LabMedica International September 2021 by Globetech

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Annual Meeting & Clinical Lab Expo

ISSN 1068-1760

Vol. 38 No.5 • 8-9/2021

Markers for Severe Dengue Identified

engue is the most common mosquito-borne viral disease to affect humans globally. In 2019, the World Health Organization identified dengue as one of the top 10 threats to global health, with transmission occurring in 129 countries and an estimated

DAILY CLINICAL LAB NEWS

Genomic Differences Cause Racial Disparities in Prostate Cancer

rostate cancer is a disease defined by the abnormal growth of cells. These abnormal cells can proliferate in an uncontrolled way and, if left untreated, form tumors which may metastasize or spread to other parts of the body. Prostate cancer (PCa) is the most common

solid organ malignancy in men, with 174,650 new diagnoses and 31,620 deaths expected in 2019 in the USA alone. Effective prognosis and personalized treatment regimens for PCa require identifying tumor-specific genomic factors and events and

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Plasma ACE2 Predicts Prognosis of Hospitalized COVID-19 Patients

19-Protein Panel Detects Alzheimer’s

19-protein biomarker panel distinguished Alzheimer’s disease (AD) patients from healthy individuals with greater than 96% accuracy and differentiated among the early, intermediate, and late stages of AD while monitoring the progression of the disease. To capitalize on results obtained by studies showing the potential of blood proteins as candidate biomarkers for AD, Cont’d on page 14

Biomarkers Diagnose and Predict Acute Pancreatitis

levated baseline plasma ACE2 levels in COVID-19 patients have been found to be significantly associated with increased disease severity in COVID-19 patients, thereby expanding viral spread and disease burden.

cute pancreatitis (AP) is an inflammatory reaction caused by the activated pancreatic enzymes in the pancreas, which leads to subsequent pancreatic autodigestion, edema, hemorrhage, necrosis, and even distal organ dysfunction. Conventional biomarkers such as amylase, lipase, C-reactive protein (CRP), and leukocytes are less specific in assessing the severity

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Liquid Biopsy Test Accurately Detects Over 50 Types of Cancer

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esults from a clinical study confirmed that a noninvasive liquid biopsy-based blood test could accurately detect more than 50 types of cancer and could be used as a multi-cancer screening test among individuals at higher risk of the disease, including asymptomatic individuals aged 50 years or older.

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IL, Inova, Biokit to Unite Under Werfen Brand Name

erfen (Barcelona, Spain) companies, including Instrumentation Laboratory (IL), Inova Diagnostics (Inova), and Biokit, are uniting under one name and one brand – Werfen. As part of this effort, the company has completed organizational transitions and adopted a new global

brand identity, including a new corporate logo. While IL, Inova and Biokit have been part of Werfen since 1992, 2009, and 1973, respectively, they will now be known simply as Werfen. The company has been known as Werfen outside of North America since 2014. The strategic Cont’d on page 37

INSIDE

COVID-19 Update. . . . . 4 Clinical News. . . . . . . . 10 IFCC News. . . . . . . . . . 33 Product News . . . . . 6-32 Industry News . . . . . . . 37 Events Calendar . . . . . 38

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LabMedica International

he report that follows provides a selection of news and advances announced from June 15 to July 30, 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. New Rapid COVID-19 Diagnostic Tests Use Innovative Techniques that Improve Accuracy Rivaling Gold Standard PCR Test Researchers at University of Maryland School of Medicine (Baltimore, MD, USA; www.med school.umaryland.edu) have developed two rapid diagnostic tests for COVID-19 that are nearly as accurate as the gold-standard test currently used in laboratories. Unlike the gold standard test, which extracts RNA and uses it to amplify the DNA of the virus, these new tests can detect the presence of the virus in as little as five minutes using different methods. They do not require the extraction of the virus’s RNA - which is both complicated and time consuming. Both tests are more reliable than the rapid antigen tests currently on the market, which detect the virus only in those with significantly high viral levels. Low Cost, Saliva-Based COVID-19 Test Inspired By Glucose Test Strips for Diabetes Detects SARS-CoV-2 in 15 Minutes Researchers from the University of Strathclyde (Glasgow, Scotland; www.strath. ac.uk) are developing a rapid, low cost and mass manufacturable saliva-based biosensor test for COVID-19 inspired by the glucose test strips used to check blood sugar levels in people with diabetes. The team claims that the test could eventually be mass manufactured for as little as 20 pence per test. It is designed for rapid in the field use, similar to a lateral flow test, to allow people in community settings to determine their COVID-19 status. Comprehensive Study of COVID-19 Detection Tools and Technologies to Help Develop Low-Cost Device for Use by Anyone, Anywhere A team of researchers led by engineers at Concordia University (Montreal, Canada; www. concordia.ca) has sifted through hundreds of research papers for determining the COVID19 detection tools and technologies that best detect the virus in order to help develop a low-cost device for use by anyone, anywhere. The researchers hope that identifying current weaknesses in our diagnostic tools will help avoid the need of adopting drastic measures like lockdowns and shuttering the economy when the next pandemic emerges. New COVID-19 Test Combines AI and Nanopore Technology to Detect SARS-CoV-2 at POC in Five Minutes Researchers at Osaka University (Osaka, Japan; www.osaka-u.ac.jp) have developed a new highly sensitive test for the SARS-CoV-2

virus that utilizes a fusion of artificial intelligence (AI) and nanopore technology which may enable rapid point-of-care testing for COVID19. The team demonstrated that single virus particles passing through a nanopore could be accurately identified using machine learning. The test platform they created was so sensitive that the coronaviruses responsible for the common cold, SARS, MERS, and COVID could be distinguished from each other. This work may lead to rapid, portable, and accurate screening tests for COVID and other viral diseases. Low-Cost, Easy-To-Use Lab-on-Paper SARS-CoV-2 Diagnostic Test Provides Accurate Results within an Hour Researchers at University of Connecticut (Mansfield, CT, USA; www.uconn.edu) have invented an easy-to-use, affordable lab-on-paper diagnostic technology for SARS-CoV-2, the virus that causes COVID-19 infection, that provides accurate results within an hour. The device uses a specialized kind of paper material to detect for two SARS-CoV-2 genes - the spike (S) and nucleoprotein (N) genes. The clinical samples validated these genes as good candidates for diagnostic tests because they are highly conserved. This means they are so essential to the virus they are likely found in all variants. By testing two genes rather than one, the test is more accurate. Easy-To-Use Breath Test Uses AI Algorithm to Accurately Detect COVID-19 in Less Than One Minute A new COVID-19 breath test system developed by Breathonix Pte Ltd (Singapore; www. breathonix.com) detects volatile organic compounds (VOCs) in a person’s exhaled breath to generate results within one minute. The BreFence Go COVID-19 breath test system has received provisional approval from Singapore’s Health Sciences Authority (HSA), and is the first breath analysis system to secure such authorization in Singapore. The BreFence Go COVID-19 breath test system works by detecting VOCs in a person’s exhaled breath that are produced by biochemical reactions in human cells. New Lateral Flow Test is Cheaper, Easier to Use and as Reliable as PCR Test for Diagnosing SARS-CoV-2 Infection A SARS-CoV-2 lateral flow test designed at King Abdullah University of Science and Technology (KAUST; Thuwal, Saudi Arabia; www.kaust.edu. sa) that combines two bacterial enzymes with genetic sequences and a couple of probes is cheaper and easier to use than PCR tests while producing comparably reliable results. Called Vigilant, the test can detect very small amounts of viral RNA in a sample. PCR tests, which are conducted in laboratories, produce more reliable results but are expensive and require sophisticated equipment and skilled personnel. Thermo Fisher Launches CE-IVD Marked Next-Generation TaqPath COVID-19 2.0 Test Thermo Fisher Scientific Inc. (Waltham, MA, USA; www.thermofisher.com) has launched a Cont’d on page 5

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ISSN 1068-1760 Vol.38 No.4. Published, under license, by Globetech Media LLC; Copyright © 2020. All rights reserved. Reproduction in any form is forbidden without express permission. Opinions expressed are solely those of the authors, and do not represent an endorsement, or lack thereof, by the Publisher of any products or services. Teknopress Yayıncılık ve Ticaret Ltd. Şti. adına İmtiyaz Sahibi: M. Geren • Yazı işleri Müdürü: Ersin Köklü Müşir Derviş İbrahim Sok. 5/4, Esentepe, 34394 Şişli, İstanbul P. K. 1, AVPIM, 34001 İstanbul • E-mail: Teknopress@yahoo.com Baskı: Postkom A.Ş. • İpkas Sanayi Sitesi 3. Etap C Blok • 34490 Başakşehir • İstanbul Yerel süreli yayındır. Yılda sekiz kere yayınlanır, ücretsiz dağıtılır.

LabMedica International August-September/2021

COVID -19 Diagnostics Update Cont’d from page 4

new CE-IVD-marked COVID-19 test named the TaqPath COVID-19 Fast PCR Combo Kit 2.0., expanding its menu of highly accurate tests that detect active SARS-CoV-2 infections. The kit uses an advanced assay design which compensates for current and emerging variants by using eight total targets across three genomic regions of the virus. This approach helps to ensure the test provides accurate results even as the virus that causes COVID-19 continues to mutate. Non-Invasive and Low-Cost Test Uses Phone Swabs to Accurately Detect COVID-19 An accurate, non-invasive, and low-cost method of testing for COVID-19 developed by UCL researchers at Diagnosis Biotech (Las Condes, Chile; www.diagnosis-bt.com) uses samples taken from the screens of mobile phones. In their study, the team analyzed swabs from smartphone screens rather than directly from people, and found that people who tested positive by the regular nasal swabbing PCRs were also positive when samples were taken from phone screens. The new method - known as Phone Screen Testing (PoST) - detected the COVID-19 virus on the phones of 81 to 100% of contagious people with a high viral load, suggesting it is as accurate as antigen lateral flow tests.

gy-independent, point-of-care device can be used to predict the severity of a COVID-19 infection or a person’s immunity against variants of the virus. New Technology Offers Cost-Effective Method for Finding New SARS-CoV-2 Variants Researchers in the Bienko-Crosetto laboratory at Karolinska Institutet and Science for Life Laboratory (SciLifeLab; (Stockholm, Sweden; www.ki.se) have developed a technology for cost-effective surveillance of the global spread of new SARS-CoV-2 variants. The new method, named COVseq can be used for surveillance of the viral genome on a massive scale at a low cost. Automated Microarray Rapid Test Detects SARS-CoV-2 Antibodies in |Eight Minutes Researchers at the Technical University of

Munich (Munich, Germany; www.tum.de) have developed a versatile and reliable automated microarray rapid test for detecting SARS-CoV-2 antibodies that provides results in only eight minutes. The low-cost automated rapid test is highly sensitive and highly specific in detecting the three most important antibodies. IgG antibodies against a protein fragment of the SARS-CoV-2 receptor binding domain (RBD), the spike protein (S1 fragment) and the nucleocapsid protein (N) are simultaneously analyzed. Graphene-Based Sensor That Detects SARS-CoV-2 Could Mark Breakthrough in Coronavirus Detection Researchers at the University of Illinois (Chicago, IL, USA; www.uic.edu) have successfully used graphene - one of the strongest, thinnest known materials - to detect the SARS-CoV-2 Cont’d on page 6

Molecular Test for Detecting SARSCoV-2 in Saliva Ideal for Frequent Screening Researchers at Columbia University’s Zuckerman Institute (New York, NY, USA: www.columbia.edu) have developed a simple, inexpensive, and sensitive molecular test for the detection of SARSCoV-2 in saliva that is ideal for frequent screening. WHotLAMP, the rapid molecular test to detect SARS-CoV-2 in saliva, is simple to use, highly sensitive (3.6 viral RNA copies per microliter of saliva) and specific, as well as inexpensive, making it ideal for frequent screening. Moreover, WHotLAMP does not require toxic chemicals or specialized equipment and thus, can be performed in point-of-care settings, and may also be adapted for resource-limited environments or home use. Test That Accurately Distinguishes SARS-CoV-2 from Other Coronaviruses Could Also Predict COVID-19 Severity Biomedical engineers at Duke University (Durham, NC, USA; www. duke.edu) have demonstrated a tablet-sized device that can reliably detect multiple COVID-19 antibodies and biomarkers simultaneously. Initial results show the test can distinguish between antibodies produced in response to SARSCoV-2 and four other coronaviruses with 100% accuracy. The researchers are now working to see if the easy-to-use, ener-

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MOLECULAR DIAGNOSTIC SYSTEM AB ANALITICA

SARS-COV-2 RNA DETECTION KIT BIORON DIAGNOSTICS

ANTIGLOBULIN TESTS SENSITIVITY CONTROL QUOTIENT DIAGNOSTICS

iPonatic performs rapid nucleic acid isolation and amplification in about 40-50 min in a special package (monostest), providing fast reliable results for diagnosis of coronavirus, other pathogens, and specific molecular markers.

The RealLine SARS-CoV-2 lyo assay kit is intended for the detection of coronavirus SARS-CoV-2 RNA in clinical specimens (nasopharyngeal and oropharyngeal swabs, sputum, bronchoalveolar lavage fluid).

The ALBAcheck-BGS AlbaSure Sensitivity Control Kit is intended for use as a sensitivity control of antiglobulin tests. The kit Anti-K, Anti-c and Anti-E have been prepared from plasma collected from blood donors.

