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 Pricing and Online Ordering at www.alphalabs.co.uk n freephone order 0800 387732 n buy online at www.alphalabs.co.uk nemail order sales@alphalabs.co.uk nfreefax order 0800 614249 2 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. We then assisted with the roll-out of FIT in the Welsh and Northern Ireland Bowel Screening programs. 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 almost two decades and supported the NICE review (DG 11) of calprotectin for differentiation between Inflammatory Bowel Disease (IBD) and Irritable Bowel Syndrome (IBS). 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. Digestive Disease Patient Pathway It’s all about the Patient... The Patient Pathway The Patient Pathway
Pricing and Online Ordering at www.alphalabs.co.uk Pricing and Online Ordering at www.alphalabs.co.uk n freephone order 0800 387732 n buy online at www.alphalabs.co.uk nemail order sales@alphalabs.co.uk nfreefax order 0800 614249 4 5 Calprotectin Assays Calprotectin Sample Extraction 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 20 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 To simplify and assist the preanalytical extraction of calprotectin from the stool samples the CALEX extraction device is available 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. CALEX Cap 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 CE Marked CALEX Cap Collection Set 25 sets CALEX-CAL-CK020 UKCA Marked Faecal Calprotectin Collection Kit 20 kits CALEX-CAL-CK020P UKCA Marked Portal Delivery Calex Calprotectin Kit 20 kits AP0021 15.2mm Vacu-Re-Caps 1000 CALEX® Cap compared to manual extraction Passing-Bablok linear regression analysis: nEase of use for laboratory personnel and patients nDelivers a precise amount of faecal sample nOptimised sample dilution for maximum efficiency in stool extraction nApplication as a primary tube for many ELISA robots and routine biochemistry analysers n95kPa postal compliant nUN3373 and IATA 650 compliant for transport by air nModifications to the blue & white caps at either end enable them to be used on laboratory track systems for a truly automated workflow nCE and UKCA marked patient collection kits are available Vacu-Re-Caps can be used to quickly and cleanly reseal the CALEX after analysis. AP0021 Kaur. et al. Annals of Clinical Biochemistry 2020
Pricing and Online Ordering at www.alphalabs.co.uk Pricing and Online Ordering at www.alphalabs.co.uk n freephone order 0800 387732 n buy online at www.alphalabs.co.uk nemail order sales@alphalabs.co.uk nfreefax order 0800 614249 6 7 Faecal Sample Collection Calprotectin IBDoc® 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 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 IBDoc App and the data is transmitted to the clinician via a secure web portal. ■ First IVDR marked Calprotectin Home Test ■ Quantitative Rapid Test with results between 30 - 1000µg/g ■ Correlation 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 B-IBDOC1 IBDoc Single Kit for Patient Delivery Each BÜHLMANN Laboratories Walsh A. et al. ECCO 2018 P262 CALEX® Faecal Calprotectin Collection Kit Collection Kit Product code Description Pack Size CALEX-CAL-CK020 UKCA Marked Faecal Calprotectin Collection Kit 20 kits CALEX-CAL-CK020P UKCA Marked Direct Portal Delivery Calex Calprotectin Kit 20 kits Now CALEX patient packs are available to enable the patient to prepare the CALEX and send to the laboratory rather than a stool sample in a pot which will transform the way calprotectin testing is performed. Each kit comes discreetly packaged in a business-style envelope and includes a CALEX extraction device, easy to understand instructions, integral label (including name, date of birth, NHS number and sample collection date), and a transparent grip-seal bag for the convenient return of both the CALEX and the request form back to the laboratory or GP. The kits come in boxes of 20 and are stored at ambient until the expiry stated which is generally 12 – 18 months, so that they can be sent out to clinics and primary care in quantities and conditions that will minimise wastage. The boxes have a dispensing tally on the front to help maintain the correct level of stock within individual locations. Hospitals can either order the kits through Alpha Laboratories and send them to clinics and primary care using their existing van delivery/sample collection services, or can have the boxes sent directly to individual locations by ordering through The Alpha Portal.
