WORLD’S CLINICAL LABORATORY NEWS LEADER ISSN 1068-1760
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Fast and Simple Device Identifies Viruses
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irologists estimate that there are some 1.67 million types of unknown viruses in animals, a number of which can be transmitted to humans. Around 263 viruses from 25 viral families are known to infect humans, and given the rate of discovery following
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Molecular Profiles and Microenvironment Signatures May Improve Lymphoma Prognosis
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he tumor microenvironment includes surrounding blood vessels, immune cells, fibroblasts, signaling molecules, and the extracellular matrix that encapsulate the cancerous cells. The non-lymphoma cells lingering in the tumor's microenvironment, for ex-
COVID-19 Testing: Acute Global Need Driving Heated Industry Scramble
ample, can modify the effect of the mutations. Although gene alterations driving a tumor provide information about cancer cell aggressiveness, non-malignant cells of the tumor microenvironment have the potential to promote malignant growth Cont’d on page 9
See article on page 4
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Immunoassay Identifies Pediatric Lyme Arthritis
n the USA, Lyme arthritis is the most common feature of late stage infection with the tickborne spirochete, Borrelia burgdorferi, usually beginning months after the initial tick bite. Patients with Lyme arthritis have intermittent or persistent attacks of joint swelling and pain in one or a few large joints, especially the knee, usuallyover a period of several years, without prominent
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ost bladder cancers start in the innermost lining of the bladder, which is called the urothelium or transitional epithelium. As the cancer grows into or through the other layers in the bladder wall, it has a higher stage, becomes more advanced, and can be harder to treat. Urothelial carcinoma, also known as transitional cell carcinoma (TCC), is by far the most common type of bladder cancer. Current Cont’d on page 6
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lobally, of the 200 million adults who undergo major surgery every year, 18% will experience serious cardiac and vascular complications, including death, within 30 days of their surgical procedure, such as hip and knee replacements, bowel resections and abdominal aortic aneurysm repair. Cont’d on page 20
Immune System Altered in Chronic Fatigue Syndrome
yalgic encephalomyelitis /chronic fatigue syndrome (ME/CFS) is a severe, chronic, and debilitating disease that can cause a range of symptoms including pain, severe exhaustion, cognitive impairment, and post-exertional malaise, the worsening of symptoms after physical or mental activity.
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Urinary DNA Detects Urothelial Carcinoma
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ith the worldwide need for COVID-19 diagnostics soaring exponentially, over 100 tests and assays, based on a range of technologies, have received US-FDA's Emergency Use Authorization (EUA) as of this time of writing, with dozens more within the certification pipeline or in development. LabMedica's special report provides a comprehensive update on latest developments.
DAILy CLINICAL LAB NewS
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A Special Update on Latest Developments
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Estimates suggest that between 836,000 and 2.5 million people in the USA may be affected by ME/ CFS. It is unknown what causes the disease and there are no treatments. There is an increasing appreciation for the role of immune and metabolic dysfunction in the disease. ME/CFS has historically presented Cont’d on page 6
INSIDE
Covid-19 Update . . . 4,13 Clinical News . . . . . . . . . 8 IFCC News . . . . . . . . . . 29 product News . . . . . 6-26 Events Calendar . . 34-35 PUBLISHED IN COOPERATION WITH
International Federation of Clinical Chemistry and Laboratory Medicine
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COVID-19 Testing: Acute Global Need Driving Heated Industry Scramble
LabMedica International
Since our last COVID-19 Update appearing in LabMedica's previous issue, total number of Emergency Use Authorizations (EUA) granted by the US Food and Drug Administration (FDA), for the detection of the SARS-CoV-2 virus that causes COVID-19, has grown to a list of over 100 separate diagnostic tools. Dozens of additional test kits and assays, based on a range of technologies, are currently within development or certification pipelines, with their emphasis being on improved reliability, speed, convenience, and cost-effectiveness of testing. As clinical laboratories and healthcare institutions around the world rush to order large volumes of COVID-19 diagnostic products, the In Vitro Diagnostics (IVD) industry appears to have entered a phase of unprecedented expansion in a race to meet the exploding global demand. The report that follows provides a survey of entries and advances from mid-April till midMay of this year. For a recap of earlier developments, the reader is invited to refer to previous issues of LabMedica.
Roche’s New COVID-19 Antibody Test System
Roche (Basel, Switzerland) has launched its Elecsys Anti-SARS-CoV-2 serology test to detect antibodies in people who have been exposed to SARS-CoV-2 that causes the COVID-19 disease. The vitro test uses human serum and plasma drawn from a blood sample to detect antibodies and determine the body’s immune reaction to SARS-CoV-2. Roche has also secured Emergency Use Authorization from the US FDA for its new Elecsys Anti-SARS-CoV-2 antibody test. Rapid, Bluetooth-Connected 60-Second COVID-19 Test
Hememics Biotechnologies Inc. (Gaithersburg, MD, USA; is developing a rapid, Bluetooth-connected, easy-to-use test to diagnose COVID-19 in 60 seconds or less. The test detects SARS-CoV-2 and associated antibodies from nasal swabs or whole blood, meeting a critical need to distinguish between individuals with active infections and those who have developed antibodies to the virus. New CRISPR-Based COVID-19 Test
Scientists at UC San Francisco (San Francisco, CA, USA; www.ucsf.edu) and Mammoth Biosciences (San Francisco, CA, USA; have jointly developed an inexpensive new test that can rapidly diagnose COVID-19 infections. The new test – officially named the “SARS-CoV-2 DETECTR” – is easy to implement and to interpret, and requires no specialized equipment. Asuragen’s Armored RNA Quant SARS-CoV-2 Control
Asuragen, Inc. (Austin, TX, USA) has developed the Armored RNA Quant SARS-CoV-2 Control for use in developing assays that tar-
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gets the SARS-CoV-2 viral nucleocapsid (N) region. The control, along with the company’s new RNAse P construct, aligns with the CDC and WHO-recommended Diagnostic Panel (CDC-006-00019) to provide a safe, stable, and reliable way to test for the novel coronavirus. World’s First Instrument-Free, POC Molecular COVID-19 Test
Sense Biodetection Limited (Oxford, UK;) has accelerated its program to launch the world’s first instrument-free, point-of-care molecular diagnostic test for SARS-CoV-2. Sense’s Veros SARS-CoV-2 exploits proprietary chemistry and device technologies developed by the company over the last six years for other infectious disease applications, Rutgers’ New Coronavirus Saliva Test Secures FDA
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
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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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Raymond L Jacobson, phD News Editor Gerald M Slutzky, phD News Editor Andreas Rothstein News Editor
A new collection approach that utilizes saliva as the primary test biomaterial for the SARSCoV-2 coronavirus has become the first such method to be granted Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA). The new saliva collection method will allow for broader population screening than the current method of nose and throat swabs. Gold Standard Diagnostics’ New COVID-19 Antibody Tests
Gold Standard Diagnostics Inc. (GSD; Davis, CA, USA) has launched three different serological assays for the detection of antibodies against the novel coronavirus SARS-CoV-2, following Emergency Use Authorization (EUA) granted by the FDA. The IgA, IgG, and IgM assays are formatted for optimal functionality in diagnostic laboratories each with a total incubation time of 90 minutes at room temperature with ready to use controls. Newly Coronavirus Blood Test Identifies Past Exposure
A pair of new serological tests can detect novel coronavirus antibodies – evidence in persons tested that they have previously been infected by SARS-CoV-2, the viral cause of COVID-19 – even if they never experienced tell-tale symptoms. The tests, developed by clinical laboratory physicians and scientists at UC San Diego (La Jolla, CA, USA), build upon two assays developed by Diazyme Laboratories, Inc. (Poway, CA, USA). Accelerate Diagnostics Partners with BioCheck
Accelerate Diagnostics, Inc. (Tucson, AZ, USA) and BioCheck, Inc. (San Francisco, CA, USA;) have entered into a commercial supply and collaboration agreement for the distribution of the BioCheck MS-FAST, a fully-automated chemiluminescence immunoassay analyzer, Cont’d on page 11
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ISSN 1068-1760
Vol.38 No.3. Published, under license, by Globetech Media LLC; Copyright © 2020. 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.
LabMedica International May/2020
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extrachromosomal Circular DNA Drives Oncogenic Genome Remodeling in Neuroblastoma To view this issue in interactive digital magazine format visit www.LinkXpress.com
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ircularized DNA falling outside of linear chromosomes may serve as a recurrent source of somatic rearrangements in neuroblastoma, a pediatric cancer affecting immature cells in the sympathetic nervous system. While past studies have pointed to a role for circularized, extrachromosomal MYCN oncogene sequences in neuroblastoma, the full suite and the frequency of somatic mutations involving small or large stretches of circularized extrachromosomal DNA amplifications had not been fully explored. An international team of scientists collaborating with those at CharitÊ-Universitätsmedizin Berlin (Berlin, Germany; www.charite.de) profiled matched tumor and normal blood samples from 93 neuroblastoma patients using whole-genome sequencing and an algorithm that uncovers circularized DNA based on paired read orientation, uncovering preliminary evidence for complex and relatively frequent extrachromosomal DNAs (ecDNAs) in neuroblastoma. The team to take a closer look at these sequences using a modified version of circle sequencing (Circle-seq) in 21 of the neuroblastoma tumors, making it possible to enrich for circularized DNA. The circularized sequences were mapped back to their original sites in the genome using additional long-read and single-molecule real-time sequences, the investigators explained, and they validated candidate DNA circles with polymerase chain reaction (PCR) and Sanger sequencing. Together, these approaches uncovered almost 5,700 small extrachromosomal circular DNAs per tumor, on average, and an average of 0.82 large, copy number-amplified extrachromosomal circular DNA sequences. Even so, the team's follow-up analyses, including RNA sequencing experiments, indicated that rearrangements stemming from extrachromosomal circular DNA from MYCN and other genes may be a recurrent and ongoing source of new mutations through a multi-hit model in neuroblastoma. The authors concluded that they had demonstrated that the majority of genomic rearrangements in neuroblastoma involve circular DNA, challenging the current understanding about cancer genome remodeling. They envision that their findings extend to other cancers and that further detailed analyses of circle-derived rearrangements will shed new insights into our understanding of cancer genome remodeling. The study was published on December 16, 2019 in the journal Nature Genetics.
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LabMedica International
Image: Scanning electron micrograph of inside the nucleus of a cancer cell, chromosomes are indicated by blue arrows and circular extrachromosomal DNA are indicated by orange arrows (Photo courtesy of Paul S. Mischel, MD, UC San Diego)
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Instrumentation Laboratory’s GEM® Premier™ 5000 analyzer with integrated CO-Oximetry panel is a revolutionary analyzer for point-of-care and centralized laboratory, featuring Enhanced Intelligent Quality Management 2 (iQM®2).
The EUROLabWorkstation ELISA provides fully automated processing of EUROIMMUN ELISA tests at a capacity of up to 15 plates per run. It is the highest throughput system on the market, processing more than 200 tests per hour.
The ECL 760 from Erba Mannheim is a fully automated coagulation analyzer for small to mid-size laboratories. It features random access operation with STAT testing for clotting, immunologic and chromogenic assays.
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Urinary Cell-Free DNA Detects Urothelial Carcinoma
noninvasive assays for urothelial carcinoma (UC) lack clinical sensitivity and specificity. Given the utility of plasma cell-free DNA (cfDNA) biomarkers, the development of urinary cfDNA biomarkers may improve the diagnostic sensitivity. Urologists at the Beijing Institute of Genomics (Beijing, China; www.big.ac.cn) and their colleagues assessed copy number alterations (CNAs) by shallow genome-wide sequencing of urinary cfDNA in 95 cancer-free individuals and 65 patients with UC, 58 with kidney cancer, and 45 with prostate cancer. They used a support vector machine to develop a diagnostic classifier based on CNA profiles to detect UC (UCdetector). A Bioanalyzer 2100 (Agilent Technologies, Santa Clara, CA, USA; www.agilent.com) was used to profile the length distribution of cfDNA isolated from the UC patients. The model was further validated in an independent cohort (52 patients). Genome sequencing data of tumor specimens from 90 upper tract urothelial cancers (UTUCs) and CNA data for 410 urothelial carcinomas of bladder (UCBs) from The Cancer Genome Atlas were used to validate the classifier. Genome sequencing data for urine sediment from 32 patients with UC were compared with cfDNA. To monitor the treatment efficacy, the team collected cfDNA from seven post-treatment patients. The investigators reported that urinary cfDNA was a more sensitive alternative to urinary sediment. The UCdetector could detect UC at a median clinical sensitivity of 86.5% and specificity of 94.7%. UCdetector performed well in an independent validation data set. Notably, the cont’d from cover
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CNA features selected by UCdetector were specific markers for both UTUC and UCB. Moreover, CNA changes in cfDNA were consistent with the treatment effects. Meanwhile, the same strategy could localize genitourinary cancers to tissue of origin in 70.1% of patients. The authors concluded that their findings underscore the potential utility of urinary cfDNA CNA profiles as a basis for non-invasive UC detection and surveillance. The study was published in the December 2019 issue of the journal Clinical Chemistry. Image: The Agilent Technologies 2100 Bioanalyzer system is an established automated electrophoresis tool for the sample quality control of biomolecules (Photo courtesy of Laboratory Controls LLC)
Immune System Altered in Chronic Fatigue Syndrome
in outbreaks, often has a flu-like onset, and results in inflammatory symptoms. A group of scientists working with Cornell University (Ithaca, NY, USA; www.cornell. edu) examined biochemical reactions involved in energy production, or metabolism, in two specific types of immune cells obtained from 45 healthy controls and 53 people with ME/CFS. The investigators focused on CD4 T cells, which alert other immune cells about invading pathogens, and CD8 T cells, which attack infected cells. They analyzed glycolysis and mitochondrial respiration in resting and activated T cells, along with markers related to
cellular metabolism, and plasma cytokines. The team found that ME/CFS CD8+ T cells have reduced mitochondrial membrane potential compared to healthy controls. Both CD4+ and CD8+ T cells from ME/CFS patients had reduced glycolysis at rest, while CD8+ T cells also had reduced glycolysis following activation. ME/CFS patients had significant correlations between measures of T cell metabolism and plasma cytokine abundance that differed from healthy control subjects. They also looked at mitochondrial size and membrane potential, which can indicate the health of T cell mitochondria. CD4 cells from healthy controls and people with ME/CFS showed no
significant differences in mitochondrial size or function. Maureen Hanson, PhD, a professor of molecular biology and genetics and first study author, said, “Our work demonstrates the importance of looking at particular types of immune cells that have different jobs to do, rather than looking at them all mixed together, which can hide problems specific to particular cells. Additional studies focusing on specific cell types will be important to unravel what's gone wrong with immune defenses in ME/CFS.” The study was published on December 12, 2019 in the Journal of Clinical Investigation. LabMedica International May/2020
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Fast and Simple Device Identifies Viruses
To view this issue in interactive digital magazine format visit www.LinkXpress.com
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LabMedica International
identification of the first human virus, it is likely many more will emerge in the future. Known viruses, such as H5N1, Zika and Ebola have caused widespread illness and death. Early detection could halt virus spread by enabling rapid deployment of countermeasures. In virus surveillance, collected samples are subjected to a series of time-consuming steps, such as ultracentrifugation and cell culture, to enrich virus particles or amplify virus titers. In addition, many viruses are not easily culturable, and bias is often introduced during amplification, leading to artifacts in the sequence data. A team of scientists led by The Pennsylvania State University (University Park, PA, USA; www.psu.edu) team developed a portable microfluidic platform containing carbon nanotube arrays with differential filtration porosity for the Image: Schematic of an array of nanotubes decorated with gold nanoparticles that rapid enrichment and optical identification of viruses. Differ- capture virus molecules for in situ Raman spectroscopy for label-free optical virus ent emerging strains (or unknown viruses) can be enriched identification (Photo courtesy of Professor Mauricio Terrones) and identified in real time through a multivirus capture component in conjunction with surface-enhanced Raman spectroscopy. More importantly, after viral capture and detection on a chip, viruses remain viable and get purified in a microdevice that permits subsequent in-depth characterizations by various conventional methods. The team validated this platform, using different subtypes of avian influenza A viruses and human samples with respiratory infections. This technology successfully enriched rhinovirus, influenza virus, and parainfluenza viruses, and maintained the stoichiometric viral proportions when the samples contained more than one type of virus, thus emulating coinfection. Viral capture and detection took only a few minutes with a 70-fold enrichment enhancement; detection could be achieved with as little as 102 EID50/mL (50% egg infective dose per microliter), with a virus specificity of 90%. After enrichment using the device, called the VIRRION, the scientists demonstrated by sequencing that the abundance of viral-specific reads significantly increased from 4.1% to 31.8% for parainfluenza and from 0.08% to 0.44% for influenza virus. This enrichment method coupled to Raman virus identification constitutes an innovative system that could be used to quickly track and monitor viral outbreaks in real time. Mauricio Terrones, PhD, a professor and senior author of the study, said, â&#x20AC;&#x153;We have developed a fast and inexpensive handheld device that can capture viruses based on size. Our device uses arrays of nanotubes engineered to be comparable in size to a wide range of viruses. We then use Raman spectroscopy to identify the viruses based on their individual vibration.â&#x20AC;? The study was published on December 27, 2019 in the Proceedings of the National Academy of Sciences.
