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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. 34 No. 1 • 2-3/ 2017

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Method Indicates Efficacy of Immune Cells he frequency of pathogen-specific and tumor-specific T cells and their functional activity reflect the effectiveness of immune responses and can serve as useful diagnostic and prognostic indicators. The immune system orchestrates large and small scale attacks on innumerous targets: viruses, bacteria, cancer, but it also

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method to speed and simplify the detection of proteins in blood and plasma has been described opening up the potential for diagnosing the early presence of infectious diseases or cancer during a doctor’s office visit. The new approach overcame several key challenges in detecting proteins that are biomarkers of disease. First,

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these proteins are often at low abundance in body fluids and accurately identifying them requires amplification processes. The new test takes about 10 minutes as opposed to two to four hours for current state-of-the-art tests. Scientists at the University of California, Los Angeles (CA, USA; www.ucla.edu) devised an approach Cont’d on page 6

Image: Courtesy of Stanford University Medical Center

New Protein Test Offers Breakthough in Early Parkinson’s Diagnosis

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he majority of primary care patients referred for bowel endoscopy do not have significant colorectal disease (SCD), and are unnecessarily exposed to a small but realistic risk of severe endoscopyassociated complications.

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Simple Blood Test Vastly Improves Severe Liver Disease Detection

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new non-invasive method of predicting the risk of developing a severe form of liver disease could ensure patients receive early and potentially life-saving medical intervention before irreversible damage is done. Non-alcoholic steatohepatitis (NASH) is the most extreme form of non-alcoholic fatty liver disease (NAFLD),

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INSIDE

Fecal Blood Test Avoids Unnecessary Endoscopies

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uruli ulcer is a subcutaneous skin disease listed among the neglected tropical diseases. Early case detection and management is very important to reduce morbidity and the accompanied characteristic disfiguring nature of the disease. The diagnosis of Buruli ulcer (BU) is based on clinical evidence that can lead to misdiagnosis, and microbiological confirmation is essential to reduce abuse of drugs, since the

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Image: An illustration of the neurons in the brain of a person with Parkinson's

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esearchers have for the first time identified a fungus, Candida tropicalis, as a key factor in the development of Crohn’s disease in humans. They have also linked a new bacterium to the bacteria previously associated with Crohn’s. The groundbreaking findings could facilitate development of new treatments and ultimately cures for the debilitating inflammatory bowel disease. The study was conducted by an international

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Novel Method Diagnoses Buruli Ulcer

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novel real-time quakinginduced conversion-based assay offers a breakthrough in the early detection of Parkinson’s disease. Till now no definitive early test existed for the disease, which was traditionally diagnosed in the course of years by way of physical observations and neurological tests. See article on page 7

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Fungus Key Factor In Crohn’s Disease

Technique Speeds Up Detection of Infectious Diseases

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which is a range of conditions caused by a build-up of fat in the liver. With NASH, inflammation of the liver damages the cells, potentially causing scarring and cirrhosis. An international team working with the scientists at the Cardiff University (UK; www.cardiff.ac.uk) used Cont’d on page 8

Clinical News . . . . . . . . . 4-26 IFCC News . . . . . . . . . . . . . 27 Product News . . . . . . . 14-24 Industry News . . . . . . . . . .32 International Calendar . . . 34 PUBLISHED IN COOPERATION WITH

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Novel Method Diagnoses Buruli Ulcer

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labmedica.com EDITORIAL BOARD

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anti-mycobacterial drugs are also used for the treatment of tuberculosis. Scientists associated with the University of Ghana (Accra, Ghana; www.ug.edu.gh) developed a method to diagnose BU using aptamers that bind to the lipid particle mycolactone, which is produced by the causative agent Mycobacterium ulcerans. The team collected swabs and fine needle aspirations from 41 patients suspected of having BU. The samples were analyzed by polymerase chain reaction for the IS2404 sequence repeat, culture, and an enzyme-linked oligonucleotide assay (ELONA). Aptamers that bind to mycolactone were isolated by the systematic evolution of ligands by exponential enrichment (SELEX) process. To measure their affinity and specificity to mycolactone, the selected aptamers were screened by means of isothermal titration calorimetry. The ELONA assays measured at absorbance 450 nm using a MultiSkan Go plate reader (Thermo Scientific, Waltham MA, USA; www.thermofisher.com). The investigators found that five out of the nine selected aptamers bound significantly to mycolactone, of these, three were able to distinguish between mycolactone producing mycobacteria, M. marinum and other bacteria whilst two others also bounded significantly to M. smegmatis. Their dissociation constants were in the micro-molar range. Fourteen swab samples tested positive for both culture and IS2404 PCR whilst positivity observed among the aptamers ranged from one to seven. The aptamer-based assay was used in a case control study and had a sensitivity of 50% and a specificity of 100%.

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The aptamer-based test had a sensitivity of 50%, which is comparable to that of microscopy and culture, whilst the specificity is comparable to that of the IS2404 PCR. The authors concluded that their preliminary proof-of-concept indicates that diagnosis of Buruli Ulcer Disease with ribonucleic acid (RNA) aptamers is feasible and can be used as point of care upon incorporation into a diagnostic platform. The study was published on October 24, 2016, in the journal Public Library of Science Neglected Tropical Diseases.

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Fungus Key Factor in Crohn’s Disease cont’d from cover

research team, co-led by Mahmoud A Ghannoum, PhD, professor at Case Western Reserve University School of Medicine, (Cleveland, OH, USA; http:// case.edu/medicine) at University Hospitals Cleveland Medical Center. “We already know that bacteria, in addition to genetic and dietary factors, play a major role in causing Crohn’s disease,” said Prof. Ghannoum, “Essentially, patients with Crohn’s have abnormal immune responses to these bacteria, which inhabit the intestines of all people. While most researchers focus their investigations on these bacteria, few have examined the role of fungi, which are also present in everyone’s intestines. Our study adds significant new information to understanding why some people develop Crohn’s disease. Equally important, it can result in a new generation of treatments, including medications and probiotics, which hold the potential for making qualitative and quantitative differences in the lives of people suffering from Crohn’s.” Bacteria as well as fungi are present throughout the body; Prof. Ghannoum’s lab previously found that people harbor 9-23 fungal species in their mouths. In the new study, by analyzing fecal samples, the researchers assessed the mycobiome and bacteriome of: (a) 20 Crohn’s disease patients and 28 Crohn’s-free individuals from among their first-degree relatives in 9 families; and of (b) 21 Crohn’s-free individuals from 4 Crohn’sfree families. The results showed strong fungal-bacterial interactions in those with Crohn’s disease: two bacteria (Escherichia coli and Serratia marcescens) and one fungus

(Candida tropicalis) moved in lock step. The presence of all three in the Crohn’s patients was significantly higher compared to their healthy relatives, suggesting that the bacteria and fungus interact in the intestines. In vitro experiments showed that the three work together to produce a biofilm – which can prompt intestinal inflammation that results in the symptoms of Crohn’s disease. The researchers observed that E. coli cells fused to the fungal cells and S. marcescens formed a connecting bridge. This is first report linking a fungus to Crohn’s in humans; previously it was only found in model Crohn’s disease mice. The study is also the first to include S. marcescens in the Crohn’s-linked bacteriome. The researchers also found that the presence of beneficial bacteria was significantly lower in the Crohn’s patients, corroborating previous findings. “Among hundreds of bacterial and fungal species inhabiting the intestines, it is telling that the three we identified were so highly correlated in Crohn’s patients,” said Prof. Ghannoum, “Furthermore, we found strong similarities in what may be called the ‘gut profiles’ of the Crohn’s-affected families, which were strikingly different from the Crohn’s-free families. We have to be careful, though, and not solely attribute Crohn’s disease to the bacterial and fungal makeups of our intestines. For example, we know that family members also share diet and environment to significant degrees. Further research is needed to be even more specific in identifying precipitators and contributors of Crohn’s.” The study, by Hoarau G, Mukherjee PK, et al, was published September 20, 2016, in the journal mBio.

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ISSN 1068-1760 Vol.34 No.1. Published, under license, by Globetech Media LLC; Copyright © 2017. 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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Technique Speeds Up Detection of Infectious Diseases cont’d from cover

to amplify a protein signal without any enzymes, thus eliminating the need for a complex system to wash away excess enzymes, and that would work only in the presence of the target protein. This novel approach made use of a molecular chain reaction that was strongly triggered only in the presence of a target protein. The team designed a transduction mechanism whereby a protein signal is transduced into an amplified nucleic acid output using DNA nanotechnology. In this system, a protein is recognized by nucleic acid bound recognition elements to form a catalytic complex that drives a hybridization/displacement reaction on a multicomponent nucleic acid substrate, releasing multiple target single-stranded oligonucleotides in an amplified fashion. The team demonstrated the approach with two target proteins, streptavidin, widely used as a test protein for new diagnostic assays, and influenza nucleoprotein, which is a protein associated with the influenza virus. In the long term the team aims to combine the technique with portable readers that could be particularly beneficial in clinics in resource-poor areas. The scientists demonstrated a synergistic handheld microplate reader suitable for protein diagnostic assays based on a cellphone’s optical and computational systems earlier this year. In addition, they demonstrated the assay in a microfluidic digital assay format leading to improved quantification and sensitivity approaching single-molecule levels. The present scheme they believe will have a significant impact on a range of applications from fundamental molecular interaction studies to design of artificial circuits in vivo to high-throughput, multiplexed assays for screening or point-of-care diagnostics. Omai B. Garner, PhD, an Assistant Clinical Professor and Associate Director of Clinical Microbiology and co-author of the study, said, “Although demonstrated initially in detecting protein associated with flu, we envision the approach can be generalized to a range of protein biomarkers associated with infectious diseases and cancer.” He noted it could be configured to detect diseases such as Zika or Ebola. The study was published on July 27, 2016, in the journal ACS Nano. Image: A molecular chain reaction detects the presence of proteins in blood and plasma in a way that is faster and simpler (Photo courtesy of UCLA). V

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New Protein Test Offers Breakthough in Early Diagnosis of Parkinson’s here is currently no definitive test for Parkinson’s and the disease is normally diagnosed through assessment of the patient’s medical history, a medical examination, and physical and neurological tests, but this can take years. A novel real-time quaking-induced conversion (RT-QuIC)-based assay has been developed to detect alpha-synuclein aggregation in brain and cerebrospinal fluid from dementia with Lewy bodies and Parkinson’s disease patients. Scientists at the University of Edinburgh (UK; www.ed.ac.uk) applied the RT-QuIC test to 20 samples of cerebrospinal fluid (CSF) taken from patients with Parkinson’s disease, alongside samples of 15 healthy controls. CSF was drawn from patients by lumbar puncture and samples with visible red color were excluded to avoid blood contamination. A total quantity of 15 mL of CSF was collected in 20 mL polypropylene tubes and samples were stored on ice until centrifuged for 5 min at 1300g at 4 °C to remove cellular components. Frontal cortex tissue was taken from patients with Alzheimer’s disease (AD), sporadic Creutzfeldt–Jakob disease (sCJD), and diffuses Lewy body dementia (DLB). Real-time quaking induced aggregation for alpha-synuclein were carried out and incubated in a BMG OPTIMA FLUOstar plate reader (BMG LABTECH, Cary, NC, USA; www.bmglabtech.com) at 30 °C for 120 hours with intermittent shaking cycles: double orbital with one minute shake (200 rpm), 14 minutes rest. Thioflavin (ThT) fluorescence measurements (450 nm excitation and 480 nm emission) were taken every 15 minutes. The team found the test was able to identify 19 out of 20 of samples with 95% accuracy and 100% specificity. It was also able to detect buildup of the protein in three spinal fluid samples of individuals at high risk for Parkinson’s. The team also applied the test to samples of patients with Lewy body dementia. Compared with control samples, the test was able to detect the disease with 92% accuracy and 100% specificity. Alison J. Green, PhD, the lead investigator said, “We have already used this technique to develop an accurate test for Creutzfeldt Jacob Disease, another neurodegenerative condition. We hope that with further refinement, our approach will help to improve diagnosis for Parkinson’s patients. “We are also interested in whether the test could be used to identify people with Parkinson’s and Lewy body dementia in the early stages of their illness. These people could then be given the opportunity to take part in trials of new medicines that may slow, or stop, the progression of disease.” The study was published on August 28, 2016, in the journal Annals of Clinical and Translational Neurology.

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Image: The BMG OPTIMA FLUOstar plate reader (Photo courtesy of BMG LABTECH).

