Diagnostics for Digestive Health Management

Faecal Sample Collection and Extraction Calprotectin Testing Anti-TNFα Therapy Monitoring Pancreatic Elastase Tests Bowel Cancer Screening and Symptomatic Testing Infectious Disease Assays Food Allergy Testing Diagnostics for Digestive Health Management

Pricing and Online Ordering at www.alphalabs.co.uk n freephone order 0800 387732 n buy online at www.alphalabs.co.uk 2 Digestive Disease Patient Pathway The Patient Pathway

Pricing and Online Ordering at www.alphalabs.co.uk n email order sales@alphalabs.co.uk n freefax order 0800 614249 3 Alpha Laboratories has been at the forefront of faecal testing in the UK for over 20 years. This was initially as the market leader for guaiac-based faecal occult blood testing. We won tenders for bowel screening in all four UK countries, as each launched its own screening programme. Continuing to provide leading edge products, Alpha Laboratories introduced the first faecal immunochemical testing (FIT) method for screening, initially being awarded the contract for quantitative FIT as the front line test in the Scottish Bowel Screening Programme. Tender wins for FIT screening in Wales and Northern Ireland followed. In addition, we have actively worked with NICE to incorporate FIT into the pathway for patients with suspected lower GI cancer. Combining a highly sensitive and specific test with logistics support, we are helping to roll out FIT for symptomatic testing right across the UK. This is leading to an improvement in the patient care pathway and a reduction in colonoscopy referrals, similar to that experienced with the introduction of calprotectin. With extensive experience in faecal diagnostic indicators Alpha Laboratories has championed calprotectin testing for more than a decade and supported the NICE review (DG 11) of calprotectin for differentiation between IBS and IBD. As calprotectin testing has developed, the BÜHLMANN assay range has continued to evolve. This has enabled us to work in partnership with clinics and laboratories, providing solutions for improved patient care and management, throughout the pathway for both screening and monitoring. In addition to this expertise in FIT and Calprotectin testing, Alpha Laboratories offers a range of other tests to assist clinicians in the assessment of digestive disorders. It’s all about the Patient... The Patient Pathway

Pricing and Online Ordering at www.alphalabs.co.uk n freephone order 0800 387732 n buy online at www.alphalabs.co.uk 4 Calprotectin Assays Future-proof your Calprotectin Testing with BÜHLMANN: IBDoc®, Quantum Blue®, fCAL ELISA and fCAL turbo Elevated faecal calprotectin is a well proven biomarker for Inflammatory Bowel Disease (IBD) such as Ulcerative Colitis and Crohn’s Disease and can be used to easily and cost-effectively differentiate between these conditions and Irritable Bowel Syndrome (IBS). Since the publication of the NICE guidelines (DG11) in October 2013, supporting the use of calprotectin to differentiate between IBD and IBS, the level of calprotectin testing in UK laboratories has significantly increased: ■ As a screening test to help clinicians make informed decisions: ■ To monitor IBD positive patients to assist in better patient management - Predicting flares - Predicting post-operative relapse - Predicting response to therapy - Helping to keep patients in remission out of hospital Calprotectin can be used more extensively than just for an initial IBS/IBD screen test. Numerous publications suggest that regular monitoring of IBD patients can help to predict, flares, response to therapy or post-operative relapse. Calprotectin concentrations can start to rise before the clinical symptoms become apparent, offering the opportunity for intervention therapy. Alpha Laboratories offers a wide range of calprotectin sample preparation and test formats, all from BÜHLMANN Laboratories AG. BÜHLMANN has specialised in calprotectin assays for more than 10 years and has the broadest range of faecal calprotectin assays available. These are scalable and flexible allowing hospitals to evolve their calprotectin service in line with changing demands. All the BÜHLMANN assays give quantitative measurements and are standardised together to give consistent results and cut-off values allowing for the smooth transition between assay technologies. For more information visit: www.calprotectin.co.uk Complete Range of Solutions for Calprotectin Testing <80µg/g Negative 80-160µg/g Retest in two weeks >160µg/g Positive Investigate for other causes of symptoms, e.g IBS, Food allergies Possible infection, NSAIDS, mild diverticulitis Refer for further evaluation

Pricing and Online Ordering at www.alphalabs.co.uk n email order sales@alphalabs.co.uk n freefax order 0800 614249 5 Calprotectin Sample Extraction A choice of devices are available, to simplify and assist the pre-analytical faecal extraction process. These are dedicated, specially designed products to minimise operator contact with the sample, whilst optimising extraction of calprotectin. Faecal Calprotectin Sample Extraction CALEX®Cap Calprotectin Stool Extraction Device CALEX® Cap is a stool extraction device providing rapid, clean and consistent sample preparation every time. The CALEX contains a measured amount of BÜHLMANN extraction buffer and is for exclusive use with all BÜHLMANN calprotectin assays. The CALEX extraction device improves laboratory workflow and efficiency by eliminating the need for sample weighing, pipetting or decanting and enables direct loading of the extraction device onto many ELISA processors and routine biochemistry analysers. Rapid, clean and consistent sample preparation is achieved every time for evaluation of faecal calprotectin. CALEX Cap Calprotectin Stool Extraction Device Product code Description Pack Size B-CALEX-C50 CALEX Cap Device 50 tubes B-CALEX-C200 CALEX Cap Device 200 tubes B-CALEX-C500 CALEX Cap Device 500 tubes B-CALEX-CCSET25 CALEX Cap Collection Set 25 sets AP0021 15.2mm Vacu-Re-Caps 1000 BÜHLMANN Laboratories CALEX® Cap compared to manual extraction Passing-Bablock over the complete ELISA range 10-1800 μg/g n Ease of use for laboratory personnel and patients n Delivers a precise amount of faecal sample n Optimised sample dilution for maximum efficiency in stool extraction n Application as a primary tube for many ELISA robots and routine biochemistry analysers n 95kPa postal compliant n UN3373 and IATA 650 compliant for transport by air n Modifications to the blue & white caps at either end enable them to be used on laboratory track systems for a truly automated workflow n NEW - CE marked patient collection kits are available containing an IFU, CALEX Cap, two stool collection sheets, a label and a plastic bag Vacu-Re-Caps can be used to quickly and cleanly reseal the CALEX after analysis. AP0021