Pricing and Online Ordering at www.alphalabs.co.uk Pricing and Online Ordering at www.alphalabs.co.uk n freephone order 0800 387732 n buy online at www.alphalabs.co.uk nemail order sales@alphalabs.co.uk nfreefax order 0800 614249 8 9 Calprotectin ELISA 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 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: Receiver Operating Characteristic (ROC) Curve Analysis for different fecal calprotectin methods. 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 Calprotectin ELISA: Quantitative High Throughput Test The BÜHLMANN fCAL ELISA method is the most popular method for ELISA calprotectin testing in the UK, with a 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-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 Pricing and Online Ordering at www.alphalabs.co.uk n freephone order 0800 387732 n buy online at www.alphalabs.co.uk nemail order sales@alphalabs.co.uk nfreefax order 0800 614249 10 11 Calprotectin High Throughput Assay BÜHLMANN fPELA ® Assay BÜHLMANN fCAL® turbo fCAL® turbo Product code Description Pack Size* 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 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 most standard clinical chemistry analysers (see www.alphalabs.co.uk/fcal-turbo 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. Products for Pancreatic Insufficiency BÜHLMANN fPELA ® Assay The 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 Results available significantly quicker than the traditional ELISA assays 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 BÜHLMANN fPELA gives comparable results to the current ELISA based methods: fPELA ® Assay Product code Description Pack Size 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 Pricing and Online Ordering at www.alphalabs.co.uk n freephone order 0800 387732 n buy online at www.alphalabs.co.uk n email order sales@alphalabs.co.uk n freefax order 0800 614249 12 13 Anti-TNFα Therapy Monitoring BioSystems BA200 Analyser 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) were 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 Antibody Testing These drugs can suffer from loss of response due to the development of antibodies against the drug molecules. This can occur in up to 46% of patients (depending on the drug). So, in addition to the importance of determining if the drug level is within the therapeutic window, antibody levels should also be tested. Monitoring patients on treatment is also very important and therefore, anti-drug antibody assays are also available to determine the free antibody level within patients. Following the same format as the drug level assays, the antibody assays will give a qualitative result within an hour enabling immediate adjustment of therapy if required. The BÜHLMANN Quantum Blue Infliximab assay and WHO calibration showed excellent correlation: Keller et al. 2020 Virtual UEGW BioSystems BA200 Analyser The BioSystems BA200 analyser is 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 Pricing and Online Ordering at www.alphalabs.co.uk n freephone order 0800 387732 n buy online at www.alphalabs.co.uk nemail order sales@alphalabs.co.uk nfreefax order 0800 614249 14 15 Quantitative Faecal Immunochemical Testing (FIT) 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, previously using qualitative, guaiac-based, faecal occult blood tests (gFOBT). In August 2023, the National Institute of Health and Care Excellence (NICE), published updated Diagnostic Guidance DG56 “Quantitative faecal immunochemical testing to guide referral for colorectal cancer pathway referral 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. The Association of Coloproctology of Great Britain and Ireland and the British Society of Gastroenterology (BSG) also published guidelines in July 2022 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 triages 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 symptomatic 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 DG56 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 bespoke Patient Packs, and The Alpha Portal, 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) HM-JACKarc Analyser + Barcode reader Product code Description Pack Size 065787 HM-JACKarc II 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 Canon Medical Diagnostics 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 Canon Medical Diagnostics Ltd. 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 nBespoke 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 Pricing and Online Ordering at www.alphalabs.co.uk n freephone order 0800 387732 n buy online at www.alphalabs.co.uk nemail order sales@alphalabs.co.uk nfreefax order 0800 614249 16 17 Quantitative Faecal Immunochemical Testing (FIT) Complete FIT Patient Packs 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, supplements, or medication 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 faeces. Faeces 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 faeces. This offers a hygienic sampling method, which only involves collecting one faeces sample, and sampling the faeces once. The device contains a biocide to minimise the risk of haemoglobin degradation by the microbiome in the faeces, 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 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, faeces 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 Pricing and Online Ordering at www.alphalabs.co.uk n freephone order 0800 387732 n buy online at www.alphalabs.co.uk nemail order sales@alphalabs.co.uk nfreefax order 0800 614249 18 19 Patient Pack Components The Alpha Portal Patient Pack Components Instruction Leaflet: A “how-to” guide on the collection of the faeces, 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 faeces 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 faeces 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 n Padded envelopes for general mailing n Freepost, pre-addressed envelopes for ease of use The Alpha Portal The Alpha Portal (TAP) is a dedicated online ordering system from Alpha Laboratories. This initiative enables hospitals, trusts and service coordinators to log in and order patient kits for direct delivery to clinics, GP surgeries or directly to patients; revolutionising logistical processes by reducing the administrative burden. This new system combats common issues such as dealing with bulk deliveries, HGV traffic on-site, storage limitations, postage administration and other logistical challenges. More importantly, TAP is an easier system that reduces the risk of errors in vital services. The user-friendly interface allows flexible management of urgent (24hr), ad-hoc (48hr) deliveries and forward ordering for the coming months, depending on the kits or service level required. For Calprotectin Testing Introducing individual sample collection kits for patient use can provide significant improvements in your laboratory workflow and performance. The Alpha Laboratories UKCA marked 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 (faeces 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 Additionally, TAP offers a significant time and cost saving approach, with a centralised postal tracking service which provides clear advantages above the obvious workflow improvements.
