LabMedica International April 2021 by Globetech

V I S I T

WORLD’S CLINICAL LABORATORY NEWS LEADER ISSN 1068-1760

Vol. 38 No.2 • 4/2021

Five Genes Help Predict Lewy Body Dementia

ewy body dementia usually affects people over 65 years old. Early signs of the disease include hallucinations, mood swings, and problems with thinking, movements, and sleep. Patients who initially have cognitive and behavioral problems

DAILY CLINICAL LAB NEWS

Whole-Genome Sequencing Aids Rare Disease Diagnosis

iagnostics of genetic diseases are currently being revolutionized, due to breakthroughs in sequencing technology and data analysis. The potential to transform clinical medicine using genomics is high, especially within the realm of rare diseases.

Cont’d on page 6

Rare diseases constitute a large and heterogeneous group of diagnoses that includes more than 8,000 distinct conditions of which the vast majority have a genetic basis. Each individual disease is rare, but when considered as a group, rare diseases are Cont’d on page 4

Scientists Identify Early Markers of COVID -19 Severity

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Cardiac Troponins Assessed for Acute Heart Failure

Cont’d on page 12

DiaSorin to Acquire Luminex for $1.8 Billion, Expanding Molecular Diagnostics Footprint

Noninvasive Skin Test Detects Parkinson’s

team of British investigators has developed a rapid, non-invasive method for identifying Parkinson’s disease based on compounds found on the surface of skin. The test developed by investigators at the University of Manchester (United Kingdom; www.manchester.ac.uk) was the product of previously published studies showing that volatile

eart failure (HF) is a clinical syndrome characterized by dyspnea, peripheral edema and fatigue. Diagnosing HF can be difficult due to overlapping symptoms with other conditions, and the phenotype of HF varies due to a broad spectrum of un

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Blood Biomarker for Autism Spectrum Disorder

Image: Neutrophils are part of a group of white blood cells called granulocytes and account for 55-70% of circulating white blood cells.

See article on page 4

Cont’d on page 14

he central role for neutrophil activation in the pathogenesis of severe COVID-19, may lead to the development of more accurate predictive markers of severe disease as well as new therapeutic pathways. LabMedica’s COVID-19 Diagnostics Update section starts on page 5.

n a move expected to broaden its position in the fast-growing molecular diagnostics area and strengthen its existing offerings, DiaSorin S.p.A. (Saluggia, Italy; www. diasorin.com) has signed a definitive merger agreement to acquire

Luminex Corporation (Austin, TX, USA; www.luminex.com) for approximately USD 1.8 billion. Luminex is a leader in multiplexing technology, one of the fastest growing segments in molecular diagnostics, with more than 900 Cont’d on page 18

utism spectrum disorder (ASD), a heterogeneous neurodevelopmental disorder, is characterized by deficits in social communication and social interaction, with restricted, repetitive patterns of behavior, interests, or activities. ASD impacts at least one out of every 59 children in the USA, although this is likely an underestimation. Many blood-based biomarker Cont’d on page 12

INSIDE

COVID-19 Update. . . . . 5 Clinical News. . . . . . 4-26 IFCC News. . . . . . . . . . 25 Product News . . . . . 6-28 Industry News . . . . . . . 29 Events Calendar . . 30-31

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LabMedica International

Scientists Identify Early Markers of COVID-19 Severity

or most patients, COVID-19 manifests as an upper respiratory tract infection that is self-limited. However, the progression of COVID-19 in a large subset of patients to respiratory distress, multiorgan failure, and death has resulted in an enormous global impact. Previously, a few laboratory studies had identified possible indicators of severe COVID-19, including D-dimer levels, a measure of blood coagulation, and levels of proteins known as cytokines, which are released as part of inflammatory responses in the body. A multidisciplinary team of medical scientists at Yale School of Medicine (New Haven, CT, USA; https://medicine.yale.edu) conducted a study of 49 adult patients admitted to Yale-New Haven Hospital between 13 and 24 April, 2020 with a confirmed diagnosis of COVID-19 via polymerase chain reaction (cross-sectional cohort). The team also analyzed blood samples obtained longitudinally on days 1 (within 24 hours), 4, and 7 of hospitalization from a separate cohort of 23 consecutive adult patients admitted for treatment of laboratory-confirmed COVID-19 between 23 and 28 May 2020 who remained hospitalized until at least day 4 (longitudinal cohort). Biomarker profiling analyses were conducted at Eve Technologies (Calgary, AB, Canada; www.evetechnologies.com). For the cross-sectional cohort, the following assays were performed: Human Cytokine 71-Plex, Human Complement Panels 1 and 2, Human SAA & ADAMTS13, and Human Adipokine 5-Plex. For the longitudinal cohort, the following assays were performed: Human Cytokine 48-Plex, Human Complement Panel 1, Human Adipokine 5-Plex, and Human MMP 9-Plex and TIMP 4-Plex. For confirmation, RETN levels were also measured by enzyme-linked immunosorbent assay (ELISA) (R&D Systems, Minneapolis, MN, USA; www. rndsystems.com). The scientists identified a prominent signature of neutrophil activation, including resistin, lipocalin-2, hepatocyte growth factor, interleukin-8, and granulocyte colony-stimulating factor, which were the strongest predictors of critical illness. Evidence of neutrophil activation was present on the first day of hospitalization in patients who would only later require transfer to the intensive care unit, thus preceding the onset of critical illness and predicting increased mortality. All COVID-19 patients who were admitted or transferred to the ICU had elevated neutrophil activation markers, while these biomarkers remained low for patients who never developed severe illness. None of the patients with lower neutrophil biomarker levels died. Hyung J. Chun, MD, FAHA, an associate professor of medicine and lead author of the study, said, “If a diagnostic test for these biomarkers could be ordered early, it could give us a better sense of who is more likely to become critically ill and will benefit from a higher level of care and consideration for therapies that affect the immune system early on in their hospitalization. Many of these drugs do carry potential side effects, and these tests may help identify those patients who would benefit the most.” The authors concluded that their study highlights a central role for neutrophil activation in the pathogenesis of severe COVID-19, which may help guide the development of new therapeutic strategies and more accurate predictive markers of severe disease. The study was published on February 26, 2021 in the journal Blood Advances.

Whole-Genome Sequencing Aids Rare Disease Diagnosis

cont’d from cover

common with a total prevalence of approximately 6% to 8%. Medical Molecular Scientists at the Karolinska Institutet (Stockholm, Sweden; www.karolinska.se) and their colleagues sequenced the genomes of 3,219 patients in a five year program. Clinical whole-genome sequencing (WGS) was gradually implemented at the Genomic Medicine Center KarolinskaRare Disease (GMCK-RD) over the course of five years. At first sequencing was performed on the HiSeq X Ten, but shifted to the NovaSeq 6000 (Illumina, San Diego, CA, USA; www.illumina.com) in December 2018.

Typically, samples were analyzed in a step-wise fashion, in which they were first analyzed for variants associated with the patient’s suspected disease, sometimes with very large gene panels of nearly 4,000 genes, before being escalated for additional analysis or whole-genome analysis if no diagnosis was made. To ensure there are no sample mix ups during the WGS processing, an aliquot of the extracted DNA was genotyped for 51 SNPs using MassARRAY technology (Agena Biosciences, San Diego, CA, USA; https:// agenabio.com). The scientists uncovered variants in 754 different disease genes, with the most commonly Cont’d on page 10

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ISSN 1068-1760

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LabMedica International April/2021

COVID -19 Diagnostics Update

he report that follows provides a selection of news and advances announced from February 1 to March 15, 2021. For a recap of earlier developments, the reader is invited to refer to previous issues of LabMedica or visit our website at www. LabMedica.com. Yeast-Based COVID-19 Test Could Detect SARS-CoV-2 in Saliva Faster Than RT-PCR A rapid COVID-19 diagnostic test being developed by BIOinFOOD (São Paulo, Brazil; www.bioinfood.com) that is based on a reaction between yeast and the novel coronavirus, will rapidly detect the presence of SARSCoV-2 in saliva and will be available by mid2021. The yeast-based COVID-19 diagnostic test uses a biosensor consisting of a genetically modified brewer’s yeast (Saccharomyces cerevisiae), which changes color if human ACE2 receptor expressed by the yeast’s membrane binds to the spike glycoprotein present on the external surface of the virus.

as well as other regions including Japan and Brazil. Hand-Held Biosensor Enables Immediate, Point-Of-Care Detection of SARS-CoV-2 from Saliva A handheld biosensor being developed by Blink Science, Inc. (Jacksonville, FL, USA; www.blinkscience.com) that instantaneously detects viruses and disease in saliva could revolutionize point-of-care (POC) COVID-19 testing. The company will soon bring to market, blinkTEST, a handheld biosensor device that can immediately detect COVID-19, and other disease biomarkers in saliva. Simple 15-Minute Sample-to-Answer COVID-19 Test with Desktop Detection System Costs Less than USD 2 A simple, 15-minute sample-to-answer an-

tibody test developed by researchers from the Holonyak Micro & Nanotechnology Lab at The Grainger College of Engineering University of Illinois (Urbana, IL, USA; www.illinois. edu) costs less than USD 2 and is used with a desktop detection system, making COVID-19 testing more fast, cheap, and accessible. The cost efficient COVID-19 antibody test is simple enough to be performed at schools, health clinics, pharmacies, and parts of the world where diagnostic laboratories are not available. 10-Minute COVID-19 Test Based on Nanoparticles Identifies IgG Antibodies and Costs Only Fifth of Market Average A new COVID-19 test developed by researchers at the University of São Paulo’s São Carlos Chemistry Institute (IQSC-USP; Cont’d on page 6

New COVID-19 Test Uses Smartphone Microscope to Analyze Saliva Samples and Deliver Results in 10 Minutes A new COVID-19 testing method being developed by researchers at the University of Arizona (Tucson, AZ, USA; www.arizona.edu) uses a smartphone microscope to analyze saliva samples and deliver results in about 10 minutes. The new test aims to combine the speed of existing nasal swab antigen tests with the high accuracy of nasal swab PCR, or polymerase chain reaction, tests. The researchers are adapting an inexpensive method that they originally created to detect norovirus - the microbe famous for spreading on cruise ships - using a smartphone microscope. They plan to use the method in conjunction with a saline swish-gargle test. Seegene Develops World’s First COVID-19 Mutant Identification Test Seegene, Inc. (Seoul, Korea; www. seegene.com) has developed the world’s first COVID-19 diagnostic variant test, capable of screening COVID-19 and identifying multiple mutant variations in a single reaction. Seegene’s new variant test, the Allplex SARS-CoV-2 Variants I Assay, can detect and differentiate virus variations, including those found to be more contagious and fatal. The new variant test not only detects COVID19, but can also identify major genetic variations that seem to have originated from the UK, South Africa

LabMedica International April/2021

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The KROMA Plus is a benchtop fully automated clinical chemistry analyzer with a throughput of 240 photometric tests per hour and up to 360 tests per hour with integrated ISE module.

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The StatSensor Creatinine Hospital Meter System is a handheld analyzer and miniaturized, single-use biosensor for whole blood creatinine testing. The StatSensor Creatinine incorporates patented Multi-Well™ technology.

LINEAR CHEMICALS

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INSTRUMENTATION LAB

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COVID -19 Diagnostics Update Cont’d from page 5

São Paulo, Brazil; www.fearp.usp.br) and Biolinker (São Paulo, Brazil; www.biolinker.tech) uses technology based on nanoparticles to detect antibodies to the novel coronavirus in 10 minutes and costs only a fifth of the market average. The test works similarly to the rapid tests available now in pharmacies. It analyzes a drop of blood, and two red LEDs light up if it detects the presence of immunoglobulin G (IgG) antibodies, which are produced in the acute phase of COVID-19 (10 days after the onset of symptoms on average). Pioneering Robotic COVID-19 Test Can Process 20,000 Samples for SARS-CoV-2 Testing Per 24 Hours A new COVID-19 test robot developed by scientists at the Hubrecht Institute (Utrecht, the Netherlands; www.hubrecht.eu) and Genmab (Copenhagen, Denmark; www.genmab.com) can process up to 20,000 samples for SARS-CoV-2 testing per 24 hours, making it much faster than all other systems used to date. The robot, called STRIP-1, can not only process more tests in less time than any other machine known to date, but can also track all samples precisely, because they have a barcode that is scanned multiple times throughout the process. This also enables an automatic online return of test results to the tested persons. Becton Dickinson Launches Assay for Determining COVID-19 Patients’ Risk of IMV and Mortality at Hospitalization Becton, Dickinson and Company (BD Franklin Lakes, NJ, USA; www.bd.com) has announced the CE mark of BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with expanded clinical application to help clinicians identify COVID-19 patients at increased relative risk of intubation with mechanical ventilation (IMV) and mortality at hospital admission, in conjunction with clinical findings and the results of other laboratory testing. The BD Multitest 6-Color TBNK Reagent with optional BD Trucount Tubes is a CE marked 6-color direct immunofluorescence reagent for use with a suitably equipped BD flow cytometer to identify and determine the percentages and absolute counts of T, B and natural killer (NK) cells, as well as the CD4 and CD8 subpopulations of T cells in peripheral blood. COVID-19 Diagnostic Skin Test to Measure SARS-CoV-2 Exposure and T Cell Immunity A diagnostic skin test currently under development by Tonix Pharmaceuticals Holding Corp. (Chatham, NJ, USA; www.tonixpharma.com)

NOVA BIOMEDICAL

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could have multiple potential uses, including functional measurement of T Cell immunity to SARS-CoV-2, COVID-19 diagnosis and public health surveillance; and an endpoint for COVID-19 vaccine trials. Tonix has received a written response from the US Food and Drug Administration (FDA) to a Type B pre-investigational new drug (IND) meeting package describing its technology and plans to develop a diagnostic skin test, TNX-2100 (SARS-CoV-2 epitope peptide mixtures for intradermal administration), to measure the delayed-type hypersensitivity (DTH) reaction to SARS-CoV-2 (CoV-2). New Rapid COVID-19 Test Beats ELISA Method in Identifying SARS-CoV-2 Antibodies in Blood within Just 12 Minutes A new rapid COVID-19 test to detect coronavirus antibodies developed by researchers at the University of Paraná (Paraná, Brazil; www. ufpr.br) and the University of Tübingen (Tübingen, Germany; www. uni-tuebingen.de) beats the enzyme linked immunosorbent assay (ELISA) method in delivering results within just 12 minutes, marking a milestone in the development of immunological diagnostics. The new process is based on a simple measuring principle, making it easy to carry out without expensive instruments and is therefore, suitable for use at mobile testing centers or by laboratories in less economically developed regions. DVD Technology-Based System Quickly and Inexpensively Detects SARS-CoV-2 Antigens and Specific Antibodies Researchers from the Polytechnic University of Valencia (Valencia, Spain; www.upv.es) have developed a new system at laboratory scale that allows a rapid, cheap and effective detection of COVID-19. The system consists of a biosensor based on DVD technologies, that detects specific antibodies (G, M and A) and SARS-CoV-2 antigens - differentiating them to those of influenza - in a safe way, in less than 30 minutes, by analyzing serum or saliva samples. The price of the test is estimated at less than two Euros. Portable Suitcase Mini-Laboratory for Rapid Detection of SARS-CoV-2 Provides Test Results As Good As PCR Test in Real Time A portable suitcase mini-laboratory for the rapid detection of SARSCoV-2 provides test results that are almost as good as a PCR test and almost in real time, according to new research by Leipzig University (Leipzig, Germany; www.uni-leipzig.de) in cooperation with several African universities. In the first study of the suitcase laboratory, researchers used genome analysis (RPA method, recombinase polymerase amplification) to detect an infection with SARS-CoV-2 almost in real Cont’d on page 8 LabMedica International April/2021

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SLIDE STAINER / CYTOCENTRIFUGE ELITECH GROUP

BLOOD GAS ANALYZER

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The Aerospray Hematology Stat Series 2 is a fast, economical and automated aqueous-based stainer that ensures staining is consistent with expected hematology results and is reproducible between stain cycles.