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Simple Blood Test Vastly Improves Severe Liver Disease Detection cont’d from cover

mass spectrometry (MS)-based analytic platforms to measure levels of lipids and metabolites in blood samples from 318 subjects who underwent a liver biopsy because of suspected NASH. The subjects were divided randomly into estimation group of 223 and 95 in a validation group to build and validate the model. Currently, the diagnosis of NASH can only be done with a liver biopsy, which is an invasive and costly procedure. They investigated whether MS-based profiling of plasma improves noninvasive risk estimates of nonalcoholic steatohepatitis (NASH) compared with routinely available clinical parameters and patatin-like phospholi-

pase domain-containing protein 3 (PNPLA3) genotype at rs738409. The scientists found that features of the metabolic syndrome and the variant in PNPLA3 encoding I148M were significantly more common among subjects with than without NASH. They developed a model to identify subjects with NASH based on clinical data and PNPLA3 genotype (NASH Clin Score), which included aspartate aminotransferase (AST), fasting insulin, and PNPLA3 genotype. This model identified subjects with NASH with an area under the receiver operating characteristic of 0.778 (95% confidence interval, 0.709–0.846). The team then used backward stepwise logistic regression analyses of

variables from the NASH Clin Score and MS-based factors associated with NASH to develop the NASH ClinLipMet Score. This included glutamate, isoleucine, glycine, lysophosphatidylcholine 16:0, phosphoethanolamine 40:6, AST, and fasting insulin, along with PNPLA3 genotype. It identified patients with NASH with an area under the receiver-operating characteristic of 0.866 (95% confidence interval, 0.820–0.913). The NASH ClinLipMet score identified patients with NASH with significantly higher accuracy than the NASH Clin Score or MS-based profiling alone. You Zhou, PhD, a lecturer and senior author of the study said, “Many people with non-alcoholic steatohepatitis do not have symptoms and are not aware they are developing a serious liver problem. As such, diagnosis often comes after irreversible damage is done. Our quicker and less invasive method of diagnosis

could mean that more people with non-alcoholic fatty liver disease could be easily tested to determine whether they are progressing to non-alcoholic steatohepatitis, the more severe form of the disease.” The study was published in the October 2016 issue of the journal Clinical Gastroenterology and Hepatology. Image: A histopathology of non-alcoholic steatohepatitis (NASH) in a liver biopsy (Photo courtesy of SPL).

Fecal Blood Test Avoids Unnecessary Endoscopies cont’d from cover

Serious colorectal diseases, including colorectal cancer, are difficult to diagnose as the signs and symptoms are not always clear. Any suspicion of SCD requires a general practitioner referral to a hospital for an endoscopy but studies have shown that between 60% to 80% of referred patients end up not having SCD. Scientists at the University Medical Center Utrecht (Netherlands; www. umcutrecht.nl) collected data from the large-scale study where 810 patients suspected of SCD were enrolled from 266 primary care practices in the Netherlands. A pre-endoscopy venous blood sample was drawn to estimate hemoglobin and C-reactive protein (CRP) concentrations according to routine clinical practice. The team developed a diagnostic strategy to better exclude SCD in these patients and evaluated the value of adding a fecal calprotectin point-of-care (POC) and/or a POC fecal immunochemical test for hemoglobin (FIT-Hb)) to routine clinical information. The investigators analyzed the fecal samples for calprotectin concentration by a quantitative point-of-care (POC) test (Quantum Blue; dynamic range 30 to 300 μg/g) and by an enzyme-linked immunosorbent assay (ELISA; EK-CAL Calprotectin ELISA, (both from Bühlmann Laboratories, Schönenbuch, Switzerland; www. buhlmannlabs.ch), both yielding estiLINKXPRESS COM

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mates of μg calprotectin/g feces. For fecal Hb the team used a qualitative POC FIT, the Clearview iFOBT One Step Fecal Occult Blood Test Device, (Alere Health; Waltham, MA, USA; www.alere.com), yielding either a positive or negative test result with a lower detection limit of 6 μg/g. Out of the 810 patients referred for an endoscopy, 669 were found to have no SCD. Once the results of the FIT test had been taken into account the scientists found that approximately 30% of these patients could have been prevented from having an endoscopy as they may have been correctly diagnosed as not having SCD during their doctor’s visit. The study also looked at the benefit of adding a fecal test for the protein calprotectin to the diagnostic strategy. They found that this test also improved the diagnosis of SCD but not to the same extent as FIT. Furthermore, combining both tests added little extra benefit to the diagnostic accuracy of FIT alone. The authors concluded that FIT and to a much lesser extent calprotectin POC testing showed incremental value for SCD diagnosis beyond standard clinical information. A diagnostic strategy with routine clinical data and a POC FIT test may safely rule out SCD and prevent unnecessary endoscopy referral in approximately one third of SCD-suspected primary care patients. The study was published on September 26, 2016, in the journal BMC Medicine. LabMedica International February-March/2017

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Method Indicates Efficacy of Immune Cells cont’d from cover

misfires causing allergy or autoimmune reactions. Compounding the problem, not every immune reaction is equal, sometimes a necessary reaction is not strong enough or at times it is too strong. A team of scientists at Thomas Jefferson University (Philadelphia, PA, USA; www.jefferson.edu) has developed a new way to determine the strength of an immune response to a particular antigen. The test works by attaching immune cells that can both respond to as well as display potential immune targets, and then flowing potential antigens over the immune cells to look for “matches.” If the addition of antigen leads to a match between displayer and responder, the two cells attach to each other with their receptors. That attachment triggers calcium channels to open, which then activates a green fluorescence in the cells. The green light can be easily detected by microscope and quantified by image-reading software. The test called the CaFlux assay can help see both how many T-cells respond in a given sample, as well as how powerfully and how rapidly each individual cell responds over time. These three pieces of information could more accurately predict how a person would react to a wide array of immune threats, from viral or bacterial attacks to allergens. The test could be useful in developing better vaccines, assessing the potency of immunotherapy interventions, and understanding the severity of disease, and therefore the appropriate level of medical intervention. Magnetic sorting of T-cell subsets, the CD8 T cells were purified from frozen human peripheral blood mononuclear cells (PBMC) by negative selection using MACS Cell Separation Technology (Miltenyi Biotec, Bergisch Gladbach, Germany; www.miltenyibiotec.com). The team tested T-cells from a bone marrow transplant recipient for reactivity to cytomegalovirus (CMV). Most people harbor CMV, but the infection is usually kept in check by a healthy immune system. They tested the new T cells after the transplant, the patient’s cells showed a slow and weak response to the same antigens, or CMV targets. Neal Flomenberg, MD, a professor of Medical Oncology, and a co-author of the study, said, “That weak response was mirrored by what happened in the clinic. The patient’s CMV reactivated while the immune system was still rebooting and unable to mount a strong response against CMV, and he had to be treated for the infection. Had we been able to monitor this patient’s immune system’s ability to respond to CMV, we may have been able to tailor his treatment to better keep the CMV in check.” The study was published on October 27, 2016, in the journal Nature Communications. Image: Detail of a CaFlux plate and the green fluorescent read-out from activated immune cells (Photo courtesy of Thomas Jefferson University).

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RAPIDComm Data Management System Receives Major Upgrade iemens Healthineers (Erlangen, Germany; www.healthcare.siemens.com) has released a major upgrade to the RAPIDComm Data Management System, an informatics solution used to centrally manage in vitro diagnostics (IVD) analyzers and operators at the point-ofcare (POC). The RAPIDComm System is a total solution for POC data management, including cardiac support. The system connects to the Stratus CS 200 Acute Care Diagnostic System, which provides increased IVD connections, including time synchronization with the CLINITEK Status Connect System to automatically synchronize instruments daily for consistency across the POC ecosystem. Secure access ensures the POC devices are online, operational, and properly maintained, with immediate over-

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sight and control. Other performance and productivity features include a configurable backup utility that aids customers with remote database configurations to directly manage their backup activities; generate material use reports for diabetes and urinalysis assist in inventory management; and monitor device status alerts, email notifications, and operator comments. System features such as the lock-out component – which prohibits operators not yet certified to use the equipment from running tests – are designed to improve compliance practices and enhance patient safety. The RAPIDComm Data Management System also offers online competency based training for staff, including training record management, workgroup management, personalized learning plans, e-

quizzes and qualification plans, an interface to the personalized education plan (PEP) administrator, and proficiency testing. Image: The RAPIDComm system ensures secure access to POC devices (Photo courtesy of Siemens Healthineers).

Zika Virus Detected in Conjunctival Fluid esearchers have found that Zika virus (ZIKV) can be detected in samples of conjunctival fluid from patients with ZIKV infection, suggesting the possibility for a simpler and safer noninvasive test for diagnosis and/or screening than blood testing. The results also add evidence about the cause of conjunctivitis in ZIKV-infected infants with microcephaly. Though over 80% of infections are asymptomatic, clinical symptoms are often joint pain, mild and self-limited rash, and conjunctivitis (“pink eye”). Severe eye damage in infants with microcephaly was associated with ZIKV infection; however, it has not been clear whether the eye lesions are the result of the microcephaly or directly of ZIKV infection. A team led by researchers of the Guangzhou Province department of the Chinese Center for Disease Control and Prevention (China CDC; Beijing, China; www.chinacdc.cn/en) examined ZIKV could be detected from conjunctival swab samples of laboratory-confirmed ZIKV cases. Since February 2016, 11 ZIKV infection cases had been confirmed (by PCR) of Chinese travelers entering Guangdong from Venezuela. Serum and conjunctival swab samples were taken from 6 of 11 cases. The ZIKV RNA was detectable in serum no more than 5 days after symptom onset, but it was detected in conjunctival swab samples until day 7 in case 5. “These results, though, are not sufficient to recommend the use of conjunctival swabs as alternative samples for ZIKV diagnosis because of shorter persisting and shedding time of ZIKV in conjunctiva fluid (<7 days) compared with urine and saliva samples (<20 days),” they added, “It may have implications for transmission of ZIKV, e.g. through corneal graft donors, although this report does not provide direct evidence to support that indication. Nevertheless, epidemiological data and experimental studies are needed.” The study, by Sun J et al, was published online September 15, 2016, in the journal JAMA Ophthalmology.

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Prognostic Biomarkers Predict Dengue Shock and Organ Failure here are presently no biomarkers that can predict the incidence of dengue shock and/or organ failure, although the early identification of risk factors is important in determining appropriate management to reduce mortality. Mortality rates among patients who have been hospitalized with severe dengue are 1.6% to 10.9%, and death in adults is mainly due to the development of dengue shock and organ dysfunction. The prognostic value of serum procalcitonin (PCT) and peripheral venous lactate (PVL) levels as biomarkers of dengue shock and/or organ failure have been evaluated. Scientists at Mahidol University (Bangkok, Thailand; www.mahidol.ac.th) conducted a prospective observational study among adults hospitalized for

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confirmed viral dengue infection between October 2013 and July 2015. Of 160 patients with dengue, 128 (80.0%) patients had dengue without shock or organ failure, whereas 32 (20.0%) patients developed dengue with shock and/or organ failure. Laboratory tests were conducted at admission, including a complete blood count and blood chemistry assessment, and samples for the measurement of PCT and PVL were collected. PCT was measured using an electrochemiluminescence method (Elecsys BRAHMS PCT, Roche Diagnostic, Mannheim, Germany;

www.roche.com) using a Roche Diagnostic Cobas e 411 immunoassay analyzer. The detection limit for the PCT assay was 0.02 ng/mL. PVL levels were measured by a colorimetric assay with an enzymatic reaction using a Cobas C Systems autoanalyzer (Roche/Hitachi, Indianapolis, IN, USA; https:// usdiagnostics.roche.com). All sera collected at admission and two weeks after admission were tested using four separate capture enzyme-linked immunosorbent assays (ELISA) for immunoglobulin M (IgM) and IgG against dengue virus and Japanese encephalitis virus. The team found that patients with dengue shock and/or organ failure had significantly higher PCT levels and higher PVL levels, higher hemoglobin concentrations, increased hematocrit values above baseline, elevated while blood counts (WBC), higher absolute bands, increased atypical lymphocyte counts, higher alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels. However, patients with dengue shock and/or organ failure had significantly lower platelet counts and albumin levels. Dengue shock patients with non-clearance of PCT and PVL expired during hospitalization. The authors concluded that a PCT equal to or greater than 0.7 ng/mL and a PVL equal to or greater than 2.5 mmol/L were independently associated with dengue shock and/or organ failure. The combination of PCT and PVL levels could be used as prognostic biomarkers for the prediction of dengue shock and/or organ failure. The study was published on August 26, 2016, in the journal Public Library of Science Neglected Tropical Diseases. Image: The Cobas e 411 immunoassay analyzer (Photo courtesy of Roche Diagnostics). V

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LabMedica International February-March/2017

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PRODUCT NEWS MULTIPLEX ASSAY

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HEMATOLOGY ANALYZER

STORAGE BOXES

ELITechGroup

Maccura

Eppendorf

The Coagulation ELITe MGB Kit is intended to detect/differentiate the most common genetic risk variants responsible for thrombosis and embolisms. Used with the ELITe InGenius, it is the first coagulation factors triplex, CE-IVD validated on a fully automated sample-to-result solution.

The F 580 offers enhanced sensitivity to identify immature cells, and provides early detection of many blood diseases such as leukemia. The automatic system measures 28 parameters, requires only 20 μl of blood for each test, and features 34 diagnostic alarms.

The storage boxes feature alphanumeric laser labeling of each individual sample position, and can be combined for individual storage requirements. The nine formats are compatible with common freezer rack systems, and the inner grid variants offer the perfect fit for all common vessel formats.

