LabMedica International October 2016 by Globetech

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W O R L D ’ S C L I N I C A L L A B O R AT O R Y N E W S L E A D E R ISSN 1068-1760

Vol. 33 No. 6 • 10 / 2016

DAILY CLINICAL LAB NEWS

DNA Nanosystem Reduces Testing Costs ased in a novel way on the selfassembly forces between DNA complementary strands, researchers have developed a programmable nano-system that has now been applied in a proof-of-principle study on Ebola virus diagnosis. The nanomachine is based on “the magic of how DNA works,” said Erik

Proposed Standard List of Essential Tests to Improve Healthcare in Developing Nations imilar to the long-established Model List of Essential Medicines (EML) published by the World Health Organization (WHO), a parallel list of companion diagnostic tests has now been proposed to help improve capacity and quality of testing in developing nations. In developing nations many tests

are unavailable or doctors may not put much faith in them because of the state of their country’s testing labs. Some tests, such as for emerging viruses like Zika or Ebola, could make the difference in outbreaks, which can also quickly affect the rest of the world. In hopes of changing this situation towards better health

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Image: Courtesy of Stanford University Medical Center

Low-Cost Genetic Test To Distinguish Bacterial From Viral Infections

New Methods Detect Alzheimer's Early Onset ew methods to examine the brain and spinal fluid heighten the chance for early diagnosis of Alzheimer’s disease, with important implications for early detection of the disease, the choice of drug treatment, and the inclusion of patients in clinical trials. It has become increasingly clear that, if the disease is to be treated successfully, it must be detected early, perhaps even before symptoms are

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Genetic Test for Fatal Mitochondrial Disease esearchers have discovered disease-causing inherited mutations in the TMEM126B gene and developed a test providing rapid diagnosis of related mitochondrial disorders. Defects in TMEM126B cause problems with energy generation in muscles, and can lead to muscular weakness, blindness, fatal heart failure, liver failure, learning disability, diabetes, and seizures. There is currently no cure and affected children

pon identifying a set of seven relevant genes, a newly developed breakthrough rapid blood test may soon enable physicians to determine if a patient has a bacterial or viral infection.

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s diagnostic laboratories evolve to meet growing workloads in an increasingly challenging environment, a new immunoassay module offers high value through its flexibility, which allows for the efficient use of existing resources such as space, infrastructure and personnel.

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Global IVD Test Market Crosses $60 Billion Mark

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New Immunoassay Module Doubles Testing Capacity

he global in vitro diagnostic (IVD) test market is currently worth USD 60.5 billion and will continue to grow, though a moderate and gradual change is likely to be witnessed over the next five to ten years, as more opportunities are created in novel tests and growing regions, while the traditional categories and reliable large

markets face challenges. The global IVD test market will be driven by rising consumption of healthcare services, such as heart and cancer tests, among the growing population aged between 45 and 75 years in the industrialized world, as well as increasing health consciousness and Cont’d on page 33

Clinical News . . . . . . . . . 4-26 IFCC News . . . . . . . . . . . . . 27 EFLM Corner . . . . . . . . . . . 30 Product News . . . . . . . 12-26 Industry News . . . . . . . . . .33 International Calendar . . . 34 PUBLISHED IN COOPERATION WITH

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Proposed Standard List of Essential Tests to Improve Healthcare in Developing Nations cont’d from cover

globally, a team of experts has now put together a list of key tests that every country should strive to have available, with high quality standards. They provide a list of tests that syncs with WHO’s EML, which has guided spending to provide over 300 vital pharmaceuticals by government agencies, healthcare organizations, and charity groups worldwide. When a medicine makes it onto the list, it jumpstarts a global health funding mechanism to make get the medicines flowing to developing countries. A parallel Model List of Essential Diagnostics (EDL) proposed in the new paper could help optimize that spending. When performed correctly, these tests can help health teams figure out which of the EML medications a patient needs and at what dose, track response to treatment, and monitor for medication toxicity. “Efficient delivery of healthcare requires diagnostic testing,” said lead author Lee F. Schroeder, MD, PhD, assistant professor, University of Michigan Medical School, UM Health System (Ann Arbor, MI, USA; www.uofmhealth.org), “You can’t treat what you can’t test. This list includes the most critical tests for diagnosing conditions, monitoring drug effects and toxicity, reducing over-prescription of antibiotics, and enabling surveillance of infectious threats.” The team, including Timothy Amukele, MD, PhD, of Johns Hopkins University (Baltimore, MD, USA), compiled this first EDL by scouring expert databases on diagnostic testing to determine which tests are needed to support use of each medicine on the EML. The resulting list includes 147 essential laboratory tests in 57 categories. A single test can guide the use of many EML drugs. The paper includes a table of 19 test categories that can guide the use of 10 or more EML medicines, including the following. Accurate counts of different types of blood cells in a sample, which can directly affect use of 136 EML items. Accurate blood tests assessing liver toxicity, which can support use of 104 EML V

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labmedica.com EDITORIAL BOARD Graham Beastall United Kingdom Claus Christiansen Denmark Hernán Fares Taie Argentina Bernard Gouget France Jocelyn M. Hicks United States Anders Kallner Sweden Tahir S. Pillay South Africa Christopher Price United Kingdom Andreas Rothstein Colombia Dmitry B. Saprygin Russia Rosa I. Sierra-Amor Mexico Gérard Siest France Peter Wilding United States Andrew Wootton United Kingdom A GLOBETECH PUBLICATION

Published in cooperation with the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and European Federation of Clinical Chemistry and Laboratory Medicine (EFLM). HospiMedica International • HospiMedica en Español • HospiMedica China LabMedica International • LabMedica en Español • LabMedica China Medical Imaging International • Bio Research International • Medimaging.net HospiMedica.com • LabMedica.com • BiotechDaily.com • TradeMed.com

drugs. Accurate blood tests for kidney function, which should be used in conjunction with over 80 EML items. Standardized use of microscope-based diagnostic tests, which can guide best use of 85 essential medicines, most aimed at treating and preventing infectious disease. Urinalysis, when performed well, can monitor the use of 64 EML drugs. Tests that detect DNA signatures from an infectious microbe, or that isolate and grow that microbe from a patient sample, can make a difference in outbreaks and in the use of 62 EMLs. “Many developing countries have high quality central public health labs in large cities; the missing piece in global health is a network of smaller, but still high quality, labs throughout the country,” said Prof. Schroeder. Poor test quality, or inappropriate storage of testing materials, can erode doctors’ trust in results. In fact, a recent literature review by the WHO identified multiple studies reporting that 2-10% of HIV-diagnosed patients in the developing world may not have ever been infected by HIV. These misdiagnoses were based on inappropriate use of diagnostic testing. In a recent study, Schroeder, Amukele, and colleagues at a hospital that Johns Hopkins runs jointly with Makerere University in Kampala, Uganda, evaluated diagnostic test availability in that city. While 822 labs offered malaria testing, only 5 offered testing essential to long-term management of diabetes and avoidance of complications such as blindness, amputation, and kidney failure. While it will take time and resources to ensure that developing nations have high quality testing capability for even some of the essential diagnostics, Prof. Schroeder predicts that it will prove cost-effective in the long run. “The EML is probably the single most important tool in global health,” he said, “We believe a list of essential diagnostics is long overdue and could amplify the impact of current global health investment.” The team plans further research on the topic and hopes to encourage the global health community to embrace implementation of the idea. The study, by Schroeder LF et al, was published June 30, 2016, in the New England Journal of Medicine. Image: Experts have proposed the first Model List of Essential Diagnostics (EDL), a list of key companion diagnostic tests that every country should strive to have available, with high quality standards. The list would help guide the use of medicines on the WHO’s Model List of Essential Medicines (EML) (Photo courtesy of University of Michigan Health System).

Dan Gueron Joseph Ciprut Raymond L Jacobson, PhD Jacqueline Miller, PhD Andreas Rothstein Gerald M Slutzky, PhD Marcela Jensen Brenda Silva Paul Mills Doris Mendieta Dr. Jutta Ciolek Carolyn Moody Arda Turac Elif Erkan

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ISSN 1068-1760 Vol.33 No.6. Published, under license, by Globetech Media LLC; Copyright © 2016. All rights reserved. Reproduction in any form is forbidden without express permission. Opinions expressed are solely those of the authors, and do not represent an endorsement, or lack thereof, by the Publisher of any products or services. Teknopress Yayıncılık ve Ticaret Ltd. S¸ti. adına ˙Imtiyaz Sahibi: M. Geren • Yazı is¸leri Müdürü: Ersin Köklü Müs¸ ir Dervis¸ ˙Ibrahim Sok. 5/4, Esentepe, 34394 S¸is¸ li, ˙Istanbul P. K. 1, AVPIM, 34001 ˙Istanbul • E-mail: Teknopress@yahoo.com Baskı: Promat Web Ofset Tesisi • Orhangazi Mahallesi 1673. Sokak, No: 34 • 34510 Esenyurt, B. Çekmece • ˙Istanbul Yerel süreli yayındır. Yılda sekiz kere yayınlanır, ücretsiz dag˘ıtılır.

