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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. 6 • 10 / 2017

DAILY CLINICAL LAB NEWS

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Blood Test Predicts Huntington’s Disease

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Reliable Test Sought for Anti-Phospholipid Antibody Syndrome

untington’s disease (HD) is a fatal genetic neurological disease. It usually develops in adulthood and causes abnormal involuntary movements, psychiatric symptoms and dementia and approximately 10,000 people in the UK have HD with around 25,000 at risk. Huntington’s disease is caused by

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sing patient-derived antibodies, researchers have succeeded to identify a peptide motif in the protein B2GP1 recognized by antibodies characteristic of the autoimmune disease anti-phospholipid antibody syndrome (APLAS). This is enabling the researchers to develop a more accurate diagnostic assay for patients with

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this disease, and could also lead to better treatment options. Binding of the APL antibodies circulating in the blood plasma leads to a tendency for abnormal increase in blood clot formation, which can lead to a range of vascular incidents, including venous thromboses, strokes, or repeated miscarriages. In APLAS,

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Molecular Test Speeds Up Multiple Sclerosis Diagnosis

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Blood Test Improves Breast Cancer Detection reast cancer is predicted to be the second leading cause of cancer deaths in the USA women. Approximately 232,000 cases of invasive breast cancer and 60,000 cases of ductal carcinoma in situ (DCIS) are diagnosed and 40,000 deaths occur annually. A multi-protein biomarker blood test that is able to detect breast cancer can help inform better decisionmaking after abnormal mammogram

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Microscopy Technique Advances Biopsy Diagnosis

pioneering blood test expedites multiple sclerosis (MS) diagnosis to just seven days, as opposed to current methods such as magnetic resonance imaging (MRI) scans that take much longer because they rely on measuring progress of irreversible neurological damage.

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Image: Courtesy of IQuity

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xpansion microscopy (ExM), is a method for improving the resolution of light microscopy by physically expanding a specimen, but so far had not been applied to clinical tissue samples. In the ExM method a tissue sample is expanded to 100 times its original volume before imaging it. This expansion allows scientists to see features with a conventional light microscope that ordinarily could be seen only with an expensive,

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ika is a mosquito-borne disease and is linked to severe congenital birth defects. Assays already exist to detect Zika virus infection, but they either work only shortly after infection or are poor at differentiating Zika from other flaviviruses.

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Simple Method Measures Bacterial Tolerance to Antibiotics

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Test Distinguishes Zika From Other Flaviviruses

growing number of pathogens are developing resistance to one or more antibiotics, threatening the ability to treat infectious diseases. Resistance is typically achieved by mutations that reduce the activity of an antibiotic, for example by decreasing drug binding to the target. Tolerance, on the other hand, is a

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poorly characterized phenomenon, and is seldom taken into account explicitly in healthcare. Unlike resistance, which is an increase of the drug concentration in which the bacteria can grow indefinitely, tolerance is an extension of the period of time that bacteria can survive in lethal concentrations of Cont’d on page 12

Clinical News . . . . . . . . . 4-28 IFCC News . . . . . . . . . . . . . 29 Product News . . . . . . . 18-26 Industry News . . . . . . . . . .33 International Calendar . . . 34 PUBLISHED IN COOPERATION WITH

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Blood Test Improves Breast Cancer Detection viene de portada

or other breast imaging results and potentially reduce use of biopsy by up to 67%. If diagnosed early in a localized state, five-year survival rates are greater than 98%. Medical scientists working with a privately held molecular diagnostics company carried out two prospective, randomized, multi-center and blinded clinical trials, in more than 1,350 patients, ages 25-75. It is the first prospective study of a proteomic assay composed of serum protein biomarkers and tumor-associated autoantibodies being used to detect breast cancer in women with abnormal imaging results. Serum was evaluated for 11 serum protein biomarkers and 33 tumor-associated autoantibodies. The team used the Videssa Breast test (Provista Diagnostics, Inc, New York, NY, USA; www.provistadx. com), which is the first blood-based proteomic test of its kind to provide early and accurate detection of breast cancer. The overall performance of the Videssa Breast test in women with a breast cancer prevalence of 5.87% resulted in a sensitivity of 87.5%, specificity of 83.8%, positive predictive value (PPV) of 25.2% and a negative predictive value (NPV) of 99.1%. The authors noted that that the high NPV helps clinicians identify patients who are highly unlikely to have breast cancer. Depending on age, approximately 70% to 90% of breast biopsies are benign. The improved PPV of Videssa Breast over imaging of 25.2% versus 8.8% can increase the percentage of biopsies that yield a breast

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

Published in cooperation with the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).

cancer diagnosis from one in 11 to one in four. Josie R. Alpers, MD, a radiologist specializing in mammography and diagnostic radiology, and co-author, said, “When a mammogram yields an abnormal result, the challenge for every clinician is to decide which patients need follow-up, further imaging or biopsy. A test that is well-validated in a prospective trial means clinicians have a new way to accurately identify which patients may or may not need additional follow-up.” The study was published on May 23, 2017, in the journal Clinical Breast Cancer. Image: The Videssa Breast protein biomarker blood test for breast cancer evaluates 11 serum protein biomarkers and 33 tumor-associated autoantibodies (Photo courtesy of Provista Diagnostics).

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Test Distinguishes Zika From Other Viral Infections viene de portada

The limited ability of assays to detect Zika virus has led to difficulty in determining the prevalence of Zika virus infections, the incidence of congenital Zika syndrome and the frequency of neurological complications associated with Zika virus infections. An international team of scientists led by those at University of California – Berkeley (CA, USA; www.berkeley.edu) developed a new test, which is the best-to-date in differentiating Zika virus infections from infections caused by similar viruses. The antibody-based assay is a simple, cost-effective way to determine if a person’s infection is from the Zika virus or another virus of the same family, such as dengue and West Nile viruses. The assay was developed using detailed patient samples from Nicaragua, a large step forward over previous studies. These samples included multiple, longitudinal samples from Zika patients, with or without prior exposure to dengue virus, and samples from dengue patients infected either once or more than once with different types of the dengue virus. The samples were obtained from a 14-year study of a cohort of children whose previous viral infection histories were well documented. These samples were central to the study, because prior dengue virus infections can cross-react and confound many current Zika antibody-based assays; having a thoroughly analyzed pool of patient samples helped the team characterize and avoid this cross-reactivity. The teams utilized the proprietary CellClone discovery technology and Humabs BioMed SA (Bellinzona, Switzerland; www.humabs.com) generated a new hu-

man antibody to the Zika virus, which the company then used to develop the assay. The assay is based on a well-established approach to detecting viral infections, but the new antibody and protocol give the assay superior sensitivity and specificity, two key assay metrics. The enzyme-linked immunosorbent assay was implemented in five countries and tested using a large number of clinical samples from travelers and patients living in areas with a high level of exposure to Zika virus and other flaviviruses. The new assay had a high sensitivity of 91.8%, and was specific and robust. When the assay was run on patients infected with Zika virus and also on a control group of 540 patients infected by other flaviviruses or other viruses, plus healthy donors, the specificity was 95.9%. The authors concluded that The ZIKV nonstructural protein 1 (NS1) blockade-of-binding ELISA assay is a simple, robust, and low-cost solution for Zika surveillance programs, seroprevalence studies, and intervention trials in flavivirus-endemic areas. Davide Corti, PhD, senior vice president and chief scientific officer of Humabs BioMed, said, “These results support that the antibody-based assay that we have developed is highly effective in detecting both recent and past Zika virus infections and in discriminating Zika from other flavivirus infections. This novel assay has the potential to become an effective, simple and low-cost solution for Zika surveillance programs, prevalence studies and clinical intervention trials in flavivirus-endemic areas.” The study was published on July 17, 2017, in the journal Proceedings of the National Academy of Sciences.

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ISSN 1068-1760 Vol.34 No.6. 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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Blood Test Predicts Huntington’s Disease viene de portada

a single known genetic mutation, and each child of a carrier of the mutation has a 50% chance of inheriting the disease. Currently, the best biomarkers available are measured with neuroimaging or cerebrospinal fluid, which are more difficult and expensive to obtain than a blood test. An international team of scientists collaborating with the University College of London (UK; www. ucl.ac.uk) investigated whether neurofilament light protein NfL (also known as NF-L) in blood is a potential prognostic marker of neurodegeneration in patients with Huntington’s disease. The team used a blood test to measure NfL, a protein released from damaged brain cells, which has been linked to other neurodegenerative diseases but has not been studied in the blood of Huntington’s disease (HD) patients before. The international project followed 366 volunteers for three years. Neurofilament light protein (NfL) were measured in plasma with an ultrasensitive single-molecule array method, the NF-Light assay (UmanDiagnostics, Umeå, Sweden; www.umandiagnostics.com) and transferred onto the Simoa platform with a homebrew kit (Quanterix Corp, Boston, MA, USA; www.quanterix.com). All NfL values were within the linear ranges of the assays. A London-based independent cohort of 37 participants (14 controls, three huntingtin gene (HTT) mutation carriers with premanifest disease and 20 participants with manifest Huntington’s disease underwent cerebrospinal fluid (CSF) and plasma collection standardized for diet, time of day, clinical procedures, and processing. NfL concentrations in CSF were quantified with the UmanDiagnostic’s enzyme-linked immunosorbent assay. The scientists found that levels of the brain protein were increased throughout the course of HD, even in carriers of the HD genetic mutation who were many years from showing symptoms of the disease. HD mutation carriers had neurofilament concentrations that were 2.6 times that of the control participants, and the level rose throughout the disease course from premanifest to stage 2 disease. In the group who had no symptoms at the start of the study, the level of neurofilament predicted subsequent disease onset, as volunteers with high neurofilament levels in the blood at the start were more likely to develop symptoms in the following three years. Edward J. Wild, MB BChir, PhD, the lead author of the study, said, “We have been trying to identify blood biomarkers to help track the progression of HD for well over a decade, and this is the best candidate that we have seen so far. This is the first time a potential blood biomarker has been identified to track Huntington’s disease so strongly.” The study was published on June 7, 2017, in the journal Lancet Neurology. Image: Scientists used a blood test to measure NfL as a potential marker of neurodegeneration in patients with Huntington’s disease (Photo courtesy of Shutterstock).