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COVID -19 Diagnostics Update Cont’d from page 5

virus in laboratory experiments. The team believes that the discovery could be a breakthrough in coronavirus detection, with potential applications in the fight against COVID-19 and its variants. New Corona Mass Test up to 100 Times More Sensitive than Rapid Antigen Tests A new corona test developed at the University Hospital Bonn (Bonn, Germany; www.ukbonn.de) can analyze a large number of swabs simultaneously using sequencing technology and has a similarly high sensitivity as the common qPCR test. The innovative corona test “LAMP-Seq” offers the possibility to test many people regularly for the SARS-CoV-2 virus. It offers great potential, especially for systematic testing in daycare centers, schools or companies. COVID-19 Rapid Tests Perform On Par With PCR Tests, Finds New Study Rapid antigen tests perform on par with lab tests when used every three

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days, according to a new screening study by researchers at the National Institutes of Health (NIH; Bethesda, MD, USA; www.nih.gov), thus building the case for frequent COVID-19 antigen testing. The study found that detecting SARS-CoV-2, the virus that causes COVID-19, improves with regularity of testing, whether using rapid antigen tests or PCR molecular tests. Technological Breakthrough Can Rapidly Scale Up Testing for SARS-CoV-2 RNA to Stop Spread of COVID-19 A new SARS-CoV-2 testing technology developed by scientists at UCLA Health (Los Angeles, CA, USA; www.ucla.edu) that leverages next-generation sequencing (NGS) to massively scale up testing capacity could stop the spread of COVID-19 and future pathogens. The high-throughput COVID-19 testing platform for SARS-CoV-2 named Swab-Seq that has been developed by UCLA scientists uses sequencing to detect COVID-19. SwabSeq uses sample-specific molecular barcodes to simultaneously analyze thousands of samples for the presence or absence of SARS-CoV-2. NGS of pooled samples tagged with sample-specific molecular barcodes enables the testing of thousands of nasal or saliva samples for SARS-CoV-2 RNA in a single run without the need for RNA extraction, offering the potential to rapidly scale up testing to stop the spread of COVID-19. Ortho’s Quantitative COVID-19 IgG Antibody Test First to Receive FDA Emergency Use Authorization Ortho Clinical Diagnostics’ (Raritan, NJ, USA; www.orthoclinicaldiag nostics.com) VITROS Anti-SARS-CoV-2 IgG Quantitative Test has become the first quantitative COVID-19 IgG antibody test to receive US Food and Drug Administration (FDA) Emergency Use Authorization (EUA). Ortho’s new quantitative COVID-19 IgG antibody test targets the S1 spike protein and is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. The test offers 100% specificity and excellent sensitivity. Portable PCR System Compresses Entire Molecular Diagnostic Laboratory into Single Device for COVID-19 Testing at POC QuantuMDx Group Limited (Newcastle upon Tyne, UK; www.quan tumdx.com) has launched a new portable PCR system that compresses an entire molecular diagnostic laboratory into a simple to use, accessible and affordable single device, offering rapid, molecular diagnostic testing at the point of care, with results in approximately 30 minutes. QuantuMDx has launched Q-POC - a rapid, PCR point of care diagnostic system - and its first test, a SARS-CoV-2 detection assay, which are now CE-IVD marked under the In Vitro Diagnostics Directive (98/79/EC), enabling use within Europe.

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Cont’d on page 7

LabMedica International August-September/2021

COVID -19 Diagnostics Update Cont’d from page 6

High-Sensitivity Neutralizing Antibody Test Detects Strength of Individual Immune Response to COVID-19 A multi-dimensional immune response test from Aditxt, Inc. (Richmond, VA, USA; www. aditxt.com) that tracks multiple combinations of antibody responses against several different antigens for COVID-19 has been enhanced to include a high-sensitivity neutralizing antibody diagnostic, which makes it possible to assess the strength of an individual’s immune response to the SARS-CoV-2 virus. Aditxt has made enhancements to its AditxtScore for COVID19 which now includes virus-specific infection blocking antibodies that assess the strength of an individual’s immune response to SARS-CoV-2. Global COVID-19 Diagnostic Market to Excede USD 65 Billion by 2028

sion of the virus circulating around the world. Seegene has received the CE-IVD mark for its Allplex SARS-CoV-2 Variants II Assay, a new lineup of the company’s variant detection kits capable of detecting the key genetic mutations of SARSCoV-2 variants such as L452R, W152C, K417T and K417N. In a single reaction, the variants diagnostic kit identifies a total of six COVID-19 variants that are known to be originated from India such as Delta, Delta Plus, and Kappa, and Gamma (Brazil), Beta (South Africa), and Epsilon (California).

ox.ac.uk), Institute for Advanced Studies (Vienna, Austria; www.ihs.ac.at), and the Medical University of Graz (Graz, Austria; www.medunigraz.at) has found that lateral flow tests detect COVID-19 with similar accuracy to laboratory-based PCR tests, providing they are used at the onset of infection and soon after symptoms start. The finding could be pivotal to strategies looking to tackle the next phase of the pandemic, especially as timely and rapid testing becomes even more important once restrictions are lifted.

Lateral Flow Tests Detect COVID-19 with Similar Accuracy to Laboratory-Based PCR Tests When Used at Onset of Symptoms

New Highly Sensitive Blood Test Accurately Measures Immunity against SARS-CoV-2

A new study by researchers at Queen Mary University of London (London, UK; www.qmul. ac.uk), University of Oxford (Oxford, UK; www.

Scientists at the Lausanne University Hospital (CHUV; Lausanne, Switzerland; www. lausanneuniversityhospital.com) and EPFL Cont’d on page 8

The global COVID-19 diagnostics market is predicted to grow from USD 49 billion in 2020 and register a stable CAGR of 3.5% from 2021-2028 to reach USD 65.75 billion in 2028, driven by the extensive use of coronavirus diagnostic kit to detect any traces of the virus quickly. These are the latest findings of Research Dive (Pune, India; www. researchdive.com), a market research firm. Blood Test That Quantifies Protein ACE2 and ACE2 Fragments Can Monitor SARS-CoV-2 Infection A blood test that quantifies the protein ACE2, the cellular protein which allows entry of the coronavirus into cells, as well as ACE2 fragments, produced as a result of interaction with the virus, could be a simple and effective method for monitoring SARS-CoV-2 infection, according to a study by the UMH-CSIC Neurosciences Institute (Alicante, Spain; www.umh.es). The study carried out during the first wave of the pandemic, found that patients with COVID-19, in the acute phase of infection, have significantly reduced plasma levels of the full-length ACE2 protein, which SARSCoV-2 binds to enter cells, compared to non-infected controls. In addition, the plasma levels of a lower molecular mass (70 kDa) ACE2 fragment, generated as a result of interaction with the virus, are increased. Seegene Launches New Multiplex PCR Test Capable of Screening Six SARS-CoV-2 Variants Seegene, Inc. (Seoul, Korea; www. seegene.com) has launched a new SARSCoV-2 variant diagnostic test capable of screening newly emerging virus variants including the Delta and the Delta Plus that have become the dominant ver-

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MOLECULAR DIAGNOSTICS SYSTEM GENMARK DIAGNOSTICS

IMMUNE PROFILING SYSTEM FLUIDIGM

MULTIPLEX GENETIC ANALYZER AGENA BIOSCIENCE

The ePlex system is a sample-to-answer solution that streamlines diagnostic workflow, integrating the entire process from order-to-report to realize patient and laboratory benefits of rapid, multiplex molecular diagnostics.

The Maxpar Direct Immune Profiling System is the first complete sample-to-answer solution for high-dimensional immune profiling of human PBMC and whole blood. It features CyTOF technology on the Helios system.

The MassARRAY Dx Analyzer is a benchtop multiplex genetic analyzer that simplifies the complex clinical genetics environment with easy-to-interpret data, flexible biomarker detection and robust performance.

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COVID -19 Diagnostics Update Cont’d from page 7

(École polytechnique fédérale de Lausanne; Switzerland; www.epfl.ch) have developed a new test that is sensitive enough to measure the amount of SARS-CoV-2 neutralizing antibodies present in the bloodstream. The discovery opens up promising new avenues for tracking immunity acquired by infection or vaccination. With this test, experts can measure the level of protection against variants of the virus and monitor their prevalence over time. New Diagnostic Test Could Detect Biological ‘Fingerprints’ of Long COVID in Blood Markers in our blood – ‘fingerprints’ of infection – could help identify individuals who have been infected by SARS-CoV-2, the coro-

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navirus that causes COVID-19, several months after infection even if the individual had only mild symptoms or showed no symptoms at all, according to researchers at University of Cambridge (Cambridge, England; www. cam.ac.uk). The researchers have received funding from the National Institute for Health Research to develop a test that could complement existing antibody tests. They also aim to use similar biological signatures to develop a test and monitor for long COVID. AACC Publishes New COVID-19 Guidelines for Clinical Laboratories The American Association for Clinical Chemistry (AACC; Washington, DC, USA; www.aacc.org) has released new guidance that offers answers on SARS-CoV-2 antibodies for clinical laboratorians amidst constant questions and emerging data about serologic testing. The document provides information about serologic assay design, antibody classes,

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and the kinetics of the humoral immune response, as well as verification and validation of both EUA and LDTs. It also discusses four indications for serologic testing: supporting the diagnosis of COVID-19 and related sequelae (e.g., multisystem inflammatory syndrome in children); identifying potential convalescent plasma donors and manufacturing of convalescent plasma; epidemiologic and seroprevalence studies; and vaccine efficacy studies. COVID-19 Severity Test Reads Immune System in Real Time Using Machine Learning for Predicting Severe Outcomes A new COVID-19 test from MeMed (Haifa, Israel; www.me-med.com) reads the immune-system in real time to accurately determine whether SARS-Cov-2 patients are likely to have a severe outcome. MeMed has received the CE Mark in Europe for its new disease management solution, MeMed COVID-19 Severity - a pioneering host response technology that measures multiple proteins from a serum sample and applies machine learning to stratify the risk that a patient with COVID-19 disease is likely to experience severe outcomes. New Sensor Uses “Glow-In-The-Dark” Signal to Indicate Presence of Molecules Associated with COVID-19 in Blood A research team at Eindhoven University of Technology (Eindhoven, Netherlands; www.tue.nl) and Utrecht University (Utrecht, the Netherlands; www.uu.nl) has developed a new type of sensor that combines the sensitivity and accuracy of current laboratory-based measurements with the speed and low-cost of current home tests. The new sensor uses a “glow-in-the-dark” signal to indicate the presence of tiny amounts proteins and anti-drug antibodies, as well as COVID-19 spike proteins and antibodies in blood.

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SEPSIS DETECTION TEST

AUTOMATED CHEMILUMINESCENCE IMMUNOASSAY SYSTEM MEDCAPTAIN

REAL-TIME PCR SYSTEM

The fully automated SeptiCyte RAPID is a rapid host-response test that distinguishes sepsis from non-infectious systemic inflammation (INSI/SIRS). The test provides actionable results in about one hour.

The Immu F6 is a point-of-care Automated Chemiluminescence Immunoassay System that utilizes Acridinium ester direct chemiluminescence technology to provide accurate quantitative results by using whole blood.

The AriaMx Real-Time PCR system is a fully integrated qPCR solution for amplification, detection, and data analysis, combining a novel thermal cycler, an advanced optical system, and comprehensive data analysis software.

BIOCARTIS

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Markers for Severe Dengue Identified

cont’d from cover

3.9 billion people being at risk. Biomarkers are used to identify the state or risk of a disease in patients. Examples of biomarkers can include naturally occurring molecules or genes in the vascular, inflammatory or other biological pathways. New findings could aid the development of biomarker panels for clinical use and help improve triage and risk prediction in patients with dengue. A large team of international scientists led by the Oxford University

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Clinical Research Unit (OUCRU, Ho Chi Minh City, Viet Nam; www. oucru.org) conducted a study using samples and clinical information from a large multi-country observational study. Of the 2,694 laboratory-confirmed dengue cases included in the study, 38 and 266 cases were classified as severe and moderate dengue, respectively. The team selected 281 cases in four countries, Vietnam, Cambodia, Malaysia and El Salvador, as the blood samples from these participants were stored at the OUCRU laboratory. For comparison, the team also selected 556 patients with uncomplicated dengue who shared similar geographies and demographic characteristics. The biomarkers were measured at two time points: at enrollment (illness day 1-3) and after recovery (day 10-31 post-symptom onset), if available. Eight biomarkers: VCAM-1, SDC-1, Ang-2, IL-8, IP-10, IL1RA, sCD163, sTREM-1, were combined in a premixed magnetic bead panel (R&D Systems, Minneapolis, MN, USA; www.rndsystems.com). C-reactive protein (CRP) was measured using a separate commercial magnetic bead panel (EMD Millipore Corporation, Burlington, MA, USA; www.emdmillipore.com). These panels were analyzed using the Luminex200 analyzer with the Luminex calibration (Austin, TX, USA; www.luminexcorp.com). Ferritin was measured using the Human Ferritin ELISA kit (Arigo Biolaboratories, Hsinchu City, Taiwan, ROC; www.arigobio.com). The investigators reported that on days 1-3 from symptom onset, higher levels of any biomarker increased the risk of developing severe and moderate dengue (S/MD). When assessing together, SDC-1 and IL-1RA were stable, while IP-10 changed the association from positive to negative; others showed weaker associations. The best combinations associated with S/MD comprised IL-1RA, Ang-2, IL-8, ferritin, IP-10, and SDC-1 for children, and SDC-1, IL-8, ferritin, sTREM-1, IL-1RA, IP10, and sCD163 for adults. They found that, during the first three days of illness, higher levels of any of the 10 biomarkers increased a patient’s risk of developing moderate to severe dengue. Sophie Yacoub, PhD, a Consultant Physician and a senior author of the study, said, “Together, our findings should assist the development of biomarker panels to help improve future triage and early assessment of dengue patients. This would help improve individual patient management and healthcare allocation, which would be of major public health benefit especially in outbreak settings.” The authors concluded that higher levels of the ten biomarkers (VCAM-1, SDC-1, Ang-2, IL-8, IP-10, IL-1RA, sCD163, sTREM-1, ferritin, and CRP), when considered individually, are associated with increased risk of adverse clinical outcomes in both children and adults with dengue. The study was published on June 22, 2021 in the journal eLife. LabMedica International August-September/2021

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The Fecal Occult Blood (FOB) One Step Assay is a rapid chromatographic immunoassay (non-invasive assay) for the qualitative detection of human hemoglobin in human feces specimens to screen for gastrointestinal bleeding.