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New Methods Detect Alzheimer's Early Onset cont’d from cover

evident. Thus, there is a great need for reliable diagnostic methods so that treatment to slow or prevent the disease can begin as early as possible. Scientists at the Karolinska Institute (Solna, Sweden; www.ki.se) and their colleagues studied a population consisted of 243 subjects for whom Pittsburgh compound B imaging positron emission tomography (PiB PET) data and cerebrospinal fluid (CSF) data and samples were available. These were collected across seven European academic centers belonging to the Biomarkers for Alzheimer’s and Parkinson’s Disease (BIOMARKAPD) initiative. In addition, 13 with normal cognition were recruited from relatives and carers of patients. Apolipoprotein E (APOE) genotyping was performed in a subset of 106 subjects via polymerase chain reaction (PCR) of genomic DNA extracted from EDTA-anticoagulated blood. Subjects were classified as ε4 allele carriers or non-carriers. Amyloidβ42, total tau, and phosphorylated tau were measured using commercially available sandwich enzyme-linked immunosorbent assays (ELISAs) (INNOTEST, Fujirebio-Europe, Gent, Belgium; www. fujirebio-europe.com). Meso Scale Discovery electrochemiluminescence analyses (MSD, Rockville, MD, USA; www.mesoscale.com) and a novel mass spectrometry method for amyloid-β42 and amyloid-β40 were also performed. The scientists found that the best fit was achieved when the amyloid level in the brain was compared with the ratio between the levels of amyloid42 and amyloid40 in the spinal fluid. Given this finding, the team hypothesized that the forms of β-amyloid found in the brain and spinal fluid are not completely identical. While technical factors cannot be excluded outright as contributing to measured amyloid-β42 and amyloid-β40 levels in CSF assays, even when run in the same time and place, continued discordance using centrally re-analyzed samples suggests that biological factors are also at play. Agneta K. Nordberg. MD, PhD, a professor and the study coordinator said, “Interestingly, there was also a difference between the values measured in the brain and spinal fluid in a smaller group of patients. This may justify that, in some unclear cases, the diagnosis should include an amyloid PET scan to complement the cerebrospinal fluid sample. These findings are also important because it is increasingly common to perform amyloid-PET studies upon the inclusion of patients in new drug studies.” The study was published on July 7, 2016, in the journal Brain. Image: The Quickplex SQ 120 plate reader for electrochemiluminescence analyses (Photo courtesy of Meso Scale Discovery).

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Age Should Be Considered in Developing Diagnostic Assays

n a new study on breast cancer, blood test results have demonstrated age-related differences in Tumor-Associated Antibodies (TAAbs), showing for the first time age-related differences that should be taken into consideration when developing diagnostic

tests. Data and results from the study, by Provista Diagnostics, Inc. (New York, NY, USA; www.provistadx.com), were presented in a poster at the 2016 Miami Breast Cancer Conference (Miami Beach, FA, USA). The researcher team examined the TAAbs and Serum Protein Bio-markers (SPBs) of 492 women between the ages of 25–75 who received a BI-RADS 3 (probably benign) or BI-RADS 4 (suspicious) assessment upon diagnostic imaging. Age-related differences were found in the majority of individual protein biomarkers even when accounting for breast density and cancer prevalence. The data further suggests that age 50 serves as a strong guide to when TAAb expression changes may occur as hormone level changes associated with menopause may be a factor. “While there have been studies showing age being a factor in SPB expression, we believe this is the first study to examine whether there were age-related differences in the expression of TAAbs,” said lead investigator Kasey Benson, PhD, Provista. “This knowledge is extremely valuable as we continue to develop Videssa Breast – a blood-test that detects the presence or absence of breast cancer – for women of all ages.” Videssa Breast analyzes a patient’s SPBs and TAAbs and can improve detection of early breast cancer, irrespective of breast density. With the new results, Provista will now be able to produce two variations of Videssa Breast to account for agerelated changes in TAAbs. “The data allows us to produce bloodbased tests to provide accurate results regardless of age,” said Susan Gross, MD, Chief Medical Officer. Videssa Breast uses Provista’s patented ProteoMark technology that examines SPBs and TAAbs to detect breast cancer with high sensitivity and specificity. It is a proteomic test that analyzes blood for specific types of proteins emitted by cancer tumors. SPBs detection alone provides a high degree of certainty that cancer is present, but does not provide the evidence needed for typing. To provide specificity, Videssa Breast also measures the presence of TAAbs, involved in mounting an attack against the specific cancer cells. The unique signature of breast cancer TAAbs provides the certainty on cancer type. The combination of imaging (anatomical evidence) with a proteomic approach (biochemical evidence) offers a powerful detection model, and reduces the rate of both false negatives and false positives. Videssa Breast transforms breast cancer detection and brings clarity to imaging results. Image: The Videssa Breast diagnostic test provides accurate early detection and typing of breast cancers by combining anatomical evidence from imaging with evidence from its proteomics test for proteins released into the blood system by cancer tumors (Photo courtesy of Provista Diagnostics).

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Low-Cost Genetic Test to Distinguish Bacterial from Viral Infections cont’d from cover

Too often there’s no easy way to diagnose whether a patient’s illness is bacterial or viral or if there is any infection at all. “A lot of times you can’t really tell what kind of infection someone has,” said lead author Timothy Sweeney, MD, PhD, engineering research associate, Stanford, “If someone comes into the clinic, a bacterial or a viral infection often look exactly the same.” “The idea to look for a diagnostic test came from our previous paper in Immunity last year,” said senior author and team leader Purvesh Khatri, PhD, assistant professor, Stanford University Medical Center (Stanford, CA, USA; http://med.stanford.edu), “In that paper, we found a common response by the human immune system to multiple viruses that is distinct from that for bacterial infections. We wondered whether we could exploit that difference to improve the diagnosis of bacterial or viral infections. But we needed a gene signature consisting of far fewer genes for the test to be clinically useful.” The team used publicly available patient gene expression data to pinpoint 7 genes whose activity changes during an infection such that their pattern of activity can distinguish whether an infection is bacterial or viral. The 7-gene test is a vast improvement over earlier tests that look at the activity of 100s of genes. Because so few genes are involved, the new test will be cheaper and faster, while remaining accurate. A study in Nepal co-authored by assistant professor Jason Andrews, MD, revealed that only 5% of patients who received antibiotics actually needed them, said Prof. Khatri. The Nepalese patients got antibiotic treatment because the drug was cheaper than trying to figure out if they actually needed it. “If we really want to make a difference,” Prof. Khatri said, “our test has to be more cost-effective than the drug itself.” That’s an important breakpoint. The work is part of a global response to the need to reduce the use of antibiotics, driven in part by President Obama’s National Action Plan for Combating Antibiotic-Resistant Bacteria. Besides promoting evolution of drug-resistant microbes, antibiotics increase the risk of side effects such as tendon rupture or kidney damage, and can damage gut and other microbiomes essential to overall health. The new test for bacterial infection faces two main hurdles before it can be made clinically available. First, it must be thoroughly tested in a clinical setting. Until now, the data and test results for this ongoing work have all come from preexisting, online digital data sets of gene expression from patients with different kinds of infections – not from current patients. The new study tested the 7-gene test on blood samples from 96 critically ill

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children, using a NanoString assay, and found that the test was accurate. This is a proof-of-concept but needs to be further validated in larger numbers of patients. Second, the test needs to be incorporated into a device that can give a result in up to 1 hour. The preliminary NanoString version of the blood test takes 4-6 hours, rapid but too long for critically ill patients who, for example, have sepsis. So the researchers are working on a way to engineer the test to provide results in under an hour. The plan is to combine an 11-gene test (that they recently created a few months ago) with the newer 7-gene test. The 11-gene test reveals if the patient has an infection

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at all. If they do have an infection, the 7-gene test reveals if it is bacterial or viral. Both tests would be run simultaneously. The researchers envision the two tests as a decision tree. “When you put the new 7-gene set together with the 11-gene set, we can make a decision tree that matches how a physician might think about a patient,” said Dr. Sweeney, “First we ask, ‘Is an infection present?’ Because some people present with an inflammation, a fever, a high heart rate, but it’s not due to an infection. Then we ask, ‘If so, what kind?’” The study, by Sweeney TE et al, was published July 6, 2016, in the journal Science Translational Medicine.

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FDA Approves Molecular Diagnostics Platform for Smaller Labs latest-generation molecular diagnostics platform due to be released to the clinical laboratory market in the near future has already been cleared for use by the [U.S.] Food and Drug Administration (FDA). The Luminex Corporation (Austin, TX, USA; www. luminexcorp.com) has announced the receipt of FDA clearance (510k) for the company’s new ARIES M1 System. Having been designed for lower throughput clinical labs, the ARIES M1 System is a fully integrated, sample to answer platform for performing real-time PCR assays. The ARIES system utilizes the Luminex proprietary MultiCode realtime polymerase chain reaction

(PCR), and multiplex PCR-based technologies. MultiCode products, which are used for the early detection of infectious diseases and genetic-based conditions, are centered on the unique MultiCode bases, isoC and isoG. The synthetic isoC:isoG DNA base pair differs from the naturally occurring base pair in its hydrogen bonding pattern. As a result, the MultiCode bases, isoC and isoG, can only base pair with each other. This property enables site-specific incorporation of the isobases during amplification. The isoC and isoG MultiCode bases form the building blocks for Luminex’s next generation MultiCode assays for nucleic acid-based testing. The ARIES instrument uses inter-

nal barcode scanning and other advanced features to minimize operator errors. Two independent modules each support from one to six cassettes, allowing for both STAT and batch testing. An integrated touch screen PC eliminates the need for a separate computer, stand-alone keyboard, and mouse; thus maximizing valuable bench space. The low throughput ARIES M1 System provides one module with the ability to run one to six different assays according to the ARIES Universal Assay Protocol. “In developing the ARIES family of

systems, we listened closely to the needs of our customers and crafted these products to increase laboratory efficiency, ensure result accuracy, and fit seamlessly into today’s lean laboratory. We are now adding another system based on customer feedback, and in doing so, expanding our market reach,” said Homi Shamir, president and CEO of Luminex. Image: The ARIES systems are crafted to increase laboratory efficiency, ensure result accuracy, and fit seamlessly into today’s lean laboratory (Photo courtesy of Luminex).