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Reliable Test Sought for Anti-Phospholipid Antibody Syndrome viene de portada

anti-β2GP1 antibodies attach themselves to antigens on the surface membrane of certain cells, particularly those of the blood vessels and placenta. This generates a signal that produces pro-inflammatory and pro-thrombotic factors that cause the vascular disease events. Diagnosis is complicated as the currently used test has a number of problems in terms of variability, specificity, and sensitivity. Now, researchers at the University of Geneva (UNIGE; Geneva, Switzerland; www.unige.ch/international/en) and the Geneva University Hospitals (HUG) have succeeded in identifying the binding motif at which the anti- 2GP1 antibodies attach, which will enable development of a more accurate and standardized diagnostic test. The target protein is the only protein in the entire human proteome to have 5 of these motifs, which gives it multiple potential binding points for the pathogenic antibody. They also established that the APL antibodies-interacting motifs are determined by the polarity, but not by the sequence or charge, of amino acids. On the importance of this discovery, Karim Brandt, researcher at UNIGE’s faculty of medicine, said: “The current diagnostic tests use the entire protein, which reduces its specificity and leads to standardization issues. Consequently, two tests are required at an interval of 12 weeks after a thrombotic episode or following one or more miscarriages. Our new test specifically targets this pathogenic antibody, with rapid and more accurate results.” APLAS is usually treated with oral anticoagulants such as low-molecular-weight heparin and aspirin, long-term treatments that are not without side effects, and that must be used with caution by pregnant women. Moreover, treatment becomes very burdensome in patients suffering from the most severe form of the disease, called “catastrophic APLAS”. Dr. Brandt stressed that the researcher team is also focusing their work in this therapeutics direction: “Our breakthrough could also give rise to a targeted treatment that would neutralize specific pathogenic antibodies, reducing not just their actions but also the side effects associated with the current treatment. It would involve injecting the protein motif we have identified into a patient’s circulatory system so that it explicitly binds itself to the pathogenic antibody and prevents it from causing harm.” The diagnostic test is being optimized for development of prototypes. To ensure validity, the researchers will reanalyze hundreds of samples already tested with the old method and compare results with the new test. The study, by de Moerloose P et al, was published May 2017 in the journal Haematologica. Image: In autoimmune diseases, the immune system wrongly identifies its “enemy”, and produces antibodies that attack the patient’s own cells. One of these diseases, the anti-phospholipid antibody syndrome (APS), is still poorly understood, even though it can have serious consequences (Photo courtesy of the University of Geneva).

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Molecular Test Speeds Up Multiple Sclerosis Diagnosis pioneering blood test expedites multiple sclerosis (MS) diagnosis to just seven days. Current testing methods such as magnetic resonance imaging (MRI) scans take much longer to reach a diagnosis because they rely on measuring the progress of irreversible neurological damage. Neurologists, especially those who specialize in MS, have a long backlog of new patients to be seen. It's not uncommon for patients to wait a couple of months before they can be seen in a clinic to either confirm or exclude the diagnosis of MS. That is a long time between a primary care physician or someone in the community is suspecting it is MS, and it is either confirmed or refuted by the clinician. Molecular diagnostics startup IQuity (Nashville, TN, USA; https://iquity.com) have introduced IsolateMS, which works by assessing patients’ RNA levels and gene expression in a blood sample. Previous IQuity’s research showed that autoimmune

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disease patients exhibit distinct long non-coding RNA (lncRNA) expression patterns in their blood that are different from individuals without the disease, suggesting that these RNA markers could be a way to diagnose autoimmune conditions. The scientists used machine-learning to create a disease-identifying algorithm by recognizing differentially expressed protein-coding genes and noncoding genes. IQuity’s suite of algorithms, IQIsolate, works by helping scientists analyze RNA markers extracted from a patient’s blood sample and matching their RNA profiles against healthy and sick patient profiles. This determines if the patient’s gene expression pattern is consistent with a specific disease. Chase Spurlock, PhD, CEO of IQuity, said, “The 90% accuracy rate of IsolateMS should give providers and patients a great deal of confidence in their results. This test augments existing clinical

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practice and eliminates the period of uncertainty that can accompany an MS diagnosis. IsolateMS allows patients and providers to begin discussing next steps immediately.”

Microscopy Technique Advances Biopsy Diagnosis viene de portada

high-resolution electron microscope. It also reveals additional molecular information that the electron microscope cannot provide. Scientists at Massachusetts Institute of Technology (Cambridge, MA, USA; www.mit.edu) and their colleagues developed a clinically optimized form of ExM that supports nanoscale imaging of human tissue specimens that have been fixed with formalin, embedded in paraffin, stained with hematoxylin and eosin, and/or fresh frozen. The method, which they call expansion pathology (ExPath), converts clinical samples into an ExM-compatible state, then applies an ExM protocol with protein anchoring and mechanical homogenization steps optimized for clinical samples. The team tested this approach on tissue samples from patients with early-stage breast lesions. One way to predict whether these lesions will become malignant is to evaluate the appearance of the cells’ nuclei. Benign lesions with atypical nuclei have about a fivefold higher probability of progressing to cancer than those with typical nuclei. However, studies have revealed significant discrepancies between the assessments of nuclear atypia performed by different pathologists, which can potentially lead to an inaccurate diagnosis and unnecessary surgery. ExPath enables ~70-nm-resolution imaging of diverse biomolecules in intact tissues using conventional diffraction-limited microscopes and standard antibody and fluorescent DNA in situ hybridization reagents. After expanding the tissue samples, the scientists analyzed them with a machine learning algorithm that can rate the nuclei based on dozens of features, including orientation, diameter, and how much they deviate from true circularity. This algorithm was able to distinguish between lesions that were likely to become invasive and those that were not, with an accuracy of 93% on expanded samples compared to only 71% on the pre-expanded tissue. They also analyzed kidney tissue samples from patients with nephrotic syndrome and when they showed the images of the expanded tissue samples to a group of scientists that included pathologists and non-pathologists, the group was able to identify the diseased tissue with 90% accuracy overall, compared to only 65% accuracy with unexpanded tissue samples. Edward S. Boyden, PhD, a professor of Biological Engineering and co-senior author of the study, said, “Now you can diagnose nephrotic kidney disease without needing an electron microscope, a very expensive machine. You can do it with a few chemicals and a light microscope. If you can expand a tissue by one-hundredfold in volume, all other things being equal, you’re getting 100 times the information.” The study was published on July 17, 2017, in the journal Nature Biotechnology. LabMedica International October/2017

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Exhaled Breath Test Discriminates COPD hronic obstructive pulmonary disease (COPD) is a type of obstructive lung disease characterized by long-term poor airflow. The main symptoms include shortness of breath and cough with sputum production. COPD is a progressive disease, meaning it typically worsens over time. Analysis of exhaled breath by real-time mass spectrometry helps discriminate between patients with chronic obstructive pulmonary disease (COPD), healthy controls, and patients with asthma. COPD is presently diagnosed based upon airflow restriction in spirometry, respiratory symptoms, and history of exposure to risk factors. Scientists at the University Hospital Zurich (Switzerland; www.zhh.ch) compared 49 patients with COPD whose mean age was 64 years 59.2% were male; 53 healthy control subjects whose mean age was 43 years and 52.8%were female, and 31 patients with asthma whose mean age was 41 years and

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64.5% were male. The team used secondary electrospray ionization/high-resolution mass spectrometry to define a series of potential markers in exhaled breath with the potential to discriminate patients with COPD from healthy controls. The team identified 57 specific COPD discriminatory markers, with a further 56 that overlapped with the control subjects, and 17 with the subjects with asthma, all 17 of which were common to all of these patients. Identification of 23 compounds using realtime mass spectrometry that best defined signals significantly correlated with forced expiratory volume in one second predicted (FEV1%-predicted) in terms of the FEV1/ forced vital capacity (FVC-predicted) ratio. These compounds generally belong to the oxidative stress cascade and the lipolysis cascade. Patients with COPD showed FEV1 44.6, FVC 75.8, and FEV1/FVC ratio of 44. The healthy control subjects showed FEV1 101.2, FVC 105.3, and FEV1/FVC ra-

tio of 81. Patients with asthma had FEV1 84.4, FVC 99.5, and FEV1/FVC ratio of 70. The study was presented on June 8, 2017, at the Joint CHEST-Swiss Society of Pneumology Congress (CHEST-SGP) held in Basel, Switzerland. Image: A patient undergoing a breath test for chronic obstructive pulmonary disease and other lung diseases (Photo courtesy of Prof. Malcolm Kohler, MD).

Simple Method Measures Bacterial Tolerance to Antibiotics viene de portada

an antibiotic before succumbing to its effects. Scientists at The Hebrew University (Jerusalem, Israel; www. huji.ac.il) developed a tolerance metric called the minimum duration for killing 99% of the population (MDK99). The protocol, which can be performed manually or using an automated robotic system, involves exposing populations of approximately 100 bacteria in separate microwell plates to different concentrations of antibiotics for varied time periods, while determining the presence or lack of survivors. The team used a Freedom EVOware 75 base unit (Tecan, Männedorf, Switzerland; www.tecan.com) enclosed in a laminar flow hood equipped with a HEPA filter. A Tecan 8 Plus 1 liquid handling arm and a Tecan RoMa-3 EVO 75 arm were used for pipetting and plate handling. Plates were incubated in a Storex 40 Incubator (Liconic, Woburn, MA, USA; www.liconic.com) with a shaking option, and culture was kept at 2 °C to 3 °C on a chill/heat plate (Torrey Pines Scientific, Carlsbad, CA, USA; www. torreypinesscientific.com). The scientists applied MDK99 to six Escherichia coli strains, which showed tolerance levels ranging from two to 23 hours under ampicillin treatment. MDK99 also facilitates measurements of a special case of tolerance known as time-dependent persistence, the presence of transiently dormant subpopulations of bacteria that are killed more slowly than the majority of the fast-growing population. Like other forms of tolerance, time-dependent persistence can lead to recurrent infections because the few surviving bacteria can quickly grow to replenish the entire population once antibiotic treatment stops. Nathalie Q. Balaban, PhD, a professor and senior study author, said, “If implemented in hospital clinical microbiology laboratories, MDK99 could enable the efficient classification of bacterial strains as tolerant, resistant, or persistent, helping to guide treatment decisions. In the end, understanding tolerance and finding a way to combat it could significantly reduce the ever-growing risk of resistance.” The study was published on June 20, 2017, in the Biophysical Journal. LINKXPRESS COM

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Congenital Herpes Virus Tied to Common Childhood Cancer hildhood acute lymphoblastic leukemia develops when the bone marrow makes too many immature white blood cells, stem cells that become lymphoblasts, B lymphocytes, or T lymphocytes. It is widely suspected, yet controversial, that infection plays an etiologic role in the development of acute lymphoblastic leukemia (ALL), the most common childhood cancer and a disease with a confirmed prenatal origin in most cases. Children who develop ALL are over three times more likely to have tested positive for the common herpes virus cytomegalovirus (CMV) at birth. Scientists at the University of California (Berkeley, CA, USA; www.berkeley.edu) and their colleagues first compared bone marrow infections in 127 children diagnosed with ALL, and in 38 children diagnosed with another type of leukemia, acute myeloid leukemia (AML). They used state-of-

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the-art methods to screen the samples for all known viruses and bacteria. They then used an ultra-sensitive digital droplet screen to test for CMV in newborn blood samples of 268 children who went on to develop ALL. They also tested newborn blood samples from 270 healthy children. The team found genetic traces of CMV in abnormal white blood cells and intact virus particles in blood samples in the children with ALL, but rarely in those with AML. They found that the children who went on to develop ALL were 3.71 times more likely to be CMV-positive at birth. The odds were higher for Hispanic children who developed ALL as they were 5.9 times more likely to be CMV-positive at birth. They demonstrated active viral transcription in leukemia blasts as well as intact virions in serum. The study was published on December 15, 2016, in the journal Blood.

