Leading Edge An Alpha Laboratories Ltd. Publication 2025 - Issue 2 Bowel Cancer Awareness Month - How Alpha Labs got involved on page 8 All the latest Alpha Labs News - Page 2 Sustainable IBD Management: IBDoc® Home Calprotectin Test Reduces NHS Carbon Footprint - Page 6 Editorial: Home Is Where the Health Is: Future-Proofing Healthcare Through Home Testing - See page 10 for more details Alpha Laboratories – Gastroenterology Conference Highlights - Page 4 Improving Turnaround and Clinical Confidence: NHS Tayside’s Experience with fCAL® turbo and CALEX® - Page 12 Tasso+ Packaging Redesign Reduces Plastic by 68%! - Page 15 Improved Workflow at Bowel Screening Wales - Page 9 Introducing the Venous Blood Collection Transport Kit - Page 14 Global Guideline for the Diagnosis and Management of Cryptococcosis - Page 18 Discover more articles inside...
Important Update - Alpha Laboratories Ltd is Now Part of Diploma PLC We are pleased to announce that Alpha Laboratories Ltd (Alpha Labs) has been acquired by Diploma PLC, a FTSE 100 UK-listed group, specialising in value-added technical products and services across Life Sciences, Seals, and Controls. Diploma adds value by providing essential products and solutions through a decentralised, customer-orientated approach within each of its end markets. Rob Vint, Managing Director of Alpha Laboratories, said: “Our extensive range of value-added solutions makes us an excellent fit with Diploma PLC, whose focus is the creation, innovation and delivery of value-added solutions within their life sciences division. We also share an ethos. Our passion for sustainability, proven ESG credentials, outstanding ISO accreditation, and significant academic achievements among our employees is something that is mirrored across the group.” As one of the fastest growing diagnostics companies in the UK and Ireland, with leading market positions in bowel cancer screening and inflammatory bowel disease diagnostics, Alpha Lab’s regional footprint and product expertise are a natural fit within the Diploma Life Sciences sector. Our commitment to our customers , passion for our products and expertise are paramount to our continued success. A partnership with Diploma allows us to remain agile and responsive while giving us the added strength of a public company that maintains the highest standards of compliance, commercial practice, and Leading Edge 2025 Issue 2 Alpha Labs News customer-centric vision. Alpha Laboratories will continue to operate under the same brand, from the same location, representing the same products and suppliers, with the same employees and leadership team that you, our customers, have come to know and trust. While we are no longer family-owned, the family spirit that defines Alpha Labs remains stronger than ever. For all intents and purposes, it is business as usual, with the added support of Diploma reinforcing what we do. We are excited to enter this next stage of growth, and look forward to using these newfound resources to source more innovative products that advance diagnostic practice, improve patient care and provide cost-effective solutions. For more information, please visit: alphalabs.co.uk/diploma or if you have any questions, please contact us at info@alphalabs.co.uk. 2 Leading Edge Scan to view all news and events
We have now closed our competition for our 50th anniversary celebration. Each winner received a £50 Amazon gift card, along with a heartfelt BIG thank you for their kind words about Alpha Labs – we’re truly humbled. Here are some of the quotes from the winners below. You can view all the feedback on our 50th Anniversary webpage. If you’d like to know more about our 50th year celebrations and history please visit: alphalabs.co.uk/50th 50 Years of Trust: Competition Winners Announced Six members of Alpha Laboratories recently participated in a charity golf event for Crohn’s and Colitis UK at the picturesque South Winchester Golf Club. Our six enthusiastic golfers competed in a friendly match, divided into two teams: Team Blue and Team Black. The day was filled with camaraderie and healthy competition, culminating in Team Blue narrowly defeating Team Black by just one shot. Although neither of the Alpha teams won the event, they had a lovely day and certainly looked the part. We are proud to have contributed to an event that not only promoted team spirit but also supported a charity dedicated to improving the lives of over 500,000 people in the UK living with these lifelong conditions. The Crohn’s and Colitis Berkshire Network stated “they were proud to host their 3rd annual Charity Golf Day. This group raises awareness and funds for those with IBD (Inflammatory Bowel Disease). This is a life changing condition and patients suffer from bleeding, constant pain, incontinence, fatigue and other unpleasant symptoms. A significant number need surgery and a stoma, and most are on a lifetime of medication. Raising funds enables us to support those who have been diagnosed and are struggling to manage their condition. We receive over 2.5million hits to our website and thousands of calls a year to the Helpline. We help with a wide variety of information about medication, diet, lifestyle, treatments, therapies and support webinars, as well as surgeries, stomas, side effects Teeing Off for a Good Cause and patient journeys. We were delighted that 38 players joined us on the prestigious South Winchester Golf club. We had lovely weather, and everyone had a most enjoyable days golf, by all accounts. We had a ‘nearest the pin’ and ‘ longest drive’ competitions and we all had a pleasant meal in the clubroom at the close of play. The Mayor of Winchester, Councillor Sudhakar Achwal presented the prizes and thanked everyone for ‘making a difference’. We are now planning our 4th annual Golf Day - watch this space!” Left to Right: Dom Saville, Rizky Nelson, Caroline Durbin, Mike Godley, Brad Gilham and Rob Flooks It is a pleasure working with you, and I sincerely appreciate the exceptional service you provide. Your timely support has been invaluable in ensuring the smooth operation of our laboratory without any delays. From customer service to management, the level of service you offer is truly outstanding. Please continue your excellent work as it contributes significantly to advancing our shared goals. Thank you once again for your continued support. - Customer in Surrey Alpha Labs have been efficient and always had our vital absorbent sheeting in stock. We store autologous human tissue for use in reconstructive surgery mainly for cancer but also for the aesthetic market. Without the Absorbant sheeting Alpha provides we would be unable to run our niche service to the NHS in the way we do. Staff have always been particularly helpful at Alpha keen to satisfy our rather stringent requirements. - Customer in Cambridge www.alphalabs.co.uk © 2025 Copyright Alpha Laboratories Ltd. 3
