LabMedica International November 2021 by Globetech

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WORLD’S CLINICAL LABORATORY NEWS LEADER

MEDICA® 2021

ISSN 1068-1760

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Vol. 38 No.7 • 11/2021

Early Detection of Gastric Cancer

astric cancer (GC) is the fourth most-commonly diagnosed cancer, and the third leading cause of cancer-associated mortality worldwide. Despite improvements in treatment modalities, the prognosis for advanced GC following curative resection

DAILY CLINICAL LAB NEWS

Glial Fibrillary Acidic Protein Investigated as Stroke Biomarker

mergency medical services (EMS) encountering patients with acute stroke symptoms are challenged with the difficult task of rapidly triaging the patient to the appropriate hospital with sufficient therapeutic capabilities. Glial fibrillary acidic protein

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(GFAP) and tau are differentially released in ischemic and hemorrhagic stroke (HS), but their very early release dynamics are unknown, as previous studies have focused on single-time point measurements after hospital admission. Circulating GFAP was Cont’d on page 12

Novel Probe Algorithm Detects Unknown Deadly Pathogens

Artificial Intelligence Identifies Leukemia

ulti-parameter flow cytometry (MFC) is a cornerstone in clinical decision making for leukemia and lymphoma. MFC data analysis requires manual gating of cell populations, which is time-consuming, subjective, and often limited to a two-dimensional space. Typical symptoms of malignant B-cell lymphomas and related leukemias are that the lymph nodes Cont’d on page 8

Biomarker for Dementia Diagnosis

biomarker panel based on five groups of metabolites was shown to be potentially useful for diagnosis and therapy of various forms of dementia, such as Alzheimer’s disease. Dementia, which is caused by factors that damage neurons, is characterized by a slowly progressing, chronic, and usually irreversible decline in cognitive function. The exact cause of

cientists have developed a sophisticated new diagnostic tool that provides early warnings on unknown viruses and identifies potentially deadly bacterial pathogens. See article on page 17

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Rapid COVID-19 Variant Test Speeds Mutation Tracking from Weeks to Hours

fforts by researchers to identify and track variants of the SARS-CoV-2 virus has led to the creation and future implementation of a new method to “fingerprint” all currently known COVID-19 mutations. The method developed

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Blood Lipid Biomarkers Linked to Lower Risk of ALS

myotrophic lateral sclerosis (ALS) ALS belongs to a wider group of disorders known as motor neuron diseases, which are caused by gradual deterioration (degeneration) and death of motor neurons. Motor neurons are nerve cells that extend from the brain to the spinal

cord and to muscles throughout the body. Premorbid body mass index, physical activity, diabetes and cardiovascular disease have been associated with an altered risk of developing amyotrophic lateral sclerosis (ALS). There is evidence of shared Cont’d on page 19

INSIDE

COVID-19 Update. . . . . 4 Clinical News. . . . . . . . . 8 IFCC News. . . . . . . . . . 29 Product News . . . . . 6-26 Industry News . . . . . . . 33 Events Calendar . . . . . 34

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LabMedica International

he report that follows provides a selection of news and advances announced from September 15 to October 15, 2021. For a recap of earlier developments, the reader is invited to refer to previous issues of LabMedica or visit our website at www.Lab Medica.com. New Ultra-High-Throughput PCR Testing System for SARS-CoV-2 Detection Can Test up to 150,000 Patient Samples per Day A new ultra-high-throughput PCR testing system for SARS-CoV-2 detection developed by LGC, Biosearch Technologies (Hertfordshire, UK; www.biosearchtech.com) can test up to 150,000 patient samples per day. The proven molecular genomics testing platform with unmatched capacity is expected to redefine largescale COVID-19 testing. For labs ready to scale to support mass testing, the company is offering the ultra-high-throughput (uHTP) end-point PCR testing system for SARS-CoV-2 detection. COVID-19 Saliva Test Outperforms Commercial Swab Tests The “DRUL” saliva test developed in-house at The Rockefeller University (New York, NY, USA; www.rockefeller.edu) to identify positive cases within the Rockefeller community performs as well, if not better, than FDA-authorized nasal and oral swab tests, according to the findings of a new study. In a direct head-to-head comparison of 162 individuals who received both Rockefeller’s “DRUL” saliva test and a conventional swab test, DRUL caught all of the cases that the swabs identified as positive - plus four positive cases that the swabs missed entirely. New Testing Approach Leverages Metagenomic Sequencing and Analysis to Detect COVID-19 and Identify New SARS-CoV-2 Variants Jumpcode Genomics (San Diego, CA, USA; www.jumpcodegenomics.com), a genome technology platform company focused on improving the understanding of human biology, has entered into a collaboration with the Translational Genomics Research Institute (TGen; Phoenix, AZ, USA; www.tgen.org) to aid investigations into the genomic epidemiology of SARS-CoV-2, the virus that causes COVID-19. The collaboration aims to leverage meta-genomic sequencing and analysis to facilitate detection of COVID-19 and other infectious diseases, as well as identify new SARS-CoV-2 variants. Cheap 5-Minute COVID-19 Test Accurately Detects SARS-CoV-2 Antibody in Blood or Saliva Researchers at The Hong Kong Polytechnic University (Hong Kong; www.polyu.edu. hk) have developed an ultrafast, low-cost, label-free, and portable SARS-CoV-2 immunoglobulin G (IgG) detection platform based on organic electrochemical transistors (OECTs), which can be remotely controlled by a mobile phone. The device can detect SARS-CoV-2

IgG with an ultralow detection limit of 1 fM in aqueous solutions and 10 fM in serum and saliva within five minutes. Groundbreaking Solution Enables Enhanced Screening and Genomic Surveillance of SARS-CoV-2 and its Mutations The first-ever turn-key solution for whole genome sequencing (WGS) of COVID-19 from Clear Labs (San Carlos, CA, USA; www.clearlabs.com) is expected to help hospitals, reference labs, public health organizations and epidemiologists more easily identify and trace all strains of SARS-CoV-2. Clear Labs, provider of the only fully-automated next-generation sequencing (NGS) platform for turnkey diagnostics, has launched Clear Dx WGS, the first automated WGS solution that determines the complete RNA sequence of the SARS-CoV-2 genome in less than 24-hours, a fraction of time, compared with traditional manual WGS workflows, requiring only minutes of hands-on time. Thermo Fisher Launches CE-IVD Marked Next-Generation TaqPath COVID-19 RNase P 2.0 Assay Kit Thermo Fisher Scientific Inc. (Waltham, MA, USA; www.thermofisher.com) has launched the CE-IVD marked TaqPath COVID-19 RNase P 2.0 kit, a newly designed test that provides accurate results by compensating for current and future COVID-19 viral mutations. The kit has been redesigned to detect active SARS-CoV-2 infections by identifying the presence of any one of eight gene targets from the virus. By surveying across multiple genes, the test can net accurate results even as mutations shift the genes they express. Diasorin Molecular’s New Multiplex COVID-19/Influenza Test Receives CE Mark DiaSorin Molecular (Cypress, CA, USA; www.molecular.diasorin.com) has CE marked its Simplexa COVID-19 & Flu A/B Direct kit. The multiplex test allows for the in vitro qualitative detection and differentiation of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus and influenza B virus from the same patient sample in one reaction well. The assay is designed for use on the LIAISON MDX and is run directly from nasopharyngeal swabs (NPS) without the need for off board extraction. Global COVID-19 Antigen Test Market to Continue Being Driven by Evolution of New SARS-CoV-2 Strains The global COVID-19 antigen test market is witnessing increasing demand due to the evolution of new strains of the SARS-CoV-2 virus and increasing spikes in the instances of new COVID-19 infections. Products in the global COVID-19 antigen test market are expected to gain traction owing to their benefits such as shorter test-to-result timeline, as well as their Cont’d on page 5

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EDITORIAL BOARD

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

Published in cooperation with the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). LabMedica International • LabMedica en Español • LabMedica.com HospiMedica International • HospiMedica.com • MedImaging.net TradeMed.com • LabMedicaExpo.com • LinkXpress.com

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ISSN 1068-1760 Vol.38 No.7. 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 November/2021

COVID -19 Diagnostics Update Cont’d from page 4

patient-friendly and easy-to-use nature. Furthermore, scalability and timeline challenges regarding PCR testing for the SARS-CoV-2 virus are among the major factors resulting in increased uptake of products in the global COVID-19 antigen test market. These are the latest findings of Transparency Market Research (Albany, NY, USA; www.transparencymarketresearch.com), a next-generation market intelligence provider. Global COVID-19 Saliva Collection Kits Market Driven by Rising SARSCoV-2 Infections and Convenient Specimen Testing The global COVID-19 saliva collection kits market was valued at close to USD 190 million in 2020 and is expected to register a CAGR of 3.9% over 2026-2031, driven by rising COVID-19 infections, focus on developing convenient kits, and increasing awareness of self-testing. Growing prevalence of COVID-19, preference for convenient specimen testing, and new product launches beyond 2021 are expected to drive short-term market growth. These are the latest findings of Persistence Market Research (New York City, NY, USA; www.persistencemar ketresearch.com), a global provider of market research and data analytics.

to target and detect infectious viruses in minutes without the need to pre-treat samples. They demonstrated the sensor’s power with two key viruses that cause infections worldwide: the human adenovirus and the virus that causes COVID-19. Blood Test for Combined Measurements of WBCs and Biomarkers Can Predict COVID-19 Severity Combined measurements of characteristics of white blood cells called granulocytes and well-known biomarkers in the blood of COVID-19 patients can predict the severity of the disease, according to a new study by researchers at the Karolinska Institutet (Stockholm, Sweden; www.ki.se). The study aimed at providing a comprehensive overview of the immune response to SARS-CoV-2 in

hospitalized patients with moderate or severe COVID-19. The findings which showed that COVID-19 disease severity seems to be affected by granulocytes, which are part of the innate immune system, could eventually contribute to more tailored treatments for COVID-19 patients. New COVID-19 Antigen Testing Method Offers Highly Accurate Results in Less than Three Minutes Researchers at Northwestern University (Evanston, IL, USA; www.northwestern. edu) have leveraged a cantilever-based sensor platform to develop rapid, cost-effective and multiplexed antigen test, with potential for point-of-care diagnosis. Its high sensitivity to specific proteins may allow the platform to Cont’d on page 6

Rapid COVID-19 Variant Test Speeds SARS-CoV-2 Mutation Tracking From Weeks to Hours Efforts by researchers at the UW School of Medicine (Seattle, WA, USA; www.uwmedicine.org) to identify and track variants of the SARS-CoV-2 virus has led to the creation and future implementation of a new method to “fingerprint” all currently known COVID-19 mutations. The method identifies the presence of dozens of mutations at once and requires only three ingredients: a dipstick, a common thermocycler instrument, and a processed test sample. Upon coming into contact with the sample, the dipstick records which variant is present by exposing a series of lines, or bands. Every known variant of interest and concern has a correlating band pattern, which the test administrator can match to the sample.

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New DNA Sensor Detects Presence of Virus and Also Whether it’s Infectious A new sensor developed by researchers at the University of Illinois Urbana-Champaign (Champaign, IL, USA; www.illinois.edu) can detect not only whether a virus is present, but whether it’s infectious - an important distinction for containing viral spread. The sensor, which integrates specially designed DNA fragments and nanopore sensing,

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PRODUCT NEWS

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SEMI-AUTOMATIC BIOCHEMISTRY ANALYZER TECO DIAGNOSTICS

IMMUNOASSAY ANALYZER CAROLINA LIQUID CHEMISTRIES

AUTOMATED HEMATOLOGY ANALYZER ARK DIAGNOSTICS

The TC-3300 PLUS semi-automatic biochemistry analyzer is a microcomputer-based in-vitro diagnostics instrument combining optics, mechanics and automation control all in one system.

The FREND System is a small, fast and near-patient in vitro diagnostic device that uses microfluidics technology and immunofluorescent techniques for measurement of biomarkers in patient samples.

Smart Count 3p is a 22 parameters and 3 part differential automated hematology analyzer with the lowest sample volume requirement of less than 10 µL. It automatically creates a log sheet for maintenance and malfunction.

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COVID -19 Diagnostics Update Cont’d from page 5

detect different viruses, COVID-19 variants and test-related markers, with potential for using breath for COVID-19 testing First-of-its-Kind SARS-CoV-2 Antibody Testing System Tests both Anti-Nucleocapsid and Anti-Spike Antibodies in One Reaction SCIENION (Berlin, Germany; www.scienion.com) has entered into a strategic collaboration with Pictor Limited (Auckland, New Zealand; www.pictordx.com) to commercialize the new high throughput SARS-CoV-2 antibody testing system. The two companies will incorporate SCIENION’s CL2 sciREADER system into Pictor’s PictArray SARS-CoV-2 Serology Test to create the only platform capable of testing both anti-nucleocapsid and anti-spike antibodies in one reaction. This analysis will be key to support the sustained fight against COVID-19 by measuring a population’s level of herd immunity through natural infections and vaccinations.

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T-Cell Tests Unreliable in Establishing Previous COVID-19 Infection, Finds New Study T-cell tests can be unreliable in establishing previous COVID-19 infection, according to a joint study by scientists at Uppsala University (Uppsala, Sweden; www.uu.se) and Karolinska Institutet (Stockholm, Sweden; www.ki.se). In the study, the researchers analyzed if T-cell tests can be used to determine whether people have had COVID-19. By analyzing the T cells’ responses to varying peptide compositions, the researchers were able to see that different peptide pools produced divergent responses, and that a risk of false-positive responses existed. In the scientists’ view, this risk is due to the fact that the peptides can give rise to responses from memory T cells that originated in some way other than through a SARS-CoV-2 infection – from a common cold, for example. EUROIMMUN Anti-SARS-CoV-2 S1 Curve ELISA Granted FDA Emergency Use Authorization EUROIMMUN, a PerkinElmer, Inc. (Waltham, MA; USA; www. perkinelmer.com) company, has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration has provided for its Anti-SARS-CoV-2 S1 Curve ELISA (IgG). The assay allows for the qualitative and semi-quantitative detection of IgG antibodies formed against the SARS-CoV-2 S1 antigen, in human serum and plasma. The assay can run manually or using the EUROLab Workstation ELISA, Sprinter XLTM and other third party ELISA platforms. Study Questions Popular COVID-19 Test and Proposes New Marker of Disease Severity Researchers at the Skolkovo Institute of Science and Technology (Moscow, Russia; www.skoltech.ru) who were studying the immune response to COVID-19 in patients with different levels of disease severity have found that half of the patients without symptoms did not actually produce significant amounts of IgG antibodies of a kind targeted by many popular test kits. Nevertheless, the study found that nearly all patients produced another kind of antibodies, whose count was sometimes even higher in asymptomatic cases, leading the researchers to suggest the ratio between the two counts as an indicator of disease severity. CT Values Should Not Be Used to Assess Performance of SARS-CoV-2 PCR Tests or Triage COVID-19 Patients, Finds Study A novel study by an international group of scientists, led by the National Measurement Laboratory for Chemical and Bio-Measurement team at LGC (Middlesex, UK; www.lgcgroup.com), has shown that coronavirus test cycle threshold (Ct) values should not be used to assess the Cont’d on page 7

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performance of coronavirus tests or to triage COVID-19 patients. These findings could improve the development of coronavirus tests, which are crucial for managing the pandemic, as well as care for COVID-19 patients. Study Examines Proteins in Saliva to Predict COVID-19 Severity Risk in Children with Help of AI Model A team of researchers at Penn State College of Medicine (Hershey, PA, USA; https://med. psu.edu) is conducting a study to look at the relationship between proteins called cytokines in saliva and COVID-19 infection to help predict the severity of infection with the help of an artificial intelligence (AI) model. The researchers are looking at cytokines and microRNAs (non-coding RNAs) in saliva in children. These biomarkers may control the inflammation in the body once infected with the virus and help determine the seriousness of the infection.