DNA Nanosystem Reduces Testing Costs cont’d from cover

R. Henderson, professor, Iowa State University (Ames, IO, USA: www. iastate.edu). Prof. Henderson and former student Dr. Divita Mathur developed the system and its first application: genetic detection of Ebola virus. Such a machine would prove valuable in the developing world, where access to diagnostic medical equipment can be rare. This nanotechnology could be fabricated cheaply and deployed easily. In conjunction with a smartphone app, it could be used independently of traditional medical facilities to detect Ebola or other pathogens and diseases. The trick lies in understanding the rules that govern how DNA works, said Prof. Henderson, “It’s possible to exploit that rule set in a way that creates advantages for medicine and biotechnology.” The researchers harnessed DNA hybridization forces so that the components of the nanomachines, once added to water and then heated and cooled, find each other and assemble correctly without further effort from the individual deploying the machines. More technically, they harnessed the difference in persistence length LINKXPRESS COM

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(“rigidity”) of single-stranded and double-stranded DNA to elicit a defined physical state change in a selfassembling DNA nanosystem, a platform they call OPTIMuS (Oligo-Propelled Technology for Interrogating Molecular Systems). This inducible state change can be used to interrogate user-programmed molecular interactions within OPTIMuS. In this study they showed how OPTIMuS can be used to detect a soluble target molecule and assess the relative strength of a non-covalent (base stacking) molecular interaction. They employed an embedded photonic system that tests for the presence of the target molecules, where upon detection the photonic system flashes a light, which can be read with a fluorometer. This sort of technology could be modified to detect other pathogens and other kinds of molecules. Prof. Henderson also envisions development of similar nanomachines that would encapsulate medication for targeted delivery. The study, by Mathur D & Henderson ER, was published online June 7, 2016, in the journal Scientific Reports. LabMedica International October/2016

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Genetic Test for Fatal Mitochondrial Disease cont’d from cover

affected children often die in early infancy. A team of medics and scientists at Wellcome Trust Centre for Mitochondrial Research, Newcastle University (Newcastle, Tyne & Wear, UK; www.ncl.ac.uk), together with international collaborators identified the mutations and used next generation sequencing (NGS) to develop the test, which provides a result within 2-3 days. Their research confirmed the identity of a mutation in TMEM126B that causes mitochondrial disease affecting Complex I, one of five complexes involved in energy production. TMEM126B normally makes a protein necessary for complex I assembly. First author Charlotte Alston, PhD student, described the technique, which has already identified 6 patients from 4 families affected by this form of mitochondrial disease: “Identifying a fault in Complex I [...] combined with our custom gene capture and the latest sequencing technology means we can screen many more genes to diagnose this debilitat-

ing disease. It means families can get a rapid diagnosis within days rather than the weeks and months that testing can currently take. For families who are waiting on a genetic diagnosis before trying for another baby, or they may already be expecting their next child, time really is of the essence.” Senior author Professor Rob Taylor said: “The diagnosis of mitochondrial disease is often a complicated and time consuming process. There are over 1,300 potential genes that can lead to disease and, as such, finding the genetic cause is sometimes like looking for a needle in a haystack.” For a family with one child affected with this type of mitochondrial disease, there is a 25% chance of each further child being affected. Professor Taylor added: “There is sadly no cure for mitochondrial disease so rapid diagnosis means parents who are wanting to have further children can opt for prenatal testing to ensure future children are healthy and without risk of developing severe disease. It provides options for families at risk of an

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otherwise incurable disease.” The study, by Alston CL et al, was published July 7, 2016, in the American Journal of Human Genetics. Image: Mitochondria. Researchers have inherited mutations in the TMEM126B gene that cause debilitating and often fatal disease from infancy, and have developed a rapid diagnostic test that has already identified 6 patients from 4 families (Image courtesy of Newcastle University).

New Immunoassay Module Doubles Testing Capacity cont’d from cover

The module is designed for maximum consolidation at a high throughput, continuous operation and, at the same time, it reduces the amount of waste generated, for more environmentally friendly testing and is now available for countries accepting the Conformité Européene (CE) Mark. The cobas e 801 module (Roche Diagnostics, Basel, Switzerland; www. roche.com) almost doubles the currently available immunochemistry testing capacity on the same footprint. The system only requires a low sample volume, offers an extensive assay menu and delivers fast, reliable and consistent patient results across systems. This benefits patients and healthcare professionals by providing the accurate and timely results needed to make the correct treatment decisions. The cobas e 801 module is the newest member of the cobas 8000 modular analyzer series. It offers more than 100 immunoassays, across a wide range of disease areas. Up to four cobas e 801 modules can be configured in series, delivering up to 1,200 tests per hour across up to 192 reagent positions. The possible turn-around times for routine and emergency samples are the lowest available on the central laboratory market, with 18 minutes for routine and nine minutes for emergency tests, for instance with cardiac markers. The small sample volumes required for testing are especially beneficial for critical patients, such as neonates and oncology patients. The cobas e 801 module uses the well-established Elecsys technology. The cobas e 801 allows for continuous loading of reagents and consumables and has a high uptime while requiring less hands-on time. Roland Diggelmann, MBA, the CEO Roche Diagnostics, said, “Today, laboratories need to deliver more diagnostic tests than ever before, while in many cases their resources are constrained. The cobas e 801 module is an important part of Roche’s connected laboratory solutions that allows laboratories to test efficiently and to sustainably grow their testing capacity.” LabMedica International October/2016

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Tissue Biomarker Identified for Dementia With Lewy Bodies ccurate diagnosis of Parkinson’s disease, and the related disease “dementia with Lewy bodies,” can be difficult in the early stages of both conditions. While brain biopsies can be more accurate, the risk of complications has been considered too high. A biopsy of the submandibular gland can help identify the same pathology that is seen in the brain, providing some of the increased accuracy of brain biopsy, but not the increased risk. It has previously been reported, from autopsy and needle biopsy, that there is a high prevalence of submandibular gland synucleinopathy in Parkinson’s disease (PD). Scientists at Banner Sun Health Research Institute (Sun City, AZ, USA; www.bannerhealth.com) and their colleagues studied 228 autopsied histological specimens including those with Lewy body disorders included 46 with Parkinson’s disease, 28 with dementia with Lewy bodies (DLB), nine with incidental Lewy-body disease, 33 with Alzheimer’s disease with Lewy bodies, and two with progressive supranuclear palsy with Lewy bodies (PSPLB). Control subjects, defined as individuals without centralnervous-system Lewy-type synucleinopathy (LTS), included 79 normal elderly subjects, 15 with Alzheimer’s disease, 12 with progressive supranuclear palsy, two with corticobasal degeneration and two with multiple system atrophy (MSA). Submandibular gland sections from autopsied subjects were stained with an immunohistochemical method for α-synuclein phosphorylated at serine 129. The investigators found submandibular gland alpha-synuclein pathology in 42/47 (89%) of autopsies of individuals with Parkinson’s disease and 20/28 (71%) of those with dementia with Lewy bodies, but in none of the 110 control subjects. The authors concluded that their results provide support for further clinical trials of in vivo submandibular gland diagnostic biopsy for PD and DLB. The study was published on March 30, 2016 in the Journal of Parkinson’s Disease.

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PRODUCT NEWS REFRIGERATORS/FREEZERS

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SUSCEPTIBILITY TEST DISCS

IMMUNOASSAY POCT ANALYZER

Helmer Scientific

Mast Group

Sugentech

The i.Series line offers the i.C3 Information Center door-mounted, touch-screen interface with constant temp monitoring and control. The line allows the customization of drawer, shelf, and basket combinations and locations, enabling improved inventory control and operational efficiency.

The ceftolozane/tazobatam 30/10 (C/T40C) test discs are intended to assist in the treatment of various infections. The discs are conveniently available in a stock cartridge format, with each pack containing 5 x 50 discs and compatible with Mast’s new DiscMaster 4 dispenser (MDD64).

The INCLIX quantitative immunoassay POCT analyzer facilitates automatic detection of various biomarkers with high accuracy and sensitivity. It also offers a user-friendly touch screen interface, built-in thermal printer, efficient data management, and remote access for after-sales support.

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Biomarker Predicts Breast Cancer Risk in Asymptomatic Women biomarker has been identified that may allow clinicians to predict the risk of an asymptomatic woman eventually developing breast cancer. To identify this disease indicator, investigators at Harvard Medical School (Boston, MA, USA; www.med.harvard.edu) studied the association between breast cancer risk and the frequency of mammary epithelial cells expressing the proteins p27 (Cyclin-dependent kinase inhibitor 1B), estrogen receptor (ER), and Ki67 (Marker of proliferation Ki67) in normal breast tissue from 302 women (69 breast cancer cases, 233 controls) who had been initially diagnosed with benign breast disease. Immunofluorescence assays for p27, ER, and Ki67 were performed on tissue microarrays constructed from benign biopsies containing normal mammary epithelium and scored by computational image analysis. Results revealed that the frequency of Ki67+ cells was positively associated with breast cancer risk among premenopausal women. Conversely, the frequency of ER+ or p27+ cells was inversely, but not significantly, associated with subsequent breast cancer risk. Notably, high Ki67+/low p27+ and high Ki67+/low ER+ cell frequencies were significantly associated with a five-fold higher risk of breast cancer compared with low Ki67+/low p27+ and low Ki67+/low ER+ cell frequencies, respectively, among premenopausal women. “Currently, we are not able to do a very good job at distinguishing women at high and low risk of breast cancer,” said senior author Dr. Rulla Tamimi, associate professor of epidemiology at Harvard Medical School. “By identifying women at high risk of breast cancer, we can better develop individualized screening and also target risk reducing strategies.” The study was published in the April 1, 2016, issue of the journal Cancer Research.