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The RAPIDPoint 500 Blood Gas System tests blood gas, electrolytes, glucose, lactate, full CO-oximetry and total hemoglobin) using multiple sample types, including whole blood (arterial and venous), pleural fluid and dialysate.
The ECL 105 is a 1 channel semi-automated coagulometer which performs measurements of all clotting assays as well as D-Dimer and features a 3.5-inch resistive color touchscreen along with a built-in thermal printer.
The SERO 12 blood banking centrifuge is carefully designed to facilitate high-quality blood grouping, typing, cross matching, and other cellwashing procedures for a wide range of tube sizes.
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Acute Myeloid Leukemia Diagnosed by Convolutional Neural Networks
very day, millions of single blood cells are evaluated for disease diagnostics in medical laboratories and clinics. Most of this repetitive task is still done manually by trained cytologists who inspect cells in stained blood smears and classify them into roughly 15 different categories. Scientists have now shown that deep learning algorithms perform similar to human experts when classifying blood samples from patients suffering from acute myeloid leukemia (AML). Their proof of concept study paves the way for an automated, standardized and onhand sample analysis in the near future. Scientists from the Helmholtz Zentrum München (Neuherberg, Germany; www. helmholtz-muenchen.de) and their colleagues compiled an annotated image dataset of over 18,000 white blood cells, use it to train a con-
volutional neural network for leukocyte classification and evaluate the network’s performance by comparing to inter- and intra-expert variability. They used images which were extracted from blood smears of 100 patients suffering from the aggressive blood disease AML and 100 controls. The new AI-driven approach was then evaluated by comparing its performance with the accuracy of human experts. The network classifies the most important cell types with high accuracy. It also allowed the investigators to decide two clinically relevant questions with human-level performance: (1) if a given cell has blast character and (2) if it belongs to the cell types normally present in non-pathological blood smears. The result showed that the AI-driven solution is able to identify diagnostic blast cells at least as good as
a trained cytologist expert. Carsten Marr, PhD, a computational stem cell biologists and the senior author of the study, said,Together with our partners we could prove that deep learning algorithms show a similar performance as human cytologists. In a next step, we will evaluate how well other disease characteristics, such as genetic mutations or translocations, can be predicted with this new AI-driven method.” The authors concluded that their approach holds the potential to be used as a classification aid for examining much larger numbers of cells in a smear than can usually is done by a human expert. This will allow clinicians to recognize malignant cell populations with lower prevalence at an earlier stage of the disease. The study was published on November 12, 2019 in the journal Nature Machine Intelligence.
lostridioides difficile is a spore-forming, gram-positive anaerobic bacillus spread by fecal–oral transmission of spores, which remain viable for long periods of time ex vivo. Although C. difficile carriers do not have diarrhea, they do shed spores that can contaminate environmental surfaces. Annually, there are more than 400,000 cases and almost 30,000 deaths from C.difficile– associated diarrhea occur in the USA. Efforts to reduce the spread of C. difficile have focused on reducing transmission from patients with symptomatic C. difficile–associated diarrhea. Asymptomatic carriers may serve as a reservoir and spread C. difficile to those around them. Medical scientists associated with the Montefiore Medical Center (The Bronx, NY, USA; www.montefiore.org) performed a prospective cohort study on a sample of patients being admitted to a large university hospital between July 2017 and March 2018. The team tested 220 patients who showed no symptoms of C.
difficile infection when they were admitted. Perirectal swabs (Copan Diagnostics, Murrieta, CA, USA; www.copanusa.com) were completed within 24 hours of admission, and the patients were followed for six months. Two testing methodologies were used for all specimens: C. difficile Quik Chek Complete (Abbott, Chicago, IL, USA; www.abbott.com) to test for glutamate dehydrogenase (GDH) and toxins A and B and XPert C. difficile/Epi (Cepheid, Sunnyvale, CA, USA; www.cepheid. com) real-time polymerase chain reaction (PCR) assay that detects the toxin B gene. The scientists reported that of the 220 subjects, 21 (9.6%) were C. difficile carriers, including 10.2% of the nursing facility residents and 7.7% of the community residents. Among the 21 C. difficile carriers, eight (38.1%) progressed to symptomatic C. difficile, but only four (2.0%) of the 199 non-carriers progressed to symptomatic C. difficile. The authors concluded that asymptomatic carriers may represent a significant reservoir
for transmission of C. difficile, and progression from asymptomatic carriage to symptomatic C. difficile infection (CDI) may account for a significant proportion of CDI that is classified as “healthcare-facility onset.” Therefore, identification of asymptomatic carriers could reduce the spread of C. difficile. Specific environmental, isolation, and stewardship strategies to prevent spread of C. difficile from carriers to uninfected patients as well as prevent progression to symptomatic CDI warrant further study. Sarah Baron, MD, MS, an Assistant Professor of Medicine and lead author of the study, said, “It has generally been assumed that patients get the bacteria during their stay in the hospital. However, when we tested patients being admitted to the hospital, we found that many of them were carrying the bacteria that cause this diarrhea in their bodies already and often went on to develop the infection.” The study was published on December 11, 2019 in the journal Infection Control & Hospital Epidemiology.
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C. Diff Carriers Are Source of Infections in Hospitals
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Molecular Profiles and Microenvironment Signatures May Improve Lymphoma Prognosis To view this issue in interactive digital magazine format visit www.LinkXpress.com
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LabMedica International
by supporting immune evasion and enabling the development of new blood vessels. In the past few years, scientists have profiled the genomes of lymphomas, defined mutations that confer good and bad prognoses, and found several clinically actionable mutations. Scientists at Weill Cornell Medicine (New York, NY, USA: https://weill.cornell.edu) and their colleagues at BostonGene Corporation (Boston, MA, USA; www.bostongene.com) developed and deconvoluted transcriptomics signatures of lymphoma microenvironment (LME) cells and pathways from 3,026 diffuse large B-cell lymphomas (DLBCLs) from 13 datasets including a new cohort of 127 patients. Mutations were available for 562 patients of the datasets and for 22 patients from that cohort (whole-exome sequencing with matched normal). Applying density-based clustering they Image: Micrograph of a diffuse large B cell lymphoma, from a bone marrow aspirate; identified four LME signatures, independent of reported the nucleus may be convoluted and irregular (Photo courtesy of Peter Maslak) transcriptional and genetic classifications based on lymphoma cells. The team applied density-based clustering to identify four lymphoma microenvironment signatures that provided prognostic information beyond what could be gleaned from just lymphoma cell transcriptomes and mutations. Two of the signatures, named "immunosuppressive" and "mesenchymal," were associated with making tumor mutations behave better, and the other two, called "anti-tumor immunity" and "depleted," were associated with making mutations behave worse. When patients have a tumor mutation associated with poor prognosis in a good tumor microenvironment, that mutation may not be that bad, they showed. Conversely, when patients have a tumor mutation that usually indicates a good prognosis but it is in a bad microenvironment, that mutation can be detrimental. For example, double-hit (DH) lymphomas are wellknown subgroups that harbor both BCL2 and MYC gene translocations. Considering the genetics alone, this subgroup is usually associated with a bad prognosis. However, when DH lymphomas exhibit a microenvironment subtype with a good prognosis, the prognosis of these DH lymphoma patients is usually improved. Leandro Cerchietti, MD, an Oncologist and first author of the study, said, â&#x20AC;&#x153;We classified the tumors, we considered new categories that were not considered before to increase the precision of the diagnosis. It also offers the possibility of doing more precise clinical trials now that we have this information available for the patients.â&#x20AC;? The study was presented on December 9, 2019 at the American Society of Hematology annual meeting held in Orlando, FL, USA.
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The ABL90 FLEX blood gas analyzer can deliver 17 parameters from a sample as small as 65µL in35 seconds and ensures standardized mixing of blood samples in only 7 seconds using safePICO syringes and a built-in sample mixer.
The BC-2800 is a compact, fully automatic hematology analyzer with 19 parameters for CBC test and micro sampling technology, featuring a user-friendly interface that facilitates an easy and efficient workflow.
The Atellica IM 1600 immunoassay analyzer can run up to 440 tests per hour using the proven acridinium ester (AE) technology. It offers 42 primary assay positions and 35 ancillary reagent positions.
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Immunoassay May Help Identify Pediatric Lyme Arthritis
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systemic manifestations. In Lyme disease endemic areas, initial management of children with arthritis can be challenging because diagnostic tests take several days to return results, leading to potentially unnecessary invasive procedures. Synovial fluid polymerase chain reaction (PCR) testing for B. burgdorferi DNA is often positive prior to treatment, but it is not a reliable marker of spirochetal eradication after antibiotic therapy. Doctors at the Boston Children's Hospital (Boston, MA, USA; www.childrenshospital. org) and their colleagues examined the role of the C6 peptide enzyme immunoassay (EIA) test to guide initial management of children with acute arthritis undergoing evaluation for Lyme disease presenting to a participating Pedi Lyme Net emergency department (2015– 2019). They defined Lyme arthritis with a positive or equivocal C6 EIA test result followed by a positive supplemental im-
T
munoblot result and defined septic arthritis as a positive synovial fluid culture result or a positive blood culture result with synovial fluid pleocytosis. The scientists reported that of the 911 study patients, 211 children (23.2%) had Lyme arthritis, 11 (1.2%) had septic arthritis, and 689 (75.6%) had other inflammatory arthritis. A positive or equivocal C6 EIA result had a sensitivity of 100% (211/211) and specificity of 94.2% (661/700) for Lyme arthritis. None of the 250 children with a positive or equivocal C6 EIA result had septic arthritis, although 75 children underwent diagnostic arthrocentesis and 27 underwent operative joint washout. Lise Nigrovic, MD, MPH, an assistant professor of Pediatrics and co-author of the study, said, “We demonstrated that the C6 EIA test, a previously approved first-tier test for Lyme disease, with results available within a few
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hours, could be used to safely guide initial management for children with inflamed joints to avoid unnecessary invasive procedures for children with Lyme arthritis.” The authors concluded that in Lyme disease endemic areas, a C6 EIA result could be used to guide initial clinical decision-making, without misclassifying children with septic arthritis. The study was published in the December, 2019 issue of the journal Pediatrics. Image: The Diagnostic Performance of C6 Enzyme Immunoassay for Lyme Arthritis has been evaluated (Photo courtesy of Lonnie R. Marcum, PT, BSHCA)
Diagnosis and Monitoring of Patients with Hepatitis C Virus
he global prevalence of people with hepatitis C virus (HCV) antibodies (anti-HCV-positive) is estimated to be 115 million, and 80 million of them have an active infection (anti-HCV-positive and HCVRNA-positive). Most HCV-infected individuals remain asymptomatic for decades and only 25% of them achieve spontaneous viral clearance, while 75% develop chronic infection. Around 10%–20% of chronically infected patients develop liver cirrhosis or hepatocellular carcinoma and despite improvements in diagnosis and screening, the morbidity and mortality
due to chronic HCV infection remain high. Medical microbiologists at the Complejo Hospitalario Navarra (Pamplona, Spain; www.chnavarra.es) and their colleagues carried out a prospective study included a sample of patients attending a regional reference hospital in Spain between September 2016 and December 2017, for whom viral load (VL) quantification was required. For these patients, HCV core antigen (HCV-cAg) determination was performed in parallel. The team tested plasma or serum samples from three patient groups: new diagnosis, treatment monitoring, and treatment failure. The treatment
monitoring group was tested at the beginning of treatment, at four weeks post-initiation, at the end of treatment, and at 12 weeks posttreatment completion. VL testing was performed by RT-PCR using the Cobas 6800 system (Roche Diagnostics, Mannheim, Germany; www.roche.com), with a linear range of between 15 and 108 IU/mL. The detection and quantification of HCV-cAg was performed by chemiluminescence immunoassay (CLIA) in an Architect system (Architect HCV core antigen; Abbott Diagnostics, Wiesbaden, Germany; www.abbott.com), with a linear range of between 0 and 20,000
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along with BioCheck’s SARS-CoV-2 tests for the detection of IgG and IgM antibodies. ELITech’s Rapid Detection Test Kits
ELITechGroup MDx LLC (Puteaux, France), a global provider of diagnostic testing products, and its Korean partner, OSANG Healthcare (South Korea), have secured Emergency Use Authorization (EUA) from the FDA for its SARS-CoV-2 virus test for use in the US. The GeneFinder COVID-19 Plus RealAmp Kit provides a fast and easy-to-use diagnostic solution to rapidly identify clusters of infection and has been validated using the ABI 7500 thermocycler and Bio-Rad CFX96 cycler. GenoSensor COVID-19 RT-PCR Kit
GenoSensor Corporation (Tempe, AZ, USA) has received FDA Emergency Use Authorization (EUA) for its GS COVID-19 RT-PCR KIT which provides accurate, reproducible, high-quality results for clinical decision-making for patients with suspected COVID-19 (coronavirus) infection. With its high sensitivity detection (single copy detection) when run according to its instructions for use in a qualified clinical lab, it is one of the most sensitive tests currently available under an FDA EUA.
test and system performance, and ultimately, guarantee laboratory quality assurance.
Quantitative Test for G6PD Status of COVID-19 Patients
MedTest Dx, Inc. (Canton, MI, USA), a solution provider for clinical diagnostic testing, is offering its Pointe Scientific-branded assay for the highly sensitive quantification of G6PD in whole blood. Understanding the G6PD status of COVID-19 patients is essential to prevent severe adverse reactions to Chloroquine and Hydroxychloroquine, increasingly being aimed at tackling the pandemic.
Coronavirus-Detecting Breathing Device
Scentech Medical (Tel Aviv, Israel; www. scent.tech) has developed a coronavirus-detecting breathing device based on the breathalyzer
machine used by the police for detecting alcohol levels in a person’s blood stream. Similarly, academics at Northumbria University (Newcastle, England; www.northumbria.ac.uk) have developed a new device which enables diagnosis of the disease through breath collection. Rockefeller Foundation’s COVID-19 Testing Action Plan for The US
The Rockefeller Foundation (New York, NY, USA) has laid out a National COVID-19 Testing Action Plan which outlines the precise steps necessary to enact robust testing, tracing, and coordination to more safely reopen the US economy – starting with a dramatic expansion of testing from one million tests per week to initially three million per week and then 30 million per week.
Vela Developing Manual and Automated COVID-19 Tests
Vela Diagnostics (Singapore) has been awarded a USD 225,000 contract by the Singapore's Biomedical Advanced Research and Development Authority (BARDA) to develop manual and automated tests to detect SARS-CoV-2. Under the agreement, Vela Diagnostics will perform verification and clinical validation of the ViroKey SARS-CoV-2 RT-PCR Test to be used on automated and manual workflows for Emergency Use Authorization submission to the US Food and Drug Administration. Additionally, Vela has received the CE mark for in vitro diagnostic use for the manual version of its ViroKey SARS-CoV-2 RT-PCR Test which detects SARS-CoV-2 in patients suspected of COVID-19 by their healthcare providers. Randox’s Whole Pathogen Molecular Controls for SARS-CoV-2
Randox Laboratories (Crumlin, UK) has developed whole pathogen quality controls to support accurate coronavirus testing. The molecular controls are currently being used as part of a nationwide testing program for frontline NHS workers. Randox is using these third-party quality controls to ensure accurate coronavirus
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PRODUCT NEWS
CLINICAL CHEMISTRY ANALYZER
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MICROPLATE READER
H. PYLORI TEST
JEOL
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BIOMERICA
The JCA-BM8000 series of clinical chemistry analyzers offers 1,200 TPH per module with connectivity of maximum six modules along with a high throughput, auto rerun and back-up capability.
The ChroMate 4300 is a PC-controlled ELISA microplate reader that measures absorbance of 96 wells in approximately 12 seconds. The open system uses standard microwell plates for all reactions, with automatic positioning.
The Biomerica Helicobacter pylori (H. pylori) test is a lateral flow immunoassay for the rapid determination of the presence (or absence) of Helicobacter pylori antigen in human stool samples.
