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Alpha Laboratories’ Communications Keeping You Up to Date Alpha Laboratories is constantly sourcing innovative new laboratory and diagnostic products to support your work and help improve Pricing and Online Ordering at www.alphalabs.co.uk n freephone order 0800 387732 n buy online at www.alphalabs.co.uk 312 healthcare practices. We aim to keep you updated with all the latest developments through regular communications. Diagnostic Newsletter: Leading Edge Laboratory Brochure: LabVantage Autumn/Winter 2013 Alpha Laboratories Ltd Using the New Theranostic ELISA for Infliximab Spring 2014 Alpha Laboratories Ltd Summer 2014 Alpha Laboratories Ltd of haemolysis; aliquots of each sample were spiked with varying amounts of haemolysate. As expected, patient samples with a HI greater than 20, gave higher results when tested using the Wako method, due to the negative interference inherent in the Roche assay. Assay precision showed CVs from 1.3% (48 μmol/L) to 6.5% (5 μmol/L) and UK NEQAS performance was close to ALTM Mr Edward Kearney and Dr Elodie Hanon at East Kent Hospitals University NHS Foundation Trust have also evaluated the Wako Direct Bilirubin assay, using the Abbott Architect platform. JANE FRENCH 2014 ISSUE 1 Autumn 2013 ■ Liquid Handling Pipettes, Tips, Pastettes ■ Molecular Biology The New Bioer LineGene 9600 ■ New Products ■ Special Offers ■ Clearance Stock Savings PCR, Electrophoresis ■ Sample Handling Collection, Storage, Transport Real Time Thermal Cycler Series - Novel, easy-to-use technology In this edition » New Bioer LineGene 9600 Heat Sealing Films - A hot new range Thermo Q Dry Bath Seeing Red? - Ripette® Dispenser can help New Clinical Lab Consumables Range PCR Strip Tubes DNA-VIEW Electrophoresis System mLINE® Pipette - Back by popular demand! Pipet-Aid XP2 goes Technicolour Dual-Bulb Pastettes® - New pack size Pipette Tips - Suitable for Rainin LTS™ Alpha Dispenser Tips Shades of Summer - Test Tube Racks Clearance Stock Bargains Ex-Demo Pipette Deals 2014 ISSUE 2 In this edition » mLINE® Pipettes New Style New Great Value Multipacks Regular Targeted Email Communications to bring you: New Product Introductions Exclusive Money Saving Special Offers Technical Updates Events News and Invitations IN THE NEWS 1 Anti-TNFα Theranostics - Testing to Tailor Treatment Anti-Tumour Necrosis Factor alpha (anti-TNFα) drugs provide a major biotherapeutic breakthrough in the treatment of chronic inflammatory rheumatism (CIR) such as rheumatoid arthritis, ankylosing spondylitis, and juvenile idiopathic arthritis. They are also used for the treatment of Inflammatory Bowel Diseases (IBD) when patients do not respond to steroids. These biologics bind TNFα, thus blocking the action that is responsible for the inflammatory state. However, not all patients undergoing such treatment respond well. The level of response can vary between patients or within the same individual over time. Theranostic tests provide a new approach for monitoring biotherapies and a significant advance in the development of a customised and responsible treatment programme that can be tailored, dependent on individual patient response. The varying effectiveness of anti-TNFα treatment can be due to different pathophysiology in the patients and fluctuations of the effective serum concentration for a given dosage. The active site of antibodies (ADAb) or there may be other drug neutralised through anti-the drug can be causes side-effects. rapid drug clearance. of the appearance of response and they affect clinical neutralising ADAbs has been are significant since ADAbs the anti-TNFα, the appearance of Whatever demonstrated in 20% to 60% of treated patients presenting therapeutic resistance and their presence appears as a precursor to potential clinical deterioration. Anti-TNFα drugs are very expensive with annual costs in the region of £10,000 a year per patient, rising to around £40,000 for over-dosed patients or those not responding to therapy. In 2011, the total cost of anti-TNFα to the NHS in England was £677.8 million according to the 2011 NHS Statistics. Tailoring individual treatments could help control these high costs. Continued on page 2 Allergy Testing- without the Risk New Products • New Products • New Products New Products • New Products • New Products Make sure you are signed up to receive the information you need, contact us today marketing@alphalabs.co.uk LISA TRACKER for Anti-TNFα ScreenFect™A Transfection Reagent Bühlmann Enzymatic GHB Kit CD-Chex™ CD117 In this issue Anti-TNFα Theranostics 1 Testing to Tailor Treatment User Report: 1 Derriford Hospital - Infliximab ELISA User Report: 1 University Hospital Southampton - FlowCAST® Allergy Test Stop Sepsis Save Lives 1 The French Connection 2 Introducing Theradiag Enterococcus ID? 2 - Enter the Solution! Positive Blood Culture? 