Image: In acute lymphoblastic leukemia, white blood cells develop abnormally and cannot fight infection comprehensively (Photo courtesy of Prof. Stephen Francis).

Genomic Sequencing Illuminates Recent Shigellosis Outbreaks higellosis is an acute gastrointestinal infection caused by bacteria belonging to the genus Shigella. Shigellosis is the third most common enteric bacterial infection in the USA with 500,000 infections, 6,000 hospitalizations, and 70 deaths each year. There are four Shigella species that cause shigellosis: Shigella dysenteriae, considered to be the most virulent species due to its ability to produce a potent cytotoxin called Shiga toxin, while S. flexneri, S. boydii, and S. sonnei generally do not produce Shiga toxin and, therefore, cause mild forms of shigellosis. Scientists at the California Department of Public Health (Richmond, CA, USA; www.cdph.ca.gov) and their colleagues identified 68 Shigella sonnei human isolates from California (CA); 57 outbreak-related isolates from 2014 to 2015 and 11 archival isolates from 1980 to 2008, which were serotyped by standard methods. Polymerase chain reaction (PCR) detection of the stx1 and stx2 genes and Vero cell neutralization assay for confirmation of Shiga toxin production were performed. DNA was extracted with a Wizard Genomic DNA kit (Promega, Madison, WI, USA; www.promega. com). Sequencing libraries were constructed using the Nextera XT (Illumina Inc, San Diego, CA, USA; www.illumina.com) library preparation kit. Sequencing was performed using 2 × 300-bp sequencing chemistry on an Illumina MiSeq sequencer. High-quality single nu-

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cleotide polymorphism (hqSNP)based phylogeny was used to determine genetic relationships between the local California (CA) S. sonnei populations and their connection to global S. sonnei strains. The team found two clusters in these outbreaks: one that primarily struck San Diego and the San Joaquin Valley and one more localized to the San Francisco Bay Area. The San Diego/San Joaquin strain has been in California since at least 2008. However, some of the isolates had been infected with a bacteriophage (a virus that attacks bacteria) that carried a Shiga toxin (stx) gene found in the more virulent S. flexneri and S. dysenteriae. By contrast, the strain that hit San Francisco lacked stx but contained genes that gave it resistance to the broad-spectrum fluoroquinolone class of antibiotics. The fluoroquinolone-resistance genes were similar to ones found in strains from Southeast Asia. James P Watt, MD, MPH, the Chief of Division of Communicable Disease Control, said, “Shigella sonnei bacteria normally cause a less severe disease and are not known to produce Shiga toxin. The toxin gene was most likely acquired by Shigella sonnei via genetic exchanges with Escherichia coli and other Shigella species. Discovering a functional toxin gene was concerning in this large outbreak. Finding this gene raises concerns that illness due to Shigella sonnei could become more severe in the future.” The study was published on December 21, 2016, in the journal mSphere. LabMedica International October/2017

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Immunosignaturing Platform Provides Pre-Symptom Diagnostics esearchers have developed an immunosignature profiling technology aimed to provide people with a means of monitoring their health status and a means for early detection of disease by rapidly testing for many diseases at once from a single drop of blood. In addition, the versatile technology could be used to secure a nation’s blood supply or give early warning of a disease epidemic. An international group of scientists, inventors, and entrepreneurs are bringing this invention to fruition and “will give people a deeper understanding of the medical, behavioral, and environmental factors that can accelerate disease or optimize health,” according to a recent announcement by Prof. Jun Wang, iCarbonX founder and creator of the Digital Life Alliance, based in Shenzhen, China. ImmunoSignature, the diagnostic platform developed by a team led by Prof. Stephen Albert Johnston and Prof. Neal Woodbury of Arizona State University (ASU) Biodesign Institute (Tempe, AZ, USA; https://biodesign.asu.edu), was a critical final piece needed to complete iCarbonX’s potentially revolutionary approach to healthcare. With a single drop of blood, the platform can detect diseases that involve an immune response (e.g. autoimmune, cancer, infectious disease, metabolic, and neurologic diseases). The team has already successfully demonstrated the potential of immunosignaturing for diagnosing over 50 diseases, including diabetes, cancer, and Alzheimer’s. “Scientists with expertise, imagination, and boundless aspiration are who we recruit to Arizona, ASU, and Biodesign,” said ASU President Michael Crow, “Today we are being recognized as a powerhouse in the world of innovation and for generating use-inspired solutions. iCarbonX’s significant investment in technologies conceived at ASU is a real demonstration of what can happen when public and private enterprises bring their best minds together.” Launched in 2004, ASU’s Biodesign Institute represents the state’s largest single investment in research infrastructure in the history of Arizona. Digital Life Alliance includes HealthTell as one of 7 core companies. According to Prof. Johnston, HealthTell’s high-density peptide array platform is the first real-time assessment that will be simple, inexpensive, and comprehensive. The HealthTell technology, particularly when combined with data from the other Digital Life Alliance partners, has the potential to enable health monitoring on a regular basis using single-drop blood samples. Catching diseases early save lives, helps eradicate challenges faced by those who suffer from illness, and results in

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cost savings. Some of the leading causes of disease – both infectious and chronic – give rise to immune responses fairly early. Immunosignatures of antibody patterns that indicate early-response would provide snapshots for monitoring a person’s health as well as a more detailed picture of health status. Image: The technology consists of a chip with peptide arrays for binding antibodies in blood samples from patients and healthy individual, and is enabling researchers to discover, define, and detect immunosignatures for various diseases (Photo courtesy of ASU Biodesign Institute).

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Liquid Biopsy Assists with Tumor Treatment Response Monitoring on-invasive “liquid biopsies” such as blood tests are growing in use as they help overcome problems of inherent tumor heterogeneity of cancer cells, while providing previously unavailable insight into drug-resistance. They are essential in tracking and monitoring an otherwise intractable disease. Due to their non-invasive nature, liquid biopsies can be less expensive than surgically obtained tissue biopsies. Liquid biopsies are more comfortable for patients, which is especially important given the stress that cancer and associated treatments already place on patients. Circulating tumor DNA (ctDNA) are small DNA fragments shed by the

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tumor. Tumor genes may mutate over time, either as the cancer grows, or the treatment suppresses the cancer and ctDNA gives an accurate, realtime picture of these cancer mutations. Being able to detect the smallest signals and trends from the ctDNA biomarker throughout the cancer management process offers timely insight and may yield information into the most effective treatment regimens tailored to the patient’s specific cancer genomic profile. CellMax-LBx liquid biopsy (CellMax Life, Sunnyvale, CA, USA; www.cellmaxlife.com) is a cancer blood test, which analyzes circulating tumor DNA (ctDNA). The assay provides oncologists with a valuable tool

in managing their patients’ cancer treatments, monitoring treatment response, and assessing the risk of recurrence. The non-invasive blood test allows for greater testing frequency for “real-time” monitoring. CellMax-LBx is intended as a supplement to a tissue biopsy and as an ideal alternative when tissue biopsy is not possible. The test profiles 73 genes from circulating tumor DNA (ctDNA), to identify and assess actionable genomic alterations using CellMax Life’s proprietary single-molecule-sequencing SMSEQ platform, which has a greater than 99.999% specificity and an analytical detection limit or sensitivity of 0.1%. Ruey-Kuen Hsieh, MD, an Oncologist and Senior Attending Physician, said, “CellMax-LBx Liquid Biopsy provides a systemic gene analysis to help oncologists identify optimal targeted cancer treatments with fewer side-effects, either as a supplement to

tissue biopsy, or when tissue-biopsy is not possible. Additionally, since this test requires only a routine blood draw, it enables us to track our patients’ response to treatment in realtime, as well as monitor them more frequently to warn of cancer recurrence as early as possible.” Image: A diagram of circulating tumor cells in a blood sample that can be analyzed for DNA (Photo courtesy of CellMax Life).

Faster Way of Detecting Bacteria Developed faster way to detect the pathogenic bacteria that may cause patients to become sick has now been developed, giving physicians a better chance at saving lives by proscribing the most suitable antibiotic. Today, patients generally have to wait days to get final test result, but the new method of testing of urine samples, for example, produces positive results in two hours from start to finish versus the days it can take for equivalent hospital laboratory tests. Scientists at Michigan State University (East Lansing, MI, USA; www.msu.edu) developed a point-ofcare diagnostic test known as In-Dx. The detection process is relatively simple for both the patient and physician. A sample is collected and concentrated into a smaller amount. After applying heat, which breaks down the sample cells, it is then placed into the In-Dx testing panel and after 20 minutes of incubation time, the positive sample changes color, revealing the invading organism. The team is more than one year into a clinical trial that aims to validate the point-ofcare diagnostic test, and the preliminary results already look promising.