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Genomic Differences Cause Racial Disparities in Prostate Cancer

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discovering disease-associated mechanisms. Although previous studies have demonstrated the existence of genomic differences between African-American (AAM) and EuropeanAmerican (EAM) men, the underlying mechanisms driving poor survival in AAM patients are not completely understood. Urologists at the Icahn School of Medicine at Mount Sinai (New York, NY, USA; https:// icahn.mssm.edu) and their colleagues analyzed a cohort of 1,152 men, 596 of whom were African American and 556 of whom were European American, and all of whom had undergone radical prostatectomy. Overall, African-American men had higher pre-treatment prostate-specific antigen levels and higher scores indicating increased risk of post-surgery recurrence, emphasizing the more aggressive disease generally found among AfricanAmerican men. From post-radical prostatectomy (RP) formalin-fixed paraffin-embedded blocks were submitted for Decipher testing. Submitted tumor tissue included the highest GG with at least 0.5 mm2 of tissue. RNA was extracted using

the RNeasy kit (Qiagen, Santa Clara, CA, USA; www.qiagen.com), and cDNA was prepared and amplified using the NuGEN Ovation WTA assay (NuGEN, Redwood City, CA, USA; www. nugen.com) and hybridized to Human Exon 1.0 ST microarrays (Thermo Fisher Scientific, Carlsbad, CA, USA; www.thermofisher.com). Quantitative real-time PCR was analyzed on the CFX384 Touch real-time PCR system (Bio-Rad Laboratories, Hercules, CA, USA; www.bio-rad.com). Comparative analyses between the race groups were conducted at the clinical, genomic, pathway, molecular subtype, and prognostic levels. The EAM group had increased ERG and ETS expression, decreased SPINK1 expression, and basal-like molecular subtypes. After adjusting for confounders, the AAM group was associated with higher expression of CRYBB2, GSTM3, and inflammation genes (IL33, IFNG, CCL4, CD3, ICOSLG), and lower expression of mismatch repair genes (MSH2, MSH6). At the pathway level, the AAM group had higher expression of genes sets related to the immune response, apoptosis, hypoxia,

and reactive oxygen species. EAM group was associated with higher levels of fatty acid metabolism, DNA repair, and WNT/beta-catenin signaling. The authors concluded that their findings suggest that African-American men who undergo radical prostatectomy should be closely monitored following treatment, as they are generally at increased risk for recurrence. The study was published on June 3, 2021 in the journal Communications Biology. Image: The CFX384 Touch real-time PCR detection system (Photo courtesy of BioRad)

Two Immunoassays Compared for Determination of Serum Vitamin D

itamin D is a fat-soluble steroid prohormone that is generated mainly in the skin by photochemical conversion of 7-dehydrocholesterol. 25-hydroxyvitamin D (25(OH)D) is its main storage form and is present in blood at very high concentration with respect to the active form 1,25-dihydroxyvitamin D. The difficulties in the determination of 25(OH)D are related to its fat soluble nature, as well as its strong binding to the vitamin D binding protein (VDBP) and to serum albumin. On the other hand, although it would be appropriate for the different immunoassays to

detect vitamin D2 and D3 in equimolar form, this is not usually fulfilled. Clinical Biochemists at the Hospital Universitario Miguel Servet (Zaragoza, Spain; http://sectorzaragozados.salud.aragon.es) carried out a transversal descriptive observational study on a total of 184 individuals. The median age of the total of patients was 61 years old, with a minimum of 1 year and a maximum of 92. There were 31.5% men and 68.5% women. The samples came from both healthy patients and patients with various pathologies as bone, kidney, thyroid, cardiovascular, immune, neurological diseases

and cancer. The concentration of 25(OH)D was measured, as routine health analysis, by the automated IDS-iSYS 25VitD assay in an IDSiSYS Multi-Discipline Automated System Analyzer (Vitro, Immunodiagnostic Systems Holdings PLC, Boldon Colliery, UK; www.id splc.com), which uses a chemiluminescence technology, which is fully automated. The same samples were processed by the Alinity i 25-OH Vitamin D assay in an Alinity i automated Analyzer (Abbott, Abbott Park, IL, USA; www.corelaboratory.abbott), which is Cont’d on page 28 LabMedica International August-September/2021

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Circulating Tumor DNA Following Surgery Predicts Colorectal Cancer Recurrence

ccording to a recent paper, levels of circulating tumor DNA (ctDNA) – which can be measured using noninvasive liquid biopsy – predict the likelihood of recurrence of colorectal cancer following surgery. Previous studies have shown that ctDNA analysis, as a marker of minimal residual disease, is a powerful prognostic factor in patients with nonmetastatic colorectal cancer (CRC). In this regard, investigators at the Walter and Eliza Hall Institute (Melbourne, Australia; www.wehi.edu.au) performed a validation study to confirm the prognostic impact of postoperative ctDNA in resectable (treatable by surgery) colorectal liver metastases (CRLM) observed in a previous discovery study. For this study, the investigators used a liquid biopsy approach, based on the Illumina (San Diego, CA, USA; www.illumina.com) Safe-sequencing system (Safe-Seq). Safe-Seq assigns a unique identifier (UMI) to each template molecule and amplifies each uniquely tagged template molecule to create UMI families. The abundance of each UMI can be used to distinguish between rare mutations and technical errors and it can also be used to correct for PCR amplification bias. In the current study, the Safe-Seqbased liquid biopsy was used to evaluate 54 patients with resectable CRLM to confirm the ability of postoperative ctDNA to detect microscopic residual disease and predict relapse. The investigators also analyzed serial ctDNA during and after chemotherapy. Results revealed that ctDNA was detected in 24% of patients immediately after surgery, and these patients had a very high recurrence risk of 83% compared to only 31% in those with undetectable ctDNA after surgery. All patients with detectable postoperative ctDNA who failed to clear their ctDNA following adjuvant chemotherapy experienced recurrence, while 67% of patients whose ctDNA became undetectable after chemotherapy remained disease-free. “What we found is that if ctDNA is present after surgery, it predicts an almost 100% recurrence rate for these patients. In contrast, for patients who were ctDNA-negative after surgery, the likelihood of the cancer reoccurring was far lower, about 25%,” said first author Dr. Jeanne Tie, associate professor of medical oncology at the Walter and Eliza Hall Institute. “This biomarker could also identify whether patients would respond to chemotherapy treatment. Until now, we had no way of measuring the effectiveness of chemotherapy in real time. The usual process is to do the surgery to remove the cancer metastases, give the patient chemotherapy, and then follow up with CT scans every six to 12 months, to see if the cancer recurs. And if the cancer does recur, you know the treatment has not worked. By measuring the ctDNA in the blood, we could immediately see whether the chemotherapy had cleared the cancer and were therefore able to predict the likelihood of the cancer recurring.”

LabMedica International August-September/2021

The ctDNA study was published in the May 3, 2021, online edition of the journal PLOS Medicine. Image: Crypts and buds in the small intestine and colon (Photo courtesy of Dr. Maree Faux, Walter and Eliza Hall Institute)

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Mucin Protein a New Prognostic Biomarker for Chronic Obstructive Pulmonary Disease

he mucin protein MUC5AC has been shown to be a novel biomarker for chronic obstructive pulmonary disease (COPD) prognosis and for testing the efficacy of potential therapeutic agents. COPD is an inflammatory lung disease that causes obstructed airflow from the lungs and affects about 16 million people in the USA. Symptoms include breathing difficulty, coughing, mucus production, and wheezing. Development of COPD has been linked to long-term exposure to irritants and especially to cigarette smoking. Investigators at the University of North Carolina (Chapel Hill, USA; www.unc.edu) previously described the contributions of increased total airway mucin concentrations to the pathogenesis and diagnosis of the chronic bronchitic component of COPD. In the current study, they investigated the relative contribution of each of the major airway gel-forming mucins, MUC5AC and MUC5B, to the initiation, progression, and early diagnosis of airways disease in COPD.

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Over the course of the study, they used stable isotope-labelled mass spectrometry to measure levels of MUC5AC and MUC5B in induced sputum samples taken from 331 participants (mean age 63 years) in the multicenter SPIROMICS study, of whom 40 were healthy nonsmokers, 90 were at-risk smokers, and 201 were smokers with COPD. Participants were extensively characterized using results from a variety of questionnaires, Results revealed that increased MUC5AC concentrations were more reliably associated with manifestations of COPD than were MUC5B concentrations. Increased MUC5AC, but not MUC5B, concentration at baseline was a significant predictor of COPD progression during the three-year follow-up period. Moreover, current smokers in the at-risk group showed raised MUC5AC concentrations at initial visits and decreased lung function over three years. By contrast, former smokers in the at-risk group showed normal MUC5AC concentrations at the initial visit and preserved lung function over three years.

“Currently, we cannot forecast which individuals in the at-risk smokers group will progress to COPD because we do not have an objective biological marker to underpin the disease-causing pathways. Our research shows that MUC5AC could be a predictor of who will develop COPD from the large group of aging “at-risk” smokers,” said senior author Dr. Mehmet Kesimer, professor of pathology and laboratory medicine at the University of North Carolina. “We think MUC5AC could be a new biomarker for COPD prognosis and it could be a biomarker for testing the effectiveness of therapeutic strategies. Our data indicate that increased MUC5AC concentrations in the airways may contribute to the initiation of COPD, as well as disease progression, symptom exacerbation, and how the disease progresses over time, in general. We did not observe the same association with MUC5B.” The study was published in the May 28, 2021, online edition of the journal The Lancet Respiratory Medicine.

19-Protein Panel Detects Alzheimer’s

investigators at Hong Kong University of Science and Technology (China; www.ust. hk) and their colleagues at University College London (United Kingdom; www.ucl.ac.uk) systematically profiled the plasma proteome to identify novel AD blood biomarkers and develop a high-performance, blood-based test for AD. To do this, they used a proximity extension assay technique to quantify 1160 plasma proteins in samples obtained from a Hong Kong Chinese cohort. Proximity extension assay (PEA) is a direct one-step protein quantification method using a pair of DNA oligonucleotides linked to antibodies against the target molecule.

It requires polyclonal or two monoclonal antibodies that bind to target epitopes close enough to form a DNA duplex which is quantified by real-time PCR. The results of the PEA analysis identified 429 proteins that were dysregulated in the plasma of AD patients. The investigators selected 19 “hub proteins” representative of the AD plasma protein profile, which were used to form the basis of a scoring system that accurately classified clinical AD (as characterized by the presence of amyloid, tau, phosphorylated tau, and neurodegeneration). In addition to distinguishing AD patients from healthy individuals with more than 96% accuracy, the system could also differentiate

among the early, intermediate, and late stages of AD and be used to monitor the progression of the disease over time. “With the advancement of ultrasensitive blood-based protein detection technology, we have developed a simple, noninvasive, and accurate diagnostic solution for AD, which will greatly facilitate population-scale screening and staging of the disease,” said senior author Dr. Nancy Ip, professor of life science at Hong Kong University of Science and Technology. The plasma protein screening method for detection of Alzheimer’s disease was described in the May 25, 2021, online edition of Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association. LabMedica International August-September/2021

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The CoronaCHEK COVID-19 IgG/IgM Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum, or plasma.

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Liquid Biopsy Test Accurately Detects Over 50 Types of Cancer

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The Circulating Cell-Free Genome Atlas study (CCGA) was a prospective, case-controlled, observational study and demonstrated that a bloodbased multi-cancer early detection (MCED) test utilizing cell-free DNA (cfDNA) sequencing in combination with machine learning could detect cancer signals across multiple cancer types and predict cancer signal origin (CSO) with high accuracy. Liquid biopsy analysis of circulating cfDNA from peripheral blood has emerged as a valuable diagnostic tool in oncology, since sample collection is quick and minimally invasive. In cancer patients, cfDNA consists in part of cancer-derived circulating tumor DNA (ctDNA), and it has been shown that tumor-related genetic and epigenetic alterations can be detected by analyzing cfDNA in cancer patients. As a consequence, cfDNA analysis holds great promise for precision oncology and personalized therapies, and is currently being evaluated in a broad range of clinical studies. The CCGA study was designed to develop and validate an MCED test to detect cancer signals across multiple cancer types and predict CSO via a single blood draw. Modeled data from this test have shown that its use in the general population could shift cancer detection from

stage IV to earlier stages (stages I-III), potentially reducing cancer mortality. CCGA was divided into three studies; in the first, a comprehensive comparison of genomic sequencing approaches identified that whole-genome bisulfite sequencing (WGBS; detecting genome-wide DNA methylation status) outperformed other methods. In the second study, the selected WGBS assay was refined into a targeted methylation assay, and machine learning classifiers for cancer detection and CSO prediction were developed. The objective of this third and final CCGA study was to validate an MCED test version further refined for use as a screening tool. To this end the GRAIL, Inc. (Menlo Park, CA, USA; https://grail.com) Galleri MCED test was used to evaluate 4077 participants (2823 with cancer and 1254 normal controls), Results revealed that the MCED test detected cancer signals from more than 50 different types of cancer and found that across all four cancer stages (I, II, III, IV), the test correctly identified when cancer was present (the sensitivity or true positive rate) in 51.5% of cases. The test’s specificity (the true negative rate) was 99.5%, meaning that the test wrongly detected cancer (the false positive rate) in only 0.5% of cases. For all cancers, detection improved with each cancer stage with a sensitivity rate of 16.8% at the

early stage I, 40.4% at stage II, 77% at stage III and 90.1% at stage IV - the most advanced stage when symptoms are often showing. In addition, the multi-cancer early detection test correctly identified the tissue in which the cancer was located in the body in 88.7% of cases. First author, Dr Eric Klein, chairman of the Glickman Urological and Kidney Institute at the Cleveland Clinic (OH, USA: www.clevelandclinic.org), said, “Finding cancer early, when treatment is more likely to be successful, is one of the most significant opportunities we have to reduce the burden of cancer. These data suggest that, if used alongside existing screening tests, the multi-cancer detection test could have a profound impact on how cancer is detected and, ultimately, on public health. We believe that cancers that shed more cfDNA into the bloodstream are detected more easily. These cancers are also more likely to be lethal, and prior research shows that this multi-cancer early detection test more strongly detects these cancer types. Cancers such as prostate shed less DNA than other tumors, which is why existing screening tests are still important for these cancers.” The third CCGA study was published in the June 24, 2021, online edition of the journal Annals of Oncology.

