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WORLD’S CLINICAL LABORATORY NEWS LEADER ISSN 1068-1760
Vol. 36 No.1 • 2-3/2019
DAILY CLINICAL LAB NEWS
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Test for Uterine Infections That Impact Fertility pproximately 10% of women in the general population may have chronic endometritis, but among infertile women undergoing IVF, the rate is 15%, with rates estimated as high as 60% among women experiencing recurring implantation failure or miscarriage.
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New Test Procedure Diagnoses Multi-Resistant Pathogens atients with bloodstream infections caused by gram-negative pathogens such as Escherichia coli (E. coli) have a high mortality rate. However, the infection has so far usually been treatable with antibiotics. Due to the increased antibiotic
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resistance of bacteria, also against the group of carbapenems, therapy has become increasingly difficult. Infections with multi-resistant pathogens that are also resistant to such ‘reserve antibiotics’ often lead to ineffective antibiotic therapy and thus to higher mortality.
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Saliva Test Could Transform Diabetes Management
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recently developed liquid biopsy cell-sorting device was able to detect circulating epithelial cells of hepatocyte origin in blood from healthy individuals, patients with chronic liver disease without hepatocellular cancer (HCC), and those with HCC. A cell-sorting device had previously been developed to isolate epithelial cells in the circulation (circulating epithelial cells, or
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ale fertility is a serious and growing concern globally. Yet, the field of andrology faces critical gaps in diagnostic technologies and knowledge, affecting scientific advancement as well as clinical management by both reproductive endocrinologists and urologists. Although effective at identifying descriptive parameters, traditional semen analysis fails to identify defects in Cont’d on page 5
Compact Hematology Analyzer Line Offers Economy and Throughput
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new line of compact hematology analyzers meet the need for affordable yet powerful and reliable differential analysis of blood counts, in flexible lab settings across hospital departments and clinics.
Clinical News . . . . 4-26 IFCC News . . . . . . . . 27 Product News . . 10-26 Industry News . . . . 33 Events Calendar . . . 34
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Liquid Biopsy Identifies Chronic Liver Diseases
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he world's first truly noninvasive test that measures glucose in saliva instead of blood, offers a breakthrough in diabetes management. By eliminating the need for fingerprick blood testing that often leads to poor adherence to testing protocols, the new technology could lead to increased glucose monitoring and better healthcare outcomes.
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uest Diagnostics, a leading provider of diagnostic services, together with other similar providers, have announce the formation and launch of the Global Diagnostics Network, a strategic working group of diagnostic laboratories, each committed to un-
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leashing and sharing local innovation to increase global access to diagnostic science, information, and services in order to improve the delivery of global healthcare. GDN initiatives will benefit patients, healthcare providers, referring practitioners, pharmaceutical Cont’d on page 4
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Saliva Test Could Transform Diabetes Management he world’s first saliva-based glucose test for diabetes management that measures glucose in saliva rather than blood has been introduced. The core scientific innovation of the biosensor lies in the patent protected modified organic thin film transistor architecture, incorporating Glucose Oxidase (GOX) as the recognition element to initiate an electrochemical reaction that produces an electrical signal. This electrical signal can be displayed on the patient’s smart device in real time. The biosensor exhibits high sensitivity hence is able to detect glucose levels at considerably lower levels than in blood. It has a linear glucose sensing capability at concentrations of 100 times lower than current blood measuring methodologies. The Saliva Glucose Biosensor (iQ Group Global, Sydney, Australia; www.theiqgroup global.com) is comprised of the Glucose Biosensor Unit and a digital healthcare app. The Glucose Biosensor Unit is a small, disposable strip, which when exposed to an individual’s saliva instantly provides a glucose measurement. The glucose measurement will be presented in real-time, via a proprietary digital app on a patient’s smart device.
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The glucose measurement recorded by the biosensor will be presented via the proprietary digital app on the patient’s smart device in real-time where the patients may also compare historic glucose levels. This will open significant opportunities to improve the way diabetes is monitored and managed, enabling patients to store and analyze their data, share monitoring data with their healthcare team or relatives, create and send automated reminders when it is time to test glucose levels, offer educational services, and act as a provider for healthcare companies who offer patient support programs. George Syrmalis, PhD, Chief Executive Officer and Chairman of the iQ Group Global, said, “Diabetes is a global epidemic, with 1 in 11 adults living with the disease. Achieving normoglycemia is one of the main targets for diabetes patients. However, finger prick testing is a painful and frustrating process, with many citing the pain as the main reason for poor adherence to testing protocols. By eradicating the need for finger prick blood tests, the saliva-based test will lead to increased glucose monitoring and better healthcare outcomes among these patients.”
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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). HospiMedica International • HospiMedica en Español • HospiMedica China LabMedica International • LabMedica en Español • LabMedica China Medical Imaging International • Bio Research International • Medimaging.net HospiMedica.com • LabMedica.com • BiotechDaily.com • TradeMed.com
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New Global Network Improves Access to Diagnostic Insights cont’d from cover
innovators, government agencies, non-governmental organizations (NGOs), and academic institutions. Starting priority areas of focus include a global launch platform for high quality companion diagnostics and the creation of an emerging pathogen preparedness network in order to expedite infectious disease research and response. Additional initiatives will be rolled out based on regional and global priorities. “The Global Diagnostics Network (GDN; www.globaldiagnosticsnetwork.com) will help solve some of the world’s most pressing healthcare challenges by enabling fast and consistent access to leading diagnostic innovations and best practices,” said Steve Rusckowski, chairman, president, and CEO of Quest Diagnostics (Madison, NJ, USA; www. QuestDiagnostics.com). “As we met with regional lab leaders over the past year, it became clear that we can accelerate the development and delivery of advanced diagnostics and diagnostic insights by bringing together our peers and sharing best practices.” “The GDN collaboration will open up new opportunities by removing silos around unique knowledge and resources,” said Carrie
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Eglinton Manner, senior VP of advanced diagnostics at Quest Diagnostics. “We see this as a pragmatic approach to driving growth and excellence for all network members, while providing customers global access to innovations in diagnostics science, information, and service delivery.” In addition to Quest Diagnostics, charter members of the GDN are Al Borg Medical Laboratories (Jeddah, Saudi Arabia), Dasa (Sao Paolo, Brazil), GC Labs (Yongin-Si, South Korea), KingMed Diagnostics (Hong Kong, China), Primary Health Care (Sydney, Australia), and SYNLAB (Munich, Germany). Image: The world’s major diagnostic companies have formed an international network (Photo courtesy of Shutterstock).
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ISSN 1068-1760 Vol.36 No.1. Published, under license, by Globetech Media LLC; Copyright © 2019. 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. Şti. adına İmtiyaz Sahibi: M. Geren • Yazı işleri Müdürü: Ersin Köklü Müşir Derviş İbrahim Sok. 5/4, Esentepe, 34394 Şişli, İstanbul P. K. 1, AVPIM, 34001 İstanbul • E-mail: Teknopress@yahoo.com Baskı: Postkom A.Ş. • İpkas Sanayi Sitesi 3. Etap C Blok • 34490 Başakşehir • İstanbul Yerel süreli yayındır. Yılda sekiz kere yayınlanır, ücretsiz dağıtılır.
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LabMedica International
Compact Hematology Analyzer Line Offers Economy and Throughput here is a growing demand for high quality clinical diagnostics in laboratories in hospital or independent settings and in doctor’s offices. In hematology laboratories, demand is increasing for compact, powerful and affordable analyzers to provide accurate and reliable differential analysis of blood counts. Common requirements for the hematologists are high throughput, broad parameter ranges, a small footprint and minimum blood volumes to cater for pediatric and point-of-care applications. Addressing these issues, two new hematology analyzers have been introduced to cover the essential requirements and other parameters. The new analyzers are the H360 and H560, both from Erba Mannheim (Miami, FL, USA; www.erbadiagnostics.com). They have been designed to meet or exceed current requirements, providing high quality devices with a wide linearity range, as well as reliability with clear and reliable reporting, enabling a fast turnaround time. The H360 uses only 9 μL of blood and provides a three part differential report with 22 parameters including WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, LYM#, MID#, GRA#, LYM%, MID%, GRA%, RDW-
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SD, RDW-CV, PDW-SD, PDW-CV, MPV, PCT, P-LCC, P-LCR + three histograms (WBC-3part, RBC, PLT). The H560 offers full five part differential report with 33 parameters including WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, LYM#, MON#, NEU#, EOS#, BASO#, ATY#, LIC#, LYM%, MONO%, NEUT%, EOS%, BASO%, ATY%, LIC%, RDW-SD, RDW-CV, PDW CV, PDW SD, MPV, PCT, P-LCC, P-LCR, n RBC #, n RBC % and corrected WBC # + 3 histograms (WBC-3part, RBC, PLT) and Scattergram with just 15 μL of blood. The parameters RDW- CV and RDW- SD, MCH, ATY, P-LCR, PDW, MPV and differential counts provide powerful tools to clinicians and pathologists for timely diagnosis of patients, helping to provide accurate and cost effective treatment. The nRBC & corrected WBC c-WBC parameters flag subsequent smear examinations. Both systems include optimum throughput of 60 tests/hour, cyanide free reagent for HGB, excellent correlation and customizable re-run of abnormal samples. Usability is easy with a built-in 10.4-inch LCD color touch screen, USB external printer and external bar code reader. A high storage capacity of 50,000 sample results is also offered.
New Test Measures Male Fertility cont’d from cover
sperm function. Put simply, it does not provide information about whether a man’s sperm can fertilize an egg, and the probability of that man generating a pregnancy. A team of scientists working with Cornell University (Ithaca, NY, USA; www.cornell.edu) collected 208 semen samples from men having medical evaluations because of questions regarding their fertility. In addition to undergoing traditional semen analysis, the team tested the samples and assigned them prospectively into groups predicted to have low versus normal fertility. The samples were collected and processed using Cap Score Male Fertility Assay kits (Androvia LifeSciences LLC, Mountainside, NJ, USA; www.androvialifesciences.com). Clinical outcomes were later reported for 91 of these men. The team reported that men with normal Cap-Scores had a 2.78-fold higher chance of pregnancy than men with a low score, and a 4.23-fold higher success rate at achieving pregnancy in their first attempt at intrauterine insemination (IUI). In contrast, none of the elements of semen analysis, such as sperm swimming or concentration, had any relationship with male fertility. The team collected more CapScores and clinical outcomes from a total of five fertility clinics and urology practices and using data from 124 men, the scientists generated a curve that translates a Cap-Score into the probability of generating a pregnancy. The study was published on September 24, 2018, in the journal Molecular Reproduction and Development.
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Next-Gen Test Authorized for Minimal Residual Disease n estimated 6,000 people in the USA will be diagnosed with acute lymphoblastic leukemia (ALL) and 31,000 people will be diagnosed with multiple myeloma this year. In patients with these diseases, Minimal Residual Disease (MRD) is a metric for gauging how many cancer cells remain in their bone marrow after treatment, which can be indicative of their response to treatment and extent of their remission. Currently, MRD is measured using flow cytometry assays or polymerase chain reaction (PCR)-based assays, which can pick up 1 in 10,000 or 1 in 100,000 cells. The US Food and Drug Administration (FDA, Silver Springs, MD, USA; www.fda.gov) authorization of clonoSEQ (Adaptive Biotechnologies, Seattle, WA, USA; www.adaptivebiotech.com) was based on retrospective analysis of three studies that together involved samples from 273 ALL patients and more than 1,000 multiple myeloma patients. ALL patients who were MRD negative had longer event-free survival (the time after treatment that a patient is free of complications or other events), while those with higher MRD results had lower event-free survival rates.
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ClonoSEQ was used to demonstrate that MRD was similarly associated with progression-free survival, the amount of time during and after treatment that a patient’s disease does not get worse and disease-free survival, the length of time after primary cancer treatment that a patient does not have any signs of that cancer. The clonoSEQ Assay leverages the power of immunosequencing coupled with groundbreaking advances in chemistry and proprietary bioinformatics to assess the presence of malignant cells at levels below the detection limit of conventional cytomorphological methods. When a sufficient sample is provided, the assay can routinely identify the presence of one cancer cell in a sample of one million healthy cells. Image: Bone marrow aspirate of a patient with acute lymphoblastic leukemia revealing increased blasts which are small to medium in size with high nuclear-to-cytoplasmic ratios, round to irregular nuclei, smooth chromatin, and scant basophilic agranular cytoplasm. Some background maturing myeloid cells are also present in this case (Photo courtesy of Dr. Karen M. Chisholm).
