Leading Edge 2020 Issue 1

2020 ISSUE 1 2 Welcome to the first issue of Leading Edge in the new decade which introduces you to a number of new products and services. Haemostasis specialists will be very interested in two complementary new kits from Precision BioLogic to help with the management of haemophilia A. The Factor VIII inhibitor testing kit will bring increased confidence in results for a modified Nijmegen-Bethesda assay. Alongside this the Chromogenic Factor VIII Assay provides a reliable testing method less prone to interference (p2-3). Building on the success of the BÜHLMANN fCAL® turbo high throughput calprotectin assay, the new fPELA assay for faecal pancreatic elastase will bring similar workflow benefits. With the ability to use a single patient sample, for both tests from the same CALEX® extraction device, there are distinct efficiency advantages (p6-7). We also launch our new dedicated website www.alphalabservice.co.uk This offers you a single resource for help and advice on the service, maintenance and cleaning of your diagnostic instruments from Alpha Laboratories. You’ll also find access to high quality calibration services for all your pipettes - whatever their brand (p12). The roll out of faecal immunochemical testing (FIT) for symptomatic patient assessment continues to accelerate. Many trusts are eager to share their experience and success and you can read all about the patient and clinician engagement with the South West Cancer Alliance programme on pages 4-5. Quality assessment is vital for diagnostic assays and a recent EQA report (p8-9) for Antiganglioside Antibody Testing verifies the clinical performance of the BÜHLMANN ELISA assays. On pages 10-11 find out how we’ve been investing in improving our warehousing to better support your supply chain and our efforts for environmental sustainability. Plus you can meet Gina Sanki our new technical specialist on page 12. Haemophilia A is a rare bleeding disorder, which affects the ability of person’s blood to clot. The condition is normally inherited and mostly affects males. Haemophilia A is caused by a deficiency in clotting Factor VIII, which ranges in severity depending on the level of clotting factors a person has. Symptoms include prolonged bleeding, bruising easily, and stiff, painful joints caused by internal bleeds. There are roughly 6,000 people affected by this condition in the UK. There are several different treatment options available for haemophilia A. One of the preferred options is to use Factor VIII concentrates, to replace the missing clotting Factor VIII. Factor concentrates are very effective at controlling bleeds and offer patients the opportunity to lead normal lives. Factor VIII Inhibitors In some patients, their immune system doesn’t recognise the factor concentrates (as naturally they produce very little, or no Factor VIII) and responds to it as if it were a foreign protein. In these patients, the immune system begins to produce neutralising allo antibodies, known as inhibitors, against the Factor VIII concentrates. The inhibitors bind to the functional epitopes on the infused Factor VIII concentrates, affecting the function and rendering the factor concentrates treatment ineffective. Screening It’s important to routinely screen patients for inhibitors, so that individuals at risk from developing them can be identified before they become non-responsive to treatment. The development of Factor VIII inhibitors is a significant management challenge for patients with haemophilia A. Inhibitors most commonly occur in those patients with severe haemophilia A. Those with severe haemophilia A have a 25-40% lifetime risk of developing inhibitors, compared to a 5-15% lifetime risk for those with mild to moderate haemophilia A. Most patients who develop inhibitors do so within the first 75 exposures to factor concentrates, with the greatest risk occurring between the first 10-20 treatments. Therefore, it is often children with severe haemophilia that develop inhibitors. Factor VIII inhibitors reduce the effectiveness of factor concentrates therapy. Therefore, it is crucial to precisely quantify inhibitors using methods such as a modified NijmegenBethesda assay. The CRYOcheck Factor VIII Inhibitor kit, manufactured by Precision BioLogic and supplied exclusively by Alpha Laboratories in the UK, is a new way to efficiently and conveniently determine and quantify the presence of functional Factor VIII inhibitors in patient samples. The CRYOcheck Factor VIII Inhibitor kit is a ready-to-use sample preparation kit to facilitate the performance of a modified Nijmegen-Bethesda assay. Increase Confidence in Your Results The kit offers standardised components and a validated protocol, delivering excellent repeatability and reproducibility to reduce intra and inter laboratory variation and increase confidence in your results. New Diagnostics to Help in the Management of Haemophilia Increase Confidence in Your Factor VIII Inhibitor Assay

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