Newly-Launched Portable Molecular Diagnostic Platform Detects COVID-19 at Point-Of-Care within 30 Minutes A new portable molecular diagnostic platform and its compatible diagnostic test for the detection of SARS-CoV-2 from BIOPIX-T (Voutes, Greece; https://biopix-t.com) delivers results within 30 minutes at the Point-of-Care (POC). BIOPIX-T has launched its portable molecular diagnostic platform, the PEBBLE qcLAMP Platform, along with its compatible diagnostic test for the detection of the SARS-CoV-2 virus. PEBBLE is the first Greek portable molecular diagnostic device based on LAMP technology (Isothermal PCR), which can be used at the POC. PEBBLE as well as COV19 qcLAMP kit, the corresponding diagnostic kit to be used together with the diagnostic instrument for the

detection of SARS-CoV-2, are now CE Marked. New Nanomechanical Technique for Fast, One-Step, Immune-Affinity Tests Rapidly Quantifies Transmissibility of COVID-19 Variants A team of researchers at Trinity College Dublin (Dublin, Ireland; www.tcd.ie) has developed a new nanomechanical technique for fast, one-step, immune-affinity tests, which can quantify the immune response induced by different COVID-19 variants in serum. The technique provides a new tool for tracking infection immunity over time and for analyzing new vaccine candidates. The team’s specific quantitative assay enables direct classification of variant-binding properties for screening emerging variants.

Pooled Saliva Testing for COVID-19 Can be Cheaper and as Accurate as Individual Nasopharyngeal Diagnostic Tests Testing pooled saliva samples twice weekly for SARS-CoV-2 on a residential college campus yielded a greater than 95% agreement with the gold standard for accuracy— nasopharyngeal diagnostic samples tested singly, according to a study by researchers at Olivet Nazarene University (Bourbonnais, IL, USA; www. olivet.edu). The study revealed that at an average of 665 tests per week, the cost, just USD 0.43 per sample, likely remains the least expensive method to date. Lateral Flow Tests for COVID-19 More Accurate than Previously Reported, Cannot Be Compared to PCR Tests Lateral flow tests (LFTs) for COVID-19 are more accurate than previously reported and cannot be compared directly to how polymerase chain reaction (PCR) tests work, according to new research led by the University College London (London, UK; www. ucl.ac.uk). In a study, the researchers used a new formula to show that LFTs are likely more than 80% effective at detecting any level of COVID-19 infection and likely more than 90% effective at detecting those who are most infectious when using the test. This level of accuracy is much higher than some previous studies have suggested, and the researchers say the tests are a reliable public health tool in stopping the spread of the virus.

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PRODUCT NEWS AUTOMATED SAMPLE PREPARATION SYSTEM

MGI TECH

The MGISP-100 Automated Sample Preparation System is an automated workstation specialized for high-throughput sequencing library preparation. Through automated operation the system processes samples in batches. LINKXPRESS COM

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CHEMILUMINESCENCE IMMUNOASSAY ANALYZER SHENZHEN YHLO BIOTECH

COVID-19 FLUORESCENT RT-ISOTHERMAL ASSAY

The iFlash 1200 Chemiluminescence Immunoassay Analyzer is an ideal workstation for low-mid volume testing laboratories. It has a throughput of up to 120 tests/hour along with more than 120 available reagents.

iAMP COVID-19 SANO Assay is a real-time fluorescent RT-isothermal assay based on Atila’s proprietary isothermal amplification technology, intended for the qualitative detection of nucleic acid from SARS-CoV-2.

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Artificial Intelligence Identifies Leukemia

become swollen, there is weight loss and fatigue, as well as fevers and infections. If such a cancer of the lymphatic system is suspected, the physician takes a blood or bone marrow sample and sends it to specialized laboratories for flow cytometry analysis. Clinical Scientists and Bioinformaticians associated with University of Bonn (Bonn, Germany; www.uni-bonn.de) and colleagues from other institutions present a workflow that allows existing artificial intelligence (AI) to adapt to multiple MFC protocols. They combined transfer learning (TL) with MFC data merging to increase the robustness of AI. The base dataset consists of around 18,000 training samples acquired using a 9-color MFC panel at Munich Leukemia Laboratory (MLL, Munich, Germany; www.mll.com), between 2017 and 2018. Four additional MFC target datasets were obtained with different MFC panel compositions. All samples were analyzed on Navios flow cytometers (Beckman Coulter, Miami, FL, USA; www.beckman.com). Flow cytometry is a method in which the

blood cells flow past measurement sensors at high speed. The properties of the cells can be detected depending on their shape, structure or coloring. Detection and accurate characterization of pathological cells is important when making a diagnosis. The laboratories use “antibodies” that dock to the surface of the cells and are coupled to fluorescent dyes. Such markers can also be used to detect small differences between cancer cells and healthy blood cells. Flow cytometry generates large amounts of data. On average, more than 50,000 cells are measured per sample. These data are then typically analyzed on screen by plotting the expression of the markers used against each other. The great new feature of the AI presented in the study lies in the possibility of knowledge transfer. Particularly smaller laboratories that cannot afford their own bioinformatics expertise and may also have too few samples to develop their own AI from scratch can benefit from this study. After a short training phase, during which the AI learns the specifics of the new laboratory, it can then draw on

knowledge derived from many thousands of data sets. Peter M. Krawitz, MD, PhD, a Professor at the Institute for Genomic Statistics and Bioinformatics and a senior author of the study, said, “The gold standard is diagnosis by hematologists, which can also take into account results of additional tests. The point of using AI is not to replace physicians, but to make the best use of the information contained in the data.” The authors concluded their workflow extended deep learning models to multiple MFC panels and achieve high accuracy for multi-label classification across datasets. They addressed some of the previous challenges for automated flow cytometry classification by allowing models to be trained with smaller training sizes and generalizing models to work with multiple MFC panels. The workflow is a step toward making deep learning models robust so that AI for diagnostic MFC can move from the “proof of concept” stage into routine diagnostics. The study was published on September 17, 2021 in the journal Patterns.

Rapid COVID-19 Variant Test Speeds Mutation Tracking from Weeks to Hours

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by researchers at the UW School of Medicine (Seattle, WA, USA; www.uwmed icine.org) identifies the presence of dozens of mutations at once and requires only three ingredients: a dipstick, a common thermocycler instrument, and a processed test sample. Upon coming into contact with the sample, the dipstick records which variant is present by exposing a series of lines, or bands. Every known variant of interest and concern has a correlating band pattern, which the test administrator can match to the sample. Currently the definitive method of tracking variants of the virus, including the delta variant, is done through genomic sequenc-

ing. The process is thorough but can take up to two weeks to collect a sufficiently large batch of samples and yield results. The new method provides high-resolution results much more quickly, with a single or a few samples in hand. A grant awarded through the National Institutes of Health is fueling the development of the test, which will also include a barcode component that can be scanned through a smartphone app. The app connects the user to a database of all variant fingerprints. Preprogrammed and battery-capable thermocyclers will also be made available for distribution with test materials. The test is already available as a prototype in the form of a same-day to next-day service

in the UW School of Medicine lab on a collaborative basis, while a wider distribution of the full kit for clinical epidemiologists and researchers could come by this winter. The method is also designed with a key ability: potentially tracking new variants as they emerge, according to the researchers. “It’s a rapid test. We can identify the variant within two hours of the sample being in hand,” said UW School of Medicine Microbiology Professor Evgeni Sokurenko. “With emergence of new variants, generally, what we see right now involves a new combination of the known mutations. So we will be able to detect with this test, [the] emergence of new combinations of mutations, meaning new variants.” LabMedica International November/2021

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SARS-COV-2 RT-PCR TEST EUROFINS TECHNOLOGIES

MOLECULAR DIAGNOSTIC PLATFORM LUMINEX CORPORATION

COVID 19 IGG/IGM RAPID ANTIBODY TEST SEROSEP

The GSD NovaType III SARS-CoV-2 RT-PCR is developed for rapid detection of SARS-CoV-2 variants of concern including B.1.427 / B.1.429 (Epsilon) / B.1.617.2 (Delta), B.1.617.1 (Kappa) / B.1.617.3, B.1.351 (Beta) / P.1 (Gamma).

The VERIGENE II System is a sample-to-answer molecular diagnostic platform able to perform both targeted and multiplex testing. The system performs extraction, amplification, hybridization, and detection — all in one cartridge.

The COVID 19 IgG/IgM Rapid Gold test is an in-vitro diagnosis kit that makes use of immunochromatography method combining antigen-antibody reaction and chromatography for the qualitative detection of COVID-19 IgG and IgM.

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Early Detection of Gastric Cancer

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remains poor. Patients diagnosed with early-stage GC have a favorable prognosis, underscoring the paradigm that identification at earlier stages remains an attractive strategy for reducing GC-associated patient mortality. The use of liquid biopsy-based, noninvasive cancer biomarkers has become increasingly desirable, and several promising molecular biomarkers have been identified in blood, urine, and gastric juice. Gastroenterologists at the Baylor University Medical Center (Dallas,

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Image: Schematic representation of cancer-related biomolecules such as cells, proteins, nucleic acids, miRNA and microvesicles circulating into the bloodstream, and collection of these biomarkers by liquid biopsy (Photo courtesy of University of Florence)

TX, USA; www.bcm.edu) and their international colleagues analyzed more than 1,900 tissue and serum specimens from patients with GC, adjacent normal tissues, and healthy participants across four phases. Study phases included a biomarker discovery phase, a tissue validation phase, a retrospective serum validation phase, and a prospective serum performance evaluation phase. The biomarker discovery cohort (436 GC tissues and 41 adjacent normal mucosae) was analyzed to identify miRNA candidates. In the tissue validation phase, quantitative reverse-transcription–polymerase chain reaction (qRT-PCR) assays were performed to interrogate the expression levels of candidate miRNAs in 50 pairs of matched, fresh-frozen, primary tumor and adjacent normal tissues from patients with GC. In the prospective serum validation phase, serum specimens were collected from 176 patients with GC and 173 healthy participants, matched by age and sex, who were prospectively recruited from March 2017 to August 2018. The 10 miRNAs were validated in two additional independent datasets that included 40 GC and 40 non-cancerous tissue specimens with miRNA profiling data acquired using the miRNA microarray (Agilent Technologies, Santa Clara, CA, USA; www.agilent.com). The scientists reported that the data sets for the genome-wide expression profiling analysis stage included 598 total patient samples Cont’d on page 13 LINKXPRESS COM

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NUCLEIC ACID DETECTION KIT FOR COVID-19 SINGUWAY BIOTECH

BMP WHOLE BLOOD ANALYZER WERFEN

COVID-19 IGA/IGG/IGM ANTIBODIES TEST DIASOURCE

The Nucleic Acid Detection Kit For COVID-19 (PCR Fluorescence Probe) uses real-time PCR fluorescence technology to detect the nucleic acid of patients with convection-like symptoms, severe pneumonia and COVID-19.

The GEM Premier ChemSTAT is a rapid Basic Metabolic Panel (BMP) whole-blood analyzer with a menu customized for the Emergency Department, including lab-quality Creatinine results.

The EIA COVID-19 NP IgA/IgG/IgM kit is intended for detection of specific IgA/IgG/IgM antibodies in a sample by means of a sandwich type of the EIA method. It requires 10 µL volume of serum or plasma sample.

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Prehospital Plasma GFAP Analyzed as Stroke Biomarker

increased in only 36% of patients with intracerebral hemorrhage (ICH). Clinical Neuroscientists at the Helsinki University Hospital (Helsinki, Finland; www. hus.fi) and their colleagues performed ultra-sensitivite single-molecule array measurements of plasma GFAP and total tau in a stroke code patient cohort with cardinal stroke symptoms. Sequential sampling included two ultra-early samples and a follow-up sample on the next morning. The team included 272 cases (203 acute cerebral ischemia [ACI], 60 HS, and nine stroke mimics). The investigators performed plasma GFAP and total tau (T-tau) measurements using commercially available GFAP Discovery and Tau 2.0 kits on the Simoa HD-1 Analyzer, (Quanterix, Billerica, MA, USA; www.quanterix.com). The median (IQR) last-known-well to sampling time was 53 (35–90) minutes for initial prehospital samples, 90 (67–130) minutes for secondary acute samples, and 21 (16–24) hours for next

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neuron damage, and methods for its detection and treatment have remained elusive. To rectify this situation, investigators at the Okinawa Institute of Science and Technology (Japan; www.oist.jp) employed nontargeted liquid chromatography–mass spectroscopy (LCMS) to quantify small molecular markers in whole blood samples taken from of dementia patients. For this study, the investigators exhaustively analyzed blood samples collected from eight patients with dementia, from eight healthy elderly individuals, and from eight healthy young individuals. Overall, the investigators measured the levels of 124 different metabolites for each patient. Analysis of the results revealed that 33

morning samples. The scientists reported that the plasma GFAP was significantly higher in patients with HS than ACI (P < 0.001 for <1 hour and <3 hour prehospital samples, and <3 hour secondary samples), while total tau showed no intergroup difference. The prehospital GFAP release rate (pg/mL/minute) occurring between the two very early samples was significantly higher in patients with HS than ACI [2.4 (0.6–14.1)] versus 0.3 (0.3–0.9) pg/mL/ minute. For cases with <3 hour prehospital sampling (ACI n = 178, HS n = 59), a combined rule (prehospital GFAP >410 pg/mL, or prehospital GFAP 90–410 pg/mL together with GFAP release >0.6 pg/mL/minute) enabled ruling out HS with high certainty (NPV 98.4%) in 68% of patients with ACI (sensitivity for HS 96.6%, specificity 68%, PPV 50%). The authors concluded that their study demonstrated that when sufficiently sensitive assay technology is applied, the very early prehospital GFAP plasma concentration and

its prehospital release rate can in combination provide improved differential diagnosis of patients with ACI and HS. GFAP ruled out HS in two-thirds of patients with ACI with high certainty, with improved performance in cases with moderate to severe stroke symptoms. The study was published on August 12, 2021 in the journal Clinical Chemistry. Image: Simoa HD-1 Analyzer is the latest model fully automated Simoa bead-based immunoassay platform (Photo courtesy of Quanterix)