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Simple Sensitive Assays Used For Analyzing Fragile X Syndrome ragile X syndrome, the most common heritable cause of intellectual disability and a frequent cause of autism, is characterized by abnormalities of the fragile X mental retardation 1gene (FMR1) that are difficult to analyze. Preclinical studies of Fragile X and the Fragile X related disorders are hampered by the lack of low-cost and sensitive yet simple methods, but a newly developed a set of assays that are robust, cheap enough for routine use may be suitable for initial patient screening. Scientists at the National Institute of Diabetes and Digestive and Kidney Diseases (Bethesda, MD, USA; www. niddk.nih.gov) developed the assays which have the ability to amplify alleles with up to approximately 1,000 repeats, even in samples from patients who are mosaic, that is those who have a mixture of cells with different repeat numbers. The assays are sensitive enough to analyze saliva samples with minimal purification. Testing can be completed within a timeframe similar to that of recent commercial diagnostic assays in less than 24 hours to determine repeat size and/or methylation status and in less than 24 hours to determine the interruption status and percent methylation and are comparable in terms of hands-on time required. These assays make it possible to detect even small changes in DNA methylation, making them useful in the hunt for new drugs to reverse the effects of repeat expansion. Genomic DNA from cell lines was prepared using standard procedures. Genomic DNA from human saliva was collected in an OGR-500 (Oragene, DNA Genotek, Kanata, ON, Canada; www.dnagenotek.com) and purified using their prepIT-L2P reagent. DNA quantification was performed on a Denovix DS-11 spectrophotometer (DeNovix, Wilmington, DE, USA; www.denovix.

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com). A quantitative FMR1 promoter methylation polymerase chain reaction assay (qMS-PCR) was performed using a StepOne Plus PCR machine (Thermo Fisher Scientific, Waltham, MA, USA; www.thermofisher.com). Karen Usdin, PhD, the senior investigator and co-author of the study, said, “Careful analysis of the total number of repeats, the number of interruptions in the repeat tract, and the methylation status of the FMR1 gene is important for a proper understanding of an individual’s risk of transmission of larger alleles to their offspring and to their personal risk of disease pathology. Without the ability to verify CGG-repeat number and methylation status, it is impossible to distinguish between bona fide developmentally-regulated changes and artifacts arising from the instability in repeat number and methylation commonly associated with these cells.” The study was published online on August 1, 2016, in The Journal of Molecular Diagnostics. Image: A DS-11 spectrophotometer (Photo courtesy of Denovix). LabMedica International February-March/2017

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Increased Risk of HIV Associated with Parasitic Worm Infections eople infected with a parasitic worm called Wuchereria bancrofti in areas where human immunodeficiency virus (HIV) is endemic may be more likely to acquire HIV than people who are not infected with the worm. W. bancrofti is a mosquito borne parasitic worm or helminth and worldwide, it causes 90% of lymphatic filariasis cases, a disease commonly known as elephantiasis, which is a neglected tropical disease. Lymphatic filariasis currently affects 120 million people, mostly in Asia, Africa, the western Pacific, and parts of the Caribbean and South America, and causes abnormal enlargement of limbs, causing pain, severe disability and social stigma. German and Tanzanian scientists led by those at the University of Munich Medical Centre (Germany; www.klinikum. uni-muenchen.de) analyzed 2,699 people in the Kyela district of Mbeya, southwest Tanzania between 2006 and 2011. Samples of blood, urine, stool, and sputum were collected to test for HIV and for W. bancrofti infection, as well as for Schistosoma haematobium, intestinal helminths, tuberculosis, and malaria. Participants with lymphatic filariasis were twice as likely to become infected with HIV as those without lymphatic filariasis. Overall, there were 1.91 new HIV infections per 100 person-years in patients with lymphatic filariasis, versus 0.80 new HIV infections per 100 person-years in patients without lymphatic filariasis. In the 1,055 initially HIV-negative adolescents and adults with clearly defined lymphatic filariasis status, 32 new HIV infections were observed in 2,626 person-years. Lymphatic filariasis status remained an independent and significantly relevant risk factor for HIV infection when controlled for other known risk factors such as sexual behavior and socioeconomic factors. Inge Kroidl, the lead author of the study said, â&#x20AC;&#x153;W. bancrofti worms live in the lymphatic system of patients, often without symptoms, for years. The long disease duration of W. bancrofti infection of around 10 years creates an ongoing immune response, which we suspect might leave infected persons more susceptible to HIV infection. Our findings add another argument to push neglected diseases, in this case filarial infection, into the focus of global prevention strategies, as they create not only morbidity but in addition may generate an increased risk of acquiring HIV.â&#x20AC;? The study was published on August 3, 2016, in the journal The Lancet.

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Image: A microfilaria of Wuchereria bancrofti in a thick blood smear stained with Giemsa (Photo courtesy of the CDC).

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Hormone Test May Reduce Rate of Teens Misdiagnosed with PCOS easuring blood levels of the recently discovered hormone irisin may improve accurate diagnosis rates of teenagers with polycystic ovary syndrome (PCOS) and so reduce the number of unnecessary treatments prescribed to healthy girls at an especially critical stage in their lives. Doctors are cautious when diagnosing PCOS in teenagers because the symptoms can be confused with normal pubertal changes. Women with PCOS are more likely to suffer from irregular periods, have excessive levels of male hormones, and may have difficulty in conceiving due to irregularities in the ovaries. The cause of PCOS is unknown and there is currently no cure. Studies have associated high levels of irisin, which is released from muscles and regulates energy metabolism, with PCOS in adults.

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In the new study, researchers from Aghia Sophia Children’s Hospital (Athens, Greece; www. paidon-agiasofia.gr) compared the hormones of 23 teenagers with PCOS with 17 healthy teenagers of the same age and BMI. They found that the teens with PCOS had significantly higher irisin levels compared to the healthy control group, and that this was associated with higher levels of the male sex hormone testosterone, a key marker of PCOS. The group will next focus on confirming their results and investigate the biological role of irisin in PCOS. “If high irisin levels in teenagers with PCOS is established, this could lead to the development of treatments for PCOS. Lifestyle changes and different exercise-related signals that regulate the secretion of irisin could provide a potential option for the management of PCOS. The potential of irisin as a

meaningful drug target in PCOS is very promising,” said Dr Bacopoulou. The study was presented September 11, 2016, at the 55th Annual European Society for Paediatric Endocrinology Meeting (Paris, France, September 10-12). Image: Researchers in Greece found the hormone irisin may help improve decrease diagnosis of PCOS in teenagers, and may prove to be an effective target for treatment (Photo courtesy of Alexander Raths / Shutterstock).

Combined Use of Assays Identifies Cancer Patient Response to Crizotinib n screening of a large cohort for anaplastic lymphoma kinase (ALK) fusions through both fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC) assays, researchers found many non-small cell lung cancer (NSCLC) patients who had negative and atypical FISH patterns accompanied with positive IHC results, who showed response to crizotinib treatment. ALK gene rearrangements are found in 3-5% of patients with NSCLC. Identification of appropriate patient population with reliable detective methods is the key to use of targeted therapies. It is routine clinical practice to screen patients with adenocarcinoma NSCLC for ALK rearrangements due to the availability of ALK inhibitors and for their ability to provide remarkable benefit to patients. FISH has long been the gold standard used to screen patients

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for ALK rearrangements. However, IHC platforms that are used to detect overexpression of protein caused by ALK gene rearrangements have been found to be both highly sensitive and specific in determining ALK status in patients. Further, several studies have shown that patients with tumors that were ALK negative (ALK-) via FISH were ALK positive (ALK+) via IHC, and that those ALK+ patients showed response when treated with the ALK inhibitor crizotinib. The discordant FISH and IHC phenomenon showed the need for further examination to identify the existence of unknown ALK fusion genes and led to the new study led by investigators at Chinese Academy of Medical Sciences and Peking Union Medical College (Beijing, China; http://english.pumc.edu. cn). Of the 3,128 cases screened, 2,991 cases were

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subjected to both FISH and IHC analysis. IHC was performed with the FDA-approved Ventana-D5F3 IHC assay. 14 cases with negative and atypical FISH demonstrated IHC positivity (11 cases were ALK- via FISH and ALK+ via IHC; 3 cases were atypical FISH patterns and ALK+ via IHC). These 14 cases were further investigated using targeted next-generation sequencing (NGS), which revealed that 8 cases housed EML4ALKfusions, 2 cases revealed novel ALK fusion partners (BIRC6 and PICALM), 1 case had a novel translocation partner (CEBP ), and 3 patients did not exhibit any type of ALK fusions. Among all 14 patients, 4 patients received crizotinib treatment and demonstrated partial responses at the end of follow-up. The study, by Li W, Zhang J, et al, was published September 7, 2016, online ahead of print in the Journal of Thoracic Oncology.

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Neutrophil CD64 Index Helps Diagnose Spontaneous Bacterial Peritonitis pontaneous bacterial peritonitis (SBP) is a common and serious complication in patients with ascites caused by decompensated liver cirrhosis, and most cases are caused by bacterial infections spreading to the peritoneum across the gut wall or mesenteric lymphatics. Although a diagnostic paracentesis and appropriate ascitic fluid analysis is considered essential for all patients admitted with ascites, the procedure is associated with dangerous complications such as bleeding and infection. In the emergency setting, performing ascitic fluid culture examinations is time-consuming and not always possible. Scientists affiliated with the Capital Medical Hospital (Beijing, China; www.mbbs. cucas.edu.cn) conducted a prospective study of a total of 123 patients with ascites caused by cirrhosis who fulfilled the inclusion criteria were enrolled from March 2014 to June 2015. Aspirated ascitic fluid was collected in ethylenediaminetetraacetic acid (EDTA) tubes and analyzed within three hours of aspiration. Relevant tests were performed on blood samples to assess the condition of the patients. Blood samples were collected within six hours after paracentesis and before antibiotic therapy; they were processed within 24 hours after collection for the measurement of CD64 expression on leukocytes by FACSCalibur flow cytometry (Becton Dickinson, Franklin Lakes, NJ, USA; www.bd.com) using a Becton Dickinson CD14/CD64 assay kit. The kit includes fluorescein isothiocyanate (FITC)-conjugated anti-CD14 and phycoerythrin (PE)-conjugated anti-CD64 antibodies. The lymphocyte, monocyte, and neutrophil populations are defined by their forward and side scatter characteristics along with surface CD14 staining. The teams found that the neutrophil CD64 (Fc receptor I) index results were significantly higher in cirrhotic patients with SBP than in those without SBP. There was a positive correlation between the neutrophil CD64 index and the polymorphonuclear neutrophil (PMN) count in ascites. In the receiver operating characteristic curve (ROC) analysis, the area under the curve (AUC) was 0.894. The optimal cut-off value for the neutrophil CD64 index was 2.02. The sensitivity and specificity of the neutrophil CD64 index for cirrhotic patients with SBP were 80.49% and 93.90%, respectively. The elevated neutrophil CD64 index was down regulated by antibiotic therapy. The authors concluded from the results of their study the neutrophil CD64 index could be used as a sensitive and specific indicator for the diagnosis of SBP in cirrhotic patients with ascites. In addition, the neutrophil CD64 index is modulated by antibiotic therapy and could be used to evaluate the effect of therapy in SBP patients. The study was published on July 4, 2016, in the journal International Journal of Infectious Diseases.

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Image: The BD FACSCalibur flow cytometer (Photo courtesy of BD).

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Screening for Latent Tuberculosis Infection Recommended uberculosis remains an important preventable disease, including active tuberculosis infection, which may be infectious and latent infection (LTBI), which is asymptomatic and not infectious, but can later reactivate and progress to active disease. People who are considered at increased risk include people who were born in or have lived in countries where tuberculosis is highly prevalent, or who have lived in group settings where exposure to tuberculosis is more likely, such as homeless shelters or correctional facilities. The US Preventive Services Task Force (USPSTF, Rockville, MD, USA; www.uspreventiveservicestaskforce.org) recommends screening for latent tuberculosis infection in populations at increased risk. The USPSTF reviewed the evidence on screening for LTBI in asymptomatic adults seen in primary care, including evidence dating from the inception of searched databases. This is a B recommendation, indicating that there is high certainty that the net benefit is moderate, or there is moderate certainty that the net benefit is moderate to substantial. The USPSTF found adequate evidence that accurate screening tests are available to detect LTBI. Screening tests include the Mantoux tuberculin skin test (TST) and interferon-gamma release assays (IGRAs); both are moderately sensitive and highly specific. The TST requires intradermal placement of purified protein derivative and interpretation of response 48 to 72 hours later. The skin test reaction is measured in millimeters of the induration (a palpable, raised, hardened area or swelling). Interferon-gamma

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Image: The T-SPOT.TB Interferon-gamma release assay for tuberculosis screening (Photo courtesy of Oxford Immunotec Global).

release assays require a single venous blood sample and laboratory processing within eight to 30 hours after collection. Two types of IGRAs are currently approved by the US Food and Drug Administration (FDA, Silver Springs, MD, USA; www.fda.gov): TSPOT.TB (Oxford Immunotec Global, Abingdon, UK; www.oxfordimmunotec.com) and QuantiFERON-TB Gold In-Tube (Qiagen, Hilden, Germany; www. qiagen.com). When using a positive threshold of 10 mm of induration, the TST has moderate sensitivity and high specificity for detection of LTBI. Based on pooled analyses of studies reviewed by the USPSTF, when using a positive threshold of 10 mm, the TST has sensitivity of 79% (11 studies; n = 988) and specificity of 97% (nine studies; n = 9,651). Pooled analyses

of the T-SPOT.TB test (a type of IGRA) indicate sensitivity of 90% (16 studies; n = 984) and specificity of 95% (5 studies; n = 1,810). Pooled analyses of the QuantiFERON-TB Gold In-Tube test (another type of IGRA) indicate sensitivity of 80% (24 studies; n = 2,321) and specificity of 97% (4 studies; n = 2,053). The USPSTF found adequate evidence that accurate screening tests for LTBI are available, treatment of LTBI provides a moderate health benefit in preventing progression to active disease, and the harms of screening and treatment are small. The USPSTF has moderate certainty that screening for LTBI in persons at increased risk for infection provides a moderate net benefit. The study was published on September 6, 2016, in The Journal of the American Medical Association.