The GEM Premier 3500 blood gas analyzer measures pH, blood gases, electrolytes, metabolites and more, and is fully adaptable to the needs and volume of any point-of-care testing location or laboratory.

The DxH 600 hematology analyzer uses multi-dimensional, high-definition technology to characterize individual cells, providing enhanced visual cellular investigation with 2D data plots, surface plots and 3D cube formats.

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COVID -19 Diagnostics Update Cont’d from page 6

time, with an accuracy of 94%. Blood Biomarker Test Rapidly Identifies COVID-19 Patients Likely To Develop Severe Infection and Require Ventilator A new blood biomarker test developed by scientists at Queensland University of Technology (QUT; Brisbane, Australia; www.qut.edu.au) rapidly detects the severity of COVID-19 infections when a person with flu-like symptoms first presents to a clinic and allows clinicians to know at onset of symptoms if the patient will need ventilation. The blood biomarker test could allow doctors to differentiate the serious COVID-19 patients from those likely to experience a milder case and who could go home and self-isolate. Thermo Fisher’s TaqPath COVID-19, Flu A, Flu B Combo Kit Granted FDA Emergency Use Authorization Thermo Fisher Scientific Inc. (Waltham, MA, USA; www.thermo fisher.com) has been granted emergency use authorization (EUA) by the US Food and Drug Administration (FDA) for the company’s Applied Biosystems TaqPath COVID-19, Flu A, Flu B Combo Kit. The TaqPath COVID-19, Flu A, Flu B Combo Kit is a real-time PCR test for the detection and differentiation of RNA from the SARS-CoV2, influenza A and influenza B viruses in nasopharyngeal and nasal swabs. The kit helps labs expand their existing COVID-19 testing menu for respiratory samples while maintaining low operational costs and workflow simplicity. Diagnostic Device Identifies COVID-19 Patients at Risk of Potentially Lethal Cytokine Storm Researchers from the Australian Institute for Bioengineering and Nanotechnology (AIBN) at The University of Queensland (Queensland, Australia; www.uq.edu.au) have developed a diagnostic device, called an Immunostorm chip, that could identify which cancer and COVID-19 patients are at risk of a potentially lethal ‘cytokine storm’. The device could help healthcare workers triage and closely monitor high risk patients and to begin treatment much earlier. First-Ever Highly Sensitive Antibody Tests Could Detect Infection with All Known Human Coronaviruses, Including New SARS-CoV-2 Variants Scientists at the Center for Infection and Immunity (CII) at Columbia University Mailman School of Public Health (New York, NY, USA; www.pub

BECKMAN COULTER

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lichealth.columbia.edu) and the SunYat-Sen University (Guangzhou, China; www.sysu.edu.cn) have set the stage for the development of highly sensitive antibody tests for infection with all known human coronaviruses, including new variants of SARS-CoV-2. The CII researchers have developed the HCoV-Peptide consisting of three million immune markers on a glass chip and covering proteins of all known human coronaviruses, including the SARS-CoV-2. In collaboration with a team at the SunYat-Sen University, the CII researchers have identified 29 immune signatures specific to SARS-CoV-2. These genetic fingerprints (peptides) provide the blueprint for tests that will be used for diagnostics and surveillance. World’s First AI Rapid Antigen Test System for COVID-19 Delivers Highly Accurate Results on Smartphone within 5-8 Minutes Laipac Technology Inc. (Ontario, Canada; www.laipac.com), a developer of IoMT (Internet of Medical Things), has entered into a partnership with YAS Pharmaceuticals LLC (Abu Dhabi, UAE; www. yasholding.ae) and Pure Health LLC (Dubai, UAE; www.purehealth.ae) to launch the world’s first rapid COVID-19 antigen test system using artificial intelligence (AI). The European CE-IVD approved LooK SPOT AI COVID-19 Antigen Rapid Test System could revolutionize medical diagnostics, enabling early disease detection with consistent and accurate results. PerkinElmer Launches New Highly Sensitive Point-of-Care COVID-19 Antigen Test for Mass Screening PerkinElmer, Inc. (Waltham, MA; USA; www.perkinelmer.com) has launched the PerkinElmer COVID-19 Antigen Test for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in nasal (NS) or nasopharyngeal (NP) swab specimens. The lateral flow immunoassay test can be used to screen or to aid in diagnoses of COVID-19 in asymptomatic or symptomatic individuals. A positive or negative result can be obtained in as little as 15 minutes to facilitate immediate isolation or treatment decisions. Two New Diagnostic Tests Can Differentiate Between COVID19 Variants and Multiple Viruses with Rapid Turnaround Researchers at University of Minnesota Medical School (Minneapolis, MN, USA; www.umn.edu) have developed two new rapid diagnostic tests for COVID-19 - one to detect COVID-19 variants and one to help differentiate with other illnesses that have COVID-19-like symptoms. The first test is a rapid diagnostic test that can differentiate between COVID-19 variants and can be performed without specialized expertise Cont’d on page 9 LabMedica International April/2021

COVID -19 Diagnostics Update Cont’d from page 8

or equipment. The second, more sensitive test allows researchers to analyze the same sample simultaneously for COVID-19 (SARS-CoV-2), Influenza A and B and respiratory syncytial virus by measuring fluorescence. COVID-19 Test To Scan Saliva or Nasal Swabs Using Specialized Probes for Detecting SARS-CoV-2 RNA Sequences A new test developed by researchers at Johns Hopkins Medicine (Baltimore, MD, USA; www.hopkinsmedicine.org) has the ability to analyze and detect the many subtle changes that can occur in the SARS-CoV-2 viral genome - so-called variants, such as those first identified in the UK and South Africa. The technique scans biological specimens, including saliva or nasal swabs, using specialized DNA probes that sift through a complex “forest” of RNA sequences. Stamp-Sized Microfluidic Chip Uses Programmed Magnetic Nanobeads and Off-The-Shelf Cellphone to Diagnose COVID-19

sands of COVID-19 samples at once has the potential to revolutionize how labs track the spread of viruses and other pathogens, according to a new study by researchers from the Lunenfeld-Tanenbaum Research Institute (LTRI) at Sinai Health (Toronto, ON, Canada; www.lunenfeld.ca). In the study, the team found that their next-generation, ultra-high-throughput sequencing platform, called C19-SPAR-Se, has a sensitivity rate greater than 95% in positive cases during peak onset. Rapid Molecular Diagnostic Platform Sends Precise COVID-19 RNA Results to Smartphone in Minutes IdentifySensors Biologics (Cleveland, OH, USA: www.identifysensors.com), a nanosensor technology firm which has developed a rapid diagnostic platform for detecting pathogens, including SARS-CoV-2, has now joined

the SMART Film Consortium, led by the Birck Nanotechnology Center at Purdue University (West Lafayette, IN, USA; www.purdue.edu) that seeks to develop the first foundry dedicated to low-cost non-silicon printed sensors. The all new technology can detect COVID19 RNA in saliva through newly developed electronic nanosensors, which significantly reduces error rates associated with chemical-based home tests. New COVID-19 Test Detects Cell Mediated (T Cell) Immune Response to SARS-CoV-2 Infection Oxford Immunotec Global PLC (Oxford, UK; www.oxfordimmunotec.com) has launched the T-SPOT.COVID test, a CE marked ELISPOT based test intended for qualitative detection of a cell mediated (T cell) immune response to SARS-CoV-2 in human whole blood. The Cont’d on page 10

Researchers at Rice University (Houston, TX, USA; www.rice.edu) have developed a stamp-sized microfluidic chip that measures the concentration of SARS-CoV-2 nucleocapsid (N) protein in blood serum from a standard finger prick. The researchers argue their process simplifies sample handling compared to swab-based PCR tests that are widely used to diagnose COVID-19 and need to be analyzed in a laboratory. Next-Generation PCR-Based COVID-19 Test Can Distinguish SARS-CoV-2 Strains and Quantify Viral Load Biocept, Inc. (San Diego, CA, USA; www. biocept.com) and Aegea Biotechnologies, Inc. (San Diego, CA, USA; www. aegeabiotech.com) have entered into a supply agreement for a new PCRbased COVID-19 assay kit that uses proprietary switch-blocker technology and could provide answers which support screening and managing patients. The new COVID-19 assay is a next-generation PCR-based test using proprietary switch-blocker technology for viral RNA detection as well as discrimination of L- and S-strain types. As a result of this core technology, which enables robust single nucleotide discrimination, the assay has several technical advantages compared with other COVID-19 PCR assays. Robotic Next Generation Sequencing Platform Accurately Screens Thousands of COVID-19 Samples At Once A robotics platform to screen thou-

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BIOCHEMISTRY ANALYZER

IMMUNOASSAY ANALYZER BEIJING CHEMCLIN BIOTECH

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The NUCLISENS EASYQ real-time NASBA amplification platform an automated system combining NASBA amplification and real-time detection using molecular beacon probes for fast, sensitive, and convenient molecular testing.

AWARENESS TECHNOLOGY

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COVID -19 Diagnostics Update Cont’d from page 9

company developed the T-SPOT.COVID test as an evolution of its T-SPOT Discovery SARS-CoV-2 assay, a research use only test used to gain insights about the immune response to SARS-CoV-2. Oxford Immunotec has filed an EUA request to the FDA for the test. First-Ever Test Measures Antibodies that Prevent SARS-CoV-2 from Entering Host Cells

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Fast and Easy-To-Perform Test Detects Emerging SARS-CoV-2 Variants In Just Over One Hour A new rapid COVID-19 test developed by researchers at Rutgers University (New Brunswick, NJ, USA; www.rutgers.edu) can detect all three of the rapidly spreading variants of the SARS-CoV-2 virus in a little over one hour – much shorter than the three to five days required by current tests, which can also be more technically difficult and expensive to perform. The fast and easy-to-perform test is the first to use “sloppy molecular beacon probes,” which are highly sensitive and specific DNA sequences used to detect frequent mutations in organisms, and can help the world identify hot spots of transmission.

AXIM Biotechnologies, Inc. (San Diego, CA, USA; www.axim biotech.com) has successfully completed point-of-care clinical trials on the first-ever COVID-19 rapid diagnostic test for measuring levels of functional neutralizing antibodies that are believed to prevent SARSCoV-2 from entering the host cells has successfully completes pointof-care clinical trials. AXIM has completed point-of-care clinical trials on its ImmunoPass rapid test that semi-quantitatively measures levels of COVID-19 neutralizing antibodies to help understand COVID-19 immunity, validate vaccine’s effectiveness and estimate how long the vaccine will be effective in patients.

First-Ever T Cell-Based Test to Detect Prior SARS-CoV-2 Infection Receives FDA Emergency Use Authorization

Pioneering Platform Combines Saliva-Based Sampling, Pooled Testing and PCR Diagnostics

Machine Vision-Based Blood Analyzer Supports Validation of AI-based COVID Screening System

A pioneering COVID-19 testing platform from Mirimus, Inc. (Brooklyn, NY, USA; www.mirimus.com) combines saliva-based sampling, pooled testing and PCR diagnostics to enable high-quality, high-throughput, low-cost detection of SARS-CoV-2. Mirimus’ SalivaClear platform is designed to provide a SARS-CoV-2 diagnostic system that can be easily and repeatedly utilized by myriad organizations, from schools to businesses to government organizations, to test (and retest) groups of individuals in order to quickly isolate COVID-19 hotspots before they can become outbreaks.

A machine vision-based blood analyzer from Sight Diagnostics (Tel Aviv, Israel; www.sightdx.com) has been made part of an assessment of an AI-based test to rapidly screen for COVID-19 in patients arriving in emergency departments at the John Radcliffe Hospital - part of the Oxford University Hospitals NHS Foundation Trust (Oxford, UK; www. ouh.nhs.uk). Sight Diagnostics has deployed Sight OLO at the John Radcliffe Hospital that allows rapid FBC testing, in minutes, for patients attending the emergency departments and is supporting validation of a rapid AI triage system for COVID-19.

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Adaptive Biotechnologies Corporation (Seattle, WA, USA; www.adap tivebiotech.com) has received Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for T-Detect COVID, which is the first and only clinical T cell-based test for patients to detect the unique T-cell signature specific to SARS-CoV-2. This first-in-class T cell- based test is the first indication resulting from Adaptive’s TCR-Antigen Map collaboration with Microsoft Corp. (Albuquerque, NM, USA; www.micro soft.com).