Biomarker for Dementia Diagnosis metabolites, classified into five groups (A to E), differed significantly in dementia patients, compared with healthy elderly subjects. Seven Group A metabolites present in plasma, including quinolinic acid, kynurenine, and indoxyl-sulfate, increased. The investigators suggested that these compounds may act as neurotoxins, damaging the central nervous system. The remaining 26 compounds (in groups B to E) decreased in dementia patients, possibly causing a loss of support or protection of the brain in dementia. These compounds were thought to protect the nervous system against oxidative stress, maintain energy reserves, supply nutrients and act as neuroprotective factors. “Identification of these compounds means that we are one step closer to being able to

molecularly diagnose dementia,” said senior author Dr. Mitsuhiro Yanagida, head of the G0 Cell Unit at the Okinawa Institute of Science and Technology. “It is still too early to say, but it could suggest a possible mechanistic cause of dementia as these compounds may lead to impairment of the brain. In the future, we hope to start some intervention studies, either by supplementing dementia patients with metabolic compounds in sub-groups B-E, or by inhibiting the neurotoxins from sub-group A, to see if that can slow, prevent, or even reverse symptoms of dementia.” The dementia study was published in the September 14, 2021, online edition of the journal Proceedings of the National Academy of Sciences of the United States of America. LabMedica International November/2021

LabMedica International

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Point-of-Care Testing Device Evaluated for Anemia Detection

nemia is a serious public health problem worldwide. Several methods are commonly used to assess an individuals’ hemoglobin (Hb) and hematocrit (Hct) levels, including automated hematology analyzers, microhematocrit centrifuge, gravimetric copper sulfate method, cyanmethemoglobin method, and color code Hb estimation. Although automated hematology analyzers are the gold standard and produce significantly accurate results for diagnosing anemia, their availability is limited to the regional, provincial, and district hospital levels. In resource-poor settings, a handheld or portable point-of-care testing (POCT) device for Hb and Hct level assessment potentially plays a key role as a tool for anemia detection, improving the problems of delayed diagnosis and interventions that lead to increased morbidity and mortality. Clinical Laboratorians at the Phramongkutklao College of Medicine (Bangkok, Thailand; www.pcm.ac.th) conducted a prospective and hospital-based study to compare a new POCT Hb Testing System with an automated hematology analyzer in Thai adult males and non-pregnant adult females. A total of 300 participants were involved in the study and were aged between 20 and 94 years, with 50.7% of them being anemic. The team used the POCT device the Mission Ultra Hb Testing System (ACON Laboratories, Inc., San Diego, CA, USA; www.aconlabs.com) that consists of a handheld meter and disposable test strips. The device uses the principle of electrochemistry for Hb detection, while Hct is measured by electrical impedance. The POCT device was compared with the Sysmex XN-3000 hematology analyzer (Sysmex Corp., Kobe, Japan; www.sysmex. com) which is an automated blood cell counter for diagnostic use in clinical laboratories. Sysmex XN-3000 uses cyanide-free sodium lauryl sulfate (SLS) to determine Hb levels, whereas Hct level is measured based on the principle of hydrodynamic focusing. The investigators reported that in all participants, near-perfect correlation and agreement were observed between the two methods for Hb measurement (r = 0.963) with an interclass correlation coefficient (ICC) of 0.981 and Hct measurement (r = 0.941) with an ICC of 0.965. The sensitivity and specificity of the device in detecting anemia were 86.2% and 98.6% , respectively. The area under the curve was 0.976. The device showed average biases of 0.76 g/dL (95% limits of agreement [LOA]: −1.03 to 2.54) for Hb measurement and −2.73% (95% LOA: −9.28 to 3.82) for Hct measurement in all participants. The authors concluded that venous Hb and Hct determinations using the Mission Ultra Hb Testing System were in acceptable agreement with the measurements obtained from the automated hematology analyzer. The performance of the device for detecting anemia was excellent. However, the essential evidence showing biases of the Hb and Hct measurements obtained from the device was revealed; therefore, laboratory interpretation should be carefully performed, particularly at the near cutoff values. The study was published on August 24, 2021 in the Journal of Clinical Laboratory Analysis.

Image: The Mission Ultra Hb Testing System portable point-of-care testing device detects anemia (Photo courtesy of ACON Laboratories)

Early Detection of Gastric Cancer Cont’d from page 10

(284 [55.4%] from men; mean ±SE patient age, 65.7 ± 0.5 years). The resulting 10-miRNA signature was validated in two retrospective GC serum cohorts (586 patients; 348 [59.4%] men, mean ± SE age, 66.0 ± 0.7 years), which led to the establishment of a 5-miRNA signature (AUC, 0.90) that also exhibited high levels of diagnostic performance in patients with stage I disease (AUC, 0.89) A risk-scoring model was derived and the assay was optimized to a minimal number of miRNAs. The performance of the resulting 3-miRNA signature was then validated in a prospective cohort of 349 patients with GC. The final 3-miRNA signature (miR-18a, miR-181b, and miR335) exhibited high diagnostic accuracy in all stages of patients (AUC, 0.86), including in patients with stage I disease (AUC, 0.85). This miRNA signature was superior to currently used blood markers and outperformed the endoscopic screening in a cost-effectiveness analysis (incremental cost-effectiveness ratio [USD 2,304.80 per quality-adjusted life-year]). The authors concluded that their study established a robust, noninvasive, circulating miRNA signature for GC detection, and validated its diagnostic potential in multiple independent patient cohorts, both retrospective and prospective, highlighting its potential application for the early detection of patients with GC. The study was published on August 24, 2021 in the journal JAMA Network Open.

LabMedica International November/2021

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ONE-STOP SOLUTION FOR COVID-19 RT-PCR TEST FAPON

FLUORESCENCE IMMUNOASSAY ANALYZER MERIDIAN BIOSCIENCE

HEMOGLOBIN A1C ANALYZER ACCESS BIO

Fapon Biotech’s One-Stop Solution for COVID-19 RT-PCR Test provides the comprehensive reagents, components, materials required to simplify collection, transport, storage and detection of SARS-CoV-2.

Curian is an efficient fluorescence immunoassay platform focused in gastrointestinal testing that is packaged in a small footprint to improve hospital operational efficiencies.

The CareU ANALYZER 100 is a device for measuring Hemoglobin A1c using the boronate affinity method. It requires 3 µL of whole blood (capillary and venous) sample and has a test time of three minutes.

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Serum Levels of Thymidine Kinase Predict Disease Progression and Overall Survival of Metastatic Breast Cancer Patients

lood serum levels of the enzyme thymidine kinase 1 (TK1) have been found to predict disease progression and overall survival of patients with metastatic hormone receptor-positive breast cancer (MBC). Previous studies have found that elevated blood serum levels of TK1 were associated with the presence of many types of malignancy and that TK1 levels were elevated in serum even before the appearance of clinical symptoms. Based on these findings, investigators at the University of Michigan (Ann Arbor, USA; www.umich.edu) and their colleagues at other institutions assessed the prognostic effect of TK1 in patients with hormone receptor-posi-

tive MBC treated in a prospective randomized trial of single drug treatment (anastrozole [A]) compared to dual drug treatment (anastrolzole plus fulvestrant [A+F]). For this study, the investigators assessed TK1 levels in 1,726 sera from 432 patients (base line, before the start of their treatment, and at four time points during treatment) using the Biovica International (Uppsala, Sweden; https://biovica.com) DiviTum assay. The DiviTum assay determines the enzymatic activity of TK in human serum samples. During the assay procedure, thymidine is replaced by its synthetic analog bromodeoxyuridine (BrdU), which becomes phosphorylated and then incorporated into a synthetic DNA strand fixated in each well of a 96-well ELISA

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Image: Structure of the TK1 protein (Photo courtesy of Wikimedia Commons)

immunosorbent titer-plate. The extent of BrdU incorporation depends on the activity of TK present in the serum sample; the more TK activity in the sample, the more BrdU is incorporated into synthetic DNA strands in the titer-plate well. The synthetic BrdU is then

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PRODUCT NEWS

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CARTRIDGE INCUBATOR GUANGDONG WESAIL BIOTECH

SARS-COV-2 ANTIGEN TEST NG BIOTECH

LAMP MOLECULAR DIAGNOSTIC SYSTEM MERIDIAN BIOSCIENCE

The WS-i60 Cartridge Incubator offers ±0.1°C precise temperature control and supports six cartridge incubations at the same time. The instrument is flexible for any combination according to the number of samples.

The NG-Test SARS-CoV-2 Ag Cassette is a rapid diagnostic test for the qualitative detection of SARSCoV-2 antigen in nasopharyngeal and oropharyngeal swabs.

The Alethia is an affordable LAMP (loop-mediated isothermal amplification) based molecular platform with a simple to use instrument that generates between 1 -10 qualitative results in less than one hour.

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Benign Hypertension-Causing Tumors Linked to Somatic Co-Driver Mutations

ost aldosterone-producing adenomas (APAs) have gain-of-function somatic mutations of ion channels or transporters. However, their frequency in aldosterone-producing cell clusters of normal adrenal gland suggests a requirement for co-driver mutations in APAs. Primary aldosteronism is a major cause of hypertension. This is potentially curable when due to an APA in one adrenal. Conversely, when primary aldosteronism (PA) is overlooked, it leads to resistant hypertension and high cardiovascular risk. The genes whose mutation increases aldosterone production may differ from those responsible for tumor formation. An international team of Biomedical Scientists led by the Queen Mary University of London (London, UK; www.qmul.ac.uk) group performed whole-exome sequencing on matched tumor and germline samples from 41 individuals with APA, identifying hotspot somatic mutations in ion channel or transporter genes such as CACNA1D or KCNJ5 in dozens of the samples. Genomic DNA of samples was quality assessed by gel electrophoresis, Agilent 2200 Tapestation and Genomic DNA screentape (Agilent Technologies, Santa Clara, CA, USA; www. agilent.com), or as per GATC Biotech (Ebersberg, Germany; https://

Image: The Agilent TapeStation system is an established automated electrophoresis tool for DNA and RNA sample quality control (Photo courtesy of Agilent Technologies)

eurofinsgenomics.eu), The team used the HiSeq 2000 Sequencer, the NextSeq 500 Sequencer and the HiSeq 2500 sequencer (Illumina, San Diego, CA, USA; www.illumina.com) on extracted genomic DNA samples. The investigators reported the whole-exome sequencing identified somatic mutations of the four ion channel/transporter genes at known hotspots in 29 of the 41 APAs. Somatic mutations of CACNA1D were the most frequent (n = 11), followed by KCNJ5 (n = 9), ATP1A1 (n = 5) and ATP2B3 (n = 4). Three APAs had a known mutation of CTNNB1 and all three were noted to have a second mutation of the Q209 residue of GNA11, which encodes the G-protein G11. Among multiple transcripts upregulated more than tenfold in double-mutant APAs was LHCGR, the receptor for luteinizing or pregnancy hormone (human chorionic gonadotropin). Transfections of adrenocortical cells demonstrated additive effects of GNA11 and CTNNB1 mutations on aldostrone Cont’d on page 17

LabMedica International November/2021

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LabMedica International

Novel Tool Developed to Detect and Identify Pathogens

athogens in clinical or wildlife settings samples of blood or saliva, for example, are particularly challenging to isolate, since they can easily make up less than one one-millionth of a sample, especially in early stages of an infection, when concentrations are still low and detection is most critical for patients. A wide array of metagenomic study efforts are hampered by the same challenge: low concentrations of targets of interest combined with overwhelming amounts of background signal. Although PCR or naive DNA capture can be used when there are a small number of organisms of interest, design challenges become untenable for large numbers of targets. A team of scientists at McMaster University (Hamilton, ON, Canada; www.mcmaster.ca) and their colleagues have developed a sophisticated new tool that could help provide early warning of rare and unknown viruses in the environment and identify potentially deadly bacterial pathogens which cause sepsis. The new algorithm is an advanced tool that can help develop probes to capture trace quantities of pathogens, both known and unknown from a wide variety of situations, like the animal-to-human transmission of infections such as SARS-CoV-2 or monitor reservoirs in the environment for possible emerging pathogens. The team successfully tested the probes on the entire family of coronaviruses, including SARS-CoV-2. The probes provide a shortcut by targeting, isolating and identifying the DNA sequences, specifically and simultaneously, that are shared among related organisms, most often due to evolutionary history or ancestry. To demonstrate the capabilities and effectiveness of the tool, The Hierarchical Unique Bait Design (HUBDesign), they designed and tested two probe sets: a coronavirus probe set capable of simultaneously detecting all sequenced coronaviruses, and a set of probes targeting bacterial pathogens associated with sepsis. The majority (62.5%) of the probes have targets that are specific to one virus. Of the probes targeting multiple viruses, most (78.1%) target two or three. The remaining three sets of probes target loci specific to merbecoviruses and embecoviruses (both are Betacoronavirus subgenera) and loci common to the Deltacoronavirus genus. Both SARS-CoV-2 and HCoV-NL63 have probes at two levels in the hierarchy. The HUBDesign probe set for sepsis pathogens contained 26,870 probes targeting bacterial pathogens, covering 2.09% of all nucleotides in the input dataset at an average depth of coverage of 3.64x. The investigators demonstrated the effectiveness of probes for capturing the incredibly wide array of pathogens associated with sepsis, a life-threatening and rapidly developing condition that occurs when the body overreacts to an infection which typically starts in the lungs, urinary tract, skin or gastrointestinal tract. Hendrik Poinar, PhD, a Professor of Molecular Evolutionary Genetics and a lead author on the study, said, “We currently need faster, cheaper and more succinct ways to detect pathogens in human and environmental samples that democratize the hunt and this pipeline does exactly that.” The study was published on September 15, 2021 in the journal Cell Reports Methods.

Image: The workflow of the HUBDesign pipeline: Probe design for simultaneous, targeted capture of diverse metagenomic targets (Photo courtesy of McMaster University)

Benign Hypertension-Causing Tumors Linked to Somatic Co-Driver Mutations Cont’d from page 16

secretion and expression of genes upregulated in double-mutant APAs. In adrenal cortex, GNA11/Q mutations appear clinically silent without a co-driver mutation of CTNNB1. The authors concluded that onset of hypertension in the first trimester, the period of peak human chorionic gonadotropin (HCG) secretion, should prompt consideration of PA. Most pregnancy-associated hypertension arises in later trimesters. Patients are diagnosed relatively quickly because of the explosive onset of PA, when the ‘dormant’ LHCGR sees its stimulatory hormone. The study was published on August 12, 2021 in the journal Nature Genetics.

LabMedica International November/2021

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AUTOMATED BODY FLUID CELL COUNT CONTROL STRECK LABORATORIES

SARS-COV-2 SPIKE PROTEIN ANTIBODIES TEST GENRUI BIOTECH

NEONATAL ANALYZER ACCESS BIO

Cell-Chex Auto is a tri-level body fluid control for evaluating the accuracy of and precision of hematology analyzers that measure automated blood cell counts in patient body fluid samples.

The SARS-CoV-2 Spike Protein Antibodies Test is a colloidal gold used for the qualitative detection of Spike Protein Antibodies of SARSCoV-2 in human fingertip blood, venipuncture whole blood, serum and plasma specimen.

The CareStart S1 Analyzer is a neonatal solution that is capable of quantifying total G6PD, Hemoglobin, and Bilirubin levels. The analyzer's handheld format along with Bluetooth enables patient-side accuracy and convenience.