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COVID-19 Tests Use Molecular Beacons Technology
The molecular beacons technology invented by researchers at Rutgers University (New Brunswick, NJ, USA) will be used in about 50,000 COVID-19 tests produced per day by Abbott (Lake Forest, IL, USA). Abbott’s COVID-19 rapid test, which has received Food and Drug Administration’s emergency use authorization, includes the molecular beacons technology that has been invented and perfected by Rutgers scientists over the last decade. Seegene’s Allplex 2019-nCoV Assay Granted FDA EUA
Seegene, Inc. (Seoul, Korea) has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for its Allplex 2019-nCoV Assay, a Real-time RT-PCR test for SARS-CoV-2. Seegene anticipates that the FDA EUA approval will now enable laboratories in the US to run its test immediately for high-volume testing. COVID-19 Antibody Rapid, Finger Prick POC Test
NovaBay Pharmaceuticals, Inc. (Emeryville, CA, USA) has entered into an agreement with Shenzhen Microprofit Biotech Co., Ltd. (Guangdong, China) to become the exclusive US distributor of a rapid, finger prick test to determine the presence of COVID-19 or a potential indication of antibody immunity to COVID-19. The test uses a drop of blood for the detection of COVID-19 antibodies with results available in approximately 10 minutes. Siemens’ Laboratory-Based SARS-CoV-2 Total Antibody Test
Siemens Healthineers (Erlangen, Germany) has developed a laboratory-based total antibody test to detect the presence of SARS-CoV-2 anti-
bodies in blood. The test, which detects both IgM and IgG, has demonstrated specificity and sensitivity of greater than 99%. Meanwhile, Siemens has registered its molecular Fast Track Diagnostics (FTD) SARS-CoV-2 Assay2 test kit for diagnostic use with the Luxembourg Ministry of Health, allowing for its immediate rollout for diagnostic use in Europe, and has secured Emergency Use Authorization from the US FDA for the test. Enzo Biochem’s Comprehensive COVID-19 Program
Enzo Biochem, Inc. (New York, NY, USA) has launched its Comprehensive COVID-19 Program incorporating its molecular diagnostic virus screening products, detection for immunity through IgG/IgM serological ELISA products, detection of inflammation on Enzo’s ELISA platform, and a promising proprietary drug candidate (SK1-I). ChromaCode High-Throughput HDPCR SARS-CoV-2 Real-Time Assay
ChromaCode, Inc. (Carlsbad, CA, USA) has launched the HDPCR SARS-CoV-2 real-time PCR Assay which is intended to detect severe acute respiratory syndrome coronavirus 2 from nasopharyngeal swab specimens from patients suspected by their healthcare provider of having contracted COVID-19. SD Biosensor Coronavirus PCR Test Receives US EUA
SD Biosensor, INC. (Suwon, Gyungido, Korea) has secured Emergency Use Authorization from the US FDA for its STANDARD M nCoV Real-Time Detection Kit. The kit is used for rapid identification and detection of novel coronavirus (2019-nCoV) nucleic acids in human nasopharyngeal swabs and throat swab samples. CRISPR-Based SARS-CoV-2 Test
In a newly-published study of an assay for detecting SARS-CoV-2 from respiratory swab RNA
extracts in less than 45 minutes, Mammoth Biosciences (San Francisco, CA, USA) has demonstrated how the diagnostic capabilities of CRISPR can be leveraged to offer a faster, lowercost and visual alternative to traditional quantitative polymerase chain reaction (qRT-PCR) assays for diagnosing SARS-CoV-2. 3D-Printed Nasopharyngeal Swabs for COVID-19 Testing
In response to the severe shortage of testing supplies for widespread COVID-19 testing of millions of people, millions of 3D-printed nasal swabs are expected to soon reach health workers. Stratasys, Inc. (Eden Prairie, MN, USA) and Origin (San Francisco, CA, USA) have signed an agreement in which Stratasys will market and promote Origin 3D-printed nasopharyngeal swabs to healthcare providers and other testing centers in the US.
Promising Antibodies for Development of COVID-19 Diagnostic Test
Leinco Technologies, Inc. (St. Louis, MO, USA) has entered into an agreement with Van derbilt University Medical Center (VUMC; Nashville, TN, USA) to scale up production of its most promising antibodies for development of a rapid, point of care COVID-19 diagnostic test. Under the agreement, Leinco will co-develop a rapid, point of care, immunodiagnostic test for the detection of the SARS-CoV-2 virus responsible for COVID-19. This is the type of test that can be mass-produced for use on the front lines. Ortho’s Second COVID-19 Antibody Test With 100% Specificity
Ortho Clinical Diagnostics (Raritan, NJ, USA) has introduced its second COVID-19 antibody test—the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test (COVID-19 IgG antibody test). The test is among only a handful of Cont’d on page 13
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antibody tests to be granted Emergency Use Authorization by the US Food and Drug Administration. Ortho’s COVID-19 total antibody test has also received CE Mark and offers excellent performance, with 100% specificity and sensitivity. Meanwhile, Ortho is working with Quest Diagnostics (Secaucus, NJ, USA) to expand COVID19 antibody testing to more than 20 Quest laboratories across the US. Quest will use Ortho’s VITROS Immunodiagnostic Products Anti-SARSCoV-2 IgG Test to test patients for detectable levels of SARS-CoV-2 antibodies, which are generated by the body in response to infection. ERBA’s CE Marked COVID-19 Antibody ELISA Kits
Erba Mannheim (London, England) has launched its ErbaLisa COVID-19 ELISA kits for detection of IgG and IgM antibodies to SARS-CoV-2. The assays have been designed for use either manually or with any open automated ELISA analyzer, such as the Erba Mannheim ELAN 30s.
testing across the population has led to a race for technology innovations for COVID-19 diagnostics. From the technological perspective, molecular diagnostics (MDx) and lateral flow assays (LAFs) dominate COVID-19 diagnostics. These are the latest findings of IDTechEx (Cambridge, UK), a global market research firm, that have been published in its new report “COVID-19 Diagnostics”.
BioMérieux’s BioFire SARS-CoV-2 Respiratory Panel
BioMérieux’s (Marcy-l’Étoile, France) subsidiary, BioFire Diagnostics, has received Emergency Use Authorization by the US FDA for the BIOFIRE RP2.1 panel, which includes 22 pathogens that cause respiratory infections, including SARS-CoV-2. The inclusion of SARS-
CoV-2 in the BIOFIRE RP2.1 panel allows healthcare providers to quickly identify patients with common respiratory pathogens, as well as those with COVID-19, using one simple test. BioMérieux has also announced performance validation and the upcoming launch of VIDAS anti-SARS-CoV-2 serology tests to detect antibodies in people who have been exposed to the SARS-CoV-2. The VIDAS anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG can identify in less than 30 minutes the presence of antibodies in people who have been infected with SARS-CoV-2. Injection-Molded Nasopharyngeal Swabs For COVID-19
Researchers at the Wyss Institute at Harvard University (Boston, MA, USA) have designed a
DiaSorin’s LIAISON SARS-CoV-2 S1/S2 IgG Test
DiaSorin (Saluggia, Italy) has received Emergency Use Authorization (EUA) from the US Food and Drug Administration for its LIAISON SARS-CoV-2 S1/S2 IgG test. The product is one of the first high-throughput assays based on the CLIA (Chemiluminescent ImmunoAssay) technology to receive EUA in the US. Microproof SARS-CoV-2 Screening/Identification Kits
BIOTECON Diagnostics (Potsdam, Germany) has developed and launched its own microproof SARS-CoV-2 Screening/Identification Kits, which are available immediately for purchase and can be distributed globally. The assays are based on the WHO reference methods, adapted according to the Charité (Berlin, Germany) protocol for the detection of SARS-CoV-2. Seasun’s New COVID-19 Rapid Molecular Assay
Seasun Biomaterials (Seoul, Korea) has released its second COVID-19 assay AQ-TOP COVID-19 Rapid Detection Kit following the completion of FDA EUA (April-27) of the company’s U-TOP COVID-19 Real-Time Detection Kit. The kit targets the ORF1ab gene of the SARSCoV-2 with an endogenous control human RNase P gene and obtained CE-IVD marking in March. MDx and LAFs Dominate COVID-19 Diagnostics
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PRODUCT NEWS
QA CHECK SET/CHECK STRIPS
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POC DIAGNOSIS SYSTEM
EBOLA TEST
AWARENESS TECHNOLOGY
BIOSENSIA
VEDA LAB
Redi-Check® verifies calibration, linearity and repeatability of filter photometers (aspirating and tube reading). Dri-Dye® monitors calibration, linearity and repeatability of microwell strip and microwell plate readers.
The RapiPlex is a point-of-care diagnosis system capable of producing quantitative and qualitative laboratory quality test results, comprised of a disposable assay cartridge and a small table top instrument.
The Ebola eZYSCREEN® is a rapid test for detection of Ebola virus (ZAIRE strain), allowing diagnosis of the disease within 15 minutes, using a few drops of serum/plasma or whole blood samples, and shows excellent specificity.
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new, fully injection-molded nasopharyngeal swab that can be manufactured quickly and inexpensively at high volume to help address the shortage of swabs for COVID-19 testing and research.
NIH’s RADx Initiative for COVID-19 Testing
The National Institutes of Health (NIH; Bethesda, MD, USA) has announced a new initiative aimed at speeding innovation, development and commercialization of COVID-19 testing technologies. With an investment of USD 1.5 billion from federal stimulus funding, the newly launched Rapid Acceleration of Diagnostics (RADx) initiative will infuse funding into early innovative technologies to speed development of rapid and widely accessible COVID19 testing. New COVID-19 Test with 30X Higher Throughput
A highly accurate and cost-effective novel COVID-19 test protocol has the potential for unlocking more than one million testing capacity per day in the US alone. Using the patentpending qSanger spike-in and proprietary machine learning algorithms, Billiontoone, Inc.’s (Palo Alto, CA, USA) COVID-19 assay takes advantage of the 30X higher throughput Sanger sequencing capacity (1,536 samples on qSanger at a time vs. 48 samples on qPCR at a time).
Altona SARS-CoV-2 RT-PCR Kit
Altona Diagnostics GmbH (Hamburg, Germany) has received Emergency Use Authorization (EUA) from the US FDA for its RealStar SARS-CoV-2 RT-PCR Kit US. The RT-PCR based molecular diagnostic test can be used under the EUA by authorized US laboratories for in vitro qualitative detection of SARS-CoV-2 RNA in upper respiratory samples from individuals, who are suspected of COVID-19.
Rheonix Fully Automated Molecular COVID-19 Test
Rheonix Inc. (Ithaca, NY, USA) has received Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) for the fully automated Rheonix COVID-19TM MDx Assay which enables detection of SARS-CoV-2 directly from respiratory samples. The assay is processed on the fully automated Rheonix Encompass MDx workstation using proprietary Rheonix Encompass CARD cartridge technology. Mass Spectrometry helps Develop Coronavirus Antigen Test
Avacta Group plc (Wetherby, England) has entered into a collaboration with Adeptrix (Beverly, MA, USA) to develop a high throughput COVID-19 antigen test using Adeptrix’s proprietary bead-assisted mass spectrometry (BAMS) platform. Both the companies will collaborate to develop and manufacture an Affimer-based BAMS coronavirus antigen test that will provide clinicians with a significant expansion of the available testing capacity for COVID-19 infection in hospitals. Aalto Bio’s Lysis Buffer Reagent for COVID-19 Testing
Aalto Bio Reagents Ltd. (Dublin, Ireland), a supplier of critical raw materials and reagents for diagnostic tests, has launched its first RNA Lysis buffer reagent for the pre-treatment of COVID 19 samples prior to testing. This essential RNA Lysis buffer was produced by Aalto Bio due to the unavailability of similar reagents from other manufacturers in Europe. Bio-Rad’s First Total COVID Antibody Test to Secure FDA EUA
Bio-Rad Laboratories, Inc. (Hercules, CA, USA) has been granted US FDA’s Emergency Use Authorization for the company’s SARS-CoV2 Total Ab test, making it the first total antibody
test to secure Emergency Use Authorization (EUA) from the FDA. The blood-based immunoassay test can help clinicians identify if an individual has developed antibodies against SARS-CoV-2 and has also met the CE mark requirements for Europe. Bio-Rad’s SARS-CoV-2 Droplet Digital PCR (ddPCR) test kit which runs on its QX200 and QXDx ddPCR systems has also been granted EUA by the FDA. Hologic’s Second High-Throughput Molecular Assay For Coronavirus
Hologic, Inc. (Marlborough, MA, USA) has launched a new Aptima molecular assay to detect the SARS-CoV-2 virus that can be used by labs for clinical testing on the company’s Panther system after completing performance verification testing. The Panther system is a fully automated, high-throughput molecular diagnostic platform which can provide initial results in approximately three hours and process more than 1,000 coronavirus tests in a 24hour period. Quotient SARS-CoV-2 Antibody Microarray Receives CE Mark
Quotient Limited (Eysins, Switzerland) has completed the process for declaring conformity to the essential requirements of the In Vitro Diagnostics Directive (IVDD 98/79/EC) and has CE marked its SARS-CoV-2 (COVID-19) antibody microarray. The company’s MosaiQ COVID-19 Antibody Microarray is designed as a serological disease screen specific to COVID-19.
Antibody Tests Can Complement PCR Diagnostics
A project by the UC San Francisco (San Francisco, CA, USA) and UC Berkeley (Berkeley, CA, USA) will evaluate some of the more than 120 available COVID-19 antibody test kits, out of which only a handful have received Emergency
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Use Authorization from the Food and Drug Administration. The project aims to provide the test performance data needed by doctors and public health officials to decide which tests to employ and provide an understanding of how reliable the results are. PerkinElmer Secures FDA EUA for EUROIMMUN’s Anti-SARS-CoV-2 ELISA Serology Test
PerkinElmer, Inc. (Waltham, MA; USA) has secured Emergency Use Authorization (EUA) from the US FDA for Euroimmun’s (a PerkinElmer company) Anti-SARS-CoV-2 ELISA (IgG) serology test. The test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
its Anti-SARS-CoV-2 Rapid Test. The immunoassay intended specifically for determining the possibility of a COVID-19 infection was developed by Autobio Diagnostics Co., Ltd. (Zhengzhou, Henan, China), which has appointed Hardy Diagnostics as the US supplier of the new test.
Biomerica’s High-Volume Production Version of COVID-19 IgG/IgM Rapid Test
Biomerica Inc. (Irvine, CA, USA) has received a CE mark and launched a new highvolume production version of its COVID-19 IgG/IgM Rapid Test in countries outside the US. The new high-volume version of the test uses the same technology as the cassette ver-
sion which has been well accepted in Europe and other countries in terms of performance.
Eurofins’ CE-IVD Marked Multiplex Real-Time PCR assay for SARS-CoV-2 Detection
Eurofins Technologies (Budapest, Hungary) has launched its CE-IVD marked multiplex Real-Time RT-PCR (reverse-transcriptase polymerase chain reaction) assay for the direct qualitative pathogen detection of the novel coronavirus (SARS-CoV-2). The launch of Eurofins’ new GSD NovaPrime SARS-CoV-2 (COVID-19) Real-Time PCR follows the commercialization of CE-IVD marked serology-based antibody detection ELISA kits that were successfully launched in April 2020.
PlexBio PCR-based Coronavirus Detection Kit
PlexBio Co., Ltd. (Taipei, Taiwan) has received the CE mark for its IntelliPlex SARS-CoV-2 Detection Kit which is now available in European countries. PlexBio’s PCR-based test detects SARSCoV-2 in nasopharyngeal swab specimens from patients who may or may not exhibit symptoms of COVID-19. The test runs on the company’s IntelliPlex platform for multiplex assays and can process up to 564 samples within eight hours.
FDA’s Revised Policy for COVID-19 Antibody Tests
The US FDA (Silver Spring, MD, USA) has updated its policy on antibody tests for COVID-19 from March 16, 2020, tightening the requirements for such tests. Under the revised policy, the FDA now requires commercial manufacturers of antibody tests to submit emergency use authorization requests, with their validation data, within 10 business days from the date they notified the FDA of their validation testing OR from the date of this policy, whichever is later. Furthermore, the FDA has provided specific performance threshold recommendations for specificity and sensitivity for all serology test developers. Additionally, the FDA now requires molecular diagnostic developers to use actual positive specimens as part of its validation process for granting EUA to COVID-19 tests. Hardy Diagnostics COVID-19 Antibody Test
Hardy Diagnostics (Santa Maria, CA, USA) has been granted Emergency Use Authorization by the US FDA for
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PRODUCT NEWS
MOLECULAR DIAGNOSTIC SYSTEM CDG BIOTECH
The GeneXpert Xpress fully integrated molecular diagnostic system offers standardized molecular testing for any healthcare setting, front-line access and control, with a single system storing 20,000+ test results. LINkXPReSS COM
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To receive prompt and free information on products, log on to www.LinkXpress.com or fill out reader service form located on last page, or scan the QR code on your mobile device
CLINICAL CHEMISTRY ANALYZER
REAL-TIME RT-PCR COVID-19 TEST
DIAZYME LABORATORIES
LINEAR CHEMICALS
The DZ-Lite c270 is a fully automated, benchtop clinical chemistry analyzer with a throughput of up to 270 tests/hour. It is compact, with a userfriendly interface, and supports both 1 & 2-reagent and 3 & 4-reagent assays.