The first half of the year is always an active period for gastroenterology, with many of the field’s major conferences taking place. Alpha has maintained a strong presence at several of these events – not only attending sessions and engaging with peers, but also hosting our own stand to showcase our solutions and expertise, and connect directly with delegates. Here’s a look at our recent participation. GINCon 24 January 2025 The year started in January with the 12th Gastrointestinal Nursing Conference in London with around 300 attendees who listened to talks on IBD and pregnancy, adverse event reporting, a round table discussion on the future of nursing in gastroenterology, and a very interesting discussion on the use of AI. There were also talks on advances in stoma care, Liver competencies, managing patient distress and future treatment options in Crohn’s Disease. Alpha Laboratories – Gastroenterology Conference Highlights ECCO February 19–22, 2025 In February it was a pleasure to join the BÜHLMANN team on their stand at ECCO in Berlin – this was the 20th Congress of the European Crohn’s and Colitis Organisation with more than 8,000 delegates from 99 countries, which is the highest number of participants since the event started. There were 746 delegates from the UK, which was second only to the host nation – Germany. The main focus for this event was again the BÜHLMANN home and POC calprotectin assays and the therapeutic drug monitoring. 4 Leading Edge
Come and see us! For all our upcoming events, please visit: www.alphalabs.co.uk/events LabMedUK25 9–11 June 2025 At the start of June it was LabMedUK in Manchester, and although it wasn’t overly gastroenterology focused in the programme we presented the BÜHLMANN fCAL® turbo, elastase and CALEX® patient packs, the HM-JACKarc FIT solution and bespoke patient packs, all of which are available through The Alpha Portal. We also had a fantastic poo emoji stamp on the passport that delegates needed to collect to win attendance at next year’s conference. There was a session on therapeutic drug monitoring that featured data from the BÜHLMANN Quantum Blue Rapid infliximab assay compared to standard laboratory ELISA testing. BÜHLMANN have infliximab and adalimumab (which are used in the treatment of IBD) serum trough and antibody levels with results available inside one hour. For further information on this please visit the website: www.calprotectin.co.uk/tnf Three posters were also presented at MedLabUK featuring gastroenterology assays – if you didn’t get to see them at the conference then follow the QR code at the end of this section: 1. Verification of an automated faecal elastase assay for use in NHS Lanarkshire. Z This shows performance on the Roche analyser compared to the Schebo ELISA assay. 2. Evaluation of the BÜHLMANN fPELA ® turbo assay on the Beckman Coulter AU5822 automated chemistry analyser Z This shows the performance comparison to the Schebo ELISA assay. 3. Patient extraction of faecal calprotectin at home does not significantly impact the currently used screening thresholds for inflammatory bowel disease. Z They are currently using the York Care pathway: Z Negative < 100µg/g Z Intermediate 100 – 250µg/g Z Positive > 250µg/g Scan to view all the posters from LabMedUK 2025 here British Society for Gastroenterology (BSG), 23–26 June 2025 Lastly, towards the end of June came the British Society for Gastroenterology’s BSG Live event in Glasgow, where we were piped into the conference centre on the first day to get that true Scottish feeling. ‘Colin the Colon’ also made a special appearance after having had to miss last year due to space constraints: With around 6,000 delegates, mostly from the UK, there was plenty of opportunitytotalktoGastroenterologists and specialist IBD and endoscopy nurses. The real focus of interest from delegates was in the rapid testing for calprotectin and therapeutic drug monitoring with specific interest in the rapid self-testing with the BÜHLMANN IBDoc and the direct to patient delivery service via The Alpha Portal. There was also a very interesting poster presentation on this highlighting the reduction in the environmental impact that implementation of a home test can achieve. This is detailed in the article from County Durham and Darlington on page 6. www.alphalabs.co.uk © 2025 Copyright Alpha Laboratories Ltd. 5
Sustainable IBD Management: IBDoc® Home Calprotectin Test Reduces NHS Carbon Footprint Amanda Appleton, Product Manager, Alpha Laboratories Ltd. There has been a big drive in recent years to reduce the environmental impact of the NHS – be that their direct (NHS Carbon footprint) or indirect carbon footprint (NHS Carbon footprint Plus which is emissions they can influence), or single use plastics. The aim is to reach net zero for the direct carbon footprint by 2040 and the indirect carbon footprint by 2045. In addition, there are targets to achieve 80% reduction by 2032 and 2039 respectively.1 This is a big ask, and is easier said than done, especially in the diagnostics/procedural side of things, because there is a heavy reliance on single use plastics and patients attending hospitals. County Durham and Darlington introduced the BÜHLMANN IBDoc® calprotectin home test, available from Alpha Laboratories, into the gastroenterology department in mid2023 and rapidly started enrolling patients onto the new test. Dr Saad Khan and Lead IBD nurse Sue Ritchie presented a retrospective audit the IBD team had completed at The British Society for Gastroenterology conference in Glasgow in June 6 Leading Edge