Whole-Genome Sequencing Aids Rare Disease Diagnosis

affected genes being COL2A1 and FKRP. A number of variants were also recurrent, some of which were known founder mutations, such as Leu27Ile in FKRP, which was homozygous in 12 people with limb girdle muscle dystrophy, and homozygous expansions in the RFC1 gene among individuals with cerebellar ataxia, neuropathy,

and vestibular areflexia syndrome. Other patients, though, had variants known to arise recurrently as de novo mutations, such as one affecting the PRRT2 gene that leads to seizures. For some patients having a molecular diagnosis can change their treatment. As the team noted, patients with acute-onset inborn errors of metabolism are often treated

with glucose infusion, but for patients with pyruvate dehydrogenase deficiency, this can be harmful. Such patients are instead treated with a ketogenic diet. The scientists generated molecular diagnoses for 1,287 patients, or 40%, with a median turnaround time of 13 days. The study was published on March 17, 2021 in the journal Genome Medicine. LabMedica International April/2021

COVID -19 Diagnostics Update

Five Genes Help Predict Lewy Body Dementia cont’d from cover

are usually diagnosed as having dementia with Lewy bodies, but are sometimes mistakenly diagnosed with Alzheimer’s disease. Many patients that are initially diagnosed with Parkinson ’s disease may eventually have difficulties with thinking and mood caused by Lewy body dementia. In both cases, as the disease worsens, patients become severely disabled and may die within eight years of diagnosis. A growing body of evidence suggests genetics may play a role in the disorder and that some cases may be inherited. A large international team of scientists led by those at the National Institute of Neurological Disorders and Stroke (Bethesda, MD, USA; www.ninds.nih.gov) compared the chromosomal DNA sequences of 2,981 Lewy body dementia patients with those of 4,931 healthy, age-matched control participants. Samples were collected from participants of European ancestry at 44 sites: 17 in Europe and 27 across North America. The team found that the sequences of five genes from the Lewy body dementia patients were often different from those of the controls, suggesting that these genes may be important. It was the first time that two of the genes, called

disorders, our results support the idea that the problems that cause those diseases may also happen in Lewy body dementia. The challenge we face in treating these patients is determining which specific problems are causing the dementia. We hope studies like this one will help doctors find precise treatments for each patient’s condition.” The study was published on February 15, 2021 in the journal Nature Genetics. Image: Histopathology of Lewy bodies in the midbrain. A Lewy body in a melanized neuron from the substantia nigra. The Lewy body is the spherical body indicated by an arrow (Photo courtesy of Dr. Susan Daniel)

Hemoglobin Levels Measured with AI Microscope, Microfluidic Chips

complete blood count can help ascertain the health of a patient and typically includes an estimate of the hemoglobin concentration, which can indicate several conditions, including anemia, polycythemia, and pulmonary fibrosis. All techniques used in the estimation of hemoglobin in the blood can be classified into invasive and non-invasive. Non-invasive techniques, though very convenient because of the absence of needle prick, suffer from inferior performance; therefore, these techniques are almost always used as screening tools. Bioengineers at Sigtuple Technologies (Bengaluru, India; https://sigtuple.com) and the Indian Institute of Science (Bengaluru, India; www.iisc.ac.in) have developed a new AI-powered imaging-based tool to estimate hemoglobin levels. The setup was developed in conjunction with a microfluidic chip and an AI-powered automated microscope that was designed for deriving the total as well as differential counts of blood cells. The assay parameters, including SLS reagent-to-blood volume ratio, total reaction volume, the concentration of sodium dodecyl sulfate, and microfluidic chamber design, were optimized in order to achieve quantitation capability across a clinical range of hemoglobin using a path length suitable for the microfluidic platform. Besides quantitative correlation with a clinically accepted-validated standard method, the spectral absorption characteristics of the hemoglobin–SLS reagent mixture in the

BIN1 and TMEM175, had been implicated in the disease. These genes may also have ties to Alzheimer’s and Parkinson’s diseases. The other three genes, SNCA, APOE, and GBA, had been implicated in previous studies, and thus, strengthened the importance of the genes in Lewy body dementia. They also saw differences in the same five genes when they compared the DNA sequences of another 970 Lewy body dementia patients with a new set of 8,928 control subjects, confirming their initial results. Further analysis suggested that changes in the activity of these genes may lead to dementia and that the GBA gene may have a particularly strong influence on the disease. The gene encodes instructions for beta-glucosylceramidase, a protein that helps a cell’s recycling system break down sugary fats. The team found that both common and rare variants in the GBA gene are tied to Lewy body dementia. They also found that the genetic profiles of the patients in this study had higher chances of suffering from either Alzheimer’s or Parkinson’s disease than the age-matched control subjects. Sonja W. Scholz, MD, PhD, a Neurologist and the senior author of the study, said, “Although Alzheimer’s and Parkinson’s disease are molecularly and clinically very different

LabMedica International April/2021

newly developed assay were compared with those of conventional SLS assays. The SLS– blood/Hb standard solutions were analyzed using Erba Chem 5× clinical chemical analyzer (ERBA Diagnostics GmbH, Mannheim, Germany; www.erbadiagnostics.com), and for hemoglobin estimation, the recommended settings with absorbance measurement at 546 nm were used. All UV–vis absorption measurements were performed using the

NanoPhotometer NP 80, IMPLEN, Munich, Germany, www.implen.de). The hemoglobin concentrations of both blood samples and in-house prepared hemoglobin standard solutions were measured using a commercial XP-100 hematology analyzer (Sysmex, Kobe, Japan; www.sysmex.com). The scientists reported that the microfluidic chip in combination with an automated Cont’d on page 12

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CHEMISTRY ANALYZER BIOSYSTEMS

HIGH-SENSITIVITY TROPONIN I ASSAY SIEMENS HEALTHINEERS

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The A15 is a compact and easy to use automatic chemistry analyzer designed especially for small laboratories as their main analyzer and has a throughput of 150 tests per hour.

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The AFT-800D electrolyte analyzer is designed for accurate and rapid tests on ion concentration of Li+, K+, Na+, Cl-, Ca2+, pH value and total carbon dioxide content in serum samples.

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Blood Biomarker Discovered for Autism Spectrum Disorder

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candidates have been investigated, including neurotransmitters, cytokines, and markers of mitochondrial dysfunction, oxidative stress, and impaired methylation. However, given the prevalence of ASD, the use of machine learning to incorporate demographic and clinical data into the analysis could more powerfully examine disease status and symptom severity. Medical Scientists at the Johnson Center for Child Health and Development (Austin, TX, USA; www.johnson-center.org) enrolled a total of 154 male pediatric subjects. The ASD group was comprised of 76 subjects with a mean age of 5.6 years ± 1.7 years. The typically developing (TD) group was comprised of 78 subjects with a mean age of 5.7 years ± 2.0 years. The ethnic breakdown was as follows: 73 White/ Caucasian, 32 Hispanic/Latino, 17 African American/Black, five Asian or Pacific Islander, 23 multiple ethnicities or other, and four not reported. A panel of nine proteins was identified as optimal for predicting ASD using three computational methods. The scientists then evaluated the biomarker panel for quality using machine learning methods. The team reported that five proteins were common to all three prediction models used: mitogen-activated protein kinase 14 (MAPK14), immunoglobulin D (IgD), dermatopontin (DERM), ephrin type-B receptor 2 (EPHB2), and soluble urokinase-type plasminogen activator receptor (suPAR). These five proteins were defined as core proteins. Four proteins providing additive power were combined with the five core proteins, and together, the nine proteins resulted in an AUC of 86% (sensitivity 83%; specificity 84%). These proteins have pathway significance related to a number of processes, including negative regulation of CD8+, alpha-beta T cell proliferation, immune response, neuron projection retraction, MAPK14 activity, and glutamate receptor signaling, all of which have previously

been associated with ASD. Dwight German, PhD, a Professor of Psychiatry and senior author of the study, said, “The more significantly affected the child is, the higher or lower than normal the blood biomarker is. Ideally, there will be a day when a child is identified using blood biomarkers as being at risk for developing ASD and therapies can be started immediately. That would help the child develop skills to optimize their communication and learning.” The authors concluded that all nine proteins were significantly different in ASD compared with TD boys, and were significantly correlated with ASD severity as measured by Autism Diagnostic Observation Schedule (ADOS) total scores. Using machine learning methods, a panel of serum proteins was identified that may be useful as a blood biomarker for ASD in boys. The study was published on February 24, 2021 in the journal PLOS ONE. Image: Diagram of an LC-MS system (Photo courtesy of Wikimedia Commons)

Hemoglobin Levels Measured with AI Microscope, Microfluidic Chips

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microscope was able to achieve a Pearson correlation of 0.99 in a validation study comparing the newly developed method and a commercially available hematology analyzer, with a turnaround time of 10 minutes, including incubation time. The clinical performance was ascertained, and the method achieved a sensitivity of 92.3% and a specificity of 53.8%.

The automated microscope, which normally uses a combination of the red, green, and blue LED, used just the green LED during the hemoglobin estimation mode, and additionally, the grayscale values from the green channel of the image generated by an e-con camera. These optimized parameters, including exposure time, gain, white balance, and local tone mapping, were found to result in a setup

capable of measuring hemoglobin in the blood, which was demonstrated through a clinical verification with 27 blood samples. Besides measuring hemoglobin in the blood, a similar setup with minor modifications could be used to measure protein content, cholesterol, and glycated hemoglobin. The study was published on February 23, 2021 in the journal AIP Advances. LabMedica International April/2021

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LabMedica International

Childrens’ Urinary MicroRNAs Predict Future Development of Heart or Kidney Diseases

panel of microRNAs isolated from the urine of young children was shown to be able to predict the likelihood that a child would develop heart or kidney disease later in life. MicroRNAs (miRNAs) are short, non-coding RNAs of approximately 20 nucleotides that act as post-transcriptional regulators by modifying target gene expression. Urinary miRNAs are promising biomarkers of subclinical kidney damage or dysfunction because they reflect kidney signaling and histological changes at the molecular level, enabling early detection of chronic kidney disease or progression of acute kidney injury. Urinary miRNAs are also readily obtained and are stable in stored samples. Exosomes contain the major fraction of miRNA in urine and consequently are an ideal target to probe for molecular biomarkers of kidney diseases. Exosomes are lipid-enclosed extracellular vesicles measuring 30–150 nanometers in diameter that are released by most cells in the body and play an important role in intercellular communication by carrying bioactive molecules (soluble proteins and nucleic acids such as miRNAs) to a target cell. Exosomes in urine are primarily released from renal epithelial cells derived from renal tubular structures and hold promise as one component of a noninvasive liquid biopsy for detecting molecular changes in distinct nephron regions even in the absence of disease. Thus, the study of miRNA expression in exosomes (exo-miR) presents an opportunity in biomarker discovery for blood pressure (BP) regulation and altered renal signaling by identifying new diagnostic biomarkers and therapeutic targets. In this light, investigators at the Mount Sinai School of Medicine (New York, NY, USA; www.moun tsinai.org) sought to understand the relationship between urinary exomiR expression and children’s BP and estimated glomerular filtration rate (eGFR) as well as urinary sodium and potassium levels as correlates of heart and kidney health. For this study, the investigators extracted exo-miRs from urine samples obtained from 88 healthy Mexican children aged four to six years. The study was conducted in Mexico, since children there are considered to be at much higher risk than American children for many heart and kidney problems. Differential centrifugation of spot urines enabled isolation and detection of 193 exomiRs. Linear regression was then used to analyze the relationship between the extracted exo-miRs and children’s BP, eGFR, and urine electrolyte levels. Results revealed that three exomiRs had increased expression with urinary sodium, 17 with urinary sodium-to-potassium ratio, and one with decreased estimated glomerular filtration rate. “Our findings are encouraging for future studies of noninvasive indica-

LabMedica International April/2021

tors of kidney and heart health, especially for individuals at an increased risk of kidney dysfunction,” said senior author Dr. Alison Sanders, assistant professor of environmental medicine, public health, and pediatrics at Mount Sinai School of Medicine. “Further research may discover different combinations of miRNAs that could inform early diagnosis of a wide range of kidney and cardiac diseases. So many children around the world are at risk of developing cardiorenal problems which can impact their health throughout their lives. Assessment of microRNA expression on a targeted scale could present valuable opportunities to detect and intervene with kidney disease before it can progress. That is why we are so encouraged by our team’s work in this vital field.” The urinary microRNA study was published in the February 26, 2021, online edition of the journal Epigenomics.

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Noninvasive Skin Test Detects Parkinson’s

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compounds on skin could be used to diagnose Parkinson’s disease (PD). The compounds were localized to the sebum, which is secreted by the sebaceous glands in the skin. It is primarily composed of triglycerides (approximately 41%), wax esters (approximately 26%), squalene (approximately 12%), and free fatty acids (approximately 16%). Wax esters and squalene are unique to sebum and not produced as final products anywhere else in the body. Sapienic acid is a sebum fatty acid that is unique to humans, and is implicated in the development of acne. Sebum is odorless, but its breakdown by bacteria can produce strong odors.

For the current study, the investigators used liquid chromatography-mass spectrometry (LC-MS) to analyze 274 sebum samples taken with swabs from the upper backs of participants (80 drug naïve PD, 138 medicated PD, and 56 well matched control subjects) in order to detect metabolites that could predict the PD phenotype. Result revealed that LC-MS identified10 chemical compounds in sebum, which were elevated or reduced in PD patients. Pathway enrichment analysis indicated that there were alterations in lipid metabolism related to the carnitine shuttle, sphingolipid metabolism, arachidonic acid metabolism, and fatty acid biosynthesis. Senior author Dr. Perdita Barran, profes-

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sor of mass spectrometry at the University of Manchester, said, “We believe that our results are an extremely encouraging step towards tests that could be used to help diagnose and monitor Parkinson’s. Not only is the test quick, simple, and painless but it should also be extremely cost-effective because it uses existing technology that is already widely available. We are now looking to take our findings forwards to refine the test to improve accuracy even further and to take steps towards making this a test that can be used in the NHS (National Health Service) and to develop more precise diagnostics and better treatment for this debilitating condition.” The sebum analysis method was described in the March 11, 2021, online edition of the journal Nature Communications.

