LabMedica International April 2022 by Globetech

WORLD’S CLINICAL LABORATORY NEWS LEADER ISSN 1068-1760

Vol. 39 No.2 • 4/2022

ELISA Blood Test for Heart Risk Prediction

DAILY CLINICAL LAB NEWS

‘Fingerprint’ Machine Learning Technique Identifies Various Bacteria in Seconds

ardiovascular disease (CVD) is the leading cause of death worldwide and a large proportion of these patients ultimately die from sudden cardiac death (SCD). Now, a new secretoneurin (SN) blood-based ELISA (enzyme-linked immunosorbent

ynergistic combination of surface-enhanced Raman spectroscopy and deep learning serves as an effective platform for separation-free detection of bacteria in arbitrary media. Researchers at the Korea Advanced Institute of Science and

Technology (KAIST, Daejeon, Korea; www.kaist.ac.kr) have demonstrated a quicker, more accurate process for bacterial identification which can take hours and often longer, despite time being precious when diagnosing infections and selecting appropriate

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Groundbreaking DNA Test Profiles Biomarkers in Hundreds of Cancer-Relevant Genes

n lieu of conventional tests, a single diagnostic test can now evaluate biomarkers in 517 cancer-relevant genes across 30 types of solid tumors, thus enabling physicians to make precision medicine decisions for cancer patients.

Image: Cancer in the blood outbreak and treatment for malignant cells.

See article on page 4 V

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Hematology Analyzer Offers Integrated CBC and ESR Testing

raditionally, erythrocyte sedimentation rate (ESR) tests, T which measure how quickly red blood cells (RBCs) settle in diluted plasma over a specified period of time, are performed on an independent analyzer, and can take up to 60 minutes to get the results. Cont’d on page 22

Blood Test Predicts Likely Progression to Alzheimer’s Up to 6 Years in Advance

he first approved blood test can identify whether individuals with early cognitive impairment will or will not progress to Alzheimer’s disease with high accuracy. Diadem Srl (Brescia, Italy; www. diademdx.com) has received CE

V I S I T

IVD certification for its AlzoSure Predict prognostic blood test for the early prediction of Alzheimer’s disease, allowing the company to take the test to markets in the UK and the 27 countries of the European Union (EU). It also enables market Cont’d on page 8

Detecting Pancreatic Cancer in High-Risk Individuals

n immunoassay was able to detect pancreatic cancer in high-risk individuals and with high sensitivity and specificity. Pancreatic cancer arises when cells in the pancreas, a glandular organ behind the stomach, begin to multiply out of control and form a mass. These cancerous cells have the ability to invade other parts of the body. A number of types of pancreatic cancer are known. Cont’d on page 20

Test Predicts Recurrence of Oropharynx Cancer

n extensive multi-institutional study demonstrates that a blood test to detect circulating tumor DNA can accurately predict recurrence of HPV-driven oropharyngeal cancer following treatment. Results also indicate that the biomarker test may detect recurrent disease earlier than imaging or other standard methods of post-treatment surveillance, allowing physicians to Cont’d on page 10

INSIDE

COVID-19 Update. . . . . 5 Clinical News. . . . . . 4-24 IFCC News. . . . . . . . . . 25 Product News . . . . . 6-24 Events Calendar . . 30-31 PUBLISHED IN COOPERATION WITH

International Federation of Clinical Chemistry and Laboratory Medicine

GLOBETECH >>> MEDIA <<<

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LabMedica International

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EDITORIAL BOARD

Illumina has launched a groundbreaking comprehensive genomic profiling test for cancer in Europe (Photo courtesy of Illumina Inc.)

Graham Beastall United Kingdom Hernán Fares Taie Argentina Bernard Gouget France Maurizio Ferrari Italy Jocelyn M. Hicks United States Tahir S. Pillay South Africa Andreas Rothstein Colombia 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).

Groundbreaking DNA Test Profiles Biomarkers in Hundreds of Cancer-Relevant Genes

onventional tests for profiling biomarkers from tumor samples, such as single biomarker tests and targeted hotspot panels, are limited in the number of targets they analyze which increases the chances of missing critical information. Now, a single in vitro diagnostic (IVD) diagnostic test can help inform therapy decisions according to clinical guidelines to enable precision medicine decisions for cancer patients. Illumina Inc. (San Diego, CA, USA; www.illumina.com) has launched TruSight Oncology (TSO) Comprehensive (EU), a single test that assesses multiple tumor genes and biomarkers to reveal the specific molecular profile of a patient’s cancer. With its global launch first taking place in Europe, the IVD kit will help inform precision medicine decisions for cancer patients across the continent. This new IVD comprehensive genomic profiling (CGP) kit covers a broad range of mutations and current and emerging biomarkers associated with the European Society for Medical Oncology guidelines, drug labels and clinical trials, maximizing the chances of finding actionable information from each patient’s biopsy. TSO Comprehensive (EU) assesses biomarkers in 517 cancer-relevant genes across nearly 30 solid tumor types by evaluating both DNA and RNA, and complex genomic signatures, such as microsatellite instability (MSI) and tumor mutational burden (TMB). This comprehensive assessment eliminates the need for running separate, sequential gene tests from multiple biopsy procedures. The fast turnaround time of four to five days for sample-to-clinical report generation, versus weeks in some cases, enables clinicians to make decisions regarding personalized medicine or clinical trial enrollment for their cancer patients. TSO Comprehensive (EU) is the first CE (Conformité Européenne)-marked IVD kit for CGP based on DNA and RNA content, having met important European standards for quality and efficacy. The CE-