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LabMedica International

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On-the-Go Microfluidics Device May Improve HIV/HCV Diagnostics esearchers have created the first paperbased electrochemical immunosensing platform for rapid, inexpensive, point-ofcare (POC) diagnosis of human immunodeficiency virus (HIV) and Hepatitis C virus (HCV) co-infections with broader multiplexing range and higher sensitivity than currently available antibody tests. An estimated one-third of people with HIV/AIDS are co-infected with HCV. While rapid POC tests are available, they tend not to be affordable or accurately quantify marker concentrations, which help determine stage of infection. The new portable platform, developed by researchers at McGill University (Montreal, QC, Canada; www. mcgill.ca) for diagnosing HIV/HCV co-infection within serum samples, includes an electrochemical microfluidic paper-based immunosensor array (EμPIA) and has multiplexing ELISA and telemedicine capabilities. “Our experimental setup consists of a paper device with 8 electrochemical biosensors – for handy, one-time, disposable use – and a custom-made, handheld electrochemical reader, or potentiostat, to keep costs as low as possible,” explained Prof. Xinyu Liu, “It enables 8 [simultaneous tests]: 4 for HIV antibodies and 4 for HCV antibodies,” which makes the test broader than existing HIV and HCV point-of-care tests. When assessing sensitivity with spiked mouse serum samples, the device could detect HIV and HCV antibodies at 300 pg/mL and 750 pg/mL, respectively – values lower than available antibody tests. To run a test, the paper device is simply inserted into a slot on the potentiostat, and microliter drops of serum sample and reagents are added to each biosensor. Pressing a button triggers the electrochemical measurements. The device is compat-

ible with internet-based and mobile network-based e-health systems. Data from the 8 tests can be directly displayed on an LCD screen of the potentiostat or transmitted to a smartphone or personal computer and then to a remote site – a centralized laboratory or hospital – for diagnoses. The researchers tested for potential cross-reaction between the HIV and HCV antibody tests and found no significant interference, demonstrating “that our diagnostic platform shows great potential for diagnosing HIV/HCV co-infections in real patient samples,” said Prof. Liu. The main advantage offered is the ability to run 8 tests for HIV and HCV in parallel within 20 minutes with high accuracy, sensitivity, and specificity. Beyond this, the “handheld multiplexing potentiostat makes the entire electrochemical platform portable and significantly improves its adaptability to POC applications,” explained Prof. Liu. The next step is to continue fine-tuning for practical

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use: “We’ll explore the stability of the paper device during long-term storage, and then begin real patient sample testing in Canada and Kenya,” he added. Given the wide applicability of electrochemical detection to many types of biomolecules, the platform “can be readily extended to the detection of other disease markers such as proteins, metabolites, ions, and nucleic acids,” added Prof. Liu, “Our long-term goal is to further extend the functionality of this diagnostic platform.” The study presenting the device design and testing, by Zhao C and Liu X, was published April 12, 2016, in the American Institute of Physics’ journal Biomicrofluidics. Image: A portable, paper-based microfluidic platform with multiplexing and telemedicine capabilities that may enable low-cost, POC diagnosis of HIV & HCV co-infections within serum samples (Photo courtesy of C. Zhao, McGill University).

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LabMedica International

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Dedicated Blood Culture Diagnostics Cartridge Set for CE-IVD Marketing Release n application cartridge for the dedicated identification of pathogens in blood cultures is set for CE-IVD market release. The Curetis N.V. (Holzgerlingen, Germany; www.curetis.com) Unyvero BCU Blood Culture Application Cartridge covers a broad range of diagnostic targets. These include 87 of the clinically most relevant pathogenic microorganisms, among them Gram positive and Gram negative bacteria, several fungi and atypical pathogens, as well as 16 related antibiotic resistance markers. The cartridge was introduced at the 26th European Congress of Clinical Microbiology and Infectious Diseases (EC-

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CMID) in Amsterdam (The Netherlands), April 8-12, 2016. While the blood culture cartridge will be available as a consumable for Curetis’ Unyvero System, it is also compatible with the two most common systems and bottle types in the industry – Becton Dickinson (Franklin Lakes, NJ, USA; www.bd.com) and bioMérieux (Marcy-l’Étoile, France; www.biomerieux.com) – as well as with other blood culture systems and bottles such as those produced by the Thermo Fisher Scientific (Milford, MA, USA; www.thermo scientific.com) subsidiaries Oxoid and VersaTREK. The Blood Culture Application

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Cartridge is the third Application Cartridge made for the Unyvero System. It follows the P55 Pneumonia Application launched in 2015 and the ITI Application for implant and tissue infections launched in 2014. “We are excited to start marketing the third Application Cartridge for our Unyvero Platform,” said Dr. Achim Plum, chief commercial officer at Curetis. “With over 100 diagnostic targets covered by the Unyvero BCU cartridge, we believe to have the broadest available panel for suspected blood stream infections

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that can be used with a wide range of routine blood culture systems. The new Unyvero application will provide physicians with timely, comprehensive and actionable information in situations where every hour counts for the patient.” Image: The Unyvero system boasts special operating software, corresponding accessories, and three different disposable cartridges for the detection of pneumonia, of implant and tissue infections, and of pathogens in blood cultures (Photo courtesy of Curetis).

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PRODUCT NEWS BLOOD GAS ANALYZER

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INFLUENZA A&B TEST

HEMATOLOGY ANALYZER

Instrumentation Lab

Roche Diagnostics

Ortho Clinical Diagnostics

The GEM Premier 4000 provides quantitative measurements of whole blood pH, pCO‚ÇÇ, pO‚ÇÇ, Na‚Å∫, K‚Å∫, ICA‚Å∫‚Å∫, glucose, lactate, hematocrit, and co-oximetry. With a throughput of 30 samples/hour, it offers quality management for RT automatic error detection and correction.

The cobas Influenza A/B and RSV nucleic acid test is a RT-PCR assay for the rapid in vitro qualitative detection and discrimination of Influenza A virus and Influenza B virus and respiratory syncytial virus RNA. It analyzes swab specimens, and is meant for use on the cobas Liat System.

The Ortho Vision automates the full range of immunohematology testing including serial dilutions for titration studies and selected cell panels. It provides responsive safety checks and balances to give blood bankers the ability to monitor every critical step in the automation process.

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Immunoassay Detects Severe Fever with Thrombocytopenia Syndrome Virus evere fever with thrombocytopenia syndrome (SFTS) is a tick-borne infectious disease with a high case fatality rate, and is caused by the SFTS virus (SFTSV) and the disease is endemic to China, South Korea, and Japan. The viral ribonucleic acid (RNA) level in sera of patients with SFTS is known to be strongly associated with outcomes and therefore virological SFTS diagnosis with high sensitivity and specificity are required in disease endemic areas. Scientists at the Japanese National Institute of Infectious Diseases (Tokyo, Japan; www.nih.go.jp) and their colleagues collected 63 serum samples from 55 acute phase patients suspected of SFTS in Japan. Viral gene detection by the quantitative reverse transcription polymerase chain reaction (qRT-PCR) and viral antibody detection by immunoglobulin G (IgG) enzyme-linked immunosorbent assay (ELISA) and/or indirect fluorescent antibody (IFA) were conducted to diagnose SFTS. From 55 patients, 34 of these were diagnosed as having SFTSV. The investigators generated novel monoclonal antibodies (MAbs) against the SFTSV nucleocapsid (N) protein and developed a sandwich antigen (Ag)capture enzyme-linked immunosorbent assay (ELISA) for the detection of N protein of SFTSV using MAb and polyclonal antibody as capture and detection antibodies, respectively. The Ag-capture ELISAs were read using an optical density at 405 nm (OD405) was measured against a reference of 490 nm using a Model 680 Microplate Reader (BioRad Laboratories Inc.; Hercules, CA, USA; www. bio-rad.com). The Ag-capture system was capable of detecting at least 350 to 1,220 50% Tissue Culture Infective Dose (TCID50)/100 L/well from the culture supernatants of various SFTSV strains. The study was published on April 5, 2016, in the journal Public Library of Science Neglected Tropical Diseases.

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PRODUCT NEWS DNA/RNA ANALYSIS SYSTEM

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ELISA READER

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QIAGEN

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The QIAxcel Advanced automates high-resolution capillary electrophoresis of up to 96 samples per run, and allows DNA fragment analysis of 12 samples to be performed in three minutes. It uses ready-to-run gel cartridges that reduce handling errors and eliminate the need for gel preparation.

The ELx800 automated reader offers a reading speed of 30 seconds, a working range from 400 to 750 nm (five filters) and a reading range from 0.000 to 3.000 Abs. It can store up to 55 different methods, and save up to eight microplate tests results in its memory.

The QUANTA-Lyser 4000 uses four probes that work independently to process up to 480 samples in less than five hours. It features two dual probes for rapid and complete washing after each incubation, along with bar code scanning, reagent tracking, and direct slide transfer to NOVA View.

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Uropathogenic Bacteria Linked to Deadly Disease In Preterm Infants ecrotizing enterocolitis (NEC) is an intestinal disease that afflicts about one in ten extremely premature infants and is fatal in nearly one-third of cases. The premature infant gut is believed to react to colonizing bacteria, causing damage to the intestinal walls and severe infection. An association has been described between necrotizing enterocolitis and a subset of Escherichia coli bacteria, called uropathogenic E. coli (UPEC) that colonize the infant gut. Scientists at the University of Massachusetts Medical School (Worcester, MA, USA; www.umassmed.edu) and their colleagues obtained stool samples from a cohort of 166 infants: 144 preterm and 22 that had been carried to term from hospitals in Cincinnati, Ohio, and Birmingham, Alabama. The team sequenced the infantsâ&#x20AC;&#x2122; stool and developed metagenomic analysis tools to identify the bacteria colonizing each infant. Previous work had already identified Enterobacteriaceae, a family of bacteria that includes E. coli, as potentially associated with NEC. The team singled out UPEC as the E. coli type most strongly linked to infants who developed NEC. In the study cohort, 27 of the infants developed NEC, all preterm. The disease was fatal in 15 of those cases. UPEC was found in 44% of the infants who developed NEC, compared to only 16% of the 111 infants who survived without developing NEC. Although the team did not address the question of where UPEC in an infantâ&#x20AC;&#x2122;s gut might originate, they did observe an association between vaginal delivery and death from NEC in these extremely preterm infants. Metagenomic multilocus sequence typing analysis further defined NEC-associated strains as sequence types often associated with urinary tract infections, including ST69, ST73, ST95, ST127, ST131, and ST144. The study was published on March 15, 2016, in the journal Cell Reports.