The Virella SARS-CoV-2 seqc real-time RT-PCR kit is intended for the simultaneous detection of RNA of the novel coronavirus (SARS-CoV-2) and the RNA of the Subgenus Sarbecoviruses with the results delivered in 75 minutes.
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IDEXX OPTI SARS-CoV-2 RNA PCR Test Kit
IDEXX Laboratories, Inc.’s (Westbrook, ME, USA) subsidiary, OPTI Medical Systems, Inc. (Roswell, GA, USA), has been granted Emergency Use Authorization by the US FDA for its OPTI SARS-CoV-2 RT-PCR laboratory test kit for the detection of SARS-CoV-2. The test is designed for the detection of SARS-CoV-2 RNA extracted from nasopharyngeal swabs, oropharyngeal swabs, bronchoalveolar lavage and sputum samples. Sherlock CRISPR SARS-CoV-2 Kit
Sherlock Biosciences (Cambridge, MA, USA) has received Emergency Use Authorization from the US FDA for its Sherlock CRISPR SARS-CoV-2 kit for the detection of the virus that causes COVID-19, providing results in approximately one hour. The Sherlock CRISPR SARS-CoV-2 test kit is designed for use in CLIA-certified laboratories to perform high complexity tests. Quidel’s First COVID-19 Antigen Test to Secure FDA EUA Quidel Corporation’s (San Diego, CA, USA) Sofia 2 SARS Antigen FIA has become the first COVID-19 antigen test to be granted Emergency Use Authorization by the US FDA. Quidel’s Sofia 2 SARS Antigen FIA is a rapid point-of-care test to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid detection of SARS-CoV-2 in nasal or nasopharyngeal specimens from patients meeting CDC criteria for suspected COVID-19 infection. Abbott’s SARS-CoV-2 Antibody Blood Test
Researchers have found Abbott’s (Lake Forest, IL, USA) SARS-CoV-2 IgG lab-based serology blood test had 99.9% specificity and 100% sen-
sitivity for detecting the IgG antibody in patients 17 days or more after symptoms began. Abbott has significantly scaled up its manufacturing and has already shipped more than 10 million antibody tests for its ARCHITECT platform to hospital systems and reference labs in all 50 states in the US and around the world. Meanwhile, Abbott has secured the US FDA’s Emergency Use Authorization (EUA) for its SARS-CoV-2 IgG lab-based serology blood test on the Alinity i system. Abbott has also secured EUA from the FDA for the company’s molecular test for the novel coronavirus (COVID-19) for use on its new Alinity m molecular laboratory instrument.
Johns Hopkins’ New COVID-19 Testing Insights Initiative
Johns Hopkins University (Baltimore, MD, USA) has launched the COVID-19 Testing Insights Initiative, a one-stop resource hub that fills the void of publicly-available information about COVID-19 testing data and offers critical insights, resources, and expert analysis about COVID-19 testing in the US. Through dynamic, continuously updated data visualizations, the Testing Insights Initiative offers a new, intuitive way to view and understand key data and insights to inform public policies and responses to the pandemic.
1drop’s 1copy COVID-19 qPCR Multi Kit
1drop Inc. (Gyeonggi-do, Korea) has secured emergency use authorization from the US FDA for its 1copy COVID-19 qPCR Multi Kit which allows for the qualitative detection of SARSCoV-2 by amplification of two target genes (E gene and RdRp gene) of the virus. The test uses real-time qPCR (including reverse-transcription reaction) via RNA extracted from clinical specimens (nasopharyngeal swabs or oropharyngeal swabs) of suspected respiratory infectious disease patients.
Thermo Fisher SARS‑CoV‑2 Multiplex Real-Time PCR Test
Thermo Fisher Scientific Inc. (Waltham, MA, USA) has announced that the US FDA has further expanded emergency use authorization (EUA) for its multiplex real-time PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2. The test, which was initially granted EUA on March 13 and subsequently expanded on April 20, is designed to deliver test results within four hours of a sample being received and processed by a CLIA high-complexity laboratory. Additionally, Thermo Fisher will be developing a total antibodies test in collaboration with Wuxi Diagnostics (Shanghai, China) and Mayo Clinic (Rochester, NY, USA). The new Thermo Scientific OmniPath COVID-19 Total Antibody ELISA test is the result of ongoing collaboration between the three organizations. New One Minute Coronavirus Test
Israeli researchers have developed and are now validating a test that identifies carriers of the COVID-19 virus in less than a minute with greater than 90% accuracy and at a dramatically lower price than any other method available. The test, developed by Ben-Gurion University of the Negev (Beer-Sheva, Israel), uses a chip with a dense array of metamaterial sensors that was designed specifically for this purpose. New Purpose-Built COVID-19 LIMS Solution
A new purpose-built COVID-19 laboratory information management system (LIMS) solution can jump-start the ability of laboratories everywhere to enter biospecimens into a biobank and rapidly begin conducting COVID-19-related testing and research. The new COVID-19 Biobanking Accelerator is built on the LabVantage Solutions, Inc.’s (Somerset, NJ, USA) industry-leading LIMS and Biobanking platforms used by clinical laboratories around the globe. LabMedica International May/2020
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Hemophilia B Gene Increases Risk for Postpartum Bleeding
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regnancy influences the levels of blood clotting factors. In healthy women, the activity of factor VIII (FVIII), the missing coagulation factor in hemophilia A, more than doubles in the third trimester and drops back to normal levels within days following delivery. Conversely, factor IX (FIX) activity, the clotting factor defective in hemophilia B, increases slightly or remains the same during normal pregnancy biomarker testing. In female carriers of hemophilia A, who have a deficiency in FVIII, the activity of this clotting factor can also increase significantly during pregnancy and reach normal levels in most cases. For hemophilia B carriers, however, FIX levels do not rise significantly and remain low during pregnancy. Although most carriers have normal pregnancies without any bleeding complications, factor levels should be tested in the third trimester of pregnancy when they are at their highest. Hematologists at Sahlgrenska University Hospital (Gothenburg, Sweden; www.sahlgrenskaic.com) and their colleagues wanted to determine the risk of bleeding among pregnant hemophilia A and B carriers under routine clinical practice in Sweden. They also wanted to evaluate the rate of maternal and neonatal complications. They retrospectively analyzed data from 298 pregnancies in 153 hemophilia A carriers, and 51 pregnancies in 27 hemophilia B carriers, between 1987 and 2013, collected from the Swedish Medical Birth Register and the countryâ&#x20AC;&#x2122;s National Patient Register. The control group consisted of 3,494 pregnancies. The scientists looked at several maternal and neonatal characteristics, including the risk of bleeding after delivery or postpartum hemorrhage (PPH). In Sweden, the more recent definition of PPH is blood loss of more than 1,000 mL following vaginal delivery or cesarean delivery. A previous guideline defined PPH as blood loss of more than 600 mL for vaginal births. The team found that the risk of bleeding was more than three times higher in hemophilia B carriers than in non-carriers, but the risk for having other pregnancy complications, such as preeclampsia, was similar in all groups. PPH occurred in 7.4% of the hemophilia A carriers, 21.6% of the hemophilia B carriers, and 6.6% of the control group. Additional results indicated that the incidence of pregnancy or neonatal complications was similar in carriers of hemophilia A or B compared with noncarriers. These complications included preeclampsia (3.0% in the hemophilia A group, 2.0% in the hemophilia B
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group, and 2.5% in the non-carrier group), preterm birth (gestational age of 32 to 37 weeks; 6.0%, 2.0%, and 5.4%), low birth weight (1,500 to 2,500 grams; 3.7%, 2.0%, and 3.2%) or low Apgar score (a measure of a newbornâ&#x20AC;&#x2122;s state of health; 1.0%, 0.0%, and 0.9%). The authors concluded that the lack of increase in FIX activity, in contrast to FVIII activity, during pregnancy is likely to have contributed to this main finding, since hemophilia carriers typically have prepregnancy FVIII and FIX activities at about 50% of those in non-carrier women. There is an increased risk of PPH in unselected hemophilia B-carrier deliveries. The absence of increased FIX activity, but not FVIII activity, during pregnancy is likely to have influ-
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enced the results. The study was published on November 19, 2019 in the journal Haemophilia. Image: An assay kit for the determination of Factor IX activity in plasma and Factor IX preparations, including potency assignment of FIX concentrates. The lack of increase in FIX activity, in contrast to FVIII activity, during pregnancy is likely to have contributed postpartum hemorrhage (Photo courtesy of Cryopep)
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THERMAL CYCLER
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The GBA-1000 is a compact, automatic chemistry analyzer that has a throughput of up to 100 tests per hour and uses whole blood/serum/plasma/urine samples. It features a built-in PC, auto reagent ID & level detection.
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The COVID-19 IgG/IgM Detection Kit (Colloidal Gold) requires one sample drop of blood, serum or plasma to deliver results in 10 minutes. The test card contains novel coronavirus antigen and colloidal gold labeled antibody.
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Three Factors Distinguish MODy, a Rare Diabetes, in youth
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dentifying maturity-onset diabetes of the young (MODY) in pediatric populations close to diabetes diagnosis is difficult. Misdiagnosis and unnecessary insulin treatment are common. MODY is a monogenic, dominantly inherited form of diabetes that typically arises in adolescence or young adulthood, and accounts for 1%-4% of cases of pediatric diabetes. Among youth newly diagnosed with diabetes, a simple clinical approach, looking for moderate hyperglycemia (HbA1c less than 7.5%), asking about parental history of diabetes, and checking for autoantibodies associated with type 1 diabetes, should help determine whether young people need to be genetically screened for maturity-onset diabetes of the young (MODY). Scientists from the Skåne University Hospital (Malmo, Sweden; https://vard.skane.se) and their colleagues recruited 3,933 Swedish patients aged 1–18 years, diagnosed with diabetes May 2005 to December 2010 from the national consecutive prospective cohort Better Diabetes Diagnosis. Clinical data, islet autoantibodies (GAD antibody, insulinoma antigen2A, zinc transporter 8A, and Insulin autoantibodies [IAA]), HLA type, and C-peptide were collected at diagnosis. MODY was identified by
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sequencing GCK, HNF1A, and HNF4A, either through routine clinical or research testing. The authors reported that overall, 88% (3,471) were positive for at least one of the four autoantibodies. On sequencing, none of those individuals were found to carry the MODY genes, GCK, HNF1A, or HNF4A, via routine clinical or research testing. When 303 of the autoantibody-negative patients were genetically tested, 15% (46) had MODY, resulting in a minimal prevalence of 1.2%. The others had either antibody-negative type 1 diabetes, type 2 diabetes, or other types, such as cystic fibrosis-related diabetes. Limiting testing to the 73 islet autoantibody-negative patients with HbA1c less than 7.5% (58 mmol/mol) at diagnosis identified 36 out of 46 (78%) patients with MODY (detection rate 49%). On follow-up, the 46 patients with MODY had excellent glycemic control, with an HbA1c of 6.4% (47 mmol/mol), with 42 out of 46 (91%) patients not on insulin treatment. In an adjusted analysis, only plasma glucose and parental history of diabetes remained significant predictors of MODY. The authors concluded that at diagnosis of pediatric diabetes, absence of all islet autoantibodies and modest hyperglycemia (HbA1c <7.5% [58 mmol/mol]) should result in testing
Image: HbA1c Advanced Clinical Chemistry Diabetes Assay: to diagnose maturity-onset diabetes of the young (MODY), screening for at least three autoantibodies and HbA1c testing should takes place in all youth at the time of diabetes diagnosis (Photo courtesy of Beckman Coulter)
siemens-healthineers.com). The scientists reported that a total of 303 samples from 124 patients were analyzed and there was excellent correlation was seen between HCV-cAg and HCV-RNA. The optimal cut-off value was 3 fmol/L in the receiver operating characteristics curve analysis, and the area under the curve was 0.987 (95% confidence interval 0.972–1.000). HCV-cAg sensitivity and specificity were 97% and 95%, respectively. Most diverging results
were observed in the treatment follow-up group. The authors concluded that the hepatitis C virus core antigen demonstrated good sensitivity and specificity as a marker for the detection of active HCV infection in the diagnosis of new cases, for the detection of antiviral therapeutic failures, and for monitoring of the antiviral treatment. The study was published in the December, 2019 issue of the International Journal of Infectious Diseases.
for GCK, HNF1A, and HNF4A MODY. Testing all 12% patients negative for four islet autoantibodies is an effective strategy for not missing MODY, but will result in a lower detection rate and identifying MODY results in excellent long-term glycemic control without insulin. The study was published on November 8, 2019 in the journal Diabetes Care.
Diagnosis and Monitoring of Patients with Hepatitis C Virus
fmol/L. For the detection of anti-HCV antibodies, the Architect (Architect HCV anti-Ab) and Liaison (DiaSorin, Saluggia, Italy; www.diasorin.com systems were used, and/or confirmed with INNO-LIA (Innogenetics, Fujirebio, Gent, Belgium; www.fujirebio.com). Viral genotype and subtype data were determined by reverse hybridization assay Versant HCV Genotype 2.0 (LiPA; Siemens Healthcare Diagnostics, Tarrytown, NY, USA; www.
LabMedica International May/2020
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Mycobacterium Infection Found in Gastric Patientsâ&#x20AC;&#x2122; Stomachs
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LabMedica International
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evelopment of gastric diseases such as gastritis, peptic ulcer and gastric cancer is often associated with several biotic and abiotic factors. Helicobacter pylori infection is such a well-known biotic factor. However, not all H. pylori-infected individuals develop gastric diseases and not all individuals with gastric diseases are infected with H. pylori. H. pylori is not the only bacterium that can colonize human stomach. Culture independent metagenomic sequence analyses have shown that human stomach carries a unique microbiota. The dominant phyla that are present in human stomach are Proteobacteria, Firmicutes, Actinobacteria and Fusobacterium. Interestingly, however, most of these bacteria cannot be cultured using traditional techniques. Microbiologists at the Rajiv Gandhi Centre for Biotechnology (Thiruvananthapuram, India; https://rgcb.res.in) recruited patients aged between 20 and 70 with various gastric and esophageal symptoms ranging from mild dyspepsia, gastro-esophageal reflux disorder to severe gastric diseases like gastric cancer and who were recommended to have upper gastrointestinal endoscopy. Three gastric biopsy specimens were collected from each patient for this study. The aim of this study was to isolate prevalent gastric bacteria under microaerobic condition and identify them by 16S rRNA gene sequence analysis. The team employed various technologies including gastric bacteria culture, bacterial DNA isolation, extraction of intracellular bacterial DNA from biopsy tissues, molecular characterization of the bacteria isolated from stomach. The purified DNA fragments were sequenced by a 3730XL DNA analyzer (Thermo Fisher Scientific, Waltham, Massachusetts, USA; www. thermofisher.com). The team also performed Hematoxylin and Eosin (H&E) and Ziehl-Neelsen Acid-fast staining on tissue biopsies, and immunohistochemistry. Analysis of gastric biopsies showed infection of Mycobacterium abscessus (phylum Actinobacteria) to be highly prevalent in the stomachs of subjects included. The data showed that of 129 (67 male and 62 female) patients with gastric symptoms, 96 (51 male and 45 female) showed the presence of M. abscessus in stomach tissues. Infection of M. abscessus in gastric epithelium was further confirmed by imaging with acid fast staining, immunohistochemistry and immunofluorescence. Surprisingly, the subjects studied, the prevalence of M. abscessus infection in stomach is even higher than the prevalence of H. pylori infection. The authors concluded that their study on 129 individuals with gastric diseases shows that the prevalence of gastric M. abscessus is higher in the local population as compared to the
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prevalence of H. pylori. The route of transmission is not known at present, but water could be a source. Significance of this infection is also presently unknown, but it may have a significant role in the formation or progression of gastric disease. The study was published on November 4, 2019 in the journal PLOS Neglected Tropical Diseases. Image: Growth characteristics of rough and smooth phenotypes of Mycobacterium abscessus on 7H11 agar cultured at 37 °C: representative single rough (left) and smooth (right) colonies (Photo courtesy of Hannover Medical School)
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The Haemoatokrit 200 tabletop centrifuge from Hettich delivers high-performance hematocrit centrifugation and can hold up to 24 capillaries per run and achieves best results within seven minutes.
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The QuantGene 9600 real-time PCR features thermoelectric refrigeration technology, with a brand-new light source and light path design, and unique constant current power and six-zone independent temperature control method.