Novel Turbidimetric Immunoassay Evaluated for Fecal Calprotectin alprotectin is a multifunctional protein that plays an important role in the diagnosis and follow-up of inflammatory bowel disease and high levels of calprotectin in stool samples are associated with inflammation of the intestinal tract. Fecal calprotectin assays are widely used to exclude inflammatory bowel disease (IBD)

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in patients with suspected IBD, but the problem with most of the fecal calprotectin assays is the rather long test-turnaround times, before the results are available to the physician. Scientists at Uppsala University (Sweden; www.uu.se) optimized a particle enhanced turbidimetric immunoassay (PETIA) for fecal calprotectin

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and validated the assay for two clinical autoanalyzers using routine fecal samples. They compared the PETIA with a commercial enzyme-linked immunosorbent assay (ELISA), known as the Bühlmann fCAL ELISA (Bühlmann Laboratories, Schönenbuch, Switzerland; www.buhlmannlabs. ch). This new latex based turbidimetric calprotectin assay applies particles coated with anti-human calprotectin (MRP8/14) antibodies: the agglutination is proportional to the calprotectin concentration. The fecal calprotectin PETIA was validated on two chemistry analyzers, the Mindray BS-380 (Mindray, Shenzhen, China; www.mindray.com) and the Cobas 501 (Roche Diagnostics, Basel, Switzerland, www.roche.com). The assay is linear in the range 11 μg/g to 2,000 μg/g, with a limit of quantitation of approximately 10 μg/g. No antigen excess hook effect was observed up to 10,000 μg/g to 15,000 μg/g depending on the instrument used. The turbidimetric method showed a good agreement with the Bühlmann ELISA. The total coefficient of variation was 3% to 8% in the 50 μg/g to100 μg/g range. The authors concluded that the fecal calprotectin PETIA, fCal Turbo, is well suited for rapid analysis of fecal calprotectin on Mindray BS-380 or Cobas 501 clinical chemistry analyzers. The test results are concordant with the Bühlmann fecal MRP8/14 ELISA. The study was published in the September 2016 issue of the Journal of Clinical Laboratory Analysis. LabMedica International February-March/2017

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LabMedica International

Rapid Bacterial Infection Test Reduces Antibiotic Use nappropriate antibiotic use for acute respiratory tract infections is common in primary health care, but distinguishing serious from self-limiting infections is difficult, particularly in low-resource settings. A rapid test is able to detect Creactive protein (CRP), a marker of infections caused by bacteria, in patients’ blood and a low level of CRP is suggestive of viral infection and therefore antibiotic treatment is not required. An international team of scientists led by those at the Radboud University, (Nijmegen, Netherlands; www.radboudumc.nl) performed a multicenter open-label randomized controlled trial in ten primary health-care centers in northern Vietnam. Patients aged 1 to 65 years with at least one focal and one systemic symptom of acute respiratory tract infection were assigned 1:1 to receive either C-reactive protein pointof-care testing or routine care, following which antibiotic prescribing decisions were made. Between March 17, 2014, and July 3, 2015, 2,037 patients including 1,028 children and 1,009 adults were enrolled and randomized. For patients in the intervention group, a finger prick to obtain capillary blood was done and analyzed using the quantitative NycoCard analyzer; the CRP single test kit was used with the NycoCard II Reader (Alere Technologies, Oslo, Norway; www. alere.com) on enrolment (day 0) and retested on day 3, 4, or 5. Patients in the control group were treated according to routine practice and local treatment guidelines on enrolment and the second visit. All patients were followed up at two weeks after the initial health clinic visit by a structured telephone interview. The cutoffs used to recommend that antibiotics not be prescribed were a CRP of 20 mg/L or less for patients aged 6 to 65 years, and a CRP of 10 mg/L or less for patients aged 1 to 5 years. Doctors were advised that adults with a CRP of 100 mg/L or more and children with a CRP of 50 mg/L or more should generally receive antibiotics and hospital referral should be considered. The number of patients who used antibiotics within 14 days was 581 (64%) of 902 patients in the C-reactive protein group versus 738 (78%) of 947 patients in the control group. Highly significant differences were seen in both children and adults, with substantial heterogeneity of the intervention effect across the 10 sites. Heiman Wertheim, PhD, a professor and principal investigator, said, “There were large differences in the effect of the intervention between health centers; one center saw no effect due to antibiotic stocks they wanted to get rid of. This nicely illustrates one of the practical obstacles that need to be overcome.” His colleague, Nguyen Van Kinh, MD, PhD, added, “With this easy-to-use tool, primary healthcare providers can safely limit the unnecessary antibiotic use for viral respiratory infections. The study provides important evidence for simple solutions in antibiotic stewardship programs.” The study was published on August 2, 2016, in the journal The Lancet Global Health.

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Image: The NyoCard II reader and test kits (Photo courtesy of Alere Technologies).

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PRODUCT NEWS IMMUNOFLUORESCENT ASSAYS

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BENCHTOP CENTRIFUGE

HEMATOLOGY SYSTEM

Vircell

Sarstedt

Mindray

The ZIKV-DENV-CHIKV indirect immunofluorescent assays are meant for the detection of IgG and IgM antibodies against the arbovirus Zika, dengue, and chikungunya. The kits provide easy-to-read results by using fully coated separate wells with a pool of infected and uninfected cells.

The SMC 6plus can be used to form a reliable gel barrier in serum or plasma tubes for sample stability. It features a swing-out rotor for optimum horizontal separation and is suitable for all standard sample tubes up to a maximum filling volume of 10 ml and maximum diameter of 17 mm.

The CAL 8000 combines the BC-6800 hematology analyzer with the SC-120 slide maker and stainer into one comprehensive workstation. It allows the possibility to include up to four BC-6800s and up to two SC-120s, and can be scaled to meet the workload requirements of large laboratories.

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Comprehensive Liquid Biopsy Guides Metastatic Cancer Treatment iquid biopsies offer a promising approach for identifying druggable genomic alterations, which is the ability of a portion of a genome to be targeted by a drug, especially by a small molecule drug, without the need for costly and invasive tissue biopsies. The results of the first prospective clinical trial using a comprehensive liquid biopsy test as the sole diagnostic tool used by doctors to guide metastatic cancer patients to matched therapy across multiple cancers has been recently announced. Scientists at the Samsung Medical Center (Sungkyunkwan University School of Medicine, Seoul, Korea; www.samsunghospital.com) and a commercial company collaborated in the first prospective study to evaluate the response of advanced cancer patients to matched therapy based on circulating tumor DNA (ctDNA)-detected alterations across different solid tumor cancers without tissue biopsies available for molecular testing. The study of 200 patients demonstrated high actionability in matching patients to targeted therapies, as well as statistically significant response rates in lung

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(88%) and gastric (60%) cancers. The study used Guardant360 (Guardant Health, Inc, Redwood city, CA, USA; www.guardanthealth. com), the first and only comprehensive liquid biopsy that covers all guideline recommended biomarkers in a single test. Guardant360 is a biopsy free, simple blood test for tumor genomic profiling. It takes 14 days or less from the time it is received at the laboratory for a full report to reach the ordering doctor. This is two full weeks sooner than with a tissue sample from a best in class cancer center. The Guardant360 blood test also provides samples with an adequate level of cell free DNA to test 99.8% of the time. In contrast, the samples used for tissue sequencing typically have insufficient DNA from 20% to 40% of the time. This adds further delays as either a new sample from the original tumor block must be present or another biopsy must be done to get enough tissue to test. Jeeyun Lee, MD, the primary investigator on the study, said, “The genomic landscape of variants we found with Guardant360 were comparable to what we saw in a tissue-based prospective clinical utility

study. When these patients are then guided to matched therapy based on ctDNA profiling, the response rate was again comparable to what we see when selection is based on tumor specimens. This blood-based technology also overcomes tumor heterogeneity by providing a more global summary of all the aberrations in different metastatic sites. It also may reduce harm to patients by obviating the need for invasive biopsy. The study was presented on June 6, 2016, at the American Society of Clinical Oncology Annual Meeting held in Chicago, IL, USA (https://am.asco.org). Image: The Guardant360 kit for biopsy-free tissue sequencing for cancer (Photo courtesy of Guardant Health).

Diagnostic Tests for Lung and Colon Cancer Introduced in Europe unique combination of reliability, sensitivity, ease of use, and cost-effectiveness for targeted genetic testing for cancer has now become available to molecular pathologists. The multiplexed assays allow the user to concurrently analyze the relevant oncogenes and thereby reduce cost and turnaround time compared to existing methods. The two test panels support personalized treatment and improved patient care through rapid analysis of clinically actionable mutations implicated in lung and colon cancer. Agena Bioscience (San Diego, CA; USA; www.agenabio.com) has launched its Conformité European In Vitro Diagnostic Medical Devices (CE-IVD) marked MassARRAY Dx products in Europe. Two targeted diagnostic

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panels will be sold, the MassARRAY Dx Lung Panel and the MassARRAY Dx Colon Panel, in addition to the company’s MassARRAY Dx instrumentation. The MassARRAY Dx Colon Panel simultaneously analyzes over 200 mutations in the four major oncogenes involved in the pathogenesis of colorectal cancer (KRAS, BRAF, NRAS, and PIK3CA), using less than 40 ng of DNA extracted from fresh, frozen, or paraffin-embedded tissue. The MassARRAY Dx Lung Panel simultaneously analyzes over 300 mutations in 10 genes implicated in the pathogenesis of lung cancer (EGFR, KRAS, BRAF, PIK3CA, NRAS, ALK, ERBB2, DDR2, MAP2K1, and RET), using less than 40ng of DNA extracted from fresh, frozen, or paraffin-embedded tissue.

The CE-IVD marked MassARRAY Dx products, consisting of the MassARRAY Dx Colon Panel, MassARRAY Dx Lung Panel, and MassARRAY Dx instrumentation (MassARRAY Dx Analyzer 4, MassARRAY Dx Nanodispenser RS 1000), are sold exclusively in Europe for diagnostic use, and are not available for sale in the USA. Peter M. Dansky, MS, MBA, Chief Executive Officer of Agena Bioscience, said, “Our entry into the European clinical diagnostics market is a pillar of Agena’s global strategy to grow its clinical business with targeted, clinically actionable tests. The MassARRAY Dx Lung and Colon Panels will provide rapid and reliable diagnostic results to help physicians select the most effective treatments for their oncology patients.” LabMedica International February-March/2017

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LabMedica International

Next-Generation Blood Glucose Monitoring System he next-generation blood glucose monitoring system has recently been launched and this system is designed to make everyday blood glucose (BG) monitoring easier. The system is designed with features such as the spill-resistant test strip vial, which helps users to remove just one strip at a time and avoid spillage or contamination and also provides for advanced accuracy, which enables reliable diabetes management. The Accu-Chek Guide system (Roche Diagnostics, Basel Switzerland; www.accu-chek.com) enables on-board pattern detection that helps to increase awareness of too high or too low glucose readings as well as Bluetooth Low Energy connectivity to the Accu-Chek Connect diabetes management solution via a mobile app. This cloud-based solution guarantees a secure online data exchange and automatic data logging. People with diabetes, caregivers, and healthcare providers can share diabetes information virtually anywhere for timely advice and remote monitoring. Such telemedicine solutions can help people with diabetes and their caregivers manage diabetes more efficiently and give them peace of mind and a feeling of relief. Hence, 97% of 197 participants in

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a recently published study from France and the USA agreed that the system was very easy to use and offers a better testing experience. The AccuChek Guide system not only fulfills current accuracy standards, but delivers even tighter 10/10 accuracy for more reliable results. Consistently accurate measurements are essential for reliable BG monitoring and deriving the correct therapy decisions. Large deviations of the measured BG values from the true glucose levels can result in higher HbA1c levels, glycemic excursions and markedly increased rates of hypoglycemic events, as a recently published retrospective study revealed. In addition, studies have demonstrated that only about half of the BG meters evaluated meet the minimum accuracy requirements as defined by the ISO standards. Roland Diggelmann, MBA, CEO of Roche Diagnostics, said, “As the global leader in diabetes man-

agement we are dedicated to supporting people with diabetes, in thinking less about their daily therapy routines. We are very excited to introduce this innovative system that simplifies blood glucose monitoring and improves the testing experience.” Image: The Accu-Chek Guide blood glucose meter monitoring system (Photo courtesy of Roche Diagnostics).