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The molecular diagnostic system can identify dangerous bacteria such as Escherichia coli, Staphylococcus infections, and even some superbugs. The test can produce results within two hours using blood, urine, saliva, wound, stool or cerebral spine fluid samples from infected patients. The team have concentrated on sepsis, a serious, life-threatening infection occurring more commonly in hospitalized patients, is one of the medical problems. If not treated properly, septic patients may have only hours to live. Currently, millions of people die each year worldwide partly because a definitive diagnosis of the sepsis-causing bacteria often takes too long. Brett Etchebarne, MD, PhD, an assistant professor of emergency medicine, who helped develop the test said, “In-Dx has high sensitivity and specificity for detection of the most common infectious organisms which will help physicians quickly rule in or rule out specific bacteria. Knowing what your target is early in the fight against sepsis will be an invaluable advantage in helping maximize patient care strategies and outcomes.” LabMedica International October/2017

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Blood Test Differentiates Parkinson’s from Similar Diseases n early stages of disease, it can be difficult to differentiate between Parkinson’s disease and atypical parkinsonism disorders (APDs) like multiple system atrophy, progressive supranuclear palsy and corticobasal degeneration, because symptoms can overlap. A simple blood test may be as accurate as a spinal fluid test when trying to determine whether symptoms are caused by Parkinson’s disease or another atypical Parkinsonism disorder as identifying these diseases early is important because expectations concerning progression and potential benefit from treatment differ dramatically between Parkinson’s and APDs. Scientists at Lund University (Lund, Sweden; www.med.lu.se) and their colleagues examined 504 people from three study groups. Two groups, one in England and one in Sweden, had healthy people and people who had been living with Parkinson’s or APDs for an average of four to six years. The third group was comprised of people who had been living with the diseases for three years or less. In all, there were 244 people with Parkinson’s, 88 with multiple system atrophy, 70 with progressive supranuclear palsy, 23 with corticobasal degeneration and 79 people who served as healthy controls. The investigators used a sensitive sandwich method, the Nflight enzymelinked immunosorbent assay (ELISA) kit (UmanDiagnostics AB, Umeå, Sweden; www.umandiagnostics.com) to measure cerebrospinal fluid (CSF) neurofilament light chain protein (NfL). NfL concentrations in blood were measured using the monoclonal antibodies and calibrator from the NfL assay, transferred onto the Simoa platform using an in-house kit (Quanterix, Lexington, MA, USA; www.quanterix.com). The team found the blood test was just as accurate as a spinal fluid test at diagnosing whether someone had Parkinson’s or an APD, in both early stages of disease and in those who had been living with the diseases longer. The nerve protein levels were higher in people with APDs and lower in those with Parkinson’s disease and those who were healthy. In the Swedish group, the protein levels averaged around 10 pg/mL. People with multiple system atrophy had levels averaging around 20 pg/mL; those with progressive supranuclear palsy averaged around 25 pg/mL; and those with corticobasal degeneration averaged around 27 pg/mL. Oskar Hansson, MD, PhD, the lead author of the study said, “We have found that concentrations of a nerve protein in the blood can discriminate between these

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diseases as accurately as concentrations of that same protein in spinal fluid. Lower concentrations of the nerve protein in the blood of those with Parkinson’s may be due to less damage to nerve fibers compared to those with atypical Parkinsonism disorders.” The study was published on February 8, 2017, in the journal Neurology. Image: The Simoa HD-1 ultrasensitive immunoassay platform (Photo courtesy of Quanterix).

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PRODUCT NEWS RT-PCR ASSAY

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POCT ANALYZER

PIPETTE HOLDER SYSTEM

ELITechGroup

DiaSys

Eppendorf

The Meningitis Viral 2 ELITe MGB Panel combines reverse transcription, and RT-PCR amplification for the detection/differentiation of Enterovirus, Parechovirus and Adenovirus. The assay offers results in two hours and 30 minutes, with 100% diagnostic sensitivity and specificity for all targets.

The InnovaStar automatic analyzer for the daily practice delivers result quality comparable to laboratory analyzers for HbA1c, CRP, Glucose and Hemoglobin directly from whole blood samples. By the integration of a colored touch screen the ease of use of InnovaStar is further improved.

The Pipette Holder System is perfect for all users of handheld liquid handling instruments who need a highly flexible system for their pipettes and multipettes. The small footprint system features a charger carousel with intelligent charging electronics that carries up to six instruments.

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Rapid Tuberculosis Test Updated n updated version of a rapid polymerase chain reaction (PCR)-based assay for the detection of Mycobacterium tuberculosis complex DNA (MTBc) and mutations associated with rifampin resistance (RIF) has been evaluated. The updated version the assay in-

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cludes modifications to one of the five rpoB-specific assay probes (probe B) and to the analytic software settings with the goal of decreasing both false positive rifampin resistance (RIF) resistance results and the more than 5% non-determinate result rate reported in some settings.

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A team of scientists led by those at the New Jersey Medical School (Newark, NJ, USA; www. njms.rutgers.edu) performed a clinical study in which specimens from US and non-US persons suspected of tuberculosis (TB) were tested to determine the performance characteristics of the assay. All specimens underwent smear microscopy, mycobacterial culture, conventional drug-susceptibility testing and PCR testing; DNA from isolates with discordant rifampin resistance results was sequenced. The updated assay under investigation was the Xpert MTB/RIF G4 assay (Cepheid, Sunnyvale, CA, USA; www.cepheid.com). In the analytical study, culture-positive isolates were confirmed to be MTBc positive by AccuProbe MTBC Identification Test (Hologic Incorporated, Marlborough, MA, USA; www.hologic.com). Acidfast bacilli (AFB) smear status was determined using the specimen with a corresponding Xpert result. An MTB positive case was defined as MTB growth on solid or liquid culture from any specimen. The team found that among 191 laboratory-prepared isolates in the analytical study, Xpert sensitivity for detection of rifampin resistance associated mutations was 97.7% and specificity was 90.8%, which increased to 99.0% after DNA sequencing analysis of the discordant samples. Overall, Xpert detected MTBc in 439 of 468

culture-positive specimens for a sensitivity of 93.8% and did not detect MTBc in 620 of 628 culture-negative specimens for a specificity of 98.7%. Sensitivity was 99.7% among smearpositive cases, and 76.1% among smear-negative cases. Non-determinate MTBc detection and false-positive RIF resistance results were low (1.2% and 0.9%, respectively). The authors concluded that the G4 Xpert assay had low rates of nondeterminate and false positive RIF resistance results that were not consistent with previously reported rates observed at some sites. In addition, they found high sensitivity and specificity for MTBc and RIF resistance detection that compared well to the previous versions of the assay. The study was published on December 20, 2016, in the journal BMC Infectious Diseases. Image: The GeneXpert MTB/RIF assay is a rapid diagnosis test of Tuberculosis (TB) and drug resistance (Photo courtesy of Cepheid). LabMedica International October/2017

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PRODUCT NEWS URINE TESTS

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HEMATOLOGY ANALYZER

POCT ANALYZER

ALFA Scientific

Instrumentation Laboratory

Sugentech

The Instant-view tests can measure up to as many as 14 different analytes and are designed to qualitatively measure drugs and produce results within four-seven minutes, The multi-drug cassettes and SplitScreen cup designed with flat surfaces for easy photocopying or scanning.

The GEM Premier 5000 Critical Care whole-blood testing system provides automated QA with every sample. Key features include new iQM2 for realtime assurance; an all-in-one, multi-use GEM PAK that offers advanced simplicity; and GEMweb Plus custom connectivity for complete control.

The INCLIX is a POCT analyzer with CRP, hsCRP, dual CRP, PCT, Troponin I, HbA1c and Influenza A&B tests available. Within 2017, β-hCG, hCG, Zika IgM/IgG, and Total IgE tests will be available. Benefits include remote support, storage at room temperature and a 24-month shelf life.

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Digital CTC Assay Improves Liver Cancer Diagnosis iver cancer, including hepatocellular carcinoma (HCC), is the second highest cause of cancer death in the world. HCC is particularly prevalent in developing countries, where its incidence is driven by infection with the hepatitis

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B virus, which now affects more than 248 million individuals. The use of an advanced form of the commonly used polymerase chain reaction (PCR) method to analyze circulating tumor cells may greatly increase the ability to diag-

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nose early-stage cancer, increasing the likelihood of successful treatment as current blood-based strategies for detecting HCC, such as serum levels of alpha-fetoprotein (AFP), have had poor results. A large team of scientists working with those at Massachusetts General Hospital Cancer Center (Charlestown, MA, USA; www.massgeneral. org) developed a digital PCR assay by first identifying 10 specific ribonucleic acid (RNA) transcripts that were expressed in HCC cells but not in blood components. They assayed blood samples from six groups of individuals: newly diagnosed HCC patients; HCC patients receiving treatment who still had evidence of disease; HCC patients who appeared to be cured after surgical treatment, including liver transplantation; patients at risk for developing HCC because of other chronic liver diseases; patients with other types of cancer, including some with liver metastases; and healthy volunteers. The circulating tumor cells (CTC)-iChip digital PCR analysis revealed significantly higher levels of the HCC-associated RNA transcripts in blood samples from patients with HCC than from those with other cancers, with chronic liver disease or healthy controls. The use of a CTC score based on the nine RNA transcripts most significantly associated with HCC generated positive results for more than half of those with untreated HCC, but only around 8% of healthy controls and 3% of those with other liver diseases. Around 28% of patients currently being treated had positive scores, and the percentage of positive scores among patients with no

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evidence of disease after treatment was similar to that of healthy controls. Mark Kalinich, an MD/PhD candidate and co-lead author of the study said, “We have developed an assay capable of detecting a single cancer cell within a background of the tens of billions of cells that comprise whole blood. Our test provides highly specific detection of cancer in patients with HCC, compared with healthy individuals and with those at high risk for developing the disease. These results hold promise for both the early detection of HCC and for the monitoring of treatment over time.” The study was published on January 17, 2017, in the Proceedings of the National Academy of Sciences of the United States of America. Image: The circulating tumor cells (CTC)-iChip is composed of two separate microfluidic devices that house three different microfluidic components engineered for inline operations (Photo courtesy of Massachusetts General Hospital). LabMedica International October/2017

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LabMedica International

Immunoproteomics Identifies New Biomarkers for Crohn’s Disease sing a new screening approach, a study aimed at developing a better blood test for Crohn’s disease (CD) successfully identified several antibodies that could serve as diagnostic markers. The study, based on links between CD and the immune response against self-proteins, was led by scientists Josh LaBaer and Ji Qiu of the Biodesign Institute of Arizona State University (AZ, USA; www.asu.edu), along with gastroenterologists Shabana Pasha and Jonathan Leighton from Mayo Clinic Arizona. Currently, diagnosis can be very difficult and involves expensive MRIs, invasive biopsies, or cataloging symptoms. The cause of CD remains a mystery, but the immune system is somehow triggered to attack the gut. Knowing this, Profs. LaBaer and Qiu advanced a new immunoproteomics approach to broadly sift through immune system proteins in blood to identify early-warning markers. "There has been increasing evidence that suggests the Crohn's disease immune response may be a result of altered microbes in the gut or exposure to harmful toxins that will result in antibodies against microbial and human proteins being made that are very specific manifestation of the disease," said Prof. Qiu, many potential “blood-based biomarkers have been discovered, but currently commercially available blood tests have not been widely adopted into clinical practice because they fail to accurately diagnose CD." The researchers developed a method they called nucleic acid programmable protein arrays (NAPPA), which avoids making protein arrays by standard timely and costly protein purification, but rather by making fresh protein at the time of the test from more stable DNA on the slide. With this they probed 48 patient and 48 healthy control sera (obtained from biobanks at Mayo Clinic Rochester (MN, USA) and Mayo Clinic Arizona) against proteins on the arrays – 1906 unique proteins culled from Prof. LaBaer's human gene collection bank. Several marker-candidate autoantibodies were identified based on having a sensitivity of over 15% in the patients, then validated in an independent set of patients and controls. The best were used to create a biomarker panel that optimized accuracy of their new test. "Biomarker studies can be plagued with issues of sensitivity and specificity," said Prof. Qiu, “we have to ensure that that they have the required classification performance in distinguishing patients from healthy controls and other gut disorders." The strongest biomarker candidates were for bacterial flagellin antibodies, which showed the strongest reactivity and highest prevalence on the arrays, achieving a sensitivity of 46% at 95% specificity. A novel biomarker was the an-

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tibody against SNRPB (small nuclear ribonucleoprotein-associated proteins B and B'), which plays a general role in protein synthesis. SNRPB has also been associated with Lupus patients, known as the "Smith antigen." What does the detection of these autoantibodies mean in our understanding of Crohn's disease? "One possibility is that these antibodies reflect dysregulated immune response in the gut," said Prof. LaBaer, "Another is that they could play a pathogenic role. But so far, we simply don't have enough such antibodies discovered to understand their functional role." The ~2,000 human proteins used in the study are but a fraction of human and micro-

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bial proteins in the over 30,000 unique proteins contained in their collection. They will conduct future studies on autoantibodies and anti-microbial antibodies against CD-related microorganisms from microbiome studies. "No single biomarker is going to be predictive and meet clinical needs," said LaBaer, "Only a panel of biomarkers, made of individually validated biomarkers, will achieve the best performance in the clinic. But we are excited about the potential of this immunoproteomics approach for CD and will work to discover additional biomarkers." The study, by Wang H et al, was published February 14, 2017, in the Journal of Crohn’s and Colitis.