Pricing and Online Ordering at www.alphalabs.co.uk n freephone order 0800 387732 n buy online at www.alphalabs.co.uk 6 Faecal Sample Collection Extraction Buffer Product code Description Pack Size B-CAL-EX3 Extraction buffer 3 x 125ml B-CAL-EX12 Extraction buffer 12 x 125ml BÜHLMANN Laboratories Manual Weighing Weighing the sample is still considered the Gold-Standard sample extraction method. Step 1: Pre-weigh empty tube and inoculation loop and tare to zero Step 2: Add 50 – 100mg faeces Step 3: Add 49 volumes of 1 x B-CAL-EX Step 4: Close tube and vortex vigorously for 30 min (highest speed) Step 5: Transfer 1.5ml into a fresh tube Step 6: Centrifuge for 5 min at 3,000 x g Step 7: Transfer supernatant into a fresh tube Step 8: Continue immediately to ELISA procedure, or store at >-20°C

Pricing and Online Ordering at www.alphalabs.co.uk n email order sales@alphalabs.co.uk n freefax order 0800 614249 7 Calprotectin IBDoc® Managing chronic conditions through patient self-testing has become common place, and it is now possible for sufferers of inflammatory bowel disease (IBD) to manage their conditions at home. The BÜHLMANN IBDoc® enables patients to perform quantitative calprotectin tests themselves and then use their smartphones to read the results. The CALEX® Valve allows patients to process their own samples without the need for vortex mixing, centrifuging or pipetting. The valve at the base of the device dispenses a precise amount of liquid onto the lateral flow test device. After 12 minutes the calprotectin assay result is read using the smartphone CalApp and the data is transmitted to the clinician via a secure web portal. ■ First marked Calprotectin Home Test ■ Quantitative Rapid Test with results between 30 - 1000μg/g ■ Consistent results with other BÜHLMANN Calprotectin assays: - Quantum Blue® - fCAL ELISA - fCAL Turbo ■ Consistent results with endoscopic and histologic results. (See Figure 1) ■ Calibrated for use with numerous smartphones including: Apple, Samsung, LG, Sony and HTC; please see our website for an up-to-date list Customised, patient centric approach for management of disease and therapy. Calprotectin Monitoring with IBDoc® Home Test IBDoc® Home Test Product code Description Pack Size LF-IBDOC8 IBDoc Home Test Kits 8 BI-IBDOC IBDoc Starter Pack Each BÜHLMANN Laboratories Walsh A. et al. ECCO 2018 P262

Pricing and Online Ordering at www.alphalabs.co.uk n freephone order 0800 387732 n buy online at www.alphalabs.co.uk 8 Calprotectin Quantum Blue® Why Use Quantum Blue Calprotectin? n Quantitative measurement of calprotectin in faecal samples n Results in 12 minutes n Excellent correlation with laboratory assays and endoscopic findings n Simple, rapid extraction and test process n Unilateral connectivity to LIMs via dedicated middleware n Compact benchtop reader with touch screen n 2 analytical ranges available for screening or monitoring applications n High and low control included in the kits n Barcode scanner for patient/sample data entry n Results directly printable or downloadable to USB n Other assays are also available including: Serum calprotectin and Serum trough levels for Biologics and Antibody levels Quantum Blue®: Quantitative Rapid Calprotectin Test The Quantum Blue® fCAL rapid tests combine the ease and speed of lateral flow technology (using a highly specific monoclonal antibody to calprotectin), with full quantitation by means of a small, dedicated bench top reading device. The Quantum Blue® reader analyses the signal intensity from the test and control line to give a quantitative value and is standardised with the BÜHLMANN fCAL™ ELISA. This diagnostic tool enables a rapid gatekeeper strategy based on calprotectin levels in patient stool samples to support the physician’s decision on whether to prepare patients for colonoscopy or to treat them for the symptoms associated with Irritable Bowel Syndrome (IBS) and other gastric conditions. Correlation Across the Healthcare Network: Correlation of the Quantum Blue Calprotectin Test and the BÜHLMANN fCAL™ ELISA (EK-CAL) Quantum Blue ® fCAL Assays Product code Description Pack Size LF-CHR25 Quantum Blue® fCAL high range 100-1800 µg/g 25 tests LF-CALE25 Quantum Blue® fCAL extended range 30-1000 µg/g 25 tests BI-POCTR-ABS3 Quantum Blue Reader 3rd Generation 1 unit BÜHLMANN Laboratories Correlation of the Quantum Blue Calprotectin Test and the BÜHLMANN fCAL turbo

Pricing and Online Ordering at www.alphalabs.co.uk n email order sales@alphalabs.co.uk n freefax order 0800 614249 9 Calprotectin ELISA Calprotectin ELISA: Quantitative High Throughput Test The BÜHLMANN fCAL ELISA method is the most popular method for ELISA calprotectin testing in the UK, with flexibility to choose the extraction method and kit size options with flexi-strip format for large and small volume users. There is excellent correlation with the BÜHLMANN Quantum Blue and fCAL turbo methods so laboratories who are looking to scale up their testing either to or from fCAL ELISA get a continuity of result which is very important in ensuring a smooth transition. Assay Details: n Measurable range is 10-600 µg/g or 30-1800 µg/g: same test kit, two different protocols n Easily automated on ELISA processors with protocol available for the DS2® and DSX® n The kit includes all calibrators and quality controls ready to use n Excellent correlation with endoscopic findings and clinical outcome n Linear beyond the stated range Calprotectin ELISA Product code Description Pack Size EK-CAL fCAL ELISA single plate 96 wells EK-CAL2 fCAL ELISA two plates 192 wells EK-CAL2-WEX fCAL ELISA two plates without buffer 192 wells BÜHLMANN Laboratories ROC analysis for IBD/IBS differentiation ROC Area Under the Curve (AUC) = 0.939 Using the calprotectin to monitor patients can also determine the level of severity of the disease activity:

Pricing and Online Ordering at www.alphalabs.co.uk n freephone order 0800 387732 n buy online at www.alphalabs.co.uk 10 Calprotectin High Throughput Assay BÜHLMANN fCAL® turbo fCAL® turbo Product code Description Pack Size* KK-CAL fCAL turbo kit (reagents, controls and calibrators) ~200 B-KCAL-RSET fCAL turbo reagents ~200 B-KCAL-CASET fCAL turbo calibrators 6 levels, 1ml each B-KCAL-CONSET fCAL turbo controls 3 x 2 levels, 1ml each B-CAL-EX3 Extraction buffer 3 x 125ml B-CAL-EX12 Extraction buffer 12 x 125ml BÜHLMANN Laboratories *Will vary depending on analyser Why Use BÜHLMANN fCAL® turbo? n Fastest calprotectin test with results in 10 minutes n Wide initial test range (20 - 2000 µg/g) keeps dilutions to a minimum n Optional automatic on-board dilution for samples >2000 µg/g to give reportable results up to 8000 µg/g n CALEX extraction device simplifies sample preparation and is loaded directly onto the analyser streamlining the workflow n Can be used with track systems in full random access mode n Sample preparation device, controls and calibrators are in stable, ready to use format n Excellent linearity across the assay range n Excellent correlation with other BÜHLMANN assays 0 250 500 750 1000 1250 1500 1750 2000 2250 0 250 500 750 1000 1250 1500 1750 2000 2250 Measured Mean (µg/g) Th. Conc (µg/g) Linear Dilution - Linearity plot performed with stool extract fCAL turbo on the Siemens Advia 2400 Mindray BS-380 vs. AU5800 n=14 The BÜHLMANN fCAL® turbo is a quantitative random access calprotectin assay that combines speed, quality and flexibility. The wide assay range (20 - 8000μg/g) provides sensitivity at the low end for differentiation between IBS and IBD patients, whilst also giving an actual value to monitor IBD positive patients at the high end. With the ability to run on many standard clinical chemistry analysers (see www.alphalabs.co.uk/kk-cal for the most up to date list of analyser protocols available), there is no requirement for additional equipment saving expense on capital purchase, service contracts and valuable laboratory space.

Pricing and Online Ordering at www.alphalabs.co.uk n email order sales@alphalabs.co.uk n freefax order 0800 614249 11 Anti-TNFα Therapy Monitoring Anti-TNFα Therapy Monitoring Quantum Blue® Anti-TNFα Monitoring Product code Description Pack Size LF-TLIF10 Trough level Infliximab 0.4-20 µg/ml 10 tests LF-TLIF25 Trough level Infliximab 0.4-20 µg/ml 25 tests LF-TLAD10 Trough level Adalimumab 1-35 µg/ml 10 tests LF-TLAD25 Trough level Adalimumab 1-35 µg/ml 25 tests LF-ADIF10 Trough level anti-infliximab antibody 10 tests LF-ADIF25 Trough level anti-infliximab antibody 25 tests LF-ADAD10 Trough level anti-adalimumab antibody 10 tests LF-ADAD25 Trough level anti-adalimumab antibody 25 tests BÜHLMANN Laboratories Anti-TNFα drugs provided a major biotherapeutic breakthrough in the treatment of chronic inflammatory conditions and are also used for the treatment of Inflammatory Bowel Diseases when patients do not respond to steroids. These drugs bind TNFα, blocking the action that is responsible for the inflammatory state. However, not all patients undergoing such treatment respond well and among those that do, the level of response can vary between patients and within the same individual over time. The BÜHLMANN Quantum Blue® Therapeutic Drug and Antibody Monitoring Assays (TDM) are the first rapid test to measure trough drug levels in patients’ serum. They allow timely decision making for dose adjustments before the next infusion. Why use Quantum Blue® TDM Assays? n Single use assay - No need to batch samples n Good correlation with ELISA methods n Good linearity across the range n Individually sealed cassette ensures quality n High and low control included in the kit

Pricing and Online Ordering at www.alphalabs.co.uk n freephone order 0800 387732 n buy online at www.alphalabs.co.uk 12 BioSystems BA200 Analyser BioSystems BA200 Analyser The BioSystems BA200 analyser is also available either for capital purchase or on a reagent rental basis to run the BÜHLMANN fCAL turbo and fPELA asssays. This bench top instrument offers an excellent alternative to the main stream analysers for faecal testing with comparable performance and efficiency: Key Features n CE marked applications for BÜHLMANN fCAL turbo and fPELA assays n CALEX Cap can be loaded directly onto the analyser n Software is LIM enabled with built in barcode reader for samples and reagents n 200 tests per hour n 88 position free configuration n LED technology n Quick pause (6-24 seconds) to enable loading and unloading of samples and reagents n Chilled rota for reagents and samples n Other assays are available to be used on the instrument Method comparison with the Roche c501 BioSystems BA200 Analyser Product code Description Pack Size 83200 Bench top analyser Each BioSystems