Rapid Test Detects Drugs of Abuse In Fingerprint Samples rapid lateral flow assay accurately detects drugs of abuse in finger print samples from living or deceased individuals. Investigators at the University of East Anglia (Norwich, UK www. uea.ac.uk) and the biotechnology company Intelligent Fingerprinting (Cambridge, United Kingdom; www.intelligentfingerprinting.com) developed a fluorescence based lateral flow competition assay for the screening of four classes of drugs: delta9-tetrahydrocannabinol (THC), cocaine (through the detection of benzoylecgonine, BZE), opiates (through the detection of morphine, MOR) and amphetamine (AMP) present in the sweat of a fingerprint. This “Drug Screening Cartridge” was specifically developed for fingerprint sample collection and analysis. In addition to testing samples from living individuals, the investigators worked with three coroners in the United Kingdom to test the ability of the Drug Screening Cartridge, together with its fluorescence reader, to detect drugs in the sweat of a fingerprint from deceased individuals. The presence of the drugs was confirmed using LC–MS-MS analysis of a second fingerprint sample collected simultaneously. This fingerprint sample method had a collection time of just five seconds and a total analysis time of less than 10 minutes. Results revealed that there was sufficient sweat present on the fingertips to enable analysis and that the Drug Screening Cartridge could detect the presence, or absence, of each drug. Excellent correlation was achieved between the results obtained from the Drug Screening Cartridge and the LC–MS-MS analysis of the fingerprint samples obtained from 75 individuals. The accuracy of the results was: 99% for THC, 95% for BZE, 96% for MOR, and 93% for AMP. The results obtained using the Drug Screening Cartridge were also compared to toxicological analysis of blood and urine samples with good correlation. The accuracy of the results between the Drug Screening Cartridge and blood was: 96%, 92%, 88%, and 97% for THC, BZE, MOR, and AMP, respectively. The comparison with urine showed an accuracy ranging between 86% and 92%. The study was published in the October 1, 2018, online edition of the Journal of Analytical Toxicology.
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New Test Procedure Diagnoses Multi-Resistant Pathogens cont’d from cover
Medical microbiologists at the University Hospital of Cologne (Cologne, Germany; www.uni-koeln.de) and their partners analyzed in a study, a total of 126 Enterobacteriaceae clinical isolates harboring different carbapenemases and 44 Enterobacteriaceae clinical isolates that were carbapenemase-negative. Klebsiella pneumoniae was the most frequent species (N = 84), followed by Escherichia coli (N = 53) and Enterobacter cloacae (N = 15). Carbapenemase-producing isolates (CPE) included the three carbapenemases: 79 carbapenemhydrolysing class D -lactamases (OXA-48-like), 29 New Delhi metallo-betalactamase (NDM) or 18 Klebsiella pneumoniae carbapenemase (KPC). The team developed and evaluated a new method for the rapid detection of carbapenemases directly from positive blood culture (BC) using a new multiplex immunochromatographic test (ICT). After spiking with bacteria and incubation in a BC system, blood from positive BC bottles was hemolyzed, and bacteria concentrated by centrifugation and lysed. The lysate was transferred to the RESIST-3 O.K.N. ICT (Coris BioConcept, Gembloux, Belgium; www.corisbio.com), which detects OXA-48-like, KPC and NDM carbapenemases. The final results of the immunochromatography test (ICT) were read when they became positive, at the latest after 15 minutes. All CPE isolates (126/126) were correctly detected with the new protocol (100% sensitivity, 100% specificity). There was perfect concordance between ICT results and molecular characterization and total time to result was 20 to 45 minutes. Three of the four most common carbapenemases, OXA-48, KPC and NDM, were discovered directly from positive blood cultures using a single test procedure without the need for time-consuming further cultivation on agar plates. The new method is fast, easy to use, inexpensive, approximately EUR 10/test and can be performed in any clinical microbiology laboratory. Axel Hamprecht, MD, a professor and lead author of the study said, “With this procedure, we have come a giant step closer to our goal of being able to help patients infected with multi-resistant pathogens as quickly as possible. In the case of the aggressive pathogens we are confronted with, every minute counts in order to start a targeted therapy.” The study was published on September 14, 2018, in the journal PLOS ONE. Image: A single immunochromatography test for the triple independent identification of OXA-48-like, KPC and NDM carbapenemase on bacterial colony using the RESIST-3 O.K.N. assay (Photo courtesy of Coris BioConcept).
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Diagnostic Accuracy of Histoplasma Urine Antigen Assay Evaluated istoplasmosis is an endemic mycosis in many regions of Latin America. In the human immunodeficiency virus (HIV) infected population it manifests as progressive disseminated histoplasmosis (PDH), an entity hard to diagnose since the causative fungi, Histoplasma capsulatum, is slow growing and requires advance biosafety for its handling. The standard of reference for PDH diagnosis is the isolation of Histoplasma capsulatum from a non-respiratory sample, typically bone marrow or peripheral blood, or the visualization of yeast-like structures in the histopathologic examination. In the USA, histoplasmosis is also endemic, and its PDH presentation is commonly diagnosed by the detection of Histoplasma urine antigen (HUAg). Scientists at The National Institute of Med-
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ical Sciences and Nutrition Salvador Zubirán (Tlalpan, Mexico City, Mexico; www.innsz.mx) conducted a multicenter, prospective, diagnostic test study in two secondary and eight tertiarycare facilities from seven states of Mexico, from December 2015 to October 2017. At least 5 mL of peripheral blood were inoculated in a BD BACTEC Myco F/ Lytic (Becton Dickinson, Franklin Lakes, NJ, USA; www.bd.com) vial; for bone marrow aspirates, a similar amount (5 mL) was inoculated in a BACTEC Myco F/ Lytic and a BACTEC Peds Plus F (3 mL), and 1 mL in a Löwenstein-Jensen and Sabouraud solid media. The team evaluated the diagnostic accuracy of IMMY ALPHA Histoplasma Enzyme immunoassay (EIA) Test Kit, (ALPHA-HUAg, IMMY, Inc, Norman, OK, USA; www.immy.com). The scientists included 288 cases for this analysis. From these patients, the central laboratory processed 1,068 samples: 277 blood cultures, 252 bone marrow aspirate cultures, 104 biopsies for tissue culture, 147 biopsies for the histopathologic examination, and 288 urine samples for HUAg detection. They classified 85/288 (29.5%) patients as PDH–proven, 28.2% (24/85) based on positive histopathologic examination and positive culture, 58.8% (50/85) by positive culture only and 12.9% (11/85) by positive histopathologic exam only. The sensitivity of ALPHA-HUAg was 67.1%
(95% CI, 56–76.8%) and the specificity was 97.5% (95% CI, 94.3%-99.1%). The positive likelihood ratio was 27.2 (95% CI; 11.6–74.4). In 10.5% of the PDH–proven patients, a co-existing opportunistic infection was diagnosed, mostly disseminated Mycobacterium avium complex infection. The authors concluded that ALPHA-HUAg is a useful test for the diagnosis of PDH, in patients with high level of suspicion in endemic regions for H. capsulatum, and may favor early targeted-antifungal treatment, thus improving the prognosis of these frail HIV-patients. Nevertheless, the culture-based approach should ensue simultaneously since co-infections are frequent and a negative result of ALPHA-HUAg does not discard PDH in patients from endemic regions for H. capsulatum. The study was published on November 5, 2018, in the journal Public Library of Science Neglected Tropical Diseases. Image: The ALPHA Histoplasma Enzyme Immunoassay (EIA) test kit (Photo courtesy of IMMY).
Sensitive Tumor Detection Uses Cell-Free DNA Methylomes combination of “liquid biopsy,” epigenetic alterations and machine learning has been used to develop a blood test to detect and classify cancer at its earliest stages. The method holds promise of being able to find cancer earlier when it is more easily treated and long before symptoms ever appear. The use of liquid biopsies for cancer detection and management is rapidly gaining prominence. Current methods for the detection of circulating tumor DNA involve sequencing somatic mutations using cell-free DNA, but the sensitivity of these methods may be low among patients with early-stage cancer given the limited number of recurrent mutations. Scientists at the Princess Margaret Cancer Centre (Toronto, ON, Canada; www.uhn.ca) and their colleagues developed a sensitive, immunoprecipitation-based protocol to analyze the methylome of small quantities of circulating cell-free DNA, and demonstrate the ability to detect large-scale DNA methylation changes that are enriched for tumor-specific patterns. The investigators tracked the cancer origin and type by comparing 300 patient tumor samples from seven disease sites (lung, pancreatic, colorectal, breast, leukemia, bladder and kidney) and samples from healthy donors with the analysis of cell-free DNA (cfDNA) circulating in the blood plasma. In every sample, the “floating” plasma DNA matched the tu-
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mor DNA. The team has since expanded the study and has now profiled and successfully matched more than 700 tumor and blood samples from more cancer types. By profiling epigenetic alterations instead of mutations, the team was able to identify thousands of modifications unique to each cancer type. Then, using a big data approach, they applied machine learning to create classifiers able to identify the presence of cancer-derived DNA within blood samples and to determine the cancer type. This basically turns the ‘one needle in the haystack’ problem into a more solvable ‘thousands of needles in the haystack’, where the computer just needs to find a few needles to define which haystack has needles. This work sets the stage to establish biomarkers for the minimally invasive detection, interception and classification of early-stage cancers based on plasma cell-free DNA methylation patterns. Daniel D. De Carvalho, PhD, a professor of cancer genetics and senior author of the study, said, “We are very excited. A major problem in cancer is how to detect it early. It has been a ‘needle in the haystack’ problem of how to find that one-in-a-billion cancer-specific mutation in the blood, especially at earlier stages, where the amount of tumor DNA in the blood is minimal.” The study was published on November 14, 2018, in the journal Nature. LabMedica International February-March/2019
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PRODUCT NEWS HEMATOLOGY ANALYZER
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The CELL-DYN Emerald 22 automated optical 5-part differential analyzer delivers smarter results for small- to mid-sized clinical laboratories. It is considered ideal for shrinking lab spaces and budgets.
The PolarSafe buckets and pans provide mess-free benchtop cryogenic chilling without sweating or leaking. The EVA products are compatible with ice, dry ice, liquid nitrogen, alcohol and saline solutions.
The Simplexa Group B Strep Direct assay enables the direct in vitro detection of Group B Streptococcus. The assay is more specific than traditional testing methods and features a fast workflow.
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Test for Uterine Infections That Impact Fertility cont’d from cover
Microbiological culture can identify the pathogen in some cases and lead to tailored antibiotic treatment, but cultures are laborious and time consuming, and some pathogens that are quite typical causes of endometritis do not grow under standard culture conditions, so infections can be missed using this method. Igenomix (Valencia, Spain; www.igenomix.com), a reproductive genetics firm, have developed the first commercial assay for diagnosing chronic endometritis, a symptomless infection in the uterine lining that can impact a woman’s fertility. The firm is commercializing the test, along with other genetic analyses of endometrial status, in the EU and plans to bring it to its USA laboratories upon CLIA approval. The assay is called Analysis of Infectious Chronic Endometritis, or ALICE, and the Igenomix test uses next-generation sequencing to detect nine different pathogens causing chronic infection: Chlamydia trachomatis, Enterococcus, Escherichia coli, Gardnerella vaginalis, Klebsiella pneumoniae, Mycoplasma hominis, Neisseria gonorrhoeae, Staphylococcus, and Streptococcus. The ALICE test will be commercialized along with two other genetic assays the firm has already been marketing, which assess receptivity of the endometrium and health of the uterine microbiome, respectively. The Igenomix endometrial microbiome metagenomic analysis, or EMMA, uses 16S RNA sequencing to determine the proportion of Lactobacillus, or healthy bacteria, in the uterus. The firm’s scientists recent-
ly demonstrated that Lactobacillus-dominated microbiota led to improved implantation rates and pregnancy outcomes in a small preliminary study. The Igenomix endometrial receptivity test, or ERA, measures the expression of 248 genes involved in receptivity to embryo implantation, and is designed to tell physicians a woman’s personalized optimal window for an embryo transfer. More than 32,000 patients worldwide have already used the test. A study was published in the June 2018 issue of the American Journal of Obstetrics and Gynecology. Image: The biotech company Igenomix has developed the first molecular test to identify the nine most common bacterial species underlying chronic endometritis, a persistent inflammation of the uterine endometrium that particularly affects women with endometriosis (Photo courtesy of Patricia Inacio, PhD).