Novel Dengue Virus IgG Rapid Diagnostic Test Evaluated

engue fever is a mosquito-borne tropical disease caused by the dengue virus. Symptoms typically begin three to fourteen days after infection. These may include a high fever, headache, vomiting, muscle and joint pains, and a characteristic skin rash. The virus has five serotypes; infection with one type usually gives lifelong immunity to that type, but only short-term immunity to the others. Subsequent infection with a different type increases the risk of severe complications. A number of tests are available to confirm the

diagnosis including detecting antibodies to the virus or its RNA. Scientists at Sanofi Pasteur (Lyon, France; www.sanofi.com) tested their novel lateral flow immunoassay, OnSite Dengue immunoglobulin G (IgG) on blood samples that had been archived from participants aged 6 to 16 years in two phase three trials. Each serum sample was first tested using a plaque reduction neutralization test (both PRNT90 and PRNT50 levels) and an IgG ELISA for anti-nonstructural protein 1 (anti-NS1) to establish the baseline (pre-vaccination) dengue virus

serostatus. A total of 346 blood samples tested seronegative for the dengue virus. The investigators used all of these seronegative samples to evaluate the specificity of the rapid diagnostic test, and the results showed a specificity of 98.0%. For sensitivity, a random subset of 233 blood samples that were seropositive for dengue virus were used. The sensitivity of the rapid diagnostic test to be able to identify previous dengue virus infection status was found to be 95.3%. Cross-reactivity of the rapid diagnostic test to Cont’d on page 29 LabMedica International August-September/2021

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Sensitive PCR Test Predicts Treatment Response in Metastatic Head and Neck Cancers

recently developed droplet digital PCR (ddPCR)-based assay for circulating tumor DNA (ctDNA) from human papillomavirus HPV16 (which is responsible for almost 90% of HPVpositive oropharyngeal cancers) predicts treatment response in metastatic human papillomavirus related (HPV+) oropharyngeal squamous cell carcinoma (OPSCC). Head and neck squamous cell carcinomas (HNSCC) constitute 3–5% of all malignancies worldwide and there are approximately 600,000 newly diagnosed cases annually. The majority of patients with HNSCC present with locally and/or regionally advanced disease at diagnosis. Despite the rising incidence of HPV + OPSCC, treatment of metastatic disease remains palliative rather than curative. Even with new treatments such as immunotherapy, response rates are low and can be delayed, while even mild tumor progression in the face of an ineffective therapy can lead to rapid death. Real-time biomarkers of response to therapy could improve outcomes by guiding early change

of therapy in the metastatic setting. Investigators at the University of Michigan (Ann Arbor, USA; www. umich.edu) turned to a sensitive liquid biopsy-based PCR test for such biomarkers. The classical PCR test carries out one reaction per single sample. The digital PCR (dPCR) method also carries out a single reaction within a sample, however the sample is separated into a large number of partitions and the reaction is carried out in each partition individually. This separation allows a more reliable collection and sensitive measurement of nucleic acid amounts. The dPCR method has been demonstrated as useful for studying variations in gene sequences - such as copy number variants and point mutations - and it is routinely used for clonal amplification of samples for next-generation sequencing. Droplet digital PCR (ddPCR) is a variation of dPCR in which a 20 microliter sample reaction including assay primers and either Taqman probes or an intercalating dye, is divided into about 20,000 nanoliter-sized oil droplets through a water-oil emulsion technique, thermocycled to endpoint in a 96-well PCR plate, and fluorescence amplitude read for all droplets in each sample well in a droplet flow cytometer. In initiating the current study, the investigators hypothesized that: 1) a HPV16 ctDNA test would offer a precise assay for detection of HPV+ OPSCC and 2) the assay would predict progressive disease prior to radiographic imaging in patients undergoing treatment for recurrent or metastatic HPV+ OPSCC. Thus, they developed and analytically validated a highly sensitive and specific ddPCR assay for absolute quantification of HPV ctDNA from plasma specimens and performed an evaluation of clinical utility in a prospective, longitudinal patient cohort. For this study the investigators analyzed more than 100 samples taken over nearly two years from 16 patients with advanced cancers that were positive for HPV16. Seven of the patients were treated with immunotherapy regimens. Eleven patients underwent treatment that included chemotherapy. Results revealed that increasing levels of HPVpositive circulating tumor DNA after a course of treatment were a strong indicator that the cancer was not responding to the treatment. Furthermore, it was found that the tumor DNA could be detected months earlier than tumor growth that could be measured on imaging scans. “Currently, the only way doctors know if a treatment is working is for the patient to get an imaging scan every few months to see whether their tumors are shrinking,” said contributing author Dr. Paul Swiecicki, assistant professor of medical oncology at the University of Michigan. “And this is not fully accurate since some cancers show what we call pseudoprogression, where a successful treatment actually makes the tumors bigger before it shrinks them. Our goal was to develop a test that could tell us whether a treatment is likely to work after a single cycle.” The study was published in the June 22, 2021, online edition of the journal Oncotarget. Image: Micrograph image of human papilloma virus associated oropharyngeal cancer (HPV+ OPSCC). The tissue was stained to show the presence of the virus by in situ hybridization (Photo courtesy of Wikimedia Commons)

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Two Inflammatory Proteins Linked To Slower Cognitive Decline

revious meta-analyses of case-control and prospective cohort studies showed that cytokines and inflammatory markers, such as interleukin-6 (IL-6), C-reactive protein (CRP), and others are elevated in Alzheimer’s dementia cases and predicted incident of all-cause dementia. While it seems counterintuitive that people with high levels of inflammation-inducing proteins are protected against cognitive decline, it may be that their immune systems are better primed to fight infection. However, whether cytokine levels are predictive of cognitive decline in cognitively unimpaired (CU) elderly, especially in the setting of elevated amyloid beta (Aβ), remains unclear. A team of Medical Scientists at the Harvard Medical School (Boston, MA, USA; www.med. harvard.edu) and their colleagues measured nine cytokines in the baseline plasma of 298 longitudinally followed CU elderly and assessed whether these measures were associated with cognitive decline, alone or synergistically with Aβ. They next examined associations between cytokine levels and neuroimaging biomarkers of Aβ/tau/neurodegeneration. The mean baseline age was 72; 62% were female and 81% were white and participants were followed an average of 4.3 years.

The investigators reported that neither IL-12p70 nor IFN-γ was associated with age, sex, or APOE4 carrier status. Immunosuppressant medication use did not affect baseline IL-12p70 or IFN-γ levels. Concentrations of IL-12p70 and IFN-γ from the same individual remained stable on repeat measures up to several years apart. Higher IL-12p70 was associated with slower cognitive decline in the setting of higher amyloid-beta. Higher IFN-γ was associated with slower cognitive decline independent of amyloid burden. Higher IL-12p70 was associated with less neocortical tau on PET and hippocampal neurodegeneration in people with a higher amyloid-beta burden. IFN-γ was not correlated with tau or neurodegeneration. Rudolph E. Tanzi, PhD, a Professor of Neurology and senior author of the study, said, “Greater IL-12/IFN-γ axis activation may be protective against cognitive decline and early-stage Alzheimer’s disease progression. Moreover, the effect sizes of IL-12 and IFN-γ in predicting cognitive decline were statistically significant, but small. “These cytokines should be considered ancillary biomarkers rather than stand-alone prognostic indicators.” The study was published on June 23, 2021 in the journal Alzheimer’s & Dementia. LabMedica International August-September/2021

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LabMedica International

FABP4 Concentrations Quantified in Proliferative Diabetic Retinopathy

roliferative diabetic retinopathy (PDR), a progressive and serious stage of diabetic retinopathy (DR) due to retinal ischemia, is characterized by neovascularization (NV), vitreous hemorrhaging (VH) and tractional retinal detachment (TRD), all of which are major causes of blindness in patients with diabetes mellitus (DM). Fatty acid-binding proteins (FABPs) that act as intracellular lipid chaperones are a group of molecules that coordinate lipid responses in cells. Among the currently known FABPs, the FABP4, known as adipocyte FABP (A-FABP) or aP2, is expressed in both adipocytes and macrophages, and can be detected in most bodily fluids. Scientists specializing in Ophthalmology at the Sapporo Medical University School of Medicine (Sapporo, Japan; https://web.sapmed.ac.jp) and their colleagues recruited 20 PDR patients (mean age 63.27 ± 11.9 years; 10 males and 10 females), and 20 non-DR patients (mean age 69.2 ± 9.1 years; eight males and 12 females). Body height and weight measurements, blood pressure measurements and the collection of peripheral blood specimens for a complete blood count and biochemical analyses were performed. The team performed biochemistry measurements of the vitreous concentrations of FABP4 (V-FABP4) or vascular endothelial growth factor A (V-VEGFA) and several blood chemistry analyses including plasma glucose levels, hemoglobin A1c (HbA1c), creatinine (Cr), blood urea nitrogen (BUN), uric acid, aspartate transaminase (AST), alanine aminotransferase (ALT), γ-glutamyl transpeptidase (γ-GTP), lipid profiles, including total cholesterol and triglycerides, high-sensitivity C-reactive protein (hsCRP) and estimated glomerular filtration rate (eGFR). The concentrations of V-FABP4 (ng/mg protein) or V-VEGFA (pg/mg protein) were determined by enzyme-linked immunosorbent assay for FABP4 (Biovendor R&D, Modrice, Czech Republic; www. biovendor.com) or human VEGFA (Fuji film Wako. Co., Osaka, Japan; www. fujifilm.com), respectively. The investigators reported that the levels of V-FABP4 and V-VEGFA were significantly higher in PDR patients than in non-PDR patients with a high positive correlation between them. The findings were not affected by body mass index values and the presence of vitreous hemorrhaging. Among the clinical parameters, V-FABP4 correlated positively with creatinine and negatively with age and aspartate transaminase (AST) levels, while V-VEGFA correlated positively with fasting plasma glucose and hemoglobin A1c (HbA1c) levels, but negatively with AST. Multiple regression analyses indicated that V-VEGFA, or V-FABP4, AST and HbA1c were independent predictors of V-FABP4 or V-VEGFA, respectively. Both were negatively correlated, but more evident in V-FABP4, with the optic nerve head (ONH) ocular blood flow. The authors concluded that the concentrations of both V-FABP4 and V-VEGFA were substantially elevated in eyes with PDR, and a significantly higher positive correlation was observed between them.

LabMedica International August-September/2021

However, correlation analyses and stepwise multiple regression analyses for V-FABP and V-VEGFA strongly suggested that both factors were independently regulated, suggesting that V-FABP4 might also be involved in the pathogenesis of PDR. The study was published on June 11, 2021 in the journal Scientific Reports. Image: Enzyme-linked immunosorbent assay (ELISA) kit for Fatty acid-binding proteins 4 (FABP4) (Photo courtesy of Biovendor R&D)

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Gestational Diabetes May Predict Autoimmune Diabetes Risk

estational diabetes is high blood sugar (glucose) that develops during pregnancy and usually disappears after giving birth. It can happen at any stage of pregnancy, but is more common in the second or third trimester. Autoimmune diabetes, commonly referred to as type 1 diabetes mellitus (an older synonym is insulin-dependent diabetes mellitus), is a chronic immune-mediated disease characterized by insulin deficiency due to pancreatic islet beta-cell destruction with increasing blood glucose levels.

Medical Scientists at the Helsinki University Hospital (Helsinki, Finland; www.hus.fi) in a prospective cohort study, analyzed data from 391 women with gestational diabetes and 391 age-, parity- and delivery date-matched controls who delivered from 1984 through 1994 and underwent autoantibody testing during the first trimester of pregnancy. The team assessed levels of four autoantibodies associated with type 1 diabetes: Islet cell autoantibodies (ICA), glutamic acid decarboxylase autoantibodies (GADA), insulin autoantibodies (IAA) and insulinoma-associated antigen-2 autoantibodies (IA-2A). Women completed a follow-up questionnaire assessing later type 1 or type 2 diabetes diagnosis in 2012-2013. The mean follow-up time was 23 years. The scientists observed single autoantibody positivity in 41(12%) of the gestational diabetes cohort and in eight (2.3%) of the control cohort. In the gestational diabetes cohort, nine (2.6%) tested positive for two autoantibodies and eight (2.3%) tested positive for three autoantibodies, whereas only one woman in the control cohort had two autoantibodies detected. Islet cell autoantibodies (ICA) positivity was found in 12.5% of cases, followed by GADA (6%), IA-2A (4.9%) and IAA (1.2%). In the control cohort, GADA positivity was found in 1.4% of cases, followed by IA-2A (0.8%), IAA (0.6%) and ICA (0.3%). All women with three positive autoantibodies developed type 1 diabetes within seven years from pregnancy with gestational diabetes. Development of type 2 diabetes and gestational diabetes occurred independent of autoantibody positivity. Kaisu Luiro-Helve, MD, PhD, consultant in obstetrics and gynecology and reproductive endocrinology and senior author of the study, said, “If you are not the typical gestational diabetes candidate, but you have it, that may warrant more screening. Type 1 diabetes is not just a disease of the young. Type 1 usually occurs within 10 years of gestational diabetes, and that is the time when we need to stay alert and perhaps conduct another oral glucose tolerance test. Do not forget about these women after delivery.” The study was presented at the European Congress of Endocrinology virtual meeting held May 22-26, 2021. Image: Women diagnosed with gestational diabetes are more likely to be autoantibody positive and develop type 1 diabetes in the decade after delivery compared with pregnant women without gestational diabetes (Photo courtesy of Kernodle Clinic)

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LabMedica International August-September/2021

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LabMedica International

Low-Cost Transcriptional Diagnostic Accurately Categorizes Lymphomas

ymphoma is a cancer of the lymphatic system, which is part of the body’s germ-fighting network. The lymphatic system includes the lymph nodes (lymph glands), spleen, thymus gland and bone marrow. Lymphoma can affect all those areas as well as other organs throughout the body. Many subtypes of lymphoma can be effectively treated with available therapies, including chemotherapies, monoclonal antibodies, or small molecule–targeted agents. As a result, there is a pressing need for inexpensive, accurate, and operator-independent diagnostics to guide therapeutic selection for patients with lymphoma. An international team of medical scientists led by the Fred Hutchinson Cancer Research Center (Seattle, WA, USA; www.fredhutch. org) collected Formalin-fixed Paraffinembedded (FFPE) biopsy specimens obtained at Instituto de Cancerología y Hospital Dr. Bernardo Del Valle (INCAN, Guatemala City, Guatemala; www.ligacancerguate.org), that were performed because of clinical suspicion of lymphoma over a 13-year period. This included 3,015 tissue blocks from 1,836 individual patients. Most biopsy specimens were from lymph nodes or secondary lymphoid tissue, but additional extranodal sites (e.g., palate, testicle, eyelid, femur, thyroid, skin, mesentery, tongue, breast, and lung) were included. One-half of each FFPE block and H&E slides were generated from whole sections and reviewed by two expert hematopathologists. Representative areas were selected, and two cores from each sample were included for tissue microarray (TMA) construction. TMAs

were sectioned at 4-μm thickness and subjected to immunohistochemistry (IHC) per routine protocol on automated Leica BONDIII immunostainers (Leica Biosystems, Buffalo Grove, IL, USA; www.leicabiosystems.com) or BenchMark ULTRA, Roche/Ventana Medical Systems, Tucson, AZ, USA; www.roche. com). Capillary electrophoresis was run on an Applied Biosystems 3500 or SeqStudio Genetic Analyzer (Thermo Fisher Scientific, Waltham, MA, USA; www.thermofisher.com). The team established a chemical ligation probe-based assay (CLPA) that quantifies expression of 37 genes by capillary electrophoresis with reagent/consumable cost of approximately USD 10/sample. To assign bins based on gene expression, 13 models were evaluated as candidate base learners, and class probabilities from each model were then used as predictors in an extreme gradient boosting super learner. Cases with call probabilities < 60% were classified as indeterminate. Four (2%) of 194 biopsy specimens in storage <3 years experienced assay failure. Diagnostic samples were divided into 397 (70%) training and 163 (30%) validation cohorts. Overall accuracy for the validation cohort was 86%. After excluding 28 (17%) indeterminate calls, accuracy increased to 94%. Concordance was 97% for a set of 37 high-probability calls assayed by CLPA in both the USA and Guatemala. Accuracy for a cohort of 39 relapsed/refractory biopsy specimens was 79% and 88%, respectively, after excluding indeterminate cases. Machine-learning analysis of gene expression accurately classifies paraffin-embedded lymphoma biopsy specimens and could transform

diagnosis in lower- and middle-income countries. The study was published on May 14, 2021 in the journal Blood Advances. Image: An automated Leica BOND-III immunostainer (Photo courtesy of Leica Biosystems)

