EH 4_2015

Ultimate 8MP Colour Performance With its 31,5” 8 Megapixel workspace, the MD322C8 is the perfect solution for large, high detail colour and grayscale diagnostics in CT, MRI and other medical imaging modalities. In addition, this feature rich display includes an LED backlight sensor and special Anti-Reflection coating which help to deliver first-class image quality with reliability over sustained periods with reduced energy consumption. For more information www.medical.nec-display-solutions.com NEC_AD_medical_MD322C8_strip_new-format_3.indd 1 14/08/15 12:23 28 LABORATORY & INFECTION New standards speed data sharing between devices The LAW of the LabFirst they fixed the cables to hard- wire a faster data transfers from laboratory instruments. Now a coa- lition of the largest manufacturers of lab equipment for patient diagnostic tests have agreed on shared proto- cols for how software should report results. This is the first update to international standards in 20 years. ‘Past standards left too much room for interpretation and had a Baskin-Robbins 31 Flavours out- come, where each vendor had a different implementation,’ said Serge Jonnaert, from the sponsor- ing organisation the IVD Industry Connectivity Consortium (IICC). The resulting set of standards, called the Laboratory Analytical Workflow (LAW), has been doc- umented and published by the non-profit, open platform asso- ciation Integrating the Healthcare Enterprise (IHE). The new LAW integration profiles were recently tested for true interoperability of data sets among diverse vendors at the IHE Connectathon 2015 held in Chicago. Lab vendors who have certified their equipment conforms to the new standards include Abbott Diagnostics, Beckman Coulter, Impeco, Omnilab, Orchard Software, and Siemens Healthcare. ‘We expect more vendors to come online as customers demand con- formance to the IHE LAW profile,’ Jonnaert said. Members of the consortium who will test IVD analysers at upcom- ing Connectathons in Europe, Japan or North American include Becton Dickinson, bioMérieux, Data Innovations, Hitachi, Ortho Clinical Diagnostics, Roche Diagnostics, Samsung, Sunquest Information Systems, and Systelab Technologies. After grinding its way through five years of arcane processes with IT engineers, the new lab stand- ards promise a new era of open exchanges of data with plug-and- play connectivity among analysers, middleware and laboratory informa- tion systems. A key piece in this puzzle was the first milestone marked by the ICC, at the European Connectathon 2012 in Bern, Switzerland, when companies demonstrated a successful switch from serial cables for transmitting data to a transmission control pro- tocol (TCP) internet protocol (IP) communication port. Most lab instruments to that point, and many still today, were running on what some may remember as the clunky 9-pin printer cables that had to be screwed onto the back of a computer. In most cases laboratory results were being communicated at the extremely low-bandwidth rate of 9600 baud, for those who remem- ber what a ‘baud’ is. Now instru- ments can send data at the blistering speeds that TCP/IP allows. Thanks to the successful testing of the interoperability profile at the Connectathon 2015, in July, 2015 the Clinical and Laboratory Standards Institute (CLSI) said it had begun development of a standard on next generation in vitro diagnostic (IVD) instrument interface. The new standard, to be called AUTO16, based on the IICC/IHE work around the LAW profile, will improve IVD instrument connectiv- ity by defining an interface that is more consistent across instruments and leverages the faster connectivity protocols and network technologies. The Institute specifically high- lighted the deep work undertaken by the consortium of manufacturers with IHE to develop the necessary use cases, transactions, data flows, and Health Level Seven (HL7) mes- saging conventions and definitions. Additionally in July, the IICC work was boosted by an endorsement from the European Commission that selected 27 IHE Integration Profiles to be part of the eHealth European Interoperability Framework that can be referenced in public procure- ment tenders in Europe. Among the 27 is the LAW profile, and the specification of conform- ance to the LAW is one of the key endpoints among manufacturers for the work of the jointly sponsored IICC. According to Jonnaert, ‘LAW substantially reduces connectivity installation cost and time, improves integrity of patient data, and stand- ardises the data flow of IVD, which have been key pain points for labo- ratory customers for many years.’ ‘Using LAW for specifications in requests for proposals is certainly our expectation. It benefits the customer to do so, reducing complexity and unpredictability as it comes to large, multi-vendor laboratory projects,’ he said. ‘The plug-and-play dimension to this assures that connectivity and interoperability will become a negli- gible cost component.’ High-res image of 20,000 cells speeds far more than blood count… Bloodhound approaches fully digitised analysisA fully integrated haematology analyser with novel digital scanning capabilities – the cobas m 511 – can transform the work of lab technologists, John Brosky reports. With its innovative Bloodhound tech- nology, Roche Diagnostics is hot on the trail leading to full digitisation of laboratory analysis. Instead of the conventional tech- nique of smearing blood on a glass slide for analysis, the cobas m 511 uses a one-microlitre droplet to print a patient’s sample on the slide to a thickness of one cell using a principle comparable to ink jet tech- nology, and then stain the sample for study. Imaging the slide using four LED sources, the bloods cells are individ- ually assessed. There can be more than three million individual cells automatically counted on the slide and the digital assistant on-board the cobas m511 presents a high res- olution snapshot of each of 20,000 of them, images that can then be identified as platelets, red or white blood cells, counted, classified and categorise The results are produced in less than six minutes and presented on a Viewing Station for the technolo- gist in a standard format showing all complete blood count (CBC) parameters, a traditional five-part differential display and a reticulo- cyte count. Results for additional samples are produced at a rate of one per minute. The system also measures the mean corpuscular volume (MCV), the mean corpuscular haemoglobin (MCH) and uses multiple measure- ments to determine total haemoglo- bin concentration. Whenever the system detects cells that it cannot clearly identify, they are highlighted on the system’s viewing station for subsequent re- classification by the medical tech- nologist. Sorting is as rapid and familiar as working with any data worksheet and, according to Jan Hoogendijk, the International Business Leader for Haematology in the Roche Diagnostics division, the cobas m 511 algorithms can single out a subset of just a few individual cells from among the 20,000-cell sample to show, for example, cells with an inclusion. This could include cells that are infected with malaria. The new system integrates three instruments into one compact solu- tion, combining a digital morpho- logic analyser, cell counter and clas- sifier for a complete haematology result including morphology assess- ment. Requiring the mentioned low blood volume of just 30 microliters, it can perform a complete analysis of white blood cells, red blood cells and platelets. Every third tube moving through the central lab is a haematology sample, said Hoogendijk, and the cobas m 511 with Bloodhound is designed to allow medical technolo- gists to increase efficiency while processing a higher volume of tests and only highlighting for the tech- nologists cells of interest in a next- generation digital format. Presenting results comparing the analysis of the cobas m 511 with an established haematology system, Roche Diagnostics Chief Science Officer for Haematology, David Zahniser, showed a strong correlation and noted that the cobas m511 Bloodhound technology demonstrated ‘excellent repeatabil- ity with equal-to-or-better-than the published percentage of coefficient of variation (CV) of automated hae- matology analysers.’The new all- digital Bloodhound technology is transformative for haematology with capabilities for multispectral imag- ing at low and high-powered mag- nification and computing power to differentiate and assess size, shape, colour, and optical density for final morphology assessment. Imagine then, the potential, said Zahniser, who posed an open ques- tion for lab technologists: ‘What else can we learn from the morphologic analysis of each cell on the slide, and what will be the clinical value?’ Using Bloodhound technology, the cobas m 511 combines a digital morphology analyzer, cell counter and classifier into one streamlined instrument preparing, staining and analyzing microscopy blood smears. Copyright:Shutterstock/hxdyl NEC_AD_medical_MD322C8_strip_new-format_3.indd 114/08/1512:23

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