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Circulating Progenitor Cell Traffic Reflects Blood Vessel Repair
dentifying patients with otherwise stable coronary artery disease (CAD) who are high-risk and would benefit from more intense or invasive interventions is currently a major theme in cardiology studies. In healthy people, physical exercise causes the cells to leave the bone marrow and enter the blood, because their job is repairing blood vessels. In people with coronary artery disease whose arteries are narrowed enough so that they develop ischemia (restriction of blood flow); more of the cells are diverted to the heart to repair the damage. Medical Scientists from the Emory University School of Medicine (Atlanta, GA, USA; www.med.emory.edu) carried out a prospective cohort study included a population-based sample of 454 patients with stable CAD who were recruited between June 1, 2011, and August 15, 2014, and followed up for three years. Data were analyzed from September
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15, 2018, to October 15, 2018. The patients were divided into two groups, based on whether circulating progenitor cells (CPC) counts increased or decreased during a treadmill exercise test. Circulating progenitor cells were enumerated with flow cytometry as CD34-expressing mononuclear cells (CD45med/CD34+), with additional quantification of subsets co-expressing the chemokine (C-X-C motif) receptor 4 (CD34+/CXCR4+). The team reported that of the 454 patients (mean age ± SD, 63±9 years; 76% men) with stable CAD enrolled in the study, 142 (31.3%) had stress-induced ischemia and 312 (68.7%) did not, as measured by single-photon emission computed tomography. During stress testing, patients with stress-induced ischemia had a mean decrease of 20.2% (interquartile range [IQR], −45.3 to 5.5) in their CD34+/CXCR4+ counts, and patients without stress-induced ischemia had a mean in-
crease of 3.2% (IQR, −20.6 to 35.1) in their CD34+/CXCR4+ counts. Twenty-four patients (5.2%) experienced adverse events. Kasra Moazzami, MD, MPH, a cardiologist, and the first author of the study said, “A fall in CPC count after exercise appears to be an independent determinant of high risk in patients with stable coronary artery disease, even after adjusting for known clinical risk factors. The information gained from the changes in CPC counts during exercise may be more useful to cardiologists in risk stratifying these patients than the treadmill exercise test itself.” The authors concluded that patients with CAD, a decrease in CPC counts during exercise is associated with a worse disease prognosis compared with the presence of stressinduced myocardial ischemia. The study was published on December 4, 2019 in the journal JAMA Cardiology.
cardiac complications after surgery. The study included 10,402 patients aged 45 years or older having non-cardiac surgery with overnight stay from 16 hospitals in nine countries. The team determined whether preoperative NT-proBNP has additional predictive value beyond a clinical risk score for the composite of vascular death and myocardial injury after noncardiac surgery (MINS) within 30 days after surgery. All patients had NT-proBNP levels measured before surgery and troponin T levels measured daily for up to three days after surgery. The investigators reported that in multivariable analyses, compared with preoperative NTproBNP values less than 100 pg/mL (the reference group), those of 100 to less than 200 pg/mL, 200 to less than 1,500 pg/mL, and 1,500 pg/mL or greater were associated with adjusted hazard ratios of 2.27, 3.63, and 5.82 and corresponding incidences of the primary
outcome of 12.3% (226/1,843), 20.8% (542/2,608), and 37.5% (223/595), respectively. Adding NT-proBNP thresholds to clinical stratification resulted in a net absolute reclassification improvement of 258 per 1,000 patients. Preoperative NT-proBNP values were also statistically significantly associated with 30day all-cause mortality. Emmanuelle Duceppe, MD, an internist and first author of the study, said, “This simple blood test can be done quickly and easily as part of patient's pre-operative evaluation and can help patients better understand their risk of post-operative complications and make informed decisions about their surgery. This blood test is twenty times cheaper than more timeconsuming tests such as cardiac stress tests and diagnostic imaging.” The study was published on December 24, 2019 in the journal Annals of Internal Medicine.
Cardiac Blood Test Predicts Post-Surgical Outcomes
Results of a simple blood test may inform the type of surgery the patient will undergo, such as laparoscopic or open surgery, the type of anesthesia used during surgery and who will require more intense monitoring post-operatively. Blood test results can also reduce the need for pre-surgical medical consultations for patients that show no risk for cardiac complications. A large international team of medical scientists led by those at McMaster University (Hamilton, ON, Canada; www.mcmaster.ca) looked at whether levels of a cardiac blood test, N-Terminal Pro–B-Type Natriuretic Peptide (NT-proBNP), measured before surgery can predict cardiac and vascular complications. Higher levels of NT-proBNP, which can be caused by various anomalies in the cardiac muscle, such as stress, inflammation or overstretch, can help identify which patients are at greatest risk of
LabMedica International May/2020
20
Novel Biotech-Based Assay for Detection of Fluoride
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LabMedica International
A
simple, yet sophisticated biotech-based assay for the detection of fluoride levels was successfully tested in the laboratory and in the field. Around one-third of the human population drinks water from groundwater resources. Of this, about 10%, approximately three hundred million people, obtain water from groundwater resources that are heavily contaminated with arsenic or fluoride. When consumed in high amounts over long periods of time, fluoride can cause skeletal fluorosis, a painful condition that hardens bones and joints. Current laboratory methods to measure fluoride levels in groundwater are expensive and time consuming and may not be available in developing countries. Investigators at Northwestern University (Evanston, IL, USA; www.northwestern.edu) suggest replacing this methodology with a rapid, easy-to-use, inexpensive biotech-based assay. This assay comprises a biosensor consisting of a cell-free system containing a DNA template that encodes a fluoride-responsive riboswitch, which regulates genes that produce a fluorescent or colorimetric output. A riboswitch is a regulatory segment of a messenger RNA molecule that binds a small molecule, resulting in a change in production of the proteins encoded by the mRNA. Thus, an mRNA that contains a riboswitch is directly involved in regulating its own activity, in response to the concentrations of its effector molecule. In the current assay system, the presence of fluoride causes the RNA to produce a protein enzyme that makes a yellow pigment that is readily visible to the naked eye. Senior author Dr. Julius Lucks, associate professor of chemical and biological engineering at Northwestern University, said, "RNA folds into a little pocket and waits for a fluoride ion. The ion can fit perfectly into that pocket. If the ion shows up, then RNA expresses a gene that turns the water yellow. If the ion does not show up, then RNA changes shape and stops the process. It is literally a switch." Reagents for individualized tests may be lyophilized for long-term storage. Following reconstitution with 20 microliters of liquid sample and incubation at room temperature for two hours, the test could detect fluoride at levels above two parts per million, the [U.S.] Environmental Protection Agency’s most stringent regulatory standard, in both laboratory and field conditions. The prototype assay was successfully tested in Costa Rica, where the Irazu volcano causes heavy contamination of the groundwater with fluoride. "In the United States, we hear about fluoride all the time because it is in toothpaste and the municipal water supply," said Dr. Lucks. "It makes calcium fluoride, which is very hard, so it strengthens our tooth enamel. But above a certain level, fluoride also hardens joints. This mostly is not an issue in the United States. But it can be a debilitating problem in other countries if not identified and addressed. Every test on these field samples worked. It is exciting that it works in the lab, but it is much more impor-
tant to know that it works in the field. We want it to be an easy, practical solution for people who have the greatest need. Our goal is to empower individuals to monitor the presence of fluoride in their own water." The fluoride detection test was described in the December 13, 2019, online edition of the journal ACS Synthetic Biology. Image: The test tube on the left shows a real positive result from water sampled in Costa Rica. The middle tube is a negative control. The tube on the right is a positive control (Photo courtesy of Dr. Julius B. Lucks, Northwestern University)
High Performance of Rapid Influenza Diagnostic Test Validated
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nfluenza is a leading infectious cause of morbidity and mortality worldwide. Annually, about 5% to 10% of adults and 20% to 30% of children have symptoms of influenza-like illness (ILI), and approximately 650,000 deaths secondary to influenza occur each epidemic season. Timely diagnosis and early antiviral therapy are crucial to counteract influenza spread. However, current diagnostic tools such as the real-time polymerase chain reaction (RT-PCR) are expensive and time-consuming. Some rapid influenza diagnostic tests (RIDTs) are also used to rapidly support treatment decision during influenza outbreaks. Nonetheless, RIDTs’ performance varies according to the prevalence of different influenza virus strains and the method used to determine their results. A large group of scientists working with the National Institute of
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DIASYS DIAGNOSTIC SYSTEMS
The MASTER T semi-automatic clinical chemistry analyzer performs endpoint, kinetic, fixed time, multistandard, dichromatic assays using an open system for user-defined programs.
The VISION Pro automatic ESR analyzer uses primary EDTA tubes, delivering results in 20 minutes. It offers unique real time ESR curve display and temperature-corrected ESR results, with excellent Westergren correlation.
The responsÂŽ5H is a 5 part differential hematology analyzer with a throughput of 60 tests/hour and requires only one drop of blood sample. Its reagent consumption is approximately 70% less than most other analyzers.
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Autoimmunity Markers Prevalence Assessed in Immune Thrombocytopenia
mmune thrombocytopenia (ITP) is an acquired autoimmune disorder resulting from decreased platelet production and increased platelet destruction. Platelet autoantibodies in ITP lead to both acceleration of platelet destruction in the spleen and inhibition of platelet production by bone marrow megakaryocytes. Although current guidelines recommend against routine testing of patients with ITP for autoimmune markers in the absence of disease-specific symptoms, there is general recognition that they frequently have autoantibodies associated with other autoimmune disorders in the absence of any clinical evidence of these disorders. A number of studies have suggested that patients with ITP have a higher prevalence than the general population of positive autoimmune markers, including (ANA), rheumatoid factor (RF), anticardiolipin antibodies (ACL) immunoglobulin G (IgG) and immunoglobulin G (IgM), red blood cell direct antiglobulin test (DAT), antithyroid peroxidase antibodies (antiThyPeroxAb), and lupus anticoagulant (LAC). Hematologists at Massachusetts General Hospital (Boston, MA, USA; www.mgh.harvard.edu)
and their colleague performed retrospective review of patients with ITP presenting to their center from 1 January 1992 to 1 December 2015. ANA assays were performed by indirect immunofluorescence assay, using Hep-2 cells (Zeus Scientific, Inc, Branchburg, NJ, USA; www. zeusscientific.com). ThyPeroxAb assays were performed at Quest Diagnostics (Secaucus, NJ, USA; https://questforhealthsystems.com) using an immunoassay method. RF markers were measured with an immunoturbidimetric assay on a cobas c 502 platform (Roche, Basel, Switzerland; www.roche.com). Positive results for ACL were defined as >15 for IgG phospholipid units or IgM phospholipid (MPL) units. Glycoprotein-specific direct platelet autoantibody testing was performed with the PakAuto assay (Immucor, Brookfield, WI, USA; www.immucor.com). The scientists reported that there was a high rate of autoimmune marker positivity in this population, with antinuclear antibody (65%), antithyroid peroxidase antibody (31%), and direct antiglobulin (29%) the most commonly found. Antithyroid peroxidase antibody positivity was associated with a lower probability of remission (odds ratio [OR], 0.26). Lupus anticoagulant pos-
Image: The cobas c 502 is a medium throughput clinical chemistry module that performs photometric assay tests for a wide range of analytes (Photo courtesy of Roche).
engue fever (DF) is currently one of the most severe public health problems. Each year, an estimated 390 million dengue infections occur around the world. Clinical presentations of dengue are diverse and non-specific, often with unpredictable clinical progression and outcome. Severe dengue is a leading cause of serious illness and death among children and adults in some Asian and Latin American countries. It requires management by medical professionals in hospitals. Hepatic dysfunction and abnormal coagulation factors are common in
acute dengue illness, reflected by abnormal alanine aminotransferase (AST), aspartate aminotransferase (ALT), activated partial thromboplastin time (aPTT), and platelet counts. Medical scientists at National Cheng Kung University (Tainan, Taiwan; www.ncku.edu. tw) performed a retrospective study using 20,213 laboratory test results from 4,069 patients who were diagnosed with DF at NCKUH, a major tertiary hospital in Tainan city, between January and December 2015. Only those dengue patients who had at least one of
the laboratory diagnosis criteria were included. Serum from patients with suspected dengue infection was determined using the one-step immunochromatographic Dengue Duo Dengue NS1 Ag + Ab Combo assay (SD Bioline, Yongin, Korea; www.alere.com). Hepatic markers were determined using a biochemical assay analyzer (Cobas 8000 c 702 module; Roche Diagnostics GmbH, Mannheim, Germany; www.roche.com). Coagulation mark ers were tested using a Coulter LH 750 Hematology Analyzer (Beckman Coulter, Inc., Brea, CA,
D
itivity was associated with a higher rate of thrombosis (OR, 8.92), and antinuclear antibody was strongly associated with thrombosis. There was no relation between platelet autoantibody positivity and the presence of autoimmune markers. The authors concluded that their results suggest that many patients with ITP have a state of immune dysregulation that extends beyond platelet autoantibodies and that certain autoimmune markers may be prognostically useful in this disorder. The study was published on November 15, 2019 in the journal Blood Advances.
Hepatic Dysfunction and Coagulopathy Quantified in Fatal Dengue Fever
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22
Childhood kidney Cancer Arises from Altered Normal Tissue
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LabMedica International
W
hile kidney cancer in children is rare, the most common type is Wilms tumor, which mostly affects children under the age of five. Most cases of Wilms tumor can be cured through surgery to remove the afflicted kidney in combination with chemotherapy and possibly radiotherapy. In adults, cancers are typically thought to arise through premalignant clonal expansion, but it's been unclear whether the process is similar in pediatric cancers. Scientists have sequenced tumor and normal kidney tissue to find that alterations indicative of disease were present in some normal tissue from patients as well as in tumors, indicating that that these changes affect cells from which Wilms tumors may later arise. A large team of scientists working with the Wellcome Sanger Institute (Hinxton, UK; www.sanger.ac.uk) sequenced kidney samples from 54 people, including nearly two dozen children with Wilms tumor, the parents of children with Wilms tumor, and others. The team constructed phylogenetic trees of tumor development based on the somatic mutations present. For three children with unilateral Wilms tumor, they sampled their tumors, blood, and histologically normal kidney and uncovered mosaic mutations within these samples. As some of these mosaic mutations were found in both normal and tumor kidney tissue, though not in blood the investigator suspected that these mutations might have undergone clonal expansions within the kidney. The scientists folded in additional samples from other Wilms tumor cases; they found these clonal expansions within normal kidney tissue in 61% of the 23 cases they examined. But when they examined tissues from people without Wilms, they found that these clonal expansions were not common in normal kidney development. Instead, these expansions within histologically normal tissue were atypical outcomes of renal development that appear to precede development of Wilms tumor. Nearly 60% of these normal kidney tissues with clonal nephrogenesis exhibited hypermethylation of the H19 locus, which typically acts to regulate cell growth and is a known Wilms tumor driver. This hypermethylation was found throughout the clone. This suppression of H19 leads cells to grow more rapidly to create this swathe of pre-malignant cells from which Wilms tumor may then arise. Sam Behjati, MA, BM, BCh (Oxon), PhD, a consultant pediatric oncologist and senior study author, said, â&#x20AC;&#x153;The discovery of the genetic root of Wilms' tumor signals a shift in our understanding of this particular cancer and childhood cancer more generally. Our findings represent a radical departure from how we think about Wilms' tumors because we never expected to find the root of cancer in normal-looking tissue.â&#x20AC;? The authors concluded that phylogenetic analyses of bilateral tumors indicated that clonal expansions can
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evolve before the divergence of left and right kidney primordia. These findings reveal embryonal precursors from which unilateral and multifocal cancers develop. The study was published on December 6, 2019 in the journal Science. Image: Histopathology of Wilms tumor or nephroblastoma which is a type of kidney cancer that is seen predominantly in children (Photo courtesy of Nephron).
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Purair PCR workstation enclosures are ideally suited for assay setup and amplification applications, providing a safe, energy-efficient, contamination-free environment, with Air Science Multiplex HEPA filtration technology.