Serum Leptin Concentration Predicts Cardiovascular Outcomes in Hemodialysis Patients

eptin, a 16-kDa protein product mainly secreted by adipocytes, has been known to increase energy expenditure, suppress appetite, and leads to weight loss. Hyperleptinemia was common in maintenance hemodialysis (MHD) patients, and it was likely to be one of the causes of anorexia and malnutrition. End-stage renal disease (ESRD) is the fifth stage of chronic kidney diseases (CKD) whose effective treatment includes kidney transplantation and dialysis. Hemodialysis could be one of the optimal choices for ESRD patients to obtain a better prognosis. However, cardiovascular events, malnutrition, infection and other complications were still the major factors affecting the prognosis of MHD patients. Nephrologists at the West China Hospital of Sichuan University (Chengdu, China; www. wchscu.cn) enrolled a total of 165 eligible patients with a mean age of 51(range: 43–65) years, 98 (59.4%) were male and 67 (40.6%) were female, in a prospective study to explore the associations between serum leptin concentration and cardiovascular prognosis

LabMedica International August-September/2021

in maintenance hemodialysis patients. Serum biochemical parameters were recorded based on the blood samples from a routine checkup, which were collected close to the day that body composition assessment was carried out and measured in a central laboratory. Blood specimens from patients were obtained before a midweek hemodialysis session and immediately prepared for the subsequent leptin concentration tests. After centrifugation at 3,000 rpm for five minutes, serum was extracted and stored at −80° C. The human leptin ELISA kit (American Laboratory Products Company, ALPCO, Salem, NH, USA; www.alpco.com) was used to measure the serum leptin concentration in duplicate. The detection limit was 0.1 ng/mL. The intra-assay and inter-assay variation were < 3.5% and < 6.4%, which suggested the test method was reliable. The scientists reported that the mean serum leptin concentration was 35.49 ± 29.98 ng/ mL and patients were divided into two groups of serum leptin concentration ≥ 15.31 ng/ Cont’d on page 25

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The COVID-19 Sero NP/RBD test allows to detect and differentiate antibodies against nucleocapsid protein (NP) and the antibodies against the receptor binding domain (RBD) of the spike protein in a single assay.

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CtDNA Analysis Assesses Early Relapse Detection in Colorectal Cancer

olorectal cancer (CRC) is a type of cancer that begins in the large intestine (colon). The colon is the final part of the digestive tract. Colon cancer typically affects older adults, though it can happen at any age. It usually begins as small, noncancerous (benign) clumps of cells called polyps that form on the inside of the colon. Over time some of these polyps can become colon cancers. Challenges in the postoperative management of stage III CRC include selection of high-risk patients for adjuvant chemotherapy (ACT), lack of markers to assess ACT efficacy, assessment of recurrence risk after ACT, and, lack of markers to guide treatment decisions for high-risk patients e.g. additional therapy or intensified surveillance. Circulating tumor DNA (ctDNA) is a promising marker with potential to mitigate the challenges. Medical Scientists from Aarhus University Hospital (Aarhus, Denmark; www.au.dk) collected blood samples from 166 stage III CRC patients treated with curative intent at Danish and Spanish hospitals in 2014-2019. There were 1, 227 blood samples were collected prior to and immediately after surgery, and every third month for up to 36 months. Per patient 16 personal mutations were used to quantify plasma ctDNA, using the Signatera, bespoke mPCR NGS assay Natera, Austin, TX, USA; www.natera.com). The team reported that detection of ctDNA was a strong recurrence predictor, both postoperatively (Hazard ratio [HR] = 7.2), directly after ACT (HR = 18.2), and when measured serially after end of treatment (HR = 41). The recurrence rate of postoperative ctDNA positive patients treated with ACT was 80% (16/20). Patients who stayed ctDNA positive during ACT, all recurred. Serial post-treatment ctDNA measurements revealed exponential growth for

all recurrence patients following either a SLOW (26% increase/month) or a FAST (126% increase/month) pattern. From ctDNA detection to radiologic recurrence, ctDNA levels of FAST patients increased by a median 117-fold, and up to 554-fold. The 3-year overall survival was 43% for FAST patients and 100% for SLOW and non-recurrence patients (HR = 41.3). Coinciding CT scans and ctDNA measurements (n = 113 patients, 235 coinciding events, median 2 per patient) showed a high agreement (92%) and ctDNA either detected residual disease before the CT scan (n = 7 patients) or at the same time (n =

14 patients). The median lead-time was 7.5 months. The authors concluded they had confirmed the prognostic power of serial postoperative ctDNA analysis. Moreover, it provided novel analyses demonstrating that ctDNA is more sensitive for recurrence detection than CT scans and can be used for tumor growth rate assessments. The difference between FAST and SLOW growing tumors suggest that growth rates could guide whom to start on systemic therapy rapidly and whom to send for diagnostic imaging. The study was presented at the 2021 ASCO Annual Meeting held June 4-8, 2021. LabMedica International August-September/2021

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LabMedica International

Plasma ACE2 Predicts Prognosis of Hospitalized COVID-19 Patients

evere acute respiratory syndrome coronavirus 2 (SARSCoV-2), has caused a devastating global pandemic. The disease caused by SARS-CoV-2 infection has been termed coronavirus disease of 2019 (COVID-19) with clinical manifestations ranging from asymptomatic and subclinical infection to severe hyperinflammatory syndrome and death. SARS-CoV-2 binds to the angiotensin converting enzyme 2 (ACE2) receptor enabling entrance into cells through membrane fusion and endocytosis. The ACE2-receptor is distributed in different tissues including vascular endothelial cells, smooth muscle cells, nasal and oral mucosa, enterocytes within the intestines, and is especially abundant in the kidneys and type II alveolar pneumocytes in the lungs. An international team of scientists collaborating with those at Aarhus University Hospital (Aarhus, Denmark; www.au.dk) analyzed data from a large longitudinal study of 306 COVID19-positive patients and 78 COVID-19-negative patients (Massachusetts General Hospital Emergency Department COVID19 Cohort). Subjects included patients 18 years or older, who were in acute respiratory distress with a clinical concern for COVID-19 upon arrival to the Emergency Department. Samples from the patients were analyzed by the Olink Explore 1536 platform (Olink, Uppsala, Sweden: www.olink.com), which includes measurement of the ACE2 protein. The Olink platform is based on Proximity Extension Assay (PEA) technology. The team reported that the analysis demonstrated that high admission plasma ACE2 in patients with COVID-19 was associated with increased maximal illness severity within 28 days (odds ratio [OR] = 1.8). In models correcting for age, body mass index (BMI),

hypertension, and pre-existing heart conditions, kidney disease, lung disease, diabetes, and immunosuppressive conditions, significant associations were still observed between plasma ACE2 at admission and maximal illness severity within 28 days. Further, studies found that plasma ACE2 was also significantly higher in patients with COVID-19 with hypertension compared with patients without hypertension, and in patients with pre-existing heart conditions and kidney disease compared with those without these comorbidities. However, there was no significant difference in plasma ACE2 comparing patients with or without pre-existing lung disease, diabetes, or immunosuppressive conditions. Additionally, elevated plasma ACE2 in COVID-19-positive patients was significantly associated with increasing age, but there was no significant association between plasma ACE2 and BMI. Tue W. Kragstrup, MD, an associate professor and lead author of the study, said, ““Elevated baseline plasma ACE2 in COVID-19 patients was significantly associated with increased disease severity during the 28-day study period. This indicates that abundant ACE2 production could be involved in increased viral spread and disease burden.” The authors concluded that the design of the data analysis using the Olink platform does not allow assessment of quantitative differences. However, previous studies have described a positive correlation between plasma ACE2 and ACE1 activity. This is interesting because ACE1 (serum ACE) analysis is a standardized test in most hospital laboratories. Therefore, their study encourages quantitative investigations of both plasma ACE 1 and 2 in COVID-19. The study was published on June 4, 2021 in the journal PLOS ONE.

Serum Leptin Concentration Predict Cardiovascular Outcomes in Hemodialysis Patients

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mL and serum leptin concentration < 15.31 ng/mL by the optimal cut-off point from ROC curve for cardiovascular events (CVEs). During a median follow-up of 18 (12–22) months, CVEs occurred in 37 (22.4%) patients and the cardiovascular and all-cause mortality was 10.9% and 21.82%. Serum leptin concentration was

LabMedica International August-September/2021

associated with CVEs (hazard ratio [HR] = 0.982), cardiovascular death (CVD) (HR = 0.934) and all-cause death (HR = 0.943). Decreased serum leptin concentration was an independent risk factor for the development of left ventricular hypertrophy (LVH, odds ratio [OR] = 0.98) and peripheral vascular disease (PVD, OR = 0.974). The authors concluded that serum

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leptin concentration can independently predict cardiovascular outcomes and allcause death in MHD patients. They suggest that the effects that serum leptin concentration has on development of LVH and PVD maybe the potential mechanism. The study was published on June 4, 2021 in the journal Clinica Chimica Acta.

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The AMPLIRUN SARS-CoV-2 RNA control panel contains complete purified RNA of SARS-CoV-2 and main variants of concern to be used to control IVD techniques based in nucleic acids amplification.

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Liquid Biopsies Detect Pediatric Bone Tumors Based on Epigenetic Profiles

equencing of cell-free DNA (cfDNA) in the blood of cancer patients (liquid biopsy) provides attractive opportunities for early diagnosis, assessment of treatment response, and minimally invasive disease monitoring. As a consequence, cfDNA analysis holds great promise for precision oncology and personalized therapies, and is currently evaluated in a broad range of clinical studies. Ewing sarcoma (EwS) constitutes an ideal model cancer for establishing and validating fragment-based liquid biopsy analysis for pediatric tumors. EwS has a unique epigenetic signature with established clinical associations, which constitutes a potential epigenetic marker for early diagnosis and tumor classification based on cfDNA. Moreover, EwS tumors have well-established genetic aberrations that can be used for comparison. An international team led by scientists at the St. Anna Children’s Cancer Research Institute (Vienna, Austria; www. ccri.at) and their colleagues included 200 plasma samples from 95 patients with EwS and 41 plasma samples from 31 patients with other types of sarcoma: EwS-like sarcoma (three patients, two of which were positive for the CIC-DUX4 fusion gene), osteosarcoma (eight patients), rhabdomyosarcoma (12 patients), synovial sarcoma (three patients), and other types of sarcoma (five patients). Plasma samples from 22 healthy individuals (24–50 years old) were used as controls. cfDNA was isolated using the QIAsymphony Circulating DNA Kit with the QIAsymphony SP instrument or the QIAampMinElute cfDNA Kit (Qiagen, Hilden, Germany; www.qiagen.com). Whole-genome sequencing libraries were generated from 10 ng of cfDNA. Final libraries were eluted in 20 µl nuclease-free water, quantified with the Qubit dsDNA HS Assay Kit (Thermo Fisher Scientific, Waltham, MA, USA; www.thermofisher.com). Patient-specific assays for fusion gene detection and quantification were designed following the guidelines from the Bio-Rad ddPCR (Bio-Rad, Hercules, CA, USA; www.bio-rad.com). The team reported that after confirming that they could detect tumor-derived DNA in their cell-free DNA samples, they noted that the tumor-derived DNA tended to be shorter than the cell-free DNA found among healthy controls. These fragments were often about 167 base pairs in size, which

corresponds to the length of DNA that wraps around a nucleosome plus linker DNA. These shorter tumor-derived DNA fragments were additionally found among patients for whom there were no detectable genetic changes. This suggested that fragmentation patterns could be used to identify tumor-derived DNA independent of genetic alterations. The scientists further developed a tool they dubbed LIQUORICE, for liquid biopsy regions-of-interest coverage estimation, that overlays these genome-wide cell-free DNA fragment profiles atop a predetermined set of genomic regions where epigenetic changes often occur in the cancer type. In that way, it develops a consensus signature of fragment coverage in those regions. They additionally developed machine-learning classifiers to not only distinguish individuals with cancer from controls but also between different types of pediatric sarcoma, without relying on the recurrent genetic changes. When they tested their classifiers, they found they were highly sensitive. The authors concluded that their study demonstrated how deep whole-genome sequencing of cfDNA enables comprehensive detection, classification, and monitoring of pediatric tumors based on their genetic and epigenetic profiles, thus providing a clinically relevant method for liquid biopsy analysis in cancers with few or no genetic alterations. The study was published on May 28,2021 in the journal Nature Communications. Image: The QIAsymphony SP enables sample preparation of DNA, RNA, and bacterial and viral nucleic acids from a wide range of starting materials (Photo courtesy of Qiagen) LabMedica International August-September/2021

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LabMedica International

Biomarkers Diagnose and Predict Acute Pancreatitis

cont’d from cover

of AP. Control of the systemic inflammatory response is a key factor in the prognosis of AP; thus, pro-inflammatory markers can be mined as potential diagnostic and prognostic indicators of AP. Clinical Laboratorians at the Zhejiang University School of Medicine (Hangzhou, China; www.cmm.zju.edu.cn) included in a study 451 participants, including 343 AP patients and 108 healthy controls. According to the clinical outcome within 28 days, all patients were divided into the deceased group and survival group, while the survival group included four subgroups based on the clinical manifestations: pancreatic infection and necrosis, pancreatic tissue accumulation, extrapancreatic infection, and new-onset diabetes, some of which overlapped with each other. Systemic inflammatory response syndrome (SIRS) score were evaluated for each patient within 24, 24, and 48 hours of admission, respectively. Laboratory indicators included were plasma levels of plasma procalcitonin (PCT), heparin-binding protein (HBP), and interleukin-6 (IL-6) on days 1, 3, 7, and 10 after admission for all patients in the study. Patient outcomes were recorded: death, infectious pancreatic necrosis, necrotic tissue accumulation, septic shock, new-onset diabetes, and extrapancreatic infection. The investigators reported that a statistically significant increase in the mean plasma analyte levels was detected in the study group compared to the control group. Multivariate comparison showed that plasma levels of PCT, HBP, and IL-6 were all significantly different among the three groups at different sampling times (1st, INTERACTIVE 3rd, 7th, and 10th day of admisDIGITAL EDITION sion). The combination of the three indicators had significantly higher diagnostic value than either the individual markers or pairwise combinations. The levels of the three were all significantly higher in severe acute pancreatitis (SAP) patients than in non-SAP patients. The patients with high levels had a worse prognosis than those with low levels. The authors concluded that the combined detection of plasma PCT, HBP, and IL-6 provided a new idea for the diagnosis of patients with AP; increased concentrations of PCT, HBP, or IL-6 within three days of admission were associated with AP severity and poor prognosis; high concentrations of PCT, HBP, or IL-6 may be the useful predictors of SAP and the independent risk factors for AP. The study was published on June 21, 2021 in the Journal of Clinical Laboratory Analysis.