Liquid Biopsy Identifies Chronic Liver Diseases cont’d from cover
CECs) from patient blood samples and combined it with a messenger RNA (mRNA) analysis system to identify CECs with liver-specific markers. Scientists from Massachusetts General Hospital (Charlestown, MA, USA; www.massgeneral.org) and their colleagues obtained blood samples from 10 healthy donors, 39 patients with chronic liver disease (CLD) and no evidence of HCC, 54 patients with HCC, and 10 who underwent curative treatment for HCC with no evidence of disease. The team had developed an antigen-agnostic cell-sorting device, called the iChip, which isolates CECs while preserving cell viability and high-quality RNA content. The procedure included RNA sequencing and immunofluorescent quantification with a threshold of five cells per 10 mL of whole blood. CECs presented in a similar proportion of patients with CLD (79%), those with HCC (81%) and those with no evidence of HCC after treatment (90%) in contrast to 5% in the healthy donors. Among patients
with CLD, those with advanced fibrosis (stage 3 or 4) had a higher concentration of CECs compared with those without advanced fibrosis (5.1 versus 0.7 cells/mL). In a subanalysis, the investigators found that liquid biopsy CEC detection could phenotypically differentiate underlying disease state in cases of chronic liver disease versus. HCC with a preliminary sensitivity of 85% at a specificity of 95%. The authors concluded that the novel detection of cells from diseased livers circulating in the bloodstream both by immunofluorescence and RNA-sequencing have the potential to use these cells as biomarkers. Important applications of this liquid biopsy may include CLD etiology determination, fibrosis staging, and HCC surveillance. Further study of CECs could open a new field of biomarker development leading to a spectrum of non-invasive diagnosis and monitoring techniques for patients with liver disease. The study was published on September 12, 2018, in the journal Gastroenterology. LabMedica International February-March/2019
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Goldsite Diagnostics
Dymind Biotechnology
The ECL 760 is for clotting and chromogenic tests and immunological assays. It can accept 23 reagents, trace samples to rack/position and onboard cooling and stirring is available for 20 reagents.
The GPP-100 uses an all-in-one cartridge for a single test and allows for auto ID of assays by barcode. Other features include a wide test menu, maintenance-free operations, and color touch screen.
The DF50 provides 23 reportable parameters and 4 research parameters. It also offers a throughput up to 60 tests/hour and supports capillary blood test mode, and a 10.4-inch touch screen display.
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Epigenomic Method Detects Pancreatic Cancer ancreatic cancers are typically diagnosed at late stage where disease prognosis is poor as exemplified by a 5-year survival rate of 8.2%. Earlier diagnosis would be beneficial by enabling surgical resection or earlier application of therapeutic regimens. A non-invasive liquid biopsy assay that tracks epigenetic modifications linked to gene regulation and pancreatic cancer pathogenesis in circulating cell-free DNA (cfDNA) in patient blood samples has been developed and a link has been uncovered between an epigenomic signal in cfDNA and pancreatic cancer in patients. A team of scientists working with Bluestar Genomics (San Francisco, CA, USA; www. bluestargenomics.com) investigated the detection of pancreatic ductal adenocarcinoma (PDAC) in a non-invasive manner by interrogating changes in 5-hydroxymethylation cytosine status (5hmC) of circulating cell free DNA in the plasma. The team first collected and isolated plasma samples from a cohort of 51 pancreatic cancer patients and 41 non-cancer controls, then enriched for and sequenced regions
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of interest. The team used use a method called “click chemistry” to modify hydroxymethyl groups on cytosine by attaching biotin tags. They then enriched the biotinylated DNA fragments by using streptavidin-coated magnetic beads, which enables an effective “pull-down” assay to separate DNA molecules that contain 5hmC from those that do not contain the biomarker. The team then sequences the fragments using a NextSeq 550 instrument (Illumina, San Diego, CA, USA; www.illumina. com), generating the data that can be used to derive an epigenetic signature. After performing a set of regression models on the sequenced data, the investigators found that PDAC patients possessed thousands of genes with different epigenomic signatures, including areas of enrichment and absence of 5hmC, compared to non-diseased individuals. By filtering the genes with the most differentially hydroxymethylated states, the team found genes that were previously linked to pancreas development or pancreatic cancer. The team validated the method on external
cohorts from previous studies that contained pancreatic cancer and healthy samples, producing an area under the curve of 74% to 97%. The authors of the study believe that sub-partitioning PDAC and non-cancer individuals into different categories will improve detection and classification of the disease. The study was posted on September 26, 2018, on the preprint server BioRxiv. Image: The NextSeq 550x instrument, a benchtop high-throughput sequencing system (Photo courtesy of Illumina).
Multiple Myeloma Subtypes Linked to Patient Ancestry ultiple myeloma (MM) is two- to three-fold more common in African Americans compared to European Americans. This striking disparity, one of the highest of any cancer, may be due to underlying genetic predisposition between these groups. African Americans (AAs) have a 2–3-fold higher prevalence of monoclonal gammopathy of undetermined significance (MGUS) and a similarly higher incidence of MM, along with approximately 4-year younger age of onset compared to European Americans (EAs). An international team of scientists led by those at the Mayo Clinic (Rochester, MN, USA; www.mayoclinic.org) performed cytogenetic analyses, genotyping, and genetic ancestry profiling on samples from 881 individuals with monoclonal gammopathy, a set of blood plasma cell neoplasms ranging from non-cancerous conditions that increase myeloma risk, such as MGUS to multiple myeloma itself. Patients were identified who had an abnormal plasma cell proliferative disorder fluorescence in situ hybridization (FISH) result and a concurrent
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conventional G-banded chromosome evaluation as part of routine clinical testing. DNA was isolated from fixed cell pellets from residual chromosome studies that yielded normal results using the DNeasy Blood and Tissue Kit (Qiagen, Germantown, MD, USA; www.qiagen.com). DNA was quantitated using a Qubit Fluorometric Quantitation Instrument (Thermo Fisher Scientific, Waltham, MA, USA; www.thermofisher.com) and 100 ng of DNA (5 ng/ L) was used for genotyping on a 96-well Axiom array (Affymetrix, Santa Clara, CA, USA; www.affymetrix.com), the Precision Medicine Research Array (PMRA). The authors concluded that future studies will include enlarging their 80% or greater African ancestry cohort and increasing the granularity of their studies with regards to specific regions within Africa. Understanding the cause of health disparities in monoclonal gammopathies has the potential to provide previously unrecognized interventions. The study was published on October 10, 2018, in the Blood Cancer Journal. LabMedica International February-March/2019
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PRODUCT NEWS MICROPLATE READER
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PATHOGEN ASSAY
PROTEIN ANALYZER
Erba Mannheim
EUROIMMUN
Genrui Biotech
The LisaScan EM can perform various ELISA tests with elaborate reports. Features include 100 test programs, built-in shaker with three-speed variable mixings, and various wavelength reading options.
The EUROArray Dermatomycosis provides detection and differentiation of dermatomycosis pathogens. It detects 50 dermatophyte species, and provides species ID for 23, along with 6 yeasts and molds.
The PA200 features 50 samples on board capacity, continuous sample loading, and STAT function. A wide test menu is provided including HbA1c, CRP, IgM, IgG, IgA, with a throughput of 180 tests/hr.
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Rapid Test Uses Glow-in-the-Dark Paper practicable and reliable way to test for infectious diseases has been found and all that is needed are a special glowing paper strip, a drop of blood and a digital camera. The test uses fully integrated “sample in signal out” microfluidic paper based analytical devices (μPADs) relying on bioluminescence resonance energy transfer (BRET) switches for analyte recognition and colorimetric signal generation. Scientists from the Eindhoven University of Technology (Eindhoven, the Netherlands; www.tue.nl) and their colleagues at the Keio University (Kohoku-ku, Japan; www.keio.ac.jp) developed the devices use BRET based antibody sensing proteins integrated into vertically assembled layers of functionalized paper, and their design enables sample volume independent and fully reagent free operation, including on device blood plasma separation. User operation is limited to the application of a single drop (20–30 μL) of sample (serum, whole blood) and the acquisition of a photograph 20 minutes after sample introduction, with no requirement for precise pipetting, liquid handling, or analytical equipment except for a camera. The color is created thanks to the secret ingredient of the paper strip: a so-called luminous sensor protein. After a droplet of blood comes onto the paper, this protein triggers a reaction in which blue light is produced (known as bioluminescence). An enzyme that also illuminates fireflies and certain fish, for example, plays a role in this. In a second step, the blue light is converted into green light, but here comes the clue: if an antibody binds to the sensor protein, it blocks the second step. A lot of green means few antibodies and, vice versa, less green means more antibodies.
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The ratio of blue and green light can be used to derive the concentration of antibodies. By measuring the ratio precisely, they suffer less from problems that other biosensors often have, such as the signal becoming weaker over time. In their prototype, the team successfully tested three antibodies simultaneously, for human immunodeficiency virus (HIV), influenza and dengue fever. Maarten Merkx, PhD, a professor of Bioengineering and a leading author of the study, said, “A biochemical reaction causes the underside of paper to emit blue-green light; the bluer the color, the higher the concentration of antibodies. A digital camera, for example from a mobile phone, is sufficient to determine the exact color and thus the result.” The study was published on August 31, 2018, in the journal Angewandte Chemie International Edition. Image: This close-up of the glow-in-the-dark paper strip contains two copies of the test. The three glowing dots per test indicate that you can check on three different antibodies within one test (Photo courtesy of Bart van Overbeeke).
Human Pegivirus Identified in Encephalitis Patients uman pegivirus (HPgV), was previously called hepatitis G virus or GB virus C, and is a lymphotropic virus with undefined pathology and many viruses from the family Flaviviridae, to which HPgV belongs, are neurotropic. Infection with HPgV is common worldwide; about 5% of healthy blood donors in industrialized countries are viremic, whereas in some developing countries the prevalence of viremia among blood donors is approximately 20%. There is evidence that HPgV is transmitted parenterally, sexually, and also vertically from mother to child. However, the high proportion of HPgV infection in apparently healthy blood donors and the general population suggests existence of nonparenteral routes. Scientists from the Medical University of Warsaw (Warsaw, Poland; www.wum.edu.pl) and their colleagues prospectively enrolled 96 pa-
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tients with encephalitis at the Warsaw Hospital for Infectious Diseases (Warsaw, Poland; www.zakazny.pl) from June 2012 through July 2015. They collected cerebrospinal fluid (CSF) and serum samples from patients at admission (5 to 7 days after symptom onset). The authors concluded that they had detected HPgV sequences in the CSF of three patients with encephalitis of unclear origin, and these sequences from CSF differed from those circulating in serum. These findings are compatible with the presence of a separate viral compartment in the CNS. Determining if the pegivirus was responsible for encephalitis or if it was present along with another cause of encephalitis will require further studies including histopathological analysis. The study was published in the October 2018 issue of the journal Emerging Infectious Diseases. LabMedica International February-March/2019
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PRODUCT NEWS URINE ANALYZER
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LATERALFLOW IMMUNOASSAY
GLUCOSE/KETONE MONITOR
Erba Mannheim
NG Biotech
Nova Biomedical
The LAURA XL provides evaluation of drypad urine chemistry and sediment microscopy. It offers reproducible results, evaluation of 13 parameters and a throughput of 180 samples/hr.
The NG-Test Carba 5 allows detection and ID of NDM-, OXA-48-, KPC-, VIM- and IMP- like producers on bacterial colony. Results are correlated with the genotype of the strains determined by PCR analysis.
The StatStrip GLU/KET monitor uses glucose measurement technology proven safe and effective. It offers wireless connectivity to hospital HIS or LIS and can transmit patient results from the bedside.
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Diagnostic Test Aids Determination of Menopausal Status enopause refers to the time in a woman’s life when she stops having a menstrual period and is no longer fertile. During the menopausal transition, the body’s production of estrogen and progesterone, two hormones made by the ovaries, varies greatly. After menopause, women enter postmenopause, when they are more vulnerable to heart disease and osteoporosis. It is important for women to understand their stage of menopausal transition to learn what, if any, additional health risks they may face and any preventative health steps to take. The US Food and Drug Administration (FDA, Silver Springs, MD, USA; www.fda.gov) has approved marketing of an enzyme-linked immunosorbent assay diagnostic test as an aid in the determination of a patient’s menopausal status. The FDA reviewed data submitted by the sponsor that included 690 women aged 42 to 62 years who participated in the multicenter, longitudinal Women’s Health Across
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the Nation study. The PicoAMH ELISA test (Ansh Labs, Webster, TX, USA; www.anshlabs.com) measures the amount of Anti-Müllerian Hormone (AMH) in the blood. AMH levels represent an indicator available to clinicians to determine whether a woman is approaching or is likely to have reached her final menstrual period. The PicoAMH Elisa test is meant for use only in conjunction with other clinical assessments and laboratory findings. The data from the FDA review showed that the PicoAMH Elisa test performed reasonably well at determining levels of AMH in the blood and identifying women who had their last menstrual period and women who were more than five years away from their last menstrual period. Clinicians should carefully evaluate PicoAMH Elisa test results in the context of a full clinical work up to ensure that contraceptives are not discontinued in women who have not yet reached menopause and that uterine bleeding due to endometrial cancer is
not dismissed as a diagnosis. The PicoAMH Elisa test should not be used to assess a woman’s fertility status or to monitor or predict the ovarian response in women undergoing or planning to undergo fertility treatments. Image: The PicoAMH ELISA test measures the amount of Anti-Müllerian Hormone (AMH) in the blood (Photo courtesy of Ansh Labs).