For more information visit: www.calprotectin.co.uk/ibdoc Scan to view the full poster 2025. The audit covered from July 2023 to November 2024 and involved 158 patients that were enrolled onto the IBDoc home test. They used the patient postcode information and calculated the distance to the hospital – from this they determined that 1658 miles were saved in delivering stool samples for calprotectin testing to the laboratory, which is an average of 10.4 miles per patient. This then equates to the following in CO2 emissions depending on the vehicle type used for the journey:2 County Durham and Darlington is one of the largest geographical trusts in the North of England, so the patients can be quite a distance from the hospital. They also have patients who go off to university that like to maintain their care under their existing healthcare team. The IBDoc home test enables this without them having to travel large distances to get their calprotectin levels checked, and so the potential mileage/CO2 saving in these circumstances is even higher. Apart from the CO2 emissions, the use of the IBDoc home test over this time period also saved on the use of approximately 237 single use plastic pots, and sealable plastic bags (which equates to 4266 grams of plastic and 948 grams of plastic respectively) for the transport of the faeces to the laboratory for testing. It also saves 237 request forms to authorise the analysis within the laboratory - everything with the IBDoc is electronic, so the paper request form is not required. In addition to the environmental benefits, the other benefits are (depending on your perspective) even more significant: 9 The time to starting patients on the correct treatment pathway was reduced to an average of 1.7 days which is down from~2 weeks. In the audit, just over 66% of results were ‘abnormal’, so a quicker result is obviously better for the patient by improving treatment strategies. It is also potentially cost saving for the NHS due to intervention being initiated before the disease state progresses further, which might potentially require more significant intervention. 9 A quicker result for the 33% of results that were ‘normal’ relieves patient anxiety. 9There is a benefit to the staff in not having to chase (or be chased by patients) for lab results. 9In addition to the obvious benefit of the quicker result meaning quicker start of the appropriate treatment pathway the patients also have the added benefits of: Z Reduced anxiety due to reduced time waiting for the results Z Home testing eliminates the risk of samples getting lost/leaking enroute to the hospital which then require a sample to be repeated and increases the time to obtaining the result Z Elimination of the time required to deliver the References: 1. NHS England: Greener NHS - https://www.england.nhs.uk/greenernhs/a-net-zero-nhs 2. Khan et al; BSG 2025: Impact of Home based faecal calprotectin testing in IBD patients: Environmental sustainability and timely disease monitoring IBDoc faecal calprotectin testing demonstrated significant environmental benefits by reducing travel and CO2 emissions while enabling faster clinical assessment. These findings support its adoption as a sustainable, efficient alternative for managing IBD patients. traditional sample to the GP/hospital for analysis Z Potentially having to get someone else to deliver the sample because the patient isn’t well enough. Z That’s not to mention the challenges faced with hospital parking! Within the diagnostic arena it is hard to reduce carbon emissions and the requirement for single use plastics, but the IBDoc calprotectin home test does achieve this, as the team conclude in their poster: www.alphalabs.co.uk © 2025 Copyright Alpha Laboratories Ltd. 7
Bowel Cancer Awareness Month at Alpha Labs In a year filled with milestones (Happy 50th Birthday, Alpha Laboratories!) and big events such as the exciting launches of Alpha Solutions® tailored kitting, fulfilment and distribution services, and the innovative digital Urine Testing System (UTS™), Bowel Cancer Awareness Month in April stood out as an important event in our calendar. This influential campaign is dedicated to raising public awareness of one of the most common cancers worldwide. Throughout the month, we worked to raise awareness of the key warning signs, which include changes in bowel habits, abdominal discomfort, blood in the stool, unexplained weight loss, and persistent fatigue. Unfortunately these signs are often ignored, and by the time a diagnosis is made, the cancer may have already progressed. As part of Bowel Cancer Awareness Month, our team proudly participated in Bowel Cancer UK’s Active April campaign once again. Having taken part since 2022, we pushed ourselves even further this year. In a bid to encourage as many people to get involved as possible, the Alpha team were set a target of walking 500,000 steps throughout April. Managing to reach this goal just seven days, we upped the ante to two million steps! We even set up a staff leader board for those with Active April 2025: A Record-Breaking Success! Announcing Our Official Partnership with Bowel Cancer UK Alpha Laboratories’ history working with Bowel Cancer Screening programmes put us in the prime position to uplift the ongoing work at Bowel Cancer UK. Therefore, following several years of contributions and involvement in the ‘Active April’ campaign, we are proud to announce that we are now an official corporate partner of Bowel Cancer UK. Bowel Cancer UK shares: a competitive streak, and our top three walkers all achieved over 300,000 steps over the duration of the month! We were thrilled that, collectively, we ended up achieving an incredible 4,590,285 steps, far exceeding our original target. From dog walks and Park Runs to exploring the Jurassic Coast, every step contributed to raising an incredible £8,000 for Bowel Cancer UK. This donation supports Bowel Cancer UK’s mission to ensure a future where nobody dies of bowel cancer. We’re proud to have supported this worthy cause again and look forward to making an even bigger impact next year. Early detection is crucial, around 90% of patients diagnosed at stage one survive for five years or more, compared to only 10%when diagnosed at stage four. Alpha Laboratories has always proudly supported Bowel Cancer Screening programmes and Faecal Immunochemical Testing (FIT) – from the guaiacbased Faecal Occult Blood (FOB) cards, through to the fully automated quantitative FIT analysers and buffered sample collection pickers in use across screening and symptomatic testing sites today. We invite you to explore the articles (right hand side) we released throughout Bowel Cancer Awareness Month, where we share insights, patient and healthcare professional perspectives, resources and information on the support and services we offer at Alpha Laboratories. What is Bowel Cancer Screening? Alpha Labs Charitable Support News The Backbone Behind Bowel Cancer Support FIT for all Fight Early Onset with Early Detection “As the longest-standing providers of tests to the National Bowel Cancer Screening Programmes, Alpha Laboratories have always shared our vision of a future where nobody dies of bowel cancer. We’re so grateful for their continued support of our work and their role in bowel screening and can’t wait to see where our partnership can go!” www.bowelcanceruk.org.uk/support-us/partnerwith-us/our-corporate-partners/ We are excited to continue supporting the amazing work Bowel Cancer UK does in raising awareness, advancing early detection, and offering vital support to everyone affected by bowel cancer. 8 Leading Edge
Improved Workflow at Bowel Screening Wales Alex Ure, Product Manager, Alpha Laboratories The Bowel Screening Laboratory in Wales have been running the Alpha Laboratories Faecal Immunochemical Testing (FIT) kits on the HM-JACKarc analyser for over five years. The lab runs around 350,000 FIT tests per annum and have recently changed their control reagents from lyophilised controls to the new innovative liquid controls. Andrew Jones, the Laboratory Section Lead at Bowel Screening Wales, has provided some useful feedback on how the change has positively impacted their laboratory. Valuable Time Saved and Variability Minimised Before use, lyophilised quality controls must first be reconstituted with 1ml of deionised water and left to sit for a minimum of fifteen minutes before aliquoting. The process of reconstitution can vary depending on operator technique and equipment used, and any disruption to the reconstitution process could lead to poor end results. Andrew at Bowel Screening Wales found that: “Using the liquid controls thoroughly improved efficiency and workflow due to the removal of the reconstitution process. All variability has been massively reduced without having different operators making up controls each day.” Although reconstitution of controls is a simple process, cutting this step out not only saves precious testing time, but also saves valuable storage space without the need to create and store any reconstituted aliquots. When asked, “What is the highlight of changing over to liquid controls for FIT?”, Andrew reiterated that ‘’The removal of the reconstitution process has been most beneficial in managing laboratory procedures.” Simple, Stress-Free Transition Bowel Cancer Screening is a huge operation that requires precise planning and constant monitoring. When switching over any laboratory reagents, it is often expected to be a tedious initiative. At Alpha Laboratories, we have a dedicated team who can help integrate the new controls onto your existing For more information about liquid controls, please visit: www.faecal-immunochemical-test.co.uk/controls quote, answer any technical queries throughout the process, and deliver any specific training associated with the product, if required. The Welsh Bowel Cancer Screening team found the transition “Easy with no challenges, an in-house, free-of-charge verification was performed first, which streamlined the whole process.” Ease of Use Despite the lack of need for reconstitution, users have often assumed the liquid controls still require pipetting into sample cups for analysis. We can confirm this is not the case with the HM-JACKarc liquid controls, the user can simply bring the bottles to room temperature, and fire away! The liquid controls are supplied within 3ml bottle droppers, which ensure swift and simple dispensing of reagent for analysis. When asked about the 3ml liquid control dropper bottles, Andrew highlighted “The laboratory staff found the dropper bottles highly practical and easy to use, they all preferred this method.” Contact your local Key Account Manager today for more information on how you can bring this workflow-enhancing product into your lab. www.alphalabs.co.uk © 2025 Copyright Alpha Laboratories Ltd. 9
Home Is Where the Health Is: Future-Proofing Healthcare Through Home Testing Kayleigh Roberts, Product Manager, Alpha Laboratories Ltd. At the onset of the COVID-19 pandemic, the global healthcare landscape had to undergo a swift transformation. Traditional face-to-face healthcare delivery was significantly disrupted, and accommodations had to be made to ensure that patients could be triaged and monitored in ways that protected public health and also enabled timely and accurate diagnosis or treatment of disease without the need for repeated clinic or hospital visits. The increased use of telephone or video appointments allowed patients to maintain continued contact with their healthcare providers. However, even after the worst of the crisis had passed, budgets, staffing, and resources within the healthcare landscape still required alleviation from the immense pressures of the pandemic, and answers were still needed on howbiological samples could be obtained in a safe, quick, and accurate way. Enter: at-home patient testing. In 2017, Scotland became the first country within the UK to overhaul its bowel screening programme and introduce a new quantitative Faecal Immunochemical Test (FIT) in place of the guaiac-based cards. With this came the implementation of new patient packs which provided all of the instructions and tools necessary for patients to collect their faecal samples quickly and hygienically, and return them to the laboratory for automated processing. It was off the back of this initiative that home testing started to become a viable option on a wider scale, and through the pandemic, new bespoke kits were created in the same way to ensure that symptomatic patients could also be supplied. Today, the bowel screening programmes across the UK are some of the most successful examples of at-home sample collection, with the combined