3 Complement MALDI-TOF species ID with QuickFISH™ Transfection Defection 3 Improve Transfection Efficiency Sunshine Booster 3 Vitamin D ELISA Methotrexate Monitoring 3 The Highs and Lows Rapid Detection of GHB Misuse 3 User Report: 4 Great Ormond Street Hospital - Frozen Factor Deficient Plasmas Those Interfering Antibodies 4 Anti-Interferon β ELISA Positive Control For Your Flow 4 CD117 Flow Cytometry Control New Products • New Products • New Products Dr Ruth Ayling, Consultant Biochemist and Francesca Mills, Senior Clinical Biochemist at the Combined Laboratory - Department of Clinical Biochemistry, Derriford Hospital, Plymouth, describe their experience with the Theradiag kit for the anti-TNFα Infliximab. Sepsis is the most common, but least recognised disease and carries a high risk of death and long-term complications. World Sepsis Day1, an initiative of the charity Global Sepsis Alliance has key goals aimed at reducing the incidence of sepsis and increasing survival rates. It took place this year on September 13th, a day when the BBC News2 also highlighted the issue. Their coverage focused on a report from the Health Service Ombudsman that describes numerous patient deaths from sepsis, as a result of the correct treatment not being received urgently enough. Speed of identification and treatment of sepsis is critical for a positive patient outcome. Alpha Laboratories is helping contribute to the fight against sepsis by offering new diagnostic technology that aims to identify infection species much faster than conventional methods. QuickFISH™ could help improve septicaemia patient prognosis, promoting higher survival rates and fewer complications by enabling clinicians to administer more targeted therapy, sooner. 1. www.world-sepsis-day.org/ 2. www.bbc.co.uk/news/health-24063623 Find out more about QuickFISH on pages 2 & 3 In a Spring 2013 Leading Edge article we looked at the identification of allergens causing immediate type reactions and recognised that in some cases, such as more complex reactions to drug allergens, specific IgE fails to give absolute diagnostic reliability. Whilst drug provocation tests remain the gold standard for diagnosis of immediate drug allergies, they are very time-intensive procedures associated with the significant risk of severe and potentially fatal reactions. Likewise, skin prick and intradermal testing are slow and risk severe reactions. In vitro tests such as specific IgE to drugs offer a limited range of drugs that can be tested.  We have evaluated a new kit for the measurement of serum Infliximab drug concentrations and Infliximab Antibodies and are now ready to launch this service. Anti-TNFα drugs are therapeutic agents used to treat patients with a number of inflammatory diseases. Infliximab is specifically used for treatment of rheumatoid arthritis, Crohn’s disease and ankylosing spondylitis. The drug (a monoclonal antibody), binds to TNFα and blocks its action which is responsible for the inflammatory state. Continued on page 2 Basophil Activation Tests (BAT) provide an alternative test that does not carry risks to the patient. They have emerging potential in assisting in the clinical work-up and diagnosis of immediate drug allergies. Here a team from the Department of Immunology, University Hospital Southampton NHS Foundation Trust, describe an example of their experience using BAT in a clinical setting. Continued on page 2 1 Fe-Col® Faeces Collection Device Fe-Col® Faecal Collection Paper PrimeSurface from Wako Read All About It - The Clinical Benefits of Rapid Sepsis Diagnostics Hospital Associated Infections (HAI) are a major concern for patient wellbeing and healthcare finances. Time is of the essence in their treatment, generating increased pressure on laboratory professionals to provide prompt pathogen identification from blood cultures. Once species diagnosis is obtained, clinicians can then initiate more effective targeted antimicrobial therapy, minimising the use of broad spectrum antibiotics. There is now increasing evidence in the literature that the patented PNA-FISH technology, developed by AdvanDX, demonstrates significant clinical utility in accurately