Cardiac Troponins Assessed for Acute Heart Failure

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derlying pathophysiology. Cardiac troponins are cornerstone markers for diagnosis, risk stratification and selection of treatment strategy of acute coronary syndrome (ACS). The diagnostic accuracy for ACS has greatly improved, due to novel high-sensitivity cardiac troponin (hs-cTn) assays with very low limit of detection. A team of Medical Scientists from the Akershus University Hospital (Lørenskog, Norway; www.ahus.no) and their colleagues carried out a prospective, single-center study at the hospital conducted from June 2009 through November 2010. Of 468 patients hospitalized with acute dyspnea, 314 patients were included in the final study cohort. Blood samples were obtained within 24 hours of hospital admission in all 231 patients, and day 2 and from 95 patients before discharge, in a subgroup of the cohort. Samples were centrifuged, serum immediately frozen and stored at −80 °C before

analysis. In the total population, median age was 73 years and 48% were women. To measure cTnT concentrations, the team used the high-sensitivity assay, Elecsys TnT hs stat, (Roche Diagnostics, Penzberg, Germany; www.roche.de). The assay has a range of detection from 3 to 10,000 ng/L, a 10% coefficient of variation of 13 ng/l, and a 99th percentile in healthy individuals of 14 ng/L. hs-cTnT values below the limit of detection were assigned the value 3 ng/L. N-terminal pro-B-type natriuretic peptide (NT-proBNP) was measured on a Cobas Platform (Roche Diagnostics, Basel, Switzerland; www.roche.ch) using the proBNP II assay, with a range of detection from 5 to 35,000 ng/L. The team reported that 143 patients were categorized as AHF (46%) and these patients had higher hs-cTnT concentrations than patients with non-AHF-related dyspnea: median 38 (Q1-3 22–75) versus 13 (4–25) ng/L. hs-cTnT concentrations were similar

between patients with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF), in contrast to NT-proBNP, which was higher in HFrEF. During median 27 months of follow-up, 114 (36%) patients died in the total population. Higher hs-cTnT concentrations were associated with increased risk of all-cause mortality after adjustment for clinical variables and NT-proBNP: hazard ratio 1.30 (95% CI 1.07–1.58). The authors concluded that hs-cTnT provides useful diagnostic information among patients admitted to the Emergency Department with dyspnea. In particular, elevated hs-cTnT seems to be valuable in identifying patients with HFpEF. The hscTnT also provides prognostic information for an unselected population with dyspnea, but a larger cohort is needed to examine the prognostic value of hs-cTnT for the subgroup of HF/HFrEF/HFpEF patients. The study was published in the February 2021 issue of the journal Clinical Biochemistry. LabMedica International April/2021

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The AUTO SCANION is a fully automated system for electrophoresis on cellulose acetate strips. It is suitable for the most common determinations, such as serum proteins, hemoglobins, lipoproteins, and urinary proteins.

ORTHO CLINICAL DIAGNOSTICS

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Elevated Plasma Levels of Glial Fibrillary Acidic Protein Indicate Increased Alzheimer’s Risk

recent study has demonstrated that plasma levels of the protein GFAP (glial fibrillary acidic protein) are elevated in cognitively normal older adults at risk of developing Alzheimer’s disease. GFAP is a protein in the cytoskeleton of brain astrocytes. Previous studies have shown that it can be measured in blood samples and is associated with Alzheimer’s disease (AD). However, plasma GFAP has not been investigated in cognitively normal older adults at risk of AD, based on brain amyloid-beta (Abeta) load. In the current study, investigators at Edith Cowan University (Perth, Australia; www. ecu.edu.au) compared plasma GFAP levels between cognitively normal older adults with low brain Abeta load (Abeta−) and cognitively normal older adults at risk of AD, due to high brain Abeta load, (Abeta+). They postulated that plasma GFAP levels would be higher in the Abeta+ group compared to the Abeta− group. To confirm this hypothesis, the investigators used the Quanterix (Billerica, MA, USA; www.quanterix.com) Simoa GFAP Discovery

Kit on the ultra-sensitive Single molecule array (Simoa) platform (HDx instrument) to measure levels of GFAP, Abeta1–42, and Abeta1–40. Cross-sectional analyses were carried out for plasma GFAP and plasma Abeta1–42/Abeta1–40 ratio, a blood-based marker associated with brain Abeta load, in participants (65–90 years) categorized into low (Abeta−) and high (Abeta+) brain Abeta load groups via Abeta positron emission tomography (PET). Results revealed that plasma GFAP levels were significantly higher, and plasma Abeta1–42/Abeta1–40 ratios were significantly lower, in Aß+ participants compared to Aß− participants. This finding demonstrated that plasma GFAP levels were elevated in cognitively normal older adults at risk of AD. Furthermore, these observations suggested that astrocytic damage or activation began from the pre-symptomatic stage of AD and was associated with brain Abeta load. “Blood biomarkers are becoming an exciting alternative to the existing expensive and invasive methods of diagnosing Alzheimer’s disease,” said senior author Dr. Ralph N.

Martins, professor of aging & Alzheimers disease at Edith Cowan University. “The GFAP biomarker could be used to develop a simple and quick blood test to detect if a person is at very high risk of developing Alzheimer’s. Early diagnosis is critical to allow us to implement medication and lifestyle interventions that can help delay the progression of the disease and give people more time before symptoms develop.” The study was published in the January 11, 2021, online edition of the journal Translational Psychiatry. Image: The HD-X Analyzer is the latest model of the fully automated Simoa bead-based immunoassay platform. (Photo courtesy of Quanterix)

Vitamin D Levels Tied to COVID-19 Risk for African-Americans

itamin D has diverse physiological effects, including on calcium regulation, bone density, and immune function. Deficient levels, typically defined as 25-hydroxyvitamin D (also known as calcifediol) level less than 20 ng/mL are common, especially in African-Americans individuals. Vitamin D is also important for immune function, and a meta-analysis of randomized clinical trials using daily or weekly dosing has found vitamin D supplementation was associated with substantially decreased viral

respiratory infections, especially in individuals who were deficient in vitamin D, but also individuals without a deficient level. A team of Medical Scientists from The University of Chicago (Chicago, IL, USA; www.uchicago.edu) examined whether COVID-19 test results are associated with differences in vitamin D levels of 30 ng/mL or greater, including for White individuals and for African-Americans individuals. The team assessed data from 4,638 people tested for COVID-19 from March 3, 2020 to April

10, 2020, who also had data on vitamin D levels within a year prior to COVID-19 testing. COVID-19 status was determined by the Centers for Disease Control and Prevention or Viacor polymerase chain reaction (PCR, Lee’s Summit, MO, USA; www. viracor-eurofins.com) test used until in-house testing with the Cobas SARS-CoV-2 RT-PCR (Roche Diagnostics, Rotkreuz, Switzerland; https://diagnostics.roche.com) began March 15, 2020.

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LabMedica International April/2021

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ctDNA Provides Prognostic Clues in Advanced BRAF-Mutated Melanoma Cases

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RAF mutation is a change in a BRAF gene. That change in the gene can lead to an alteration in a protein that regulates cell growth that could allow the melanoma to grow more aggressively. Approximately half of melanomas carry this mutation and are referred to as mutated, or BRAF positive. Melanoma lacks validated blood-based biomarkers for monitoring and predicting treatment efficacy. Circulating tumor DNA (ctDNA) is tumor-derived fragmented DNA in the bloodstream that is not associated with cells. Because ctDNA may reflect the entire tumor genome, it has gained traction for its potential clinical utility. Medical Scientists at the NYU Langone Health (New York, NY, USA; https://nyulangone.org) tracked circulating BRAFV600 mutation patterns in 383 individuals with melanoma, using analytically validated Droplet Digital PCR (Bio-Rad Laboratories, Hercules, CA, USA; www.bio -rad.com) profiles to pick up ctDNA mutations in individuals before and during treatment. The investigators found that enhanced levels of circulating BRAFV600 mutation fragments in the blood prior to treatment in more than 350 patients with available blood plasma samples coincided with shorter overall survival times in the melanoma patients, regardless of whether

they were getting dabrafenib or dabrafenib-trametinib treatment. In contrast, those with 64 ctDNA copies or fewer in each milliliter of blood at baseline saw overall average survival times of more than 35 months compared with 13.4 months in those with higher ctDNA levels. The team noted that patients who had BRAF mutation-based ctDNA levels that were too low to detect by Droplet Digital PCR after four weeks of treatment had longer overall survival and progression-free survival times, based on data for more than 260 melanoma patients with available plasma samples at that point in their treatment. David Polsky, MD, a Professor of Dermatology and a senior author of the study, said, “Our findings suggest that levels of ctDNA may serve as a fast and reliable tool to gauge whether an anticancer medication is working. A blood test based on such ctDNA-based markers could help support continuing the current treatment strategy or else encourage patients and physicians to consider other options.” The authors concluded that pretreatment and on-treatment BRAF V600-mutant ctDNA measurements could serve as independent, predictive biomarkers of clinical outcome with targeted therapy. The study was published on February 12 2021 in the journal Lancet Oncology. LabMedica International April/2021

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Low Lymphocyte Counts Linked to More Severe Sarcoidosis Inflammation

recent paper identified unique phenotypes of sarcoidosis and demonstrated the relationship between these phenotypes and inflammatory activity, as measured by serologic markers of inflammation and avidity on 18FDG-PET/CT scan. Sarcoidosis is a systemic inflammatory disease that can affect any organ, although it can be asymptomatic and is discovered by accident in about 5% of cases. Common symptoms, which tend to be vague, include fatigue (unrelieved by sleep; occurs in 66% of cases), lack of energy, weight loss, joint aches and pains (which occur in about 70% of cases), arthritis (14–38% of cases), dry eyes, swelling of the knees, blurry vision, shortness of breath, a dry, hacking cough, or skin lesions. Investigators at the University of Illinois at Chicago (USA; www. uic.edu) hypothesized that a set of demographic features along with clinically relevant therapeutic, radiographic, and laboratory features would identify subgroups of subjects (clusters) with sarcoidosis at risk of active disease characterized by high levels of inflammation as determined by 18FDG-PET/CT. Fluorodeoxyglucose F 18 (18F-FDG) is a radiopharmaceutical used in the medical imaging technique positron emission tomography (PET). Chemically, it is 2-deoxy-2-[18F]fluoro-D-glucose, a glucose analog, with the positron-emitting radionuclide fluorine-18 substituted for the normal hydroxyl group at the C-2 position in the glucose molecule. The uptake of 18F-FDG by tissues is a marker for the tissue uptake of glucose, which in turn is closely correlated with certain types of tissue metabolism. After 18F-FDG is injected into a patient, a PET scanner can form two-dimensional or three-dimensional images

of the distribution of 18F-FDG within the body. For this study, the investigators conducted a retrospective study of 58 mainly African American patients who had been diagnosed with sarcoidosis based on biopsy results and who also underwent PET/CT scanning. These patients all had blood tests that included lymphocyte counts. Results revealed three distinct clusters of patients: (1) a predominantly African American cluster with chronic, quiescent disease, (2) a predominantly African American cluster with elevated conventional inflammatory markers, advanced pulmonary disease and extrathoracic involvement, and (3) a predominantly Caucasian cluster characterized by reduced lymphocyte counts and acute disease. The results also showed that lymphocyte counts could predict levels of inflammation seen on PET/CT scans, with lower lymphocyte levels associated with greater levels of inflammation as picked up on the scans. “Having a biomarker signature that indicates active inflammation could be very useful in helping guide treatment and for helping us understand the underlying mechanisms associated with the disease,” said senior author Dr. Nadera Sweiss, professor of medicine at the University of Illinois at Chicago. “Using measurements of blood lymphocyte levels in combination with PET/CT scans could help guide treatment, since treatment differs for active versus inactive disease states. Our finding represents another tool in our toolbox for guiding treatment of this very variable disease, and helping us learn more about its underlying biology.” The sarcoidosis paper was published in the February 24, 2012, online edition of the journal Frontiers in Medicine.

Rapid Lateral Flow Assays Detect COVID-19 Variants and Differentiate them from Other Respiratory Viral Diseases

recent publication reported the development of two rapid diagnostic tests - one that detects COVID-19 variants and one that differentiates COVID19 from other respiratory viral diseases. Investigators at the University of Minnesota Medical School (Minneapolis/ St.Paul, USA; www.med.umn.edu) used the CRISPR/Cas9 gene editing tool to develop two rapid lateral flow diagnostic tests. CRISPRs (clustered regularly interspaced short palindromic repeats) are segments of prokaryotic DNA containing short repetitions of base sequences. Each repetition is

followed by short segments of “spacer DNA” from previous exposures to a bacterial virus or plasmid. Since 2013, the CRISPR/Cas9 system has been used in research for gene editing (adding, disrupting, or changing the sequence of specific genes) and gene regulation. By delivering the Cas9 enzyme and appropriate guide RNAs (sgRNAs) into a cell, the organism’s genome can be cut at any desired location. The conventional CRISPR/ Cas9 system from Streptococcus pyogenes is composed of two parts: the Cas9 enzyme, which cleaves the DNA molecule and specific RNA guides that shepherd the Cas9

protein to the target gene on a DNA strand. The investigators integrated commercially available reagents into a CRISPR/Cas9-based lateral flow assay (LFA) that could detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) sequences with single-base specificity. This approach required minimal equipment and represented a simplified platform for field-based deployment. They also developed a rapid, multiplex fluorescence CRISPR/Cas9 nuclease cleavage assay capable of detecting and differentiating SARSCoV-2, influenza A and B, and respiratory Cont’d on page 26 LabMedica International April/2021

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LabMedica International

Immune Response to Insulin Identifies Risk of Juvenile-Diabetes

ype 1 diabetes (T1D), also known as juvenile diabetes, is a form of diabetes in which very little or no insulin is produced by the islets of Langerhans (containing ß-cells) in the pancreas. Insulin is a hormone required for the body to use blood sugar. T-cell responses to posttranslationally modified self-antigens are associated with many autoimmune disorders. Type 1 diabetes (T1D) is a prototypical organ-specific autoimmune disease that results from the T-cell–mediated destruction of insulin-producing ß-cells within pancreatic islets. The natural history of the disease is such that it allows for the study of T-cell reactivity prior to the onset of clinical symptoms. Diabetes Specialists at the University of Colorado Anschutz Medical Campus (Aurora, CO, USA; www.cuanschutz.edu) collected blood samples from genetically at-risk adolescents every six months for two years. The team measured T-cell responses from genetically at-risk individuals to both naturally occurring insulin and hybrid insulin peptides, novel neo-epitopes implicated in T1D pathogenesis. The scientists reported that both proinflammatory (interferon-ß) and anti-inflammatory (interluekin-10) cytokine responses to hybrid insulin peptides (HIPs) were more robust than those to native peptides, and the ratio of such responses oscillated between pro- and anti-inflammatory over time. However, individuals who developed islet autoantibodies or progressed to clinical type 1 diabetes had predominantly inflammatory T-cell responses to HIPs. Additionally, several HIP T-cell responses correlated to worsening measurements of blood glucose, highlighting the relevance of T-cell responses to posttranslationally modified peptides prior to autoimmune disease development. Aaron W. Michels, MD, an Associate Professor specializing in Endocrinology, Diabetes and Metabolism, and a senior study author,

said, “We want to know why people develop T1D, and this research has helped provide a lot more information and data as to what it looks like when genetically at-risk individuals are headed towards clinical diagnosis. Ideally, you want to treat a disease when it’s active, so this is a need in our field to understand when people have an immune response directed against insulin producing cells.” The authors concluded that their results have important implications to stratify the risk of developing T1D and identifying individuals who may benefit from immune intervention studies. The study was published on Feb. 9, 2021 in the journal Proceedings of the National Academy of Sciences of the USA.