programmes sending out approximately nine million screening invitations per year. The average return rates across all programmes range between 60-70%,1, 2, 3, 4 so although there are still opportunities for improvement, the overall uptake can still be considered successful for triaging the wider population and sending referrals for appropriate further investigation. Key Challenges for Home Testing Luckily, healthcare in the UK has continually evolving guidelines, which means that as new problems arise, so do answers and new opportunities. Innovative end-to-end kitting and logistics can now help improve compliance by empowering patients to take their health into their own hands. Alpha Solutions® patient home testing kits are now available with tailored messaging, bespoke instructions and sampling methodologies, thus providing users with the knowledge needed to accurately collect and handle their samples, whilst also reducing the burden on resources within the laboratories and clinics. Public perception and subsequent compliance for the sample collection process can alter massively depending on the sample type (e.g, faeces, blood, urine, saliva, etc.) collection methodology, frequency of collection, and even just speed of results feedback from their healthcare provider. This means that any messaging about the testing process must be clear, direct, and simple to prevent misconceptions. Equity and accessibility also need to factor into any considerations when 10 Leading Edge
building a home-testing initiative; from average reading-age of the local population to language requirements, as well as physiological issues such as visual impairment or dexterity. Beside the issue of compliance, home testing has common operational challenges which may affect efficacy and outputs. These can include: Kit generation and distribution Z Initial identification of what is needed to ensure kits are fit-for-purpose and appropriate for their intended user. This scoping process may also require consideration of potential risks and benefits, as well as timescales for kit builds and distribution. Additionally, small-scale clinical trials may benefit tremendously from scalable solutions to improve compliance and cost-effectiveness. Z Regulatory and Quality Control considerations including: 9 UKCA marking (MHRA registered) 9 ISO 13485 certified (kit registration and assembly) 9 UN3373, Category B compliant (where applicable, for biological or infectious substances) 9 CE/CE IVD marking (where applicable, for kits being utilised outside of the UK) Z Initialising and maintaining a new distribution network. This task can quickly become an administrative burden – are any specific programme coordinators required? Can an established logistics service be utilised to remove pressures on internal resources? Patient Sampling Z There may be significant variations in the way each user collects and returns their sample for processing, particularly for faecal samples which can present in many different consistencies. Interpretation of instructions and sample handling during the collection process is the primary issue as patients may mishandle samples resulting in too much or too little sample being collected. Instructions must be clear and concise to remove ambiguity and achieve the desired outcomes. Z Multi-step processes that require additional data to be recorded, or labels added may be missed, so should be minimised wherever possible. Z In addition to the regulatory requirement for transport of biological samples, if returning to a laboratory or clinic, there may be specific packaging requirements to protect sample integrity and reduce the risk of degradation. Brought to you by Alpha Laboratories, Alpha Solutions is here to support the evolving needs of healthcare in the UK with tailored kitting solutions and comprehensive streamlined fulfilment and distribution services. The Building Blocks for a Robust Solution The true promise of at-home sampling lies in its ability to shift care from reactive, crisis-driven responses to a more proactive and integrated part of routine healthcare. By facilitating early triage and monitoring in the community, it can significantly reduce the burden on both primary and secondary care, preventing unnecessary GP appointments and specialist referrals. Moreover, at-home testing empowers patients to take an active role in managing their health and get them onto appropriate treatment pathways as quickly as possible, which is especially critical for those with chronic conditions. To fully realise this potential, however, the implementation of flexible, end-to-end solutions is essential. As healthcare systems strive to become more resilient and adaptable, home testing with customisable, compliant kits stands out as a viable option for clinically effective, scalable, and patient-centric innovation, which could be a crucial component of future diagnostic toolkits. The Alpha Solutions at-home portfolio consists of kits for Faecal Immunochemical Testing, Faecal Calprotectin (CALEX® Patient Packs and IBDoc Direct Delivery), and Capillary Blood Collection. …This enables us to log in and order patient kits for delivery to clinics, providing traceability and reducing administrative burden… - Lisa Thompson, The Royal Marsden NHSFT on ‘The Alpha Portal’6 (Available through Alpha Solutions) Case Study Confirmed IBD patients are a particular cohort who needtoregularly collect samples fordiseasemonitoring via their faecal calprotectin levels. This cohort may understand more than most the importance of disease monitoring due to the often-lengthy process to confirm a diagnosis, so are typically accustomed to faecal collection via a poo pot, however, even so, timely compliance and general quality of sample has historically been inconsistent – from tiny samples that cannot be extracted to samples which have degraded by the time they’ve reached the lab. A poster by Edwards et al., shown at ECCO 2021, illustrates that in a study of 50 IBD patients there was a compliance rate of 70% in home-based testing using the BÜHLMANN IBDoc® versus 52% compliance with hospital-based sampling with a poo pot.5 Through the empowerment and ease of at-home testing, with the addition of an easy-to-use bespoke sample collection device, IBD patients routinely using the IBDoc have consistently responded positively. General feedback has shown that they are impressed with both the ease of test and speed of result, as these are available on the dedicated app on the day of testing as opposed to having to call or email clinics to receive results up to two weeks later. For more information on home testing or to enquire about Alpha Solutions® bespoke kitting and logistics from Alpha Laboratories, visit:alphalabs.co.uk/kits References: 1. Bowel cancer screening standards data report 2023-24 - GOV.UK. 2. Scottish Bowel Screening Programme Statistics. 3. Bowel Screening Wales Annual Statistical Report 2022-23 - Public Health Wales. 4. Programme Performance and Standards | Cancer Screening Northern Ireland. 5. BÜHLMANN IBDoc® Publications - Calprotectin Home Testing, 6. Leading Edge 2025 Issue 1. www.alphalabs.co.uk © 2025 Copyright Alpha Laboratories Ltd. 11