Pricing and Online Ordering at www.alphalabs.co.uk n email order sales@alphalabs.co.uk n freefax order 0800 614249 13 BÜHLMANN fPELA ® Assay Products for Pancreatic Insufficiency BÜHLMANN fPELA ® Assay The new BÜHLMANN fPELA ® assay for faecal pancreatic elastase utilises the same CALEX extraction device as the fCAL turbo assay, so it is possible to run both tests from a single extract. The fPELA assay is random access and runs on standard clinical chemistry analysers (Roche, Abbott, Beckman, Siemens etc) although there is also the BioSystems BA 200, a stand-alone solution as well. The assay is turbidimetric, with a dynamic range of 10 - 5000μg/g. Time to first result is 10 minutes with further results following every few seconds thereafter, making it one of the fastest faecal elastase assays available. Why use the BÜHLMANN fPELA Assay? n Utlilises the same CALEX extraction device as the fCAL turbo assay n Random access testing on standard clinical chemistry analysers n Comparable results to the current ELISA based methods Data from historic NEQAS samples shows the new BÜHLMANN fPELA gives comparable results to the current ELISA based methods: fPELA ® Assay Product code Description Pack Size KK-PELA fPELA turbo kit ~100 tests* B-KPELA-RSET fPELA turbo reagents ~100 tests* B-KPELA-CONSET fPELA turbo controls 3 x 1ml High and Low control B-KPELA-CASET fPELA turbo calibrators 6 x 1ml calibrators B-CALEX-C50 CALEX sample extraction device 50 tubes B-CALEX-C200 CALEX sample extraction device 200 tubes B-CALEX-C500 CALEX sample extraction device 500 tubes BÜHLMANN Laboratories *Will vary depending on analyser Pancreatic insufficiency is the reduction of production or transportation of the digestive enzymes which results in the inability to properly digest a meal (fats, proteins and carbohydrates). The insufficiency is not usually absolute, it is variable, which then has a graded impact on digestion and hence symptoms. Patients can suffer from a variety of gastric symptoms which can range in severity but include abdominal pain, weight loss, diarrhoea, smelly loose stools, flatulence, loss of appetite and fatigue – all of which can be confused with a variety of other gastric complaints; so performing a simple stool test to determine the level of elastase (a pancreatic enzyme) helps with the diagnosis of this condition – then clinicians just need to determine the cause...

Pricing and Online Ordering at www.alphalabs.co.uk n freephone order 0800 387732 n buy online at www.alphalabs.co.uk 14 Quantitative Faecal Immunochemical Testing (FIT) The faecal immunochemical test (FIT) is an established test for the quantification of haemoglobin in faeces. Faecal haemoglobin has been used as a biomarker for gastrointestinal disease for decades, primarily in colorectal cancer screening programmes, using qualitative, guaiac-based, faecal occult blood tests (gFOBT). In July 2017, the National Institute of Health and Care Excellence (NICE), published the Diagnostic Guidance DG30 “Quantitative faecal immunochemical tests to guide referral for colorectal cancer in primary care”. This recommends the use of FIT in primary care to guide referral for suspected colorectal cancer in patients who present with unexplained gastrointestinal symptoms, but do not meet the criteria for referral in the suspected cancer referral pathway. Furthermore, in July 2022, the Association of Coloproctology of Great Britain and Ireland and the British Society of Gastroenterology (BSG) published guidelines for identifying patients requiring further bowel disease investigation. The recommendations emphasized FIT testing in primary care, the diagnostic accuracy of FIT for colorectal cancer with suspected cancer signs or symptoms, acceptability of FIT testing for symptomatic CRC in most circumstances, antidiscrimination at any stage of the diagnostic pathway and finally, the development of a programme to facilitate FIT implementation. Colonoscopy resource is overburdened, and many colonoscopies yield no pathology. Implementing FIT can triage patients into secondary care, reserving resource for high risk patients or those presenting with red flag symptoms. FIT has proven not only to be an invaluable resource in the identification of colorectal cancer, but also for detection of pre-cancerous growths. Colorectal cancer is the fourth most common cancer in the UK and is highly treatable if identified early. FIT is now used in all UK nation’s Bowel Cancer Screening Programmes, and it is the test of choice in primary care referral pathways for colorectal cancer. Using a cut-off of 10 μg Hb / g faeces, FIT can be used by clinicians to determine the ideal pathway for patients, quickly and reliably. It presents a cost-effective, easy to use, non-invasive test, which has helped improve the uptake of testing in screening and symptomatic cohorts, helping increase the value of the test in the pathway. The complete FIT solution provided by Alpha Laboratories Ltd, includes the HM-JACKarc platform which is recommended for use in the NICE DG30 guideline. A compact, bench-top system for rapid, automated testing of FIT samples, the HM-JACKarc is straightforward to use, low-maintenance, and features excellent low-end sensitivity (limit of detection: 1.25 μg Hb / g faeces) with a linear assay range of 7 – 400 μg Hb / g faeces. In conjunction with the user-friendly sampling device and bespoke Patient Packs, the FIT solution offered by Alpha Laboratories provides a tailor-made package to support primary care, patients, laboratories, and clinicians throughout the entire pathway. For more information, case studies, and to view videos including discussions with experts in the field, please visit: www.faecal-immunochemical-test.co.uk FIT for All CLINICIAN LABORATORY PATIENT Quantitative Faecal Immunochemical Test (FIT)

Pricing and Online Ordering at www.alphalabs.co.uk n email order sales@alphalabs.co.uk n freefax order 0800 614249 15 Quantitative Faecal Immunochemical Testing (FIT) HM-JACKarc Analyser + Barcode reader Product code Description Pack Size 057562 HM-JACKarc Analyser 1 unit 065553 EXTEL HEMO AUTO HS Latex 4 x 18ml 065556 EXTEL HEMO AUTO HS Calibrator 8 x 1ml 065557 EXTEL HEMO AUTO HS Control 8 x 1ml 065555 EXTEL HEMO AUTO Buffer 1 x 250ml 063631 EXTEL HEMO-AUTO MC Collection Picker 200 pieces 063632 EXTEL HEMO-AUTO MC Collection Picker 400 pieces 053150 HM-JACK Reaction Cell 1000 pieces 053151 HM-JACK Sample Cup 500 pieces 057848 HM-JACK Print Paper A 2 rolls 052404 Wash Liquid (Auto Detergent H) 1 x 200ml Minaris Medical Co., Ltd. The HM-JACKarc is a dedicated bench-top analyser which uses integrated spherical turbidimetry for the quantification of haemoglobin in faeces. The analyser is easy to use; a touchscreen, minimal menu depth, and password protection allows safe customisation of the system according to your pathway regardless of your cut-off. Up to 80 samples can be loaded at any one time, with a time to first result of 5.6 minutes, and subsequent results every 18-seconds, giving a throughput of 200 samples per hour. Being quick to set up and maintain, the analyser can be used in high-throughput screening settings or lower-throughput symptomatic testing. The assay has a linear range of 7 – 400 µg Hb / g faeces, a limit of detection of 1.25 µg Hb / g faeces, and no prozone effect to 200,000 µg Hb / g faeces. This provides assurance that the result is accurate: no patient is given an artificially low result while samples with a very low haemoglobin concentration will not be missed. HM-JACKarc Automated Faecal Immunochemical Testing System The automated quantitative Faecal Immunochemical Testing system from Minaris Medical integrates Analyser technology, with Reagent and Collection device (ARC), to provide a rapid and consistent, high throughput solution for both screening and symptomatic faecal immunochemical testing. The system comprises of three key components: the analyser, the reagents, and the sample collection device. n HM-JACKarc state-of-the-art automated analyser n Dedicated, sensitive, latex agglutination reagents n Bespoke faecal sample tube Key features: n Limit of Detection: 1.25 µg Hb / g faeces n Limit of Quantitation: 7.00 µg Hb / g faeces n Linear assay range: 7 – 400 µg Hb / g faeces n No prozone effect up to 200,000 µg Hb / g faeces n High-speed performance: 200 samples / hour n Time to first result: 5.6 minutes 1. Load samples and reagents 2. Press START 3. First result in 5.6 minutes HM-JACKarc Analyser

