EH 3_2015

www.gbo.com/diagnostics Greiner Bio-One GmbH | Bad Haller Straße 32 | A-4550 Kremsmünster Phone: (+43) 75 83 67 91-0 | Fax: (+43) 75 83 63 18 | E-mail: office@at.gbo.com MRSA (Methicillin-resistant Staphylo- coccus aureus) is recognized world- wide as the most significant cause of nosocomial infections. Clostridium dif- ficile infection (CDI) is the most com- mon healthcare-associated infection causing antibiotic-associated diarrhoea (AAD) potentially leading to pseudo- membranous colitis and even death [1] . Both infections increase mortality rates and prolong hospitalization and repre- sent a major burden for healthcare sys- tems across Europe [2], [3] . It is therefore essential to detect these pathogens as soon as possible and, if necessary, to treat patients separately from other unaffected patients. To achieve the rapid identification of nosocomial infections in general, Greiner Bio-One has developed the Genspeed® Test System, a unique molecular diagnostics system that combines crude lysis of bacteria with multiplex-PCR before the final automat- ed analysis of PCR-products in the new Genspeed® R2 Analyzer. The Genspeed® MRSA test is a DNA- based CE-IVD certified test for quali- tative detection of MRSA within 100 minutes* from human nasal and phar- yngeal smears, targeting both resist- ance genes mecA and mecC. The Genspeed® C.Diff OneStep test is CE-IVD certified and identifies toxigenic C. difficile by detecting glu- tamate dehydrogenase (GDH), toxin A, toxin B and binary toxin genes in one step in less than 100 minutes*. The Genspeed® C.Diff OneStep one-step procedure represents a true alternative to currently used sequential two-step diagnostic procedures, e.g. a GDH an- tigen assay followed by a toxin assay. The compact and virtually mainte- nance-free Genspeed® Test System provides fast results at high sensitiv- ity. Analyses of individual samples are possible at any time. Pre-filled reagents and the automated Genspeed® R2 Analyzer reduce the number of process steps to a minimum. The easy-to-use Genspeed® Test System provides fast results to drive decisions and comes at a reasonable price. * Time can vary with validated PCR-cycler used All Genspeed® products are currently available for sales in the EU and EFTA countries only. Not for sales in the U.S.A. Availability in other countries on request. visit us at EuroMedLab: Booth N° F068 Niv. 1 (hall Paris) Literature: 1. European Centre for Disease Prevention and Control. Point prevalence survey of healthcare-associated infec- tions and antimicrobial use in European acute care hos- pitals. Stockholm: ECDC; 2013. 2. R. Köck, K. Becker, B . Cookson, J.E. van Gemert-Pijnen, S. Harbarth, J. Kluytmans, M. Mielke, G. Peters, R.L. Skov, M.J. Struelens, E. Tacconelli, A. Navarro Torné, W. Witte, A.W. Friedrich. Methicillin-resistant Staphylococ- cus aureus (MRSA): burden of disease and control chal- lenges in Europe. Euro Surveill. 2010, 15 (41): 19688. 3. E. Bouza. Consequences of Clostridium difficile infection: understanding the healthcare burden. Clin Microbiol In- fect. 2012, 18 Suppl 6:5-12. Reliable detection of MRSA and toxigenic C. difficile in less than 100 minutes* with the Genspeed® Test System www.healthcare-in-europe.com 15INFECTION CONTROL From alcohol to cancer detection Report: Mark Nicholls Phase I clinical trials of a diagnos- tic breathalyser developed by Cambridge-based Owlstone Ltd have shown accurate identification of 12 lung cancer biomarkers in breath specimens. A Phase II trial is now targeting development of a small, handheld device that can be used in GP surgeries, clinics and the hospital bedside. The latest trials are under way at University Hospitals of Leicester and Cambridge’s Papworth Hospital on the nanotechnology device that employs Field Asymmetric Ion Mobility Spectrometry (FAIMS) to detect chemicals at the very low quantities found in breath. Originally invented to detect explosives in air- ports, the technology has now been developed for medical use. Data from Cancer research UK shows that lung cancer survival is 75% in Stage 1 patients but only 5% in Stage 4 patients. A goal of this project is to detect lung cancer earlier and save 10,000 lives by 2020 and £254 million in NHS healthcare costs. Billy Boyle, co-founder and President of Operations at Owlstone Ltd, said: ‘If you could change only one thing in the fight against cancer, it would be to detect the disease earlier, where existing treatments are already proven to save lives. FAIMS technology has the potential to bring a quick and easy-to-use breath test to the GP’s office. ‘The human body makes chemicals: a lot of them are just normal, eve- ryday chemicals, but with cancer and other diseases the cells start to make chemicals differently. By pro- gramming the chips in software to look for these different characteris- tic signatures and chemical markers, you can programme it to look for a range of different diseases.’ Breath test technology is a grow- ing area and has the advantage of being convenient and non-invasive, avoiding the cost and discomfort of biopsies. Dr Salman Siddiqui, a clinical sen- ior lecturer and adult chest physician at the University of Leicester and Glenfield Hospital lead the Leicester study; trial results are expected in early 2016. ‘This project will seek to identify and evaluate biomarkers in order to improve the accuracy and reliability of breath diagnostic methods,’ Siddiqui explained. ‘We will also be aiming to establish FAIMS as a faster, less expensive and more portable alternative to gas chromatography-mass spectrometry (GC-MS) for breath diagnosis appli- cations.’ In a separate breakthrough, researchers in Israel are using nano- array analysis to identify key volatile organic compounds, which could be used to screen for early detection of stomach cancer. The technology senses minute changes in the levels of particu- lar compounds in exhaled breath and accurately identifies high-risk changes that herald the develop- ment of stomach cancer. The research, led by Professor Hossam Haick from the Department of Chemical Engineering and Russell Berrie Nanotechnology Institute in Haifa, also suggests that the technol- ogy could be used not only to test for the presence of stomach cancer, but also to monitor those at high risk of subsequently developing the disease. Gastric cancer develops in a series of well-defined steps, but there is currently no effective, reli- able, and non-invasive screening test for picking up these changes early on. Nano-array analysis is accurate, highly sensitive and cost-effective and its ability to accurately differ- entiate between low and high-risk changes would avoid unnecessary endoscopies and enable any pro- gression to cancer or signs of dis- ease recurrence to be monitored. A large trial, involving thousands of patients, is now underway in Europe to test the technology’s suit- ability as a screening method. Clinical trials are under way at two NHS hospitals in England to assess breathalyser technology to detect lung cancer. Hossam Haick is a professor in the Department of Chemical Engineering and Russell Berrie Nanotechnology Institute in Haifa, Israel. Phone: (+43) 75836791-0 | Fax: (+43) 75836318 | E-mail: office@at.gbo.com

EH 3_2015

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