Chromaffin Cell Tumors Diagnosed by Plasma Panel heochromocytomas and paragangliomas include adrenal and extraadrenal chromaffin cell tumors as well as head and neck paragangliomas and measurements of plasma or urinary metanephrines are recommended for diagnosis of pheochromocytoma and paraganglioma (PPGL). Current clinical practice guidelines stipulate with a high level of evidence that biochemical screening for PPGLs should include measurements of plasma free or urinary fractionated metanephrines that is normetanephrine and metanephrine, with no recommendation concerning preference of either test. An international team of scientists led by those at Technische Universität Dresden (Dresden, Germany; https://tu-dresden.de) screened a study population included 2,056 patients (1,011 male) with a median age of 53 years (range, 10–93 years) for PPGLs. A reference population of 351 normotensive (132 male) and 239 hypertensive (129 male) volunteers with a median age of 42 years (range, 18–82 years) was also included for establishing reference intervals. Blood samples collected into heparinized tubes were placed on ice or cool pads at 4 °C before centrifugation to separate plasma. On the final
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day of collection, 24-hour urine specimens were returned to study centers. Urine volumes were then determined and samples aliquoted. Measurements of plasma and urinary metanephrines (normetanephrine, metanephrine) and methoxytyramine were performed at a single laboratory using liquid chromatography tandem mass spectrometry (LCMS/MS), with a AB Sciex QTRAP 5500 triple quadrupole mass spectrometer (Sciex, Framingham, MA, USA; https://sciex.com). The scientists reported that measurements of plasma free metabolites offered higher diagnostic sensitivity (97.9%) than urinary free (93.4%) and deconjugated (92.9%) metabolites at identical specificities for plasma and urinary free metabolites (94.2%) but at a lower specificity for deconjugated metabolites (92.1%). The addition of methoxytyramine offered little value for urinary panels, but provided higher diagnostic performance for plasma measurements than either urinary panel according to areas under ROC curves. Diagnostic performance of urinary and plasma tests was similar for patients at low risk of disease, whereas plasma measurements were superior to both urinary panels for high-risk patients. The study was published in the October 2018 issue of the journal Clinical Chemistry. LabMedica International February-March/2019
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PRODUCT NEWS SPECIMEN SWABS
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DIPSTICK CONTROL
IMMUNOASSAY ANALYZER
Puritan Medical Products
Quantimetrix
Shenzhen YHLO Biotech
The HydraFlock and PurFlock Ultra swabs use multi-length flock fiber technology and are available in a variety of sizes, tip shapes and with various break points. The swabs come as sterile or non-sterile.
The Dipper allows users to verify full immersion of the dipstick, minimizes contamination risk and reduces the test volume required. It offers room temp stability of 3 months and 3 years refrigerated.
The iFlash 1800 offers a throughput of 180 tests per hour. With 50 sample positions, 20 refrigerated reagent positions and random reaction vessel loading design, it is suitable for different lab needs.
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Proteins Used for Diagnosing Amyotrophic Lateral Sclerosis roteins have been identified that may be useful in both earlier diagnosis of Amyotrophic Lateral Sclerosis (ALS) and in more accurate disease prognosis. ALS, often referred to as Lou Gehrig’s disease, is a progressive, neurodegenerative disease that affects the brain and spinal cord. Currently, there is no effective treatment or cure. No molecular biomarkers of neither diagnostic nor prognostic value exist for ALS. Diagnosis is often delayed one to two years from symptom onset while other confounding disorders are excluded and appropriate phenotypes present themselves. Since cerebrospinal fluid (CSF) is proximal to site of injury, it is more likely to be enriched with biomarkers of ALS compared to plasma and is often the fluid of choice for ALS and other diseases of the central nervous system. Scientists from North Carolina State University (Raleigh, NC, USA; www.ncsu.edu) obtained samples of cerebrospinal fluid (CSF) and blood plasma from 33 ALS patients and 30 healthy individuals. The team used mass spec-
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trometry and they identified over 1,000 different proteins in the fluids, and then used advanced machine learning techniques to develop models that consisted of multiple proteins. Nanoflow liquid chromatography tandem mass spectrometry (LC MS/MS) was performed and peptides were loaded directly on column at a flow rate of 400 nL/min. Peptides were separated at a flow rate of 300 nL/min using a 30 cm self-packed column. Data were collected using a top 12 data-dependent acquisition method on a quadrupole orbitrap (QE-Plus, Bremen Germany; www.planetorbitrap.com). The team selected two proteins that looked promising for both diagnostic and prognostic applications, and then conducted further analysis to validate their usefulness as biomarkers. The proteins, chitinase-3 like1 and alpha-1-antichymotrypsin, are associated with immune-system activation in the brain and thus could also be used as an objective way to measure effectiveness of current therapies directed at tempering this pathway. Proteins involved in complement activation, acute phase
response and retinoid signaling pathways were significantly enriched in the CSF from ALS patients. Interestingly, immune-system activation is also known to play a role in other neurodegenerative diseases, such as Parkinson’s and Alzheimer’s, indicating the assays could potentially be used in these diseases as well. The study was published on November 5, 2018, in the journal Scientific Reports. Image: Q Exactive hybrid quadrupole-Orbitrap mass spectrometer (Photo courtesy of Thermo Fisher Scientific).
Ebola Test with Portable Reader Authorized for Emergency Use bola is a rare but deadly virus that causes fever, body aches, and diarrhea, and sometimes bleeding inside and outside the body. As the virus spreads through the body, it damages the immune system and organs. Ultimately, it causes levels of blood-clotting cells to drop. This leads to severe, uncontrollable bleeding and kills up to 90% of people infected. The disease is spread from human to human is through contact with blood and/or bodily fluids (urine, saliva, feces, vomit, sweat, breast milk and semen) of infected individuals. This may be through direct contact and/or droplet spread (droplets of infected bodily fluids produced by sneezing, coughing or talking) or via objects (such as needles) and environments that have been contaminated with the virus. The US Food and Drug Administration (FDA, Silver Springs, MD, USA; www.fda.gov) issued an emergency use authorization (EUA) for a rapid, single-use test for the detection of Ebola virus (Zaire Ebola virus). This is the second Ebola rapid antigen fingerstick test available under
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EUA, but the first that uses a portable battery-operated reader, which can help provide clear diagnostic results outside of laboratories and in areas where patients are likely to be treated. The test, called the DPP Ebola Antigen System (Chembio Diagnostic Systems Inc, Medford, NY, USA; http://chembio.com) is used with blood specimens, including capillary “fingerstick” whole blood, from individuals with signs and symptoms of Ebola virus disease (EVD) in addition to other risk factors, such as living in an area with large numbers of EVD cases and/or having contact with other individuals exhibiting signs and symptoms of EVD. It is important to note that a negative result from the DPP Ebola Antigen System, especially in patients with signs and symptoms of EVD, should not be used as the sole basis for patient management decisions. The diagnosis of EVD must be made based on multiple factors such as, history, signs, symptoms, exposure likelihood and other laboratory evidence in addition to the detection of Ebola virus. LabMedica International February-March/2019
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LabMedica International
Kidney Function Decline Linked with Inflammatory Marker Levels umor necrosis factor receptor-1 (TNFR-1), which plays a causative role in endothelial cell dysfunction and inflammation, is expressed on the cell surface in glomerular and peritubular capillary endothelium of the kidneys. Higher soluble TNF receptor-1 (sTNFR-1) concentrations are associated with kidney disease progression among persons with established diabetic kidney disease. Previous studies have demonstrated that blood levels of sTNFR-1 are linked with kidney disease progression in individuals with established kidney disease. Scientists at the University of Washington School of Medicine (Seattle, WA, USA; www.uwmedicine.org) and their colleagues conducted a multi-ethnic study of 2,548 adults with an average age of 61 years and 51% were women. Study participants were generally free of known kidney or heart disease at the start of the study, when sTNFR-1 levels were measured. The team tested associations between baseline sTNFR-1 concentrations and 10-year decline in estimated glomerular filtration rate (eGFR: incident ≥40% decline and annual proportional decline). Serum creatinine concentrations were determined at enrollment and study years 3, 5, and 10. The scientists reported that the mean baseline eGFR was 79 mL/min per 1.73 m2. Serum sTNFR-1 was inversely associated with baseline eGFR. Over median follow-up of 9.3 years, 110 participants developed ≥40% decline in eGFR; each SD higher concentration of sTNFR1 was associated with higher risk of 40% eGFR decline (adjusted hazard ratio, 1.43; 95% confidence interval [95% CI], 1.16 to 1.77). The highest sTNFR-1 tertile was associated with adjusted annualized decline in eGFR of 1.94% (95% CI, 1.79 to 2.09). Associations persisted across subgroups defined by demographics, hypertension, diabetes, and baseline CKD status. The authors concluded that elevated serum sTNFR-1 concentrations are associated with faster declines in eGFR over the course of a decade in a multiethnic population, independent of previously known risk factors for kidney disease progression. sTNFR-1 was associated with substantial differences in kidney function decline over time. Rates of decline over 10 years were nearly 4-times higher among people in the highest versus lowest sTNFR-
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1 categories. This association was independent of previously known risk factors for kidney disease progression and persisted across multiple sub-groups of participants. Pavan K. Bhatraju, MD, MSc, the lead author of the study, said, “Many people continue to progressively lose kidney function despite treatment with current medications. New treatments are urgently needed to help prevent or slow the loss of kidney function. Our studies identify a novel marker that is strongly related to kidney function decline over time in a large multi-ethnic cohort and suggest follow up studies are warranted to investigate the potential role of sTNFR-1 in the development of kidney function decline.” The study was published on October 4, 2018, in
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the Journal of the American Society of Nephrology. Image: Higher levels of the inflammatory biomarker soluble tumor necrosis factor receptor-1 (sTNFR-1) are tied to kidney decline in healthy adults (Photo courtesy of Enbrel).
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PRODUCT NEWS INTEGRATED LAB SYSTEM
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HBA1C ANALYZER
HEMATOLOGY ANALYZER
SNIBE
Siemens Healthineers
Maccura Biotechology
The Biolumi 8000 combines immunology, biochemistry, electrolyte and sample handling modules. The combination offers enhanced throughput, and is designed to satisfy many different lab requirements.
The DCA Vantage helps monitor glycemic control and detect early kidney disease. It provides HbA1c results in six minutes from a fingerstick, and does not require any reagent prep prior to testing.
The F560 combines specific NA and advanced molecular biological staining to guarantee accuracy of results. Its sensitivity enables various alarm information, which enhances the analysis capability.
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POC Immune Response Test Cleared for Europe single-use, disposable test identifies patients who have a clinically significant underlying infection and aids in the differentiation of viral and bacterial acute respiratory infection (ARI) through the rapid detection of both Myxovirus resistance protein A (MxA) and C-reactive protein (CRP). MxA is an intracellular protein that becomes elevated in the presence of acute viral infection and CRP is a nonspecific inflammatory protein that is elevated in the presence of any clinically significant infection. Thus, unlike a standalone CRP test, MxA confers specificity to the test through the combined interpretation of the results. The FebriDx test (RPS Diagnostics, Sarasota, FL, USA; www. rpsdetectors.com) provides clinicians with a 10-minute assessment of the body’s immune response to an acute respiratory infection (ARI) directly from a fingerstick blood sample. The updated FebriDx test incorporates an all-in-one plastic housing technology that includes a built-in safety lancet, blood collection and delivery system, and integrated push button buffer delivery feature, which together, improve test convenience. The FebriDx test requires no additional equipment to perform or to interpret results.