Guide Helps Physicians Diagnose and Manage Food Allergies ased on recent evidence from guidelines, randomized controlled trials, and other research, a new review aims to provide physicians with a guide to help diagnose and manage food allergies in children and adults. It outlines common symptoms, causes, diagnosis, treatment, management, and immunization guidelines. Food allergy involves an immune response that can be reproduced; it is different from food intolerance, such as lactose intolerance and other nonimmune reactions. Skin reactions are most common in allergy, along with respiratory and other multiorgan symptoms. Diagnosis can be difficult, and usually involves a clinical history combined with diagnostic testing, such as skin-prick tests and measurement of serum food-specific IgE levels. An oral food challenge supervised by an allergy specialist is the gold standard, but takes time and can result in anaphylactic reactions. “There is no standardized step-wise approach to testing,” wrote review authors Dr. Elissa Abrams, University of Manitoba (Winnipeg, Manitoba, Canada; http://umanitoba.ca) and Dr. Scott Sicherer, Icahn School of Medicine at Mount Sinai (New York, NY, USA; http://icahn.mssm.edu), “Skin testing, serum food-specific IgE testing or both may be used to evaluate IgE-mediated food allergies.” They caution that food avoidance owing to perceived food “sensitivities” can cause people to eliminate important foods from their diets, resulting in nutritional deficiencies. “Food-specific [IgG] testing is being increasingly used to identify food “sensitivities,”“ they stated, “This testing has not been validated nor supported by research.” The review, by Abrams EM and Sicherer SH, was published ahead of print September 6, 2016, in the Canadian Medical Association Journal (CMAJ).

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CARDIAC ANALYZER

CLINICAL CHEMISTRY ANALYZER

Sphere Medical

Siemens Healthineers

Randox Laboratories

The Pelorus rapidly measures the concentration of propofol using a small volume of whole blood and a single-use cartridge for each measurement. It displays the propofol concentrations on the screen within around five minutes after injection time with precision and accuracy comparable to HPLC.

The Stratus CS provides quantitative cardiac assays for evaluation of patients with suspected myocardial ischemia. It delivers the first result in 14 minutes and each subsequent result in four minutes, and offers a broad test menu to support better chest pain differentiation from a single sample.

The RX Monaco offers a throughput of 170 tests per hour with STAT priority function, and provides 66 cooled, user-defined, reagent and sample positions. It can be integrated into any lab with the option of a floor standing unit if bench-top space is limited, and is ideal for smaller labs.

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Blood Test Detects Breast Cancer Spread Earlier ore sensitive, non-invasive tests are required for secondary breast cancer, which occurs when new tumors grow in the bone, liver, lung or brain, to make diagnosis easier and for treatment to begin as early as possible. Secondary breast cancer is difficult to diagnose before symptoms are experienced and occurs in up to a third of breast cancer patients, sometimes many years after seemingly successful treatment for localized, primary cancer that remained in the breast. Scientists at the University of Westminster (London, UK; www.westminster.ac.uk) collected serum samples from breast cancer patients were recruited onto the study nine to15 months post breast cancer diagnosis, whereupon the first of five annual venipunctures was performed. There were 207 patients who developed distant metastases by October 2012, of which 120 had available serum samples from year one and at least one other year of the study. In a nested case–control study of serum samples from breast cancer patients, of which 52 had developed a distant metastatic recurrence within five years post-diagnosis and 60 who had remained recurrence-free.

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Enzyme-linked immunosorbent assays (ELISA’s) were used to quantify patient serum cadherin-5 (CDH5) levels and assess glycosylation by Helix pomatia agglutinin (HPA) binding. The reaction was monitored using a Dynatech MRX plate reader (Dynatech Medical Products, Alexandria, VA, USA; www.dyna-techmedical.com), and following quenching the absorbance was read at 450 nm in a Wallac 1420 Victor 2 plate reader (Perkin Elmer, Beaconsfield, UK; www.perkinelmer.com). Serum cancer antigen 15.3 (CA15.3), and carcinoembryonic antigen (CEA), and Vascular endothelial growth factor (VEGF) levels were also measured. The investigators detected higher levels of a protein called CDH5 that had unusual sugars decorating its surface in women who went on to be diagnosed with secondary breast cancer over a year later. This indicates that the sensitivity of current blood tests could be improved upon for earlier diagnosis of secondary disease. Serum CDH5 levels and CDH5:HPA ratio values showed these biomarkers to be significantly elevated in patients with metastatic breast cancer, a finding which was paralleled by measurements of CA15.3, which is a more specific but less sensitive marker than CDH:HPA ratios.

Miriam Dwek, PhD, who leads the cancer group, said, “The blood test worked particularly well at identifying metastasis in a sub-group of patients with estrogen responsive breast cancers, which make up 70% of all breast cancers diagnosed. We are excited and hope to develop this test further so in the future there will be improved methods for the better monitoring of patients.” The study was published on March 24, 2016, in the journal British Journal of Cancer (www.nature.com). Image: The MRX microplate reader (Photo courtesy of Dynatech Medical Products).

Deadly Brain Cancer Genes Identified liomas are a type of tumor that starts in the glial cells of the central nervous system, the brain and spinal cord, and glia are the support cells of the nervous system, providing physical support and insulation to neurons. Glioblastoma multiforme, also known as grade 4 astrocytoma, is the most common and aggressive form of glioma and for this subtype of cancer, patients rarely survive much longer than a year from diagnosis, even when surgery, radiation, and chemotherapy are used, prognosis is poor. Scientists at the First Hospital of China Medical University (Shenyang, People’s Republic of China; www.cmu.edu.cn) examined tissue samples from 297 people with brain tumors and of these, 127 peo-

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ple had glioblastoma and the others had less aggressive forms of glioma. All tissue samples were immediately snap-frozen in liquid nitrogen after surgery. A hematoxylin and eosin–stained frozen section was prepared from each sample to assess the percentage of tumor cells before ribonucleic acid (RNA) extraction. RNA concentration and quality were measured using the NanoDrop ND-1000 spectrophotometer (NanoDrop Technologies, www.nanodrop.com). Microarrays were prepared and the integrity of total RNA was checked using an Agilent 2100 bioanalyzer (Agilent Technologies, Santa Clara, CA, USA; www.agilent.com) and data were acquired using Agilent’s G2565BA microarray scanner system.

In all, the team analyzed 322 genes involved in the immune system and after extensive screening; eight specific genes were identified as playing a significant role in glioblastoma multiforme. Even after controlling for factors such as treatment type, those in the high-risk genetic group were twice more likely to have a shorter survival time than those in the low-risk group. The high-risk group survived an average of 348 days after diagnosis while the low-risk group survived an average of 493 days. Those in the high-risk group were also likely to have a shorter time between diagnosis and the first signs that the tumor was becoming worse, 242 days compared with 369 for the lower-risk group. The study was published on May 25, 2016, in the journal Neurology. LabMedica International February-March/2017

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LabMedica International

Device Offers More Effective Diagnosis of Blood Disorders esearchers have developed a microfluidic device with fixed endothelial cells to mimic cellular and vascular flow conditions inside a patient’s body, which could help monitor blood clot formation, diagnose effectiveness of antiplatelet therapy, and prevent dysfunctional hemostasis. When in dysfunction, the vascular endothelium (tissue that lines the blood vessels) plays a major role in the development of many diseases because endothelial cells are sensitive to blood flow and interact with blood cells through surface molecules. In normal hemostasis, the endothelium prevents life-threatening blood loss and clot formation, but dysfunction or inflammation may result in aberrant blood coagulation leading to blockages or hemorrhage. “Abnormal blood coagulation and platelet activation are major medical problems and the ways we study them now are overly simplified,” said Prof. Donald Ingber, MD, PhD, founding directlor of the Wyss Institute for Biologically Inspired Engineering at Harvard University (Boston, MA, USA; http://wyss.harvard.edu), “Clinicians currently do not have tools to monitor hemostasis that take into account physiologically important interactions between endothelial cells and flowing blood.” The crucial interface between endothelial cells and circulating blood has not been replicated in a practical diagnostic device due to the challenge of incorporating living endothelial cells into a robust testing tool. In the new study, a Wyss Institute team led by Prof. Ingber has discovered that endothelial cells need not be “living” in order to confer their effects on blood coagulation. By microengineering tiny hollow channels lined by chemically fixed human endothelial cells that mimic cellular and vascular flow conditions inside a patient’s body, a new device developed by the team could monitor blood clot formation and diagnose effectiveness of antiplatelet therapy. “It’s a bioinspired device that contains the endothelial function of a diseased patient without having actual living cells, and this greatly increases the robustness of the device,” said first author Abhishek Jain, PhD, assistant professor at Texas A&M University, former Wyss Institute postdoctoral fellow. This blood coagulation diagnostic can even be used to study the effects of endothelial inflammation on the formation of blood clots, which is highly relevant in patients suffering from atherosclerosis. “This is one of the first examples of how a microfluidic cell culture system could have added value in clinical diagnostics,” said study co-author Andries van der Meer, PhD, former Wyss Institute postdoctoral fellow, now assistant professor at University of Twente, The Netherlands, “Using chemically fixed tissue that is no longer alive offers a clear, low-risk path toward further testing and product development.” A previous study by Prof. Ingber and team showed that recreating the physicality and blood flow of vasculature within microfluidic channels allowed them to predict precise times that blood

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might clot, with potential applications in real-time monitoring of patients receiving intravenous anticoagulants in order to prevent complications such as stroke and vascular occlusion. The new device adds another layer of complexity by embedding the functionality of the vascular endothelium within a diagnostic tool that might be manufactured, stored, and shipped for clinical use, which was not considered possible. “Our efforts to mimic the vascular system in a meaningful way within a microfluidic device has led to two avenues of technology development,” said Prof. Ingber, “Together they represent a new suite of physiologically relevant microdevices.” The study, by Jain A et al, was published online July 27, 2016, in the journal Biomedical Microdevices.

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Image: The new device emulates the interface between the endothelium and circulating blood, opening new doors to diagnosing blood clotting diseases caused by dysfunction or inflammation of endothelial cells, which line all blood vessels and influence the process of hemostasis (Image courtesy of the Wyss Institute at Harvard University).

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PRODUCT NEWS HEMATOLOGY SYSTEM

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Abbott Diagnostics

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The CELL-DYN Emerald 22 allows programming of startup and shutdown to occur automatically each workday. It delivers a full CBC and five-part optical differential in a compact design, which is ideal for smaller laboratories seeking greater productivity under tighter space limitations.

The GloCyte CSF uses a combination of fluorescence technology, highly specific reagents, and an intelligent counting algorithm. Its quick assay procedure generates results with only 30 µL of sample per test, and provides accurate cell counts at clinically relevant low levels.

The EasyBloodGas analyzer combines calibrating gases and liquid buffers to create a reagent module containing single-phase calibrants. It measures pH, PCO2, and PO2, and calculates 11 additional parameters, while allowing patient parameters to be entered and integrated into the results.

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Norovirus Assays Compared in Acute Gastroenteritis Patients oroviruses (NoVs) are the most common cause of acute viral gastroenteritis worldwide and they affect all age group and are frequently involved in outbreaks in communal facilities, such as hospitals, schools, prisons, cruise ships. Norovirus infections mainly cause nausea, vomiting, diarrhea and fever, the symptoms are generally of a relatively short duration and they usually resolve within 2 to 6 days. The virus affects approximately 267 million people and causes over 200,000 deaths each year. NoVs include six distinct genogroups, and NoV GI and GII are the most frequently detected in human infections, while NoV GIV is also implicated in human gastroenteritis. Scientists at the Fondazione IRCCS Policlinico San Matteo (Pavia, Italy; www.sanmatteo.org) and their colleagues collected 173 stool samples during the period February 2012 to April 2014 from 173 adult patients hospitalized with acute gastrointestinal syndromes, patient age ranged from 29 years to 101 years (median age 79 years). Acute gastroenteritis was defined as the rapid onset of two or more

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of the following symptoms: diarrhea, vomiting, nausea, fever or abdominal pain.185 (5) The stool samples were tested in parallel with a laboratory developed (LD) real-time reverse transcription-polymerase chain reaction (RT-PCR) assay and with Xpert Norovirus Assay (Cepheid, Sunnyvale, CA, USA; www.cepheid.com). Both the LD real-time RT-PCR assays and the new molecular “on demand” test Xpert Norovirus Assay are designed to detect NoV GI and GII. Stored archival samples volumes were tested with two specific NoV realtime RT PCR assays, one targeting a portion of NoV GI capsid gene and the other targeting a portion of NoV GII ORF1-ORF2 junction gene. When the scientists used the Xpert Norovirus Assay, 62/173 (36.0%) samples were positive: one for NoV GI and 61 for NoV GII, while 111/173 (64.0%) samples were negative. The laboratory real-time RT-PCR assays detected NoV in 65/173 (37.5%) samples: one NoV GI and 64 NoV GII, while 108/173 (62.5%) were negative. The Xpert Norovirus Assay results were concordant with results obtained using LD real time RT-PCR in 62/65

(95.4%) samples tested, while in 3/65 (4.6%) samples were discordant. The study was published online on May 4, 2016, in the journal Diagnostic Microbiology and Infectious Disease. Image: The Xpert Norovirus assay cartridge (Photo courtesy of Cepheid).