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LabMedica International

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New Nano-Biosensor for Rapid Detection of Viruses cientists have invented a compact, easy-to-use biosensor for rapid, sensitive detection of flu and other viruses by utilizing the optical method of upconversion luminescence resonance energy transfer (LRET). The new method, invented by researchers at the Hong Kong Polytechnic University (PolyU; Hong Kong; www.polyu.edu.hk), involves simple operational procedures that significantly reduce testing time from around 1â&#x20AC;&#x201C;3 days to 2â&#x20AC;&#x201C;3 hours, making it over 10 times quicker than traditional clinical methods. Furthermore, it is a low-cost test â&#x20AC;&#x201C; about 80% lower than traditional tests, and the technology can be widely used to detect different types of viruses. RT-PCR is expensive and time-consuming while the sensitivity for ELISA is relatively low. Such limitations make these methods difficult for use in frontline and on-site virus detection. This challenge paved the way for the researchers to develop a new biosensor based on the luminescent technique. The luminescent technique operates analogous to two matching pieces of magnet with attraction force. It involves the development of upconversion nanoparticles (UCNPs) conjugated with an oligo probe whose DNA base pairs are complementary with that of the gold nanoparticles (AuNPs) flu virus oligo. Given the complementarity, the two oligos undergo DNA-DNA hybridization. Upon being illuminated by a portable near-infrared laser pen, the UCNPs emit eye-visible green light while the AuNPs would absorb the green light. One can easily quantify the concentration of the targeted flu virus by measuring the decrease in green light intensity. Initially, the researchers used upconversion LRET for ultrasensitive virus detection in liquid-phase system. The team then further improved the sensitivity by using a solid-phased nanoporous membrane system (NAAO). As NAAO membrane consists of many hollow channels, it allows more space for oligo hybridization to take place, increasing sensitivity by over 10 folds compared to the liquid-phase system, based on detection using inactivated virus samples. The new biosensor does not require expensive instruments and sophisticated operational skills, and has sensitivity comparable to traditional clinical methods. In comparison to conventional downconversion luminescent technique, it causes low damage to genetic materials and does not induce background fluorescence. In addition, a complementary probe can be designed to target detection of any virus with known genetic sequence. In other words, the new method can be widely used for the detection of different types of viruses simply by modifying the UCNPs capture probe. The team will continue to enhance the biosensor for virus detection, including increasing sensitivity and specificity, and developing a matrix for multiplex detection of multiple flu viruses on a single testing platform. The related results have been recently published in the two nanomaterial research journals ACS Nano and Small.

Image: A novel nano-biosensor has been developed for lower-cost, rapid virus detection based on upconversion luminescence resonance energy transfer (LRET) technology and DNA oligo hybridization. Testing takes only 2-3 hours, about 10x faster traditional clinical methods (Photo courtesy of the Hong Kong Polytechnic University).

LabMedica International October/2016

Edited by Tahir Pillay MBChB, PhD, FRCPath(Lon), FCPath(SA)

NEWS

IFCC members may send news to: Tahir Pillay MBChB, PhD, Head, Dept of Chemical Pathology, Faculty of Health Sciences, University of Pretoria, Private Bag Bag x323, Arcadia, 0007, South Africa Tel: (27) 012-319-2114; Fax: (27) 012-328-3600; Email: enews@ifcc.org

Madrid IFCC General Conference at a Glance

Photo: The IFCC family at the Madrid General Conference

by Dr Bernard GOUGET, Chair IFCC General Conference, Chair, IFCC Nominations Committee, Counselor Public Health FHF n March 19-21 of this year, the IFCC organized the XII. General Conference in Madrid, Spain, under the slogan "Feeding the future of IFCC now!". We were grateful to welcome 273 leaders from across labs and academia plus 59 accompanying attendees, providing the oppportunity of reviewing the operational, scientific, and strategic management of the Federation in a collaborative and foresighted manner. We were joined this year by a large international community of scientists coming from 71 national societies, as well as students and young scientists and by 14 representatives from the industry. It was one of the biggest General Conferences in terms of number of participants. A survey was conducted, in collaboration with the IFCC office, to help the Federation for a better understanding of the scientific and educational needs and aspirations of the full members and partners, and to provide feedback on accumulated experience. We received 138 responses (out of a total 273) from the national representatives, chairs and members of functional units, corporate members, guests and speakers. 40% of respondents said that they participated for the first time at this IFCC-GC. The overall satisfaction rate was over 95%. We would like to say once again how grateful we are for the Greek speaker who gave an excellent lecture on Mediterranean diet, he helped us to digest the food! In addition of the board session, the event featured 18 plenary conferences, 12 training seminars, 3 round tables, numerous breakout discussions and networking opportunities covering various aspects of the IFCC strategic plan, and the progress and outcomes achieved by the IFCC functional units led by the divisions and the executive board. After the opening, the IFCC-EB Secretary chaired the EB session on the IFCC strategic plan and outlook for IFCC in the years ahead in terms of the financial situation. The IFCC President reported on the outcome of the SWOT analysis. He emphasized the need to

cont’d on page 28

IFCC OFFICE Via Carlo Farini 81, 20159 Milan, ITALY Tel: (39) 02-6680-9912 • Fax: (39) 02-6078-1846 E-mail: ifcc@ifcc.org • Web: www.ifcc.org Office Hours: 8.30-13.00 and 13.30-17.30 Staff Members: Paola Bramati, Silvia Cardinale, Silvia Colli-Lanzi

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NEWS cont’d from page 27

News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information

Madrid IFCC General Conference at a Glance

provide strategies for improving the crucial role of Lab Medicine in patient care, and the importance of quality and use of the IFCC's unique expertise in standardization. He stressed the fact that IFCC's future increasingly depends on the activity of the regional federations. The presidents of the six regional federations participating in the round-table were convinced of the value of the dialogue with the IFCC toward reinforcing collaboration and encouraging efficient communications. This is the reason why the regional presidents will be seated at the EB beginning with 2018. The IFCC President also wants to increase collaboration with other international organizations, clinical societies, and international stakeholders in healthcare, while inviting more young scientists to participate in the committees and WGs. The IFCC Treasurer recalled that in recent years, our scientific and educational activities have increased significantly, leading to a growth in related expenditures, while on the other hand the income of the IFCC has not kept pace. Financial difficulties are anticipated in 2016 due to the fact that no major conferences will be held during the year. In addition, improved results need to be achieved with the IFCC portfolio at the LGT bank, pursuant to the recent low performance. It was decided to lower our protfolio's risk exposure and develop protective measures against possible financial fluctuations. The CM-EB Representative highlighted the evolution of the IVD industry's ongoing support in accordance with new regulations and ethics codes -- changes that are bound to impact IFCC and the current business model

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of conducting conferences. The new Code of Ethical Business Practice, developed by MedTech Europe, that sets mandatory rules for the interaction of the IVD industry vis a vis healthcare professionals and organizations, becomes effective in January 2018 with regard to the sponsorship of conferences. Win-win partnerships have to be set up toward building an integrated continuum of services and collaborations. The future hybrid conference model presented during the CCC session raised a great deal of concern with regard to IFCC congresses, despite a potential of providing opportunities for increased interaction and revenues. During the three-day conference, the level of satisfaction with the plenary sessions (>96%) and interactive sessions (>79%) was very well balanced to allow for personal interaction during the breaks. The time devoted to questions and discussions was also satisfactory. Each division received a half-day session to discuss the hot topics and research programs chosen by the chairs. Clinical Effectiveness, Quality, Standardization and Harmonization Procedures were particularly appreciated, as well as the e-Academy Project, Distance Learning Programs and the Ethics Session. The choice of topics attracted the interest of the participants and most of the sessions were informative and excellent. Thank you again to the speakers for having agreed to repeat their talk three times for the interactive sessions. There is always a need to develop more "group discussions" and breakout brainstorming workshops to be conducted, and the results reported back to the GC audience for further

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deliberation. A large number of proposals and ideas have been submitted for the next General Conference, including: improving clinical lab performance through standardization and tracability, quality management and accreditation. Also valuable insight was gained on major technological advances and new tools -- selective robotics, nano/biosensors, POCT, genomics and other “omics”, precision medicine, oncology, microbiology, mobile health, ethics, big data, etc. The good news was the lack of criticism about travel and access to the venue. Clearly, choosing a venue next to a major international airport was a wise decision. Many cities from respondents to the survey were suggested for the venue of the next GC, mainly in Europe or in North and South America, or in the African or Asian Pacific regions. The current EB has a challenge in determining where and when to hold the next meeting. The EB has also to select someone to provide the leadership for the next GC. Among the most beneficial aspects of the General Conference, networking and knowledge gain were reported as key elements. More than 98% of the attendees consider this conference as an important and valuable event. The conference provided an in-

clusive environment and great opportunities for a better understanding of the structure and functioning of the IFCC, with the opportunity to meet face to face, to strengthen relations with the IFCC-EB members, the IFCC staff and colleagues, and getting an up-to-date and comprehensive picture of the IFCC. Feedback has been very positive on both the organization and the scientific content: very high level, quite the optimum. However, more visibility of the national representatives, more interaction with young scientists, more attention to developing countries, more discussion on the future of the profession, must be adequately addressed in the context of the evolution of Laboratory Medicine. It was a great pleasure to chair the XII. General Conference with the valuable support of the IFCC office. The 2016 GC provided a unique opportunity to immerse the IFCC community in a variety of managerial, scientific and educational experiences and to demonstrate that Laboratory Medicine is at the forefront of a fundamental transformation in healthcare. Thank you again for your encouraging comments. We truly valued your active participation and profound commitment to a strong and sustainable IFCC future!