Image: Histology of acute pancreatitis. Microscopically, the fat necrosis consists of steatocytes (adipocytes) that have lost their nuclei and whose cytoplasm has a granular pink appearance as seen on the right. Some hemorrhage is seen at the left in this case of acute pancreatitis (Photo courtesy of Texas A&M University)

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Leukocyte Differential on Hematology Analyzer Compared and Evaluated

complete blood count (CBC), also known as a full blood count (FBC), is a set of medical laboratory tests that provide information about the cells in a person’s blood. The CBC indicates the counts of white blood cells, red blood cells and platelets, the concentration of hemoglobin, and the hematocrit (the volume percentage of red blood cells). Different hematology analyzer models use various principles to measure the complete blood count (CBC) and leukocyte differential for routine tests in clinical laboratories. The accuracy performance of a hematology analyzer is evaluated using the manual differential leukocyte (Manual-Diff) on blood wedge film (Wedge-Diff) as the traditional reference method. Clinical Laboratorians at the Kindai University Hospital (Osakasayama, Japan; www.kindai.ac.jp) selected for method comparison, 598 clinical samples and 46 healthy volunteer samples. All samples were collected in tubes containing K2-EDTA. The blood collection tubes, blood collection procedure, and mixing procedure were according to described methods. For method comparison between the three analyzers, 388 clinical samples were used. Blood films were stained with May-Giemsa. The automated hematology analyzer Celltac G (Nihon Kohden, Tokyo, Japan; www.nihonkohden.com) was designed to improve leukocyte differential performance. The two comparative hematology analyzers (CAAs) used were XN-9000 (Sysmex, Kobe, Japan; www. sysmex.co.jp) and CELL-DYN Sapphire (Abbott Diagnostics, Santa Clara, CA, USA; www.corelaboratory.abbott). In manual differential, two kinds of automated slide makers were used: the Sysmex SP-10 for wedge technique and SPINNER-2000 (Lion-Power, Komatsu, Japan; https://lionpower.co.jp) for spinner technique. The immunophenotypic leukocyte differential reference method (FCM-Ref) was selected, and a flow cytometer Navios (Beckman-Coulter, Indianapolis, IN, USA; www.beckman.com) was used. The investigators reported that the Celltac G showed sufficient comparability with the CAAs for each leukocyte differential counting value up to 40.87 × 109/L, and sufficient comparability with FCM-Ref for each leukocyte differential percentage at 0.4–78.5. The identification ratio of the FCM-Ref in CD45-positive cells was 99.7% (99.4% to 99.8%). Differences were found between FCM-Ref/Celltac G/ XN-9000/Spinner-Diff and Wedge-Diff for monocytes and neutrophils. The appearance ratio of smudge cells on wedge and spinner film was 12.5% and 0.5%. The authors concluded that the Celltac G hematology analyzer’s leukocyte differential showed adequate accuracy compared with two

comparative hematology analyzers, reference flow cytometry method, and two manual methods and was considered suitable for clinical use. The study was published on June 12, 2021 in the Journal of Clinical Laboratory Analysis.

Two Immunoassays Compared for Determination of Serum Vitamin D

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a one-step delayed-action immunoassay using chemiluminescent microparticles immunoassay (CMIA) technology. The scientists reported that of the total patients, 52.7% received vitamin D supplements. The correlation coefficient of agreement for general group, supplementation group and group without supplementation was 0.92, 0.91 and 0.89, respectively. In all of them, a kappa index>0.75 was obtained. The mean value of the bias was higher for the supplemented group (−20.4 nmol/L) than for the group without treatment (−4.9 nmol/L). Graphically, a greater concordance between both assays was observed when patients receiving vitamin D supplements were excluded. The team observed lower concentrations of 25(OH)D in the IDS-iSYS 25 VitD assay when compared to the results obtained with the Alinity i 25-OH Vitamin D assay. The authors concluded that the assays evaluated were not comparable to each other. Despite this, they show an excellent concordance in the evaluation of the vitamin D status. The study was published on June 23, 2021 in the journal Practical Laboratory Medicine. LabMedica International August-September/2021

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LabMedica International

Rapid Diagnostic Tests Evaluated for Chronic Chagas Disease Patients

hagas is a disease caused by the parasite Trypanosoma cruzi, and is one of the most important public health concerns affecting the population of Latin America. This disease presents an acute phase that generally goes undiagnosed and a chronic phase with cardiac manifests principally, is diagnosed through serological tests that are generally not available. In the Americas, up to 99% of cases of Chagas Disease (CD) and more than 90% of cases of CD in Europe are undiagnosed. Serological diagnosis in the chronic phase of CD is based on the detection of circulating antibodies through conventional reactions such as the enzyme-linked immunosorbent assay (ELISA) test, Indirect Immunofluorescence (IIF), Indirect Hemagglutination (IHA), Chemiluminescence (ChLIA) and Western blot/Immunoblot. A group of international scientists led by the Universitat Autònoma de Barcelona (Barcelona, Spain; www.uab.cat) evaluated the diagnostic precision of two rapid diagnostic tests (RDT’s) on patients with chronic CD. They included in the study 305 participants from rural and urban area of Colombia of which 215 were negative for T. cruzi and 90 were positive according to the reference criteria. Of the participants, 60.7% were women, 39.3% were men, the median age was 47.1 ± 18.5years old, the youngest participant was 3 years old and the oldest participant was 80 years old. All samples were analyzed using the ELISA Chagas III tests (GrupoBios, Santiago, Chile; www.grupobios.cl) and with the Chagas ELISA IgG+IgM tests (Vircell, Granada, Spain; www.vircell.com) as reference standards. The Two RDT’s were performed to all participants were the Chagas Detect Plus (CDP, InBios, Seattle, WA, USA; www. inbios.com) and the Chagas Stat-Pak (CSP, Chembio Diagnostics, Hauppauge, NY, USA; www.chembio.com). The scientists reported that 305 subjects were included in the study (38 patients with leishmaniasis), of which 215 tested negative for T. cruzi and 90 tested positive according to the reference standard. The sensitivity of the RDT’s were 100% (CI 95% 95.9–100), and the specificity of the CDP was 99.1% (CI 95% 96.6–99.8) and for CSP was 100% (CI 95% 98.3–100). The agreement of CDP was 99.5% and for CSP was 100% with Kappa values of (k = 99.1; CI 95% 92.6–99.8%) and (k = 100; CI 95% 94.3–100), respectively. RDT’s did not present cross-reactions with samples from patients who were positive for leishmaniasis. The authors concluded that the findings demonstrated excellent results from the RDT’s in terms of validity, safety, and reproducibility. The results obtained provide evidence for the recommendation for using these tests in a Colombian epidemiological context principally in endemic areas in which laboratory installations necessary to perform conventional tests are not available, or they are scarce and to help in diagnosing chronic Chagas disease in order to provide access to treatment as soon as possible. The study was published on June 2, 2021 in the journal PLOS Neglected Tropical Diseases.

Image: Examples of negative and positive Chagas Stat-Pak RDT results. From left to right, negative, weakly positive, and strongly positive Stat-Pak results are shown (Photo courtesy of Yves Jackson)

Novel Dengue Virus IgG Rapid Diagnostic Test Evaluated

Cont’d from page 16

Flaviviruses other than the dengue virus was also tested. For each type of Flavivirus tested, the samples used were seronegative for dengue virus but seropositive for the Flavivirus on a neutralization test or IgG ELISA, or the participant’s records showed prior vaccination against the Flavivirus. For this group, the rapid diagnostic test was found to be cross-reactive for the yellow fever virus in one blood sample (one cross-reactivity out of 42 samples that were seropositive for the yellow fever virus; 2.4%) and for Japanese encephalitis virus in one blood sample (1/36; 2.8%). For the blood samples displaying previous exposure to Zika virus (0/35) and the West Nile virus (0/32), the novel rapid diagnostic test had zero cross-reactivity. Yasemin Ataman-Önal, PhD, from Sanofi Pasteur, said, “These findings support the use of this first-in-class point-of-care test to determine dengue serostatus and eligibility for dengue vaccination and because the tetravalent dengue vaccine is only indicated only for people who have had prior infection with the virus, pre-vaccination screening is necessary.” The study was presented at the Virtual 39th Annual Meeting of the European Society for Pediatric Infectious Diseases held 24-29 May, 2021.

LabMedica International August-September/2021

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Hyperglycemia Evaluated as a Risk Factor in Pancreatic Cancer

ancreatic ductal adenocarcinoma (pancreatic cancer) has a five-year survival rate of 9%. Most patients are diagnosed with metastatic disease due to late presenting symptoms and only 10% to 20% are able to undergo surgery with a curative intent. Diabetes mellitus is common in pancreatic cancer patients. At diagnosis, only 14% have a normal fasting glucose and nearly half have diabetes mellitus. Although this is a wellknown phenomenon, neither the underlying etiology nor the impact on prognosis has been established. Medical Scientists mainly from Umeå University (Umeå, Sweden; www.umu.se) carried out a prospective nested case-control study that included 182 patients in the analysis after various exclusions. Seventy-four cases

had participated more than once, with a total of 310 surveys. Most cases were matched with four control surveys (96%). The object of the study was to determine the risk association between fasting glucose levels and pancreatic cancer using systematically collected prediagnostic blood glucose samples. Plasma samples were drawn after overnight fasting. Oral glucose tolerance test (OGTT) was performed according to World Health Organization standards, with plasma glucose levels measured at 120 minutes after a 75 gram oral glucose load. The methods of glucose analysis differed slightly over time, i.e. capillary versus venous samples and different bench-top analyzers. Additional clinical data were collected on the pancreatic cancer cases from medical records, including fasting glucose

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at diagnosis (measured at the time of diagnosis ± three months), TNM Classification of Malignant Tumors stage, tumor grade, survival after diagnosis and treatment. The investigators reported that the unadjusted risk of developing pancreatic cancer increased with increasing fasting glucose levels (odd ratio [OR] = 1.30). Impaired fasting glucose (≥6.1 mmol/L) was associated with an adjusted risk of 1.77 for developing pancreatic cancer. In subgroup analysis, fasting glucose levels were associated with an increased risk in never-smokers (OR = 4.02) and non-diabetics (OR = 3.08) (non-significant for interaction). The ratio between fasting glucose and BMI was higher among future pancreatic cancer patients and an increased ratio was associated with elevated risk of pancreatic cancer (OR = 1.66). Fasting glucose levels were not associated with TNM stage at diagnosis or survival. The authors concluded that their nested case-control study showed that fasting glucose levels were associated with pancreatic cancer risk. Impaired fasting glucose in individuals aged >55 is associated with an increased risk. Impaired fasting glucose is an independent risk factor and should be investigated further in pancreatic cancer risk assessment including other risk factors in a larger study population. The study was published on May 15, 2021 in the journal Pancreatology. Image: A blood test for glucose may reveal hyperglycemia which has been evaluated as a risk factor in pancreatic cancer (Photo courtesy of Amit Akirov, MD) LabMedica International August-September/2021

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LabMedica International

Genetic Variants Associated with Unexplained Sudden Cardiac Death

s many as 450,000 Americans die every year from a sudden, fatal heart condition, and in slightly more than one in ten cases the cause remains unexplained even after an autopsy. Most sudden cardiac deaths are caused by abnormal heart rhythms called arrhythmias and the most common life-threatening arrhythmia is ventricular fibrillation. Unexplained sudden cardiac death (SCD) describes SCD with no cause identified. Genetic testing helps to diagnose inherited cardiac diseases in unexplained SCD. However, the associations between pathogenic or likely pathogenic (P/LP) variants of inherited cardiomyopathies (CMs) and arrhythmia syndromes have never been systematically examined. Cardiovascular Scientists at the University of Maryland School of Medicine (Baltimore, MD, USA; www.medschool.umaryland.edu) and their many colleagues performed genetic sequencing in 413 patients, who died at age 41 on average of sudden unexplained heart failure. This genetic association study included 683 African American and White adults who died of unexplained SCD and were included in an autopsy registry. Overall, 413 individuals had DNA of acceptable quality for genetic sequencing. Data were collected from January 1995 to December 2015. A total of 30 CM genes and 38 arrhythmia genes were sequenced, and variants in these genes, curated as P/LP, were examined to study their frequency. The team reported that the median (interquartile range) age at death of the 413 included individuals was 41 (29-48) years, 259 (62.7%) were men, and 208 (50.4%) were African American adults. A total of 76 patients (18.4%) with unexplained SCD carried variants considered P/LP for CM and arrhythmia genes. In total, 52 patients (12.6%) had 49 P/LP variants for CM, 22 (5.3%) carried 23 P/LP variants for arrhythmia, and two (0.5%) had P/LP variants for both CM and arrhythmia. Overall, 41 P/LP variants for hypertrophic CM were found in 45 patients (10.9%), nine P/LP variants for dilated CM were found in 11 patients (2.7%), and 10 P/LP variants for long QT syndrome were found

in 11 patients (2.7%). No significant difference was found in clinical and heart characteristics between individuals with or without P/LP variants. African American and White patients were equally likely to harbor P/ LP variants. Aloke Finn, MD, Clinical Associate Professor of Medicine and the senior author of the study, said, “Genetic screening isn’t routinely used in cardiology, and far too many patients still die suddenly from a heart condition without having any previously established risk factors. We need to do more for them. What we found opens the door and asks some important questions. Should we be doing routine genetic screening in those who have a family history of unexplained sudden cardiac death?” The authors concluded that in this large genetic association study of community cases of unexplained SCD, nearly 20% of patients carried P/ LP variants, suggesting that genetics may contribute to a significant number of cases of unexplained SCD. The findings regarding both the association of unexplained SCD with CM genes and race-specific genetic variants suggest new avenues of study for this poorly understood entity. The study was published on June 2, 2021 in the journal JAMA Cardiology. Image: Genetic variants are associated with unexplained sudden cardiac death in both adult White and African American individuals (Photo courtesy of Latin American Society of Interventional Cardiology)