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Fecal Calprotectin Predicts Therapy Outcome in Ulcerative Colitis Patients

lcerative colitis (UC) is a chronic intestinal disorder of unknown etiology and characterized by a relapsing and remitting course. The diagnosis and assessment of the disease activity has been based on clinical symptoms, laboratory measurements, findings of endoscopy and pathological examinations. The development of a non-invasive and simple biomarker for evaluating the disease activity is considered necessary for the clinical management of UC. Calprotectin is a complex of mammalian

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proteins found in the cytosol of human neutrophils, monocytes and macrophages. Granulocyte and monocyte adsorptive apheresis (GMA) is widely used as a remission induction therapy for active UC patients. A large team of Gastroenterologists at the (Asahikawa Medical University, Asahikawa, Japan; www.asahikawa-med.ac.jp) and their colleagues conducted a multicenter prospective observation study of patients who received 10 sessions of GMA, twice a week, for five consecutive weeks. A total 36 patients with active UC were enrolled in the study. Fecal calprotectin was measured at entry, one week, two weeks, at the end of GMA and on the day of endoscopy within 24 weeks after GMA. The patients’ stool samples were homogenized by mixing with a predefined extraction buffer volume. After centrifugation, the supernatants were subjected to a fluorescence enzyme immunoassay using EliA Calprotectin 2 (Thermo Fisher Scientific, Tokyo, Japan; www.thermofisher.com). Laboratory values, including the white blood cell (WBC) count and C- reactive protein (CRP) level were also measured at the same time points as FC measurement: at entry, one and two weeks and at the end of GMA and on the day when endoscopy was performed within 24 weeks after GMA. The team analyzed the relationships between the clinical outcome (clinical remission [CR] and endoscopic remission [ER]) and the change in FC concentration. The investigators reported that the overall CR and ER rates were 50.0% and 19.2%, respectively. After GMA, the median FC concentration in patients with ER was significantly lower than that in patients without ER (469 mg/kg versus 3,107 mg/kg). When the cut-off value of FC concentration was set at 1,150 mg/kg for assessing ER after GMA, the sensitivity and specificity were 0.8 and 0.81, respectively. The FC concentration had significantly decreased by one week. An ROC analysis demonstrated that the reduction rate of FC (ΔFC) at one week was the most accurate predictor of CR at the end of GMA (AUC = 0.852). When the cut-off value of ΔFC was set at ≤ 40% at one week for predicting CR at the end of GMA, the sensitivity and specificity were 76.9% and 84.6%, respectively. The authors concluded that they had evaluated the utility of FC as a biomarker for assessing ER after GMA and predicting CR in the early phase during GMA in patients with active UC. The findings will benefit patients with active UC by allowing them to avoid unnecessary invasive procedures and will help establish new strategies for GMA. The study was published on August 6, 2021 in the journal BMC Gastroenterology. LabMedica International November/2021

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LabMedica International

Heparin-Binding Protein Levels Dramatically Increase in Acute Pancreatitis

eparin-binding protein (HBP), also known as CAP37 and azurocidin, is a glycoprotein stored in azurophilic granules and secretory vesicles in neutrophils that is released upon neutrophil activation early in the systemic inflammatory response. Most patients with acute pancreatitis (AP) present with mild, self-limiting disease, with little or no need for hospital care. However, 20%–25% of patients develop a more severe and potentially life-threatening condition with progressive systemic inflammatory response syndrome (SIRS). Clinical Scientists at the Skåne University Hospital (Malmö, Sweden; https://vard. skane.se) enrolled 260 patients with acute pancreatitis who were admitted to the hospital between 2010 and 2013. The mean age was 63.8 ± 18.7 years, and 50% of patients were female. EDTA plasma samples were obtained upon admission to the hospital, centrifuged at 2,000 rpm for 10 minutes (25 °C) and stored at − 80 °C until analysis. Measured levels of heparin-binding protein upon hospital admission in 204 patients with confirmed acute pancreatitis served as the primary outcome. Secondary endpoints included associations between heparin-binding protein concentrations, disease severity and fluid balance. HBP concentration was determined by an enzyme-linked immunosorbent assay (ELISA), and in addition, C-reactive protein

(CRP) was analyzed using standard methods. The investigators reported that the overall median HBP concentration in this study was 529 (307–898) ng/mL. In mild pancreatitis, the median HBP level was 527 (301–887) ng/ mL; in moderately severe cases, it was 529 (338–955) ng/mL; and in the severe group, the median HBP was 640 (383–1465) ng/ mL. The CRP on the day of admission was 28 (11–59) mg/L, 30 (19–97) mg/L and 122 (83–170) mg/L in the mild, moderately severe and severe groups, respectively. The team also found that the fluid balance between patients with mild compared with moderately severe and severe pancreatitis was significantly different after day 2 (83 versus 510 versus 2,260 mL). However, there was no association between heparin-binding protein concentration and fluid balance. The authors concluded that HBP levels are dramatically increased in patients with AP, and these levels far exceed those previously reported in other conditions. In their study, they did not observe any significant correlation between HBP levels and disease severity or the need for intravenous fluid. Additional studies on HBP are needed to further explore the role of HBP in the pathogenesis of AP and its possible clinical implications. The study was published on August 28, 2021 in the journal BMC Gastroenterology.

Image: Histopathology of acute pancreatitis: necrosis of pancreatic parenchyma (lower left) with acute inflammation and fat necrosis (right and upper part of photograph) (Photo courtesy of Florida State University College

Blood Lipid Biomarkers Linked to Lower Risk of ALS

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genetic risk between ALS and lipid metabolism. Scientists are keen to identify biomarkers linked to ALS, which could ultimately lead to much earlier diagnosis, potentially before symptoms appear, and the hope of preventative treatments. Clinical Scientists specializing in Neurosciences at the University of Oxford (Oxford, UK: www.ox.ac.uk) used data for 502,409 people who enrolled in the UK Biobank study between March 2006 and October 2010 when aged 39 to 72 years. All had blood tests at enrolment and were followed for a median of 11.9 years. They looked at the relationship between ALS and baseline blood levels of high and low density lipoprotein (HDL and LDL), total cholesterol, apolipoproteins A1 and B (apoA1 and apoB), triglycerides, glycated hemoglobin A1c (HbA1c) and creatinine. They also looked at the relationship between ALS and self-reported exercise and body mass index. The investigators reported that after controlling for age and sex, they found that higher HDL and apoA1 were associated with a lower risk of ALS. A higher total cholesterol: HDL ratio was associated with a higher risk of ALS. When models incorporating multiple

LabMedica International November/2021

metabolic markers were used to assess risk of the condition, HDL and apoA1 continued to be associated with a reduced risk of ALS independent of other factors. Lower LDL and apoB levels were also associated with a decreased risk of ALS. In further analysis, levels of LDL and apoB were shown to be higher long before diagnosis, but lower in people closer to diagnosis, whereas HDL and apoA1 levels showed no such differences. They authors concluded that their study adds to a growing literature documenting differences in the premorbid metabolic profile of those who eventually develop ALS. The persistence of these findings in models controlling for statin use, smoking and vascular disease indicates that the association of lipid levels and ALS is not attributable to a confounding association between lipids, ALS and these factors. In addition to providing novel insights into pathogenesis, this emphasizes the need to consider a broader set of potential pre-symptomatic ALS biomarkers. Such markers might help to target population screening for ALS and also build confidence in future trials of preventative therapy. The study was published on September 13, 2021 in the Journal of Neurology Neurosurgery & Psychiatry.

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SARS-COV-2 RAPID ANTIGEN TEST AESKU.DIAGNOSTICS

AUTOMATED RNA EXTRACTOR AGAPPE

FLUORIMETRIC IMMUNOASSAY ANALYZER GENBODY

The AESKU.RAPID SARS-CoV-2 Rapid Test is based on immunochromatographic polymer technology combined with the sandwich principle for the qualitative detection of the nucleocapsid protein antigen in human nasal swab specimens.

The Mispa MagenTa is a fully automated compact RNA extraction unit based on magnetic beads technology for high throughput applications providing the highest yield. The instrument can purify up to 32 samples simultaneously.

Confiscope F20 is a semi-automated fluorimetric immunoassay analyzer intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/ or biological markers in a clinical specimen.

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More Complete Genetic Screening Benefits Cardiovascular Disease Patients

esults of a pilot study suggested that information obtained by comprehensive genetic testing would benefit treatment of patients suffering from a wide range of cardiovascular diseases. Investigators at Baylor College of Medicine (Houston, TX, USA; www.bcm.edu) reported creating a “HeartCare” panel that provided DNA sequences for 158 genes associated with medically actionable cardiovascular conditions along with a genetic risk score for developing cardiovascular disease and genetic data on drug interactions. The HeartCare panel was used as the basis for assessing 709 individuals from cardiology clinics at Baylor College of Medicine. Samples were analyzed in a CAP/CLIA-certified laboratory, and results were returned to the ordering physician and uploaded to the electronic medical record.

Results revealed that 32% of participants received genetic information that impacted their clinical management. Of those participants, 11% were referred to a genetic specialist for further care. Out of all participants, 9% had an inherited pathogenic gene mutation associated with cardiovascular diseases such as cardiomyopathy and high cholesterol, and 9% had a high overall genetic risk score for developing cardiovascular disease. Among surveyed physicians, 84% reported initiating medical management changes based on these results, including specialist referrals, cardiac tests, and medication changes. “This study shows that a large proportion of individuals in select ambulatory care clinics can benefit from genetic data,” said senior author Dr. Richard Gibbs, professor of molecular and human genetics at Baylor College of Medicine. “There is tangible follow-up care for

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people who received a positive result, and in many cases for their family members.” The study was published in the August 6, 2021, online edition of the journal Genetics in Medicine. Image: Gross pathology of idiopathic cardiomyopathy. Opened left ventricle of heart shows a thickened, dilated left ventricle with subendocardial fibrosis manifested as increased whiteness of endocardium. (Courtesy of [U.S.] Centers for Disease Control and Prevention)

LabMedica International November/2021

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High-Sensitivity Cardiac Troponin T Identifies Myocardial Injury with COVID-19

ardiac troponin (cTn) is the preferred biomarker for the detection of myocardial injury (MI), which is defined when there is at least one cTn concentration above the 99th percentile upper-reference limit (URL) of a healthy reference cohort. While pulmonary complications are frequent with COVID-19, studies suggest that myocardial injury is common, in particular among those with chronic cardiovascular conditions and more severe COVID-19 presentations, and that its presence and magnitude is associated with worse outcomes. Cardiologist and a large team of medical scientists at the Mayo Clinic (Rochester, MN, USA; www.mayoclinic.org) conducted a multicenter, retrospective, observational, US-based study of COVID-19 patients undergoing high-sensitivity cardiac troponin T (hs-cTnT). The final study cohort included 367 COVID-19 patients in whom at least one hs-cTnT was obtained, amongst which 46% were identified to have myocardial injury based on hs-cTnT concentrations above the sex-specific 99th percentiles. The mean ± SD age of the cohort was 61 ±17 years and most patients presented through the Emergency Department (83%). The hs-cTnT was measured with the Elecsys Troponin T Gen 5 STAT (Roche Diagnostics, Indianapolis, IN, USA; https://diagnostics. roche.com). The lowest reportable clinical value is the <6 ng/L limit of quantification (LoQ).

Sex-specific 99th percentiles URLs of 10 ng/L for women and 15 ng/L for men were used. Patients with suspected MI are evaluated using a 0/2 hour hs-cTnT protocol that uses sex-specific 99th percentile URLs to rule-in and rule-out myocardial injury and an absolute delta (serial change) of ≥10 ng/L to identify patients with acute injury. MI is diagnosed when there is objective evidence of myocardial ischemia. The team reported that among 367 COVID19 patients undergoing hs-cTnT, myocardial injury was identified in 46%. They had a higher risk for mortality (20% versus 12%), unadjusted hazard ratio (HR) of 4.44 and major adverse events (35% versus 11%). The hs-cTnT results were independent predictors of major adverse events. Most (95%) increases were due to myocardial injury, with 5% classified as type 1 or 2 myocardial infarction. A single hs-cTnT <6 ng/L identified 26% of patients without mortality, with a 94.9% (negative predictive value and 93.1% sensitivity for major adverse events in those presenting to the ED. The authors concluded that myocardial injury is frequent and prognostic in COVID-19. While most hs-cTnT increases are modest and due to myocardial injury, they have important prognostic implications. A single hs-cTnT <6 ng/L at presentation may facilitate the identification of patients with a favorable prognosis. The study was published in the August 2021 issue of the journal Clinical Chemistry.

Image: The Automated Elecsys Troponin T Gen 5 STAT assay facilitates the diagnosis of myocardial infarction, also in patients with COVID-19 (Photo courtesy of Roche Diagnostics)

Pneumocystis Frequently Found Lethal in Dermatomyositis

he term idiopathic inflammatory myopathy (IIM) denotes a group of autoimmune diseases characterized by myasthenia and typical skin rash, among which dermatomyositis (DM) and polymyositis (PM) are the most common. Idiopathic inflammatory myopathies (IIM) are associated with a significantly higher risk of opportunistic infections including Pneumocystis jirovecii pneumonia (PJP), a potentially fatal opportunistic infection. In patients with rheumatic immune diseases, most PJP occurs in the first three months after initiating immunosuppressive therapy. A team of Rheumatologists at the Renji Hospital (Shanghai, China; www.renji.com) prospectively followed 463 consecutive patients with IIM a period of at least one year to analyze the incidence of PJP. In the second part of the study, they enrolled 30 consecutive PJP patients with any rheumatic disease in order to identify the mortality rate and risk factors. The diagnosis of PJP was based on comprehensive evaluation by clinical manifestations such as fever or acute dyspnea, characteristic radiographic findings, and etiological evidence. For confirmation, a case needed to have positive microbiological tests such as by next-generation sequencing and Grocott-Gomori methenamine-silver staining of

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LabMedica International November/2021

bronchoalveolar lavage fluid. The team reported that the prevalence of PJP in IIM patients was found to be 3.0/100 person-years, while in anti-melanoma differentiation-associated gene 5 antibody positive (MDA5+) DM patients it was 7.5/100 person-years and in MDA5− IIM patients 0.7/100 person-years. PJP typically occurred in the first two months in the case of MDA5+ DM patients who had a significant decrease in their CD4+ T cell counts and lymphocyte counts. In PJP patients, 3-month mortality was higher for MDA5+ DM patients than in those with other rheumatic diseases (83.3% versus 38.9%). Worryingly, MDA5+ DM patients seemed not to benefit from prompt anti-PJP treatment, unlike patients with other rheumatic diseases whose survival improved when anti-PJP treatment was started within six days. The authors concluded that the MDA5+ DM patients are highly susceptible to infection with Pneumocystis jirovecii, which is also harder to cure than in other rheumatic diseases. The reason for the higher incidence and mortality may be related to the lower CD4+ T cell counts and progressive interstitial lung disease in MDA5+ patients. The study was published on September 4, 2021 in the journal Arthritis Research & Therapy. LINKXPRESS COM

