Health
- Washington Post
At-home health tests are here. But they aren't always the best option
The doctor is in — the mailbox, that is. You can now do self-administered tests for everything from thyroid function to HIV in the privacy of your own home — and that list continues to grow, as the Food and Drug Administration recently approved the first at-home cervical cancer test .