Pricing and Online Ordering at www.alphalabs.co.uk Pricing and Online Ordering at www.alphalabs.co.uk n freephone order 0800 387732 n buy online at www.alphalabs.co.uk nemail order sales@alphalabs.co.uk nfreefax order 0800 614249 20 21 Faeces Sample Collection Device DIAQUICK FOB / Dynex DS2® ELISA Processor The DS2® ELISA Processor from Dynex Technologies is a fully automated system that can process 96-well microtitre plates. 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. 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 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 No dietary restrictions DIAQUICK FOB Product code Description Pack Size Z01101CE FOB DIAQUICK Test Cassette 25 tests Dialab n Easy-to-use, hygienic, sample collection paper n Flushable and biodegradable n Simple instructions for use n Convenient for patients n Reduced risk of sample contamination Demonstration video available at: www.alphalabs.co.uk/fe-col Fe-Col® Faecal Collection Papers Product code Description Pack Size FC2010 Fe-Col® Faecal Collection Paper with Instructions for Use (IFU) 1000 FC2031 Fe-Col® Faecal Collection Paper in Dispenser Box of 50 6 x 50 Alpha Laboratories Ltd. See Website for more information and details Fe-Col® Faeces Sample Collection Device 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. 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 ) < 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 Expert Information 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 through the provision of 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 Pricing and Online Ordering at www.alphalabs.co.uk n freephone order 0800 387732 n buy online at www.alphalabs.co.uk nemail order sales@alphalabs.co.uk nfreefax order 0800 614249 22 23 Infectious Diseases Basophil Activation Testing 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 PRIMA ® Professional 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 sample collection probe and pre-filled buffer tube. The lateral flow test results are clear and easy to read. There is also an integral control to validate the assay. Sensitivity is 95.2%, specificity 96.6%, and accuracy 96%. Helicobacter pylori Product code Description Pack Size 800016IP-20P PRIMA ® Professional H. pylori antigen test 20 tests Sentinel Infectious Diseases Helicobacter pylori (H. pylori) Food Allergy Testing In the UK, approximately 2 million people are affected by food allergies, including both children and adults. Allergies significantly impact patients, with many experiencing reactions and requiring lifestyle changes to manage their condition effectively. Among infants, about 1 in 40 develop a peanut allergy, and roughly 1 in 20 develop an egg allergy. It is important to note that while allergies are more common in infants, they can develop later in life as well. Accurate diagnosis is crucial to distinguish true allergies from non-allergic reactions, and Basophil Activation Testing (BAT) offers a valuable solution in this regard. Offering BAT before a challenge test can significantly reduce the number of patients who need to undergo a provocation challenge, improving patient safety and comfort. The true value of BAT lies in its high specificity, with some studies reporting near 100% specificity. BÜHLMANN Flow CAST ® System: Advancing Allergy Testing The Flow CAST ® system, developed by BÜHLMANN Laboratories, represents a significant advancement for in vitro allergy testing. Utilising a dual-marker approach (CCR3 and CD63), it enables the detection of Basophil Activation in whole blood samples through flow cytometry. This is particularly effective for identifying both IgE and non-IgE mediated immediate-type allergic reactions and hypersensitivities to various allergens. Key Features Improved Workflow: n Higher sensitivity and specificity with BAT compared to standard skin prick tests nDetecting the CCR3 receptor with a PE-fluorescence labelled monoclonal antibody eliminates the need for labour intense leukocyte isolation nResults are typically available within 60 minutes nSamples can be analysed up to 5 days after processing Confidence in quality: n IVDR certified nImproved wash buffer with stabiliser extends the timeframe for sample stability before analysis Overall, the Flow CAST ® system marks a notable progression in basophil activation testing, enhancing both the accuracy and flexibility of allergy testing and making a substantial impact in the realm of in vitro research. Recent studies confirm the BAT as a useful tool in the in vitro diagnosis of food allergies. In one study, assessing cow’s milk allergy, BAT demonstrated a higher sensitivity (82.6%) and specificity (90.9%), compared to serum-specific IgE, which showed sensitivity and specificity of 55.1% and 80%, respectively (Schoos et al., 2021). BÜHLMANN Flow CAST® Product code Description Pack Size FK-CCR Basophil Activation Test Allergy in vitro blood assay 100 tests 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. All the allergens are optimised for in vitro use in BÜHLMANN cellular allergy assays. Visit www.alphalabs.co.uk/allergens for the full range of available allergens. 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 specialists 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 BA200 platform, 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: Receiver Operating Characteristic (ROC) curves comparing the diagnostic performance of the Basophil Activation Test (BAT), Skin Prick Test (SPT), Peanut-specific IgE (P-sIgE), and Ara h 2-specific IgE (sIgE to Ara h 2) in the study population (n = 92). (Santos et al., 2014). Additionally, another study examining food allergies to apple, carrot, celery, and hazelnut reported BAT sensitivity of 85-90% and a specificity of 80-90%, further supporting its effectiveness in food allergy diagnostics (Journal of Allergy and Clinical Immunology, 2011).
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