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Virome Shifts Analyzed in Children with Islet Autoimmunity
iruses are implicated in autoimmune destruction of pancreatic islet β cells, which results in insulin deficiency and type 1 diabetes (T1D). Certain enteroviruses can infect β cells in vitro, have been detected in the pancreatic islets of patients with T1D and have shown an association with T1D. Obstacles to convincingly linking RNA viruses to islet autoimmunity may be attributed to rapid viral mutation rates, the cyclical periodicity of viruses and the selection of variants with altered pathogenicity and ability to spread in populations. β cells strongly express cell-surface coxsackie and adenovirus receptor (CXADR) genes, which can facilitate enterovirus infection. A large team of scientists associated with the University of South Florida (Tampa, FL, USA; www.usf.edu) used metagenomic sequencing to assess eukaryotic DNA and RNA virus repertoires in stool samples collected over time from almost 500 children with islet autoimmunity or T1D, searching through shards of viral DNA shed into the feces to find clues to the pancreatic islet cell viruses that might prompt disease-related autoimmunity. The team focused on almost 8,700 prospectively collected fecal samples from the children with islet autoimmunity and nearly 3,400 samples from children who developed
T1D, comparing the RNA and DNA virus profiles with those found in nested-matched paired controls from the same locations. To complement that analysis, enteroviruses found in the fecal samples were grown with the help of virus-susceptible cell cultures before being sequenced and analyzed with a VirMAP virus taxonomy classification method. The investigators tracked down viruses from 96 eukaryotic virus genera and dozens of bacteria-infecting bacteriophage viruses in the samples, which contained a total of 621 known viral taxa. Among them were viruses identified in children in the past, they reported, including human mastadenoviruses, parechoviruses, bocaviruses, mamastroviruses, noroviruses, and enteroviruses. The results suggested ongoing enterovirus B infections or lower-than-usual exposure to a double-stranded DNA virus known as human mastadenovirus C may be more common in children with islet autoimmunity. The analyses also highlighted a variant called rs6517774 in the host CXADR gene that appeared to coincide with islet autoimmunity which is consistent with the pronounced expression of cell surface receptors for coxsackie and adenovirus receptor (CXADR) genes that have been documented in pancreatic beta cells in the past. Kendra Vehik, MPH, MD, an associate professor and first author of the study said, “This
study showed that prolonged enterovirus B rather than independent, short-duration enterovirus B infections may be involved in the development of islet autoimmunity, but not T1D, in some young children. We found fewer early-life human mastadenovirus C infections, as well as CXADR rs6517774, independently correlated with islet autoimmunity.” The study was published on December 2, 2019 in the journal Nature Medicine. Image: Degree of islet degradation in human pancreatic islets infected with isolates of enteroviruses, and in uninfected controls. (A) Uninfected human islet displayed no degradation of the islets. (B) Islets infected with an Enterovirus isolate three days post infection. (C) Islets infected with a different isolate three days post infection. (D) Islets infected with the same isolate six days post infection (Photo courtesy of Gun Frisk, PhD).
Hepatic Dysfunction and Coagulopathy Quantified in Fatal Dengue Fever
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USA; www.beckmancoulter.com). The team reported that there were 4,069 dengue patients, of which 0.9% died in one week after illness onset. Both AST and ALT values of the fatal group were significantly higher than those of the survivor group from Day 3 (AST median, 624 U/L versus 60 U/L, ALT median, 116 U/L versus 29 U/L) of illness onset
and peaked on Day 6 (AST median, 9,805 U/L versus 90 U/L; ALT median, 1,504 U/L versus 49 U/L). The platelet counts of the fatal group declined significantly than those of the survivor group since Day 3 of illness onset (median, 19 ×103/μL versus 91 ×103/μL), and activated partial thromboplastin time (aPTT) values of the fatal group significantly prolonged longer since Day 5 (median, 68.7 seconds versus 40.1 sec-
onds). The authors concluded that the AST, ALT, and platelet counts should be monitored closely from Day 0 to Day 3 of dengue infection, and aPTT be followed up on Day 5 of infection to identify the individuals at risk for early mortality. The study was published on December 5, 2019 in the journal PLOS Neglected Tropical Diseases. LabMedica International May/2020
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Single-Cell Analysis Uncovers Regulatory Program in Rare Leukemia
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dentifying the causes of human diseases requires deconvolution of abnormal molecular phenotypes spanning DNA accessibility, gene expression and protein abundance. Mixed-phenotype acute leukemia exhibits features of both acute myeloid leukemia and acute lymphoblastic leukemia and, as such, is marked by features of multiple hematopoietic lineages. Mixed phenotype acute leukemia is a very rare type of leukemia where more than one type of leukemia occurs at the same time. This can happen when a person has either: both acute lymphoblastic leukemia (ALL) blasts (cancer cells) and acute myeloblastic leukemia (AML) blasts at the same time or leukemic blasts that have features of both ALL and AML on the same cell. Scientists at the Stanford University School of Medicine (Stanford, CA, USA; www.stanford.edu) and their colleagues identified pathological molecular features of mixed-phenotype acute leukemia by first analyzing the single-cell transcriptomic and epigenetic profiles of healthy blood cells during their development. Once they established profiles of those healthy cells, they examined how the profiles of leukemic cells compared. The team performed droplet-based cellular indexing of transcriptomes and epitopes by sequencing (CITE-seq) and single-cell assay for transposase-accessible chromatin by sequencing (scATAC-seq) of more than 35,000 healthy bone marrow and peripheral blood mononuclear cells. With this, they generated multi-omic maps of hematopoiesis. They validated the maps and found them to reflect the essential phenotypic, transcriptomic, and epigenetic features of blood development. They developed a framework to analyze signatures of hematopoietic development at the single-cell level. With this, they then sought to examine how those signatures differed between healthy and leukemic cells. The team assayed thousands of single cells from mixed-phenotype acute leukemia (MPAL) samples using both CITE-seq and scATAC-seq and identified 4,616 genes that were differentially upregulated and 72,196 significantly upregulated peaks. They projected these single-cell analyses onto their hematopoietic maps to find epigenetic and gene ex-
Image: Bone marrow smear from a patient with mixed phenotype acute leukemia. The marrow aspirate smear has 71% blasts by differential count, with a similar dimorphic morphology as in the peripheral blood with numerous blasts with a dimorphic morphology (Photo courtesy of Elizabeth Courville, MD).
lioblastoma patients who tested positive for antibodies indicating exposure to human cytomegalovirus (HCMV) had more aggressive tumors and poorer prognosis than patients without anti-HCMV antibodies. Glioblastoma (GBM) is the most common primary tumor of the central nervous system and is almost always fatal. The aggressive invasion of glioblastoma cells into the surrounding normal brain makes complete surgical removal impossible, significantly increases resistance to the standard therapy regimen, and virtually assures tumor recurrence. Treatment of glioblastoma usually comprises surgical removal of the tumor followed by radiation treatment and chemotherapy using the drug temozolomide (TMZ). However, the penetration of the tumor into adjacent brain tissue prevents the surgical removal of all tumor cells, which usually develop resistance to TMZ. HCMV is a human herpesvirus that has been detected in GBM and is associated with worse prognosis in patients with the disease. The effects of HCMV systemic infection on survival in GBM patients, however, are largely unknown. In this regard, investigators at the University of Cincinnati (OH, USA; www.uc.edu) and their collaborators sought to determine the association between levels of anti-HCMV antibodies at time of GBM diagnosis and survival via a retrospective cohort study of GBM patients. The investigators analyzed plasma from 188 GBM patients by testing for anti-HCMV immunoglobulin (Ig)G antibodies using enzymelinked immunosorbent assays. HCMV IgG seriological status was evaluated with respect to each patientâ&#x20AC;&#x2122;s progression-free and overall sur-
vival (OS) via log-rank and multivariable Cox regression analysis. Results revealed that 97 of the 188 patients (52%) were anti-HCMV IgG seropositive. Individuals who tested positive for HCMV exposure lived an average of 404 days after their cancer diagnosis compared to an average of 530 days for patients who had never been infected by HCMV. "We believe that human cytomegalovirus is a possible contributor to the aggressiveness of human glioblastoma tumors," said senior author Dr. Charles Cobbs, director of the Ben & Catherine Ivy Center for Advanced Brain Tumor Treatment at the Swedish Neuroscience Institute (Seattle, WA, USA; www.swedish.org/services/neuroscience-institute). "These are highly malignant tumors, and there is significant evidence, albeit controversial, that HCMV is present in a high percentage of these tumors." The results obtained during the current study suggest that having a prior infection and a presumed latent infection with HCMV may somehow predispose patients to have a more aggressive course with glioblastoma. "This could potentially be due to either a viral infection of the tumor itself, as shown with a mouse model from our collaborators at Harvard Medical School (Cambridge, MA, USA; www.harvard.edu), or potentially systemic effects of reactivation of the virus during radiation and chemotherapy, which in and of itself could be an independent factor in promoting encephalitis and other life-threatening complications," said Dr. Cobbs. The glioblastoma-HCMV study was published in the September 7, 2019, online edition of the journal Neuro-Oncology Advances.
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pression diversity and grouped the cells into broad hematopoietic development compartments. They focused on the transcription factors that might regulate these leukemia programs and found that RUNX1 motifs were enriched among certain MPAL subsets. RUNX1, they noted, is a frequently mutated gene in hematological malignancies, and they uncovered 732 genes regulated by a RUNX1containing distal element in at least two MPAL subsets. Additionally, CD69 which has been linked to lymphocyte activation through JAKSTAT signaling and lymphocyte retention in lymphoid organs was differentially upregulated in nearly every MPAL subset. The authors concluded that their results demonstrate how integrative, multiomic analysis of single cells within the framework of normal development can reveal both distinct and shared molecular mechanisms of disease from patient samples. The study was published on December 2, 2019 in the journal Nature Biotechnology.
exposure to Human Cytomegalovirus Increases Aggressiveness of Glioblastoma
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LDL Subclasses Ratio Predicts Cardiovascular Risk More Accurately than LDL-Cholesterol Alone
easurement of low-density lipoprotein (LDL) cholesterol may a less effective way to predict risk of cardiovascular disease than is the further analysis of the relative proportions of LDL subclasses. About 75% of patients with heart attacks have cholesterol levels, particularly LDL-cholesterol levels - that do not indicate a high risk for a cardiovascular event. LDL comprises a diverse group of macromolecules that may be grouped according to size: large low density LDL particles are described as subclass A, and small high density LDL particles are subclass B. Subclass B has been associated by some with a higher risk for coronary heart disease. This is thought to be because the smaller particles are more easily able to penetrate the endothelium of arterial walls. Subclass I, for intermediate, indicates that most LDL particles are very close in size to the normal gaps in the endothelium. A recent study carried out at Ohio University (Athens, USA; www.ohio.edu) suggested that contrary to the current [U.S.] national guidelines
it was not the total LDL, rather it was the concentration of subclass B in relation to subclasses A and/or I, that should be used for diagnosis of atherosclerosis and the risk of heart attack. The investigators reached this conclusion after utilizing a nanomedical approach. They used nanosensors with a diameter of less than 300 nanometers, to simultaneously measure, in nearreal time, the concentration of cytoprotective nitric oxide (NO) and cytotoxic peroxynitrite (ONOO−) released from a single endothelial cell exposed to each of the LDL subclasses (A, B, and I). The ratio of NO concentration to ONOO− concentration (NO)/(ONOO−) was used as a marker of oxidative stress and the dysfunction of the enzyme endothelial nitric oxide synthase (eNOS). Results revealed that all n-LDL (native LDL) and ox-LDL (oxidized LDL) subclasses unfavorably shifted the balance of the (NO)/(ONOO−) ratio, imposing toxic effects such as: elevated oxidative stress, a shortage of cytoprotective NO, and the up-regulation of adhesion mole-
cules in the endothelium. However, subclass B dramatically shifted (NO)/(ONOO−) balance to a very low level, causing significant damage to endothelial function. "Our studies can explain why a correlation of total "bad" cholesterol with a risk of heart attack is poor and dangerously misleading – it is wrong three quarters of the time," said senior author Dr. Tadeusz Malinski, professor of chemistry and biochemistry at Ohio University. "These national guidelines may seriously underestimate the noxious effects of LDL cholesterol, especially in cases where the content of subclass B in total LDL is high (50% or higher). Understanding this could lead to improving the accuracy of diagnosis for the evaluation of cardiovascular disease rates. Analyzing the mixture of LDL subclasses may provide a parameter-based model for an early medical diagnosis of estimating the risk of cardiovascular disease." The study was published in the November 18, 2019, issue of the International Journal of Nanomedicine.
rapid influenza diagnostic tests (RIDTs), adding the silver amplification principle of photographic development to improve its sensitivity. Detection of influenza viruses was assessed by RT-PCR and nucleic acid extraction from the clinical samples was performed with the PureLink Viral RNA/DNA mini kit (Thermo Fisher Scientific, Inc, Waltham MA, USA; www.thermofisher. com). The amplification was accomplished using the CFX96 Real Time System Bio-Rad Platform (Bio-Rad Laboratories Inc, Hercules, CA, USA; www.bio-rad.com). The investigators reported that of the enrolled 592 patients. RT-PCR detected 93 cases of influenza A(H1N1)pdm09, 55 of AH3N2, 141 of B, and 13 A/B virus infections. RIDT showed
90.7% sensitivity and 95.7% specificity for influenza A virus detection, and 91.5% sensitivity and 95.3% specificity for influenza B virus detection. Overall vaccines’ effectiveness (VE) was 33.2% against any laboratory-confirmed influenza infection. VE estimates against influenza B were higher for the quadrivalent vaccine. Immunization and occupational exposure were protective factors against influenza. The authors concluded that the RIDT was useful to detect influenza cases during an outbreak setting. Effectiveness of 2016/17 influenza vaccines administered in Mexico was low, but significant. The study was published in the December, 2019 issue of the International Journal of Infectious Diseases.”
High Performance of Rapid Influenza Diagnostic Test Validated
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Respiratory Diseases (INER, Mexico City, Mexico; www.iner.salud.gob.mx) enrolled in their study 592 participants, 45.6% males and 54.3% females; their median age was 14 years. From these, 171 subjects (28.9%) received influenza vaccination for the evaluated season: 127 were immunized with the IIV3 and 44 received the IIV4. They enrolled the patients attending to the INER from October 2016 to March 2017. The team used the Fuji dri-chem immuno AG cartridge FluAB kit (Fujifilm Corporation, Tokyo, Japan; www.fujifilm.com) for detection of influenza viruses in fresh respiratory specimens. This test utilizes the immunochromatographic principle of virus detection as other conventional
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Blood-Based Sequencing Identifies Pediatric Cancer Infections Before Symptoms
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nfections are common, yet life-threatening complications that affect immuno-compromised cancer patients and bloodstream infection (BSI) is a common, life-threatening complication of treatment for cancer. Predicting BSI before onset of clinical symptoms would enable preemptive therapy, but there is no reliable screening test. Currently, patients are prophylactically treated with a broad-spectrum antibiotic to prevent infection and are switched to more specific antimicrobials when they exhibit symptoms of infection. Medical scientists at St. Jude Children's Research Hospital (Memphis, TN, USA; www. stjude.org) evaluated the sensitivity and specificity of microbial cell-free DNA sequencing (mcfDNA-seq) test from the infectious disease diagnostics for detecting bloodstream infections prior to their onset. The team enrolled 47 patients who were a median 10 years old with relapsed or refractory leukemia into their study. Remnant clinical blood samples were collected during chemotherapy and hematopoietic cell transplantation. Samples collected during the seven days before and at onset of BSI episodes, along with negative con-
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emptive treatment. The study was published on December 19, 2019 in the journal JAMA Oncology. Image: The Karius Test, which uses microbial cell-free DNA (mcfDNA-seq), can predict bloodstream infections in leukemia patients up to three days before the onset of symptoms (Photo courtesy of Karius)
Rapid Diagnostic Test for Detection of G6PD Deficiency evaluated
o reduce the risk of drug-induced hemolysis, all patients should be tested for glucose-6-phosphate dehydrogenase (G6PD) deficiency (G6PDd) prior to prescribing primaquine (PQ)-based radical cure for the treatment of vivax malaria. The gold standard method for measuring G6PD activity is quantitative spectrophotometry, but this method is expensive and requires laboratory facilities that are often unavailable in malaria-endemic communities, especially in remote areas. The fluorescent spot test (FST) is a qualitative alternative; however, it also requires laboratory infrastructure and extensive training for reliable interpretation. An international team of scientists led by the Charles Darwin University (Darwin, Australia; www.cdu.edu.au) carried out a systematic review and individual patient meta-analysis assessed the utility of a qualitative lateral flow assay from CareStart Screening test for G6PD deficiency (CSG, Access Bio/CareStart, Somerset, NJ, USA; www.accessbio.net) for the diagnosis of G6PDd compared to the gold standard spectrophotometry using kits from Trinity Biotech PLC (Wicklow, Ireland; www.trinitybiotech. com). All of the studies included were undertaken between 2014 and 2018. Six studies were conducted in Southeast Asia, one in Africa, and one in the Americas. In total, three studies (four countries, 2,845 participants) assessed G6PD status from capillary blood and three from ve-
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trol samples from study participants, underwent blinded testing using a mcfDNA-seq test (Karius, Inc; Redwood City, CA, USA; www. kariusdx.com). The team uncovered the infecting pathogen in 12 of the 16 episodes for a predictive sensitivity of 75%, and in 12 of the 15 bacterial infection episodes for a predictive sensitivity of 80%. Diagnostic sensitivity, meanwhile, was 83% overall and 88% for bacterial infections. The investigators also tested 33 negative control samples. No bacterial or fungal organisms were found in 27 of the samples; a specificity of 82%, and 30 of the 33 samples had no common bloodstream pathogen organism found, a specificity of 91%. The team noted that this predictive sensitivity of 75% is higher than their pre-defined favorable value of 50 %, so chosen as it reflects the efficacy of prophylactic antibacterial treatment. However, they noted that the 82% specificity they reported would make screening in this manner impractical due to the high falsepositive rate. The authors concluded that a clinically relevant pathogen can be identified by mcfDNA-seq days before the onset of BSI in a majority of episodes, potentially enabling pre-
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nous blood (three countries, 2,066 participants). In one study, CSG and spectrophotometry were performed on both venous and capillary samples, and in one study CSG was performed on both venous and capillary samples; however, spectrophotometry was only performed on capillary blood. A total of 5,815 individual participant data (IPD) were available, of which 5,777 results (99.3%) were considered for analysis, including data from 3,095 (53.6%) females. Overall, the CSG had a pooled sensitivity of 0.96 and a specificity of 0.95. When the prevalence of G6PDd was varied from 5% to 30%, the unconditional negative predictive value (NPV) was 0.99, with a positive likelihood ratio (LR+) and an LRâ&#x2C6;&#x2019; of 18.23 and 0.05, respectively. Performance was significantly better in males compared to females but did not differ significantly between samples collected from capillary or venous blood. The authors concluded that the CSG performed well at the 30% threshold. Its high NPV suggests that the test is suitable to guide PQ treatment, and the high LR+ and low LRâ&#x2C6;&#x2019; render the test suitable to confirm and exclude G6PDd. In a comparison between Trinity spectrophotometry kits, considered for this analysis, and another spectrophotometry kit (Pointe Scientific, Canton, MI, USA; www.pointescientific. com), both assays showed a very good correlation. The study was published on December 13, 2019 in the journal Public Library of Science Medicine.