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Breathalyzer Test for Personalized Disease Detection novel breathalyzer device has been developed that enables detection of volatile compounds produced by respiratory viruses such as the influenza virus and other pathogenic microorganisms. A common feature of the inflammatory response in patients who have actually contracted influenza is the generation of a number of volatile products of the alveolar and airway epithelium. These products include a number of volatile organic compounds (VOCs) and nitric oxide (NO). Investigators at the University of Texas (Arlington, USA; www.uta.edu) designed a portable three-sensor array microsystembased device to detect these biomarkers, which can be used to detect the disease. The device, which may in the future be available over-the-counter in pharmacies, resembles the breathalyzers used by police to determine alcohol

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levels in drivers suspected of being under the influence. The patient simply exhales into the device, which uses gas-specific semiconductor sensors to measure levels of biomarker in the breath. “I think that technology like this is going to revolutionize personalized diagnostics. This will allow people to be proactive and catch illnesses early, and the technology can easily be used to detect other diseases, such as Ebola virus disease, simply by changing the sensors,” said first author Dr. PelagiaIrene Gouma, professor of materials science and engineering at the University of Texas. “Before we applied nanotechnology to create this device, the only way to detect biomarkers in a person’s breath was through very expensive, highly-technical equipment in a lab, operated by skilled personnel. Now, this technology could be used by ordinary people to quickly and accurately diagnose illness.”

The breathalyzer device was described in detail in a paper published in the January 20, 2017, online edition of the journal Sensors. Image: Dr. Perena Gouma displays a hand-held breath monitor that can detect the flu virus (Photo courtesy of the University of Texas, Arlington).

Genetic Study Identifies Developmental Disorders in Children he largest ever genetic study of children with previously undiagnosed rare developmental disorders has discovered 14 new developmental disorders. The study also provided diagnoses of rare conditions for over a thousand children and their families. There are over 1,000 recognized genetic causes, however many individual developmental disorders are so rare that the genetic causes are not known. Each year, thousands of babies are born who do not develop normally because of errors in their genetic makeup and this can lead to conditions such as intellectual disability, epilepsy, autism or heart defects. A large team of scientists collaborating with the Wellcome Trust Sanger Institute (Cambridge, UK; www.sanger.ac.uk) sequenced the exomes of 4,293 families containing individuals with developmental disorders, and meta-analyzed these data with data

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from another 3,287 individuals with similar disorders. The team focused on spontaneous new mutations that arise as DNA is passed on from parents to children. The children’s conditions were also clinically assessed and the team combined the results to match up children with similar disorders to provide diagnoses. Saliva samples for the whole family and blood-extracted DNA samples for the probands were collected, processed and quality controlled. Genomic DNA was fragmented to an average size of 150 base pairs (bp) and a DNA library was created using established Illumina paired-end protocols. Adaptor-ligated libraries were amplified and indexed using polymerase chain reaction (PCR). A portion of each library was used to create an equimolar pool comprising eight indexed libraries. Enriched libraries were analyzed by 75-base paired-end sequencing (HiSeq, Illumina, San Diego, CA, USA; www.illumina.com).

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The scientists showed that how that the most important factors influencing the diagnostic yield of damaging de novo mutations (DNMs) are the sex of the affected individual, the relatedness of their parents, whether close relatives are affected and the parental ages. They identified 94 genes enriched in damaging DNMs, including 14 that previously lacked compelling evidence of involvement in developmental disorders. Jeremy McRae, PhD, the first author of the study, said, “Each of these disorders is incredibly rare, so the large number of patients in this study was crucial to diagnosis. An individual doctor may see only one case, but by collaborating with hundreds of NHS staff and researchers we were able to link children from clinics across the British Isles. This allowed the team to match up children with similar disorders within the project and provide diagnoses for them.” The study was published on January 25, 2017, in the journal Nature.

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PRODUCT NEWS PAPER TEST DEVICE

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REAL-TIME PCR

CHEMISTRY ANALYZER

MAST Group

Quidel

Siemens Healthineers

The MAST ICT (D74) is a reliable screening tool for OXA, KPC, NDM, IMP and VIM enzymes. It is suitable for use with Acinetobacter, Pseudomonas spp and Enterobacteriaceae and can be interpretation by simple observation. A convenient format can also be catered to personal lab demands.

The Applied Biosystems 7500 Fast Dx is a 96-well, five-color real-time PCR instrument for in vitro diagnostic use. It features intuitive software that offers the flexibility to develop assays and also run pre-optimized protocols for users operating in a secure environment.

The Dimension EXL with LM integrated chemistry system uses the LOCI advanced chemiluminescent technology for fast and reliable results. It offers chemistry and immunoassay integration to allow for simultaneous processing to maximize workflow efficiency and deliver precise results.

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Inflammatory Markers Correlated with SCA Pain Intensity ickle cell anemia (SCA) is a hereditary hemolytic anemia where the synthesis of hemoglobin (Hb) is abnormal and the inheritance can be heterozygous (HbS) or homozygous (HbSS). Homozygous patients with SCA often develop vaso-occlusive crises (VOCs) and recurrent episodes of hemolysis causing multi-organ infarction and dysfunction. Bone pain in patients with SCA varies from acute clinical painful VOC or osteomyelitis to more chronic and debilitating disease, such as osteoporosis, osteopenia and osteonecrosis, and chronic infections with impaired growth. Inflammatory markers are increased during VOC in adult patients with SCA, but this is not clear in clinical steady state. Scientists at the Arabian Gulf University (Manama, Bahrain; www.agu.edu.bh) studied 46 patients of whom 27 were females with SCA who age ranged from 12 to 40 years and they were compared with 46 patients with bone pain but proven

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to be with no SCA. Patients were included if they were diagnosed with sickle cell disease (SCD) with homozygous hemoglobin (HbSS) using Hb electrophoresis and solubility screening test for sickling. Blood samples were obtained at base line, one month and three months after enrollment to determine the level of tumor necrosis factor- (TNF- ), interleukin-1 (IL-1), C-reactive protein (CRP), Hb, reticulocyte count, lactate dehydrogenase (LDH), vitamin D3, parathormone (PTH) and serum ferritin. Patients were examined clinically for bone pain or tenderness in the peripheral joints, chest or vertebrae within the last two days prior to assessment. Serum TNF- and IL-1 levels were measured using the enzyme-linked immunosorbent assay technique (enzyme-amplified sensitivity immunoassay kits; BioSource Europe SA, Nivelles, Belgium; www. biosource-diagnostics.com). Quantification of PTH in serum was performed by enzyme-linked immunosorbent assay (Creative Diagnostics, Shirley,

NY, USA; www.creative-diagnostics.com). The study was published on October 31, 2016, in the Journal of Blood Medicine. Image: Peripheral blood film from a patient with sickle cell anemia (Photo courtesy of iStock).

Plasma NT-ProBNP Levels Predict Severity of Enterovirus-71 Infection and, foot, and mouth disease (HFMD) is caused by a variety of human enteroviruses, mainly by enterovirus 71 (EV71) and coxsackievirus A16 (CA16), and is characterized by fever and vesicular exanthema on the hands, feet, and mouth. Brain-type natriuretic peptide (BNP) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) are released in equimolar amounts from the myocardium. Their levels increase in response to hemodynamic stress, and they have an established role in cardiovascular (vasodilation) and renal (natriuresis) physiology, conferring protection against fluid overload and hypertension. Scientists at the Hunan Children’s Hospital (Changsha, China; www.hnetyy.net) enrolled between January 2012 and December 2013, 282 patients from pediatric intensive care unit patients with HFMD, 183 (64.89%) were male and the median age of the cohort was 21 months. Cases were

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recorded as having severe HFMD if they were found to have the more serious complications including encephalitis, meningitis, acute flaccid paralysis, and cardiorespiratory failure, or died. Venous blood sample for the detection of NTproBNP was collected during the first hour of hospital admission and was stored immediately at −70 °C. The samples were centrifuged at 3,000 rpm for 20 minutes and analyzed using an electrochemiluminescence immunoassay (Elecsys NT-proBNP; bioMérieux, Lyons, France; www.biomerieux.com). The clinical caregivers were blinded to the NTproBNP values in order to avoid changes to the clinical interventions based on the results. The red blood cell count (RBC), hemoglobin level (Hb), white blood cell (WBC) count, and neutrophil count (Neu) were determined using a Sysmex XE2100 Automated Hematological Parameters Analyzer (Sysmex Corporation, Kobe, Japan; www. sysmex.com).

The scientists found that NT-proBNP levels were significantly higher in patients with elevated blood glucose of greater than 7.8 mmol/L and increased white blood cell counts of greater than 14 × 109/L. HFMD patients who had no complications had significantly lower NT-proBNP values than patients who died or had complications. The team was able to discriminate between patients with and without brainstem encephalitis, pulmonary edema, pulmonary hemorrhage, circulatory failure, and death, respectively, using NT-proBNP. An NT-proBNP cut-off value of equal to or greater than 1,300 pg/mL demonstrated a high sensitivity of 85% and specificity of 93.5% for predicting death in critical HFMD patients. Children with severe EV71-associated HFMD and NTproBNP measurements of greater than 1,300 pg/mL had significantly worse overall survival compared to those with levels less than 1,300 pg/mL. The study was published on November 3, 2016, in the International Journal of Infectious Diseases. LabMedica International October/2017

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PRODUCT NEWS NUCLEIC ACID EXTRACTOR

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ESR ANALYZER

DNA/RNA EXTRACTION SYSTEM

Taigen Bioscience

ELITech Group

General Biologicals Corporation

The LabTurbo 96XC uses a multi-functional robotic arm to achieve a sampling-to-elution workflow of 96 samples in 90 minutes. It is equipped with a 12pipette channel arm with embedded ultrasonic scanner for precise liquid handling and real-time liquid level and object detection.