mark is a pre-requisite for reimbursement of diagnostic tests by health authorities, and in some European countries, is required before laboratories can use a new testing method. As a validated, CE-marked IVD, and a kitted solution, the introduction of TSO Comprehensive (EU) provides a streamlined process for use in-house by any pathology lab, so that testing can be offered closer to patient care. Illumina has a growing pipeline of companion diagnostics (CDx) claims under development, through partnerships with pharma companies, which will be added to TSO Comprehensive (EU) over time following regulatory approval. These CDx solutions will help unlock groundbreaking targeted therapies and immunotherapies to make a difference to the lives of cancer patients. “This groundbreaking and accurate diagnostic kit provides information clinicians can use to help match their patients to available therapies according to clinical guidelines or clinical trials, based on their tumor profile,” said Kevin Keegan, General Manager for Oncology at Illumina. “At Illumina we are proud to be bringing innovations like this to market, and to be at the forefront of unlocking the power of the genome for human benefit.” “Clinicians are increasingly matching the genetics of a patient’s cancer with their therapy,” explained Phil Febbo, MD, Chief Medical Officer at Illumina. “When a medical center internalizes comprehensive genomic profiling of cancer, the multidisciplinary team includes a molecular pathologist who has more control over the biopsy sample and data generated, and can increase the number of informed cases they are able to deliver. Evidence suggests when this happens, more patients have access to CGP and precision medicine earlier on in their disease journey.”

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ISSN 1068-1760

Vol.39 No.2. 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 April/2022

COVID -19 Diagnostics Update

he report that follows provides a selection of news and advances announced from February 1 to March 15, 2022. For a recap of earlier developments, the reader is invited to refer to previous issues of LabMedica or visit our website at www.LabMedica.com. COVID-19 Molecular Gene Test Detects Early and Asymptomatic Infections IdentifySensors Biologics (Shaker Heights, OH, USA; www.identifysensors.com), along with researchers at Purdue University (West Lafayette, IN, USA; www.purdue.edu), has finalized proof-of-concept research for an all-new COVID-19 testing method. Their molecular gene test is based on innovative nanosensor technology which aims to replace 50-year PCR testing for multiple infections, including COVID variants, and could reshape the future of COVID-19 diagnostic testing.

Nano-Sensors Pinpoint Infectious Diseases like SARS COVID-19

Technique Combines Raman Spectroscopy and Machine Learning for Detecting COVID-19 Biomedical researchers at Polytechnique Montréal (Montreal, Canada; www.polymtl.ca) have developed a new and improved method that uses Raman spectroscopy and machine learning for the detection of SARS-CoV-2. The noninvasive and reagent-free technique uses saliva samples and can facilitate better COVID-19 detection in addition to paving the way for new tools for other infectious diseases.

Handheld COVID-19 Test Detects Positive Sample in 15 Minutes Pluslife Mini Dock, developed by Pluslife Biotech (Guangzhou, China; www.pluslife.com), is the first handheld POCT nucleic acid testing product for COVID-19. The handheld POCT nucleic acid testing product for COVID-19 reaches very high level of sensitivity, specificity and accuracy, which is similar as qPCR test, and can

also stably detect viruses at a very low LoD (Limit of Detection).

PCR-Based SARS-CoV-2 Assay Detects All Known COVID-19 Variants Researchers at Rutgers New Jersey Medical School (Newark, NJ, USA; www.njms.rutgers. edu) have developed a rapid test that detects all known COVID-19 variants, including the highly transmissible Omicron variant, and could guide Cont’d on page 6

A novel method, developed by researchers at Arizona State University (Minneapolis, MN, USA; www.asu.edu) and the University of Washington Seattle (Seattle, WA, USA; www.washington. edu), uses simple, inexpensive, fast and accurate nano-sensors to pinpoint infectious diseases like Ebola virus (EBOV) and SARS CoV-2. The technology represents a significant advance in the fight against infectious diseases. It can be developed and produced at very low cost, deployed within weeks or days after an outbreak, and made available for around one cent per test.

Isolation of Pure Coronavirus Nucleoprotein to Improve COVID-19 Testing Accuracy Scientists from Research Center of Biotechnology RAS (Moscow, Russian Federation; www.fbras.ru) have isolated the coronavirus nucleoprotein in its pure form to improve the accuracy and sensitivity of COVID-19 antibody tests. The team demonstrated that at least two different methods of directed RNA removal are required for obtaining SARS-CoV-2 nucleoprotein, completely free from any RNA admixtures. Such preparation helps to determine the presence of antibodies to SARS-CoV-2 with significantly higher sensitivity.