Pricing and Online Ordering at www.alphalabs.co.uk n freephone order 0800 387732 n buy online at www.alphalabs.co.uk 16 Quantitative Faecal Immunochemical Testing (FIT) The main two reagents are the latex reagent, and buffer solution. The latex reagent comprises of latex particles, coated in polyclonal antibodies specific to human haemoglobin. The high concentration of latex particle and antibody ensures a high antigen capture ratio. This provides four key benefits: n Low limit of detection: 1.25 µg Hb / g faeces n High hook (prozone) capacity: 200,000 µg Hb / g faeces n Linear assay range: 7 - 400 µg Hb / g faeces n Specific to human haemoglobin: no interference from dietary meat / iron Reagents Sample Collection Device As with all assays, pre-analytical variation must be kept to a minimum, and that’s particularly challenging when patients are completing the sampling at home, and when the sample is from stool. Stool is rarely homogenous in nature, and the variability in composition can make sample collection challenging. The HM-JACKarc collection device is designed with easeof-use in mind, while ensuring good quality laboratory samples. The collection device is designed with two small dimples in the end of the sampling stick to allow the patient to accurately sample 2 mg of faeces with no laboratory experience or measuring equipment. The septum in the sample collection device scrapes off excess faecal matter, ensuring the 2 ml of buffer solution is accurately dosed with 2 mg of stool. This offers a hygienic sampling method, which only involves collecting one stool sample, and sampling the stool once. The device contains a biocide to minimise the risk of haemoglobin degradation by the microbiome in the stool, and the device is tested to a 95 kPa pressure differential: making the tube strong and leak-proof. Once the sample is collected, the collection device is stable for 14-days at room temperature, and 120-days at 2 - 8 C. The sample is pre-diluted (in a 1:1 ratio) and is ready to be loaded directly onto the analyser. The sample does not require any pre-analytical processing (dilution / filtration etc.) prior to loading. The analyser reports results in ng Hb per ml of buffer; since the HM-JACKarc uses a 1:1 dilution ratio, this can be directly converted (1:1) to μg Hb per gram for result reporting. The hygienic sampling device has helped increase the uptake of participation in bowel screening programmes; offering participants a straightforward test, which only involves one sampling process and includes a robust sampling stick, has increased the number of those returning the test, and so helped identify more earlystage cancers. Tamper evident seal and sample viewing window Rubber septum to remove excess sample Oval sample collection dimples Overlabel prevents contamination of the piercing area

Pricing and Online Ordering at www.alphalabs.co.uk n email order sales@alphalabs.co.uk n freefax order 0800 614249 17 Complete FIT Patient Packs Complete FIT Patient Packs The convenience of patient sampling at home is one of the advantages of FIT. However, when setting up a FIT service we are often asked how best to facilitate getting the test to the patient, and how the patient returns the test to the laboratory. Alpha Laboratories has extensive experience in the area and we can help with bespoke Patient Packs. We can create a custom solution for your pathway which supports the GP, patient, and sample reception teams. Each service may be managed slightly differently; varying in the information provided to patients, the onward pathways, and the method of returning the sample. A bespoke instruction leaflet not only provides the patient with a clear, easy-to-follow guide to help them collect a good quality sample, but it can provide additional supporting information; such as links to “How-To” videos, QR-codes for additional information, or contact numbers for enquiries. The instruction leaflets have proved extremely beneficial for users. In a recent case study with the South West Cancer Alliance, their patient questionnaires highlighted that 95% of respondents found the instruction leaflet easy to understand, and 96% of respondents knew what to do with their test once complete. Getting a FIT Sample from Patient to Laboratory Customising your FIT service need not stop at a bespoke instruction leaflet. If your FIT service directly involves Primary Care (the patients are handed the sampling collection device while attending a GP consultation), your service will benefit from Alpha Laboratories’ Complete Patient Packs. The complete patient packs are bespoke to your service, and may contain: instruction leaflet, sample return envelope, test/laboratory request form, sample collection device, stool collection aid (Fe-Col®), patient information sheets, and/or questionnaire cards – all packaged into a discrete envelope for the Primary Care provider to hand to patient for at-home sample collection. For further information, or to enquire about creating your own FIT packs, please visit: www.faecal-immunochemical-test.co.uk/patient-packs