The Excyte 40 offers 40 positions and a 30-minute test time, and can perform up to 80 sed rate tests per hour. Features such as random access, on board QC, positive sample identification, barcode capability, and closed tube testing make sed rates and QC easier to run, and ensure staff safety.

The Genesis M1200 offers the flexibility of processing 1-12 samples per run, occupies minimal counter space and greatly reduces technician man hours. It is tailor-made to fit small clinics and early-stage laboratories, allowing them to operate in a much more cost-effective manner.

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Miniature Test Device Rapidly Measures Patient HIV Load device for measuring levels of HIV virus particles has been built into a USB stick for rapid use by an individual to monitor his/her viral load or as an alternative to laboratory instrumentation in remote locations. Viral levels cannot be detected by routine HIV tests, which use antibodies to detect whether a person has been infected. To measure viral levels, investigators at Imperial College London (United Kingdom; www. imperial.ac.uk) incorporated a pHmediated, point-of-care HIV-1 viral load-monitoring assay that simultaneously amplified and detected HIV-1 RNA onto a metal-oxide semiconductor (CMOS) chip. The investigators

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used the device to screen 991 clinical single-drop-of-blood samples. Results revealed a sensitivity of 95% (in vitro) and 88.8% (on-chip) at more than1000 RNA copies/reaction across a broad spectrum of HIV-1 viral clades. Median time to detection was 20.8 minutes in samples with more than 1000 RNA copies. Senior author Dr. Graham Cooke, professor of medicine at Imperial College London, said, “HIV treatment has dramatically improved over the last 20 years – to the point that many diagnosed with the infection now have a normal life expectancy. However, monitoring viral load is crucial to the success of HIV treatment. At the moment, testing often requires

costly and complex equipment that can take a couple of days to produce a result. We have taken the job done by this equipment, which is the size of a large photocopier, and shrunk it down to a USB chip.” Details of the device were pub-

lished in the November 10, 2016, online edition of the journal Scientific Reports. Image: A USB stick device that determines HIV viral load (Photo courtesy of Imperial College London).

Lipid Profiles Investigated for Coronary Heart Disease Patients ipoprotein (a) (Lp (a)) excess is an independent risk factor of coronary artery disease (CAD) and has shown wide ethnic variations and lipid parameters used in the assessment and management of risk factors for CAD may not reflect accurately the disease or its severity. Risk factors for Cardio Vascular Disease (CVD) comprise dyslipidemia, diabetes, hypertension, obesity, sedentary lifestyle, smoking, alcohol, family history, menopause and advancing age. Furthermore, homocysteine, fibrinogen, lipoprotein(a), low density lipoprotein particle size and C-reactive protein are the conditional risk factors that contribute to CVD. Medical scientists at the University of Sri Jayewardenepura (Nugegoda, Sri Lanka; www. sjp.ac.lk) conducted a prospective cross sectional study during the years 2013 and 2014. The study sample consisted of 102 consenting patients awaiting Coronary Artery Bypass Graft (CABG) at the

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Cardiothoracic Unit of the local hospital. The majority of the patients (43.1 %) were between 51 and 60 years with 4.9 % less than 40 years. The mean age of male and female patients was 56.9 ± 10 and 57.8 ± 7. Pre-operative blood samples were collected into plain tubes and the serum separated. Lp(a) content was measured by immunoturbidimetric method (Thermo Fisher Scientific, Helsinki, Finland; www.thermofisher.com). The absorbance of the immune-complex, produced from Lp(a) and antiserum was measured at 340 nm on a Thermo Scientific Konelab 20XT clinical chemistry automated analyzer. Data on total cholesterol, low density lipoprotein cholesterol (LDLc), high density lipoprotein cholesterol (HDLc), and triglyceride were collected from each patient’s data records and TC:HDLc ratio calculated. The scientists reported that total cholesterol (TC), LDL cholesterol and HDL cholesterol of the

total study sample (average ± SD) were, 150 ± 36 mg/dL, 92 ± 36 mg/dL and 34 ± 9 mg/dL respectively with no significant difference irrespective of being on pharmacological treatment or not. All lipid parameters were significantly high in females. The average Lp(a) was 50 ± 38 mg/dL with no significant difference in males or females independent of being on treatment (50 ± 39 mg/dL) or not (49 ± 39 mg/dL) and above the cut off value (30 mg/dL). The authors concluded that despite pharmacological interventions 27 % of the study population had high LDLc and majority low HDLc. Mean Lp(a) was in excess irrespective of risk factors or being on treatment or not and is confirmed as an independent, potential marker for assessing the susceptibility for CAD especially in those with other intermediate risk factors but considered non-hyperlipidemic by conventional methods. The study was published on November 8, 2016, in the journal BMC Cardiovascular Disorders. LabMedica International October/2017

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Genome Study Identifies Mutation Linked to Obesity esults obtained during what was probably the first genome-wide association study (GWAS) for body mass index (BMI) to be conducted in continental Africa identified a gene, carried by about 1% of West Africans, linked to hereditary obesity. An international team of investigators from the [U.S.] National Human Genome Research Institute (Bethesda, MD, USA; www.nhgri .nih.gov) together with a group of African collaborators performed the GWAS for BMI on a study cohort comprising 1,570 West Africans. The investigators identified a mutation in the Semaphorin-4D (SEMA4D) gene that was carried by approximately 1% of the test population. The SE-

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MA4D gene plays a role in cell signaling, immune response, and bone formation. Carriers of the mutation were found to be about six pounds heavier than those without the genomic variant. Furthermore, obese individuals had higher serum SEMA4D levels as compared to normal individuals, and elevated levels of serum SEMA4D were associated with increased obesity risk. Most previous GWAS studies on obesity have been conducted with populations of European ancestry. These studies would not have found the SEMA4D genomic variant, which is absent in both Europeans and Asians. The study was published in the March 13, 2017, online edition of the journal Obesity.

Analyzing Antibodies Predicts Prognosis of Rheumatoid arthritis heumatoid arthritis (RA) is an inflammatory disease where the joints become stiff and swollen, and is associated with future joint destruction. This is caused by immune cells, which normally attack foreign organisms but instead react against the tissues in the joints, resulting in inflammation. In some RA patients antibodies are formed that target collagen II, an important protein in joint cartilage. These antibodies drive the inflammation early in the disease and the highest amounts of collagen antibodies have been detected at the time of diagnosis, after which the levels decrease during the first year. Scientists at Uppsala University (Uppsala, Sweden; www.uu.se) and their colleagues followed a large group of RA patients during five years to see if there is a correlation between the collagen antibodies and disease development. There were 2,000 patients and 960 controls that were included in the study between 1996 and 2005. Comparisons were done concerning C reactive protein (CRP), erythrocyte sedimentation rate (ESR), tender joint count (TJC), swollen joint count (SJC). The investigators measured anti-fibrillar collagen type II (anti-CII) by enzyme-linked immunosorbent assay (ELISA) using human native collagen type II (Chondrex, Redmond, WA, USA; www. chondrex.com) as antigen. Anti-cyclic citrullinated peptide (CCP2) was measured by ELISA (Immunoscan CCPlus, Euro-Diagnostica, Malmรถ, Sweden; www.euro diagnostica.com) with a cut-off of 25 U/mL. Genotyping was done by polymerase chain reaction (PCR) using sequence-specific primers. Among 1,476 patients, 97 (6.6%) were anti-CII positive and 855 (57.9%) were anti-CCP2 positive. Thirty-nine patients (2.6%) had only anti-CII, 797 (54%) had only anti-CCP2, 58 (3.9%) were double positive and 582 (39.4%) lacked both antibodies. Among the controls, 15/926 (1.6%) were anti-CII positive (34 showed non-specific binding) and 16/958 (1.7%) were anti-CCP2 positive. Anti-CII levels were significantly higher among patients than among controls (median (mean) 13.3 (38.4) AU/mL versus 9.3 (21.6) AU/mL. The authors concluded that Anti-CII seropositive RA represents a distinct phenotype, in many respects representing the converse to the clinical, genetic and smoking associations described for anticitrullinated protein peptide autoantibodies. Although not diagnostically useful, early anti-CII determinations predict favorable inflammatory outcome in RA. The study was published on March 24, 2017, in the journal Annals of the Rheumatic Diseases.

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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

International Experts Call for Improved Standardization and Quality Control Procedures A Report from the 6th International Clinical Laboratory and Quality Symposium in Barcelona eading national and international professionals participated in the 6th International Clinical Laboratory and Quality Symposium in Barcelona on May 30th and 31st. The event was a reference event in the field both for its scientific program and for the prestige of its speakers. The field of clinical analysis is continually evolving, but it is nevertheless necessary to continue moving forward in the standardization of the entire clinical laboratory process. It is important that laboratory results be transferable between centers and countries so as to avoid confusion in their interpretation. Similarly, despite continuing improvement in measurement procedures and the constant reduction of imprecision in analytic methods, there are still systematic deviations in measurement methods among the different manufacturers of in vitro diagnostic methods. Therefore, the coordination and standardization of the entire analytic process will be key for the future in the clinical laboratory field. This was one of the central themes of the 6th International Clinical Laboratory and Quality Symposium that was held in Barcelona on May 30-31. The event was organized by the Spanish Society of Laboratory Medicine (SEQCML) and the Foundation for Quality Control in Clinical Laboratories (FPCQLC). Leading national and international professionals presented their experiences and gave updates on the latest news on topics such as quality in the sample extraction process, stability of biological tests, analytical and extra-analytical quality specifications, standardization, consensus on critical values, programs for external quality guarantees, and risk management. Among the projects presented during the symposium -- all relevant for guaranteeing quality in clinical laboratories--, some that stood out were the project to create a database for the stability of biological tests, and the project to establish critical values via the technological tool Health Consensus (a platform to facilitate consensus among health professionals by allowing them to consult online while at the same time receiving immediate replies with the opinion of all parties consulted. Thus, through an interactive process, a consensus on protocols or concrete initiatives can be reached). Equally important is the project to improve the Database on Biological Variation that is being carried out by a recently created workgroup made up of professionals from Spain (the Commission on Analytical Quality of the SEQCML) and various representatives from the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) from Norway, the United Kingdom, Italy, Holland, Canada, Turkey, and Australia. "We are making great progress to assure the launch and ongoing updating of the database, which will have a great impact on the quality of clinical analysis", stressed Prof. Sverre Sandberg, President of the EFLM and coordinator of the group. For Professor Sandberg, "Spanish Contâ&#x20AC;&#x2122;d on page 30

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Photo: Speakers at the symposium

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International Experts Call for Improved Standardization and Quality Control Procedures Cont’d from page 29 laboratories contribute greatly to the European Scientific Society in many areas, such as monitoring methods, improvement of test requests, and work on biological variation, in which Spain is strongly represented".