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Environmental Allergens Trigger Type 2 Inflammation Through Ripoptosome Activation

nvironmental allergens, including fungi, insects and mites, trigger type 2 immunity; however, the innate sensing mechanisms and initial signaling events remain unclear. The allergens trigger activity among an interlocked set of cell death-inducing signals called the ripoptosome. Although myeloid cells prime adaptive immunity in generating IgE3 and type 2 T helper cell (Th2) responses, allergens are initially recognized by the innate immune system, triggering downstream responses leading to production of type 2 effectors, before the initiation of adaptive immunity. Immunologists and their colleagues at the Cincinnati Children’s Hospital Medical Center (Cincinnati, OH, USA; www.cin cinnatichildrens.org) recently reported that allergens trigger RIPK1– caspase 8 ripoptosome activation in epithelial cells. The active caspase 8 subsequently engages caspases 3 and 7, which directly mediate intracellular maturation and release of interleukin-33 (IL-33), a pro-atopy, innate immunity, alarmin cytokine. The team used different cell line and murine models. Data were acquired on a BD LSRFortessa flow cytometer (BD Biosciences, San Jose, CA, USA; www.bdbiosci ences.com). In IL-33 secretion assays, the concentration of released IL-33 in cell culture supernatants was determined by ELISA (R&D Systems, Minneapolis, MN, USA;

www.rndsystems.com). The team reported that mature IL-33 maintained functional interaction with the cognate ST2 receptor and elicited potent pro-atopy inflammatory activity in vitro and in vivo. Inhibiting caspase 8 pharmacologically and deleting murine Il33 and Casp8 each attenuated allergic inflammation in vivo. Clinical data substantiated ripoptosome activation and IL-33 maturation as likely contributors to human allergic inflammation. They found that in the human allergic disease eosinophilic esophagitis ripoptosome activation markers and mature IL-33 levels dynamically correlated with the degree of esophageal eosinophilia and disease activity. Marc Rothenberg, MD, PhD, Director of the Division of Allergy and Immunology at Cincinnati Children’s and senior author on the study, said, “Disrupting this allergen sensing pathway could provide a unique opportunity to counteract type 2 immunity and alleviate allergic inflammation.” The authors concluded that their findings reveal an epithelial barrier, allergen-sensing mechanism that converges on the ripoptosome as an intracellular molecular signaling platform, triggering type 2 innate immune responses. These findings have significant implications for understanding and treating human allergic diseases. The study was published on September 16, 2021 in the journal Nature Immunology. LabMedica International November/2021

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NanoVelcro Cell Technology Applied in Diagnosis of Pregnancy Complications

lacenta accreta spectrum (PAS) disorders, including placenta accreta, placenta increta, and placenta percreta, are the consequences of abnormal implantation, or aberrant invasion and adherence of placental trophoblasts into the uterine myometrium. Current diagnostic modalities for PAS, including serum analytes, ultrasonography, and magnetic resonance imaging (MRI), are effective but not always conclusive, and some options are not readily available in low resource settings. Circulating trophoblast cell clusters can be used for early detection of PAS disorders. Medical Scientists at the University of California, Los Angeles (UCLA, Los Angeles, CA, USA; www.ucla.edu) and their colleagues included in a study pregnant women aged from 18 to 45 years old with singleton intrauterine pregnancies, and gestational age (GA) between 6 and 40 weeks. The team analyzed blood samples from 168 pregnant individuals, divided between those with clinically confirmed PAS, placenta previa, or normal placentation and an additional 15 healthy non-pregnant female donors served as controls. The investigators used the a cell isolation technology called NanoVelcro Chip developed by UCLA. NanoVelcro is a nanostructure-embedded microchip designed to capture and enrich specific target cells from a mixed sample. The samples were run through NanoVelcro Chips under optimized conditions and immunostained and were imaged using the Nikon Ni fluorescence microscope (Melville, NY, USA; www.microscope.health care.nikon.com). Trophoblast-specific gene expression in placenta tissue was performed to validate the selected trophoblast-specific gene panel. The team discovered a uniquely high prevalence of clustered circulating trophoblasts (cTB-clusters) in PAS and subsequently optimized the device to preserve the intactness of these clusters. The feasibility study on the enumeration of cTBs and cTB-clusters from 168 pregnant women demonstrates excellent diagnostic performance for distinguishing PAS from non-PAS. The combined cTB assay achieves an Area Under ROC Curve of 0.942 (throughout gestation) and 0.924 (early gestation) for distinguishing PAS from non-PAS. Overall, single cTBs are detected in the majority of pregnant women, with a detection rate of 98%, 85%, and 86% in the groups of PAS, placenta previa, and normal placentation, respectively. Margareta D. Pisarska, MD, an Obstetrics and Gynecology Endocrinologist and co-author of the study, said, “In maternal health and delivery, we think of having a child and having a delivery as, overall a happy, healthy event. But in situations like this, these are very difficult times to try to manage through. And if we have a plan in place, schedule the delivery, have the right members on the team on board, have all the things prepared that should lead to a more scheduled controlled delivery.” The authors concluded that the combination of cTBs and cTB-clusters captured on the NanoVelcro Chips for detecting PAS early in gestation will enable a promising quantitative assay to serve as a noninvasive test and also as a complement to ultrasonography to improve diagnostic accuracy for PAS early in gestation. The study was published on August 3, 2021 in the journal Nature Communications.

Image: The NanoVelcro device has been used to detect placenta accreta spectrum (PAS) disorders (Photo courtesy of University of California, Los Angeles)

Blood-Based Biomarker Predicts Onset of Symptomatic Alzheimer’s Disease

lzheimer’s disease (AD) is a progressive neurodegenerative disorder, starting with a preclinical phase of normal cognition lasting approximately two decades. The formal diagnosis of AD dementia, relies on neuropsychological tests further confirmed by brain imaging and cerebrospinal fluid (CSF) sampling. The pathogenic features of AD that have an onset in the preclinical phase may allow identification of such early blood-based biomarkers. By eliciting compensatory responses, these early pathogenic changes were found to initially prevent the increase in reactive oxygen and nitrogen species (ROS/RNS) through activation of antioxidant mechanisms. Scientists at the University of Brescia (Brescia, Italy; www.unibs.it) Cont’d on page 28

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The STA R Max 3 is a versatile analyzer adaptable to any lab set-up, with equivalent performance whether used alone or integrated into an automated track. It is supported by a range of reagents offering a comprehensive menu.

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Protein-Expression Changes Specific to Immunoglobulin G4-Related Disease Analyzed

mmunoglobulin 4 (IgG4)-related disease (IgG4-RD) is a lymphoproliferative disorder characterized by elevated serum IgG4 levels and infiltration of IgG4positive plasma cells into the affected tissues. The pathology of IgG4-related disease cannot be explained based only on the change in a single gene or a protein. Organs affected by this disease are distributed throughout the body, including the lacrimal/salivary glands, pancreas, retroperitoneum, and thyroid. The disease is referred to as Mikulicz disease, autoimmune pancreatitis, retroperitoneal fibrosis, and Riedel thyroiditis, depending on the affected tissues. A large team of Immunologists and Hematologists at the Kanazawa Medical University (Uchinada-machi, Japan; www. kanazawa-med.ac.jp) obtained sera from patients with IgG4-related disease receiving treat-

ments. All patients had serum IgG4 levels ≥135 mg/dL and tissue IgG4/IgG ratios ≥40%, thereby satisfying the diagnostic criteria for IgG4-related disease. The control serum samples were collected from 13 healthy male volunteers (54–64 years old, median age of 59 years old). Serum proteins from patients with IgG4related disease and healthy subjects were resolved using two-dimensional electrophoresis, silver-stained, and scanned. Alternatively, the proteins were labeled with Cy2, Cy3, and Cy5 before electrophoresis. The proteins, whose expression differed significantly between patients and healthy individuals, and between before and after steroid treatment, were identified and validated using enzyme-linked immunosorbent assays. The team used enzyme-linked immunosorbent assay (ELISA) kits for detecting

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Image: Immunohistochemical staining showing IgG4-positive plasma cells (white arrows)

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human alpha-1 antitrypsin (A1AT, Immunology Consultants Laboratory, Inc. (Portland, OR, USA; www.icllab.com), clusterin (BioVender Research and Diagnostic Products, Brno, Czech Republic; www.biovendor.com), and leucine rich α-2-glycoprotein (LRG-1) (ImmunoBiological Laboratories Co., Ltd, Fujioka-Shi, Japan; www.ibl-japan.co.jp). Pretreatment of the serum samples with ProteoMiner and the serum proteins were processed using a ProteoMiner Small-Capacity Kit (Bio-Rad, Hercules, CA, USA; www.bio-rad.com). The investigators reported that pre-treatment sera from patients with IgG4-related disease was characterized by increased levels of immunoglobulins such as IgG1, IgG4; inflammatory factors such as α-1 antitrypsin (A1AT); and proteins associated with immune system regulation such as clusterin and leucine-rich α-2-glycoprotein (LRG-1). The serum levels of A1AT, LRG-1 and clusterin, during treatment with prednisolone for up to 12 months revealed that LRG-1 levels were halved after one month of treatment, comparable to those in healthy subjects; LRG-1 levels remained normal until the end of treatment. The authors concluded that A1AT, LRG-1, and clusterin could be involved in the pathogenesis of IgG4-related disease, and their serum levels could reflect the disease state. In particular, LRG-1 could serve as a novel biomarker for the diagnosis and treatment of IgG4-related disease. The study was published on August 25, 2021 in the journal Clinica Chimica Acta.

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Antinuclear Antibody Tests Compared for Systemic Autoimmune Rheumatic Diseases

ystemic autoimmune rheumatic diseases, also known as connective tissue diseases (CTD), including all diseases triggered by the formation of immune complexes that enter the circulation, are then deposited in different tissues and organs, and cause damage. The diagnosis of systemic autoimmune rheumatic diseases (SARD) is based on the detection of serum antinuclear antibodies (ANA) for which indirect immunofluorescence (IIF) is the golden standard. New solid-phase immunoassays have been developed to be used alone or in combination with the detection of extractable antinuclear antibodies (ENA) to improve SARD diagnosis. Clinical Biochemists at the Virgen Macarena University Hospital (Seville, Spain; www.hospitalmacarena.es) evaluated 323 patients from the primary care, rheumatology, nephrology, and internal medicine services of the hospital. The samples were retrospectively classified: 147 in the SARD group, (including systemic lupus erythematosus, Sjögren’s syndrome, mixed connective tissue disease, polymyositis/dermatomyositis, systemic sclerosis, undifferentiated connective tissue diseases, rheumatoid arthritis, and vasculitis); 31 in the Organspecific autoimmune disease group; 12 in the Malignancies group; and 147 in the non-autoimmune diseases. Antinuclear antibodies (ANA) screening was performed with the following three techniques: Indirect immunofluorescence (IIF) on HEp-2 cells which allows the detection of antibodies against a wide variety of nuclear molecules and antigens located in the cytoplasm, and RELISA a qualitative indirect enzyme immunoassay (Immunoconcepts, Sacramento, CA, USA; https://immunoconcepts. com); and the EliA CTD Screen was performed using the Phadia 250 instrument (Thermo Fisher Scientific, Waltham, MA, USA; www.ther mofisher.com). Extractable nuclear antigens (ENA) screening was analyzed using two different methods: LIA Euroline (Euroimmun, Lübeck, Germany; www.euroimmun.com); and Thermo Fisher Scientific’s EliA specificities, including SmDP, Rib P, PCNA, U1RNP, Ro, Ro52, Ro60, La, CENP, Scl-70s, Fibrillarin, RNA Pol III, PM-Scl, Jo-1, and Mi-1. The authors reported the diagnostic accuracy of EliA CTD Screen had a 79% sensitivity and a 91% specificity, and was better than that of ELISA or IIF. The combination of EliA CTD plus

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LabMedica International November/2021

IIF had the highest sensitivity (93%). ENA determination revealed that Ro52 and Ro60 were the most prevalent specificities. The use of IIF alone was not able of detecting up to 36% of samples positive for Ro52, and 41% for Ro60. The authors concluded that the EliA CTD Screen has a better diagnostic performance when compared to IIF and ELISA. The combined use of EliA CTD Screen and IIF clearly improves the rate and accuracy of SARD diagnosis. The use of EliA CTD Screen as first-line screening technique allows the detection of antibodies, which could not be detected by IIF alone. The study was published on August 4, 2021 in the Journal of Clinical Laboratory Analysis.

Image: The Phadia 250 Immunoassay Analyzer: Automated processing of EliA and ImmunoCAP assays (Photo courtesy of Thermo Fisher Scientific).

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Leptomeningeal Disease Diagnosed Using CSF Cell-Free DNA

eptomeningeal disease (LMD) is a devastating complication of solid and liquid systemic and central nervous system malignant neoplasms. LMD, in which cancer metastasizes to the cerebrospinal fluid, occurs in 4% to 15% of cancer patients and is associated with poor survival, with untreated patients dying within four to six weeks. Leptomeningeal disease is typically diagnosed via identification of malignant cells in cerebrospinal fluid (CSF), most commonly obtained via lumbar puncture or ventriculoperitoneal (VP) shunt access. CSF cytological analysis. The currently most reliable diagnostic method, has a sensitivity of approximately only 75% and is known to produce persistently negative results in approximately 10% of patients. A large team of Neuro-oncologists at the Massachusetts General Hospital (Boston, MA, USA; www.mgh.harvard.edu) and their colleagues conducted a diagnostic study to assess the use of genomic sequencing of CSF samples obtained from 30 patients with suspected or confirmed LMD from 2015 through 2018 to identify tumor-derived cfDNA. This study consisted of two patient populations: 22 patients with cytologically confirmed LMD without parenchymal tumors abutting their CSF and eight patients with parenchymal brain metastases with no evidence of LMD. Cell-free DNA was isolated from blood plasma and CSF using a QIASymphony

instrument with the QIASymphony DSP Circulating DNA Kit (Qiagen, Hilden, Germany; www.qiagen.com). A subset of libraries was prepared with unique molecular identifier adapters (Integrated DNA Technologies, Coralville, IA, USA; www.idtdna.com). Prepared libraries were sequenced on HiSeq X, HiSeq 2500, or HiSeq 4000 instruments (Illumina, San Diego, CA, USA; www.illumina.com) to a targeted mean depth of 0.1X. Samples were aligned to hg19 using bwa-mem, version 0.7.7-r441. The scientists reported that in total, 30 patients (23 women [77%]; median age, 51 years [range, 28-81 years]), primarily presenting with metastatic solid malignant neoplasms, participated in this study. For 48 follow-up samples from patients previously diagnosed via cytological analysis as having LMD with no parenchymal tumor abutting CSF, cfDNA findings were accurate in the assessment of LMD in 45 samples, whereas cytological analysis was accurate in only 36 samples. Of 43 LMD-positive samples, CSF cfDNA analysis was sensitive to LMD in 40 samples and cytological analysis was sensitive to LMD in 31 samples, a significant difference. For three patients with parenchymal brain metastases abutting the CSF and no suspicion of LMD, cytological findings were negative for LMD in all three patients, whereas cfDNA findings were positive in all three patients. Priscilla K. Brastianos, MD, Assistant Professor of Medicine and a co-senior author of the study, said, “If we are able to confidently diagnose LMD using cell-free DNA earlier and with fewer invasive procedures, then we can institute treatment sooner and enroll patients in clinical trials for new LMD treatments. The ultimate hope is that we can improve patient survival with earlier diagnosis and treatment for this deadly disease.” The authors concluded that the diagnostic study found improved sensitivity and accuracy of cfDNA CSF testing versus cytological assessment for diagnosing LMD with the exception of parenchymal tumors abutting CSF, suggesting improved ability to diagnosis LMD. The study was published on August 9, 2021 in the journal JAMA Network Open. Image: Small round blue tumor cells found in the CSF of a patient with leptomeningeal disease from rhabdomyosarcoma (Photo courtesy of Pediatric Oncology) LabMedica International November/2021