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Combining RNA Sequencing with Learning Algorithm to Identify Single Cells in Biopsy Specimens To view this issue in interactive digital magazine format visit www.LinkXpress.com
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generalized method for classifying single cells based on their transcriptional dataset was published in a recent paper. Single-cell RNA sequencing has enabled the characterization of highly specific cell types in many tissues, as well as both primary and stem cell-derived cell lines. An important aspect of this approach is the ability to identify the transcriptional signatures that define a cell type or state. In theory, this information can be used to classify an individual cell based on its transcriptional profile. To test this theory, investigators at the Garvan Institute of Medical Research (Sydney, Australia; www.garvan.org.au) developed the scPred method. ScPred was designed to collapse all the transcript data obtained from scRNA-sequencing of a single cell. Then an algorithm was trained to generate a statistical model to test what features embedded in this data made a certain cell type most different from other types of cells. The investigators applied scPred to scRNA-seq data from pancreatic tissue, mononuclear cells, colorectal tumor biopsies, and circulating dendritic cells. The learning algorithm incorporated a large number (on the order of 20,000) of small differences in the mean and variance of gene expression between different cell types to arrive at a prediction model. To validate the scPred approach, the investigators used datasets from colorectal cancer cells analyzed initially by collaborators at Stanford University (Palo Alto, USA; www.stanford.edu) to identify single cancer cells within a tissue sample with over 98% accuracy. "Our scPred method gives us the possibility of earlier detection; it may allow us to determine the stage of a cancer patient, what potential drugs they will respond to, or whether their tumor cells have signatures that indicate resistance to chemotherapy," said senior author Dr. Joseph Powell, director of the single cell and computational genomics laboratory at the Garvan Institute of Medical Research. "The potential for this new method is enormous. We have developed a new way to identify very specific types of cells, which has put us at the be-
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ginning of a significant new frontier in medical diagnostics. For a long time we have mainly classified different cells in the human body based on a limited number of markers found on the cell surface or inside the cell. What we are learning now is that underneath one “type”, there is a huge diversity of different cell types - for instance, even though different cancer cells could all have the same cell surface markers, only a subgroup of those cells may actually form a metastatic tumor." The scPred paper was published in the December 12, 2019, online edition of the journal Genome Biology. Image: Artistic rendering of the surface of a human dendritic cell illustrating sheet-like processes that fold back onto the membrane surface (Photo courtesy of Wikimedia Commons)
Myelodysplastic Syndrome Subtypes Identified by Genomic and Transcriptomic Analysis
yelodysplastic syndrome is a premalignant disease that affects myeloid cell. It is a precursor to acute myeloid leukemia, an aggressive blood cancer caused by the accumulation of immature blood cells. The increased use of sequencing in the past decade has improved the field's understanding of the genetic mutations that cause myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), but for the most part, those data have not been integrated with expression data. Scientists from St. Jude Children's Research Hospital (Memphis, TN, USA; www.stjude.org) and their colleagues conducted whole-genome sequencing and transcriptomic analysis via RNA-seq of cancer samples from more than 1,300 adult patients, nearly 600 with AML and around 700 with MDS and looked at how detected genetic variants tracked with gene expression patterns, patients' clinical disease features, and outcomes. The team was able to confirm the diagnosis of 11% of patients where AML was due to recurrent genetic abnormalities according to the World Health Organizations' classifications. The investigators also identified more than 7,000 variants (including somatic and germline mutations, chimeric fusions, and structural variants) in 839 genes, around a third of which were potential driver genes. Patients harbored between one and 18 mutations, and averaged five mutations. Some genetic mutations overlapped between the two diseases, but were more frequent in one setting than the other. For example, NPM1 mutations occurred in 27% of AML and around 1% of MDS cases. The investigators showed that while AML cases had gene expression profiles that clustered with specific mutational patterns, expression profiles of MDS patients were not as variable even though they also had a
complex landscape of mutations. Around 27% of MDS cases had mutations in SF3B1, which did not show up in 14% of patients with SFRS2 mutations and 6% of cases with U2AF1 mutations. Additionally, around 14% of MDS cases had TP53 mutations and 11% had RUNX1 mutations, which occurred with mutations in epigenetic regulators and were associated with patient outcomes. Ilaria Iacobucci, PhD, the senior author of the study, said, “This study, for the first time, provides a very detailed description of how different mutations cooperate together, and shows how this can be used to stratify patients by cataloging different mutations and correlating them with outcome.” The study was presented at the at the American Society of Hematology annual meeting held December 7-10, 2019 in Orlando, FL, USA. Image: Bone marrow film from a patient with myelodysplastic syndrome demonstrates small hypolobated megakaryocytes that are typical of the syndrome with isolated del(5q) (Photo courtesy of John P. Hunt, MD) LabMedica International May/2020
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Edited by Katherina Psarra MSc, PhD IFCC members may send news to: Prof. Katherina Psarra IFCC Office, Via C. Farini 81 20159 Milano, Italy. E-mail: enews@ifcc.org
NEWS
Greetings from the Incoming IFCC President
By Khosrow Adeli, PhD FCACB, DABCC, FAACC IFCC president (2020-2023)
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y cordial greetings and compliments of the spring season to you all in the IFCC family. It is indeed an honour and privilege to become the President of IFCC at this challenging time. Thanks to the great leadership provided by Professor Ferrari, Professor Morris, and other former past presidents as well as members of the IFCC executive board, I have become responsible for a healthy, strong and financially secure organization that has enormous promise to contribute to advancing laboratory medicine around the world. Also, many thanks to IFCC member countries for their support of my nomination and election. I have been amazed at the outpouring of support from many of you in regions around the world and your encouragement to take on this important responsibility. I very much look forward to working with all of you over the next few years to continue the IFCC’s mission of “Advancing excellence in laboratory medicine for better healthcare worldwide”. Recent months have been tough for all of us around the world as we face and fight this unprecedented coronavirus pandemic. But while this crisis has caused many professional and personal challenges (medical emergencies, social isolation, economic recession, and many others), I want to assure you that the field of laboratory medicine will come of out this health emergency even stronger and much more visible in the eye of the healthcare system, governments as well as the general public. The pandemic has clearly highlighted the critical role of laboratory medicine in the fight against this health crisis. It is unimaginable to face such a health emergency without appropriate laboratory testing and popula-
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tion screening using molecular and serological assays. During this crisis, the IFCC has been in the forefront of documenting and evaluating the emerging evidence for appropriate diagnostic and serological testing as well as biosafety guidelines for clinical laboratories. Please see my editorial below for more details on the IFCC Information Guide on COVID19 as well as the IFCC taskforce and its recent publications. I am passionate about laboratory medicine and at the opportunity over the next few years to contribute to a more impactful and activist role for IFCC in the global communities to inspire and drive value to the profession and across healthcare. The future holds considerable promise for the IFCC organization and its family of national societies and corporate members. I look forward to working with all of you in the IFCC’s continued journey towards global leadership in laboratory medicine. In partnership with all IFCC divisions and functional units, we will strive to enhance IFCC’s leadership position in the field of laboratory medicine by: • Directly impacting healthcare and patient outcomes by working with developing countries around the work to develop programs such as newborn screening programs in collaboration with WHO, Gates Foundation, industry, others • Developing an international IFCC external quality assurance program and innovative quality improvement strategies and disseminate the concept of total quality management and quality systems approach to clinical laboratories and national societies, particularly in developing countries. • Becoming the largest provider of free Distance Learning/eLearning in the field of laboratory medicine worldwide. Through the new eAcademy platform and its vast network of experts, IFCC can develop the most comprehensive database of eLearning programs to support education by its member societies particularly in developing countries. • Continuing to promote the value of laboratory medicine by gathering the evidence to demonstrate the value of lab medicine in clinical decision making and healthcare delivery, communicating this to the public and all stakeholders. • Encouraging and supporting a culture of innovation in the IFCC community and communicate technological and process innovations to laboratory scientists and physicians globally. In association with regional federations, member societies, young scientists and corporate members, ensure that IFCC is a driv-
er of technological innovations such as artificial intelligence and machine learning, and their application in laboratory medicine. This is a glimpse of our new strategic plan that I have been working on with support of the IFCC Executive Board over the past few months. In the next few issues of the newsletter, I will explain in more de-
tail each of the key strategic plans and would like to seek feedback from all IFCC officers, IFCC member countries as well as our corporate members before finalizing and initiating implementation of these plans into practice with your support and participation. Till next time, Khosrow
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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
editorial
By Katherina psarra, MSc, phD
Dear colleagues, he summer is almost there. Outdoor activities are definitely safer and offer the opportunity for more normal life, for more joy but travel restrictions are still there and social life is definitely different. There are lots of questions about the future of conferences, seminars and meetings. Most of them like the IFCC EB, divisions and working groups meetings are taking place through the internet, a completely different experience from the face to face meetings, but still work is being done. Don’t forget that a new deadline has been announced for the Seoul 2021 Wordlab abstracts, where we all hope to be together once more! Laboratorians of course keep working in the labs in re-
search centers or in hospitals and try to understand better this new disease. It is IFCC ambition to keep members fully educated and informed about all new knowledge. The special IFCC Information Guide on COVID-19 on the first page of IFCC website is continuously renewed by the new IFCC Task Force on COVID-19. In this IFCC corner will find an important editorial in Clin Chem Lab Med by the new IFCC president Prof. Khosrow Adeli on the “Critical role of laboratory medicine in the global response to the COVID-19 pandemic”. A more “philosophical” and social look on the consequences of the epidemic are presented by Dr Gouget. New IFCC members societies are really interesting as well. Try to find joy and happiness in everyday small joys, dear colleagues. Pay attention to the small successes in your professional and personal life. Look forward to our next face to face meeting!
Join us in Celebrating Healthcare excellence on LinkedIn
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ealthcare is evolving rapidly, and transforming the delivery of healthcare requires agility, novel thinking, innovation and teamwork. Opportunities exist to network and stay up-to-date on key events and best practices associated with the UNIVANTS of Healthcare Excellence Award Program (www.univantshce.com). Explore and learn about best practices in integrated care projects that have achieved measurably better healthcare performance for patients, clinicians, payors and health administrations. Be inspired to emulate similar care projects, improve upon your own teams and programs, or find ways to inspire healthcare professionals on the frontlines of enhancing care. Follow these easy steps to join other like-minded individuals who are passionate about healthcare excellence and the UNIVANTS of Healthcare Excellence Award Program on LinkedIn: 1. Go to LinkedIn.com
2. On the welcome page, find the search feature on the top left corner search bar.
3. Type in #UNIVANTS and select “see all results for #UNIVANTS”
4. You will be prompted on the next screen to “Follow” the hashtag. Select the “Follow” button. 5. You are now following the #UNIVANTS hashtag.
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Upon following #UNIVANTS, you will join a global community that is passionate about healthcare transformation. Explore articles and integrated best practice initiatives that have revolutionized patient care. Share relevant articles of healthcare excellence with this community by tagging #UNIVANTS to inspire team engagement. These success stories can inspire new teams and projects for well-rounded healthcare solutions with measurably better healthcare. Please like and share with those who might benefit from this network. LabMedica International May/2020
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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 welcomes Two New Members:
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Order of Biochemists, Biologists and Chemists in the Healthcare System of Romania (OBBCSSR): Affiliate Member By Constanța Popa, PhD, EuSpLM OBBCSSR President, IFFC Național Representative for OBBCSSR
he Order of Biochemists, Biologists and Chemists in the Healthcare System of Romania (OBBCSSR) became an IFCCC Affiliate Member since April 2020. Since its founding by Law 460/2003 and until now, OBBCSSR activity resulted in drafting national legislation on the recognition of the professional status of biologists, chemists, biochemists in the Romanian health system and monitoring its implementation. Since 2004, OBBCSSR publishes the Romanian Journal of Medical Laboratory, where scientific papers are published covering the entire EC4 curriculum, with monthly appearances many years after its establishment, then quarterly and more recently semiannually The annual conferences of OBBCSSR had both scientific programs in continuing medical training and agendas dedicated to the exercise of our medical professions - for example in 2018 the theme was "Laboratory Medicine: Techniques and/or Laboratory Diagnosis". In 2017 National Conference topics was “Harmonization of Vocational Training in Laboratory Medi-
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13th OBBCSSR National Conference, Bucharest. L-R: Dr Tatiana Ciurea, OBBCSSR Professional, Scientific, Educational and Legislative Committee; Daniela Beldean, Vice President OBBCSSR National Executive Bureau: Dr Bernard Gouget, President Human Health Care Committee Cofrac, IFCC NC; Dr Constanța Popa, Chair and speaker, EuSpLM, OBBCSSR President; Nicoleta Mihaela Stan, EuSpLM, Vice President of OBBCSSR National Executive Bureau; Dr Gilbert Wieringa, Chair EFLM’s Profession Committee; Dorina Popa, EuSpLM, General Secretary of OBBCSSR National Executive Bureau; Prof Dr Gábor L. Kovács, FESCC (Federation of European Societies of Clinical Chemistry) Executive Board; Dr Dalius Vitkus, IFCC and EFLM National Representative Lithuanian Laboratory Medical Society; Prof Dr Bogdan Solnica, National Representative EC-4 Registration Commission for the Polish Society of Laboratory Diagnostics.
cine”. This event had international participation of speakers including IFCC and EFLM Executive Board Members, as Dr. Gilbert Wieringa and Dr. Bernard Gouget. This year Romania too was af-
fected by the pandemic COVID-19; from April 2020 we have published 3 practical Guides developed with the initiative of the OBBCSSR President, Dr. Constanta Popa, who coordinated the team of spe-
Iraqi Society of Molecular Biology and Genetics (ISMBG): Full Member
he Society's mission is to advance the science of molecular biology and genetics and to promote the understanding of the molecular nature of life processes through: • Publication of scientific and educational journals; • Organization of scientific meetings; • Advocacy for funding of basic and advance research and education; • Support of science education and research at all levels; And promotion of the diversity of individuals entering the scientific workforce. • The Department of Medical Laboratories was established in specialties (Molecular Biology and Genetics); • Interested in contributing to the development of medical examinations • Trying to develop staff working in medical laboratories; • Covering the activities and
31
Text on photo: “What you do for yourself disappears with you, what you do for others remains for eternity.
cialists, who contributed to the documentation. The first two Guides, concerning mainly data on molecular diagnosis and associated error factors, were dedicated especially to the laboratory specialists. The latest one, named “15 medical laboratory test panel important in COVID-19”, based on the on the IFCC “Information Guide on COVID-19” presents the scientific information and it is publicly available on the official website www.obbcssr.ro, in order to be accessed by the 3,500 members of our professional body and all the specialists involved in the clinical chemistry field. OBBCSSR has proposed to the Romanian Ministry of Health to implement this orientation Guide for the laboratory test panel with the clinical utility to identify, monitore and prognose the COVID-19 patient outcome. In the spirit of transparent scientific communication we have sent an English version of the 3-rd OBBCSSR Guide to the IFCC Office, considering that any documented information can be useful to the healthcare medical and non-medical specialists, especially in terms of the clinical utility in the current context of the COVID-19 pandemic.