2017 IFCC Awards: Call for Nominations by Prof. Howard Morris, Chair, IFCC Awards Committee, Chemical Pathology Directorate, SA Pathology Contributions in Molecular DiagnosFCC is proud to announce its Distintics - Sponsored by Abbott Molecuguished Awards for presentation at lar the IFCC Congress in October 2017, IFCC Distinguished Award for LaboDurban, South Africa. The IFCC disratory Medicine and Patient Care tinguished Awards will be conferred to Sponsored by Sekisui Diagnostic scientists and clinicians who work in IFCC-Robert Shaffer Award for Outclinical chemistry and laboratory medstanding Achievements in the Develicine or related disciplines to publicize opment of Standards for Use in Labtheir exceptional research and other oratory Medicine - Sponsored by contributions that have improved NIST-CLSI medical and healthcare, and to stimuIFCC Distinguished Award for Conlate and encourage other scientists to tributions to Cardiovascular Diagaccelerate their efforts in advancing nostics - Sponsored by HyTest clinical chemistry and laboratory medIFCC-Young Investigator Award icine. Sponsored by IFCC On behalf of IFCC and its Awards Nominations are welcome from the Committee, I am pleased to call for nominations for the following seven (7) President or National Representative of IFCC distinguished awards for presen- the nominees' national society, which tation at the IFCC Congress in October should be a full member of the IFCC. 2017, Durban, South Africa. These 7 Each nomination should contain (1) a awards for 2017 are listed below and a statement as to the reasons for nominamore detailed description of them in- tion, (2) a full CV of the nominees including the former honourees can be cluding a bibliography, and (3) other letters of support (optional). They should found clicking on www.ifcc.org IFCC-Henry Wishinsky Award for be sent to Ms Colli-Lanzi of the IFCC Distinguished International Services Office (colli-lanzi@ifcc.org). The closing date for receipt of nomi- Sponsored by Siemens IFCC Award for Distinguished Con- nations is 31 January 2017 Please do not hesitate to write to Ms tributions in Education - Sponsored Colli Lanzi or me (howard.morris@health. by Abbott Diagnostics IFCC-Abbott Award for Significant sa.gov.au) if you have any queries.

LabMedica International October/2016

News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information

NEWS

Shaping the Future of Laboratory Medicine Opportunities and Challenges for Laboratory Medicine Specialists in Modern Healthcare by Graham Beastall, Past President, IFCC, University of Glasgow; David Kinniburgh, Director, NAFCC, Alberta Centre for Toxicology, University of Calgary haping the Future of Laboratory Medicine’ is an IFCC policy, which is being implemented by the IFCC Executive Board. This article, the second of two, is an opinion paper written by two members of the IFCC Executive Board. It is addresses the second four of seven topics identified in laboratory medicine (LM) communities around the world. In each case there is a broad statement from which illustrative opportunities and challenges may be identified. A general comment is included for each area.

“S

Evidence Based Laboratory Medicine and Increasing Clinical Effectiveness: Statement. Evidence based laboratory medicine (EBLM) is being widely appreciated and adopted into clinical practice guidelines. There is a need to demonstrate that the appropriate use of LM services can increase clinical effectiveness and facilitate improved clinical outcomes. Opportunities: Provide training in EBLM at national level and be involved in EBLM studies; Participate in the preparation of clinical practice guidelines at national level and implementation at local level; Produce examples to demonstrate how LM can increase clinical effectiveness. Challenges: To blend adherence to EBLM rules with what may be achieved in practice; To obtain and use evidence to convince service users to change practice. Comment: LM specialists at local, national and international levels should practise EBLM and become familiar with the scientific and medical literature that provides evidence of the role and clinical effectiveness of appropriate laboratory investigations.

Research, Development and Innovation in Laboratory Medicine: Statement. Advances in understanding the genetic and molecular basis of disease are leading to new biomarkers and algorithms that need to be evaluated before being translated into clinical practice. Opportunities: Consolidate research, development and innovation as an integral component of the training of LM specialists; Use the scientific training of LM specialists to facilitate collaborative clin-

LabMedica International October/2016

ical and translational research; Encourage LM specialists to be coinvestigators in major research programmes. Challenges: To protect research time for laboratory scientists in an environment of financial constraint; To demonstrate the importance of innovation as part of modern healthcare. Comment: LM specialists are ideally placed to participate in collaborative research, especially translational research and service innovation. Research, development and innovation should be an essential element of the training of LM specialists.

Laboratory Medicine in Emerging Nations: Statement. Investment in healthcare is a priority for most emerging nations. The importance of quality laboratory medicine services is often under-appreciated. Opportunities: Promote the central role of LM in modern healthcare. Modest investment in equipment and staff for core services will have a huge impact on public health; Use external sources and e-learning opportunities to improve quality in LM services. Challenges: To introduce modern equipment to improve quality and service repertoire amid financial constraint; To introduce a career structure and training in LM to the standards and with the skills required to deliver modern laboratory services. Comment: Investment in improving the quality of LM services is an essential component of improving healthcare outcomes in emerging nations. Support materials are required to enable trained LM specialists to convince those responsible for policy and budget allocation.

Adding Value to Laboratory Medicine: Statement. LM specialists should add value to essential high quality results to enable data to be converted into knowledge for the benefit of users, patients and the public worldwide. Opportunities: Facilitate harmonisation of LM protocols, parameters and methods at national and international level; Promote the value of LM to local users, patients and the public; Utilise technology and innovation to enhance the clinical impact of test results;

Graham Beastall

David Kinniburgh

Demonstrate the value of LM to healthcare commissioners at national level. Challenges: To designate time and resources for identifying and promoting added value; To share examples of practice where

added value has been demonstrated. Comment: Adding value is a broad topic of growing importance with implications at local, national and international level. A future article for IFCC eNews will summarise the work of a collaboration between global LM organisations on ‘adding value’.

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EFLM CORNER

European Federation of Clinical Chemistry and Laboratory Medicine

Editor: Harjit Pal Bhattoa, MD, PhD, EuSpLM

FOREWORD his current issue of the EFLM News Corner presents a summary of a fruitful meeting of the British Association of Clinical Biochemistry and Laboratory Medicine in Warwick, UK. Paul Newland, Director of Publications and Communications & Company Secretary (ACB), highlights the most exciting moments at the Focus, 2016 in his report. Daniel Rajdl, Chair of the EFLM WG Distance Education and e-Learning, introduces the face-lifted new e-learning pages of the EFLM with a simple guide to access the different webinars. Additionally the upcoming webinars are also indicated. Please mark your calendar! MariaStella Graziani, Chair of the EFLM Communication Committee summarizes the papers published as far this year. It is an important summary and provides the reader with the important issues at a glance. Additionally she also announces the approved EFLM Strategic plan for the years 2016-2017. Merve Sibel Güngören, EFLM Working Group-Promotion & Publications, gives a summary of the EFLM Website Statistics for the period of January-July, 2016. It is interesting to note the growing popularity of the website with a very impressive number of visitors. Harjit Pal Bhattoa, MD, PhD, EuSpLM

Focus 2016, British Society’s Annual Meeting, Held in Warwick

by Paul Newland, Director of Publications and Communications & Company Secretary, The Association for Clinical Biochemistry & Laboratory Medicine he Annual Meeting of the Association of Clinical Biochemistry and Laboratory Medicine (ACB) was held on May 2016 in Warwick, the city of the famous Warwick castle and on the doorstep of Shakespeare’s birth place. As always the event was preceded by the trainees’ day, and this proved a useful and interesting day for our trainees. The following day, Focus 2016 was opened by the ACB President, Dr Gwyn McCreanor, and this together with the opening Foundation Award set the tone for the whole of the meeting. Professor Sattar gave us a superb review of novel insights into cardio metabolic diseases. For the first time at Focus, members had access to a mobile app, this meant that after each session, members and guests could rate the presentations and not surprisingly Professor Sattar’s lecture scored high, with comments such as “highly relevant”, “great speaker”, “really funny and engaging speaker”. Importantly this got the science in the conference off to a fantastic start What is important and the cornerstone for Focus meetings was the variety of sessions, you could mix and match and chose to attend broad ranging sessions each day, from sessions on education and training to molecular medicine. We were privileged to hear Professor Sir Stephen Bloom speak on Gut Hormones to treat diabesity. There were parallel session each day on topics such as Inflammatory Bowel Disease, Cancer, pre analytics, case studies and FiLM @Focus sessions exploring international perspective on Pathology delivery, and the implications for Pathology of Lord Carter’s review of productivity and efficiency. The ACB awards are an opportunity for specialists in training in laboratory medicine to showcase their work, and yet again this was a great session. The standard of presentation was exceptionally high and the scientific work being undertaken by our more junior members is of the highest quality. Warwick was an excellent venue in supporting the success of the exhibition. It was a compact and therefore an intimate venue that allowed members and guest to visit our corporate partners, enabling them to share their new products or discuss what exciting products or assays are on the way. It is fair to say that Focus 2016 was a huge success and carried the ACB tradition of providing members and guests with a scientific programme of the highest standard, coupled with a great opportunity to socialise with old and new friends alike. Focus 2017 is the next annual scientific meeting for the ACB which will be held in Leeds, the city of vibrant music and art culture.