identifying the causative pathogen species directly from positive blood cultures, much faster than other methods. Continued on page 2 Continued from page 1 Are You Under-Reporting Bilirubin Values? Neonatal bilirubinemia is common in newborn babies as they lack the intestinal bacteria that help process bilirubin. Typically this resolves itself in a couple of days. However, in some instances, the bilirubinemia is a result of red blood cell destruction caused by newborn and maternal blood type incompatibilities, or other genetic factors. In these cases it is important that the bilirubin levels do not get too high since excess bilirubin damages developing brain cells in young babies. Diazo based testing protocols are prone to negative interference from haemoglobin. This creates a risk of reporting values below the true concentrations. This presents a problem for a number of laboratories as explained by Daniel Isemede, Specialist Biomedical Scientist, South Devon Healthcare NHS Foundation Trust:  The current Roche assay for Conjugated Bilirubin (CBil) which uses a diazo method, suffers from significant negative interference from haemoglobin and a concentration as low 40mg/dL (Haemolysis Index (HI) 40) completely invalidates the result. This compromises patient management especially in the paediatric ward and special care baby unit. The Wako CBil assay was investigated to assess the claim of no significant interference from haemolysis and compared to the established diazo method on the Roche Modular*. A selection of samples with a total bilirubin concentration greater than 60μmol/L, CBil 40 -130 μmol/L and serum HI <5 were used to determine the effect (y = 1.05x + 0.64 (R2 = 0.997). The Wako Direct Bilirubin assay is not significantly affected by haemolysis up to an index of 800: levels that are commonly seen in neonatal samples. The use of this assay prevents rejection of samples as unsuitable for analysis and has been adopted by our laboratory. *Poster presented at FOCUS 2013. T16: Use of Wako vanadate oxidation method for conjugated bilirubin markedly reduces interference from haemolysis. Isemede, D.A.; Waterson, M.J. & Beo, C.M. Annals of Clinical Biochemistry (2013):50 (supplement 1) Please circle 1 on the Reply Card for more information Read their report on page 3 NICE Calprotectin! Faecal calprotectin testing hit the news headlines late last year following publication of the NICE diagnostic guidelines: ‘Faecal calprotectin diagnostic tests for inflammatory diseases of the bowel’ (DG11). Measurement of faecal calprotectin is considered to provide a reliable indicator of gastrointestinal (GI) tract inflammation and numerous studies show that, while faecal calprotectin concentrations are significantly elevated in patients with inflammatory bowel disease (IBD), patients suffering from irritable bowel syndrome (IBS) do not have increased calprotectin concentrations. Elevated concentrations are shown to correlate well with both endoscopic and histological assessment of disease activity. Continued on page 2  In this issue User Reports: 1 Are you under reporting Bilirubin Values? Rapid Sepsis Diagnostics 1 QuickFISH™ Literature Review NICE and Calprotectin 1 The new guidelines Fast Frozen Benefits of Frozen Plasma 2 Faecal Immunochemical Tests 2 The next step in faecal occult blood testing Small Box, Big Impact 3 The DS2 helps assay throughput NICE and AKI 3 Published guidelines on the horizon TB or not TB? 4 Easier testing for Mycobacteria Take Control of Your Stock 4 Less admin, more value New Fe-Col™ 4 The hygienic way to collect faecal samples New PrimeSurface 4 Spheroid Body Formation AlphaDoku 4 Win a Hamper! Leading-Edge_Spring14_FINAL_Feb14.indd 1 20/02/2014 12:55:34 1 Celltight Culture ware Ascites Calprotectin In this issue Pre-analytical Variation on 1 Calprotectin Analysis Sharing Best Practice 1 Calprotectin User Groups Providing Reliable Samples 1 Consumables can help NSAIDs and Calprotectin Analysis 1 Clinical Significance QuickFISH™ beats MALDI-TOF! 2 Pathogen identification for clinical microbiology Ascites Calprotectin 2 Not just for IBS/IBD differentiation Biofilms and 3D visualisation of 3 micro-organisms - PNA-FISH® Rapid Cryptococcosis Diagnosis 3 Lateral Flow Test Advantages Shimadzu automated protein sequencer 4 Wako reagents fit the bill MBL concentrations getting you down? 4 A simple test from BioPorto Celltight culture ware range 4 For optimal cell cultivation AlphaSearch 4 Win a Summer Hamper! The Impact of Pre-analytical Variation on