The importance of control procedures and programs for external quality assurance "The end result of laboratory services depends not only on the analytical phase, which of course is important, but also on all of the different parts of the "chain", from the request for the correct tests to the report of the results and their interpretation by doctors", explains the president of the EFLM. For her part, Dr. Mª Antonia Llopis, President of the Committee on External Quality Programs for the SEQCML, referred to the importance of quality in the preand post-analytic phases, as this is where the greatest percentage of laboratory errors occur. "Much of the pre-analytic phase takes place outside of the laboratory, with participation from the pa-

tients themselves to professionals from various areas, both in healthcare and out, which makes control more difficult. The processes of extraction, collection of samples, and identification have a great impact on patient safety. That´s why it is so important to make laboratories aware of the importance of establishing proper control procedures as well as programs for external quality assurance", she noted. Currently there are few organizations that provide programs for external guarantee of pre-analytic quality, and the SEQCML was a pioneer in Europe in the organization of these programs. With close to 20 years of experience, in 2014 it provided a new focus on this program by basing it on quality indicators. Diagnostic clinical tests for hereditary diseases Every year there is an increase in the number of hereditary diseases (generally mono-genic) for which the genetic cause is known. This is why the number of requests for these studies increases daily, as does their variety. In addition, as methodologies are be-

My IFCC Professional Scientific Exchange Program (PSEP) Experience by Ronald Khunga y name is Ronald Khunga and I was awarded a Scholarship to attend a three month PMEP training in External Quality Assurance (EQA). The Malawi government has adopted the SLMTA (Strengthening Laboratory Management towards Accreditation) as a means to get its public and private laboratories accredited by International bodies such as ASLM. EQA is one of the requirements when it comes to international laboratory accreditation. Malawi does not currently have a National EQA program which has made access to EQA material difficult and expensive for most public and private laboratories hence failure to participate in such has been the result. This has had a negative effect on individual laboratories and the nation as a whole as we seek to attain accreditation. My visit to Zimbabwe was aimed to have an experience and gain knowledge on how to organize an EQA program so I can assist coordinate the birth and function of a national program in Malawi. During my stay, I was attached to Zimbabwe National Quality Assurance Program (ZINQAP) which is a Regional Centre of Excellence according to SANAS (South African National Accreditation System) and at the department of Chemical Pathology at University of Zimbabwe. I was under the Supervision of Mr. Cuthbert Musarurwa (Chairman of the department of Chemical Pathology), Prof. Hilda Matarira and Mrs. Sibongile Zimuto (Director at ZINQAP). I spent 8 weeks (13th March to 12th May) at ZINQAP and the remainder at Chemical Pathology laboratory.

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Objectives: To acquire in depth knowledge of running an External Quality Assessment program; To be oriented in the day to day routine laboratory and administrative activities; To participate in Proficiency testing activities. Achievements: Gained knowledge in the requirements in running an EQA program; Participation in

technical and planning meetings; Participation in the preparation and dispatch of PT samples (April and May shipments); Participation in in- house orientation trainings on Quality Management Systems (QMS) in a PT laboratory; I was given an opportunity to present about my attachment at the department of Chemical Pathology. Challenges: Limitation of time meant some of the in house QMS trainings were not done; Training on some equipment was not possible as machines had not yet been installed; An initial challenge in the place I was accommodated in meant I had to move to a new house which was much better; A bench fee was requested though it had not been initially negotiated. But the request was later withdrawn. Activities: (1) Preparation and dispatch of PT samples. I participated in the shipments of April which was the Haematology shipment and May which was the Serology shipment. My responsibility was to shadow the PT team in all steps of preparation and dispatch. I had experience in preparing samples (like FBC, blood grouping), homogeneity testing, packaging of samples, checking of packages and delivery of PT samples. (2) Planning of PT Scheme. Before every shipment there is a need of planning the shipment. My responsibility like the first activity was to shadow the team and perform any other assigned activities. I had experience in using the PT Assist software in planning for a shipment, collecting action packs from FedEx and stock management. (3) Data entry and Management. With the use of PT Assist, I was able to enter data from previous shipments and also generate a report from the same software. (4) Orientation in QMS and ISO 17043. The Director and the Quality Officer briefly took me through the requirements in running a PT program according to ISO 17043. I was privileged to gain a valuable insight on this standard and also get a copy of ZINQAP’s Quality Manual. (5) Participation of Meetings. I was privileged to take part in three planning meetings chaired by the Director and assigned personnel and also a Quality Assurance Technical Working

coming simpler, they can be done more rapidly. These advances also have their negative aspect, as they can bring about requests for genetic studies without the use of appropriate diagnostic criteria. Therefore, the Symposium addressed the External Quality Assurance Programs for hereditary diseases. "It´s not always clear when to request a genetic study. To know if one should be done or not, available diagnostic guidelines for the suspected disease should be consulted, as well as recent literature. The clinical history, a physical exam, and family history are particularly relevant in this context. In general, the most important points are the age at diagnosis, multifocal or bilateral affectation, and alterations that are components of a syndrome". "To maintain a quality standard in genetic studies, these must be done in reference centers that participate in the External Quality Assurance Programs that exist specifically for each disease", concluded the president of the SEQCML Committee on External Quality Assurance Programs.

Group meeting where I interacted with some of the key stakeholders. (6) Presentation of Attachment Period. I was given an opportunity to present at the department of Chemical Pathology where my supervisors, other key members of staff and Masters in Science students were in attendance. (I have attached the presentation). Way Forward. As we plan to form a National Quality Assurance program in Malawi, there is a lot of work to be done. Though by my experience, I am confident that we are not very far behind as a country. As we charter forward we intend to do the following: (1) Develop an EQA Establishment Work plan. This is the framework that will guide us in all the activities and resources we would need to establish and implement a functional EQA program. I intend to work with the Malawi College of Medicine, Malawi Association of Medical Laboratory Scientists (MAMLS) and the Ministry of Health. (2) Establish an EQA Technical Working Group – Steering Committee. This will be a valuable way to allow the Ministry and various stakeholders to contribute to the national EQA program. This will be done under the guidance of the Diagnostics department at the Ministry of Health. (3) Involve all key stakeholders to ensure buy-in and effective operation. This cannot be overemphasized. As a team we intend to find ways in which to constantly involve key stakeholders so as to commit their technical and financial support to the project. Conclusion. I have learnt much during my stay and I believe I will be able to use this knowledge to help my country as we set up a similar program. I would like to appreciate again the President of IFCC, my supervisors and my family and friends for making the exchange programme a success. Acknowledgements: IFCC; University of Zimbabwe, Chemical Pathology Department; ZINQAP.

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 October/2017

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NEWS

THE WORLD OF IFCC

Finnish Society of Clinical Chemistry: An Update he Finnish Society of Clinical Chemistry (FSCC) was founded in 1946, has 450 members and 15 supporting members (companies). Clinical doctors or clinical chemists/biochemist who work in the field of clinical chemistry are accepted as members. FSCC is the major owner of the Finnish external quality assessment provider Labquality Ltd and is a member of the international organizations IFCC, EFLM and IUPAC, and also a member of the Nordic Society of Clinical Chemistry. FSCC provides grants for research and education, publishes the journal Kliinlab (www.skky.fi/kliinlab-lehti) and organizes two 1-2 day national congresses annually by itself or in collaboration with the other Finnish clinical chemistry societies or companies. Labquality has a history of more than 45 years of proving high quality external quality assessment for laboratories all over the world. Labquality organizes yearly a large international congress Labquali-

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ty Days for clients and experts working in the clinical laboratories and as quality management professionals. The event is being held in wintery Helsinki in February and this year almost 1000 participants came to learn more and to be inspired about clinical laboratory sciences, bioanalytics and this year also about the innovations in health technologies and digital possibilities in the field. The themes for 2017 were evidence-based laboratory medicine and Impact of total quality management. There were participants from more than 20 countries who participated in the international part of the congress. An extensive exhibition with some 60 diagnostic companies as well as the new ePosters kept the congress attendees busy even during the lecture breaks. The exhibition area also had a Speaker’s Corner where one could listen to the new and exciting things happening inside the fields like digital pathology, biomarkers and probiotics.

New Series of JCTLM Webinars Published he webinars have been published in the IFCC eAcademy: http://eacademy.ifcc.org/events/jctlm-webinars The JCTLM team has been busy over the summer period. Under the leadership of Prof Elvar Theodorsson, SE, a series of short webinars has been produced. Each webinar addresses a specific aspect of traceability in laboratory medicine and method standardization. These webinars are freely available through the IFCC eAcademy. Traceability in laboratory medicine is becoming increasingly important in the global initiative to reduce betweenmethod variability as driver for accurate results for patient care. This series of webinars will be of interest to laboratory medicine specialists and those responsible for training them; to external quality assessment (EQA) organisations; and to the manufacturers of diagnostic assays and equipment. There are currently eight webinars as follows: All results are made and interpreted by comparison. Elvar Theodorsson (SE)

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The pillars of standardization. Elvar Theodorsson (SE) Standardization and harmonization. Elvar Theodorsson (SE). Basic traceability chains. Jeanita Pritchett NIST (USA). Examples of reference materials. Jeanita Pritchett NIST (USA) Examples of reference measurement procedures Jeanita Pritchett NIST (USA) Basics of traceability applied to laboratory medicine. Anja Kessler (DE) Traceable and commutable calibrators. David Ducroq (UK). Two further webinars on commutability will be added over the next weeks to complete the series. The webinars have been published in the IFCC eAcademy: http://eacademy.ifcc.org/events/jctlm-webinars/ The webinars may also be accessed from the JCTLM website (www.jctlm.org) in the Resources section. The PowerPoint slides that support the webinars are available separately from the JCTLM website.

Next year the congress will be held on 8-9 February and the themes are: Path to Perfect Quality and New frontiers in health and laboratory technology. We warmly invite all of our colleagues to participate! You are most welcome! Learn more from the website www.labqualitydays.com. The main future effort of the Finnish society is to organize the biannual Nordic congress in clinical chemistry in Helsinki (www.nfkk2018.fi). This congress is going to gather together colleagues on 1215 June 2018 to listen and to learn about “Information beyond numbers”. We have an interesting year ahead of us in Finland with several intriguing congresses to come. We hope to see many of our international colleagues visiting us!