LabMedica International October/2016

European Federation of Clinical Chemistry and Laboratory Medicine

EFLM CORNER

EFLM Website Statistics: January-July 2016 by Merve Sibel Güngören, EFLM Working Group-Promotion & Publications s our readers already know, EFLM is using a real-time logfile analyzer (AWStats) to get information about the use of EFLM website (www.eflm.eu). Website analytic data have been collected since October 2015. Grouped in the tables below you can find the main data obtained between January and June 2016 (average per month). Previously, 5-month data (Oct 15 – Feb 16) were published in the April issue of EFLM Corner. We did not observe any significant difference among the months. Every day, 82 single visitors on average from all over the world visit approximately 500 webpages of eflm.eu. In the first semester of 2016, visitors were mainly from Italy, USA and China. Besides the main page, the most visited page is the list of the forthcoming events. Apparently, the EFLM scientific activity (including the events under the EFLM auspices) is of great interest for many Laboratory Medicine professionals all over the Europe and beyond. EFLM is therefore encouraged in organising scientific meeting of high level to continue attracting the interest of an elevated number of colleagues. Among the most downloaded papers, two are from the EFLM WG on Preanalytical phase (901 and 368 times

in six months): this confirms the validity of the work the WG is carrying on in this relevant phase of the clinical laboratory workflow. The second most downloaded paper (858 times) is an educational paper from the Committee on Education and Training; the paper provides insights into how to validate the laboratory assays and to assess the quality of methods. The list of the most downloaded five files, includes two presentations from the Continuing Postgraduate Course in Clinical Chemistry and Laboratory Medicine; the elevated number of downloads (830 and 658 times) attests the interest in this long-lasting Course, aimed to offer continuing professional development to the attendees. The attention paid by the EFLM site visitors to this kind of papers encourages the Federation and its Working Groups to go on with educational activities mainly dedicated to the harmonisation of the different aspects of the total testing process in Clinical Laboratories. Stay updated and keep visiting eflm.eu periodically! We encourage the EFLM corner readership to send us (using the contact form of the site) their opinion and suggestions on how to improve the site and what they would like to see on the site: we are looking forward to hearing from you soon!

EFLM Strategic Plan for 2016-2017 Announced by MariaStella Graziani, Chair of the EFLM Communication Committee he EFLM Executive Board is delighted to announce the issuing of the EFLM Strategic Plan for 2016-2017 (www.eflm.eu section Downloads). The Plan has been approved by the EFLM National Societies and includes seven areas of action and eighteen strategic goals. All the EFLM functional units and the EFLM office are actively involved in the achievement of the goals that will be regularly monitored. The two year plan is particularly addressed in the amelioration of the relationships between EFLM and IFCC and its Regional Federations (goal n 4 and 16), UEMS (goal n 13), and its National Societies as well (goal n 12 and 15). Another pivotal goal is the organisation of the 2nd Strategic Conference. The EFLM Executive Board thanks all National Societies and EFLM Committee Chairs who contributed with ideas and expectations to the editing of the plan.

EFLM e-Learning Activities Offer More Appealing Interface by Daniel Rajdl, Chair of the EFLM WG Distance Education and e-Learning (WG-DE) FLM e-learning activities have recently based on free webinars on “most wanted” topics in Laboratory Medicine. In addition to live webinars, EFLM WD-DE provides processed recordings of these webinars. A recent rearrangement of the main EFLM e-learning page has been set up. “We tried to simplify the access to the available information for EFLM website users”, says Ralph Lichtinghagen, chair of Education and Training Committee. “I do hope that the easy accessibility of the recordings with table of contents could be appreciated by EFLM website visitors. The recordings allow to easily reviewing just parts of the presentation one is interested in”, he adds. Incoming webinars: Critical Values (October 2016); Heart failure (November 2016); Case reports in Hematology (December 2016); Biological variation (May 2017).

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EFLM CORNER EFLM Publications in 2016 by MariaStella Graziani, Chair of the EFLM Communication Committee welve papers have been published by EFLM functional units up to now this year; please find below the list. The papers are freely downloadable at the dedicated page of the EFLM website (www.eflm.eu/index.php/eflmpublications.html)

Guidelines & Recommendations Fasting is not routinely required for determination of a lipid profile: clinical and laboratory implications including flagging at desirable concentration cut-points - a joint consensus statement from the European Atherosclerosis Society and European Federation of Clinical Chemistry and Laboratory Medicine. Nordestgaard BG, Langsted A, Mora S, Kolovou G, Baum H, Bruckert E, et al. Eur Heart J; 2016;37:1944-58 A pivotal consensus, evidence-based document on the possibility to avoid fasting when determining a lipid profile. The document also contains precious indications on laboratory reports for lipids and lipoproteins. Positions & Opinion Papers Order of blood draw: Opinion Paper by the European Federation for Clinical Chemistry and Laboratory Med-

icine (EFLM) Working Group for the Preanalytical Phase (WG-PRE). Cornes M, van Dongen-Lases E, Grankvist K, Ibarz M, Kristensen G, Lippi G, et al. Working Group for Preanalytical Phase (WG-PRE), European Federation of Clinical Chemistry and Laboratory Medicine (EFLM). Clin Chem Lab Med. 2016 doi: 10.1515/cclm-2016-0426. In this opinion paper, EFLM WGPRE supports the continued recommendation of ensuring a correct order of draw for venous blood collection to prevent sample contamination that could cause erroneous results. Biomarker development targeting unmet clinical needs. Monaghan P, Lord SJ, St John A, Sandberg S, Cobbaert CM, Lennartz L, et al for the EFLM Working Group on Test Evaluation. Clin Chim Acta 2016;460:211-9 The checklist elaborated by the Working Group intends to achieve more efficient biomarker development and translation into practice. Criteria for assigning laboratory measurands to models for analytical performance specifications defined in the 1st EFLM Strategic

European Federation of Clinical Chemistry and Laboratory Medicine Conference. Ceriotti F, FernandezCalle P, Klee GG, Nordin G, Sandberg S, Streichert T, et al. on behalf of the EFLM Task and Finish Group on allocation of laboratory tests to different models for performance specifications (TFGDM). Clin Chem Lab Med 2016 DOI 10.1515/cclm-2016-0091 Following the 1st EFLM Strategic Conference on quality specification, this report lists a number of laboratory tests under the most appropriate model for analytical performance specifications (APS). Cardiac troponins, glucose, HbA1c, cholesterol are allocated under model 1 (APS based on clinical outcomes); electrolytes, minerals and creatinine are allocated under model 2 (APS based on biological variation). Patient identification and tube labelling â&#x20AC;&#x201C; a call for harmonisation. van Dongen-Lases E, Cornes MP, Grankvist K, Mercedes Ibarz M, Kristensen GBB, Lippi G, et al. on behalf of the Working Group for Preanalytical Phase (WG-PRE), European Federation of Clinical Chemistry and Laboratory Medicine (EFLM). Clin Chem Lab Med 2016;54:1141-5. This position paper raises awareness and provides recommendations for proper patient and sample identification procedures that are amongst the most critical steps in blood collection procedures that jeopardise the patient safety. EFLM WG-Preanalytical phase opinion paper: local validation of blood collection tubes in clinical laboratories. Lippi G, Cornes MP, Grankvist K, Nybo M, Simundic AM. Clin Chem Lab Med 2016;54:755-60. This consensus document provides a set of essential requisites, technical criteria and clinical issues for supporting laboratory professionals in organization blood collection tubes tenders and validating new devices before local routine implementation. Laboratory medicine in the new healthcare environment. Ferraro S, Braga F, Panteghini M. Clin Chem Med Lab 2016;54:523-33 The paper examines the role of laboratory medicine in the 21st century and points out how the awareness of the importance of clinical laboratories in the healthcare system should be reinforced. Reviews & Surveys How well do laboratories adhere to recommended clinical guidelines for the management of myocardial infarction: the CARdiac MArker Guidelines uptake in Europe study (CARMAGUE). Collinson P, Hammerer-Lercher A, Suvisaari J, Apple FS, Christenson RH, Pulkki K, et al on behalf of the EFLM Working Group for Cardiac Markers. Clin Chem 2016; 62:1264-71 The paper presents the results of a questionnaire about the use of cardiac

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biomarkers in Europe and North America: significant differences are observed due to assay availability and different laboratory practices. Is D-dimer used according to clinical algorithms in the diagnostic work-up of patients with suspicion of venous thromboembolism? A study in six European countries. Kristoffersen AH, Ajzner E, Rogic D, Sozmen EY, Carraro P, Faria AP, et al. for the joint EFLMEQALM Working Group on Postanalytical Phase (WG-POST). Thromb Res 2016;142:1-7 The survey explores how patients suspected of having venous thromboembolism (VTE) are investigated: the D-dimer is correctly requested only by 66% of physicians. These results should encourage scientific societies to improve the dissemination and knowledge of the current recommendations for the diagnosis of VTE The role of European Federation of Clinical Chemistry and Laboratory Medicine Working Group for Preanalytical Phase in standardization and harmonization of the preanalytical phase in Europe. Cornes MP, Church S, van Dongen-LasesE, Grankvist K, Guimaraes JT, Ibarz M, et al. Ann Clin Biochem 2016;53:539-47 The paper illustrates the work performed by the Working Group in Europe: as a result of the discussions at the third conference on preanalytical phase, five main areas of interest have been identified. These are: test ordering, sample transport and storage, patient preparation, sampling procedures and management of unsuitable specimens Quality Management and Laboratory Accreditation Accreditation process in European countries - an EFLM survey. Boursier G, Vukasovic I, Mesko Brguljan P, Lohmander M, Ghita I, Bernabeu Andreu FA, et al. on behalf of the Working Group Accreditation and ISO/CEN standards (WGA/ISO) of the EFLM. Clin Chem Lab Med 2016;54:545-51 The results of this survey on accreditation show that while there are several variations in the approaches to accreditation of medical laboratories in the European countries, the ISO 15189 accreditation project has been widely accepted. The use of a unique standard and the cooperation among countries due to scientific societies, EFLM, accreditation bodies and EA enable laboratory professionals to move toward uniform implementation of the accreditation concept. Standardisation & Harmonisation in Clinical Laboratories Harmonization initiatives in Europe. Ceriotti F. eJIFCC 2016;27:23-9 The paper illustrates the different initiatives the EFLM Working Group on harmonization initiated this year. The first areas considered were the pre- and post analytical phase. LabMedica International October/2016