LabMedica International May/2020
By Dr. Mohammad I. Mezaal Atheab, ISMBG President, Baghdad, Iraq
events that serve the development of medical laboratories in private and government sectors; • Benefiting from the international experience by cooperating with the specialized international federations, officially joining it and representing Iraq. The Iraqi Society of molecular biology and genetics (ISMBG) is a nonprofit scientific, clinical and educational organization (Newly established). We seek to achieve international cooperation with other institutions in research areas in order to find solutions for the most important health challenges and problems facing the international community, through joint research and through our relations with health institutions inside Iraq. ISMBG was founded in 2019, the Society is based in Baghdad and will publish a magazine in the near future, the Iraqi Journal for Molecular Biology and Genetics
(coming soon). Objectives of Iraqi Society of molecular biology and genetics (ISMBG): 1. Supporting students and researchers in the field of molecular biology and genetics; 2. Supporting state institutions academically and scientifically in this field through joint activities, exchanging insights and ideas in this field; 3. Keeping pace with the scientific development in the field of molecular biology and genetics; 4. Contributing in the provision of advice and the formation of joint committees with the competent authorities to take appropriate decisions in this specialization (molecular biology and genetics) in the government and private sector; 5. Also, we aim to: • Society Governance; • ISMBG Meetings (inside and outside of Iraq); • Advocacy and Public Affairs • Patents;
• Research; • Our Publications; • Supporting medical laboratory activity and coordination with Iraqi Ministry of Health.
Executive Committee
• Dr. Mohammad I. Mezaal Atheab, President and Member; • Prof. Dr. Mohammed I. Nader, Asst. to President and Member; • Asst. Prof. Dr. Ismail H. Aziz, General Secretary and Member; • Esam Ghazi Mohammed Salih, Financial Secretary and Member; • Asst. Prof. Dr. Marrib N Rasheed, Member; • Asst. Prof. Dr. Kais Kassim, Ghaima Member; • Asst. Prof. Dr. Abdulameer M. Ghareeb, Member; • Prof. Dr. Mohammed Faraj Shather Al Marjani, Member; • Dr. Ilham Abdulhadi Khalaf Al. Rubaye, Member; • Dr. Mohammed Tariq Al-Mayhi, Member.
NEWS T
News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information
Critical Role of Laboratory Medicine in the Global Response to the COVID-19 Pandemic By Khosrow Adeli, President, IFCC
he global coronavirus disease 2019 (COVID-19) has presented major challenges for clinical laboratories, from initial diagnosis to patient monitoring and treatment. As I write this editorial, many laboratory specialists, technologists and trainees are selflessly and tirelessly standing on the front lines of the battle against COVID19. This is happening at hospital laboratories and at private clinical laboratories around the globe. What is becoming very clear during this crisis is that clinical laboratory operations are critical in the global fight against this unprecedented pandemic through rapid diagnosis of viral infection, serological monitoring of the affected populations, and biochemical monitoring of hospitalized patients with more severe COVID-19 induced complications. Laboratory medicine is a key driver of S TOR Y IBU AppL R T DIS ED TO IT INV
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healthcare delivery through provision of objective data to clinicians and other healthcare workers to guide appropriate clinical decision making. Indeed, laboratory medicine is integral to prevention, diagnosis, treatment, and management of clinical disease including such infectious disease outbreaks. It supplies health care professionals with evidence-based data necessary to provide safe, effective and high quality care to patients. Unfortunately, this essential role of laboratory medicine has not been widely recognized within healthcare organizations or the public, leading to poor visibility both within the field of clinical medicine and externally with the public at large. The current worldwide pandemic has clearly started to change the publics and governmental view of the critical role that clinical laboratories play in public health and safety. It is now abundantly clear that without laboratory medicine appropriate public health measures and evidence-based care of hospitalized patients are simply not conceivable. In response to the current pandemic, the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has established a global taskforce on COVID-19 (https://www.ifcc.org/executive-board-and-council/ebtask-forces/ifcc-task-force-on-covid-19/) as well as an online resource called the IFCC information Guide on COVID-19 (https://www.ifcc.org/ifccnews/2020-03-26-ifcc-information-guide-on-covid-19/. The taskforce and the online resource are helping to provide the latest evidence and up-todate information on population screening, diagnosis, biosafety guidelines for clinical laboratories, and biochemical monitoring of hospitalized patients with COVID-19. In addition to the online information guide, the taskforce has reviewed the latest evidence and has started publishing comprehensive reviews including an expert opinion article on Biosafety Measures for Preventing Infection from COVID-19 in Clinical Laboratories: IFCC Taskforce Recommendations (Lippi et al. 2020), and a critical review on Molecular, Serological, and Biochemical Diagnosis and Monitoring of COVID-19 (Bohn et al. 2020). These articles not only review the current evidence but also provide practical recommendations on both laboratory biosafety as well as diagnostic/serological/biochemical markers used in infection control and monitoring. The taskforce will continue to review the latest evidence and publish new guidelines, and high-quality reviews to ensure a wide-ranging coverage of the role that clinical laboratories play in the fight against this unparalleled and unfortunate pandemic. I recognize this is a time of immense turmoil and disruption in our lives. No one knows how long this crisis will last but one thing is certain: clinical laboratories have visibly demonstrated their vital role and value in the public health surveillance and patient care and management, and are in the front line of the global response to COVID-19. On behalf of the IFCC organization, I would like to thank members of the Taskforce on COVID-19 for their prompt and urgent action within a very short period time to gather the available evidence and assemble a number of key resources for laboratory medicine specialists and other healthcare workers around the world. The IFCC organization and the taskforce will continue this important work until the COVID-19 crisis is behind us. Lippi G, Adeli K, Ferrari M, Horvath A, Koch D, Sethi S, Wang C-B. Biosafety measures for preventing infection from COVID-19 in clinical laboratories: IFCC Taskforce Recommendations [published online ahead of print, 2020 May 12]. Clin Chem Lab Med. 2020; doi:10.1515/cclm-2020-0633
Bohn MK, Lippi G, Horvath A, Sethi S, Koch D, Ferrari M, Wang C-B, Mancini N, Adeli K. Molecular, serological, and biochemical monitoring of COVID-19: IFCC taskforce evaluation of the latest evidence; 2020 May; Clin Chem Lab Med. 2020 (in press)
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Via Carlo Farini 81, 20159 Milan, ITALY Tel: (39) 02-6680-9912 • 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
The views and positions expressed in the IFCC News section are those of the IFCC or the individual authors, and do not necessarily represent the views or positions of LabMedica magazine or its publishers.
LabMedica International May/2020
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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
VIewPOINT
ethical Digital Technologies to Flatten the Curve by Dr. Bernard Gouget
M
Chair-IFCC Committee on Mobile Health and Bioengineering in Laboratory Medicine (C-MHBLM), co-Chair IFCC -TF on History, SFBC-International Committee, President-Human Health Care Committee-Cofrac, President-Committee for selection of the French Reference Medical Laboratories, MoH.
anaging the next phase of the pandemic is all about risk. During the lockdown, the pandemic is shaking up our vision and our representation of the world and offering new ones, such as those maps produced to follow the progression of the virus 24 hours a day or even the curiously fascinating videos, taken by drone, of deserted urban spaces, of almost dead cities, as if abandoned. By capturing all our attention and dictating our actions, this virus compromises our ability think and interpret, like the Alien monster created by Ridley Scott. SARS-CoV-2 thinks and acts for us and makes it impossible to focus on anything else. Its effects can be observed in the social, political, intellectual, media and scientific spheres. COVID-19 creates a real global drama, continuously broadcast, to which the audiovisual and print media and digital networks and platforms contribute, as do the information channels of global players such as the WHO, international scientific journals, etc. The phenomenon is amplified by the exacerbation of emotions, positive or negative, starting with the fear that accentuates withdrawal, where we hope to find some security. The process affects the entire world; even those best of us equipped not do so indulge in murky theories, as if we are only obeying stimuli with no context. We have seen and heard many coronavirus experts who explained what should have been done yesterday, what should not have been done, what to do today, and what to do tomorrow, sometimes indulging in murky theories or contradictory analyses. In the context of an unparalleled proliferation of communication, everyone is asked to follow an exclusive spectacle in real time and to give their opinion on the inevitable progression of the disease, which tells us about the existence of an imminent danger for the world. Everyone claims that the world must change, but no new or unprecedented ideas arise, on the contrary everyone remains firmly settled in their role. During this time, anesthesiologist-critical care specialists, clinicians, infectologists, epidemiologists, imaging specialists and laboratory medicine specialists, etc., moving beyond scientific quarrels and ego competitions, with an educational will driven by the intelligence of the moment, continue collectively to make progress in solidarity and to confront uncertainty in order to fight the pandemic. It is time to pull ourselves together, stop the all the noise and get our bearings, to find the creativity and imagination essential for life after. Given its novelty, and the lack of specific scientific knowledge concerning this SARS CoV-2 virus, a certain degree of paralysis and gravity set in, given the contagiousness of the virus, everything indicated the need for using the precautionary principle. Everyone needed to be confined, constrained to a limited perimeter. Confinement upsets our relationship to space and the convergence between the health and security fields is crystallized in the consent to this confinement. The mystique of borders reappears. Symbolic or actual borders have always had a prophylactic function, the primary function being to protect. They do define limits, but they are not an answer to everything. Conversely, they are often directed against migratory flows while we live in a world where any notion of limits is banished and rejected. This "anarchist" virus is effective because it takes advantage of the characteristics of power and efficiency of a connected and urbanized world, and transforms them into factors of vulnerability. Viral geography follows that of global urbanization and especially uses the networks of connections that urbanization has installed, which allow everyone to move around, all the time, everywhere, and by every means. The virus quickly became a planetary stowaway, taking advantage of all possible methods of travel by accompanying its hosts who transport it. It flourishes primarily where population concentrations and social ties are strong. Now that the future becomes inseparable from the need to invent a way to live with the virus, the reflex to continue to confine populations, and especially to prevent economic and social life from continuing normally, conversely becomes unreasonable and perilous for the active and the most vulnerable, which is to say, the majority of the population. To end confinement or not to end confinement is the question. Screening policy and test availability are key factors for success. To continue confinement or end
33
LabMedica International May/2020
NEWS
confinement too timidly would claim many more victims today. First of all, there are many more victims of other diseases than we are aware of, who have not been treated for several weeks. Confinement experienced collectively has had the merit of making us very concretely aware of the vital need for the freedom to come and go. However, we will have to learn to avoid two pitfalls: an inability to be civil and docility in the face of freedomdestroying measures that are being maintained or even strengthened. Confinement has given rise to an increase in the use of the internet and digital technologies and, in particular, to the use of new surveillance technologies, especially drones, cameras, smart phones and robots that are responsible for keeping individuals in the public space in order. Five hundred million cameras operate around the world and claim to detect our emotions, spot our suspicious behavior, and even predict potential crimes, reminiscent of the plot of Steven Spielberg's Minority Report. By adopting the most sophisticated prevention/detection/suppression system in the world, will the digital revolution turn every citizen in the world into a suspect? Are we going to move towards digital totalitarianism? Will one have to choose between being safe or avoiding being scanned by an ethical AI. The use of digital tools for monitoring social interactions is an important element of the system for ending confinement. There is a need for a strict framework for the various forms of emergency and an obligation to end them as soon as they are no longer strictly necessary. With the deployment of surveillance technologies, the ethics of privacy protection are now rightly on the agenda. As the end of confinement looms, many countries, in Asia and Europe, for example, are implementing an application for monitoring the social interactions of people: digital tracking of individuals. Several technologies are used to achieve this: telephone tracking, GPS applications, Bluetooth applications, bank card and transport card systems or even video surveillance and facial recognition; there are many technical means for different purposes. The use of digital tools for tracking individuals raises the risk of harming individual and collective freedoms, in particular respect for privacy and protection of personal data, as well as the risk of discrimination. Digital tools make it possible to quantify, geolocate, map, control and sometimes inform. In a time of health crisis, tracking may be used for three purposes. Firstly, observing collective mobility and confinement practices. Obviously, this can make it possible to reconstruct population movements and thereby check whether the confinement rules are being followed. This was done in Lombardy. Secondly, tracking could permit identifying contacts. In this scenario, it is a question of detecting people who were potentially exposed to the virus following a meeting with patients (known or asymptomatic). Finally, tracking can create control of individual confinements. In this context, it is a matter of observing in an individualized way if patients are respecting the quarantine and confinement measures. This was done by China, Israel and Russia. One of the purposes is then to institute a travel authorization in a strategy for ending confinement. The collection of data without the user's consent, but for the purposes of public interest humanitarian purposes, i.e. saving lives, is an authorized exception, in particular, and very explicitly, for epidemics (see GDPR in Europe). Once again, we must avoid taking any ideological position: neither pro-surveillance nor anti-surveillance. The idea is to protect data against the possible infractions of an authoritarian state or a private company. The Korean example of obtaining data without consent did not lead to a dystopian plunge into dictatorship. Even better, the Korean government was able to hold legislative elections in April. Participation was the strongest in twenty-eight years. Thanks to its system for controlling the epidemic, not only have there been no attacks on public freedoms, but rather democratic life has been able to fully prosper there. Whether in China, Europe or the United States, countries use the legal and technical means at their disposal to legitimize these systems. Countries turn to practices usually reserved for combatting terrorism and therefore justified by protecting national security. This is where there is debate: in principle, national security does not include health issues. But the current situationâ&#x20AC;&#x201C;closing public places and educational facilities and prohibiting of freedom of movementâ&#x20AC;&#x201C;is unprecedented. To justify these exceptional surveillance measures, questions of the legitimacy and proportionality of the systems arise. Despite the very intrusive nature of surveillance systems, it is difficult not to admit their usefulness in view of the health emergency. In return, the appropriate proportionality of the measures may be more complicated to prove when several surveillance technologies are combined. This was especially the case in China. In public transportation, in businesses or on the street, the country has deployed facial recognition devices, among other things, coupled with thermal imaging to detect sick people. The real value of tracking applications comes from their interoperability and their ability to share data with central and local health IT systems. Contâ&#x20AC;&#x2122;d on page 34
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Events Calendar
ethical Digital Technologies to Flatten the Curve
cont’d from page 33 It is only by receiving this information that statistical analysis, outbreak mapping, capacity management and early clinical intervention for high-risk groups can be conducted. There has been a huge increase in cyberattacks since the start of the pandemic and especially in healthcare, with ransomware attacks targeting hospitals, government agencies and research centers, among others. This means that these e-platforms and telehealth resources are attractive targets for attackers who wish to spread malware through a health system, causing damage that really disrupts clinical care on a large scale. It is an immediate patient safety problem. The deployment of such devices must be supervised, as it is in Europe, for example, by the GDPR and the eprivacy directive. They authorize the processing of geolocation data via electronic communication means, provided that they have previously obtained either the express consent of the individuals or have anonymized the data collected. A number of considerations must be taken into account to guarantee that personal data is legally processed and, in any case, it should be remembered that any measure taken in this context must respect general legal principles and must not be irreversible, a condition that can legitimize restrictions on freedoms provided that these restrictions
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are proportionate and limited to the period of emergency. These digital tracking tools are becoming essential for mass surveillance. Of course, many people are worried about the power of the big four tech companies, but here we are not talking about commercial powers. It is a public interest mission for humanitarian purposes, which must be carried out by health authorities. We must also think about the consequences of our choices. Especially during a severe crisis when the alternatives are potentially devastating and deadly. The people of each country have adopted the protective measures they deem most appropriate or accessible, in the face of the unexpected risk. The weekly public applause for health services and key workers will be one to the enduring memories of this pandemic. It is hard not to find the common outpouring of support a little heartwarming. But are we all clapping for the same reasons? Each of us sees coronavirus in terms of culture and experience. But we are all rooted in the same humanity and faced with the same threat. As Cardinal Richelieu, Minister of France (1624-1642 ) said, "there is no need to be afraid of everything but do be prepared for everything." This is the task before us all and this global crisis will certainly make us aware of this lesson. This is, above all, an ethical consideration.
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JUNE 2020
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BIO International Convention 2020. Jun 8-11; Virtual Venue; Web: convention.bio.org
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11th African Congress of Immunology – Federation of African Immunological Societies (FAIS). Nov 29 – Dec 3; Lilongwe, Malawi; Web: www.faisafrica.com DECEMBER 2020
62nd Annual Meeting & Exposition of the American Society of Hematology (ASH). Dec 5-8; San Diego, CA, USA; Web: www.hematology.org
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41st Annual Meeting of the American College of Toxicology (ACT). Nov 15-18; Austin, TX, USA; Web: www.actox.org
Analytica China 2020. Nov 16-18; Shanghai, China; Web: www.analyticachina.com
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