Pricing and Online Ordering at www.alphalabs.co.uk n freephone order 0800 387732 n buy online at www.alphalabs.co.uk 18 Patient Pack Components Patient Pack Components Instruction Leaflet: A “how-to” guide on the collection of the stool, sampling process, and return of the sample. May contain additional supporting information such as links to helpful websites, contact numbers, and a “what next” section as to the onward pathway. Return Envelope: The collection device may be posted back to the laboratory or taken back the GP’s surgery for collection by routine laboratory transport. Test/Laboratory Request Form: A test request form may be required by the laboratory to process the sample and track result reporting. The GP is sometimes asked a series of questions as to the reason behind the FIT referral, this form can be used to collate the patient information along with the quantitative FIT result. Sample Collection Aid: The Fe-Col® collection paper is an innovative sample collection paper, designed to fit around the toilet seat, and allow you to catch the stool sample before it touches the toilet bowl or water. It is a hygienic sample collection method which allows the patient to use the toilet as they would normally. The paper contains no additives, or adhesives, and the edges can simply be torn, allowing the paper and the stool to fall into the toilet for hygienic disposal. The paper is biodegradable and is safe for the sewage system. Patient Information Sheets: Depending on the pathway (Rapid Diagnostic Centres, routine GP visit, clinics, etc) you may wish to include a patient information sheet. It may outline in more detail what the test is for, why they have been asked to complete it, and what happens next. Questionnaire Cards: Newly started services, or services undergoing changes may wish to receive feedback on their FIT service, not just regarding the test but the pathway. We can help you design a questionnaire card to include with the test return to help gather data on patient feedback. We can also provide: n Small, grip seal bags to mail the sample n Padded envelopes for general mailing n Freepost, pre-addressed envelopes for ease of use

Pricing and Online Ordering at www.alphalabs.co.uk n email order sales@alphalabs.co.uk n freefax order 0800 614249 19 The Alpha Portal The Alpha Portal The Alpha Portal offers a new perspective on the distribution of sample kits: whether it’s for issuing direct-to-patient, or for larger orders going to GPs or Clinics. This new online ordering system gives the user greater control over the associated logistics, and facilitates a traceable, efficient, and manageable solution which can be scaled up and down as required. For Calprotectin Testing Introducing individual sample collection kits for patient use can provide significant improvements in your laboratory workflow and performance. The BÜHLMANN CALEX ® Cap Collection Set is specifically designed to simplify sample handling by patients, and can be ordered through The Alpha Portal. It provides convenient, hygienic and safe sample collection for the patient and provides a quality ready extracted sample to the laboratory. ■ Samples are already extracted on receipt into the laboratory ■ Releases resource ■ Removes the requirement for time in the safety cabinet ■ Samples are stabilised in specialised buffer immediately ■ Eliminates variable degradation in sample matrix during transit ■ Frees up storage within the laboratory ■ Removes excess single use plastic (stool collection pot) from the diagnostic process ■ Reduces the number of delivery trucks required ■ Improved capacity and reduced turn around time - due to improved workflow IBDoc® kits can also be sent direct to the patient as and when they are required. For FIT Testing Customers of our bespoke FIT patient packs can now take advantage of the additional benefit of portal ordering. ■ Improved stock management: ■Live stock level updates ■ View Lot and expiry information ■ Forward planning and scheduled deliveries possible ■ Only requires administrative management: ■ Site specific stock level safety netting ■ Tracked deliveries ■ Detailed report functions available ■ Flexible delivery locations: ■ Hospital ■ GP surgery ■ Clinics ■ Directly to patients

Pricing and Online Ordering at www.alphalabs.co.uk n freephone order 0800 387732 n buy online at www.alphalabs.co.uk 20 Faeces Sample Collection Device n Easy-to-use, hygienic, stool collection paper n Flushable and biodegradable n Simple instructions for use n Convenient for patients n Less risk of sample contamination Demonstration video available at: www.alphalabs.co.uk/fecol Fe-Col® Faecal Collection Papers Product code Description Pack Size FC2010 Fe-Col® Faecal Collection Paper with Instructions for Use (IFU) 1000 FC2030 Fe-Col® Faecal Collection Paper in Dispenser Box of 50 5 x 50 Alpha Laboratories Ltd. See Website for more information and details Fe-Col® Faeces Sample Collection Device Faecal Immunochemical Test (FIT) Pack Supplied by: Lot no: 230AGD Expiry: 30/04/2019 www.alphalabs.co.uk Ŷ If you are running out of packs email: Nbn-tr.nbtfit@nhs.net to obtain more Ŷ Ensure the issuing of this collection kit is recorded in case the sample is not collected or gets lost in the post DOCTOR PLEASE NOTE : You MUST complete the request form inside this pack, including recording the date it was issued, BEFORE handing over to the patient. REQUEST FORM TO BE COMPLETED BY GP FAECAL IMMUNOCHEMICAL TEST (FIT) FOR OCCULT BLOOD USE BLOCK LETTERS & BALL POINT PEN Date issued to patient: NHS NO: SPECIMEN: Faecal Sample SURNAME: INDICATIONS - MUST BE COMPLETED A REQUEST WITH NO INDICATIONS OR FROM PATIENTS <50 YEARS WILL NOT BE PROCESSED For use in people who have symptoms that could suggest colorectal cancer, but in whom a diagnosis of cancer is unlikely. Clinical indications defined by NICE in patients without rectal bleeding: Aged over 50 with: unexplained abdominal pain or weight loss Aged 50 - 60 with: changes in bowel habit or iron deficiency anaemia Aged 60 or over and have anaemia without iron deficiency FORENAME(S): MALE FEMALE Date of Birth DD MM YY If preferred use an addressograph label REQUESTED BY: ),7 7HVWLQJ Laboratory <RXU $GGUHVV 7RZQ 32 3' Tel: 01 4 Email: \RXU HPDLO@DGGUHVV.QHW Website: www.\RXUZHEVLWH FR XN Practice Details (Code and Address) <RXU /RJR +HUH ) J < 7 T 2 Write your name and date of birth ANDthe date that the sample was taken on the label on the green bag. Date of Sampling (DD/MM/YYYY) / / NAME Mr Ms Date of Birth (DD/MM/YYYY) / / A.Sample 25 07 1957 20 04 2018 3 HOW TO CATCH THE SAMPLE It is important that your stool sample does not touch the toilet water. There are different ways to collect your sample, try: A. Several layers of folded toilet paper B. Hand inside a small plastic bag/glove C. A clean disposable container You may find a way that is easier for you, but make sure you catch your stool sample before it touches the water. 1 Write your name and date of birth on the label as shown here. Start Here... Instructions continued overleaf... NB: Please write the date of sample on the green bag. How to Collect Your Sample for the Faecal Immunochemical Test If you would like more information about FIT testing visit www.yourwebsite.co.uk How to Collect Your Sample BEFORE YOU BEGIN.... Your GP has asked you to complete this test. It is important that you do this as soon as possible. Once completed post the kit straight away in the stamped addressed envelope provided. Your Logo Here Business Reply Licence Number LYUZ Your Laboratory Your Hospital Your Address Your Town PO5 1PD FDTDTTTFAFDTTADDTTFDFTDDAFDTAAAFTTAA HOW to Pl 1. Preparation Write your NAME and Date of Birth on the Green Plastic Bag and Device. Carefully and slowly twist and pull out the Stick Part from Main BODY. Date of Sampling (DD/MM/YYYY) NAME Mr Ms Date of Birth (DD/MM/YYYY) / / / / www.faecal-immunochemical-test.co.uk A Valuable Information Resource for Bowel Cancer Detection www.faecal-immunochemical-test.co.uk is a dedicated website providing a central resource for clinicians, laboratories, patients and the public, regarding advances in the detection of colorectal cancer using FIT. Access to the Experts Covering both screening and symptomatic testing applications, experiential case studies, plus videos of presentations, and provides access to expertise from key opinion leaders in the field. With an extensive list of literature, publications, resources, related news and events that are regularly updated, this is the number one resource for FIT in the UK and Eire. Complete Support for Your FIT Service Alpha Laboratories can help patients, laboratories and clinicians, by developing customised FIT ‘Patient Packs’, that include everything the patient requires to take the sample correctly and return it to the laboratory. We will work in partnership with you to create a solution designed exactly to meet your needs and get your FIT service operational with speed and efficiency.