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LabMedica International

Immunoglobulin Levels Investigated in Adults with IgG Subclass Deficiency

mmunoglobulin G (IgG) subclass deficiency (IgGSD) is characterized by frequent or severe upper or lower respiratory tract infection, one or more subnormal IgG subclass level(s) unexplained by other causes, and decreased IgG response to pneumococcal polysaccharide vaccination (PPSV). IgG subclass deficiency is defined as the decrease of one or more subclasses of IgG antibodies with normal or near normal levels of other immunoglobulin classes. It can present as either as a complete deficiency in instances in which the serum level of a IgG subclass are below detection or as a relative deficiency in which the IgG subclass levels are below normal range for age. Medical Scientists at the University of Alabama at Birmingham (Birmingham, AL, USA; www.uab.edu) analyzed data on 207 adults: 39 with subnormal IgG1 only; 53 with combined subnormal IgG1/IgG3; and 115 with subnormal IgG3 only. They compiled data on age; sex; autoimmune condition(s) (AC); atopy; IgG, IgG subclasses, IgA, IgM; IgGsum (IgG1 + IgG2 + IgG3 + IgG4); and D (Δ percentage difference between IgGsum and IgG). The team compared attributes of patients with/without subnormal IgG (< 7.00 g/L; subnormal IgG1 subclass groups only) and analyzed IgGsum and IgG relationships. IgG at diagnosis in each patient was measured using turbidimetry (Laboratory Corporation of

America, Burlington, NC, USA; www. labcorp.com). IgG subclasses were measured using four separate quantifications on corresponding specimens using rate nephelometry (Laboratory Corporation of America), and reported separately from IgG. IgG and IgG subclasses were measured before IgG replacement therapy was initiated. The investigators reported that there were 39 patients with subnormal IgG1 only (89.7% women), 53 with subnormal IgG1/IgG3 (88.7% women), and 115 with subnormal IgG3 only (91.3% women). Fifteen patients (38.5%) and 32 patients (60.4%) in the respective subnormal IgG1 subclass groups had subnormal IgG. Attributes of patients with/without IgG < 7.00 g/L were similar, except that autoimmune condition prevalence was lower in patients with subnormal IgG1 only and IgG < 7.00 g/L than ≥ 7.00 g/L. Mean/median IgG1 and IgG2 were significantly lower in patients with IgG < 7.00 g/L in both subnormal IgG1 subclass groups. Regression analysis on IgG in three subclass groups revealed positive associations with IgG1 and IgG2. The authors concluded that both IgG1 and IgG2 are major determinants of IgG in patients with subnormal IgG1, combined subnormal IgG1/IgG3, or subnormal IgG3 and that in patients with subnormal IgG1 or combined subnormal IgG1/IgG3, median IgG2 levels are significantly lower in those

with IgG < 7.00 g/L than those with IgG ≥ 7.00 g/L. The study was published on August 9, 2021 in the journal BMC Immunology. Image: Blood sample tube for Immunoglobulin G or IgG subclass test (Photo courtesy of Blood Tests London)

Serum Levels of Thymidine Kinase Predict Disease Progression and Overall Survival of Metastatic Breast Cancer Patients

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detected with anti-BrdU specific antibodies using the ELISA assay technique. The DiviTum technology amplifies the signal, enabling the assay to measure thymidine kinase activity with high sensitivity. Results revealed that patients with high TK1 levels, either before treatment or at any time during treatment, tended to have a significantly shorter progression-free survival time (PFS). Those with high levels at the start of treatment, or baseline, had a median PFS of 11.2 months compared to 17.3 months for patients with low levels at baseline. The high-TK1 patients also survived for a shorter period of time. On average, those patients with high levels of the biomarker had median overall survival times of 30 months compared to 58 months for those with low levels. Patients with low TK1 levels responded well to the single drug anastrozole. This finding suggested that measurement of

LabMedica International November/2021

pre-treatment TK1 levels could potentially be used to determine whether a patient should start treatment with twodrug endocrine therapy (high TK1) or a single-drug endocrine therapy (low TK1). Contributing author Dr. Daniel Hayes, professor of internal medicine at the University of Michigan, said, “These results should serve as the basis for future clinical studies to distinguish patients with estrogen receptor metastatic breast cancer who might be best treated with endocrine therapy alone versus those who should receive endocrine therapy plus an ancillary treatment, such as CDK4/6, mTOR, or PIK3CA inhibitors. Each of these has been shown to complement endocrine therapy, but each is associated with additional side effects and costs.” The TK1 study was published in the September 14, 2021, online edition of the journal Clinical Cancer Research.

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Manual Aspiration by Monovette Reduces Hemolytic Sampling

emolytic blood samples are the number one cause for specimen rejection at emergency departments (ED). Triggered by unsuitable blood sampling material or incorrect handling and a related strong vacuum force, hemolytic samples often must be retaken. Hemolysis refers to the release of hemoglobin and other intracellular components into the surrounding plasma due to the ruptured cell membrane of erythrocytes. The root cause of hemolysis in vitro is an improper sample drawing or, more specifically, an evolving strong vacuum force. Clinical Laboratorians at the HFR Fribourg-Hôpital Cantonal (Villarssur-Glâne, Switzerland; www.h-fr.ch) conducted a head-to-head study between January and April 2019. In the first eight weeks, all specimens were collected using BD Vacutainer Lithium-Heparin Gel tubes (Vacutainer, Becton, Dickinson and Company, Franklin Lakes, NJ, USA; www.bd.com), in the second eight weeks, blood was taken using S-Monovette Lithium-Heparin Gel tubes (Sarstedt AG, Nümbrecht, Germany; www.sarstedt.com) in aspiration mode. Specimens were categorized into five classes (0–30, 31–50, 51–75, 76–100, and 101+ mg/ dL of cell-free hemoglobin) and for the statistical analyses, all samples exceeding 30 mg/dL were classified as hemolytic. All blood samples from the emergency department were evaluated using a Cobas 6000, (Roche Diagnostics, Rotkreuz, Switzerland; www.

diagnostics.roche.com) a state-of-the-art analyzing system, and their Hemolysis Index (HI 1 = 1 mg of free cell hemoglobin in 1 dL blood plasma) was determined. Data were collected on 4,794 blood specimens (Vacutainer: 2,634 samples, S-Monovette: 2,160 samples). The scientists reported that overall, 11.3 % of samples were rated as hemolytic because their concentration of hemolysis exceeded 30 mg/ dL. This proportion differed considerably between specimens drawn by Vacutainer (17.0 %) and S-Monovette (4.3 %), meaning that, in proportion, there were four times as many hemolytic samples when using Vacutainer. While the percentage of non-hemolytic samples (HI of 0–30 mg/dl) was substantially higher for specimens drawn by S-Monovette (95.7 %) than Vacutainer (83.0 %), the opposite was true for all HI categories above 30 mg/dl. The authors concluded that regarding hemolysis rates, a slow manual aspiration using S-Monovette was superior to vacuum tubes with predefined filling volumes, as demonstrated in the setting of their ED, which has important practical implications. This blood sampling process could be highly beneficial, not only from a financial point of view, but also with regards to reducing unnecessary tasks and stress for nursing staff and improving patient outcome overall. The study was published on July 28, 2021 in the journal Practical Laboratory Medicine.

Blood-Based Biomarker Predicts Onset of Symptomatic Alzheimer’s Disease

Cont’d from page 23

and their colleagues collected blood samples from 482 subjects aged between 60 and 85 years who did not present specific comorbidities (uncontrolled diabetes, vascular disease, severe depression, or psychiatric illnesses) and were included in a retrospective study collecting a total of 515 blood samples from the Australian Imaging, Biomarkers and Lifestyle (AIBL) study by applying a consecutive sampling approach. The team performed immunoprecipitation (IP) followed by liquid chromatography (LC) tandem mass spectrometry (MS/MS) and protein sequencing in plasma samples from the AIBL study identified the clinically relevant AZ 284 peptide (AlzoSure Predict test, Diadem, Brescia, Italy; www.diademdx.com), representing a measure of the U-p53 conformational variant (U-p53AZ). Based on U-p53AZ quantification via IP/LC electrospray ionization-coupled MS/MS (Thermo Scientific EASY-nLC 1000 HPLC system, coupled to a Thermo Fisher Scientific EASYSpray source, Waltham MA, USA; www.thermofisher. com), supported by an analytical nanoflow column system. The

LINKXPRESS COM

predictive performance of U-p53AZ was assessed and compared with amyloid load as measured by amyloid β-positron emission tomography (Aβ-PET). Its predictive performance was determined at 36, 54, 72 and 90 months. The investigators reported that U-p53AZ was able to identify individuals with AD dementia with an area under the receiver operating characteristic curve (AUC) of 99%. U-p53AZ outperformed the conventional Aβ-PET measures in predicting the onset of AD dementia both from preclinical (AUC=98%) and prodromal stages (AUC=89%), even 90 months prior to onset (AUC=99%). Additionally, the estimated predictive performance of U-p53AZ was superior (AUC ≥98%) to other risk factors (i.e., gender, Aβ-PET and APOE ε4 allele status) in identifying individuals at high risk for progression to AD. The authors concluded that their findings support use of U-p53AZ as blood-based biomarker predicting if individuals, at both asymptomatic and MCI stages, would progress to AD at least six years prior to the onset of clinical AD dementia. The study was published on August 25, 2021 in the journal medRxiv.

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LabMedica International November/2021

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

NEWS

IFCC Conference Focuses on Advancing Point-of-Care Diagnostics

By Sergio Bernardini, Chair IFCC-Emerging Technologies Division, Tommaso Trenti, President elect SiBioC, Bernard Gouget, Chair Committee on Mobile Health and Bioengineering in Laboratory Medicine (C-MHBLM)

s the COVID-19 virus spread since the beginning of 2020, the consequences impacted how people gathered with one another. The scientific events that normally were gathering specialists in lab medicine, health professionals and industry representatives for professional development and camaraderie, were threatened by the worldwide adoption of sanitary measures. The impossibility to travel abroad, the social distancing and stayat-home policies jeopardized last spring the organization of the congress “POCT: Making the point” organized by the IFCC Emerging Technologies Division, impacting all the involved professionals from IFCC/EFLM participants to organizers, and the IVD partners who had already responded. The positive development of the health situation having allowed an easing of the restrictions, it was first decided to postpone the congress and then to organize it on September 6-7, 2021. The barrier measures were strictly respected in accordance with the latest government directives, in particular the compulsory wearing of a mask in the interior and exterior spaces of the establishment. The comfortable temperature along with the changing colors of the Roman countryside, made September the best time and Roma an excellent place for a pleasant stay to interact face-toface with the colleagues who were able to come and get the opportunity to discover the new Campus X at the University “Tor Vergata”, one of the most dynamic and important research institution in Italy with a University hospital of excellence, recognized as a regional, national and international reference point. The practical organization was adapted to such critical times. The outstanding program allowed us to attend keynote sessions, available to in-person and on-line participants for two days. This Campus X POCT Hybrid meeting required more preplanning on the part of the organizing committee, from drawing up an inclusive agenda to making sure the technology was functioning properly. With the sudden shift created by the COVID-19 pandemic, the President of the Congress had the opportunity to build something new for the lab medicine community to interact with one another and create a better meeting experience with the objectives to share the IFCC-ETD vision on the promise of POCT, smart technologies, digital health, data science, cybersecurity and their impact on the future of Lab medicine. The conference brought together 200 participants, 80 followed the presentations on-line to learn about how lab medicine and healthcare will be redefined today through emerging technologies as well as allowing a better care of the patient. The conference provided an overview of the point-ofcare (POC) testing landscape in the era of improved diagnostics. It served as a networking place to learn more on quality management, education and training, rising technological innovation, clinical applications and the way POCT can be used to optimize diagnostic and treatment. A key element of the conference focused on SARS-CoV-2 and provided the most up-to-date views from researchers and companies in this fast-moving space. Alongside the conference, there was an exhibition of IVD industry, an excellent opportunity to present their target market and to meet international customers. The size of the global point of care diagnostics market is projected to reach USD 50.6 billion by 2025. It offers significant growth potential for prominent as well as emerging product manufacturers. Technological advancements in POC devices, rising incidence of infectious and chronic diseases, and increase in the investments by key players are crucial factors driving the growth of the point of care diagnostics market. There were five sessions throughout the two days, covering a wide variety of aspects of the rapidly emerging sector. Prof Khosrow Adeli, IFCC President, delivered the keynote lecture on POCT in Pediatrics. The clinical implementation of POCT platforms in pediatric institutions presents unique advantages as well, including smaller sample volume requirements. This is particularly true for emergency and critical care departments wherein rapid patient assessment and prognostication is essential to patient outcome. It is also very useful for home monitoring in the rural settings. The implementation of adult-based reference intervals for pediatric test result interpretation may cause significant and adverse clinical outcomes. To address this evidence gap, several initiatives have been developed, including the Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER). New studies are needed to develop evidence-based reference intervals and critical values for POCT platforms in children and POCT devices continue to grow in pediatric settings. Tomris Ozben, EFLM President elect, was chairing the session on qual-

LabMedica International November/2021

“Smart Connected People”; Front: Koshrow Adeli, IFCC President; Maurizio Ferrari, former IFCC President; Bernard Gouget, Chair IFCC C MHBLM; Back: Sergio Bernardini, Chair IFCC ETD and President WorldLab Rome 2023; Tommaso Trenti, President elect SIBioC. ity assurance. S. Sandberg, A. Haliassos, P. Oliver and J Shaw clarified this complex issue and how to implement suitable QC programmes. They explained the relevance of IQC, gave recommendations on the frequency of the IQC measurement as well as the right way to perform EQA. They provided guidance on quality initiatives that are needed to ensure robust and high-quality programs. A special focus was given to reagents and QC lot changes. The Noklus project illustrated the enrolment of the Norway Medical laboratories in external quality assessment schemes. Paloma Oliver described her experience at the La Paz University Hospital in Madrid on the implementation of ISO 15189 and ISO 22870. The accreditation has led to improvement of numerous areas regarding the total testing process. Due to the characteristics of POCT, the particularly crucial areas for ISO 22870 accreditation are method performance verification, internal and external quality assurance, staff training and competency, and continuous improvement, all of which have an effect on the quality assurance of patient results. The second session, chaired by E. Homsak and S. Stankovic, focused on POCT training. The presentations by S. Yenice, M.C. Tollanes, E. Randell and T.S. Isbell outlined that a proper training and competency assessment are mandatory to ensure that tests results are accurate and reliable. Moreover, following initial training and competency, the standard requires that staff must be reassessed for competency at regular intervals to assure quality and safety of the patient care. T. Scott Isbell highlighted the difference between the assessment-based certificate program and the AACC Point-of-Care Testing Professional Certification program. The AACC initiative could be useful for other National Societies even for Clinical Laboratory Federations. M. Ferrari moderated the last session of the first day dedicated to technological innovations in smart wearable devices. B. Gouget highlighted the potential of wearable electronic devices in healthcare and the clinical applications. Wearables can provide a key early warning in the early detection of asymptomatic and pre-symptomatic cases of COVID 19 as well as infection surveillance. While smart technology has allowed efficient medical data management and closer monitoring of the health, preventing more serious diseases in the process, the healthcare sector adopting it in masse has raised serious privacy concerns. Medical devices are increasingly connected to the Internet, hospital networks, and other medical devices. D. Gruson underlined that the healthcare systems around the globe have become more susceptible to cyberattacks and the Laboratory is one of the key targets with a rapid increase in cyberattacks since the start of the COVID-19 pandemic. AI and machine learning are playing a key role in cybersecurity to identify potential threats. Promoting a cybersecurity culture is essential. Medical biologists need to work closely with informatics professionals who can not only collect, manage, and leverage data, but protect it as well. R. Erasmus highlighted the relevance of intelligent connectivity strategies in managing POCT services. The intelligence connectivity is the combination of 5G, artificial intelligence and Internet of Things. It is expected that the intelligent connectivity further accelerates the technological improvement and the utilization of POCT networks. M. Orth showed Direct to Consumer Cont’d on page 32