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Through comprehensive analytical testing as well as a multicenter precision and reproducibility study, RPS Diagnostics successfully demonstrated equivalency to the previously CE marked version of the product. The timely FebriDx test results provide clinicians the ability to formulate a targeted clinical management and therapeutic decision plan during the initial patient encounter. Antibiotic misuse is a complex global problem that leads to antibiotic resistance, avoidable adverse events, and contributes to rising healthcare costs, largely driven by diagnostic uncertainty and patient pressure. More than 50% of all antibiotic prescriptions are unnecessary and are generated in the outpatient primary and urgent care setting. In a recent study in the UK, FebriDx was shown to alter clinical management decisions in 48% of patients tested and to reduce unnecessary antibiotic prescriptions by 80%. Each day that goes by without the implementation of a cost effective solution is exacerbating the current global antibiotic crisis. The updated CE mark of the FebriDx test is clearing the way for its immediate launch in the European Union and all countries recognizing the CE mark. Robert Sambursky, MD, president and chief executive officer of RPS, said, “The elegance of the FebriDx test lies in its simplicity. It’s equally important not to miss treating an underlying bacterial infection as it is withholding unnecessary antibiotics from patients with clinically insignificant or viral infection. FebriDx utilizes the body’s own immune system to provide a broad, fast, accurate, and cost-effective method to identify patients who may benefit from appropriate antibiotic therapy.” Image: FebriDx provides clinicians with a 10-minute assessment of the body’s immune response to an acute respiratory infection (ARI) directly from a fingerstick blood sample (Photo courtesy of RPS Diagnostics).
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PRODUCT NEWS MAGNETIC STIRRERS
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NA EXTRACTION SYSTEM
ELECTROLYTE ANALYZER
Karl Hecht
BioMérieux
JS Medicina Electronica
The Assistent features an adjustable speed and run time up to 999 minutes of continuous operation. Other benefits include adjustable temperature and memory function with last settings used on restart.
The NUCLISENS EASYMAG can simultaneously process various samples and volumes. It automates an enhanced version of BOOM technology, and can process up to 24 extractions in 40 minutes.
The V4 Semiautomatic Plus features a builtin printer, graphic display and external barcode reader. Other features include patient ID, external keyboard reader input, USB output, and LIS connection.
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Link Between Gut Flora and Multiple Sclerosis Discovered ultiple sclerosis (MS) is an immune-mediated autoimmune disease of the central nervous system that develops in genetically susceptible individuals and likely requires environmental triggers. In MS the body’s own immune system attacks and damages the protective coating around nerve cells. The autoantigens and molecular mimics triggering the autoimmune response in multiple sclerosis remain incompletely understood. Although it is well established that autoreactive lymphocytes induce demyelination in multiple sclerosis, the exact antigenic targets that initiate disease are undefined. An international team of scientists led by the University Hospital Zurich (Zurich, Switzerland; www.uzh.ch) used a brain-infiltrating CD4+ T cell clone that is clonally expanded in multiple sclerosis brain lesions and a systematic approach for the identification of its target antigens, positional scanning peptide libraries in combination with biometrical analysis. For the genetically defined subgroup of MS patients examined by the scientists, results show that gut microbiota could play a far greater role in the pathogenesis of the disease than previously assumed.
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The team identified guanosine diphosphate (GDP)–l-fucose synthase as an autoantigen that is recognized by cerebrospinal fluid–infiltrating CD4+ T cells from HLA-DRB3*–positive patients. Significant associations were found between reactivity to GDP-l-fucose synthase peptides and DRB3*02:02 expression, along with reactivity against an immunodominant myelin basic protein peptide. These results, coupled with the cross-recognition of homologous peptides from gut microbiota, suggest a possible role of this antigen as an inducer or driver of pathogenic autoimmune responses in multiple sclerosis. The clinical approach of the group involves drawing blood from MS patients in a clinical trial and then attaching the immunoactive protein fragments onto the surface of red blood cells in a laboratory. When the blood is reintroduced into the bloodstream of patients, the fragments help to “re-educate” their immune system and make it “tolerate” its own brain tissue. This therapeutic approach aims for effective targeted treatment without severe side effects. Mireia Sospedra Ramos, MD, the senior author of the study, said, “Our clinical approach specifically targets the pathological autoreactive immune cells. This approach therefore differs radically from other treatments that are currently available, which throttle the whole immune system. While these treatments often succeed in stopping the progression of the disease, they also weaken the immune system and can thus cause severe side effects.” The study was published on October 10, 2018, in the journal Science Translational Medicine. Image: Diminishing myelin sheaths: The damaged areas (at the bottom of the image) of the brains of MS patients lack myelin (at the top, in blue) (Photo courtesy of Dr. med. Imke Metz, University of Göttingen).
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LabMedica International
LTB Infection Estimated with Interferon-γ Release Assay atent tuberculosis (LTB), also called latent tuberculosis infection (LTBI) is when a person is infected with Mycobacterium tuberculosis, but do not have active tuberculosis. Active tuberculosis can be contagious while latent tuberculosis is not, and it is therefore not possible to get infected from someone with latent tuberculosis. In Japan, university students, including foreign-born students, undergo TB screening with chest radiograph; however, a chest radiograph cannot detect LTBI; it detects only pulmonary TB. Because immigrants may develop TB after entry, screening with chest radiograph might be ineffective; therefore, screening for LTBI may be necessary to prevent TB outbreaks. Scientists at Keio University School of Medicine (Tokyo, Japan; www. med.keio.ac.jp) and their colleagues enrolled 177 participants 20–42 years of age (median 23 years), of whom 98 (55.1%) were female. Participants were from China (55 students), Indonesia (24 students), France (19 students), Germany (nine students), and Thailand (eight students); the remaining participants were from 28 different countries; including 50 from countries with estimated TB incidence rates greater than 100 cases/100,000 persons. The team collected whole blood specimens for the T-SPOT.TB test (Oxford Immunotec Ltd., Abington, UK; www.oxford immunotec.com), an Interferon-γ Release Assay (IGRA) available in Japan. All participants were screened for pulmonary TB with chest radiograph. They interviewed participants using a structured questionnaire on identification and demographic information, the date of first arrival in Japan, and history of TB. The scientists found that overall, eight (4.5%) students tested positive on IGRA (two each from China and Thailand and one each from Ghana, Indonesia, South Korea, and the Philippines). The rate of the positive IGRA result for students from countries with an estimated TB incidence rate of >100 cases/100,000 persons was 10.0% and relative risk was 4.2, whereas the rate for students from countries with an estimated TB incidence rate of <100 cases/100,000 persons was 2.4%. The IGRA positivity of students 20–29 years of age from countries with estimated TB incidence rates of >100 cases/ 100,000 persons was 9.4%. The authors concluded that estimated LTBI rates for foreign-born students in Japan from countries with high TB incidence rates were higher than those for students from countries with low TB incidence rates and for students from Japan. Based on their findings, they recommend that universities screen for LTBI using IGRAs in students from countries with high TB incidence rates (i.e., >100 cases/100,000 persons). The study was published in the November 2018 issue of the journal Emerging Infectious Diseases.
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Image: The T-SPOT.TB test is a unique, single-visit blood test for tuberculosis (TB) screening, also known as an interferon gamma release assay (IGRA) (Photo courtesy of Oxford Immunotec).
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PRODUCT NEWS HBA1C ANALYZER
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URINE LAB SYSTEM
MICRO-OSMOMETER
DXGen
77 Elektronika
Advanced Instruments
The Epithod AutoDx measures GA and HbA1c for the entire stage of diabetes care and offers automatic walkaway convenience. It provides rapid, pipette-free and precise quantitative results.
The LabUMat 2 and UriSed 2 system offers accurate and reproducible chemistry and sediment analysis. The results from both are stored in a common database and provided on the same report.
The Fiske 210 determines the osmolality of solutions using freezing point depression and requires a small sample size. It features automated calibration, multi-language display and easy cleaning.
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Warfarin Bleeding Risk Single Nucleotide Polymorphisms Identified in African Americans ajor Warfarin-related bleeding occurs more frequently in African Americans than in other populations. Identification of potential genetic factors related to this adverse event may help identify at-risk patients. Warfarin is an anticoagulant used to prevent heart attacks, strokes, and blood clots. A handful of new variants have been identified that appear to predispose individuals of African descent to increased risk of bleeding when taking the anticoagulant warfarin. Scientists at Northwestern University (Chicago, IL, USA; www. northwestern.edu) and their colleagues conducted a genome-wide association study involving 31 individuals who experienced warfarin-related bleeding and 184 control individuals who were treated with warfarin but did experience subsequent bleeding problems. The team genotyped at almost 8.2 million single nucleotide polymorphisms (SNPs) using the Illumina 610 Quad BeadChip (Illumina, San Diego, CA, USA; www. illumina.com). Major bleeding was defined as bleeding requiring hospitalization, causing a decrease in hemoglobin level of more than 2 g/dL, requiring blood transfusion, or any combination of the 3, while taking warfarin at an international normalized ratio INR of less than 4. The team found four suspicious SNPs in linkage disequilibrium on chromosome 6. Following a replication analysis in another 40 cases and 148 bleeding-free, warfarin-treated controls, one of the variants rs78132896 in the promoter of the EPHA7 protein tyrosine kinase
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ephrin subfamily gene, showed genome-wide significant ties to bleeding risk in the African Americans assessed, based on a coagulation assay known as the international normalized ratio (INR). The team’s subsequent in vitro expression assays indicated that rs78132896 SNP, in the EPHA7 promoter, and a variant in linkage disequilibrium in the gene’s enhancer, appeared to correspond to more pronounced EPHA7 expression. The study was published on October 23, 2018, in the Journal of the American Medical Association. Image: The Human610-Quad BeadChip Kit uses the Infinium HD Super Assay and is compatible with the iScan, HiScan, and Bead Array Reader systems (Photo courtesy of Illumina).
Blood Compatibility Assay Approved by FDA lood can be grouped based on the antigens on the surfaces of red blood cells, and the presence or absence of blood group antigens other than the ABO blood group antigens can be important in matching blood for transfusions. Red blood cell antigens have typically been identified with serological methods involving the use of antisera, a blood serum that contains antibodies for testing. However, serologic testing has limitations and certain antisera may be scarce or unavailable. The US Food and Drug Administration (FDA, Silver Springs, MD, USA; www.fda.gov) announced that it has approved a molecular assay to determine blood compatibility for blood transfusions. The ID CORE XT (Progenika Biopharma, Bizkaia, Spain; www.progenika.com) is the second molecular assay approved for use in transfusion medicine, and the first to report genotypes as final results.
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ID CORE XT is a qualitative, polymerase chain reaction (PCR)-based and hybridization-based genotyping test for the simultaneous identification of multiple alleles encoding human erythrocyte antigens (HEAs) in genomic DNA extracted from whole blood specimens collected in EDTA. This test genotypes 29 polymorphisms determining 37 HEA phenotypes of blood group systems Rh, Kell, Kidd, Duffy, MNS, Diego, Dombrock, Colton, Cartwright, and Lutheran. This test can be used to obtain in-depth knowledge of samples under study. In a study comparing typing results from ID Core XT with licensed serological reagents, the Precise Type HEA test, and DNA sequencing tests, Progenika’s test demonstrated comparable performance with the other methods. Patients who require ongoing transfusions, including those with hemoglobinopathies, such as sickle cell disease and thalassemia, will benefit from the ID Core XT test. Additionally, the test will be used with cancer patients who require more thorough blood typing. LabMedica International February-March/2019
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LabMedica International
Novel POC Troponin Assay Rules Out Acute Myocardial Infarction ore than seven billion diagnostic tests are run in the USA each year to help physicians make accurate, timely decisions about a person’s medical treatment. Emergency department (ED) investigations of patients with suspected acute myocardial infarction (AMI) are time consuming, partly because of the turnaround time of laboratory tests. Point-of-care diagnostic tests, that can often provide results within minutes, are used globally as hospitals face increased pressures to address overcrowding in emergency rooms and longer wait times. The goal of with-patient diagnostic tests is to deliver results with accuracy similar to the gold standard of high-sensitivity laboratory tests. A team of scientists collaborating with Christchurch Hospital (Christchurch, New Zealand; www.cdhb.health.nz) evaluated 354 adults, including 255 (72.0%) men; mean age, 62 ± 12 years, who entered an emergency department with symptoms of acute coronary syndrome, such as a heart attack. Troponin concentrations were measured on ED arrival with both a novel point-of-care assay i-STAT TnI-Nx (Abbott Point of Care, Princeton, NJ, USA; www.pointofcare.abbott) and a high-sensitivity troponin I assay, the Architect hs-cTnI (Abbott Diagnostics, Abbott Park, IL, USA; www.corelaboratory.abbott). The investigators reported that of 354 patients, 57 (16.1%) experienced an AMI. Eighty-five patients (24.0%) presented to the ED less than three hours after symptom onset. No difference was found between the area under the curve (AUC) of the TnI-Nx assay (0.975) and the hs-cTnI assay (0.970). A TnI-Nx assay result of less than 11 ng/L identified 201 patients (56.7%) as low risk, with sensitivity and a negative predictive value of 100%. In comparison, an hs-cTnI assay result of less than 3 ng/L identified 154 patients (43.5%) as low risk, with a sensitivity and a negative predictive value of 100%. The study was published on October 17, 2018, in the journal JAMA Cardiology.