Urine Tests for Dehydrated Older Adults Questioned ater-loss dehydration happens when people do not drink enough fluid and urine tests are widely used by doctors, nurses and other health professionals to screen for waterloss dehydration among older people. Water-loss dehydration is associated with poor health outcomes such as disability and mortality in older people and urine specific gravity (USG), urine color, and urine osmolality have been widely advocated for screening for dehydration in older adults. Scientists at the University of East Anglia (Norwich, UK; www.uea.ac.uk) and their colleagues assessed 383 men and women aged over 65 living in residential care, nursing homes, or in their own homes in Norfolk and Suffolk. The team tested the participants by measuring serum osmolality to assess

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whether they were drinking enough to stay hydrated and compared the results with urine samples taken at the same time. They tested urine for color, cloudiness, specific gravity, osmolality, volume, glucose, and pH. Directly measured serum osmolality was assessed in all samples and was measured by depression of freezing point using a Model 2020 osmometer (Advanced Instruments; Norwood, MA, USA; www.aicompanies.com) with a repeatability of 63 mOsm/kg (±1 SD) in the 0–400-mOsm region. Urine measures included urine specific gravity (USG), determined by dipstick and refractometer; urine color; cloudiness; volume; other dipstick tests including glucose, ketones, blood, pH, protein, nitrite, and leukocytes. The scientists found that the diagnostic accuracy of

urine tests is too low to be useful and that the tests should not be used to indicate hydration status in older people. Lee Hooper, PhD, the lead author of the study said, “Dark urine and high urine specific gravity have long been described as clinical indicators of dehydration, with nursing and medical text books, reviews, guidelines and public websites all advocating their use. We wanted to test their accuracy. Urinary tests rely on normal kidney function. While urine tests do seem to be able to indicate hydration status in children and younger adults, ageing is associated with impaired kidney function. As we get older we cannot concentrate our urine as well as younger people, so urine tests are not useful in older adults for indicating hydration.” The study was published on May 25, 2016. in the The American Journal of Clinical Nutrition. LabMedica International February-March/2017

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LabMedica International

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CE-Marked Blood Analyzer Interfaces with Popular Data Management System nique point-of-care (POC) connectivity to a widely used information transfer and management system is now available for a novel in-line arterial blood analyzer that supports rapid and frequent measurement of blood gases, electrolytes, and metabolites to monitor critical care patients without leaving bedside. The CE-marked Proxima blood analysis device from Sphere Medical (Cambridgeshire UK; www.spheremedical.com) can now be connected into the family of laboratory information system interfaces and data management solutions from Conworx Technology (Berlin, Germany; www.conworx.com). This is a significant development since it provides near real-time feedback and ensures seamless transfer of test results from Proxim directly into laboratory information management systems (LIMSs) and electronic patient records – a key requirement for the successful implementation of POC testing. Proxima supports patient critical care, including in the ICU and OR. The device sensor is a miniaturized blood gas analyzer integrated directly into the patient’s arterial line so that analyzed blood is returned to the patient. A dedicated bedside monitor with touch screen interface also provides simple, clear user-guiding routines. With the new software drivers, users will be able to directly import diagnostics data from Proxima at patient bedside into Conworx’s POCcelerator, UniPOC middleware data management systems. In addition, the new interface will allow direct connectivity into CliniSys, a LIMS, through the CliniSys PoCT Solutions interface. Both Conworx and CliniSys software solutions are being used in many hospitals globally, which would help ensure that data transfer from Proxima can be easily implemented, and its use and performance readily monitored remotely. Conworx’s middleware solutions provide connectivity, management, and integration for over 150 different POCT device types, as well as all relevant information and patient record systems. The Conworx base currently includes 1800 hospitals in 25 countries, and CliniSys software systems are used in over 2500 laboratories in 35 countries. Sphere Medical CEO, Wolfgang Rencken, said: “This presents a huge step forward into integrating data from Proxima into laboratory information systems and electronic patient records. Partnering with Conworx allows our customers to use one middleware solution for all of their POC connectivity needs and greatly simplifies the implementation of Proxima within the hospital.” Conworx CEO, Roman Rosenkranz, said: “We are delighted to be able to offer the first interface to an ex-vivo analyzer, which provides a seamless connection from the patient right through to the laboratory information system.”

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Image: The Proxima blood gas analysis system can be connected into LIS and data management systems of Conworx (Photo courtesy of Sphere Medical). LabMedica International February-March/2017

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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

IFCC Secretary and Treasurer Elections: Candidates Announced for 2018-20 Term by Dr Bernard GOUGET, Chair, IFCC Nominations Committee he IFCC Nominations Committee received four nominations for IFCC Secretary and four nominations for the IFCC Treasurer positions for the term 1 January 2018 until 31 December 2020. The eight candidates have been nominated by their National Societies and they have given a written consent for their candidacy. All applications were declared valid. The candidates are: For the IFCC Secretary Position: David Kinniburgh, Canadian Society of Clinical Chemists (CSCC); Joseph Lopez, Malaysian Association of Clinical Biochemists (MACB); Tahir Pillay, South African Association of Clinical Biochemistry (SAACB); Rosa Sierra-Amor, Mexican Association of Clinical Laboratory Sciences (MACLS) For the IFCC Treasurer Position: Alexander Haliassos, Greek Society of Clinical Chemistry – Clinical Biochemistry (GSCC-CB); Klaus Khose, German Society of Clinical Chemistry and Laboratory Medicine (DGKL); Tomris Ozben, Turkish Biochemical Society (TBS); Binod Kumar Yadav, Nepal Association for Medical Laboratory Science (NAMLS) The full details of each candidate’s nomination including a personal statement are available on the IFCC website. All IFCC Officers’ elections take place electronically; according to this, the electronic ballot for the election of the Secretary and Treasurer positions, is held from 1-30 April 2017. IFCC full members, in good standing, constitute the voting members. Voting process’ details will be provided by the IFCC office as of February 2017.

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Candidates for IFCC Secretary Position

David Kinniburgh

Joseph Lopez

Alexander Haliassos

Klaus Khose

Tahir Pillay

Rosa Sierra-Amor

Tomris Ozben

Binod Kumar Yadav

Lab-Surfing.com: IFCC Online Network to Connect Young Scientists Around the World ab-Surfing (www.lab-surfing.com) is a laboratory social medium designed and created in order to fulfill the unattended needs of Young Scientists (YS). Results from a global survey showed communication and exchange programme deficits for young scientists. During the current era of continuously evolving professions with upcoming technologies and methods, exchange programme and communication proved to be essential for young laboratorians. Information and Communication Technologies (ICTs) are an easy and efficient way to connect people from all around the globe. Thus, willing to address these needs the IFCC-TFYS came up with the idea of creating a professional social medium exclusively for Young Laboratory Medicine Scientists, and named it Lab-Surfing.

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Aims: Principal aims: Connect YS from all around the world; Improve communication among scientists; Create a fast and easy way to find YS anywhere in the world; Improve networking and cooperation among world colleagues; Develop scientific projects with colleagues from other regions; Make exchange programme easier. Secondary aims: Increase IFCC visibility in developing

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Candidates for IFCC Treasurer Position

countries; Improve Clinical Chemistry and Laboratory Medicine in hospitals with YS; Denote the important role of YS in Laboratory Medicine; Make better use of Information and Communication Technologies (ICTs). Objectives: In order to expand and develop the YS online group, we have created a professional social medium system (website) where YS can help each other to grow and expand their horizons in our profession. Please examine and then promote the Lab-Surfing to members, and especially YS, in your society or company.


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

NEWS VIEWPOINT

Evolution of Medical Labs in France: Economic, Managerial And Architectural Challenges by Dr. Bernard Gouget Counselor for Public Health FHF; Chair-Human Health Care Committee-COFRAC; IFCC Chair-Nominations Committee; General Secretary of the International Francophone Federation Of Clinical Biology and Laboratory Medicine (FIFBCML)

hat is more today we, specialists in Laboratory Medicine, stand for shared values and interest which we can only champion with combined forces at European and International stages. Despite a challenging climate, the evolution of the laboratory medicine is bright in a competitive landscape, driven by the shift to preventive healthcare from curative healthcare. Many challenges have to be tackled. The demand of biological tests is growing with an increase in the incidence of infectious diseases, cardiac disorders, and other chronic disorders, as well as by the increase the percentage of elderly people. In the same way, the growing interest in personalized medicine is boosting the genetic testing market. Technological advances such as automation, biosensor technology, miniaturization, integration of workstations, information technology and mobile health will lead to an increased demand for innovative technologies and will drive the need for further architectures for the medical lab including consolidation versus decentralization, and news demand for specialized testing. In addition, short turnaround times, improved specificity, accuracy, quality management, and

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making data useful are essential. Automation and IT networks are changing the spatial structure of diagnostic testing services and the effects occur across organizational, architectural, and legal scales. Broad scale effects include the simultaneous proliferation of POCT. Reconciling the approaches will require developing integrated lab design strategy including both economic and technical data. The patient can expect better clinical outcomes, and the medical laboratory is well placed to address these challenges â&#x20AC;&#x201C; to find solutions for unmet bio-clinical needs and meeting the challenge of cost-effectiveness. In France, to recognize and reward the added value of lab medicine, the law 2013-442 from May 30, 2013, was enacted after many obstacles in order to reform the field of medical biology. There are four major objectives in the new law: To enhance the medicalization of the profession and to clarify academic training. Only medical doctors and pharmacists with a specialized diploma in laboratory medicine (4 years) can be recognized as medical biologists (10 years in total); To harmonize public and private practice;

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To define the organization of laboratory medicine with a new definition of the laboratory, which could be a multisite lab (one lab for a single hospital or for different hospitals; the private labs could have many sites under same management); To ensure the quality of medical biology tests, implementing mandatory accreditation for 100% of the tests. All the labs have to be accredited for 50% of the tests by December 31, 2017. Lower expenses, higher productivity, working in network and consolidation of the medical labs through regional organization were the clearly common goals. France presents several advantages when compared with other European countries as a highdensity and stable demography of the medical biologists. As of January 1, 2016, there were a total of 10,442 medical biologists: 2,975 medical doctors-medical biologists in France and 7,467 pharmacists-medical biologists. The French medical biologist is covering all the specialities of lab medicine, and is also allowed to adapt the medical prescription after discussion with the medical doctors if necessary in order to promote the right prescription for a better diagnosis. From an economic point of view, the GDP in France was EUR 2,183 billion for 2015. Medical biology represents 1.8% of routine health care expenses and 9.5% of consumption of ambulatory health care. Total expenses supported by the National Health Care system is EUR 4.3 billion for the private sector, and EUR 2.4 billion for the public sector. The medical biology tests are carried out in a laboratory of medical biology (LBM) located on one or more sites either in the same health territory, and at the maximum, in three adjoining health territories. An LBM is operated by a private structure or within a public health facility. The majority of private structures is operated in the form of Liberal Societies (SELs), but may also constitute own-name businesses or professional civil societies (SCPs), cooperative societies, nonprofit organizations, associations, foundations or health cooperation groups. The company that operates a private medical biology laboratory is

registered with the National Order of Medical Doctors or Pharmacists (Section G). The ARS (Regional Authority of Health) permits the opening of an LBM and the control of its activity. France is the first country with a mandatory accreditation based on NF EN ISO 15189 and 22870 standards. The agenda is: 50% of medical biology tests to be accredited by November 1, 2017, and 100% of tests to be accredited by November 1, 2020. The accreditation process is under the responsibility of the COFRAC, a unique national body recognized by law. There is a need to increase the number of technical assessors â&#x20AC;&#x201C; a hard task due the new territorial reorganization of the French healthcare system. Accreditation requires strong efforts from the lab medicine community and lab professionals are very much involved in it. In 2010, there were 5,000 medical labs (LBM) in France, while today that has been reduced to a total of 951 LBMs in the country. Mandatory accreditation directly impacted consolidation of the private labs and the new law on the modernization of the French healthcare system (January 2016). Setting up the territorial hospital groups (GHT) for the public hospitals will, by a common medical project and emphasis on mutualization, revitalize projects for cooperation in medical biology. Economic constraints and medico-economic studies of multi-site LBMs favor gains in productivity and economies of scale, in order to reinvest in the latest technological innovations. POCT in hospital critical care settings and for home care will play a major part in improving patient outcomes and reducing healthcare costs. All lab medicine practices must demonstrate their ability to meet at least minimum quality management standards, while aiming for excellence. The mandatory nature of practice accreditation will then become a natural concept in the future, as increasing numbers of practices seek it. Accordingly, French reform of medical biology offers better visibility and a central place for the biological diagnosis, thereby improving diagnostic pathways and clinical outcomes. There is a need to develop new organizations, new spaces for our expertise and practices, and new informatics, in order to be closer to various stakeholders. Due to the effects of globalization and rapid development in scientific communications, European and international collaboration is the way forward in order to harmonize scientific training, standardize tests, and improve the quality and impact of advances in research. A lecture will be given at The 13th EFLM Symposium for Balkan Region organized on September 21st and 22 2017 in Beograd (Serbia). LabMedica International February-March/2017

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NEWS

The IFCC Working Group “Laboratory Errors and Patient Safety” Project on Quality Indicators The Finding of Consensus Conference “Harmonization of Quality Indicators in Laboratory Medicine: Two Years Later” by Laura Sciacovelli and Mario Plebani on behalf of IFCC WG “Laboratory Errors and Patient Safety” n effective Quality Indicators (QIs) system should be part of a coherent and coordinated quality improvement strategy and should be constantly reviewed and updated in order to comply with accreditation requirements and scientific recommendations; support efforts to continuously improve laboratory performances; enhance the value of both Total Testing Process (TTP) and clinical practice, and, finally, be effective in evaluating patient outcomes. The Working Group “Laboratory Errors and Patient Safety” (WGLEPS) of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has since 2008, implemented a project aimed at defining a common Model of QIs (MQI) and a harmonized method of data collection and available to laboratories all over the world through an External Quality Assurance Program (EQAP) in which confidentiality is guaranteed and participation is free. In recent years, the MQI, managed in the EQAP, is proving to be an important tool that not only provides the TTP error rates and divulges awareness of the value of QIs in enhancing patient safety, but also highlights the more critical aspects interfering with the widespread and appropriate use of QIs themselves.

has been used since 2014. Some quality indicator definitions have been modified to allow a better comprehension about the meaning of each indicator to interested laboratory professionals. Some QIs have been added and others deleted. A priority score (1 is the highest priority) was assigned to each indicator in order to assist laboratories to gradually introduce QIs into routine practice and the reporting system has been simplified to allow homogeneous data collection. A criterion to identify Quality Specifications (QSs) for the assessing of laboratory’s performance has also been proposed. The reviewed and improved MQI was tested until a further Consensus Conference was organized in Padova on 26th October , 2016 and titled “Harmonization of quality indicators in Laboratory Medicine: two years later?”. The aim of the Conference was to bring together all the experts and interested parties in order to discuss the results of the MQI testing and and in order to better understand the data collection feasibility of all QIs by clinical laboratories operating at international level and in different countries; investigate if QIs are still valid or if they should be changed or improved; identify all possible improvement and achieve a consensus towards harmonization of QIs.