NMR-Based Method Measures Circulating Blood Citrate Levels

ecent studies show that citrate is involved in several biological processes such as inflammation, cancer, insulin secretion, acetylation of histones, neurological development and hydroxylglutaric aciduria, indicating that it has functions beyond energy regulation. Citrate associations with glaucoma, non-alcoholic fatty liver disease (NAFLD), bone disease and mortality have been observed. Monitoring circulating citrate could potentially be a diagnostic tool. While at present, urinary citrate is commonly used as a risk factor in kidney stone formation, serum/plasma citrate is scarcely utilized for disease diagnosis or prognosis. Laboratorians at the Laboratory Corporation of America Holdings (Labcorp, Morrisville, NC, USA; www.labcorp.com) took blood samples from volunteers in Greiner tubes allowed to clot (30 minutes) in an upright position and centrifuged (3,000 rpm, 10-15 minutes) immediately after clotting. Samples collected into plain red-top tubes and BD Gel Barrier serum tube (Becton Dickinson and Company, Franklin Lakes, NJ, USA; www.bd.com) were held upright (red-top tubes for 45 minutes; BD Gel Barrier tubes for 30 minutes) at room temperature to clot and were promptly centrifuged. Sample preparation (i.e., 1:1 (v/v) dilution of serum or plasma with phosphate buffer) was performed automatically on the Vantera Clinical Analyzer (Liposcience, Raleigh, NC, www. liposcience.com). One-dimensional 1H NMR spectra were collected on a 400 MHz spectrometers at 47 °C. WET was used to suppress the water signal. The total acquisition time for each spec-

LabMedica International April/2021

trum was 48 seconds. The NMR instruments are calibrated using 15 mM trimethyl acetic acid as a calibrator and reference standard to verify instrument performance on a daily basis. A restricted region of the collected spectrum, where the four citrate resonances appear, was used for quantification. To determine if the assay has adequate sensitivity to measure clinically relevant concentrations of citrate, the assay was used to quantify citrate in 533 apparently healthy adults, and in the general population (n=133,567). The team reported that the limit of quantification (LOQ) for the assay was determined to be 1.48 mg/dL. Linearity was demonstrated over a wide range of concentrations (1.40 to 4.46 mg/ dL). Coefficients of variation (%CV) for intraand inter-assay precision ranged from 5.8-9.3 and 5.2-9.6%, respectively. Specimen type comparison revealed <1% bias between serum and plasma samples, except for heparin plasma (3% bias). Stability was demonstrated up to eight days at room temperature and longer at lower temperatures. In a cohort of apparently healthy adults, the reference interval was <1.48 to 2.97 mg/dL. Slightly higher values were observed in the general population. The authors concluded that the newly developed NMR-based assay exhibits analytical characteristics that allow the accurate quantification of clinically relevant citrate concentrations. The assay provides a simple and fast means to analyze samples for clinical and other studies. The study was published on March 18, 2021 in the journal Practical Laboratory Medicine. LINKXPRESS COM

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Flow-Cytometric Expression of Endoglin Assessed in B-Acute Lymphoblastic Leukemia

ensitive detection of microsatellite instability (MSI) in tissue or liquid biopsies using next generation sequencing (NGS) has growing prognostic and predictive applications in cancer. However, the complexities of NGS make it cumbersome as compared to established multiplex-PCR detection of MSI. Tumors with MSI accumulate high numbers of somatic microsatellite (MS) insertions or deletions (indels), due to a loss of normal mismatch repair (MMR) ability. High levels of MSI are predictive for colorectal cancer (CRC) therapy outcome in chemotherapy and immunotherapy and has been associated with distinct characteristics and favorable results including better prognosis, a higher 5-year survival, and lesser metastasis. Radiation Oncologists at the Dana-Farber Cancer Institute (Boston, MA, USA; www.dana-farber.org) and their colleagues obtained snap-frozen colon adenocarcinoma stage II/III and paired normal tissue biopsies from treatment-naïve patients were obtained from the Massachusetts General Hospital Tumor Bank and gDNA was extracted using the Blood and Tissue kit (Qiagen, Hilden, Germany; www.qiagen.com). Plasma was acquired from healthy volunteers and from stage I/II colon adenocarcinoma treatment-naïve patients. cfDNA was isolated using Qiagen’s QIAamp Circulating Nucleic Acids Kit. The concentration of isolated DNA was quantified on a Qubit 3.0 fluorometer using dsDNA HS assay kit (Thermo Fisher Scientific, Waltham, MA, USA; www.thermofisher.com). To detect MSI the team developed a method called inter-Alu-PCR followed by targeted NGS that combines the practical advantages of multiplexed-PCR with the breadth of information provided by NGS. Inter-Alu-PCR employs poly-adenine repeats of variable length present in every Alu element and provides a massively-parallel, rapid approach to capture poly-A-rich genomic fractions within short 80–150bp amplicons generated from adjacent Alu-sequences. A custom-made software analysis tool, MSI-tracer, enables Alu-associated MSI detection from tissue biopsies or MSI-tracing at low-levels in circulating-DNA. To establish the method’s limit of detection in tissue samples, the scientists tested multiple scenarios using serial dilu-

tions of MSI-H tumor DNA from colon cancer into matched normal DNA. The team used droplet digital PCR to validate the dilution approach using tumor-specific somatic mutations such as KRAS for a subset of the mutations. When a paired normal sample was not present, the team found that that the method had a limit of detection of 0.15% to 0.5% percent for somatic indels using a low-tumor purity clinical sample. When matched normal tissue was available, inter-Alu-PCR had a somatic limit of detection between 0.05% to 0.5%. The team also showed how inter-Alu-PCR could be potentially used to detect MSI-related poly-adenine deletions in cellfree DNA (cfDNA) from a patient’s blood sample. Analyzing cfDNA from colon cancer patients and healthy samples, they saw that MSI-H patients produced a higher MSI-Tracer score compared to MSS or normal samples. Overall, the study authors found that inter-Alu-PCR could classify MSI using as low as 0.1 ng of input DNA from a patient’s blood sample. The authors concluded that the combined practical and informational advantages of inter-Alu-PCR make it a powerful and practical tool for identifying tissue MSI-status or tracing MSI-associated indels in liquid biopsies using minute amounts of starting material. The study was published on February 26, 2021 in the journal Nucleic Acids Research. Image: Schematic diagram for the identification of MSI status and tracing MSI+ tumors in plasma using Alu-PCR-MSI tracer (Photo courtesy of Dana-Farber Cancer Institute) LabMedica International April/2021

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LabMedica International

Three Automated Urine Analyzers Compared with Manual Microscopic Urinalysis

rinalysis is an essential screening test in clinical laboratories in order to diagnose and plan treatment for urinary tract infections, kidney disease and diabetes. Urinalysis includes visual examination, evaluation of chemical parameters and microscopic examination. Microscopic examination is fundamental to urine analysis. This is a simple way to collect informative data, but it is also labor-intensive, time-consuming, and requires experienced staff for accurate results and interpretation. Several automated urine analyzers have been introduced for urine analysis in medical laboratories. Clinical Medical Laboratorians at the Prince of Songkla University (Songkhla, Thailand; www.psu.ac.th) collected fresh 100 urine samples in preservative-free containers and transferred to four different test tubes for three automated urine analyzers without centrifuging and manual microscopy by three experienced medical technologists, independently using the same microscope slide. The scientists assessed and compared the performance of the most common three automated urine analyzers: Cobas 6500 (Roche Diagnostics, Indianapolis, IN, USA; https://diagnostics.roche.com); UN3000111b (Sysmex Corporation, Kobe, Japan; www.sysmex.co.jp); and iRICELL 3000 (Beckman Coulter, Brea, CA, USA; www. beckmancoulter.com). The Cobas 6500 is a combination of two analyzers including the Cobas u601 which analyzes physical and

enced staff is still necessary to classify urine sediments for confirmation, especially in pathologic specimens. The study was published in the March, 2021 issue of the journal Practical Laboratory Medicine. Image: The iRICELL series combines urine chemistry and microscopy in a fully automated, walk-away workcell that is easy to use and maintain and optimizes and advances urinalysis and body fluid testing (Photo courtesy of Beckman Coulter)

Toxoplasmosis Immune Status in Pregnancy Determined by Immunochromatography Assay

oxoplasmosis is a disease that results from infection with the Toxoplasma gondii parasite, one of the world’s most common parasites. Infection usually occurs by eating undercooked contaminated meat, exposure from infected cat feces, or mother-to-child transmission during pregnancy. Obstetrical toxoplasmosis involves the systematic serological screening for Toxoplasmaspecific IgG and IgM antibodies which is usually performed using enzyme-linked immunosorbent assay (ELISA) techniques. Screening tests used routinely are not sufficient and require additional techniques to determine the Toxoplasma immune status. Medical Parasitologists at the Pasteur Institute of Tunis (Tunis, Tunisia; www.pasteur. tn) selected 39 sera collected during the period 2015 to 2018 in the setting of the routine Toxoplasma serological screening in pregnant women. Sera were selected according to their anti‐Toxoplasma IgM and IgG antibodies titers in “Platelia Toxo IgG, IgM” (Bio-Rad, Marnesla-Coquette, France; www.bio-rad.com).

chemical components, and the Cobas u701 which performs microscopic examinations. The UN3000-111b has two component analyzers in a single platform including a chemical component (UC-3500 analyzer) for analyzing the physical and chemical parts of urine and a fluorescence flow cytometry component (UF-5000 analyzer) for microscopic examination of sediments. The iRICELL 3000 is a combination of two component analyzers including a chemical component (iChemVELOCITY) and a microscopic examination component (iQ200). The medical laboratorians reported that there was good correlation of urine physical and chemical analyses between the three analyzers with an overall concordance level of more than 80%. For sediment analysis, the degree of concordance between manual analysis and the three instruments was very good to good for white blood cells, red blood cells and epithelial cells, and moderate for bacteria. There were fair to good agreements between manual microscopy and the three instruments, Cobas 6500, UN3000-111b and iRICELL 3000, for casts (Cohen’s kappa 0.42, 0.38 and 0.62, respectively). The authors concluded that the three automated urine analyzers showed similar performances and good correlation with manual microscopy. The results of this study indicate that automated urine analyzers could be used for initial urine testing to reduce high workloads and to save time, but manual microscopic analysis by experi-

LabMedica International April/2021

Western blot Toxo II IgG (LDBIO DIAGNOSTICS, Lyon, France; https://ldbiodiagnostics.com) was performed for all the sera in order to precisely determine their exact Toxoplasma immune status. The LDBIO Toxoplasma ICT IgG-IgM is a rapid, simple, qualitative test based on immunochromatography technology (ICT, lateral flow). A positive test reveals the presence of anti-Toxoplasma antibodies, but does not distinguish between IgG and IgM classes. The scientists reported that in the absence of IgM and presence of IgG equivocal titers in ELISA, Toxoplasma ICT IgG-IgM and WB Toxo II results were 94.7% concordant. All positive samples in WB were also positive in ICT. The sensitivity in the detection either of low IgG titers in absence of IgM or of specific anti‐ Toxoplasma IgM was 100%. Only one serum with equivocal IgG titer by ELISA and negative with Toxo II IgG test revealed positive in ICT. However, this serum showed a P30 band in WB analysis. On the other hand, three sera Cont’d on page 28 LINKXPRESS COM