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Image: The i-STAT cardiac troponin I assay; healthcare professionals can obtain quantitative measurement of cardiac troponin I (cTnI) in ten minutes without leaving the patient’s side (Photo courtesy of Abbott Point of Care).
Ultrasensitive Screening Platform Detects Pathogenic Bacteria diagnostic platform has been developed that significantly increases the sensitivity of high-throughput sequencing for detection and characterization of bacteria, virulence determinants, and antimicrobial resistance (AMR) genes. Investigators at Columbia University (New York, NY, USA; www. columbia.edu) recently described the BacCapSeq (bacterial capture sequencing) system, which was designed to complement the earlier VirCapSeq test that screens for all known human viral infections. The BacCapSeq system is based on a probe set comprising 4.2 million oligonucleotides extracted from the Pathosystems Resource Integration Center (PATRIC) database, the Comprehensive Antibiotic Resistance Database (CARD), and the Virulence Factor Database (VFDB), representing 307 bacterial species that include all known human-pathogenic species, known antimicrobial resistance genes, and known virulence factors, respectively. These genetic probes are introduced alongside material taken from the sample being tested. A magnetic process isolates segments from the sample that match the probe, and these segments are then analyzed using high-throughput sequencing. The use of the 70-hour BacCapSeq test resulted in an up to 1,000fold increase in bacterial reads from blood samples and lowered the limit of detection by one to two orders of magnitude compared to conventional unbiased high-throughput sequencing. At this level of sensitivity, the test detected not only the presence of AMR genes but also biomarkers for AMR that included both constitutive and differentially expressed transcripts.“Microbiological intelligence must be an integral component of precision medicine,” said senior author Dr. W. Ian Lipkin, professor of epidemiology at Columbia University. “Accurate, early differential diagnosis of infectious diseases and knowledge of drug sensitivity profiles will reduce mortality, morbidity, and health care costs.” The BacCapSeq diagnostic platform was described in the October 23, 2018, online edition of the journal mBio.
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PRODUCT NEWS ELECTRONIC PIPETTE
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THROMBIN SYSTEM
LIPOPROTEIN CONTROL
BRAND
Diagnostica Stago
Quantimetrix
The Transferpette -8/-12 electronic multichannel pipette offers an adjustable finger rest. Other features include large display, intuitive operation and ergonomic ejection button with color code.
The ST Genesia fully walkway system measures thrombin generation with features such as once-daily calibration and temp control. It also offers embedded software with graphical user interface.
The Liposure control monitors the Lipoprint LDL lipoprotein subfractions testing system. It has a three-year unopened, refrigerated shelf life and a five-day reconstituted stability when stored at 2-8°C.
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High-Risk HPV Evaluated for Invasive Cervical Cancer ervical cancer is a major cause of morbidity and mortality in women worldwide and the role of high-risk human papillomavirus (hrHPV) in the development of invasive cervical cancer (ICC) is well established. Persistent infection with hrHPV in the cervical epithelium, especially types HPV16 and HPV18, is known to be associated with higher probability of progression to cervical intraepithelial lesion grade 3 (CIN3) and ICC compared to being negative for such infection. Scientists at the Karolinska Institutet (Stockholm, Sweden; https://ki.se) and their colleagues identified all ICC diagnosed in Sweden during the years 2002–2011 (4,254 confirmed cases), requested all archival formalin-fixed paraffin-embedded blocks (FFPE), and performed HPV genotyping. Twenty out of 25 pathology biobanks agreed to the study, yielding a total of 2,845 confirmed cases with valid HPV results. Cases were prospectively followed up from date of cancer diagnosis to December 31, 2015. All FFPE blocks were extracted and tested in parallel with β-globin real-time polymerase chain reaction (PCR) and HPV genotyping using general primers (MGP)-PCR targeting the L1 region, followed by typing with Luminex for 13 high-risk types (Luminex Corporation, Austin, TX, USA; www.luminexcorp.com). The investigators reported that of the 2,845 included cases, hrHPV was detected in 2,293 (80.6%), and they observed 1,131 (39.8%) deaths during an average of 6.2 years follow-up. The majority of ICC cases were diagnosed at age 30–59 years (57.5%) and classified as stage IB (40.7%). hrHPV positivity was significantly associated with screen-detected tumors, young age, high education level, and early stage at diag-
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nosis. The 5-year relative survival ratios (RSR) compared to the general female population was 0.74 for hrHPV-positive cases and 0.54 for hrHPV-negative cases, yielding a crude excess hazard ratio (HER) of 0.45 and an adjusted EHR of 0.61. The authors concluded that women with hrHPV-positive cervical tumors had a substantially better prognosis than women with hrHPV-negative tumors. hrHPV appears to be a biomarker for better prognosis in cervical cancer independent of age, International Federation of Gynecology and Obstetrics (FIGO) stage, and histological type, extending information from already established prognostic factors. The study was published on October 1, 2018, in the PLOS Medicine. Image: The MAGPIX compact multiplexing unit performs up to 50 different tests in a single reaction volume and reads a 96-well-plate in just 60 minutes (Photo courtesy of Luminex).
Functional Genomic Landscape of AML Analyzed cute myeloid leukemia is a cancer of the myeloid line of blood cells, characterized by the rapid growth of abnormal cells that build up in the bone marrow and blood and interfere with normal blood cells. The implementation of targeted therapies for acute myeloid leukemia (AML) has been challenging because of the complex mutational patterns within and across patients as well as a dearth of pharmacologic agents for most mutational events. Scientists at the Oregon Health & Science University (Portland, OR, USA; www.ohsu.edu) used exome sequencing, RNA sequencing, and/or ex vivo drug sensitivity testing to profile up to 672 tumor samples from 562 AML patients. In addition to identifying recurrent mutations not described in the condition previously, they uncovered treat-
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ment response patterns that corresponded to specific mutation combinations or gene expression signatures. As part of a program called Beat AML, the team did paired-end Illumina HiSeq 2500 exome sequencing (Illumina, San Diego, CA, USA; www.illumina.com) on 622 of the tumor samples. They also performed RNA sequencing on 451 tumor samples from 411 AML patients, and drug sensitivity testing with 122 drugs on 409 tumor samples from 363 AML patients. Jeffrey Tyner, PhD, an associate professor and the lead author of the study, said, “”Our dataset can be useful to see if that particular gene mutation corresponds with certain drug sensitivities. We believe this dataset will help physicians solve those specific kinds of questions more easily.” The study was published on October 17, 2018, in the journal Nature. LabMedica International February-March/2019
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Edited by Katherina Psarra MSc, PhD IFCC members may send news to: Katherina Psarra, MSc, PhD, Dept of Immunology â&#x20AC;&#x201C; Histocompatibility, Evangelismos Hospital, Ipsilantou 45-47, Athens 10676, Greece4; Email: enews@ifcc.org
NEWS
MESSAGE FROM THE PRESIDENT by Prof. Howard Morris, President, IFCC
Laboratory Medicine: Preparing for the 2020â&#x20AC;&#x2122;s ur triennial General Conference is one of the most important items on the IFCC calendar. It brings together National Society representatives to work with IFCC officers to identify the current major issues for our profession and to advise on our strategic plan to effectively address our mission. In order to plan for the future it is useful to think about why professional societies exist? Why do national societies join the IFCC? Why should clinical laboratory specialists join national societies? Three basic answers come to mind from my own experience. I want professional organizations to support me through (1) assistance to meet my daily challenges in providing optimal clinical laboratory practice, (2) guidance to pursue a fulfilling career, and (3) the opportunity for meeting, networking and exchanging views with other clinical laboratory specialists. To develop a strategy to meet the challenges of providing optimal laboratory practice, we need to consider our work environment and the major challenges facing healthcare providers internationally. Our laboratories are facing increased demands without the appropriate resources as a result of growing rates of chronic diseases, increasing patient expectations, ageing of populations, increasing costs of medical advances, and limited growth of healthcare budgets. These are difficult and uncertain times for our profession, but it is similar for all healthcare workers. We as professionals have a responsibility and self-interest to discover and test alternate methods for delivering sustainable healthcare. We need to be part of the solution not part of the problem. During the conference a short poll was taken of the delegates, with some 60% indicating that their major challenge in the laboratory was funding either the allocated budget or reimbursement constraints. Approximately 15% identified either quality laboratory performance or training and continuing professional development as their major challenges and some 5% identified either the introduction of new technologies and new biomarkers into the laboratory or opportunities for career development.
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What is the IFCC strategic plan to address these challenges? A. Clinical laboratory funding; budget or reimbursement constraints The Executive Board has discussed this issue over some time and is working to develop tools and conduct research to demonstrate and leverage the value of Laboratory Medicine. It is evident that implementing
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quality analytical procedures such as standardization and harmonization are necessary for optimal clinical laboratory practice but by themselves they appear to be insufficient. We have been improving the quality of our practice for over some 50 years, but our achievements have rarely been recognized across the clinical disciplines or by financial controllers. We need an extra dimension to this work. We can publicise these achievements but we need to publicise them based on evidence. Therefore we need to build a high quality evidence base, including peer-reviewed scientific publications, reporting the impacts of quality analytical improvements on patient and financial outcomes. We also need to leverage the value of Laboratory Medicine by using these data to raise the profile of Laboratory Medicine across the health disciplines including the financial controllers The IFCC is responding at a number of levels: (1) The Education and Contâ&#x20AC;&#x2122;d on page 28
News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information
NEWS
Editorial by Katherina Psarra MSc, PhD t is my pleasure and honor to address this editorial to you as the new IFCC news editor and chair of the WGIFCC News. I take this opportunity to wish you all a happy and productive New Year in your personal and professional life. I would like to underline the importance of sharing the IFCC news with you, in order to have a better communication between IFCC and IFCC member societies as well as with everybody working in a laboratory. A lot of IFCC news come from all over the world and it is
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probably the only opportunity to come in contact with the achievements and the needs of colleagues in the BROAD IFCC family. In this issue you will find information about the 2020’s future of Laboratory Medicine as it was presented during the IFCC General Conference in Budapest, as well as the regional congresses in Latin America. Special attention should be given to our young colleagues, the future of our profession. A special presentation concerns their activities within IFCC member societies congresses or other scientific organizations. Dear colleagues, I hope that you will pay special attention to the IFCC e-news and possibly provide your feedback and communications.