Join the IFCC Social Networking Community ollow the IFCC on Facebook, Twitter and LinkedIn to get regular updates on IFCC news, events and activities. Start discussions, share yours news and information and be a part of the online clinical chemistry and laboratory medicine community! www.facebook.com/IFClinChem www.twitter.com/IFClinChem www.linkedin.com/groups/3866810

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Download the New IFCC App On Your Mobile he IFCC app is available on both iOS and Android platforms and it is free to download from iTunes or Google Play. The IFCC App provides direct access to the IFCC website, the latest IFCC news and lFCC calendar of upcoming conferences and other events, access to the eAcademy eLearning modules, and the latest eJIFCC and eNews publications and ability to browse them, even when you are offline. Everything is available in one place and accessible with a single click on your mobile phone or tablet. Search for the app in the Apple AppStore or Google Play using "ifcc" today!

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Let’s All Get Together to Achieve Excellence in Lab Medicine! 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)

dependent private practice laboratory networks, built around technical platforms, via mergers or by forming subsidies from private practice companies. This last form of grouping, a common legal structure with many regional sites, with the advantage of preserving the private practice character of the pro-

he concentration of the laboratory medicine sector is increasing worldwide. This still very fragmented sector has been concentrated for several years around two major types of structures. On the one hand, there are integrated groups such as Sonic, Unilabs, Biomnis etc., and on the other, in-

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fession, is currently preferred by a number of laboratory medicine specialists. These structures constitute expert local networks with high tech platforms. In addition to economies of scale sought by forming groups, this movement is accompanied by a specific regional strategy of redefining the pathways of patient care, concentrating medical expertise, conducting training and organizing to conduct research with supporting publications. Given these new networks of regional scope, the public sector is setting up, as in France, cooperative dynamic arrangements with regional focus while combining two objectives: on the one hand, the guarantee of equal access to healthcare, and on the other hand, control of healthcare costs, notably hospital costs, by the regional cooperation of healthcare facilities as part of a coordinated and graduated care pathway. Working with legal divisions and shifting policies, cooperation between healthcare facilities and laboratories has long been at the heart of the distribution of the regional supply of hospital services. Also under increasing pressure, coupled with multiple constraints and competition, the regional cooperation of public structures is shifting towards a group focus. Any collaboration requires a reduction in the autonomy of legal entities or physical partners, involves information sharing, and at least partial coordination of strategies, actions and operations. Ties of interdependence and even solidarity are created. Thus cooperation must be understood above all as an individual and collective method of connection. Cooperation is a way of resolving complex situations faced by the hospital sector and a force to highlight the added value of laboratory medicine. In the latest law on the modernization of the French health system in 2016, functional cooperation is understood in the sense of complementarity between hospitals and laboratories. Thus cooperation becomes a lever for decompartmentalization. Setting up regional hospital groups (GHT) aims to enable facilities to implement a regional strategy of shared

and graduated patient care in order to ensure equal access to safe and quality care. To this end, a shared medical plan and a shared care plan are developed in each GHT. In each GHT, the member facilities jointly organize laboratory medicine activities. The laboratory medicine plan is an integral part of the shared medical plan. In fact, this underlines the need for consistency and connection between the laboratory medicine organization and the clinical activity organization. The common organization of laboratory medicine activities is intended to be understood within the broader framework of GHT reform, taking into account, in particular, the establishment of a convergent information system within each GHT. Jointly organizing laboratory medicine activities also leads to the understanding of other aspects in relation to specific constraints and environment, in particular any existing partnerships and markets. A joint medical laboratory, set up between the facilities participating in the GHT, leads to a single accreditation process and a better visibility of laboratory medicine at the regional level. Laboratory medicine is a particularly rich and varied speciality which has become an essential key player in the care pathway. It is a discipline at the forefront of innovation and in continuous development due to constant technological evolution and scientific advances. It is a multifaceted specialty that requires mastery of medical and technical aspects. Quality is guaranteed by the accreditation process in which all countries are involved, ensuring quality and compliance with the rules of good practice according to common standards for all independent as well as hospital laboratories. The landscape is changing and we are still at the beginning of group formation, but according to Comexium Consulting, history shows that nothing is written, because, on the one hand, laboratory medicine players and bio-financiers are emerging each year, and on the other, many cessions have shown that, despite belonging to a network or believing that laboratory medicine belongs to practitioners, when it comes time to take off, the patrimonial aspect can quickly make everyone agree on the terms of a cession. Let us remain vigilant to promote innovative, excellent and locally-based laboratory medicine, that focuses on serving the patient.

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DIAsource Acquisition Expands Range of Endocrinology Offerings IAsource ImmunoAssays SA (Louvain-La-Neuve, Belgium; www.diasource-diagnostics. com), which develops, sells and distributes clinical diagnostics products, has acquired Viro-Immun Diagnostics GmbH (Viro-Immun Diagnostics GmbH; www.viro-immun.eu), a developer and manufacturer of laboratory diagnostics for the medical diagnosis of infectious and autoimmune diseases. DIAsource manufactures and sells manual kits and open automation for clinical diagnostics, while Viro-Immun offers a portfolio of assays in infectious and autoimmune diseases, including the ToRCH panel with parameters such as Toxoplasma, Rubella, Herpes. With this transaction, DIAsource has acquired the Viro-Immun brand name and all ELISA and IFA products, as well as full inventory and infrastructure, thereby further

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strengthening and extending its portfolio of endocrinology and Vitamin D products. The acquisition of Viro-Immun fits in with DIAsource's strategy to act as a consolidator in its core business of manual kits and open automation. Effective September 5, 2017, BioVendor – Laboratornímedicínaa.s. (Brno, Czech Republic; www.biovendor. com) acquired 100% of the shares of DIAsource from Anteo Diagnostics (Queensland, Australia; www.anteo tech.com), which had acquired DIAsource in January 2016. The acquisition of DIAsource extended BioVendor’s broad panel of ELISA and RIA assays, antibodies and reagents for clinical diagnostics, as well as established a direct sales presence in Belgium, France and Spain, and a worldwide network of over 100 sales and distribution partners in over 70 countries.

Global Lateral Flow Assay Market To Exceed USD 8 Billion by 2022 he global lateral flow assay market is projected to grow at a CAGR of 8.2% from USD 5.55 billion in 2017 to USD 8.24 billion by 2022, driven mainly by the high prevalence of infectious diseases worldwide, rapidly growing geriatric population, growing demand for point-of-care (POC) testing, and rising use of home-based lateral flow assay devices. These are the latest findings of Research and Markets, (Dublin, Ireland; www.researchand markets.com), a global market research company. Based on product, the kits & reagents segment held the largest market share in 2016, due to the increasing application of lateral flow kits & reagents for POC testing, growing burden of chronic diseases, and increasing use of lateral flow kits in home care. On the basis of application, the clinical/POC testing segment accounted for the largest share of the market in 2016, led by rise in population levels and prevalence of chronic diseases, growing pressure to reduce healthcare costs, and increasing demand for patient-centric care. Based on end-user, the hospitals and clinics segment accounted for the largest share of the market in 2016, mainly due to technological advancements, increasing adoption of POC testing, innovative technologies and devices, and growing patient inclina-

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tion toward fast and early diagnosis. Geographically, North America held the largest market share in 2016, primarily due to the presence of its highly developed healthcare system, rising geriatric population, increasing incidence of chronic diseases, quick adoption of new innovative products, and a large number of lateral flow assay kits manufacturing companies in this region. However, reluctance among doctors and patients to change existing diagnostic procedures, implementation of excise duty by the US government, and stringent & time-consuming regulatory policies are restraining the growth of the lateral flow assay market. Alere Inc. (Waltham, MA, USA; www.alere.com) dominated the global lateral flow assay market in 2016 due to its diversified product portfolio of lateral flow assay kits and readers, as well as innovative contributions to the lateral flow assay market. Over the years, the company has developed innovative lateral flow assay products for various medical applications, such as POC testing products that make workflows more efficient and provide quality test results. The company has a strong manufacturing and distribution network across the globe, which allows it to serve customers across the Americas, Africa, Europe, the Middle East, and Asia-Pacific.

Industry News

Global Laboratory Informatics Market To Reach USD 3.16 Billion by 2022 he global laboratory informatics market is projected to grow at a CAGR of 6.4% from USD 2.32 billion in 2017 to USD 3.16 billion by 2022, driven by the increasing need for lab automation, development of integrated lab informatics solutions, regulatory requirements, growing demand in biobanks/biorepositories, academic research institutes, and CROs, and rising awareness. These are the latest findings of Research and Markets (Dublin, Ireland; www.researchandmarkets.com), a global market research company. In 2017, the LIMS segment is expected to account for the largest share of the global laboratory informatics market, based on the type of solutions offered, and is also projected to record the highest CAGR during the forecast period, due to the wide range of benefits associated with the use of these systems, including increased workflow efficiencies, easy integration with other lab systems, reduced transcription errors, and better regulatory compliance.

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The on-premise segment is expected to hold the largest share of the global laboratory informatics market, by deployment model, while the cloud-based segment is expected to record the highest CAGR during the forecast period, due to advantages such as on-demand self-serving analytics, absence of upfront capital investment for hardware, extreme capacity flexibility, and a pay-as-you-go pricing model. In 2017, the life sciences segment is expected to hold the largest share of the global laboratory informatics market, by industry, led by the growing applications of molecular diagnostics, rising outsourcing by pharmaceutical industries, rising need for integrated systems, stringent regulatory guidelines to be followed by pharmaceutical laboratories, increasing number of biobanks/biorepositories due to the growing number of biobanking applications, increasing need to integrate laboratory systems, and growing awareness and availability of technologically-advanced laboratory informatics solutions.

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International Calendar Cytology. May 14-15; London, UK; Web: www.cytologyjapan2016.com SEACare 2018 – Southeast-Asian Healthcare Show. May 14-16; Kuala Lumpur, Malaysia; Web: www.expocheck.com AACE 2018 – 27th Annual Meeting and Clinical Congress of the American Association of Clinical Endocrinologists. May 16-20; Boston, MA, USA; Web: www.aace.com European Congress of Endocrinology. May 19-22; Barcelona, Spain; Web: www.esehormones.org Molecular Diagnostics Europe. May 22-24; Lisbon, Portugal; Web: www.moleculardx europe.com HOSPITALAR 2018. May 22-25; Sao Paulo, Brazil; Web: www.hospitalar.com EuroPCR 2018 – European Association of Percutaneous Cardiovascular Interventions Congress. May 22-25; Paris, France; Web: www.europcr.com 25th Biennial International Congress on Thrombosis. May 23-26; Venice, Italy; Web: www.thrombosis2016.org EEACI 2018 – European Association of Allerology and Clinical Immunology. May 2630; Munich, Germany; Web: www.eaaci.org ESPID 2018 – European Society for Paediatric Infectious Diseases. May 29-Jun 2; Malmo, Sweden; Web: http://lp.www2.kenes.com

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