EH 3_2015

www.healthcare-in-europe.com 13LABORATORY The new Forensic and Postmortem Microbiology Study Full integration is key to the future of LC-MS/MS Seeking to identify what causes death Connected components are not enough Explaining the importance of liquid chromatography/tandem mass spec- trometry (LC-MS/MS) in the clinical lab, Dr Bori Shushan, of Clinical Mass Spec Consultants, pointed out that spectrometry’s ability to be very specific to the target analyte can enable clinicians to make more informed decisions. ‘Select immunoassay based methods have known interferences due to cross reactivity that can produce a less accurate result, especially in the areas of endocrinology, therapeutic drug monitoring and drugs of abuse testing.’ Why, then, aren’t labs rapidly adopting LC/MS-MS technology? Shushan: ‘First, the customer is faced with many choices in the market to piece together a comprehensive solution. It can be overwhelming to decide which LC or MS to use plus a wide range of calibrators, controls, etc. Second, labs need the expertise by which to develop and validate their own methods, and set up and run the instruments on a daily basis. Third is cost, especially when considering automation com- ponents to help reduce high labour requirements for sample prepara- tion, finance options are typically limited. What is changing to take LC-MS/ MS into a greater number of clinical laboratories? ‘I think the basic needs of the rou- tine clinical lab are quite clear. This includes systems that are easy to use, reliable, connected to the labo- ratory information system, and com- plete solutions including diagnostic kits that are regulatory compliant. ‘In Europe, many suppliers have pursued the creation of internal quality systems and product con- trols to enable them to affix the CE-IVD mark. There also have been recent efforts to package compatible technologies to help labs be more productive. We see this in the provi- sion of compatible but previously stand-alone elements, such as auto- mated sample handlers, LC-MS/MS reagent kits, and software provided together to better manage work- flow. I like to think of this emerg- ing category of LC-MS/MS systems as ‘connected components’. It does simplify the number of decisions to be made by the lab, because these components are provided together. It’s a step in the right direction, but there’s still more that can be done. The clinical lab is accustomed to highly automated easy-to-use clini- cal chemistry analysers along with the convenience of walk away operations. Random access work- flow enables samples processing as quickly as possible. ‘I think what is ultimately needed is a system that is built for purpose – a fully integrated LC-MS/MS clini- cal analyser. This turnkey solution would mean that it’s ready to install, validate, and operate in weeks versus many months. It simplifies the decision process and includes everything necessary to produce a high quality result. These results would be consistent and standard- ised between labs because the sys- tem would include test kits that are fully validated for use on the analyser. ‘Ideally everything, includ- ing automated sample preparation and handling, would be done in a single instrument which could be serviced and supported by a single manufacturer. ‘Most importantly it would allow the lab operator to be confident in the results they are producing. It would bring LC-MS/MS into the mainstream lab and help healthcare systems to operate more efficiently.’ The DxH SMS is easy to config- ure, requiring little maintenance, the company reports. ‘It provides a more reliable and consistent smear quality regardless of the blood con- sistency, reducing the number of films needing manual review. The workcell’s user-defined rules intel- ligently drive its automatic slide preparation and staining, without the need for manual intervention.’ Effective turnkey solution The solution had to deliver imme- diate workflow efficiencies with IT automated solutions, as well as provide the capacity for long-term expansion as the pathology service grew external business. Darent Valley is already a stream- lined and efficient laboratory ser- vice, capable of handling thousands of samples every day. The frame- work has been laid for the develop- ment of a laboratory service able to compete successfully within the modern NHS over the next 10 years, Beckman Coulter reports. Bringing liquid chromatography and tandem mass spectrometry (LC-MS/MS) testing into clinical laboratories has been a slow process but continues to show promise to help improve patient care. The medical device industry is on the edge of fundamental breakthroughs that can help drive the adoption into more mainstream clinical laboratories. We recently sat down with Dr Bori Shushan, Mass Spectrometry expert, to ask about LC-MS/MS adoption by clinical labs and what could leverage the technology to benefit more patients. In 1980, Bori Shushan received his doctorate from the Guelph-Waterloo Centre for Graduate Work in Chemistry in Analytical Chemistry when specialis- ing in Tandem Mass Spectrometry. He joined MDS Sciex that same year to work in R&D of inlet technology and applications for the group’s novel atmospheric-pressure ionisation tandem mass spectrometer system. In his 25-year career at MDS Sciex, Dr Shushan held key positions in Application Research and Development, Marketing and Sales, Technical Marketing and Sales Support and in the Development of the Clinical Mass Spectrometry market. He is Founder and President of Clinical Mass Spec Consultants, a consulting firm specialising in the use of mass spectrometry in clinical diagnostics. With over 18 years’ experi- ence in clinical mass spectrometry, his present clients include large and medium- size instrument companies as well as gov- ernment and private laboratories. He is a consultant for Thermo Fisher Scientific. Sample tracking at Darent Valley Thermo Scientific Orbitrap Fusion Tribrid LC-MS (I) with Thermo Scientific Dionex UltiMate 3000 Series UHPLC A new study group that aims to estab- lish guidelines on forensic micro- biology sampling and encourage increased communications between European and global organisations, has been launched by the European Society of Clinical Microbiology and Infectious Diseases (ESCMID). Named the Forensic and Post mortem Microbiology Study Group (ESGFOR) the aim is to create a new network of microbiologists, virolo- gists, anthropologists and archae- ologists working in the field of forensic medicine.Professor Amparo Fernandez-Rodriguez, from the National Institute of Toxicology and Forensic Sciences, Madrid, and head of ESGFOR, stresses the importance of this group in facilitating coopera- tion between (forensic) pathologists and (forensic) microbiologists. Microbiology, she explains, is a new area of involvement for foren- sics and it is important that these two areas can work together to detect and defeat diseases. Speaking on behalf of ESGFOR, she said: ‘We are trying to convince medical examiners and judicial authorities of the importance of performing postmortem microbiology studies to learn from how people have died and prevent future occurrences.’ Identifying the causes behind a person’s death can help trigger a prevention plan. In discovering the bacteria involved, correct treatment strategies can be implemented and, in some cases, vaccines can be administered. Fernandez-Rodriguez spoke at the ECCMID 2015 confer- ence in Copenhagen on the group’s goal to establish European guidance for standardised microbiological sampling in forensic cases.The ESCMID study group Another focus for the new group is to instigate increased coopera- tion between different societies and networks. ESGFOR, for example, is working to establish collabora- tion with the European Network of Forensic Science Institutes (ENFSI). Further details: https://www.escmid.org/ research_projects/study_groups/forensic- postmortem_microbio/

EH 3_2015

Seitenübersicht