Pricing and Online Ordering at www.alphalabs.co.uk n email order sales@alphalabs.co.uk n freefax order 0800 614249 21 DIAQUICK FOB / Dynex DS2® ELISA Processor The DS2® ELISA Processor from Dynex Technologies is a fully automated system that can process two 96-well microtitre plates simultaneously. A complete walk away system, the DS2 can execute all functions associated with ELISA assay processing including sample/reagent dilution and addition, plate incubation and shaking, wash steps and OD measurement. The DS2 is ideal for clinical laboratories that would like to enhance their processes through automation, but do not have the volume requirements to justify the investment in the larger more expensive systems. Building on the renowned Dynex DSX® walk-away workstation, the DS2 System has all the power and performance of the higher-capacity DSX, but is designed for the needs of lower-throughput labs. With advanced automation and precise liquid-handling capabilities, the DS2 eliminates variations that occur with manual processes, ensuring the rigorous, repeatable analyses required in critical applications. CE marked applications are available for the BÜHLMANN fCAL ELISA assays on the DS2. Automated ELISA Instrumentation Product code Description Pack Size 62010 Dynex DS2 Automated 2-plate system 1 Consumables 62910 Deep well dilution strips 250 x 8 wells 62930 Reagent Bottles - 15ml 10 65950 Reagent Bottles - 25ml 24 65910 Racked Sample Tips 4 x 108 65920 Reagent Tips 4 x 108 65940 Standard/Control Bottles 33 Dynex Technologies Dynex DS2® ELISA Processor Key Features n Reliable, cost-effective, and easy to use and maintain n Quickly and easily processes up to two 96well microplates and up to 12 different assays simultaneously n Features the most advanced and user-friendly control system available n Designed with full walk-away capability n Sample ID-bar-code reading, chain-of-custody, and instrument self-diagnostics Qualitative Faecal Immunochemical Test (FIT) n Result in 5 minutes n Immunochromatographic assay n Sensitivity 6µg Hb/g faeces (50ng/ml Hb) n Sample stable in collection tube for up to 3 days at ambient n No dietary restrictions DIAQUICK FOB Product code Description Pack Size Z01101CE FOB DIAQUICK Test Cassette 25 tests Dialab The DIAQUICK FOB Cassette can be used to screen for lower gastrointestinal pathologies such as colorectal cancers and adenomas which may bleed resulting in occult blood in the stools. This is a qualitative immunochromatographic lateral flow assay which specifically detects human haemoglobin. Unlike guaiac tests there is no need to follow a restricted diet prior to testing to avoid false positive results.

Pricing and Online Ordering at www.alphalabs.co.uk n freephone order 0800 387732 n buy online at www.alphalabs.co.uk 22 Infectious Diseases Helicobacter pylori (H. pylori) is a spiral bacterium and is associated with a variety of gastrointestinal diseases including gastritis, duodenal and gastric ulcers, non-ulcer dyspepsia, gastric adenocarcinoma and lymphoma. The organism is present in 95-98% of patients with duodenal ulcers and 6090% of patients with gastric ulcers. The Easy-Card H. pylori antigen test, designed for rapid detection of H. pylori antigen in stool samples, gives an answer in just 10 minutes. Sample processing is quick and simple using the dip stick sampling device and pre-filled buffer tube. The Easy-Card’s lateral flow technology means it is clear and easy to read. It also has an integral control to validate the assay. The sensitivity is 94% and specificity 99%. Infectious Disease Product code Description Pack Size 14656 Easy-Card H. pylori Ag 20 tests Sentinel Infectious Diseases Helicobacter pylori (H. pylori) alphalabservice caring for your instrument and your science a The regular service and maintenance of diagnostic laboratory equipment is essential to ensure the quality of clinical results. It also minimises the risk of unplanned downtime and interruption of workflow, helping you to provide the best possible pathology service. However, with routinely used equipment there may be times when something needs urgent attention and our team of skilled technical experts are on hand to come to your rescue. You can trust Alpha Laboratories to take care of your instrument service and repair needs, giving you the confidence in the results you provide to your clinicians and patients. We provide expertise for the HM-JACKarc FIT analyser, the Dynex DS2 ELISA processor and the BioData PAP-8E platelet aggregometer. www.alphalabservice.co.uk Visit our website for more information, to request a quotation or to book your next service:

Pricing and Online Ordering at www.alphalabs.co.uk n email order sales@alphalabs.co.uk n freefax order 0800 614249 23 Basophil Activation Testing Food Allergy Testing The incidence of food allergies is becoming increasingly more prevalent; it is estimated that, in the UK, 1 in 40 infants are developing a peanut allergy, and 1 in 20 infants are developing an egg allergy. With almost a third of allergy sufferers having to change their lifestyle, it is vital to determine who is truly allergic from those who are not; Basophil Activation Testing can be a helpful tool to do this. Studies have shown that BAT has a higher sensitivity and specificity than standard skin prick tests (SPT) and specific IgE tests (sIgE), making it a useful second line test if SPT and sIgE results are unable to offer a confirmed result. BAT is a safer alternative to a provocation challenge for your patient. Offering BAT before a challenge test will significantly reduce the number of patients having to undertake a provocation challenge. Eliminating the need for a provocation challenge improves patient safety and comfort. The true value of BAT lies in its high specificity, (reaching 100% in some studies). A positive BAT result confirms allergy with a high degree of certainty, resulting in fewer of the more dangerous positive provocation challenges being performed. Basophil Activation Testing The Flow CAST ® system, manufactured by BÜHLMANN Laboratories, represents a significant step forward in in vitro allergy testing. Using a unique dual marker combination (CCR3 and CD63) it allows the simple detection of Basophil Activation on whole blood samples via flow cytometry. Flow CAST can be used to identify immediate type allergic reactions and hypersensitivities to suspected allergens. Basophils constitutively express the eotaxin receptor CCR3 allowing for a robust and accurate selection of cells with flow cytometry. CCR3 is detected with a PE-fluorescence labelled monoclonal antibody. This negates the requirement for lengthy and labour intensive leukocyte isolation steps. Upon response to a purified allergen which is added to the sample, sensitised basophils degranulate and express the cell surface marker CD63. This is detected by a FITC-fluorescence labelled monoclonal antibody. CD63 is currently the best-validated basophil activation marker directly linked to basophil degranulation. The Flow CAST kit can identify both IgE and non-IgE mediated allergies. The Flow CAST kit is quick and easy to use, with results obtained in ~60 minutes. Samples can be analysed up to 48 hours after collection (up to 24 hours for drug responses). The kit contains all of the reagents and controls needed to run the test. A New Era for Basophil Activation Testing! The kit now includes a new version of the wash buffer which contains a stabiliser. Previously, samples needed to be analysed using flow cytometry immediately following completion of the Flow CAST protocol, but the added stabiliser now means the samples can be analysed up to five days after completion of the protocol, if stored at 2-8C and protected from light. This change will help to improve workflow in laboratories. BÜHLMANN Flow CAST® Product code Description Pack Size FK-CCR Basophil Activation Test Allergy in vitro blood assay 100 tests BÜHLMANN Laboratories Food Additive Allergens Include: BAG2-C103 TARTRAZINE BAG2-CE123 AMARANTH BAG2-C111 SODIUM-BENZOATE BAG2-CE124 NEW COCCINE BAG2-C112 SODIUM-NITRITE BAG2-CE127 ERYTHROSINE BAG2-C113 POTASSIUM-METABISULFITE BAG2-CE131 PATENT BLUE V BAG2-C114 SODIUM-SALICYLATE BAG2-CE132 INDIGO CARMINE BAG2-CE104 QUINOLINE YELLOW BAG2-CE151 BRILLIANT BLACK BN BAG2-CE110 SUNSET YELLOW FCF BAG2-CE466 CARBOXYMETHYLCELLULOSE BAG2-CE122 CHROMOTROPE FB BAG2-CE621 GLUTAMATE Food Allergens Include: BAG-F1 EGG WHITE BAG-F75 EGG YOLK BAG-F2 COW MILK BAG-F10 SESAME BAG-F13 PEANUT An extensive range of over 150 standardised allergens spanning food, drug, insect venoms, inhalants and food additive allergies are available to purchase separately. Some examples are listed below: Visit www.alphalabs.co.uk/allergens for the full range of available allergens.

Alpha Laboratories Limited 40 Parham Drive Eastleigh, Hampshire SO50 4NU United Kingdom Tel: 023 8048 3000 Fax: 023 8064 3701 Email: digestivedx@alphalabs.co.uk Web: www.alphalabs.co.uk Passionate about finding new ways to help science improve people’s lives through its evolving range of specialist diagnostic and laboratory products. Alpha Laboratories has extensive experience in diagnostics for digestive health. We have been involved with the National Bowel Cancer Screening programmes since 1998 initially as the sole supplier of hema-screen™ (faecal occult blood tests). We have worked with the programmes to support transition to the more sensitive and specific quantitative faecal immunochemical test (FIT) screening solution on the automated HM-JACKarc platform. The benefits of FIT are also being applied to symptomatic testing, to triage patients in primary care, providing an improved patient pathway and better management of endoscopy resources. Find out more at our dedicated website: www.faecal-immunochemical-test.co.uk Alpha Laboratories also helped pioneer the routine use of calprotectin assays for differentiating between IBD and IBS. This biomarker provides a reliable, non-invasive test with significant cost and patient benefits. NICE guidelines (DG11-2013), now advocate the use of faecal calprotectin as a first line test in patients presenting with gastrointestinal symptons indicative of IBD or IBS. It is also a valuable marker for monitoring and managing IBD positive patients. Find out more at our dedicated website: www.calprotectin.co.uk Continuing to bring leading edge solutions to clinical scientists and gastroenterologists alike, our latest additions to the range include innovative products for remote monitoring, scalable calprotectin testing and rapid TNFα drug monitoring. The IBDoc® calprotectin home test offers a new approach to help support patient care and customised therapy. Alpha Laboratories also offers a range of other tests to assist clinicians in the assessment of digestive disorders, from infectious diseases to allergies. JBN327 04.24