Improving Turnaround and Clinical Confidence: NHS Tayside’s Experience with fCAL® turbo and CALEX® An interview with Judith Strachan and Andrew Deans from Ninewells Hospital Barsa Manandhar, Product Manager, Alpha Laboratories Ltd. Bringing calprotectin testing in-house has made a marked difference at NHS Tayside. From improving turnaround times to easing clinical decision-making, the shift to using the BÜHLMANN fCAL® turbo assay on the Siemens Atellica, combined with providing CALEX® tubes to their IBD patients, has changed both lab workflow and patient experience. I spoke with Judith Strachan, Consultant Clinical Scientist, and Andrew Deans, Clinical Scientist at Ninewells Hospital, about how the change came about, the challenges along the way, and the impact it’s had on clinicians and patients. Background Historically, faecal calprotectin samples were sent to a referral laboratory for analysis. While the service itself was reliable, the process was slowed by storage, transport delays, and batching — particularly over weekends and bank holidays. Samples were mailed in standard blue universal pots, which we began to realise weren’t ideal for maintaining sample stability. Over time, it became clear that this approach wasn’t sustainable. Calprotectin isn’t as stable as many assume, especially in those traditional collection pots. We knew of CALEX extraction tubes on the market that offered stability up to seven days at ambient temperature and when we found out that the BÜHLMANN fCAL turbo assay could run on our existing Atellica platform, the opportunity to bring testing in-house became viable. Alongside moving to in-house testing, we introduced CALEX collection devices to our patients. Patients are provided with the CALEX device with informative instructions for use (IFU), so that they can simply collect the sample into the tube, and return the CALEX back to the lab, ready for analysis. It was a significant workflow change, but one that’s proven hugely beneficial. Impact and Audit Findings We went live in August 2024, and to properly assess the impact, we ran an internal audit comparing samples from the old referral process (FCAL) with those analysed in-house (CALP) between March 2024 and May 2025. Our mean turnaround time dropped from 11 days to 5 days. Almost half of our results are now reported within three days, and 97% are reported within 10 days. Parameter FCAL (External Laboratory) CALP (NHS Tayside) Total Samples Resulted (excludes pre-analytical issues) 663 1585 Turnaround Time 3 days and under 9 (1.4%) 774 (48.8%) 4-10 days 265 (40%) 765 (48.2%) 11-15 days 293 (44.2%) 37(2.3%) 16-20 days 47 (7.1%) 6 (0.4%) 21-25 days 33 (5%) 3 (0.2%) 26 days and over 16 (2.4%) 0 (0%) We’re currently processing around 150 calprotectin samples each month, averaging 35 to 40 per week. Weekly runs have worked well with this volume, and we’ve seen consistent turnaround with minimal backlog. This improvement has had a direct clinical benefit. In paediatrics especially, where timely decision-making is critical, we’ve had excellent feedback. One of our paediatric gastroenterologists described the Andrew Deans, Clinical Scientist and Judith Strachan, Consultant Clinical Scientist, Ninewells Hospital 12 Leading Edge
change as “transformational” for managing patients. Providing CALEX Tubes to Patients CALEX to patients has helped improve efficiency and reduce pre-analytical handling in the lab. Instead of receiving unprocessed stool samples, we now receive fully extracted, buffered and stable samples ready to run on the analyser. There is no delay due to postal delivery to a referral lab. There were some early issues, primarily patients mistakenly emptying the buffer before returning the tube, but we addressed that by updating the IFU and reinforcing it through the nursing teams. Since then, the problem has largely been resolved. We haven’t had any negative feedback from patients, which we take as a positive. Most of these IBD patients are already familiar with stool testing and seem to appreciate the simplicity of the kit. From a laboratory perspective, CALEX fits smoothly into our workflow. We no longer need to manually extract stool samples, which saves time and reduces exposure to potentially messy samples. The tubes are loaded directly onto the Atellica for analysis, making the process more streamlined overall. One thing we did notice early on was that results produced using the in-house assay were slightly higher than those returned by the referral lab. We expected this, as it’s likely a combination of For more information about the BÜHLMANN fCAL turbo, visit: calprotectin.co.uk/fcal-turbo To learn more about CALEX to patients, visit: calprotectin.co.uk/calex-pack improved sample stability and the broader analytical range of the assay. We made sure to brief clinical teams in advance and provide comparative data so they could understand the change. There’s been no pushback, and the new values appear to align well with clinical presentation. The switch to the BÜHLMANN fCAL turbo assay, run on the Siemens Atellica, and providing CALEX tubes to the patients has been smooth, straight-forward, and clinically impactful. It’s allowed us to drastically improve turnaround times, which supports faster clinical decisions, and ultimately provide a better service for both patients and clinicians. Evaluate the Entire Analytical Process MDx-Chex® for BCID2 are independent controls designed for BIOFIRE® Blood Culture Identification 2 (BCID2) Panel, used on the FilmArray® 2.0 and Torch Systems. Track lot-to-lot performance of the BCID2 assay and reduce incorrect results due to instrument or assay failures. Contains a patient-like matrix of inactivated microorganisms, blood cells, and culture media components, closely simulates actual blood culture specimens. MDx-Chex® for BCID2 Complete Quality Control for Sepsis Testing on BIOFIRE® Systems Have confidence in your Sepsis Testing. For more information on MDx-Chex® for BCID2 – Scan or visit: alphalabs.co.uk/mdx-chex 3Complete coverage of all 43 targets 3Ready-to-use, simply pipette like a patient sample 3Single-use vials reduce pipetting errors and cross-contamination www.alphalabs.co.uk © 2025 Copyright Alpha Laboratories Ltd. 13