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Immune Cells in Cerebrospinal Fluid Predict Response to Immunotherapy

mmune checkpoint inhibitors including anti-PD1, anti-PD-L1, and anti-CTLA4, have shown significant clinical benefits in patients with progressive or metastatic solid tumors, including some brain metastasis. Notably, these immune-based therapies have improved outcomes for some of those suffering from lung cancer and melanoma. Some patients with brain metastasis benefit from treatment with immune checkpoint inhibitors (ICI) and the degree and phenotype of the immune cell infiltration has been used to predict response to ICI. However, the anatomical location of brain lesions limits access to tumor material to characterize the immune phenotype. Cerebrospinal fluid (CSF) can provide fundamental information about the genomic characteristics of brain tumors and hence be used as a relatively non-invasive liquid biopsy. A large team of Oncologists and their colleagues at the Vall d’Hebron University Hospital, Barcelona, Spain; www.vhio.net) analyzed samples from 48 patients with brain metastasis. The scientists assessed the immune cells present in the brain metastases, and in parallel, performed immune cell profiling of the CSF. They sought to identify

which cell types were present in the CSF and compare them with those obtained from the metastatic lesions. A total of ten CSF samples were analyzed. The team loaded samples into the 10× Genomics Chromium Controller for droplet-encapsulation (Pleasanton, CA, USA; www.10xgenomics.com). Single-cell gene expression and T cell receptor T clonotypes (TCR) were produced using the Chromium Single-Cell 5′ Library, and sequenced on a NovaSeq 6000 (Illumina, San Diego, CA, USA; www.illumina.com). Immune cell populations were determined after processing by flow cytometry using BD FACSCELESTA (immune cell characterization panel) or BD LSRFortessa cell analyzer (BD Biosciences, San Jose, CA, USA; www.bdbiosciences.com). Other methods used by the team included Immunohistochemistry, Targeted RNA profiling and, Whole exome sequencing. The team reported that tumor immune infiltration and specifically CD8+ T cell infiltration can be discerned through the analysis of the CSF. Consistently, identical T cell receptor clonotypes were detected in brain lesions and CSF, confirming cell exchange between these compartments. The analysis of immune cells of the CSF can provide a non-invasive alterna-

tive to predict the response to ICI, as well as identify the T cell receptor clonotypes present in brain metastasis. Holger Heyn, PhD, a Genomic Scientist and co-corresponding author of the study, said, “Single cell transcriptome sequencing provides the highest resolution for the detection and monitoring of several different diseases. The identification of clonal T-cells in both metastasis and liquid biopsy is of particular interest. We have shown that the sequencing of T-cell receptors provides a cellular barcode that can be assessed outside of the tumor. Importantly, this approach opens up new avenues for the detection of systemic disease.” The study was published on March 8, 2021 in the journal Nature Communications. Image: The BD LSRFortessa X-20 cell analyzer (Photo courtesy of BD Biosciences)

Rapid Lateral Flow Assays Detect COVID-19 Variants and Differentiate them from Other Respiratory Viral Diseases

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syncytial virus (RSV) in a single reaction. The LFA test strips employed bound fluorescein isothiocyanate (FITC)/6Carboxyfluorescein (FAM) and biotin to generate a positive result. Therefore, the investigators used a FITC/FAM-labeled PCR primer and a nuclease inactive (“dead”) biotinylated Cas9 and a single sgRNA specific for the

ORF8a gene of SARS-Co-V-2 to label amplicons for detection by LFA. This approach was capable of single-nucleotide resolution and avoided false positives from primer dimer or non-specific amplification artifacts that could occur with the use of tandem FITC- and biotin-labeled primers for LFA. “The approval of the SARS-CoV-2 vaccine is highly promising, but the time between

first doses and population immunity may be months,” said first author Dr. Mark J. Osborn, assistant professor of pediatrics at the University of Minnesota Medical School. “This testing platform can help bridge the gap between immunization and immunity.” The rapid LFA tests were described in the February 12, 2021, online edition of the journal Bioengineering. LabMedica International April/2021

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COVID-19 Induces a Hyperactive Phenotype in Circulating Platelets

oronavirus Disease 2019 (COVID19) is characterized by a marked pro-inflammatory response with fever, elevated inflammatory markers, and clinical and radiological features of pneumonitis being evident among affected individuals. A complex interplay is known to exist between pro-inflammatory pathway activity and blood coagulation activation; this interplay appears to represent a source of morbidity among SARS-CoV-2–infected patients, particularly among those with severe disease. Recent postmortem studies have shown evidence of widespread thrombosis in pulmonary vasculature and other organs. A large team of Biochemical Scientists from the University College Dublin (Dublin, Ireland; www.ucd.ie) and their medical colleagues at Mater Misericordiae University Hospital (Dublin, Ireland; www.

Toxoplasmic Encephalitis in HIV Patients Detected in Urine

oxoplasma encephalitis (TE) is the most commonly reported neurological opportunistic infection in human immunodeficiency virus (HIV)-infected patients since the introduction of combination ART (cART). Diagnosis of TE is challenging under the best clinical circumstances. T h e poor clinical sensitivity of quantitative polymerase chain reaction (qPCR) for Toxoplasma gondii in blood and cerebrospinal fluid (CSF) and the limited availability of molecular diagnostics and imaging technology leaves clinicians in resource-limited settings with few options other than empiric treatment. An international team of scientists led by the University of Illinois Chicago (Chicago, IL, USA; www.uic.edu) recruited in a study 164 HIV positive patients from Peru and Bolivia and 51 ambulatory HIV/T. gondii positive patients for controls. Blood and urine specimens were taken at enrollment, which for most hospitalized patients was shortly after admission; remnant CSF was collected if the subject underwent lumbar puncture as part of their medical care. CD4 and CD8 cell counts and viral loads were abstracted from participants’ charts. The investigators have described a proof of concept for novel urine diagnostics for TE using Poly-N-isoproplyacrylamide nanoparticles dyed with Reactive Blue-221 to concentrate antigens, substantially increasing the limit of detection. After nanoparticle-concentration, a standard western blotting technique with a monoclonal antibody was used for antigen detection. Toxoplasma gondii IgG serological status was determined with an in-house enzyme linked immunosorbent assay (ELISA). For qPCR, target sequences were amplified Cont’d on page 28

LabMedica International

LabMedica International April/2021

mater.ie) collected datasets describing clinical laboratory parameters among 34 hospitalized patients with severe COVID19 requiring critical care support, 20 non-severe COVID-19 not requiring critical care, and 20 non-COVID-19–affected medical inpatients not requiring critical care, were compiled from routine clinical testing results. SARS-CoV-2 infection was confirmed in all cases by RT-PCR analysis of nasopharyngeal swab specimens. The team collected blood samples and isolated platelets for the ATP secretion assay and luminescence was measured immediately using a Perkin Elmer 1420 96-well plate reader (Waltham, MA, USA; www.perkinelmer.com). Enzyme-linked immunosorbent assays were performed for thrombopoietin, P-selectin, and platelet factor 4 (R&D Systems, Abingdon, UK; www.rndsystems.com). Optical den-

sity was determined at 450 nm within 30 minutes on a Dynex DS2 (Dynex Technologies, Worthing, UK; www.dynex technologies.com). The scientists demonstrated that routine clinical blood parameters including increased mean platelet volume (MPV) and decreased platelet:neutrophil ratio are associated with disease severity in COVID-19 upon hospitalization and intensive care unit (ICU) admission. Strikingly, Cont’d on page 28

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BIONEER

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COVID-19 Induces a Hyperactive Phenotype in Circulating Platelets

using a Light Cycler (Applied Biosciences, Foster City, CA, USA; www. appliedbioscience.com). Digested samples were analyzed by parallel-reaction-monitoring (PRM) on an Orbitrap Fusion mass spectrometer with a nanospray EASY-nLC 1200 HPLC (Thermo Fisher Scientific, Waltham, MA, USA; www.thermofisher.com). The team reported that the limit of detection (LoD) of T. gondii antigens GRA1 and SAG1 was 7.8pg/mL and 31.3pg/mL, respectively. To characterize this diagnostic approach, 164 hospitalized HIV-infected patients with neurological symptoms compatible with TE were tested for 1) T. gondii serology (121/147, positive samples/total samples tested), 2) qPCR in cerebrospinal fluid (11/41), 3) qPCR in blood (10/112), and 4) urinary GRA1

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MEDIX BIOCHEMICA

(30/164) and SAG1 (12/164). GRA1 appears to be superior to SAG1 for detection of TE antigens in urine. Fifty-one HIV-infected, T. gondii seropositive but asymptomatic persons all tested negative by nanoparticle western blot and blood qPCR, suggesting the test has good specificity for TE for both GRA1 and SAG1. In a subgroup of 44 patients, urine samples were assayed with mass spectrometry PRM for the presence of T. gondii antigens. PRM identified antigens in eight samples, six of which were concordant with the urine diagnostic. The authors concluded that their results demonstrate nanoparticle technology’s potential for a noninvasive diagnostic test for TE and that GRA1 is a promising target for antigen based diagnostics for TE. The study was published on March 2, 2021 in the journal PLOS Neglected Tropical Diseases.

Vitamin D Levels Tied to COVID-19 Risk for African-Americans

The primary outcome was whether vitamin D level within 14 days was associated with testing positive for COVID-19, and the group controlled for time and vitamin D treatment changes since the vitamin D level was measured, as well as demographic characteristics and comorbidity indicators. The team reported that patients’ mean age was around 53 and 69% were women; 49% were African-Americans and 43% were White. They were stratified into four groups by vitamin D levels. African-Americans individuals were more likely than White individuals to have vitamin D levels below 20 ng/mL (36% and 16%, respectively),

and more likely to test positive for COVID-19 (9% and 5%, respectively). COVID-19 risk decreased by 5% for each 1 ng/mL increment among individuals with a level of 30 ng/mL or greater in African-Americans individuals. The authors concluded that COVID-19 risk increased among African-Americans individuals with vitamin D level less than 40 ng/ mL compared with those with 40 ng/mL or greater and decreased with increasing levels among individuals with levels greater than 30 ng/mL. No significant associations were noted for White individuals. The study was published on March 19, 2021 in the journal JAMA Network Open.

Toxoplasmosis Immune Status in Pregnancy Determined by Immunochromatography Assay

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positive in ELISA IgM and negative in ELISA IgG revealed positive in ICT and negative in WB Toxo II IgG, the reference test. The authors concluded that their results confirm the high sensitivity

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of Toxoplasma ICT IgG-IgM in detecting both specific anti-Toxoplasma IgG and IgM, and highlight the usefulness of this rapid test as a first or second-line Toxoplasma serological test in pregnant women. The study was published on March 15, 2021 in the Journal of Clinical Laboratory

COVID-19 Induces a Hyperactive Phenotype in Circulating Platelets

agonist-induced ADP release was 30- to 90-fold higher in COVID19 patients compared with hospitalized controls and circulating levels of platelet factor 4 (PF4), soluble P-selectin (sP-selectin), and thrombopoietin (TPO) were also significantly elevated in COVID19. The team showed that distinct differences exist in routine full blood count and other clinical laboratory parameters between patients with severe and non-severe COVID-19.

The authors concluded that their study indicated that platelets from patients infected with COVID-19 display a hyperactive phenotype, a factor which may contribute to thrombotic risk. These data suggest abnormal platelet reactivity may contribute to hypercoagulability in COVID-19 and confirms the role that platelets/ clotting has in determining the severity of the disease and the complexity of the recovery path. The study was published on February 17, 2021 in the journal PLOS BIOLOGY. LabMedica International April/2021

Edited by Katherina Psarra MSc, PhD

IFCC members may send news to: Katherina Psarra, MSc, PhD, Dept of Immunology – Histocompatibility, Evangelismos Hospital, Ipsilantou 45-47, Athens 10676, Greece4; Email: enews@ifcc.org

MESSAGE FROM THE PRESIDENT By Khosrow Adeli

•

President, IFCC

y cordial greetings and compliments of the spring season to you all in the IFCC family. After the declaration of the first anniversary of the COVID-19 pandemic, I hope we are all beginning to see the light at the end of the tunnel. Vaccination rates are rapidly increasing around the world—promising news that offers hope for return to normalcy, including face-to-face meetings over the coming summer and fall. First, I would like to commemorate the late Prof. Howard Morris, the IFCC Past President. As the second anniversary of his untimely passing approaches, I hope we can all take a moment to remember his numerous contributions to the field of laboratory medicine and our organization. He was a distinguished scientist, world traveler, and an active service member of the IFCC for over 20 years. To honour Prof. Morris and in his memory, we will continue his goal of promoting the value of laboratory medicine in the effort to improve patient outcomes and safety in healthcare. To this end, I am also happy to inform you that IFCC and MZ collaborated to survey all participants and corporate sponsors of the IFCC Global Conference on COVID-19, which covered the Critical Role of Clinical Laboratories in the COVID-19 Pandemic, this past February. There were over 500 responses to the survey highlighting the success of this global scientific event, with 93.7% rating the scientific program from very good/strong to excellent/very strong. Other features such as the industry workshops, industry panel, young scientist session, eExhibits, and ePosters were also rated very highly, and the majority of respondents described the overall conference as excellent. We look forward to using this feedback to continue to improve and deliver scientific conferences of high quality and demand for a worldwide audience, either virtually, in person, or as a hybrid model. With that in mind, I would like to remind you all of some important upcoming conferences, including the POCT: Making the Point Conference, which as of right now is being planned as an in-person or hybrid meeting in Rome on September 6–7, 2021. Taking place in Munich, the XV International Congress of Pediatric Laboratory Medicine (ICPLM) is planned for November 26–29, 2021, followed by the XXIV IFCC-EFLM EuroMedLab from November 28 to December 2, 2021. Last month we also announced the Joint WorldLab-APFCB Congress, which will be held on June 26–30, 2022 in Seoul. All of these meetings are incredibly valuable in achieving our goal of advancing excellence in laboratory medicine for

better healthcare worldwide, and I look forward to seeing you all there. Aside from future conferences, the new IFCC Taskforces continue to work on the 2020–2023 strategic plan, meeting on a monthly basis to push plans into action. The IFCC Taskforce on Global eLearning/eAcademy has been busy organizing global webinars as part of the IFCC Webinars Live Series 2021. This next webinar on the Application of Laboratory Techniques in the Diagnosis of Infectious Diseases will be held on April 6, 2021. Additionally, the IFCC Taskforce on COVID-19 is currently writing a new Guideline on COVID-19 Rapid Antigen Testing and discussing a potential new Guideline on Monitoring Immunity following vaccination. I hope we can all look forward to a brighter future ahead and these excellent upcoming meetings and resources that the IFCC has committed to provide. Feel free to email me at < president@ifcc.org > with your feedback, questions, or concerns.