MQI project over the years In 2008, a preliminary MQI was developed and tested under real conditions by laboratories involved in order to check the suitability of each quality indicator and the feasibility of the reporting system and this has allowed improvements to be made for the definitions of each quality indicator, design of the Model, identification of the most appropriate possible data collection procedure and ways in which the reporting system could be of the greatest possible benefit. All findings from the use of QIs during the experimental phase, and the list of QIs have been discussed in the Consensus Conference held in Padova in 2013 (”Harmonization of quality indicators: why, how and when?”) and a series of questions have been circulated among all invited delegates to achieve a preliminary consensus on terminology, rationale, purpose of each and all QIs and procedures of data collection. A reviewed MQI has been issued, after the Consensus Conference, and

Findings from the Consensus Conference The list of QIs, included in the MQI, was presented to the meeting with an opportunity of discussion and feedback by conference participants. After discussing the MQI in use, and answering a series of related questions, all experts agreed to work on the revision of currently available QIs, starting from the already described IFCC MQI, taking into consideration the relevance of each QI, its generalizability and applicability by clinical laboratories from different countries. All speakers accepted to present their experience on QIs focusing on the main advantages and limitations of their experiences, as well as on eventual agreement and disagreement with the IFCC WG LEPS program. In particular in the Consensus Conference the following items were discussed: The use of QIs in Laboratory Medicine is necessary to identify and monitor the critical activities acknowledged as error-prone and to

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Laura Sciacovelli

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Mario Plebani

A criterion to define the Quality Specifications to evaluate the QIs data, has been defined on the basis of the State-of-the-Art, as suggested in the Strategic Conference “Defining analytical performance goals 15 years after the Stockholm Conference on Quality Specifications in laboratory Medicine“ held in Milan in 2014. Exchanges of cont’d on page 30

comply with the requirements of International Standard ISO 15189. Moreover, it is an approved tool of Risk Management procedures. The use of an approved MQI and reporting system in clinical laboratories, through an External Quality Assurance Scheme, guarantees the identification of reliable Stateof-the-Art concerning the error rate in the TTP;

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NEWS

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

News from the IFCC Committee on Clinical Laboratory Management (C-CLM) by Sedef Yenice (Chair), Ed Randell, Matthias Orth, Aye aye Khine, Modupe Kuti - IFCC Committee on Clinical Laboratory Management (C-CLM) he Committee on Clinical Laboratory Management (C-CLM) is a Committee of the Education and Management Division of IFCC whose major role is to promote strong laboratory leadership and management skills among laboratory professionals. This is done through providing resources and educational materials to build these skills. Beginning early April 2016, the C-CLM has been busy on a couple of projects including updating the website in order to make it a more user-friendly and convenient platform to showcase projects and resources of C-CLM and to facilitate its primary directives. C-CLM has launched a dynamic website that reflects C-CLM’s major tasks to include updated materials on C-CLM’s focus areas. The new website main page design presents the mission and purpose of C-CLM, introduces its full members and its target groups. From there one can learn more about C-CLM and its activities through links to its updated terms of reference, a list of its international team of full and corresponding members, a page from which all C-CLM publications and documents can be downloaded and a page providing a glossary of terms relevant to laboratory leadership and management. Using bold graphics and images and plain language principles, the new site increases awareness of clinical laboratory management and highlights C-CLM’s efforts to contribute to this field.

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In addition to the visual enhancements, the new website is also easier to navigate. New features include: Quotes - related to leadership and team management in an attempt to provide values and inspire discussion on topics that impact the clinical laboratories worldwide. We have the quotes to be rotated on the fortnightly basis that laboratory professionals can share with their team members. Thanks to Sean Glaze, the owner of the website “the greatresultsteambuilding.net” for his kind contribution; Definition of Terms - directs the audience to the information they need; Terms of Reference - includes the Purpose, Amendment, Modification or Validation and Related Policies/Bylaws; Membership - integrates general Information to foster improved communication with our full and corresponding members and introduces our collaborators; Roles and Responsibilities - emphasize Accountability, Review, Working Methods, Committee Meetings and Sharing of Information and Resources; Meetings and Minutes – comprise Upcoming Committee Meetings and Annual Committee Meeting Minutes; Publications and Survey Reports; Recorded Presentations - cover the C-CLM Online Courses, Training Modules and recorded presentations; Glossary of Terms - includes the definitions and the sources; Clinical Laboratory Management Toolbox - includes IFCC and Non-IFCC Materials Related to Clinical Laboratory Management, and Useful Websites.

The new face of C-CLM website is helping to expand the reach of the activities C-CLM undertakes - bringing the power of scientific expertise and on-the-ground experience to the global clinical laboratory community. We welcome all laboratory professionals wishing to develop good clinical laboratory leadership and management skills, especially in developing countries, to check out and also keep checking the website for updates. The C-CLM invites comments and feedback on its developing projects and recommendations on where to focus future projects. Contact the chair at sedefyenice@gmail.com, or visit www.ifcc.org/ifcc-education-division/emd-committees/c-clm/

IFCC Working Group “Laboratory Errors and Patient Safety” Project on Quality Indicators cont’d from page 29

views on the appropriateness to identify three different limits (high, medium, low) for the definition of the laboratory performance, or one (acceptable), emerged and is still under discussion; Involvement of Scientific Societies, Accreditation bodies and the Providers of External Quality Assessment Schemes/proficiency testing of different countries as a tool to divulge the project and promote participation of laboratories in the MQI project; Selection and nomination of a National Leader, to coordinate and manage the MQI project in each Country; Definition of guidelines supporting the use of QIs and implementation of improvement actions in clinical laboratories; Information included in the report provided to laboratories participating in the project have been considered adequate and useful to identify the laboratory performance compared with that of other laboratories both in the same country and all over the world. Conclusion The last Consensus Conference represents another step towards the harmonization of the use of QIs in Laboratory Medicine. In the quality journey, the continuous revision and updating of assurance tools is an important task of laboratory professionals. In fact, the analysis of criteria and quality specifications on the basis of the current State-of-the-Art is important to perform improvement activities. Quality Indicators are a strategic tool to assess and monitor the critical steps of the TTP and their use is required for Accreditation according to ISO 15189. A harmonized MQI and reporting system used in clinical laboratories all over

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the world assures the identification of the actual State-of-the-Art and, consequently, reliable quality specifications. All laboratories are called on to participate in the project in order to promote the improvement process on behalf of patient safety. References 1. ISO 15189:2012. Medical laboratories – requirements for quality and competence. Geneva, Switzerland: International Organization for Standardization, 2012. 2. Plebani M, Astion ML, Barth JH, Chen W, de Oliveira Galoro CA, Escuer MI, Ivanov A, Miller WG, Petinos P, Sciacovelli L, Shcolnik W, Simundic AM, Sumarac Z. Harmonization of quality indicators in laboratory medicine. A preliminary consensus. Clin Chem Lab Med. 2014;52:951-8. 3. Plebani M, Sciacovelli L, Marinova M, Marcuccitti J, Chiozza ML. Quality indicators in laboratory medicine: a fundamental tool for quality and patient safety. Clin Biochem. 2013;46:1170-4. 4. Plebani M, Chiozza ML, Sciacovelli L. Towards harmonization of quality indicators in laboratory medicine. Clin Chem Lab Med 2013;51:187-95. 5. Plebani M, Sciacovelli L, Lippi G. Quality indicators for laboratory diagnostics: consensus is needed. Ann Clin Biochem 2011;48:479. 6. Sciacovelli L, O'Kane M, Skaik YA, Caciagli P, Pellegrini C, Da Rin G, Ivanov A, Ghys T, Plebani M; IFCC WG-LEPS.. Quality Indicators in Laboratory Medicine: from theory to practice. Preliminary data from the IFCC Working Group Project "Laboratory Errors and Patient Safety". Clin Chem Lab Med 2011;49:835-44. 7. Sciacovelli L, Sonntag O, Padoan A, Zambon CF, Carraro P, Plebani M. Monitoring quality indicators in laboratory medicine does not automatically result in quality improvement. Clin Chem Lab Med 2011;50:463-9. 8. Sciacovelli L, Plebani M. The IFCC Working Group on laboratory errors and patient safety. Clin Chim Acta 2009;404:79-85.

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 LabMedica International February-March/2017

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

NEWS

Bolivian Continuing Education Program Extends Training Courses in Cooperation With Foundation Bioquimica Argentina by Dr. Alvaro Justiniano Grosz; Bolivian Society of Clinical Biochemistry he Bolivian Society of Clinical Biochemistry has launched the Bolivian Continuing Education Program (PROBOECO) instrument that allows biochemistry professionals in Bolivia to access classroom and distance courses and get training in current issues with the objective being to qualify professionals in the daily performance of their activities within clinical laboratories. This has been done within the framework of the cooperation agreement that the organization has with the Argentina Biochemistry Foundation which has a lot of experience and an extensive programme of continuing education in Argentina. This program will be endorsed by the new Directive of the Bolivian Society of Clinical Biochemistry. The society has made the decision that Bolivianos professionals should undergo continuous training and keep up with the current challenges and demands of the world where the development of knowledge and new technologies require the assistance of trained and skilled professionals in laboratory medicine. This will demonstrate high academic and professional standards in the delicate mis-

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sion of providing quality and accuracy in conducting laboratory tests, so that they become indispensable agents in the multidisciplinary health team and thus cooperate efficiently in solving the multiple health problems facing our country. As for the structure of the Bolivian Continuing Education Program, there are strict rules provided for in the Constitution of Bolivian Society of Clinical Biochemistry to ensure compliance and the same holds for the formation of a National Council of the Bolivian Continuing Education Program with each department being represented and strong support of the National Executive Committee. This provides guidelines for the organization of courses according to the various requirements and needs of departments. With the excellent participation of Bolivian biochemists we plan to hold the following courses: Clinical Update, Immune Diagnosis and Diseases Associated with Coeliac Disease by Dra. María E. Lasta in Santa Cruz; Infections of female genital tract and the neonate - The Role of the Laboratory by Dra. Susana Di Bartolomeo in San-

IFCC Task Force on Ethics by Ann M. Gronowski, PhD; Prof. of Pathology and of Obstetrics and Gynecology; Chair, Task Force on Ethics (TF-E) thical issues have been given limited attention by professionals in laboratory medicine. Specific issues that challenge laboratory professionals include: allocation of health-care resources, testing conducted nearer the patient, confidentiality, screening tests, direct-to-consumer testing, conflicts of interest, residual specimen use, add-on testing, whole genome sequencing, preimplantation genetics and research/ publication ethics. The IFCC Task Force on Ethics is a long-standing task force that aims to: increase awareness among Laboratory Medicine Professionals of ethical issues; encourage the practice of Laboratory Medicine to the highest ethical standards; develop position papers on appropriate ethics policies issues; provide a voice for Laboratory Medicine on ethics policies; and, link Laboratory Medicine, ethics and the public interest. In recent years, this task force has been very active. In 2015 the group published a Survey of teaching of ethics published an article entitled "Variability of ethics education in laboratory medicine training programs: results of an international survey". (Clin Chim Acta 2015, 442:115-118. www.ncbi.nlm.nih. gov/pubmed/25437910) The study concluded that formal teaching of ethics is absent from many training programs in