Alpha Solutions is excited to introduce the new UKCA Venous Blood Collection Transport Kit, a complete solution for the secure and UN3373 compliant transport of venous blood samples. Developed to support community-based healthcare, this all-inone kit simplifies logistics and helps healthcare professionals deliver faster, more efficient care, right where patients need it most. Simplifying Sample Collection With a rising demand for community healthcare services, our kit provides unmatched convenience, helping healthcare professionals streamline workflows and ultimately enhance patient care. Whether you require standard blood collection tubes or specialised options, our extensive range ensures there is a solution tailored to every service need. Introducing the Venous Blood Collection Transport Kit For Safer, Smarter, Community Care Samantha Ogles, Product Manager, Alpha Laboratories Ltd. The standard kit comprises of the following components: UN3373 Return Mailing Box Absorbent Bay Pouch Biohazard Grip-Seal Bag Vacuum Blood Tube(s) Box Sleeve (Customisable) Instruction For Use Booklet Representative image used for illustrative purposes only. Contents and packaging may vary. 14 Leading Edge
Visit our website to find out more about Alpha Solutions: alphalabs.co.uk/alphasolutions Key Benefits of Alpha Venous Blood Collection Transport Kit Enhance Patient Outcomes for Vulnerable Populations Enables essential blood collection at home for elderly, immunocompromised, and non-ambulatory patients. Improve Patient Experience Community nurse visits reduce the stress and disruption of hospital trips, particularly important for palliative care patients. Save Time for Caregivers Utilising postal return services frees nurses to dedicate more time directly to patient care. Promote Health Equity Empowers nurses to serve remote and rural areas without needing to be based near hospital sites, expanding care reach. Ensure Quality Sample Returns UN3373 compliant packaging protects samples from damage or contamination, reducing costly re-sampling. Increase Hospital Bed Availability Supports home recovery for patients who might otherwise remain hospitalised, easing pressure on bed capacity and reducing costs. Reduce Healthcare-Associated Infection Risks Minimises hospital visits for sample drop-off, lowering exposure risk to pathogens for vulnerable patients. Recognising the logistical challenges of kit fulfilment, Alpha laboratories work in partnership with our customers to provide integrated workflow solutions, such as Royal Mail tracked 24 labelling, stock management and direct to GP or patient fulfilment through the Alpha Portal. The Tasso+ wearable lancet is a revolution in convenient blood sampling; it enables users to collect clinical-grade capillary blood samples, simply through the push of a button. Now, in support of our continued commitment to environmental responsibility and operational efficiency, Tasso has implemented a meaningful packaging redesign. This change significantly reduces the environmental footprint, whilst also improving global shipping and inventory workflows. Tasso+ Packaging Redesign Reduces Plastic by 68%! Samantha Ogles, Product Manager, Alpha Laboratories Ltd. To find out more about Tasso+ please visit: alphalabs.co.uk/tasso A Smaller Tray with a Big Impact The core of this update lies in a more compact lancet tray design that brings measurable benefits to both sustainability and logistics. The updated packaging results in: 9 68% less plastic per device 9 Smaller and lighter bulk cartons, improving shipping efficiency and lowering carbon emissions 9 Smaller dimensions reduce material waste and resource use, contributing to a more sustainable product lifecycle frommanufacturing through to delivery While the lancet device itself remains unchanged, this redesigned tray is smaller in all dimensions and significantly lighter, reinforcing our mission to deliver high-quality healthcare solutions with a lower environmental impact. New Packaging Alpha Solutions’ Venous Blood Collection Transport Kit is designed to meet the evolving needs of community healthcare, supporting better outcomes, greater efficiency, and safer sample management. www.alphalabs.co.uk © 2025 Copyright Alpha Laboratories Ltd. 15
Phone: 023 8048 3000 Email: info@alphalabs.co.uk UKCA CALEX Faecal Calprotectin Collection Kits Enable patients to efficiently prepare and send in their samples, ready for calprotectin testing, freeing up valuable resources in the laboratory. Streamlined Workflow No more stool samples! CALEX provides pre-prepared, extracted samples ready for laboratory testing, saving time and resources. 3Immediate stabilisation of the calprotectin 3Transportation stability for 7 days at ambient 3On receipt it is ready to vortex, centrifuge and load onto the analyser 3Survey has demonstrated high acceptance and ease of use for patients 3Study has shown good correlation with the lab method Join the continued CALEX Workflow Revolution – Optimise, Simplify, and Elevate Your Laboratory Processes! alphalabs.co.uk/calex-pack 02-CALEX Patient Packs - 50th - 160 x 235 - March 2025.indd 1 17/03/2025 16:00:30 16 Leading Edge