Till next time, Khosrow

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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 April/2021

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NEWS

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

Editorial

By Katherina Psarra MSc, PhD Dear colleagues, ow nice and hopeful it is that our president Prof Khosrow Adeli is presenting the face-to-face IFCC congresses planned for 2021, 2022, in this issue! Let’s hope that we will all meet, and that new life will be added to our face-to-face meetings. Now when we really understand the force and the importance of social contact,

of casual discussions in addition to the official program meetings, of the joy of participating in dinners and opening ceremonies, getting to know the locals and their customs, everything will be more thoughtful and intense. Go through the articles in the following pages, dear colleagues. I am sure that you will find a lot of interesting information. Spring and good weather are here to stay, and vaccines cover more and more of the population, our next issue will be even more hopeful! Katherina Psarra

Change of Guard at IFCC Education and Management Division Nader Rifai takes over the Chair at IFCC-EMD as Leslie Lai winds up second term

Welcome to Nader Rifai

ader Rifai is a Professor of Pathology at Harvard Medical School, The Louis Joseph Gay-Lussac Chair in Laboratory Medicine, and Director of Clinical Chemistry at Boston Children’s Hospital. His research focused on biomarkers of cardiovascular disease. However, in the last decade his main interest shifted to dissemination of scientific information and E-learning. Dr. Rifai is active in national and international societies; he served on the Board of Directors of the AACC, NACB and ABCC, was the Chair of Lipids and Lipoproteins Division, acted twice as the Vice-Chair of Prof. Nader Rifai the AACC annual meeting. Dr. Rifai served on the IFCC Scientific Division, the Lp(a) Standardization Committee and the Education and Management Division and chaired the IFCC Visiting Lectureship programme. In addition, he is the Editor-in-Chief of Clinical Chemistry, the Founder and Co-Chair of Clinical Chemistry Trainee Council, the Senior Editor of both the Tietz Textbook & Fundamentals of Clinical Chemistry and Molecular Diagnostics and the Co-Editor-inChief of NEJM Knowledge+/AACC Learning Lab for Laboratory Medicine, an adaptive learning program. Best wishes for many successful results to the new Chair of the Education and Management Division!

Thank You to Leslie Lai

r. Leslie Lai originates from Malaysia and obtained his medical degree in 1983 from the University of London (United Medical Schools of Guy’s and St Thomas’ Hospitals). He received his MSc in Clinical Biochemistry, MD and MRCPath during a tenure as Lecturer/ Honorary Senior Registrar in Chemical Pathology at St Mary’s Hospital Medical School, Imperial College, University of London. Subsequent to six years as Senior Lecturer in Clinical Biochemistry and Metabolic Medicine at the Medical School, University of Newcastle upon Tyne and Consultant Chemical Pathologist and Head of Department at Freeman Hospital in Newcastle upon Tyne, in December 1996 Dr. Lai relocated to Prof. Leslie Lai Malaysia to serve as Professor of Clinical Biochemistry and Metabolic Medicine as well as Deputy Dean for Academic Affairs at University Putra Malaysia. From 2001 to 2004 he served as Dean of the Postgraduate Medical School at the International Medical University in Kuala Lumpur, Malaysia. Dr. Leslie Lai began his long association with the IFCC, first as a member of the Education and Management Division Executive Committee from 2004 till 2007, then as Vice Chair of the EMD from 2008 till 2013 and Chair of the EMD from 2015 till 2020, with a gap year in 2014. He was also the Chair of the IFCC-Abbott Visiting Lecturer Program from 2007 till June 2013. Dr. Leslie Lai has also had a long association with the Asia-Pacific Federation for Clinical Biochemistry and Laboratory Medicine (APFCB), having served as Chair of the APFCB Education Committee from 1998 till 2004, Vice President from 2004 till 2010 and President from 2010 till 2016. He currently serves as the Immediate Past President of the APFCB. For his long and distinguished service to the APFCB he was awarded the APFCB Distinguished Service Award in 2019. Dr. Leslie Lai’s current position is Consultant Chemical Pathologist and Laboratory Director at Gleneagles Hospital in Kuala Lumpur, Malaysia, where he also practices as a Consultant in Metabolic Medicine/Endocrinology. He was Associate Editor of Clinical Biochemistry from 2008 till 2018 and has been Associate Editor of the Malaysian Journal of Pathology since 2008. He also serves on the Editorial Board of CCLM, Pathology, Clinical Biochemist Reviews, Practical Laboratory Medicine, Indian Journal of Clinical Biochemistry and the APFCB eNews. He has published widely, particularly in the field of endocrine-related tumours and endocrinology. His clinical interests are in diabetes and endocrinology. Thank you Prof. Lai for all your hard work and commitment into leading this important IFCC Division, sharing your expertise and knowledge! LabMedica International April/2021

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

NEWS

Leading a Legacy of Healthcare Excellence at Marienhospital, Germany

mproving health outcomes through innovation and teamwork is the goal of many, if not all healthcare professionals. To quantifiably measure that difference such that stakeholders across disciplines and areas of focus can understand and appreciate significant outcomes is a feat unto itself. Matthias Orth, MD, PhD, Head of Institute for Laboratory Medicine, Marienhospital, Stuttgart, Germany and Karin-Johanna Haase, Pharmacist, Head of the Hospital Pharmacy are leaders by example, with a legacy of healthcare excellence and the only 2-time award-winning recipients of the UNIVANTS of Healthcare Excellence Awards since program inception. Dr. Orth collaborated and an integrated clinical care team, consisting of Karin-Johanna Haase, Pharmacist, Head of the Hospital Pharmacy, Sebastian Maus, MD, Head of Nephrology; Manfred Hofmann, MD, PhD, Head of Department of Gynecology and Obstetrics; were first recognized in 2019 for their care project that focuses on identifying patients at increased risk for erroneous glomerular filtration rate (GFR) estimations and consequently are at risk of potential under or overdosing of critical therapies. Through co-reporting of creatinine, as well as of cystatin C-based eGFR calculations their care team have established this new method for enabling optimal drug dosing, resulting in improved patient care, decreased healthcare costs and increased patient safety. Opportunities to strategically collaborate across the care continuum is not limited to chronic kidney disease. Impressively, Dr. Orth and Pharmacist Karin-Johanna Haase, have also received world-renown recognition in their approach to maintain patient safety during the COVID-19 pandemic. Successfully collaborating with colleagues Markus Bauer, MD, Head of Department of Occupational Health and Safety, and Stefan Reinecke, Head of Department of Internal Medicine, Infection Control, to establish and implement a SARS-CoV-2 testing strategy to mitigate risk and optimize health of healthcare workers and patients was paramount during these challenging times. Their efforts mitigated in-hospital transmission while ensuring confidence in healthcare workers that the protective measures in place do protect them, their families, and their patients, would meet high expectations. Upon doing so, none of their employees opted for paid sick leave as the fear of contracting the virus diminished and the need to help others was so strong. Marienhospital was consequently able to safely resume operations to 95% of pre-COVID-19 capacity very rapidly while also enabling visitations again. Despite widely varying care projects, these integrated clinical care initiatives share key success factors, including pathology leadership where laboratory data and key insights triggered strategic changes to clinical processes with measurable success. For more details on these best practice and/or other best practices that received recognition by the UNIVANTS of Healthcare Excellence Award program, please visit www.UnivantsHCE.com.

LabMedica International April/2021

“I really appreciate that UNIVANTS recognizes not only one discipline, but the team. We are unified, and we can only be successful when we work together.”

“When doctors work together with the laboratory, it’s incredibly interesting and rewarding. I often get new ideas for improving patient care.”

Matthias Orth, MD, PhD, Head of Institute for Laboratory Medicine, Marienhospital, Stuttgart, Germany.

Karin-Johanna Haase, Pharmacist, Head of the Hospital Pharmacy, Marienhospital, Stuttgart, Germany.

NEWS

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

VIEWPOINT

Vaccination: The Way Out!

By Bernard GOUGET; 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-National Committee for selection of the French Reference Laboratories, MoH

he COVID-19 pandemic has gripped the world, and one of the biggest challenges for researchers, health professionals, scientists and response teams has been the lack of data about the virus. Countries took drastic measures to mitigate the spread of Covid-19 on their homefront with varying degrees of success. The pandemic has pushed the health systems beyond the edge and turned everything upside down, increasing pressures for laboratory medicine transformation. To stay ahead of the demand for healthcare services, organizations worldwide are turning to advanced techniques like big data and AI and technology to overcome our vulnerabilities and make our society function better in these critical times. Using AI to track the spread of viruses and other infectious diseases improves the speed and efficiency of pandemic response allowing to make informed decisions in real time. We have been forced to figure how to deliver care, how to steamline healthcare processes, how to use the full capacity of digitalization and virtual care. We have also had a taste of what is possible with e-communication and telemedicine. In the last year alone, almost all of us have lost the joy of gathering together at our favorite places, at the congresses and more. Nevertheless, we were able to interact with colleagues and friends from all around the world in attending visio-conferences that otherwise we have no chance to participate in without extensive time and travel costs. The pandemic happened at a moment of convergence for biomedical and digital technology and social dynamics, which revealed enormous positive potential for IFCC community. The pandemic brought pain and suffering with an explosion of certain diseases. For some people, COVID-19 can cause symptoms that last weeks or months after the infection has gone (long COVID). Common long COVID symptoms include: extreme tiredness, shortness of breath, heart palpitations, problems with memory and concentration (brain fog), dizziness, difficulty sleeping,... Chronicity and comorbidity influence the risk of COVID-19 infection, affect the processes of routine care as well as the course of the disease. Elderly people and those with pre-existing chronic conditions including cardiovascular disease, cancer, hypertension, respiratory conditions and diabetes appear to be at a higher risk of developing complications and are at high risk of death. COVID-19 led to significant declines in healthcare utilization for preventive care, chronic care, and emergency care. Many patients did not care for themselves or used the healthcare system in 2020 as they typically would. Many underlying diagnoses have yet to be discovered. Not intervening early to prevent or treat developing chronic diseases will ultimately result in increased hospitalizations, morbidity and mortality. The coronavirus pandemic poses challenges to governments, public health authorities and medical personnel but also to the public, and each of us also face challenges in the form of immediate ethical questions. Are we ready to renounce our freedom to contain the pandemic? Are we sufficiently compliant with social distancing and preventative measures imposed by health authorities and governments while we are far from having attained collective immunity and while highly contagious variants complicate a tense health and epidemiological situation? In terms of public mental health, the main psychological impact at this time is a high level of stress or anxiety. With the implementation of new measures and the emergence of new impacts – in particular the quarantine and its effects on normal activities, habits or means of subsistence for many people –levels of loneliness, depression, harmful alcohol and drug use, and self-harming or suicidal behaviors will also necessarily increase. The pandemic strikes hard at our conception of the balance between our essential freedoms and the need to limit them. Weariness is starting to win over populations and caregivers. A certain indifference in the face of the death count has set in. Health organizations must prepare for the fallout of additional residual healthcare crises. Researchers and drugmakers are rushing to develop treatments that could hold the key to recovery. The pandemic sped things up. As the COVID -19 was raging, there were more cases to be tested against. It was easier to get results from vaccine trials and we got vaccines very fast. Perhaps, the development that will have the most profound implications for future generations is the incredible advances in synthetic messenger RNA (mRNA) biotechnology. Although there may have been an initial hesitation, the final acceptance of vaccines is high and the efficacy of vaccination has been demonstrated. Vaccination is the pillar of the way out of the crisis. Populations at risk must be vaccinated as a priority. Delivering billions of vaccines to stop the spread of COVID-19 worldwide will be one of the greatest logistical challenges ever undertaken. Several vaccines are

now available for public use, in limited quantities. On March 2, the WHO published the list of a first series of vaccine allocations to countries of the Covax system, but around ten countries have appropriated more than two-thirds of the vaccines. Unfortunately, we are witnessing doses being taken by bypassing Covax. It is clear, however, that the fight against the virus relies on generalized vaccination and the increased contagion risks of the virus mutations make this even more urgent. Is this situation an effect of vaccine nationalism, or is it the inevitable consequence of market management of health goods, or a combination of national selfishness and private interests? Several developing countries end up paying far too much for the vaccine. Low and Middle income countries have very unequal access to vaccines while it is necessary to vaccinate more than two thirds of population for adequate immunity. The biggest vaccination campaign in history is underway. On March 17, about 392 million doses have been administered across 128 countries, according to data collected by Bloomberg. There is still serious barriers in ramping up production and distribution. The latest rate was roughly 9.50 million doses a day. Israel leads all countries with 104.5 doses per 100 people. While the best vaccines are thought to be 95% effective, it may still be possible to spread the disease after getting inoculated. Vaccine equity is particularly important in cities, especially where people live in crowded conditions and the risks of transmission are high. The American company Pfizer-BioNTech has bowled a “strike”. The strike, as D. Seux, an economics columnist for Journal les Echos, recently reminded us is the best score in bowling, knocking down all ten pins at once. The vaccination champion in the United States, it has made up for its delivery delays in Europe... It can be said that Pfizer is emerging as the big winner, for the time being, in this race for vaccines and this global fight. This is due to its own success, as well as in contrast with the difficulties of its competitor AstraZeneca – which we hope will make a quick exit from its European purgatory. EMA and WHO vaccine safety panel said on March 18th that it considers that the benefits of the AstraZeneca Covid-19 vaccine outweigh any possible risks of side effects and recommends that vaccinations continue. It reiterated that there was “no indication” the vaccine causes blood clots, after several leading EU states paused their rollouts. In the short term, Pfizer, with its partner BioNTech, who invented the vaccine with novel messenger RNA technology, dominates the market, while Moderna is close behind. The two global factories in Kalamazoo, Michigan (US) and Puurs (BE), are in full production with the goal of producing 2.4 billion doses this year, and many more in 2022. They share roles, each manufacturing about half of the active ingredient and then calling on subcontractors everywhere. They just finalized an alliance with 13 companies to increase production capacities with high-end subcontractors including Novartis, Merck and Sanofi. The world has just passed the bar of 400 million injections of doses of all brands combined. Mid-March, the latest vaccination rate was roughly 9.50 million doses a day. Israel leads all countries with 104.5 doses per 100 people. In the U.S. an average of 2.44 million doses per day were administered. The rate is steadily increasing, and new vaccines by additional manufacturers are coming to market. The introduction of Johnson &Johnson’s one-shot option in March is speeding up vaccinations and making it easier to vaccinate hard-to-reach populations. It does not require freezing, and is effective for all age groups. COVID-19 has inflicted devastating losses. It has also delivered certain blessings. In the spring, we will still face some very difficult weeks. Questions loom large over whether governments have enough protection in place to defend themselves against the threat. The pandemic is not playing out in the same way from place to place. But we will hope that within the next few months, everyone will be able to move toward a more peaceful period. The industrial situation is changing and the challenge is to attain a significant level of global immunity. The development of the next generations of vaccines is important to counteract upcoming variants of the virus. Until we have better data, we are just going to have a lot of uncertainty. Given the extent of the volumes involved to cover all the needs, we will need all of them to inoculate a global population of some 7.8 billion people. It is humanity’s best chance of ending a scourge that has claimed more than 2.7 million lives ! The COVID-19 pandemic is a reminder that besides our duty to care, we are committed to continuous improvement. Working together, too, has expanded in ways that were hard to imagine without the new digital tools that allow for rapid sharing and collaboration. The pandemic has catalyzed changes that were already underway. The future of healthcare and laboratory medicine is shaping up in front of our very eyes with advances in digital technologies. Nothing will ever be the same. The post-COVID world will be unlike anything we know and it’s time to prepare for the new normal and achieving success. LabMedica International April/2021