MRD Assessed by Multiparameter Flow Cytometry in Transplant-Eligible Myeloma

ultiple myeloma (MM) treatment has considerably improved in the past 15–20 years. The current paradigm for transplant-eligible newly diagnosed MM (NDMM) patients consists of induction, stem-cell mobilization and autologous stem-cell transplantation (ASCT), followed by consolidation and/or maintenance. Currently, minimal residual disease (MRD) assessment is the most sensitive tool to measure the depth of response in MM patients. Indeed, among patients achieving a complete response (CR), MRDpositive patients have an inferior progression-free survival (PFS) and overall survival (OS) compared with MRD-negative ones, and a similar outcome to those achieving a partial response (PR). A large international team working with Hematologists at the University of Torino (Torino, Italy; www.unito.it) conducted an MRD correlative study of a MM phase III trial in newly diagnosed MM patients achieving a suspected complete response before maintenance and every six months during maintenance. Transplant-eligible patients aged ≤65 years were enrolled from February 2011 to April 2014 in 172 European centers. A total of 321 patients before lenalidomide maintenance were evaluated for MRD assessment. Bone marrow (BM) samples were processed in three European laboratories, applying EuroFlow-based multiparameter flow cytometry (MFC) protocols (eight colors, two tubes) with 10−4−10−5 sensitivity. Data were acquired using a FACSCanto II flow cytometer (BD Biosciences, San Jose, CA, USA; www.bdbiosciences.com). One of the laboratories (Torino) applied a local panel with minor differences in fluorochromes and antibodies; data were acquired using a Navios flow cytometer and analyzed with Kaluza software (Beckman Coulter, Brea, CA, USA; www.beckmancoulter.com).

LabMedica International August-September/2021

The clinical scientists reported that at enrollment in the MRD correlative study, 76% (244/321) of patients were MRD-negative. In the intention-to-treat analysis, after a median follow-up of 75 months, 5-year progression-free survival was 66% in MRD-negative versus 31% Cont’d on page 32

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Multitarget Fecal Immunochemical Test Validated for Colorectal Cancer

olorectal cancer (CRC) starts in the colon or the rectum. These cancers can also be called colon cancer or rectal cancer, depending on where they start. Colon cancer and rectal cancer are often grouped together because they have many features in common. Scientists study screening tests to find those with the fewest harms and most benefits. Cancer screening trials also are meant to show whether early detection (finding cancer before it causes symptoms) helps a person live longer or decreases a person’s chance of dying from the disease. The fecal immunochemical test (FIT) is used in colorectal cancer (CRC) screening, yet it leaves room for improvement. Medical Scientists at the Netherlands Cancer Institute (Amsterdam, The Netherlands; www.nki.nl) collected samples for FIT from 1,284 patients from a Dutch screening population. They were classified according to their most advanced lesion: 47 with CRC, 135 with advanced adenomas, 30 with advanced serrated polyps, 250 with non-advanced adenomas, and 53 with non-advanced serrated polyps, along with 769 controls. The team developed assays for nine protein biomarkers and determined that the combination of hemoglobin, calprotectin, and serpin family F member 2, defined as the mtFIT, had the best diagnostic performance, based on classification and regression tree analysis. The investigators applied classification and regression tree (CART) analysis biomarker concentrations to identify the optimal combination for detecting advanced neoplasia. They reported that with identical specificities of 96.6%, mtFIT had a similar sensitivity for CRC compared with FIT (78.7% versus 80.9%, respectively), and significantly greater sensitivity for advanced neoplasia (42.9% versus 37.3%). This increase in cross-validated sensitivity was completely due to an increased sensitivity for advanced adenomas (37.8% for mtFIT versus 28.1% for FIT. The cross-validated sensitivities of mtFIT and FIT for advanced serrated polyps were equal at 10.0%. Meike de Wit, PhD, a molecular biologist and co-author of the study,

said, “This study provides clinical validation of a mFIT with higher accuracy for detecting advanced neoplasia, in particular advanced adenomas, compared with FIT. This enables early detection and interception at a premalignant stage rather than an early invasive stage, which could have a major effect on quality of life. Moreover, compared with FIT screening, mFIT-based screening could lead to a further reduction in CRC incidence and death.” The authors concluded that compared with FIT, the mtFIT showed better diagnostic accuracy in detecting advanced neoplasia because of an increased detection of advanced adenomas. Moreover, early health technology assessment indicated that these results provide a sound basis to pursue further development of mtFIT as a future test for population-based CRC screening. The study was published on July 20, 2021 in the journal Annals of Internal Medicine. Image: A novel protein-based multitarget fecal immunochemical test (mFIT) for colorectal cancer (CRC) screening was superior to conventional FIT in detecting advanced neoplasia, particularly advanced adenomas (Photo courtesy of Mike Bassett)

MRD Assessed by Multiparameter Flow Cytometry in Transplant-Eligible Myeloma

Cont’d from page 31

in MRD-positive patients (Hazard Ratio [HR] = 0.39)), 5-year overall survival was 86% versus 69%, respectively (HR = 0.41). MRD negativity was associated with reduced risk of progression or death in all subgroups, including ISS-III (HR = 0.37) and high-risk fluorescence in situ hybridization (FISH) patients (HR = 0.38). The authors conclude that their study confirms that MRD status by MFC is a strong prognostic factor in NDMM patients

receiving intensification with novel agents or high-dose melphalan (HDM). The achievement of MRD negativity in patients with HR-FISH aberrations was associated with a significantly improved survival, underlining the importance of achieving deep responses in this setting. Finally, lenalidomide maintenance further improved the depth of response in standard-risk patients. The study was published on June 3, 2021 in the journal Blood Cancer Journal. LabMedica International August-September/2021

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

NEWS

MESSAGE FROM THE PRESIDENT By Khosrow Adeli

•

President, IFCC

hope the entire IFCC family is having an enjoyable summer season and feeling optimistic about a return to normalcy as the COVID-19 pandemic continues to ease. I am hopeful that we will soon be able to hold our IFCC scientific events in person or in hybrid format and many of the travel restrictions will be lifted by this fall. Taking advantage of the power of virtual communication tools, I am excited to announce a new strategy to significantly enhance internal communication within the IFCC organization, the IFCC Annual Town Halls. Starting this fall, these will be international virtual forums (2-3 hours) that will allow the IFCC Executive, IFCC Board Members, and Chairs of IFCC Divisions to meet with the IFCC community in different IFCC regions. There will be brief presentations by the IFCC Executive followed by a panel discussion, aimed at communicating new announcements and addressing any questions or concerns from our members. To ensure that all IFCC members have an opportunity to participate, three (3) townhall sessions will be held annually based on the following regions/time zones: 1) Europe/ Africa/Middle East, 2) North/Central/ South America, and 3) Asia-Pacific. IFCC Regional Federation Executives, National Society Presidents as well as all scientists, lab professionals and young scientists in each region will be invited to participate. An additional IFCC Town Hall is also planned for the IFCC corporate members. Official dates will be announced by the IFCC board shortly. Alongside the Town Hall, we are currently planning the IFCC General Conference, which will take place in Spring or Fall 2022. As you may know, this meeting is aimed at convening all the IFCC functional units to discuss ongoing activities as well as plan and decide on future actions. The last IFCC General Conference was held in Budapest in 2018 and was scheduled to be held again in 2020 but was unfortunately postponed due to the COVID-19 pandemic. It will be a delight for us to be able to gather in person once again and foster collaboration between our divisions. In addition to meeting updates, the IFCC is currently working towards strengthening internal procedures and structures, including our conference guidelines and accounting practices. It was previously mentioned that the IFCC Executive Board was working towards creating new guideline documents for all future conferences to aid in the planning, organization, and execution of these events. These harmonized documents are now being finalized and should be available soon. In terms of accounting, we have been in discussion with an international ac-

LabMedica International August-September/2021

counting firm, KPMG, which we will be recruiting to provide accounting and related administrative support. IFCC will continue with its internal accounting, but KPMG will support these activities to ensure the best accounting practices are in place. Thereafter, KPMG will support formal controls of documents issued and received, sample checks of recorded entries, monthly reconciliations, and review of financial statements. I anticipate these improvements to IFCC’s internal procedures and structures will truly enhance our organization and thus benefit the entire IFCC community. I look forward to hearing from you and receiving your new ideas or proposals so that we can continue making further improvements to the IFCC organization. Should you have any feedback, questions, or concerns, please feel free to email me at president@ifcc.org.   Till next time ☺ Khosrow

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, A really interesting issue is ready for you. It has enough information for the two summer months. Perhaps you would like to go through the articles to keep you cool in your lab or to keep you company at the seaside... The eNews issues always offer what is best for you (I know you agree all of you). Think of the

countries all over the world you come in touch with. Our president is promising great innovations in the IFCC structure that will make our organization even stronger and safer. A lot of national societies describe their achievements and the Univants awards are really very interesting. Some of these projects are so promising. Let’s get ready for face-to-face meetings enjoying the blue seas, the blue skies, the freedom of the summer.

CLSI and IFCC Partnership Promotes Global Harmonization of Clinical Laboratory Practices

FCC and CLSI have renewed their longstanding partnership agreement, the goal of which is promoting global harmonization of clinical laboratory practices. The partnership has led to the development of consensus-based standards and guidelines that reflect a global perspective, leading to the improvement of laboratory test result quality, and ultimately improving patient care. The Clinical and Laboratory Standards Institute (CLSI) is a volunteer-driven, membership-supported, nonprofit global laboratory standards development organization dedicated to develop best practices in clinical and laboratory testing and promote their use worldwide. CLSI promotes the development and use of voluntary standards and guidelines through a consensus process that includes stakeholders from the health care professions, government, education, and industry. CLSI connects professionals worldwide with a common purpose and mission. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) is a

worldwide, non-political organization for clinical chemistry and laboratory medicine. As such, it has a range of roles that include global standard setting in collaboration with other international organizations, supporting its members through scientific and educational endeavors, and providing a series of congresses, conferences, and focused meetings for laboratory medicine specialists to meet and present original findings and best practices. The IFCC relies very heavily on volunteers to run the organization and to undertake its range of activities and programs. The IFCC and CLSI partnership facilitates the inclusion of broad international perspectives in CLSI’s standards and guidelines. These standards and guidelines serve the global medical laboratory community by defining medical laboratory practices that improve quality, safety, consistency, and cost-effectiveness. Regulatory agencies and accrediting bodies around the world recognize the value of implementing CLSI standards and guidelines to establish best practices that meet regulatory and accreditation

requirements. Finally, the agreement recognizes IFCC and CLSI’s mission of improving the quality of laboratory medicine in resource-constrained countries that bear a heavy burden of disease. Additionally, in cooperation with the US National Institute of Standards and Technology (NIST), CLSI and IFCC cosponsor the Robert Schaffer award, which honors an individual who has made outstanding and unique contributions to the advancement of reference methods and/ or reference materials for laboratory medicine. This award is presented at the IFCC International Congresses. Volunteering with CLSI is a way to join more than 2000 experts from around the world who are actively engaged in developing consensus-based clinical and laboratory standards and guidelines. Visit clsi.org for more information about membership and to learn more about the more than 200 standards, guidelines, and other products offered by CLSI.

Democratization of Education: Adaptive Learning Courses in Laboratory Medicine Now Available Without Subscription Fee!

Prof. Nader RIFAI; IFCC EMD Chair; Boston Children’s Hospital, Department of Laboratory Medicine, MA USA

n order to increase utility and eliminate financial barriers, AACC Learning Lab for Laboratory Medicine on NEJM Knowledge+ program is now available without a subscription fee for individual users (previously $89/year). This cloudbased program consists of over 100 courses, covering topics span across all disciplines of laboratory medicine (https://area9lyceum.com/ laboratorymedicine/course/). The courses are based on the concept of adaptive learning, the closest to personalized education. Adaptive learning is an ingenious way to communicate information. Through sophisticated computer algorithms, the platform interacts with the learner and identifies the areas in which they are not proficient. It then provides targeted learning materials to remedy the deficiency, thus enabling efficient learning in small blocks of time. The program can be accessed via mobile devices for added flexibility. Over 125 leading clinical laboratory scientists and physicians from the United States, United Kingdom, Canada, Australia, Iceland, Denmark, Norway, Croatia, Italy, South Africa,

Hong Kong, Turkey, and Singapore have built these courses. Each course consists of ~100 granular learning objectives; every learning objective is coupled with one to two probes and a learning resource. The probes are the actual questions and can be presented in one of nine different formats that meant to be engaging and interesting to the learner. Each course goes through a rigorous internal and external review process followed by a beta testing evaluation. Over 250 laboratory medicine professionals have participated in reviewing and performing the beta testing evaluation of these courses. This program has been designed for laboratory medicine professionals in hospital laboratories, commercial laboratories and the in vitro diagnostics industry to help them to assess their knowledge, remain abreast with current knowledge, and prepare for certification exams. This ambitious program is a collaborative

effort between NEJM Group, the publisher of the New England Journal of Medicine, AACC, the publisher of Clinical Chemistry, and Area9 Lyceum, a global leader in education technology. We sincerely hope that laboratory medicine professionals worldwide, regardless of their financial abilities, can now take advantage of this opportunity and join the other thousands of users of this program.