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clinical chemistry and laboratory medicine. There is a perceived need for online training tools in ethics, especially tools with self-assessment components. As a result of these findings, the Task Force has been active in creating on-line training tools that teach ethics in laboratory medicine. In 2016, the group produced a chapter entitled "Ethical Considerations in Clinical Chemistry and Laboratory Medicine" that is posted on the IFCC website at www.ifcc.org/executiveboard-and-council/eb-task-forces/taskforceethics. The group also produced three teaching modules entitled: "Ethics in Laboratory Medicine", "Ethics Education" and "Publication Ethics". These modules are available on the IFCC website. Plans for 2017 include the creation of an ethics "toolbox" for Member Societies which will include examples of conflict of interest statements and codes of ethics from member societies. The group is also working on additional teaching modules on ethical considerations of biobanking and ethical cases in laboratory medicine. In June at the IFCC-EFLM EuroMedLab, the Task Force is hosting a symposium entitled "Ethical Issues in Laboratory Medicine" which will be held on Thursday, June 15, 2017 at 10:30 AM – 12:30 PM.

ta Cruz; Advances in the Physiology of Testicular and Ovarian Function Assessment in the Clinical Laboratory by Dr. Daniel R. Aquilano in La Paz; Infertility: Bacteriological, Immunological and Molecular Aspects by Dra. Adriana S. Brufman in La Paz; Cancer, Cancer Markers by Dra. Halina Grosman in Cochabamba; Advances in the Physiology of Testicular and Ovarian Function Assessment in the Clinical Laboratory by Daniel R. Aquilano in Cochabamba; Clinical Update, Immune Diagnosis and Diseases Associated with Coeliac Disease by Dra. María E. Lasta in Tarija; Cancer, Cancer Markers by Dra. Halina Grosman in Sucre; Infections of female genital tract and the neonate - The Role of the Laboratory by Dra. Susana Di Bartolomeo in Beni; Infertility: Bacteriological, Immunological and Molecular Aspects by Dra. Adriana S. Brufman in Oruro. In this first cycle I will be able to reach seven of the nine departments of Bolivia, which means that professional laboratory biochemists dedicated to the area will benefit from the direct presence of outstanding professionals who will present topics. In these training ac-

Photo: Dr Alvaro Justiniano Grosz addresses the course participants. tivities we can reach more than 500 biochemists across the country and nearly 300 final year biochemistry students from the different Bolivian universities that produce professional biochemists. In making an assessment of this first cycle, we face two major challenges; reaching across the country in person and directly and the need to develop an ambitious training programme for 2017, and develop a platform for virtual courses and expand our national coverage across the distances to benefit professionals who because of travel costs may not benefit from such courses.


Industry News

Top Five In Vitro Diagnostic Trends for 2016 ompanies in the global in vitro diagnostic (IVD) market, currently worth USD 60.5 billion, are being affected by various trends such as hospital consolidation, China’s increasingly important role in product launch decisions, service test markets, new small clinic targets, and mergers and acquisitions. These are the latest findings of Kalorama Information, (New York, NY, USA; www.kaloramainformation.com), an independent medical market research firm, which has identified the top five trends in the global IVD market for 2016. The global IVD market is responding to the trend of healthcare consolidation with a renewed

approach to core lab markets and automation systems aimed at the big accounts. Integrated health networks are increasingly demanding greater centralization of diagnostic testing to streamline workflows and direct better healthcare information to professionals. Meanwhile, in the last five years, China has strengthened its position as an IVD market close behind the US, European Union, and Japan. Apart from obtaining the US Food and Drug Administration’s (FDA) approval or European CE marking, receiving approval from the China FDA (CFDA) has now become the next significant milestone in product development for a number of IVD compa-

nies. What is particularly interesting about the significant growth of the Chinese IVD market is the growing importance of its cancer diagnostics space. Although advanced cancer testing is generally not associated with middle-income countries, China’s strong research abilities in sequencing and globally significant patient populations in the urban markets have given rise to huge opportunities for overseas IVD companies. Within the Chinese cancer diagnostics market, the highest activity is being seen in the area of next-generation sequencing (NGS), driven mainly by demand for non-invasive prenatal testing (NIPT). China’s clinical sequencer base currently includes over 40 hospitals in the region and other testing institutions catering to about 70 other hospitals and clinical clients. Cancer testing is the second-largest clinical apNE DES W plication of NGS in China. IGN Another emerging trend affecting the global IVD market is the increasing penetration of major cancer-focused US LDT companies in the EU market. However, the rising profile of LDTs in the EU could restrict the growth opWORLD’S MEDICAL PRODUCT MARKETPLACE portunities for the region’s molecular cancer diagnostics market. The increased availability of CE-marked molecular cancer kits has failed to translate into a strong growth in the IVD market segment. Nevertheless, the return of SIGN UP political stability to the region, increasingly faFOR FREE! vorable economic scenario, and growing demand for advanced LDT services, which in turn, is boosting sales of related reagents and instrumentation, has led to an improved outlook for the regional market. Molecular cancer diagnostics, which is a high-growth market segment globally, is expected to grow by about just 4% in the EU owing to market maturity (as compared to the ROW markets) and limitations on reimbursement (in comparison to the US market which has a more diversified payer system). Another notable trend is the sharp increase in urgent care centers (UCCs) numbering more than 10,000 in the US, as well as in retail clinics (1,200+), which has created a need for systems capable of dealing with the workflows generally associated with such clinics. Convenient hours are a key strength of UCCs as they offer walk-in, extended hour access for acute illness and injury care that is either beyond the scope or availability of the typical primary care practice. In comparison to traditional physicians, Connecting Buyers with UCCs have a different type of office setting Suppliers Worldwide comprising of procedure rooms for lacerations and fractures, radiology department for Reach new sources of supply providing X-ray services, and a laboratory in Identify latest products and technologies some cases. On the other hand, retail clinics Send inquiries directly to suppliers are comparatively smaller than UCCs, proReceive latest product alerts vide limited services, and are usually Chat live with suppliers manned by a single practitioner. The global IVD market also continued to TradeMed provides a sophisticated yet easy-to-use global B2B platform for sourcing medical witness brisk merger activity in 2016. Some equipment. TradeMed connects buyers and sellers worldwide through a safe, secure and dydeals have allowed larger companies to acnamic network. Solely dedicated to medical products, TradeMed is the premier choice for medquire new technologies, though a shift towards globalization of IVD knowledge is ical suppliers, hospital decisionmakers and buyers worldwide, regardless of size or budget. clearly evident.

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To view this issue in interactive digital magazine format visit www.LinkXpress.com

PerkinElmer Acquires Indian IVD Concern erkinElmer, Inc. Waltham, MA; USA; (www.perkinelmer. com), which offers products, services and solutions for the diagnostics, research, environmental, industrial and laboratory services market, has entered into a definitive agreement to acquire Tulip Diagnostics Private Ltd., (Goa, India; www.tulipgroup.com), one of India’s largest domestic providers of in-vitro diagnostic reagents, kits and instruments. PerkinElmer offers a global diagnostics portfolio focused on: reproductive health, infectious disease screening and genomics offerings for oncology and other molecular tests through its wide range of instruments, reagents, assay platforms and software offerings. The company also

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offers instruments and services to its customers in India where it even has a laboratory for providing access to technologies that screen for and help diagnose prenatal and neonatal conditions. Tulip’s solutions include products for the prevention, screening and diagnosis of infectious diseases such as malaria, HIV and hepatitis, and it has two manufacturing facilities located in India. “In-vitro diagnostics is one of the fastest growing vertical segments in India, and Tulip provides the key enablers for PerkinElmer to broaden our infectious disease screening menu and capabilities for customers throughout the region,” said Jayashree Thacker, President, PerkinElmer India.

Instrumentation Laboratory Acquires Accriva Diagnostics erfen (Barcelona, Spain; www.werfen.com) and its subsidiary Instrumentation Laboratory (IL) (Bedford, MA, USA; www.instrumentationlaboratory.com) have acquired Accriva Diagnostics (San Diego, CA, USA; www.accriva. com), which provides in vitro diagnostic (IVD) blood testing at the Point-of-Care (POC). Werfen develops, manufactures and distributes IVD testing solutions, systems, reagents and software to hospitals and clinical laboratories around the world. An integral part of Werfen, IL develops and manufactures hemostasis, critical care, and patient blood management (PBM) products. The acquisition of Accriva, whose product

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portfolio includes coagulation, platelet aggregation, CO-Oximetry, and incision devices, will allow IL to further enhance its position in hospital-based POC hemostasis testing, POC critical care testing, and the hemostasis laboratory segment. "Over the course of our 50-year history, we have demonstrated our strong commitment to expanding our IVD business through organic growth, complemented with highly strategic acquisitions," said Carlos Pascual, CEO at Werfen. "Like our recent acquisition of CA Casyso AG and its Tem subsidiaries, the acquisition of Accriva is exemplary of this commitment, as well as the confidence we have in our future together."

Agilent Technologies to Acquire Belgian Molecular Diagnostic Kits Producer gilent Technologies Inc. (Santa Clara, CA, USA; www. agilent.com) has entered into a definitive agreement to acquire European diagnostics company Multiplicom N.V. (Niel, Belgium; www. multiplicom.com), for approximately EUR 68 million in cash. Agilent, which is present in life sciences, diagnostics and applied chemical markets, provides instruments, software, services and consumables for the entire laboratory workflow. Multiplicom develops, manufactures and commercializes molecular-diagnostic solutions, provided as kits. These solutions enable

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LabMedica International February-March/2017

clinical laboratories to identify the DNA variants that are associated with a genetic disease or predisposition in patients, or that may steer cancer therapy or identify congenital defects early in pregnancy. "The acquisition of Multiplicom significantly strengthens our presence in the genomics market," said Herman Verrelst, vice president and general manager of Agilent's Genomics Division. "Multiplicom's products and technology help expand our target-enrichment portfolio and enhance our next-generation sequencing workflow capabilities – providing immediate scale in adjacent markets.”

Industry News

Qiagen Buys US Bioinformatics Firm IAGEN N.V. (Hilden, Germany; www.qiagen.com), a provider of sample and assay technologies, has acquired OmicSoft Corporation (Cary, NC, USA; www. omicsoft.com), which focuses on biomarker data management, visualization, and analysis. QIAGEN’s broad range of consumables includes complete kits for predefined applications in sample preparation and analysis and also individual enzymes and reagents that research laboratories can use to develop their own applications. QIAGEN also offers instruments for automating the full range of laboratory procedures, from the initial sample preparation to the final test result. Its solutions find applications in human healthcare, forensics, veterinary testing, food safety, pharma and biotech companies, and life sciences research. OmicSoft designs and develops bioinformatics, next generation sequencing, and cancer genomics software for biomarker data management, visualization, and analysis. Its suite of software solutions enable scientists and researchers to efficiently analyze and visualize their own data sets and

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compare them to massive volumes of publicly available ‘omics’ data sets, and share the results with colleagues. The acquisition will provide QIAGEN access to OmicSoft’s multiomics data management infrastructure solution as well as curated ‘omics’ data sets that complement its bioinformatics portfolio for gaining insights into complex biological data. With the addition of OmicSoft, QIAGEN will be able to offer solutions across the full spectrum of data management and interpretation needs. “The addition of OmicSoft to QIAGEN’s portfolio of Sample to Insight solutions reinforces our position as the gold standard for analysis and interpretation of complex biological data across many different disciplines,” said Peer M. Schatz, Chief Executive Officer of QIAGEN N.V. “The OmicSoft team has deep expertise that will enable QIAGEN to better support customers in managing vast data sets and gaining actionable insights for discovery and translational research,” said Dr. Laura Furmanski, Senior Vice President and Head of the Bioinformatics Business Area at QIAGEN.


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128 Coris Bioconcept . . . . . . . . . .28

130 Mast Group . . . . . . . . . . . . . . .30

• Fill-out all required data on Reader Service Card including signature and date (incomplete or unsigned cards cannot be processed). • Circle inquiry numbers of interest to receive free information • Fax card without delay to: ++1-954-893-0038

103 EliTech Group . . . . . . . . . . . . . .3

118 NG Biotech . . . . . . . . . . . . . . .18

112 DIASource . . . . . . . . . . . . . . .12

105 Randox . . . . . . . . . . . . . . . . . . .5

106 DiaSys . . . . . . . . . . . . . . . . . . .6

102 SNIBE . . . . . . . . . . . . . . . . . . . .2

108 EKF . . . . . . . . . . . . . . . . . . . . . .8

117 SNIBE . . . . . . . . . . . . . . . . . . .17

102 EliTech Group . . . . . . . . . . . . . .2

– TradeMed.com . . . . . . . . . . . .32

107 Erba . . . . . . . . . . . . . . . . . . . . .7

121 Veda.Lab . . . . . . . . . . . . . . . .21

109 Erba . . . . . . . . . . . . . . . . . . . . .9

129 Vicotex . . . . . . . . . . . . . . . . . .29

– EFLM Symp. Balkan Region .34

111 Zivak . . . . . . . . . . . . . . . . . . . .11

1

2

ATTENTION: IF YOUR APPLICATION IS NOT RECEIVED AT LEAST ONCE EVERY 12 MONTHS YOUR FREE SUBSCRIPTION MAY BE AUTOMATICALLY DISCONTINUED

35

LabMedica International February-March/2017

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LabMedica International March 2017