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Industry News

DiaSorin to Acquire Luminex for $1.8 Billion, Expanding Molecular Diagnostics Footprint

cont’d from cover

active clients. With its leading-edge technology and extensive Life Science solutions supporting clinical and pharmaceutical research and development, Luminex is highly complementary to DiaSorin’s growing diagnostics segment. Through the acquisition, DiaSorin anticipates to strengthen the company’s existing product range while expanding its market presence in the US. The acquisition is also expected to provide access to Luminex’s applications throughout the Life Science industry, supporting access to academic and scientific research to shape market intelligence on fu-

Philips in Digital Pathology Alliance with AI Startup

oyal Philips (Amsterdam, The Netherlands) and Ibex Medical Analytics (Tel Aviv, Israel) have entered into a strategic collaboration to jointly promote their digital pathology and AI solutions to hospitals, health networks and pathology labs worldwide. The combination of Philips digital pathology solution (Philips IntelliSite Pathology Solution) and Ibex’s Galen AI-powered cancer diagnostics platform, currently in clinical use in Europe and the Middle East, empowers pathologists to generate objective, reproducible results, increase diagnostic confidence, and enable the productivity and efficiency improvements needed to cope with ever-increasing demand for pathology-based diagnostics. The announcement marks the latest extension to Philips’ AI-enabled Precision Diagnosis solutions portfolio, which leverages Philips and third-party AI solutions to deliver cutting-edge clinical decision support and optimized workflows that enable healthcare providers to deliver on the Quadruple Aim of better patient outcomes, improved patient and staff experiences, and lower cost of care. “Building on our strong portfolio to support clinical decision-making in oncology, we bring together the power of imaging, pathology, genomics and longitudinal data with insights from artificial intelligence (AI) to help empower clinicians to deliver clear care pathways with predictable outcomes for every patient,” said Kees Wesdorp, Chief Business Leader, Precision Diagnosis at Philips. “By teaming with Ibex to incorporate their AI into our Digital Pathology Solutions, we’re further able to provide a continuous pathway, where critical patient data is made visible to both pathologists and oncologists to help improve the clinician experience and patient outcomes.” “Pathology is transforming at an increasing pace and AI is one of the major drivers, supporting a more rapid and accurate cancer diagnosis,” said Joseph Mossel, CEO and Co-founder of Ibex Medical Analytics. “By joining forces with Philips, the leader in digital pathology deployments, we can offer new end-to-end solutions enabling pathologists to implement integrated, AI-powered workflows across a broader segment of the diagnostic pathway, improving the quality of patient care and strengthening the business case for digitization.”

LabMedica International April/2021

ture market trends, engaging with biopharma companies to drive opportunities for long-term partnerships (e.g., vaccine development, biological drugs) and access to clinical multiplexing assays for future Value Based Care projects based on diagnostic algorithms. “Luminex perfectly fits with our strategy to grow our positioning in the molecular diagnostics space, to broaden our presence in the US, and to create additional value through Life Science offerings,” said Carlo Rosa, CEO of DiaSorin Group. “Together, DiaSorin and Luminex will provide a unique offer to laboratories, researchers, clinicians and patients

worldwide, matching our extensive solutions in immunodiagnostics and molecular diagnostics with Luminex’s outstanding expertise in multiplexing technology and recognized leadership in life science applications.” “The combined company should provide new opportunities for our employees within a larger company that is poised to become a strong leader in the molecular diagnostics and life sciences space, and I want to thank all of our employees, customers, and partners for their contributions over our 25+ year history,” said Nachum “Homi” Shamir, CEO of Luminex.

ATTENTION: Due to the CORONAVIRUS PANDEMIC, many events are being rescheduled for a later date, converted into virtual venues, or altogether cancelled. Please check with the event organizer or website prior to planning for any forthcoming event

Events Calendar For a free listing of your event or a paid advertisement in this section contact:

International Calendar LabMedica International E-mail: info@globetech.net

MAY ISLH 2021 – International Society of Laboratory Hematology. May 4-7; Virtual Venue; Web: www.islh.org Immunology 2021 – Annual Meeting of the American Association of Immunologists (AAI). May 10-15; Virtual Venue; Web: www.immunology2021.org ASRI 2021 – 40th Annual Meeting of the American Society for Reproductive Immunology. May 14-21; Virtual Venue, USA; Web: www. theasri.org ECE 2021 – 23rd European Congress of Endocrinology. May 22-26; Virtual Venue; Web: www.ese-hormones.org KoreaLab 2021. May 25-28; Seoul, Korea; Web: www.korealab.org AFCB Congress 2021 – Arab Federation for Clinical Biochemistry and Laboratory Medicine. May 27-29; Beirut, Lebanon; Web: www. ifcc.org JUNE ExpoMED Eurasia 2021. Jun 2-4; Istanbul, Turkey; Web: expomedistanbul.com

ASCO 2021 – Annual Meeting of the American Society of Clinical Oncology. Jun 4-8; Virtual Venue; Web: am.asco.org

professional.diabetes.org/scientific-sessions

FOCIS 2021 – Annual Meeting of the Federation of Clinical Immunology Societies. Jun 8-11; Virtual Venue; Web: www.focisnet.org Virtual Pathology Days 2021 – German Society for Pathology. Jun 8-12; Virtual Venue; Web: www.pathologie-dgp.de

ESHRE 2021 – 37th Annual Meeting of the European Society of Human Reproduction and Embryology. Jul 26-30; Virtual Venue; Web: www.eshre.eu/ESHRE2021 JULY ECCMID 2021 – 31st European Congress of Clinical Microbiology & Infectious Diseases. Jul 9-12; Virtual Venue; Web: www.eccmid.org

26th Annual Congress of the European Hematology Association (EHA). Jun 9-17; Virtual Venue; Web: ehaweb.org

EAACI Hybrid Annual Congress 2021 – European Academy of Allergy and Clinical Immunology. Jul 10-12; Krakow, Poland; Web: www. eaaci.org

ESHG 2021 – European Human Genetics Conference. Jun 12-15; Virtual Venue; Web: www. eshg.org

IAS 2021 – 11th International AIDS Society (IAS) Conference on HIV Science. Jul 18-21; Virtual Venue; Web: ias2021.org

BIO International Convention 2021 Jun 10-18; Virtual Venue; Web: convention.bio.org UKMedLab21 – Annual Conference of the Association for Clinical Biochemistry & Laboratory Medicine (ACB). Jun 14-18; Virtual Venue; Web: www.acb.org.uk

ASV 2021 – 40th Annual Meeting of the American Society of Virology. Jul 19-23; Virtual Venue; Web: asv.org/asv2021 AUGUST

FIME 2021 – Florida International Medical Expo. Sep 1-3; Miami, FL, USA; Web: www. fimeshow.com Thailand LAB International 2021. Sep 1-3; Bangkok, Thailand; Web: www.thailandlab.com ECI 2021 – 6th European Congress of Immunology. Sep 1-4; Virtual Venue; Web: eci2021.org 43rd Annual Meeting of the European Thyroid Association (ETA). Sep 4-7; Virtual Venue; Web: www.eta2021.com ESCV – 23rd Annual Meeting of the European Society for Clinical Virology. Sep 15-17; Virtual Venue; Web: www.escv2021.org ExpoMedical 2021. Sep 22-24; Buenos Aires, Argentina; Web: www.expomedical.com.ar AFCC Congress 2021 – African Federation of Clinical Chemistry. Sep 23-25; Lusaka, Zambia; Web: www.ifcc.org India Lab Expo & Analytica Anacon India. Sep 23-25; Hyderabad, India; Web: www.analyticaindia.com

World Microbe Forum – American Society for Microbiology (ASM) & Federation of European Microbiological Societies. Jun 20-24; Virtual Venue; Web: www.worldmicrobeforum.org

11th African Congress of Immunology – Federation of African Immunological Societies. Aug 1-5; Lilongwe, Malawi; Web: www.faisafrica. com

Medlab Middle East 2021. Jun 21-24; Dubai, UAE; Web: www.medlabme.com

Medical Fair India 2021. Aug 19-21; New Delhi, India; Web: www.medicalfair-india.com

SLAS Europe 2021 Conference & Exhibition – Society of Laboratory Automation and Screening. Jun 22-25; Vienna, Austria; Web: slaseurope2020.org

IFBLS 2021 – International Federation of Biomedical Laboratory Science. Aug 24-28; Copenhagen Denmark; Web: ifbls2021.org

73rd AACC Annual Scientific Meeting & Clinical Lab Expo – American Association for Clinical Chemistry. Sep 26-30; Atlanta, GA, USA; Web: www.aacc.org

33rd Congress of the European Society of Pathology (ESP). Aug 29-31; Virtual Venue; Web: www.esp-congress.org

EUROTOX 2021 – 56th Congress of the European Societies of Toxicology. Sep 26 - Oct 1; Virtual Venue; Web: eurotox-congress.com

81st Scientific Sessions of the American Diabetes Association. Jun 25-29; Virtual Venue; Web:

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ASHI 2021 – 47th Annual Meeting of the American Society for Histocompatibility & Immunogenetics. Sep 27 – Oct 1; Orlando, FL, USA; Web: www.ashi-hla.org

MEDICA 2021. Nov 15-18; Dusseldorf, Germany; Web: www.medica-tradefair.com

EndoBridge 2021. Oct 21-24; Virtual Venue; endobridge.org

AMP 2021 –Annual Meeting & Expo of the Association for Molecular Pathology. Nov 18-20; Philadelphia, PA, USA; Web: www.amp.org

EASD 2021 – 57th Annual Meeting of the European Association for the Study of Diabetes. Sep 27 - Oct 1; Virtual Venue; Web: www. easd.org

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Analitica Latin America 2021. Sep 28-30; Sao Paulo, Brazil; Web: www.analiticanet.com.br

ASCP 2021 – Annual Meeting of the American Society for Clinical Pathology. Oct 27-29; Boston, MA, USA; Web: www.ascp.org

58th Annual Scientific Conference of the Australasian Association of Clinical Biochemistry and Laboratory Medicine (AACB). Sep 28-30; Brisbane, Australia; Web: www.aacb.asn.au 90th Annual Meeting of the American Thyroid Association (ATA). Sep 29 - Oct 3; Virtual Venue; Web: www.thyroid.org OCTOBER

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61st Annual Academic Assembly of the Japan Society of Clinical Chemistry. Nov 5-7; Fukuoka, Japan; Web: jscc-jp.gr.jp

Journées Francophone de Biologie Médicale (JFBM). Oct 6-8; Rennes, France; Web: www. jfbm.fr

53rd National Congress of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC). Nov 11-13; Virtual Venue; Web: www.sibioc.it

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MEDLAB Asia Pacific 2021. Oct 20-22; Bangkok, Thailand; Web: www.medlabasia.com

32nd Regional Congress of the International Society of Blood Transfusion (ISBT). Nov 1316; Brisbane, Australia; Web: isbtweb.org

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2022 Fertility 2022– Joint Conference of the UK Fertility Societies. Jan 5-7; Liverpool, UK; Web: fertilityconference.org

Labquality Days 2022 – International Congress on Quality in Laboratory Medicine. Feb 10-11;

WSPID 2022 – 12th World Congress of the World Society for Pediatric Infectious Diseases. Feb 22-24; Virtual Venue; Web: wspid2021. com

India Lab Expo & Analytica Anacon India. Apr 20-21; Mumbai, India; Web: www.analyticaindia.com

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IFCC WorldLab Seoul 2022 – 24th International Congress of Clinical Chemistry and Laboratory Medicine. Jun 26-30; Seoul, Korea; Web: www. ifcc.org ICE 2022 – 20th International Congress of Endocrinology. Aug 25-28; Singapore; Web: www.isendo.org APFCB 2022 – 16th Congress of the Asia-Pacific Federation of Clinical Biochemistry and Laboratory Medicine. Oct 15-18; Sydney, Australia; Web: apfcbcongress2022.org

Advertising Index Page

Vol. 38 No. 2 4/2021

Inq.No. Advertiser

Page

– AACC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 – AFCC Regional Conference . . . . . . . . . . . . . 33 123 Alcor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 125 Bioperfectus. . . . . . . . . . . . . . . . . . . . . . . . . . 25 105 DiaSys. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 – Euromedlab 2021. . . . . . . . . . . . . . . . . . . . . . 31 115 Instrumentation Laboratory . . . . . . . . . . . . . . 15 121 Instrumentation Laboratory . . . . . . . . . . . . . . 21 – LabMedica. . . . . . . . . . . . . . . . . . . . . . . . . . . 27 109 NG-Biotech. . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 102 Nova Biomedical . . . . . . . . . . . . . . . . . . . . . . . 2 107 Randox. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 136 Randox. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 119 Seegene. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 111 Singuway. . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 103 Snibe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 117 Snibe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 120 Vicotex. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Provided as a service to advertisers. Publisher cannot accept responsibility for any errors or omissions.

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