IFCC OFFICE Via Carlo Farini 81, 20159 Milan, ITALY

Tel: (39) 02-6680-9912 E-mail: ifcc@ifcc.org • Web: www.ifcc.org Staff Members: Paola Bramati, Silvia Cardinale, Silvia Colli-Lanzi, Smeralda Skenderaj 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 August-September/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

NEWS

THE WORLD OF IFCC

Newly-Formed Libyan Society Launches Activities Amid National Challenges

ibyan Association of Clinical Pathology (LACP) is a recently founded association facing multiple and different hurdles along with political instability. It strives to enhance the scientific level of professionals and the quality of medical laboratory diagnostic services in the current difficult situation. LACP members are clinical chemists, laboratory scientists, and laboratory physicians, specialized in Clinical Chemistry, Clinical Hematology, Clinical Microbiology and Parasitology, Clinical Immunology, Clinical Genetics, and Blood Banks. LACP builds on the commitment of its members to raise awareness about the importance of diagnostic laboratories in good health provision. This will be followed by highlighting the primordial role of the clinical pathologist in bridging the gap between clinical services and the medical laboratories. LACP is working with the scientific council of laboratory medicine in the medical specialty council to graduate clinical pathologists and to ensure the availability of state of art training and education through connection with national and international bodies, societies, universities, and experts, and the provision of financial support. LACP participated in setting medical laboratory national plan for Covid-19 management in collaboration with the ministry of health, the center of disease control and biotechnology research center, and participated in a seminar for the establishment of national bone marrow transplantation center by providing a talk on the role of Flow cytometry in the diagnosis of hematological malignancy. LACP members are working with national centers for quality and accreditation. LACP works with the center of accreditation of health establishments in Libya, for the establishment of national quality standards in medical laboratories and blood banks, and it works with the Libyan accreditation center for the preparation of the necessary documents, manuals, and checklists needed for licensing, safety, and accreditation. LACP members presented the role of medical laboratories in good health as a third SDGs on world accreditation day and attended a seminar organized by WHO on quality in Fragile post conflict countries. LACP will serve as an advocate to develop this specialty in Libya, and to start a nonexistent specialty such as clinical genetics. Columbia University and Pasteur Institute in Tunis kindly invited an LACP member as a panelist for monthly experts talk on genetics in North Africa and Middle East. LACP will work to support Libyan scientific researches in the field. LACP members attended the WHO universal health coverage workshop, about the use of research outcome in policymaking, and participated in qualitative studies conducted by international experts for health reform. Contributed by Dr. Aisha NASEF; Libyan Association of Clinical Pathology (LACP); National Representative, Hematology; MBBCH, ADLM, Cli MSc, MSc, Ph.D; President, Scientific Council of Laboratory Medicine Medical Specialty Council, Tripoli, Libya.

LabMedica International August-September/2021

Presentation by Aisha NASEF on World Accreditation Day (WAD), on the topic, “Role of medical laboratories in achieving the good health as a third SDGs.”

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Troponin Testing Presents Problems in Kidney-Impaired People

igh-sensitivity cardiac troponin (hscTn) assays have improved the diagnosis of myocardial infarction in patients with healthy kidney function and are now widely used in clinical practice. However, in patients with kidney impairment, long-term elevations in troponin levels are common, and interpretation can be more challenging. As such, the effect of implementing hs-cTn testing on the diagnosis and outcomes of patients with kidney impairment is uncertain. Medical Scientists at the University of Edinburgh (Edinburgh, Scotland; www.ed.ac. uk) and their colleagues evaluated the use of a hs-cTnI assay in consecutive patients with suspected acute coronary syndrome across 10 hospitals in a stepped-wedge, cluster-randomized clinical trial of 46,927 consecutive patients. Throughout the trial, cTnI was measured using contemporary and high-sensitivity assays the ARCHITECTSTAT, Abbott Laboratories, Abbott Park, IL, USA; www. corelaboratory.abbott). Estimated glomerular filtration rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation. Kidney impairment was defined as an eGFR of less than 60 mL/

min/1.73 m2. The team reported that overall, hs-cTnI concentrations were elevated in 10,111 patients (22%), of whom 42% had kidney impairment. These newer assays flagged six fold more patients as kidney function declined from an eGFR of at least 90 to less than 30 mL/min/1.73 m2 (10% versus 66%). However, the proportion with acute type 1 myocardial infarction (MI) dropped precipitously across that same range of renal function, from 74% to 35%. In addition, the increase in identification did not correlate with better outcomes. Subsequent type 1 or 4b (more than 24 hours after percutaneous coronary intervention) MI or cardiovascular death were equally common at one year for patients treated before and after clinical use of the high-sensitivity test both with kidney impairment (25% versus 24%; adjusted hazard ratio [HR] = 1.00) and without it (13% versus 11%; adjusted HR = 0.89). Patients reclassified as having elevated troponin with the more sensitive versus conventional assay also did not have better outcomes. Nicholas L. Mills, MD, a consultant cardiologist and senior author of the study

said, “The reasons for this are complex. Twothirds of patients with kidney impairment and elevated hs-cTnI concentrations had a diagnosis other than type 1 myocardial infarction. In the absence of evidence from randomized trials, there is little guidance to inform clinical decisions for this heterogeneous group.” The study was published on June 7, 2021, in the journal JAMA Internal Medicine. Image: ARCHITECT STAT High Sensitivity Troponin-I blood test (Photo courtesy of Abbott Laboratories)

Paper-Based Dengue NS1 Rapid Diagnostic Test Validated

engue virus (DENV) infection is one of the world’s most important neglected tropical diseases and the fastest spreading mosquito-borne disease. About 70% of the 3.9 billion people at risk live in Asian Pacific countries, mainly in Southeast Asia. The early diagnosis of dengue is essential for clinical assessment, investigations, and disease control. Although, molecular assays were used as the gold standard for diagnosing dengue infection, these methods are expensive, tedious, and need the expertise of technicians, which is unsuitable for pointof-care tests in remote areas. A multi-disciplinary team of scientists working with those at King Mongkut’s University of Technology Thonburi (Bangkok, Thailand; www.kmutt.ac.th) analyzed 250 dengue-suspected sera samples used in a study were the archived sera of dengue-suspected patients, routinely collected during the peak of the disease epidemic in Thailand, from July to September 2019. Patients’ blood samples were routinely tested by a commercial dengue NS1 test kit (Dengue Duo test, SD BIOLINE, Abbott Park, IL, USA; www.globalpointofcare.abbott), immediately after collection to diagnose and treat patients. The team developed a simple diagnostic kit for dengue NS1 testing based on a waxprinted microfluidic paper-based analytical

device (μPAD), so-called DEN-NS1-PAD for sensitive and specific detection of dengue NS1. The DEN-NS1-PAD allows specific interaction between reporter antibodies (rAb) labeled with Gold Nanoparticles (AuNPs) and dengue NS1 protein. Viral RNAs in serum samples were extracted by using QIAamp Viral RNA Mini Kit (QIAGEN, Hilden, Germany; www.qiagen.com). They were then subjected to RT-PCR using dengue-specific primers, and the RT-PCR products were used as templates for the nested-PCR reaction. The team reported that out of the 250 dengue-suspected patients who were admitted to the hospital over the study period, there were two commercialized RDT tested, of which 219 were from SD BIOLINE Dengue Duo test and PCR testing. Prevalence of dengue infection was 45.21% by SD-NS1, 47.49% by DEN-NS1-PAD and 45.21% by nested-PCR. The results from the nested-PCR were 99 of dengue positive and 120 negative. The limit of detection of DEN-NS1-PAD was 0.78 ng/mL. It showed 88.89% sensitivity, 86.67% specificity, and a substantial agreement correlation compared with nested-PCR. In contrast, SD BIOLINE for NS1 (SD-NS1) detection showed 87.88% sensitivity, 90.00% specificity, and also had a substantial agreement correlation with nested-PCR. The authors concluded that the perfor-

mance of the DEN-NS1-PAD to be almost on par with SD-NS1 in detecting dengue infection in acute febrile cases. The device possesses better sensitivity than SD-NS1, especially for the diagnosed patient after day five of illness. The DEN-NS1-PAD can be a potential alternative to existing commercial RDTs in the detection of acute dengue infection in the future. The study was originally published in the June 2021 issue of the International Journal of Infectious Diseases. Image: Schematic representation of the procedure for dengue NS1 detection by using DEN-NS1-PAD (Photo courtesy of King Mongkut’s University of Technology Thonburi) LabMedica International August-September/2021

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

cont’d from cover

IL, Inova, Biokit to Unite Under Werfen Brand Name

hubs for the Company’s key business lines will now be led by Chief Operating Officers, and operate as Werfen Headquarters and Technology Centers. Management and organization of Werfen’s Commercial Operations in North America will now be consolidated. Field Service and Customer Service functions will be unified across business lines, while Sales, Applications, Marketing and Technical Support will remain specialized. With a new logo and brand colors, Werfen adopts a new brand identity - evoking innovation and humanity. The new Werfen logo is modern, strong and singular, signifying unity in the company’s quest to deliver innovation after innovation, for every patient whose life

could depend upon the quality of a test result. The new logo will be incorporated into the company’s products and communication vehicles gradually, over time. The legal names for IL, Inova and Biokit, and any contracts or purchasing agreements, are unaffected by this change. “This transformation represents a natural evolution for Werfen, strengthening our global leadership position in specialized diagnostics, and positively impacting our ability to drive innovation and support our customers,” said Carlos Pascual, CEO at Werfen. “By sharing one global identity, with the same vision and strategic objectives, our teams around the world will maximize collaboration to set new standards for products and services in Hemostasis, Acute Care, Autoimmunity and OEM diagnostics.”

Ortho and Thermo Fisher Enter Quality Control Alliance

rtho Clinical Diagnostics (Raritan, NJ, USA; www.orthoclin icaldiagnostics.com) has entered into a distribution agreement with Thermo Fisher Scientific Inc. (Waltham, MA, USA; www. thermofisher.com) to provide and support MAS Quality Controls and LabLink xL Quality Assurance Software through Ortho’s VITROS QC Solutions to VITROS System customers worldwide. The VITROS QC Solutions will provide customers with a combination of Ortho Clinical Diagnostics Controls and Thermo Scientific MAS Quality Controls to bring a complete quality control solution to the laboratory. Featuring consolidated, liquid-ready, Gen-Specific Value assignment along with LabLink xL, a web-based quality assurance program that provides real-time quality control monitoring with automatic data entry upload and audit-friendly reports. VITROS System customers will

have access to the unique Gen-Specific Peer Group evaluation, that is currently unavailable through any other quality control program. Paired with the proprietary technologies and benefits only available on VITROS Systems, VITROS QC Solutions improves workflows and drives efficiency, enabling labs to streamline operations without sacrificing quality. “Ortho continues to bring innovative solutions to market, like our latest VITROS QC Solutions, that allow labs to take charge of their operations with improved ease of use and optimized product utilization – saving them time and money,” said Bryan Hanson, Head of Clinical Laboratories Business Unit at Ortho Clinical Diagnostics. “Through this agreement with Thermo Fisher Scientific, we can provide laboratories with better solutions, allowing them to maximize their laboratory productivity.”

Qiagen Partners with Sysmex in Cancer Companion Diagnostics

IAGEN N.V. (Venlo, Netherlands; www.qiagen.com) and Sysmex Corp. (Kobe, Japan, www.sysmex.com) have entered into a global strategic alliance for the development and commercialization of cancer companion diagnostics, which will leverage both QIAGEN’s leadership in this field and Sysmex’s Plasma-Safe-SeqS technology for next generation sequencing (NGS). The alliance aims to foster collaborations with pharmaceutical companies for the development of drug treatments for cancer and promote early clinical adoption of ultra-sensitive liquid biopsy companion diagnostics. QIAGEN and Sysmex have a longstanding partnership, which, for example, provides the ipsogen JAK2 blood-cancer test in Japan. Cancer companion-diagnostics products will be launched by QIAGEN and Sysmex in various regions of the world. Genetic analysis of tumors makes it possible to identify the genes responsible for the development and spread of a tumor and to target treatment accordingly. But the traditional analysis of solid tumors is constrained by their heterogeneity - varying concentrations of cancer cells, for example - and by sample availability. Liquid biopsy addresses these challenges and, in combination with sensitive NGS, allows the evaluation of patients at different points of their cancer treatment. It enables doctors to spot new anomalies and adjust treatments to make them more precise, and to develop novel targeted therapies. “Combining QIAGEN’s global reach with Sysmex’s NGS capabilities is an important milestone in advancing the use of NGS technologies in clinical decision-making and is a testament to our shared vision of using this powerful technology to improve outcomes for patients worldwide,” said Jean-Pascal Viola, Senior Vice President, Head of the Molecular Diagnostics Business Area and Corporate Business Development at QIAGEN. “This alliance will add strong NGS capabilities to our regulatory and clinical expertise and commercialization, and help our partners in the pharmaceuticals industry by expanding our strong position and product offering in companion diagnostics. We look forward to this alliance creating significant benefits for our pharma partners - and ultimately for treating patients.”

Industry News

LabMedica International August-September/2021

“The alliance with QIAGEN promises Sysmex a great application for Sysmex’s Plasma-Safe-SeqS technology, which can detect gene mutations of cancer in blood with ultra-high sensitivity. We believe that QIAGEN is the best for Sysmex to expand this globally,” said Hiroshi Kanda, Member of the Managing Board and Senior Executive Officer, Head of Corporate Business Development at Sysmex.

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– AACC 2021 . . . . . . . . . . . . . . . . . . . . . . . . . . 35 118 AB Analitica. . . . . . . . . . . . . . . . . . . . . . . . . . 18 122 Absology . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 123 Alcor Scientific. . . . . . . . . . . . . . . . . . . . . . . . 23 129 Awareness Technology, Inc.. . . . . . . . . . . . . 29 131 Bioperfectus Technologies. . . . . . . . . . . . . . . 31 108 Buhlmann. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 110 CDG Biotech . . . . . . . . . . . . . . . . . . . . . . . . . 10 – COLABIOCLI 2022. . . . . . . . . . . . . . . . . . . . . . . . . . . 37 113 DiaSys Diagnostic Systems. . . . . . . . . . . . . . 13 – EuroMedLab 2021. . . . . . . . . . . . . . . . . . . . . 33 107 Feather. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 106 Mast Group . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 111 Mayo Clinic Laboratory . . . . . . . . . . . . . . . . . 11 121 NG Biotech. . . . . . . . . . . . . . . . . . . . . . . . . . . 21 119 Nova Biomedical . . . . . . . . . . . . . . . . . . . . . . 19 140 Randox. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 109 Randox. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 117 Sekisui Diagnostics . . . . . . . . . . . . . . . . . . . . 17 125 Serosep. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 130 Singuway. . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 102 Snibe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 – TradeMed. . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 105 Veda Lab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 120 Vicotex. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 115 Vircell. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 103 Werfen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Provided as a service to advertisers. Publisher cannot accept responsibility for any errors or omissions.

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