Laboratory Medicine: Preparing for the 2020’s Cont’d from page 27
Management Division (EMD) has established a Joint Committee with WASPaLM on the Value Proposition in Laboratory Medicine (C-VPLM). It aims to conduct research on the use of the value proposition to demonstrate the impact of medical tests on patient outcome and healthcare expenditure and to develop a compendium of tools for such research to be widely conducted by clinical laboratory specialists. (2) The IFCC is a partner in the UNIVANTS of Healthcare Excellence Award2 with AACC, EHMA, Modern Healthcare, Abbott Diagnostics and others to administer this Award and identify and publicise the work of teams of healthcare workers undertaking projects to demonstrate the value of Laboratory Medicine. A major component of the prize for the first round winners will be the opportunity to present their work in a symposium at WorldLab 2020 Seoul. B. Quality laboratory performance / quality laboratory specifications Quality clinical laboratory practice continues to lie at the heart of optimal patient outcomes. While we seek to demonstrate the value of Laboratory Medicine, quality is the key component of value. The level of quality we need is identified by the quality laboratory specifications which is a major focus of the European Federation of Laboratory Medicine (EFLM). Furthermore defining optimal pre-analytical practice is being undertaken by EFLM and the IFCC South American Regional Federation, COLABIOCLI. Each of the regional federations is conducting scientific projects. The inclusion of representatives of each of the Regional Federations on the Executive Board of IFCC, which commenced in 2018, has brought us closer together. This development renders the work being undertaken by the Regional Federations more accessible to the international audience. Although each of the Regional Federations is able to effectively publicise these achievements, the IFCC can assist to ensure the availability of this work internationally. Standardization of assays remains a key component of quality laboratory performance. The IFCC Scientific Division continues to provide
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
leadership in this area and has generated an enviable record. This work is translated into our routine clinical laboratories by the Joint Committee for Traceability in Laboratory Medicine, (JCTLM), a partnership between IFCC, International Bureau of Weights and Measures (BIPM) and International Laboratory Accreditation Cooperation (ILAC). JCTLM is a key resource for the In Vitro Diagnostics Industry to ensure the assays in our laboratories are striving for optimal quality. The IFCC is further developing its work in this area to include harmonization of clinical assays through hosting the International Consortium for Harmonization of Clinical Laboratory Results (ICHCLR)3 as well as IFCC becoming an ICHCLR Council member. C. New technologies, new biomarkers Approximately 5% of responding General Conference delegates identified the introduction of new technologies and new biomarkers in routine clinical laboratory practice as a major challenge. The IFCC has responded through the establishment of a fourth Division, the Emerging Technologies Divisions (ETD). The Division has established three committees during 2018, Committee on Emerging Technologies in Paediatric Laboratory Medicine, Committee on Mobile Health and Bioengineering in Laboratory Medicine, and Committee for Omics Translation. Working Groups are being established under each committee to conduct projects D. Training and continuing professional development Continuing major investment in the eAcademy is underway via collaboration between the EMD and CPD to ensure the IFCC can provide quality on-line training and continuing professional development for our members. A major accomplishment has been the design of a curriculum. All IFCC educational activities will be leveraged by focussing on the eAcademy through utilising a variety of resources for the production of webinars, including Visiting Lecturer Program presentations, authors of eJIFCC articles, as well as selected speakers. Coordinators are currently preparing learning objectives and multiple choice questions for each webinar so that participants can obtain IFCC certification for their educational activities. We hope that National Societies can utilise the eAcademy webinars as an educational resource for meetings as the experience is likely to be enhanced when groups of members come together to listen to the webinars, discuss the topics and undertake the examination to obtain certificates. We urge National Soci-
eties to make the eAcademy a resource to build your national society by providing training and continuing professional development. E. Opportunities for career development The IFCC offers numerous programs for young scientists to develop their careers. These include involvement with the Task Force for Young Scientists and their innovative use of social media for networking and skills development, the availability of scholarships for attendance at international congresses, and scholarships through the Professional Scientific Exchange Programme (PSEP) to develop high level scientific skills and the Professional Management Exchange Programme (PMEP) to develop appropriate quality management skills. Details of these schemes are available on the IFCC website.4 In 2018 the IFCC expanded the Mentoring Programme through establishment of the IFCC Working Group for Personal Support (WG-PS), which matches a Young Scientist with a well-respected experienced laboratory practitioner based on shared interests. The programme is conducted by e-mail and/or Skype at no cost to any participant. It enables an Associate to seek advice on any laboratory or research issue on an on-going basis and the Mentor is required to answer the Associate's questions or find someone who can. IFCC Membership The IFCC is currently a federation of 92 national societies as Full Members, 15 national societies as Affiliate Members and 42 Corporate Members representing more than 45,000 clinical laboratory specialists. These membership categories are recognized and defined within our Statutes and Rules along with the Regional Federations. Over recent years there has been considerable discussion regarding the limitations of expanding the numbers of Full Members, particularly in disciplines of Laboratory Medicine other than chemistry.5 In order for the IFCC to expand our skills in these disciplines, the EB will encourage recruitment of Affiliate Members. EB will place before the IFCC Council a motion to change the dues structure of Affiliate Members from a flat fee to one based on membership numbers and World Bank socioeconomic status – similar to the Full Members dues structure but at a discount because of the nature of Affiliate Membership. Corporate Membership is recognized by the EB as critical for the translation of developments in assay standardization and harmonization to achieve comparability between asCont’d on page 29 LabMedica International February-March/2019
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News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information
NEWS
IFCC Task Force for Young Scientists: Reports from Sessions Held in Greece, Italy, India, and Argentina 16th Panhellenic Congress of Clinical Chemistry, Alexandroupolis, Greece
Alexandroupolis, Greece
by Dr Pradeep K Dabla, IFCC-TFYS
October 13, 2018: The 16th Panhellenic Congress of Clinical Chemistry took place in Alexandroupolis, Greece, on 11-13 October, where a round table of IFCC Task Force Young Scientists was held on Saturday, October 13 as follows: 16:00-17:30 Symposium Theme: “Young Scientists in the field of Laboratory Medicine” Moderators: E. Konsta, MSc, PhD, EuSpLM, Faculty of Health and Caring Professions, University of West Attica, Greece and L. Louka, Chemist, MSc, Metropolitan Hospital, Athens, Greece. Young scientist speakers were: 1. Education and application of Clinical Chemistry in Sweden: P. Kompogiannis, Biomedical Sciences Student, University of West Attica, Athens, Greece; 2. Discovering the posttranscriptional regulation of HLA class I APM components and its clinical relevance in melanoma as a PhD student in Germany: M. Lazaridou Chemist, PhD Candidate in Institute for medical immunology, Halle (Saale), Germany; 3. Succeeding as a young scientist: A. Velts, MSc Gene Technology, Head of Laboratory at West Tallinn Central Hospital, Tallinn, Estonia: P. K. Dabla, Chair IFCC-TFYS, Joined the session through Skype and gave brief introduction of IFCC-TFYS. He invited young scientists to join and work together with TFYS vast network. Young professionals constitute the future of Laboratory Medicine. Continuous and proper training in the field of Laboratory Medicine is necessary. In addition, continuous education is needed up to advancements as well as competition in the medical field. It may include new practices, research and contact with innovative means and it undoubtedly offers a huge advantage for those who seek professional development. IFCC is promoting the importance of networking and cooperation with colleagues across the world with working groups and task forces which bring together people from all over the world. The Task Force for Young Scientists (TF-YS) was created to facilitate the exchange of knowledge, ideas and experience between young professionals in Laboratory Medicine and other healthcare practice and to contribute in the dissemination of the idea of the importance of Laboratory Specialist job and to help them finding their way throughout Europe and build their career by enabling access to many educational tools and to opportunities for mentoring and international exchange.
Laboratory Medicine: Preparing for the 2020’s Cont’d from page 28 says to the routine clinical laboratory. The EB aims to publicize to Corporate Members that they have largely the benefits of Full and Affiliate Members including access to IFCC expertise and to submit proposals for projects to be undertaken by IFCC functional units. A Task Force, reporting to the EB, comprising of Corporate Members’ representatives, will be established in 2019 to identify and prioritize their needs with particular reference to possible projects. Those projects recommended to be undertaken will be assigned to the appropriate Division.
Conclusion: Our profession is facing unprecedented challenges and the need for active and effective professional organizations has never been so great. The IFCC has adopted a wide-ranging strategic plan including extending the skills of our members to measure the value of Laboratory Medicine and providing extensive on-line educational resources for training and professional development. We look forward to closer interactions between national societies, regional federations and corporate members to ensure all members can contribute to optimal patient outcomes. References: 1. Wu L, Jülicher P, Liu L; ChiMei Medical Center, Tainan, Taiwan and Abbott Diagnostics, Germany Poster, ISPOR 7th Asia-Pacific Conference, 3-6 September 2016, Singapore 2. www.UnivantsHCE.com 3. www.harmonization.org 4. www.ifcc.org 5. Beastall G. Shaping the future of Laboratory Medicine: an update IFCC eNewsletter 2016; January-February: 5-7.
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Congress of the Italian Society Clinical Chemistry (SIBioC), Naples, Italy by Dr Giulia Sancesario, Coordinator of SIBioC Young Scientists Working Group
October 16, 2018: A special event was the skype participation of Prof Pradeep Kumar Dabla, invited by Prof Sergio Bernardini, President SIBioC, and Dr Giulia Sancesario, coordinator of SIBioC Young Scientists Working Group, at the Opening Ceremony of the 50° National Congress of the Italian Society of Clinical Chemistry and Laboratory Medicine (SIBioC). This event represents an important link between IFCC YS-TF and SIBioC YS WG, demonstrating the continuum between the IFCC YS TF and the YS belonging to the National Societies. The YS of the two groups had already met in Rome during the Conference “Laboratory Medicine: meeting the needs of the Mediterranean Nations” in July 2018, where TF-YS held a session, with the presentations by Dr. Miljan Savkovic, Guilaine Boursier, Josep Miquel Bauça, on “Inter-labCont’d on page 32
NEWS Cont’d from page 31
News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information
IFCC Task Force for Young Scientists & ACBI senior members and especially to the young participants.
CALILAB 2018, Buenos Aires, Argentina by Santiago Fares Taie (IFCC TF-YS)
Naples, Italy
oratory exchange of knowledge and technology”, “The mentor – mentee relationship” and “Research Perspective for Young Scientists”. Interestingly, the social dinner in front of the Colosseum was attended by young delegates from different countries and the young winners of the Roche Travel scholarship. The reinforcement of the relationship between IFCC-TFYS and national YS groups could be an important tool for disseminating initiatives and promoting the exchange and advancement of young professionals.
ACBICON, Kala Academy, Goa, India
Goa, India
fastest and most cost effective approaches to testing is becoming a challenge. Thus, duties and responsibilities of laboratory scientists are still evolving in the diversity of our profession. Laboratory medicine still attracts bright medical and scientific graduates to work in the field. There is actual need to help young scientists in promoting the essential contribution of Laboratory Medicine at the centre of healthcare as they are the future of Laboratory Medicine. The various topics covered were: (1) State of Major Transformations in Healthcare & Medical Laboratory by Prof. Praveen Sharma, EB-ACBI, APFCB, IFCC; (2) Innovations & Skills – Advancing New Delivery Systems by Prof. Damien Gruson, EurSpeLM & Consultant IFCC-TFYS; (3) Laboratory Medicine Vs. Clinical Medicine - Interface Linking by Dr. Pradeep K. Dabla, Chair IFCC-TFYS; (4) Education & Training Programmes Opportunities – Preparing Young Scientists by Dr. Danni, IFCC-TFYS & Dir Clinical Chemistry, University of Minnesota Medical Center Fairview, USA. These topics covered a big range of attributes and through the invaluable skills, capabilities, knowledge, experience and diversity of the speakers a new culture and a common vision with leaders was developed. At the end, the session was open for discussion so that young scientists and participants could interact with world leaders in order to solve their queries. IFCC-TFYS is thankful to the ACBICON-2018 organizing committee, to the IFCC
The IFCC TF-YS symposium took place during the congress CALILAB in Buenos Aires on October 24-27th 2018. The Argentinean congress was the perfect setting for a YS meeting with more than 40 participants from all around Argentina. The aim of the symposium was to encourage YS to participate actively in Laboratory Medicine and to get involved in the professional organization’s activities and committees. The first talk was conducted by Santiago Fares Taie, IFCC TF-YS and consisted on the IFCC TF-YS programs and activities. The topics discussed were: Free webinars, Research booklet, Mentorship programme, Lab-Surfing. com, Radio El Microscopio and the Professional Scientific Exchange Programme (PSEP). All of these programs are available for YS from all around the world who are willing to communicate, network and improve their expertise in Laboratory Medicine. The second talk was in charge of Benjamin Barakian from CoReBio (Argentinean National Association for Laboratory Medicine Residents). He explained the advantages of the residency system in Argentina and the different types of residencies available in the country (Clinical Chemistry, microbiology, immunology, toxicology, genetics). Moreover, CoReBio coordinates plenty of academic activities (example: congress, symposiums, meetings, surveys, etc). Every month, all the residents are invited to the Hospital Garrahanto in order to participate in a dynamic symposium where residents from different hospitals share experiences and lectures. This symposium was possible thanks to Dr. Rosa Sierra Amor (IFCC), Dr. Bernard Gouget (IFCC), Dr. Nilda Fink (CALILAB) and Dr Eduardo Freggiaro (CALILAB) that helped in the accredition and organization of this symposium, reassuring coordination with Young Scientists. Buenos Aires, Argentina
October 25, 2018: IFCC-TFYS organized an educational symposium supported by the organizing committee of the 45th National Conference of ACBICON-2018, Kala Academy, Goa, India. The symposium entitled “Next Steps in Lab Medicine of the Future – Young Specialists & Technology” was successful. The session’s chairs were Prof Maurizio Ferrari, President IFCC and Prof. Abbas Ali Mahdi, President ACBI. The healthcare system is undergoing a major transformation worldwide. The clinical laboratory is seeing a rapid introduction of new technologies and rapid progress of science related to new biomarkers for diagnosis, prognosis and response to therapy. Both interpretation of tests and understanding the
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News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information
NEWS
3rd Regional Workshop for Latin America and the Caribbean Held in Quito By Dr. Rosa Sierra-Amor, Member eNews and Regional Representative IFCC, and Dr. Thamara Andrade, Workshop Coordinator, and President SEBIOCLI n Quito, Ecuador, September 26-28, 2018, the 3rd Regional Workshop of Latin American and the Caribbean: interpretation of critical requirements of ISO 15189:2012 took place with the participation of speakers from Chile, Mexico, Germany and Ecuador. This event was broadcasted from the Simon Bolivar Andean University – Ecuador branch, which was the host venue, to the National University Network for Research and Education (REUNA) from the University in Santiago de Chile, and then to the countries connected: Argentina, Colombia, Costa Rica, Cuba, Chile, Honduras, Guatemala, Mexico, Paraguay, Uruguay and Venezuela. This event was organized in conjunction with the Chilean Society of Clinical Chemistry, the Ecuadorian Society of Clinical Biochemistry, and the Ecuadorian Society of Clinical Pathology. Auspices were provided by the Physikalisch-Technische Bundesanstalt (PTB) in Germany, and the International Cooperation Agency of Germany. The academic Aval was from the University of San Francisco in Quito. The three symposia organized and transmitted by Live Stream to Latin American and the Caribbean were: "Management of the uncertainty of measurement, mandatory requirement of ISO 15189:2012" in which the application and usefulness of the estimation of the uncertainty of measurement were raised, the models proposed to estimate uncertainty, the calculation of the uncertainty and total analytical error permissible and acceptable uncertainty for different measurements intervals. Recommendation on this regard was the use of the NORDEST model for the estimation of the uncertainty, whereas obtaining the source data in the intermediate precision of long term and the calculation of the 'bias' using data from the inter-comparison. "Traceability and uncertainty of the reference material; responsibility of manufacturers and suppliers of in vitro diagnostic reagents". In this symposium, the following was discussed, the use of reference materials, their availability and characteristics; the responsibility of the laboratories in the selection of suppliers; and, the responsibility of providers of diagnostic reagents and external quality assessment programs. The recommendation regarding this issue, was the use of reagents where the uncertainty of the reference and material was included in the kit insert of each reagent; with respect to external quality assessment schemes, it was recommended to accompany the supplier during the implementation of the service, evaluating the competence of the staff, and programs that are accredited or aligned to the standard ISO 17043. "Committee ISO TC 212, membership of countries in the region, committees ISO TC 212, procedures of approval and revision of standards ISO mirror" the experience of Chile and Mexico was determined in this third symposium. The recommendation was to ensure the participation of the largest number of countries in the region in ISO TC 212 or its counterpart ad hoc committee in the country, also that the accrediting agency was settled by representatives of scientific and professional societies in clinical laboratory sciences and Laboratory Medicine within the respective technical committee. Also discussed, the topic "Competency requirements for leaders, assessors, and peer and technical experts in accreditation based on ISO /IEC 17011:2017". In this case, it was discussed the importance of having a profile that should be designed and implemented by the accrediting agencies; in this regard, the Chilean society of Clinical Chemistry (SChQC) presented an example of profile for the assessor that was put it into consideration for the scientific societies in the region. It was mentioned the need of assessors having sufficient experience in the clinical laboratory, and not only limited to search non-conformities with respect to the list of standard´s requirements; stating that, they must identify critical points according to a new mentality of thinking on risk. Finally, the results of three surveys that were sent to non-accredited clinical laboratories in the region, as well as accredited clinical laboratories and national accreditation bodies were discussed. Upon request of all participating countries, it was decided to prolong until the end of this year the dateline to deliver the surveys, so the final result and analysis remain pending. In the workshop, participating actively and interacting with the speakers, there were 137 people. This event was available to the general public who had free access, so they could connect and followed the event from any computer; in addition this event was transmitted in Facebook. After the symposia, the forum was open for questions.