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

he weather has changed, and the fall is here to stay. Just remember to look at the sky when out. You will see beautiful cloud patterns at this time of the year, and they will make you happier. I am sure you appreciated a lot the first Townhall. It was successful, a clearly new, modern way of direct communication between the Board and all IFCC members. The IFCC president is presenting it in his message, at the same time inviting us to Euromedlab Munchen 2021 and to the General Assembly in 2022. So many exciting events to look forward to! In this issue you will find reports of meetings that took place during the last months virtually or in person. The POCT meeting in Roma, with great information about

technological innovations, the 11th International Palestinian conference of laboratory Medicine with IFCC-ABBOTT Visiting Lecturer Program (VLP) participation are thoroughly presented, so that we ourselves can have a glimpse. A royal honour for our colleague Dr Gas Weykamp. He was appointed Knight of the Order of the Dutch Lion because of his exceptional achievements in clinical chemistry and the worldwide standardisation of blood tests for diabetes in particular. Isn’t this recognition wonderful for our profession? A very interesting interview with Junior Member Rodrigo Pessoa Rejas as it answers in a very to the point way how participation in the C-CMBC course influences/d his career and four teams awarded by Univants for their successful teamwork for the patients benefit complete this exciting fall issue. Till the next issue don’t forget to look at the sky! ... and to go through all our articles.

How Participation in the C-CMBC Course Influences Careers: Interview with Dr. Rodrigo Pessoa Rejas

By Verena Haselmann; Chair, IFCC Committee on Clinical Molecular Biology Curriculum (C-CMBC) Institute for Clinical Chemistry, University Medical Center Mannheim, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany

he diagnostic value of and general interest in Molecular Diagnostics is continuously increasing, especially since outbreak of the CoViD-19 pandemic. To meet this demand, the IFCC established the C-CMBC 10 years ago with the aim to train professionals all over the world to become the next teachers and distribute profound knowledge. THE QUESTION THAT ARISES, HOWEVER, IS WHETHER THIS COURSE DELIVERS WHAT IT PROMISES. What are the benefits of participating in the IFCC Beginners Course in Molecular Diagnostics? Is it possible to gain insights into Molecular Genetics within an one-week intensive course? Is this sufficient to set up your own Genetic laboratory? Can such a course really help to lay the foundation for the establishment or expansion of new diagnostics in the long term? I have asked Dr. Rodrigo Pessoa Rejas, Junior Member of the C-CMBC, who participated in the last course in La Paz, Bolivia, in March 2020, and is currently completing his six-month internship in the Department of Molecular Genetics at the Institute for Clinical Chemistry in Mannheim, Germany, under my supervision, to answer these questions. Dr. Haselmann: What was your motivation to participate in the C-CMBC course? Dr. Pessoa Rejas: Before the course, I decided to set up my own Molecular Diagnostic Laboratory in Bolivia. At that point, I did not have profound knowledge in Genetics. At University and during my specialization I have learned the basics of Genetics, the genotype-phenotype

Dr. Verena Haselmann

Dr. Rodrigo Pessoa Rejas

correlations, the most important genetic disorders and how to interpret test results in the clinical context. But we have never learned the different techniques in detail. Therefore, I wanted to participate in this course to deepen my knowledge, learn how to develop your own tests and most importantly to obtain practical skills in the lab and in-silico assay design. Dr. Haselmann: Have you received training on the different techniques, how they work, how to design and validate your own genetics tests prior to the course? Dr. Pessoa Rejas: No, I had not have a specific training on this, even not within my specialization. Dr. Haselmann: Are there any other laboratories in your country providing genetic tests, where you may also get practical help with setting up your own laboratory? Dr. Pessoa Rejas: There are one or two laboratories, but they are only offering a limited type of tests and none in Santa Cruz. However, with the CoViD-19 pandemic this changed. Now more laboratories are getting interested in Genetics. Although they are only doing PCRtests for SARS-CoV-2, the general awareness of this diagnostics is currently rapidly increasing. Therefore, it is a really good moment to start with

setting up such a laboratory. Dr. Haselmann: After the course, did you feel confident enough to setup your own laboratory? What were your first steps? Dr. Pessoa Rejas: Yes, at first, I was 100% sure that I was able to do so. I have learned how to set-up a Genetic Laboratory, to design the different assays, to do proper quality control and finally to validate and interpret test results. Nevertheless, after a short period I realized that I was lacking practical experience, especially with all the technical work. I was not feeling confident enough to take that responsibility, but I did know that I wanted to learn it. Dr. Haselmann: From your point of view, would it be possible to improve the course, so that you are able to obtain these skills within a week? Dr. Pessoa Rejas: Maybe it would be helpful if we would have more time to practice, but on the other side that would mean to reduce the number of lectures, which were also important. To be honest, I don´t think it is possible to obtain all required skills within one week. The course rather helps you to decide whether you want to get more specialized in Genetics and demonstrates you that laboratory developed tests represent

the majority of tests in this field and you need profound skills to develop your own tests. I was able to learn the basics, to get to know what I need, and, most importantly, to get into contact with people dealing with Molecular Diagnostics within and outside Bolivia. Dr. Haselmann: Did these contacts help you to achieve your aim? Dr. Pessoa Rejas: Yes. Now I am in contact with a couple of people dealing with Genetics in Bolivia, we exchange our knowledge, and help each other. Moreover, I did get into contact with specialists from abroad. Therefore, I decided to do an internship in a Laboratory specialized in Genetics. As I had met you and the others from the course, it was quite easy for me to ask you for this opportunity. Otherwise, it might have not been possible or at least would have taken much more time to find someone offer me this possibility. Dr. Haselmann: When you were doing your internship at my department, was there any benefit for you having participated in the course before? Dr. Pessoa Rejas: Definitely, it helped me a lot. I had all the scripts, textbooks and lectures explaining the different techniques in detail, and also the practical guidance documents how to use the different in-silico tools. I looked at these documents quite often, and it helped me to consolidate my knowledge. Dr. Haselmann: Finally, after the course and your internship, do you feel confident to set-up your own Laboratory in Molecular Diagnostics? Dr. Pessoa Rejas: Yes, I am feeling prepared and trained, and I am highly motivated to do so. The course has given me the basics and helped me to get connected with others, and the internship has provided me the practical experience. I am now ready and have the confidence to use the skills I have gained to achieve my goals. Cont’d on page 32 LabMedica International November/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, Greece; Email: enews@ifcc.org

NEWS

MESSAGE FROM THE PRESIDENT By Khosrow Adeli

•

President, IFCC

y cordial greetings and compliments of the fall season to you all in the IFCC family. As you may be aware, the first-ever IFCC Town Hall was held on September 15, virtually bringing the IFCC community together in the European (EFLM), African (AFCC), and Middle Eastern (AFCB) regions for the purpose of improving internal communication within IFCC. The Town Hall was tremendously successful with over 1800 attendees and more than 40 Presidents and Board Members from IFCC, Regional Federations, and National Societies. Many topics of common interest were discussed and numerous questions from the membership were answered by the panelists from IFCC and Regional Federations. Overall, an extremely successful first townhall for the IFCC community! The IFCC Town Hall for Corporate Members, which took place on September 21, was also very successful. Over 80 corporate member representatives and colleagues were in attendance. Following presentations from the IFCC Executive and the Corporate Representative to the IFCC Board, many important topics relevant to our corporate membership were discussed and questions/ concerns addressed as much as possible. Full recordings of the IFCC Town Halls are available for on demand viewing (https://www.ifcc.org/executive-board-and-council/ifcc-townhall-2021). The next IFCC Town Hall for the Asia-Pacific (APFCB) region is scheduled for October 20. The IFCC Executive Board invites the Board Members and National Society Presidents of APFCB to join in. IFCC and APFCB members in this region are also encouraged to attend this event and participate in the discussion forum. A Town Hall will be held for North, South, and Central America (NAFCC & COLABIOCLI), and planning for this meeting is already underway. In addition to the upcoming Town Halls, I would like to take this opportunity to remind everyone of the upcoming XXIV IFCC-EFLM European Congress of Clinical Chemistry and Laboratory Medicine (EuroMedLab Congress 2021), which is taking place in Munich from November 28 to December 2, 2021. An outstanding scientific program has been organized for attendees, featuring innovative and diverse education opportunities that incorporate the best of clinical laboratory medicine and in vitro diagnostics, along with excellent social opportunities for attendees to network while enjoying many attractions around the city. As the ease of travel continues to increase with improved safety measures and reduced restrictions, I encourage everyone to attend this leading forum in person. Plans are also underway to make some key parts of the scientific program available virtually for those unable to attend in person.

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 November/2021

Looking further ahead, we are currently finalizing the planning of the IFCC General Conference. Following an extensive review of various venues, the IFCC Executive Board has selected to host this meeting in Brussels. A true global city, often referred to as the “Capital of Europe”, Brussels will set the perfect backdrop for this meeting in October 2022. Planning also continues for the WorldLab 2022, which is being held in Seoul from June 22-26, 2021, in collaboration with the APFCB as well as the Korean Society. Finally, the WorldLab Conference Guidelines have recently been updated and a new call for proposals will be released shortly for the WorldLab 2024. More information to follow. With many exciting events in the near future, I hope we can look forward to a productive fall season and beyond. 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

Dr. Cas Weykamp of the Netherlands Honored with Royal Decoration

r. Cas Weykamp (67) with the Queen Beatrix Regional Hospital in Winterswijk, the Netherlands, was appointed Knight of the Order of the Dutch Lion in a ceremony held on September 27. Dr. Weykamp received the decoration in recognition of his accomplishments in the field of Clinical Chemistry, particularly his pioneering work toward the worldwide standardization of blood tests for diabetes. Photo shows Dr. Weykamp (center) along with his wife Josè, accepting the royal decoration from Winterswijk Mayor Joris Bengevoord at the farewell symposium held to mark his retirement.

Cont’d from page 30 Dr. Haselmann: If you are successful in setting up your laboratory, what will be your next steps? Dr. Pessoa Rejas: As soon as the laboratory will be set-up and the first diagnostic tests run, I will be looking for someone helping me to run this department, to establish more tests and to provide a better diagnostic for people in Bolivia. I really do like sharing my knowledge and train others. Dr. Haselmann: In the end, would you agree that this course represents a good example of the benefits of “train the trainer” to disseminate knowledge to more countries? Could you personally see yourself becoming part of the IFCC in the long-term and helping to improve the quality of diagnostics? Dr. Pessoa Rejas: Yes, I definitely agree that this is a great concept. It might be hard to find someone being interested in teaching others within the future and disseminate knowledge, but if, this is probably the most effective way to establish new diagnostics on a quality level. Personally, I would love to be part of the IFCC in the future and help the C-CMBC/IFCC to achieve this aim. And if I have one final recommendation for the course, it would be that the future Junior Member is offered the same opportunity as me to do an internship abroad. For myself, I wish that C-CMBC teachers will further support me and help me with troubleshooting when I set-up my own Genetic laboratory. In this way finally I may become a senior member in the future. Dr. Haselmann: Thanks a lot for your time, your motivation, your enthusiasm, your persistence, and your interest in Molecular Diagnostics! I am looking forward to continuing working with you on Molecular Diagnostics in the future.

IFCC Conference Focuses on Advancing Point-of-Care Diagnostics

Cont’d from page 29 Testing (DTCT) opportunities and even more concerns about DTCT if not adequately regulated. The wide application of DTCT during the Covid 19 pandemic demonstrated how patients could be in dangerous situation without medical prescription, correct interpretation, and appropriate evaluation of the quality of the devices. The second day started with an IVD round table, coordinated by T Zima and Irena Korita, on the technological evolution of blood gases analysis, the POCT quality system in the connectivity era, the advantages of the Patient-Side Immunoassay Analyzer providing, high-sensitivity cardiac troponin I (hs-cTnI) using a patient’s fingerstick blood sample and the new development of the fully integrated and automated on-demand molecular diagnostic system, enabling access to molecular diagnostic testing everywhere. Thanks to K. Makris from Athens for chairing the morning session. The positive health economic evidence of point-of-care testing was illustrated by M. Vaubourdolle using a blood product management as point of care example. A. Khan recalled that the best laboratory practices are the cornerstone of diagnostic testing. They are essential for patient care and therefore important whether testing is performed inside or outside a hospital setting it is essential to educate healthcare professionals in the best laboratory practices

to keep up pace with the extensive proliferation of POC testing and their increasing reliance as integral components of the patient’s treatment. Pandemic highlights the need of a Public Health education about POCT for both health professionals and citizens as reported by G. Kost. During a pandemic, information transparency, communication, and trust more than in any other public health situation play a critical role. P. Sharma and M. Ciotti focused on the role of POCT in LMI Countries as well as in refugees and migrant camps. In these situations, it is reliable, easy to implement and cheap. During the second part of the afternoon session, J. Nichols outlined that the Healthcare models are changing from hospital-centered to patients-centered and that the specialist in Lab Medicine should be intellectually open towards other stakeholders, like pharmacists. As telehealth continues to gain traction and people look for new ways to engage with physicians, medical specialists and their own healthcare. Social media seems an obvious channel to enhance these goals. The last speaker T. Trenti answered to the question on the synergy and the striking a balance between Point-of-Care versus Lab-Based Testing. Connectivity is a crucial issue to the successful implementation of a POCT service and a collaborative approach of clinical laboratory professionals is required. Fostering interprofessional collaboration is the key for success.