Redefine Precision at the Point of Care NEW UTS™ Urine Testing System Introducing the world’s first digital urine testing system that is completely dipstick-free. UTS™ provides accurate, reproducible results through a fully portable, true POCT system. No dips, No drips, No doubt. By eliminating dipstick inconsistencies, UTS™ improves healthcare workflows, patient care and supports clinical decision making. 9 Hygienic single-use tests 9 Results in 90 seconds 9 Ten urine diagnostic data points direct into the patients’ notes 0800 38 77 32 • info@alphalabs.co.uk • www.alphalabs.co.uk Harmonising innovation and accuracy: The future of urine testing begins here. For more information, visit www.alphalabs.co.uk/uts
Global Guideline for the Diagnosis and Management of Cryptococcosis Nicholas Parham, Product Manager, Alpha Laboratories Ltd. Cryptococcosis is a fungal infection of worldwide importance, with its most lethal manifestation being cryptococcal meningitis. Indeed, the WHO listed Cryptococcus neoformans as a top fungal priority pathogen in 2022.1 Management of cryptococcal infections is complicatedby the diversity of syndromes, at-risk patient groups, and clinical resources available. Hence, new guideline recommendations have been developed by ECMM and ISHAM in cooperation with the ASM2. The aim is to facilitate optimal clinical decision making on cryptococcosis and address the myriad of clinical complications that are known to exist. Cryptococcosis often involves the CNS or the lungs, with cryptococcal meningoencephalitis having high mortality, ranging from 24 to 47% at 10 weeks. Although the burden of disease is highest among those with HIV and AIDS, other immunocompromised and immunocompetent risk groups are increasingly being reported. Hence, it is important for physicians to have the necessary tools to facilitate clinical decision making in identification and management of cryptococcosis. The recent paper by Chang et al.covers clinical assessment, diagnostic strategies, and treatment recommendations for various cryptococcosis syndromes (central nervous system [CNS], disseminated, pulmonary and skin).2 The guidelines emphasise the importance of accurate syndrome classification (through the use of diagnostics such as the Cryptococcal Antigen [CrAg] Lateral Flow assay [LFA]) to guide therapy, recommend optimal antifungal regimens tailored to resource settings, and stress the need for monitoring and managing drug toxicity and relapse. Some of the key diagnostic points include: Screening in People Living with HIV: CrAg LFA is used globally for screening and diagnosis in individuals with HIV, particularly those with CD4 counts <200 cells/mm3 or interruptions in antiretroviral therapy [ART]. CrAg LFA is recommended for initial screening, diagnosis, and risk stratification within this population. Patients Without HIV: In non-HIV patients, routine screening with the lateral flow assay is not advised, but is used when infection is suspected in high-risk groups (e.g. solid organ transplant). Diagnosis in All Patients: Microscopy and culture of cerebrospinal fluid (CSF), accompanied by CSF and blood (i.e. serum, plasma, or whole 18 Leading Edge
blood) CrAg testing and imaging, are central to the diagnosis of cryptococcosis. Limitations in C. gattii Disease: Not all commercial lateral flow assays are able to detect C. gattii disease. However, this is not the case for IMMY’s CrAg LFA, which has good reactivity across all serotypes.3 The IMMY Cryptococcal Antigen Lateral Flow Assay (CrAg) is a qualitative or semi-quantitative test for detection of capsular polysaccharide antigens of Cryptococcus species (Cryptococcus neoformans and Cryptococcus gattii) in serum, Find out more, please visit: alphalabs.co.uk/cr2003 References: 1.WHO. WHO fungal priority pathogens list to guide research, development and public health action. Geneva: World Health Organization, 2022. 2.Chang CC, et al. Global guideline for the diagnosis and management of cryptococcosis: an initiative of the ECMM and ISHAM in cooperation with the ASM. Lancet Infect Dis. 2024 Aug;24(8):e495-e512. doi: 10.1016/S1473-3099(23)00731-4. Epub 2024 Feb 9. Erratum in: Lancet Infect Dis. 2024 Aug;24(8):e485. doi: 10.1016/S1473-3099(24)00426-2. PMID: 38346436; PMCID: PMC11526416. 3.Shi D, et al. Neglecting Genetic Diversity Hinders Timely Diagnosis of Cryptococcus Infections. J Clin Microbiol. 2021 Mar 19;59(4):e02837-20. doi: 10.1128/JCM.02837-20. PMID: 33472900; PMCID: PMC8092738. plasma, whole blood, and cerebral spinal fluid (CSF). It is highly sensitive and specific, with a rapid turnaround time of just 10 minutes. The CrAg LFA is a professional-use, laboratory assay which can be used as an aid in the diagnosis of cryptococcosis. Streck’s ESR portfolio offers high-quality whole blood controls designed to simulate patient samples, ensuring accurate and consistent results for your erythrocyte sedimentation rate (ESR) testing. ESR-Chex® – For manual and automated ESR methods 995-day open-vial stability 9365-day closed-vial stability ESR-Chex® Plus – Optimised for automated ESR analysers that use EDTA tubes directly 97-day open-vial stability 9365-day closed-vial stability For results you can rely on, find out more about ESR Testing Quality Controls. Please visit: alphalabs.co.uk/esr-testing Ensure Reliable ESR Testing Every Time with ESR-Chex® www.alphalabs.co.uk © 2025 Copyright Alpha Laboratories Ltd. 19
40 Parham Drive, Eastleigh, Hampshire, SO50 4NU, UK Tel: 023 8048 3000 | Email: info@alphalabs.co.uk Web: www.alphalabs.co.uk Registered in England 1215816 AGG/PAK 5 Combo Kit 5-in-1 Your Manual Blood Grouping Solution For more information or to explore our wide selection of products and services, please visit: www.alphalabs.co.uk CULTURE PLANET PEOPLE Alpha Laboratories is passionate about finding new and sustainable laboratory solutions designed to further scientific discovery and improve the lives of those around them by focusing on three pillars. Made from 100% recycled paper. ALBAclone Antibodies for detection of A, B and D antigens by direct agglutination ALBAcyte Reagent red cells for reverse grouping and process control ADP • Arachidonic Acid • Collagen Adrenaline • Ristocetin A Sulphate Streamline laboratory inventory control with this convenient multipack of lyophilised aggregation reagents, following ISTH/SCC Proposed Panels to aid in the assessment of: Platelet Function Disorders von Willebrand Disease (vWD) using RIPA (Ristocetin-Induced Platelet Aggregation) Anti-Platelet Therapy Effectiveness
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