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Photo: Speakers of the Regional Workshop in Latin America and the CaribbeanEcuador 2018. From left to right, Leonardo Aguirre (Chile), Klever Saenz (Ecuador), Roberto Carboni (Chile), Rosa Sierra-Amor (Mexico), Thamara Andrade (Ecuador), Manfred Kindler (Germany), and Sandra Quintana (Mexico).
We believed that we have fulfilled the objective of this workshop, making progress on the harmonization of the criteria for the interpretation of the technical requirements of ISO 15189:2012 in the region, thus improving the competence of medical laboratories. Surely, we will meet in a next workshop, where space will be given for training, discussion and agreements in order to advance on this regard.
News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information
NEWS VIEWPOINT
Artificial Intelligence, Open Digital Resources, and Open Science by Dr. Bernard Gouget Chair, IFCC Committee on Mobile Health and Bioengineering in Laboratory Medicine (C-MHBLM), SFBC-International Committee, General Secretary of the International Francophone Federation of Clinical Biology and Laboratory Medicine (FIFBCML); Counselor for Public Health-FHF; Chair-Human Health Care Committee-COFRAC
pdating and improving the interpretation of images, predicting treatment response, drawing on genetic data to better understand disease, developing predictive and preventative medicine via genome sequencing algorithms, building data bases of previously inaccessible wealth, all things that Artificial Intelligence (IA) has made possible via improving computer calculation capacities and the progress on the part of AI, using neural networks and their ability to learn.
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Digital transformation has become an essential lever for the transformation of the health system and to increase efficiency and quality. This revolution assumes quick renewal of health professional training and practice. It simultaneously poses technical and technological challenges due to the volume of data, ethical and legal challenges to protect personal data and especially the challenge of trust to persuade and overcome reluctance. AI has become everyone’s business. Digital technology allows a collaborative approach and better information, available everywhere, at any time. The capacities of the Laboratory Medicine specialist are increased. They are better equipped to analyze and make decisions, closer to the patient and to professionally great days to come. The challenge is to truly improve diagnostic strategies and therapeutic choices and to be more available to the patient and clinician at the same time. Previously, it was necessary to consult a collection of works before issuing a hypothesis, producing data and finally analyzing them. Today, the logic is reversed: we try to make sense of a gigantic set of data as well as testing this meaning. The paradigm is evolving, and an awareness is needed on the part of biologists and researchers: that of understanding new issues arising from big data and its various aspects. Analyzing these data is complex and requires specific interdisciplinary expertise. AI is done with trained brains, so the training of a new generation of scientists with a “health-mathematics” interface becomes a major challenge as much as the need for large high-performance storage and computing centers, platforms whose role is not just to host and archive data but also to ensure the standardization thereof. Digital technology in general will transform the working methods of the youngest and oldest researchers alike. We no longer have to pay to access scientific articles. The open access movement is trying to remedy this by putting forth a model where scientific articles are accessible to everyone. Open science is linked to a generational change. Digital technology takes on an increasingly important role in the collection of research processes and in the researcher’s workflow. We slowly arrive at a general movement of researchers training in open science, big data and open data. On the European scale, there is the FOSTER (Facilitate Open Science To European Research) Initiative which seeks to establish training in this field. Open science presents various aspects: free access to scientific publications (open access), open data, open source software and participative and contributive research. For example, the accessibility of software whose development cost is sometimes exorbitant allows non-researchers to also be involved. This concept is encompassed by a particularly attractive term for young generations: open science, open data and open knowledge. This open spirit and culture also aligns the role and participation of patients in their care pathway and research processes. Open science is therefore a particularly broad concept that allows rallying a large number of stakeholders. Open data is part of this. Big data, in return, is not necessarily open. The question is knowing whether open means better science. Each emergent practice brings its own economic challenges with potential detours. Open data obviously poses ethical questions from the angle of personal data. Open access is a new market, facing challenges of information quality and new quality control protocols remain to be created. Open science certainly aims for a greater efficacy and a better idea of science. Currently all countries that wish to be included in innovation are developing AI programs. Data has become a major player for understanding, anticipating and resolving major political, economic, social and scientific issues. Data also transform our professional practices, our cultural environment, the way we live our daily lives, even going as far as restructuring our way of thinking. Science is a common good and a factor for collective enrichment that we should share as widely as possible. It has become vital to generalize open access to publications, to structure and open up research data when it is reasonably compliant with legal and ethical requirements and to be part of a sustainable European and international dynamic. Open science is not a technical evolution, but a profound paradigm change, which involves changes at different levels of scientific processes, both upstream and downstream. It constitutes an opportunity to improve research itself as well as its collaborative aspect and its relationship with society. Open science is the ideal vehicle for knowledge in the face of rumors! LabMedica International February-March/2019
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Industry News
Global In Vitro Diagnostics Market to Reach USD 90 Billion by 2025 he global in vitro diagnostics market was valued at USD 55 billion in 2016 and is projected to grow at a healthy CAGR of 5.60% between 2017 and 2025 to reach USD 89.8 billion by the end of 2025. The market growth will be driven by the rising prevalence of chronic diseases worldwide, an increase in the number of public and private diagnostic centers due to growing awareness of various diseases among the people, and an increasingly health conscious population who prefer early treatment. Additionally, the aggressive growth in the health sector and rapid technological advancements are helping to create better and more efficient products, thereby further aiding the market growth. These are the latest findings of Transparency Market Research, (Albany, NY, USA; www.transparencymarketresearch.com), a global market intelligence company providing business information reports and services. Increasing incidences of chronic diseases such as cancer, tuberculosis, diabetes, and cardiovascular diseases are likely to drive the growth of the
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global in vitro diagnostics market over the coming years. Additionally, a surge in the number of patients suffering from infectious diseases, such as sexually transmitted diseases (STDs), respiratory, and gastrointestinal, are expected to further boost the demand in the market. A sharp increase in cardiovascular diseases and diabetes, particularly in the developed countries, has helped the in vitro diagnostic market grow at a stupendous pace. Moreover, an increase in the geriatric population is also fueling market demand as the elderly people are more vulnerable to diseases due to their low immunity, thereby boosting the overall healthcare industry and resulting in the huge growth of the vitro diagnostic market. The healthcare industry has been witnessing tremendous development and is expected to continue growing during the forecasts period on the back of the advent of personalized medicines and rise in the uptake of automated instruments. Earlier, in vitro diagnostics used to be performed only in labs, but can now be quickly and accurately carried out at home without the presence of any skilled professionals.
Luminex Acquires MilliporeSigmaâ&#x20AC;&#x2122;s Flow Cytometry Portfolio uminex Corporation (Austin, Texas, USA; www.luminexcorp. com) has completed its previously announced acquisition of MilliporeSigma's (Burlington, MA, USA; www.emdmillipore. com) flow cytometry portfolio. Luminex offers a wide range of solutions applicable in diverse markets, including clinical diagnostics, pharmaceutical drug discovery, biomedical research, genomic and proteomic research, biodefense research, and food safety. Luminex's newly acquired flow cytometry portfolio includes the Amnis family of imaging flow cytometry products for cell-based analysis, as well as the Guava portfolio of systems based on microcapillary technologies. "We are pleased to announce the completion of this transaction and
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Worldwide Digital Pathology Sector Seen to Grow 8.5% Annually until 2022 he global digital pathology market is projected to grow at a CAGR of 8.5% from 2017-2022 to reach USD 600 million by 2022, despite the presence of headwinds that are suppressing market potential and limiting its growth. These are the latest findings of Signify Research, (Cranfield, Bedfordshire, England; www.signify research.net), an independent supplier of market intelligence and consultancy to the global healthcare technology industry. Despite its early hype, the world market for digital pathology, comprising whole slide scanner hardware, software and services, remains at a nascent stage, although it is showing signs of gaining momentum. The first FDA approval of a digital pathology solution for primary diagnosis in the US in 2017 was a landmark, although no other system has received approval since then. The strong trend towards consolidation of services in healthcare is driving several clinical hospital networks and clinical laboratories to centralize and consolidate their networks, which is expected to create larger â&#x20AC;&#x153;hubsâ&#x20AC;? for digital pathology. The adoption rate of image analysis software and computational pathology in the pre-clinical pharmaceuticals and life sciences sectors, especially in support of drug discovery, is expected to be higher as compared to the clinical segments. The hospital and clinical laboratory segments continue to grow and are expected to witness a stronger growth in the mid and long-term due to regulatory constraints, complexity of integration with existing clinical IT, and lengthy procurement cycles. However, the global digital pathology market also faces headwinds, such as the slow process of convincing pathologists to give up traditional microscopes for digital scanners and software viewers. Several healthcare providers and clinical laboratories have approached digitalization in a gradual manner, choosing to use digital workflow for only certain pathology diagnoses, or have adopted digital pathology for secondary uses, such as in clinical education or secondary review.
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excited to welcome the talented MilliporeSigma flow cytometry team to the Luminex family," said Homi Shamir, president and CEO of Luminex. "This acquisition enables us to enhance our existing offering of flowbased detection systems, while simultaneously expanding our direct interactions with researchers conducting cellular analysis." "The Amnis and Guava products complement our wide range of existing flow-based offerings, further differentiating our portfolio and ensuring we are well-positioned to support customers today and into the future," said Shamir. "With this acquisition, we now have expanded our installed based to include more than 5,000 flow cytometry systems worldwide."
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