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Industry News

Global IVD Test Market Crosses $60 Billion Mark contâ&#x20AC;&#x2122;d from cover

demand for quality medical care in the developing countries, which are witnessing improved income and standard of living. These are the latest findings of Kalorama Information, (New York, NY, USA; www.kaloramainformation.com), an independent medical market research firm. Currently, the demand for healthcare and diagnostic tests across all the major markets is being driven by an aging population and increased incidences of cancer, diabetes, cardiovascular disease, arthritis and obesity. The high growth countries, primarily Saudi Arabia, Brazil, China and India, are witnessing a double-digit growth,

fueled by privatization and health insurance initiatives by governments and employers. The rising demand from a growing middle class population in Brazil, India and China is being further supported by international initiatives such as the Clinton Foundation and the Gates Foundation that have begun developing treatment programs for infectious diseases like TB, HIV, malaria, and sexually transmissible diseases. All this is creating a market for test devices for diagnosing and monitoring the treatment efficacy of these diseases and other infectious diseases. A number of IVD companies have witnessed an increase in their revenues by entering into partnerships with

IL Acquires Swiss Critical Care Blood Testing Concern nstrumentation Laboratory (IL) (Bedford, MA, USA; www.ilus.com), which manufactures instruments and reagents for the global hemostasis market, has acquired CA Casyso AG (Basel, Switzerland) and its Tem subsidiaries (Tem), a provider of in vitro diagnostic (IVD) testing for patient blood management (PBM). CA Casyso AG is the parent company of Tem Innovations, Tem International and Tem Systems, while IL is a part of the Werfen family of companies. Tem manufactures Rotem whole blood analyzers, which detect coagulopathies in hospital trauma and surgical patients with clinically significant bleeding to allow treatment with targeted therapy, thereby minimizing or preventing massive bleeding and hemorrhagic shock. The acquisition of CA

Casyso AG and Tem will allow IL to complement and expand their leadership in hemostasis and critical care IVD through the product line in viscoelastic testing. "A passion for innovation, leading systems and extensive knowledge in PBM, make Tem a perfect complement to our focus, commitment, and leadership in Hemostasis and Critical Care IVD," said Ramon Benet, CEO at IL. "IL and our global Werfen organizations are ideally positioned to maximize the potential of the Rotem product line, which intersects our existing business and presents synergies in our core competencies and customer call points. Most importantly, Rotem systems share the same ultimate benefit of all our products â&#x20AC;&#x201C; to help customers reduce overall hospital costs, while improving patient care."

Beckman Parent to Acquire Cepheid for USD 4 Billion anaher Corporation (Washington, D.C., USA; www. danaher.com) will acquire Cepheid (Sunnyvale, California, USA; www.cepheid.com) by purchasing all of the companyâ&#x20AC;&#x2122;s outstanding shares, for a total enterprise value of approximately USD 4 billion, including indebtedness and net of acquired cash. Cepheid develops, manufactures, and markets molecular systems and tests, and has the largest global installed base of instruments as well as the broadest test menu in molecular diagnostics. The company will now become

LabMedica International October/2016

part of Danaher's USD 5 billion Diagnostics segment, joining the company's Beckman Coulter, Leica Biosystems and Radiometer businesses. Danaher's President and CEO, Thomas P. Joyce, Jr., said, "We expect Cepheid to be an excellent complement to our existing diagnostics businesses and to expand our runway for growth across the platform. Cepheid's extensive installed base, test menu and innovative product offering contribute to its market leadership in molecular diagnostics and we expect it to strengthen our position in this high-growth segment."

these organizations. In the U.S., new healthcare disease screening and health insurance initiatives proposed by the new administration under the guidance of President Barack Obama is further encouraging the use of IVDs, though continued economic difficulties is making Americans forgo elective procedures as the co-payments are somewhat unaffordable. The lack of trained lab technologists required to run the more complex new set of molecular and histological tests and immunoassays has led to a proliferation of sophisticated tests and lab automation tools in hematology, blood banking, microbiology, and histology. Further, the revolution in bioinformatics is allowing clinical and traditional medical engineering to blend with components derived from the telecommunications, information and computer sciences industries, thereby opening new niche markets for POC test devices, which will have a positive impact on diagnostic testing. Since getting information to care givers and patients has now become a prerequisite of all lab operations, the healthcare industry will increasingly focus on informatics, wireless communica-

tions, data networking and cost/effective healthcare delivery over the next 3-5 years. Going forward, a modest IVD growth is expected in the developed countries and a stronger IVD growth in the developing countries, along with the shift in focus from infectious diseases to chronic conditions. The IVD industry is expected to be shaped by long-term trends such as biomarker discovery and the use of newer technologies like next generation sequencing. The use of genetic factors for evaluating patients at risk for diseases is still developing. The link between genes and disease risk provides an ongoing market opportunity for IVD research and product development in cancer, autoimmune diseases, cardiac conditions, allergy, diabetes, psychiatric conditions and others. Also, the IVD market is expected witness a shift from blood sampling to breath tests for respiratory infections, gastrointestinal disorders, cancer and even chronic diseases. A number of wearable patch sensors have already been commercialized for glucose and vital signs monitoring, while more applications are under development.

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OCTOBER 2016 BCLF 2016 - 24th Meeting of Balkan Clinical Laboratory Federation. Oct 1-4; Tirana, Albania; Web: www.bclf.info 40th European Congress of Cytology. Oct 2-5; Liverpool, UK; Web: www.britishcytology. org.uk BCLF 2016. Oct 5-7; Tirana, Albania; Web: www.bclf2016.org Analytica China. Oct 10-12; Shangai, China; Web: www.analyticachina.com EQALM Symposium 2016. Oct 13-14; Barcelona, Spain; Web: www.eqalm.org 48th National SIBioC Congress – Laboratory Medicine - The Patient’s Central Role between Laboratory and Clinical Practice. Oct 18-20; Turin, Italy; Web: www.congresso.sibioc.it ASHG 2015- The American Society of Human Genetics. Oct 18-22; Vancouver, Canada; Web: www.ashg.org Joint Meeting of the “3rd Congress on Controversies in Thrombosis & Hemostasis” together with the “8th Russian Conference on Clinical Hemostasiology and Hemorheology". Oct 20-26; Moscow, Russia; Web: www.cith2016.ru International Conference "Towards Performace Specifications for the Extra-Analytical Phases of Laboratory Testing”. Oct 27; Padova, Italy; Web: www.lccongressi.it/ laboratorymedicine2016

outcomes. Nov 9-11; Leiden, The Netherlands; Web: www.eflm-test-evaluation-course. eu Association for Molecular Pathology (AMP) Annual Meeting 2016. Nov 10-12; Charlotte, NC, USA; Web: www.amp.org MEDICA 2016. Nov 16-19; Dusseldorf, Germany; Web: www.medica.de 10th International Scientific Meeting of the Centre of Metrological Traceability in Laboratory Medicine (CIRME) “Ten Years After”. Nov 17-18; Milan, Italy; Web: http:// users.unimi.it/cirme/home WASPaLM 2016- 29th World Congress of Pathology. Nov 18-21; Las Vegas, NV, USA; Web: www.waspalm.org 14th Asia-Pacific Federation for Clinical Biochemistry and Laboratory Medicine Congress. Nov 26-29; Web: www. apfcbcongress2016.org

NOVEMBER 2016 EFLM Course on Test Evaluation, Developing medical tests that improve patient

FEBRUARY 2017 SLAS 2017 - Society of Laboratory Automation and Screening. Feb 4-8; Wash-

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ACBICON 2016 . . . . . . . . . . .35 Advanced Instruments . . . . . .27 APFCB 2016 . . . . . . . . . . . . . .33 BioFire . . . . . . . . . . . . . . . . . .23 Brand . . . . . . . . . . . . . . . . . . .25 Cellavision . . . . . . . . . . . . . . .36 EliTech Group . . . . . . . . . . . . . .2 DiaSys . . . . . . . . . . . . . . . . . .22 EKF . . . . . . . . . . . . . . . . . . . . .20 EliTech Group . . . . . . . . . . . . . .2 Erba . . . . . . . . . . . . . . . . . . . . .5 Erba . . . . . . . . . . . . . . . . . . . . .7 Euroimmun . . . . . . . . . . . . . . . .8 Fluid Metering . . . . . . . . . . . . .20 Focus Diagnostics . . . . . . . . .21 Hecht, Karl . . . . . . . . . . . . . . .16 LabMedica.com . . . . . . . . . . .10

124 117 – – 109 111 103 128 106 115 132 119 112 114 131 129 115

Linear . . . . . . . . . . . . . . . . . . . .4 Medica . . . . . . . . . . . . . . . . . .17 MEDLAB 2017 . . . . . . . . . . . .26 MEMBS 2016 . . . . . . . . . . . . .34 Mindray . . . . . . . . . . . . . . . . . . .9 Nova Biomedical . . . . . . . . . . .11 Randox . . . . . . . . . . . . . . . . . . .3 Rayto . . . . . . . . . . . . . . . . . . .28 Sciex . . . . . . . . . . . . . . . . . . . . .6 Sekisui . . . . . . . . . . . . . . . . . .13 SFRI . . . . . . . . . . . . . . . . . . . .32 SNIBE . . . . . . . . . . . . . . . .18-19 Stago . . . . . . . . . . . . . . . . . . .12 Stago . . . . . . . . . . . . . . . . . . .14 Sugentech . . . . . . . . . . . . . . .31 Vicotex . . . . . . . . . . . . . . . . . .29 Zivak . . . . . . . . . . . . . . . . . . . .15

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