Faecal Calprotectin Analysis As the Director of the UK NEQAS programme for Faecal Markers of Inflammation, I’m often asked why we sometimes see quite large differences between the Faecal Calprotectin results obtained by users of a single kit on the same homogenised external quality assessment (EQA) specimen. As is nearly always the case with such questions, there’s a long answer…………. Any test result issued from a Clinical Laboratory is a product of the pre-analytical, analytical and post-analytical stages of the procedure. Even relatively simple examinations such as plasma glucose are not without variation. For Faecal Calprotectin analysis in particular, there can be a large number of steps in the pre-analytical phase. Although manufacturers provide instructions with the test kit, the guidance given for each step within that process is open to interpretation and may be performed slightly differently by various laboratories for perfectly logical reasons. The UK NEQAS programme provides all participants with identical samples of faeces in identical tubes but everything that happens to those samples after dispatch from UK NEQAS is subject to variation. For example, how long does it take for the samples to arrive at the participant laboratory? What temperatures have the samples encountered during their journey? How does the laboratory handle the samples upon arrival? Are they frozen, refrigerated or stored at room temperature, and for how long? If the samples are frozen, is it at -20°C, -40°C, -80°C or another temperature? We do ask our participants to extract the samples immediately upon receipt and freeze the extract if there will be a delay before analysis, but we do appreciate that this is not always possible. Continued on page 2 Handling Sample Handling Providing reliable, consistent results is a priority for laboratories. Quality systems and accreditation such as ISO 15189 go a long way to ensuring maximum competency is achieved. However, there are some aspects affecting data accuracy that go beyond the control of the laboratory. Sample quality is one such issue. Every laboratory professional will have stories to tell of the huge range of sample container formats, quantity or condition of specimens they are confronted with on a daily basis. Continued on page 3 Sharing Best Practice The recent Calprotectin Regional User Group meetings, organised by Alpha Laboratories, generated lively and informative discussions between new, experienced and some potential calprotectin assay users. Over 40 participants attended across the three meetings held in London, Birmingham and Manchester, travelling from as far afield as Truro and Glasgow. The majority of attendees had already set up their service, but some are just about to introduce calprotectin assays and so were keen to hear about the experiences of their peers. Also in attendance were Jane French from UK NEQAS and Dr Arne Roseth, Gastroenterologist. The round table open discussions included a range of topics relating to calprotectin testing. These covered extraction techniques, sample stability, cut-off, Quality Control and the current NICE guidance. Continued on page 3 Does NSAID use affect the Faecal Calprotecin result? In a word – yes! Is this clinically significant? in another word, no! Most non-steroidal anti-inflammatory drugs (NSAID) cause gastric damage in short-term volunteer studies, ranging Recent from erythema to ulcers.suggest that gastrointestinal estimates attributable to (non-selective GI) bleeding accounts for nearly NSAID 34% of all GI bleeding cases (mostly upper GI bleeding) in the US and may have resulted in over 32,000 hospitalisations per year during the last decade. It would be logical therefore, since faecal calprotectin is a sensitive marker for inflammation in the gut, that a patient on NSAID would have a higher calprotectin level than would normally be seen. Continued on page 3 Leading-Edge_Summer14_FINAL_May14.indd 1 28/05/2014 12:07:29 TIME FOR REAL TIME? 60 50 40 30 20 10 0 5 10 15 20 25 30 35 LV_Autumn13_FINAL_21Aug13.indd 1 22/08/2013 11:21:32 ■ Liquid Handling ■ Consumables ■ Research Products ■ Molecular Biology - Genetics at Leicester Case Study - New LifeECO™ Thermal Cycler - Thermocell Heating/Cooling Blocks - Huge Savings on PCR Consumables - New Maxi Z Clarit-E® Electrophoresis Bioer Molecular Biology Instruments endorsed by Leicester Genomics facility (NUCLEUS), part of the Core Biotechnology Service Keeping You Up To Date


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