Today, the IVD industry is boosted by both the continued advancement of molecular diagnostics and the connection to smart devices at the intersection of AI and IoT. Nevertheless, there is a huge push towards POCT. The incorporation of smart devices into POC diagnostics has increased the safety, accuracy, and user-friendliness of this technology. The second roundtable organized with representatives of the IVD Companies demonstrated the dynamic and innovative capacities of the IVD sector which is improving constantly testing techniques as well as anticipating additional opportunities to create more innovative products triggering the expansion of the IVD technologies. Close collaborations between the scientists working in the IVD R&D departments and specialists in lab medicine focusing on a Laboratory Medicine patient-centered and on the proof of concept are allowing to promote the highest quality of care. The pandemic created a multitude of challenges for the organization of the conference at Tor Vergata University expanding opportunities for evolving and improving the structure of future congresses. The hybrid congress required adjustments to the way participants connect with each other, the budget allocation and the way lab medicine science is shared in the scientific community. Running effective hybrid meetings is a new reality of the post-pandemic world and it will certainly be a key to IFCC performance in the foreseeable future. LabMedica International November/2021

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

Global Digital Polymerase Chain Reaction (dPCR) Market Projected to Reach Close to USD 1.15 Billion by 2028

he global digital polymerase chain reaction (dPCR) market is projected to grow at a CAGR of more than 9% from over USD 0.50 billion in 2020 to nearly USD 1.15 billion by 2028, driven primarily by rising infectious diseases, technological developments, as well as increased knowledge and acceptance of tailored treatments. These are the latest findings of Valuates Reports (Karnataka, India; https://reports.val uates.com), a market research company. dPCR is a laboratory technique for making multiple copies of a specific piece of DNA from a sample with very small amounts of DNA. These fragments of DNA can be amplified and detected using PCR. It also provides for precise and sensitive nucleic acid measurement. It’s also employed for absolute quantification and minority sequence analysis. The rise in the incidence of infectious diseases, as well as increased knowledge and acceptance of tailored treatments, are driving the expansion of the dPCR market. Furthermore, technological developments as a result of increased funding for R&D activities are likely to drive the dPCR market expansion during the forecast period. The growth of the digital PCR market is expected to be fueled by the rising prevalence of infectious diseases and genetic disorders. As a result of its increasing use in the diagnosis of major infectious diseases and genetic disorders, the market for genomic analysis tools has gradually expanded over the last decade. dPCR is more sensitive and clinically useful than real-time fluorogenic quantitative PCR. The typical PCR system is done by several mi-

crounits in dPCR, which greatly increases the PCR system’s tolerance to inhibitors. Traditional PCR has a sensitivity of up to 1%, whereas dPCR has a sensitivity of up to 0.1%, and in certain cases as low as 0.001%, making it a perfect technique for trace DNA identification, uncommon mutation detection, and notably circulating tumor DNA detection. Furthermore, dPCR has been technologically upgraded to become a more operational and compatible tool, with highly understandable two-dimensional data. These advantages offered by dPCR are expected to drive market growth. Even when only a small volume of sample is available, dPCR still achieves good accuracy, especially when identifying difficult-to-take samples or samples with the damaged nucleic acid. Clinical samples should be amplified when performing other genomic analyses, such as comparative genomic hybridization (CGH) chip or next-generation sequencing (NGS), to provide a large enough volume, but dPCR can be performed with a small number of samples, yielding reliable results by eliminating the error generating from preamplification. Thus, the ability to produce accurate results even with smaller sample size is increasing the adoption of dPCR, which in turn, is expected to drive market growth. There have been numerous studies published since the COVID-19 pandemic in favor of dPCR for COVID-19 testing. Due to several variables such as higher sensitivity of ddPCR (Droplet Digital PCR), absence of inhibition from sample types, and simplicity of comprehending the data, there has been a considerable

increase in the demand for ddPCR equipment and SARS-CoV-2 kits. Thus, the COVID-19 outbreak is expected to further propel the growth of the dPCR market. Based on technology, the ddPCR segment dominated the dPCR market in 2020 and will maintain its lead over the forecast period. Its ability to accurately estimate DNA molecules with each drop made the ddPCR technique the leading revenue contributor to the dPCR market in 2020. Furthermore, a crucial component of the ddPCR technology is enormous sample splitting, which has increased its demand. Based on product type, the software & services segment is projected to exhibit the fastest growth during the forecast period, as software helps to improve the efficiency of management of dPCR data. Thus, there has been an increase in the demand for these products, thereby propelling the growth of the dPCR market. Geographically, North America was the leading revenue contributor to the global dPCR market in 2020 and is expected to maintain its dominant position throughout the forecast period. This can be attributed to the region’s well-developed healthcare industry, as well as the existence of prominent molecular diagnostics firms and an increase in the number of patients receiving tailored medicines. However, the Asia-Pacific dPCR market is expected to register the fastest CAGR of almost 14.50% during the forecast period due to an increase in the number of patients suffering from chronic diseases and improvement in healthcare facilities in the region, thereby providing lucrative opportunities for molecular diagnostics players.

Global Point-of-Care Testing (POCT) Market to Reach Nearly USD 80 Billion by 2028 due to Increasing Dominance of Infectious Diseases

he global Point-of-Care Testing (POCT) market is projected to grow at a CAGR of 12.3% from USD 31.17 billion in 2020 to USD 78.85 billion by 2028, driven mainly by the increasing dominance of infectious diseases, hematological diseases, cancer, and others. These are the latest findings of Zion Market Research (New York, NY, USA; www.zionmarketresearch.com), a global market research company. POCT devices are mainly used for diagnosis of disease for early detection and monitoring along with its effective treatment and management. During the last few decades, there has been a significant growth in the pervasiveness of chronic diseases which has led to an upsurge in patient inflow. POCT is beneficial in providing instantaneous results to the patient. However, the introduction of new tests and devices in the market require manufacturers to meet strict government regulations. These stringent government regulations

Industry News

LabMedica International November/2021

and poor reimbursement policies could hinder the growth of the global POCT market. The decentralization of healthcare is one of the major trends being currently observed in patient care and is anticipated to offer new market growth opportunities. The COVID-19 pandemic has accelerated the global demand for diagnostic kits for rapid detection of the diseases. As a result, several market players are focusing on increasing the supply of tests worldwide. Owing to an increase in chronic diseases and patients suffering from such diseases, there is growing healthcare awareness among people which is also fueling the growth of the POCT market. Increasing government support, along with the rising number of clinics adopting POCT for the rapid detection of infectious diseases in the near future are expected to continue driving the growth of the POCT market during the forecast period. However, multi-layered regulations set by the FDA and laboratory regulations under CLIA could restrain the

market growth. Nevertheless, greater acceptance of new technologies among researchers and academia, technological advancements, large base of population suffering from chronic and acute diseases, and increasing number of end users such as hospitals and clinics, outpatient & ambulatory care facilities are likely to continue driving the growth of the global POCT market. Geographically, North America holds the largest share of the global POCT market owing to its huge patient population, well developed economies and high healthcare expenditure. Additionally, North America is also home to the key market players, supportive governments, people with higher awareness of self-testing and home care products, and a population that has significant adoption of novel technologies. On the other hand, Asia Pacific is anticipated to be the fastest growing market for POCT diagnostics due to its huge population base.

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2021

Pediatric Laboratory Medicine. Nov 26-28; Munich, Germany; icplm2021.org EuroMedLab 2021 – 24th IFCC-EFLM European Congress of Clinical Chemistry and Laboratory Medicine. Nov 28 - Dec 2; Munich, Germany; euromedlab2021munich.org DECEMBER JIB 2021 – Journées de l’innovation en biologie. Dec 1-2; Paris, France; jib-innovation.com Zdravookhraneniye 2021 – Russian Health Care Week. Dec 6-10; Moscow, Russia; zdravo-expo.ru/en

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

Labquality Days 2022 – International Congress on Quality in Laboratory Medicine. Feb 10-11; Helsinki, Finland; labqualitydays.fi WSPID 2022 – 12th World Congress of the World Society for Pediatric Infectious Diseases. Feb 22-24; Virtual Venue; wspid2022. com MARCH Pittcon 2022. Mar 5-9; Atlanta, GA, USA; pittcon.org KIMES 2022. Mar 10-13; Seoul, Korea; kimes. kr

63rd Annual Meeting & Exposition of the American Society of Hematology (ASH). Dec 11-14; Atlanta, GA, USA; hematology.org

65th Congress of the German Society for Endocrinology. Mar 17-19; Baden-Baden, Germany; endokrinologie.net

Labclin 2021 – 15th Spanish Clinical Laboratory Congress. Nov 7-13; Virtual Venue; labclin2021.es

ACBICON 2021 - 47th Annual Conference of Association of Clinical Biochemists of India. Dec 13-15; Virtual Venue; acbicon2021.com

ExpoMED Eurasia 2022. March 17-19; Istanbul, Turkey; expomedistanbul.com

AFCC Congress 2021 – 7th Regional Conference of the African Federation of Clinical Chemistry Nov 11-13; Lusaka, Zambia; ifcc. org. 53rd National Congress of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC). Nov 11-13; Virtual Venue; sibioc.it

LABWorld China 2021 (CPhI & P-MEC China). Dec 16-18; Shanghai, China; pmecchina.com/ labworld

42nd Annual Meeting of the American College of Toxicology (ACT). Nov 14-17; Virtual Venue; actox.org Arab Lab 2021. Nov 15-17; Dubai, UAE; arablab.com MEDICA 2021. Nov 15-18; Dusseldorf, Germany; medica-tradefair.com ICPLM 2021 – 15th International Congress of

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

FEBRUARY SLAS 2022 – International Conference & Exhibition of the Society of Laboratory Automation and Screening. Feb 5-9; Boston, MA, USA; slas.org

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WASPaLM 2022 – 31st World Congress of the World Association of Societies of Pathology and Laboratory Medicine. May 5-8; Punta del Este, Uruguay; waspalm.com Immunology 2022 – Annual Meeting of the American Association of Immunologists (AAI). May 6-10; Portland, OR, USA; aai.org ECV 2022 – 8th European Congress of Virology. May 8-11; Gdansk, Poland; eusv.eu

COLABIOCLI 2022 – 25th Latin American Congress of Clinical Biochemistry. Mar 28 Apr 2; Leon, Mexico; colabiocli2022.com

Hospitalar 2022. May 17-20; Sao Paulo, Brazil; hospitalar.com

APRIL MSACL 2022 – Congress of the Association for Mass Spectrometry & Advances in Clinical Lab. Apr 5-8; Monterey, CA, USA; msacl.org AACR Annual Meeting 2022 – American Association of Cancer Research. Apr 8-13; New Orleans, LA, USA; aacr.org

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ECCMID 2022 – 32nd European Congress of Clinical Microbiology & Infectious Diseases. Apr 23-26; Lisbon, Portugal; eccmid.org

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LabMedica International November/2021

ratory Hematology. May 25-27; Bologna, Italy; islh.org JUNE ASCO 2022 – Annual Meeting of the American Society of Clinical Oncology. Jun 3-7; Chicago, IL, USA; asco.org ALACI 22 – 13th Latin American and Caribbean Congress of Immunology. Jun 6-10; Varadero, Cuba; iuis.org/events/ alaci-2021 105th Annual Meeting of the German Society for Pathology. Jun 9-11; Muenster, Germany; pathologie-dgp.de EHA 2022 - Annual Congress of the European Hematology Association. Jun 9-12; Vienna, Austria; ehaweb.org ESHG 2022 – European Human Genetics Conference. Jun 11-14; Vienna, Austria; eshg.org ENDO 2022 – Annual Meeting of the Endocrine Society. Jun 11-14; Atlanta, GA, USA; endocrine.org KoreaLab 2022. Jun 14-17; Seoul, Korea; korealab.org Analitica Latin America 2022. Jun 21-23; Sao Paulo, Brazil; analiticanet.com.br 47th CBAC – Congress of the Brazilian Society of Clinical Analysis. Jun 19-22; Fortaleza, Brazil; sbac.org.br Analytica 2022. Jun 21-24; Munich, Germany; analytica.de FOCIS 2022 – Annual Meeting of the Federation of Clinical Immunology Societies. Jun 21-24; San Francisco, CA, USA; focisnet.org

IFCC WorldLab Seoul 2022 – 24th International Congress of Clinical Chemistry and Laboratory Medicine. Jun 26-30; Seoul, Korea; ifcc.org JULY ESHRE 2022 – 38th Annual Meeting of the European Society of Human Reproduction and Embryology. Jul 3-6; Milan, Italy; eshre. eu 74th AACC Annual Scientific Meeting & Clinical Lab Expo – American Association for Clinical Chemistry. July 24-28; Chicago, IL, USA; aacc.org FIME 2022 – Florida International Medical Expo. Jul 27-29; Miami, FL, USA; fimeshow. com

EAHP-SH 2022 – 21st Meeting of the European Association for Haematopathology. Sep 17-22; Florence, Italy; eahp-sh2022.com ICT 2022 – 16th International Congress of

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MEDICA 2022. Nov; Dusseldorf, Germany; medica-tradefair.com

44th Annual Meeting of the European Thyroid Association (ETA). Sep 10-13; Brussels, Belgium; eurothyroid.com

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CAP22 – Annual Meeting of the College of American Pathologists. Oct 8-11; New Orleans, LA, USA; cap.org

NOVEMBER Analytica China. Nov 14-16; Shanghai, China; analyticachina.com

ASCP 2022 – Annual Meeting of the American Society for Clinical Pathology. Sep 7-9; Chicago, IL, USA; ascp.org

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OCTOBER 35th IFBLS World Congress 2022 – International Federation of Biomedical Laboratory Science. Oct 5-9; Suwon, Korea; ifbls.org

APFCB 2022 – 16th Congress of the Asia-Pacific Federation of Clinical Biochemistry and Laboratory Medicine. Oct 15-18; Sydney, Australia; apfcbcongress2022.org

SEPTEMBER 34th Congress of the European Society of Pathology (ESP). Sep 3-7; Basel, Switzerland; esp-congress.org

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EASD 2022 – 58th Annual Meeting of the European Association for the Study of Diabetes. Sep 19-23; Stockholm, Sweden; easd.org

46th ISOBM Congress - International Society of Oncology and Biomarkers. Oct 14-16; Bled, Slovenia; isobm2020.net

AUGUST ICE 2022 – 20th International Congress of Endocrinology. Aug 25-28; Singapore; isendo.org

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Toxicology. Sept 18-22; Maastricht, Netherlands; ict2022.com

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Vol. 38 No. 6 10/2021

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– 8th European Congress of Virology 2022 . . . 16 – 34th European Congress of Pathology. . . . . 26 – AACC 2022 . . . . . . . . . . . . . . . . . . . . . . . . . . 31 123 AB Analitica. . . . . . . . . . . . . . . . . . . . . . . . . . 23 110 Absology . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 127 Alcor Scientific. . . . . . . . . . . . . . . . . . . . . . . . 27 113 Awareness Technology, Inc.. . . . . . . . . . . . . 13 121 Bioperfectus Technologies. . . . . . . . . . . . . . . 21 128 CHROMagar . . . . . . . . . . . . . . . . . . . . . . . . . 28 116 Dymind. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 105 DiaSys Diagnostic Systems. . . . . . . . . . . . . . . 5 120 DIAsource . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 117 Euroimmun. . . . . . . . . . . . . . . . . . . . . . . . . . . 17 119 GenBody . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 118 JOKOH. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 106 Mast Group . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 115 Nova Biomedical . . . . . . . . . . . . . . . . . . . . . . 15 107 NG Biotech. . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 103 Randox. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 114 Serosep. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 124 Singuway. . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 102 Snibe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 125 Veda Lab. . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 122 Vicotex. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 111 Vircell. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 109 Werfen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 136 Werfen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Provided as a service to advertisers. Publisher cannot accept responsibility for any errors or omissions.

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