Test Detects COVID-19 with Accuracy of PCR Testing in 4 Minutes Scientists at Fudan University (Shanghai, China; www.fudan.edu.cn) have developed a new coronavirus test that is accurate as a polymerase chain reaction (PCR) lab test but gives results within four minutes. The test uses a hypersensitive electromechanical biosensor to detect nucleic acids that were earlier difficult to identify owing to their low concentration in test samples. The sensor which uses microelectronics to analyze genetic material from swabs could reduce the need for time-consuming lab tests for diagnosing COVID-19.

LabMedica International April/2022

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PRODUCT NEWS

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IMMUNOTURBIDIMETRIC TEST

PROTEIN ASSAY

LATERAL FLOW TEST READER

The D-Dimer FS test is an emergency test for the exclusion of thrombosis and can be used on any clinical chemistry analyzer. It features a wide measuring range, high prozone security and excellent sensitivity/ specificity.

The QuanTtest Red is a pyrogallol red total protein reagent for the quantitative determination of protein in cerebrospinal fluid and urine for both manual and automated systems.

The RIDAQUICK SCAN II is a lateral flow test reader for the automated readout of RIDAQUICK tests from R-Biopharm AG using a camera-based system to evaluate high-resolution gray-scale images.

DIASYS DIAGNOSTIC SYSTEMS

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QUANTIMETRIX CORP

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R-BIOPHARM

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COVID -19 Diagnostics Update Cont’d from page 5

treatment as well as identify high-risk patients. The test, which can be performed at laboratories experienced in COVID-19 testing, can quickly detect clinical samples that contain the SARS-CoV-2 virus with signature mutations for each known variant of concern - namely, the Alpha, Beta/ Gamma, Delta and Omicron variants.

Optical Methodology for Detection of COVID-19 Scores Over RT-PCR An optical methodology for the rapid detection of COVID-19 developed by researchers at the University of Seville (Seville, Spain; www. us.es) provides an advantage over PCR in terms of the speed of sample processing and the ability to simultaneously analyze a large number of samples. The new methodology has obtained a sensitivity of 100% and a specificity of 87.5% in the detection of SARS-CoV-2 in nasopharyngeal exudate (the same samples used in a PCR test) from symptomatic people.

Portable Instrument Enables Fast Detection of SARS-CoV-2 in Saliva Researchers from the Institute of Photonic Sciences (ICFO Castelldefels, Spain; www.icfo. eu) and IrsiCaixa AIDS Research Institute (Badalona, Spain; www.irsicaixa.es) have developed a portable, low-cost instrument that combines a fluorescence reader and microfluidic chip to enable fast, sensitive detection of COVID-19 in saliva samples. Although still in the research stage, the new device could offer a higher sensitivity than today’s COVID-19 rapid antigen tests while also being faster and more cost-effective than PCR tests.

Low-Cost Transistor Quantifies SARSCoV-2 Neutralizing Antibodies in Blood A fast, effective, reliable, and low-cost new technology developed by a research team led by scientists from the University of Bologna (Bologna, Italy; www.unibo.it) aims to quantify SARS-CoV-2 neutralizing antibodies in the blood, but also test the efficacy of new vaccines against COVID-19. The device is an “organic electrochemical transistor” (OECT), based on a special

conductive polymer (PEDOT:PSS), which allows to monitor the integrity of cell tissue remotely and in real-time, thus helping understand whether or not a coronavirus-infected in vitro culture is protected by the neutralizing antibodies found in the blood serum.

Robotic VR System Helps Conduct COVID-19 Swab Tests A research team co-led by City University of Hong Kong (CityU Hong Kong; www.cityu.edu. hk) has developed a new robotic virtual reality (VR) human-machine interface (HMI) system that can teleoperate the robot to imitate the user’s actions to perform complicated tasks such as COVID-19 swab tests. The innovative HMI system consists of flexible, multi-layered electronic skin and provides both visual and haptic feedback to users. The system can teleoperate the robot to imitate the user’s actions to perform complicated tasks. It demonstrates the potential for conducting COVID-19 swab tests and nursing patients with infectious diseases.

COVID-19 Test Provides Lab-Quality Results in 15 Minutes The all new Veros COVID-19 test from Sense Biodetection Limited (Oxford, UK; www.sensebio.com) is the first and only fully integrated, easy-to-use COVID-19 molecular diagnostic test that provides laboratory-quality results in 15 minutes. The test is over 1,000 times more sensitive than widely used antigen tests and detects all Variants of Interest and Concern of the SARSCoV-2 virus.

FTIR-Based Saliva Test Detects Body’s Response to COVID-19 Researchers at the QIMR Berghofer Medical Research Institute (Brisbane, Australia; www. qimrberghofer.edu.au) collaborated with Agilent Technologies Inc. (Santa Clara, CA, USA; www. agilent.com) on a study that found a potential new saliva test can rapidly detect COVID-19 infection and may even indicate if a person is likely to become seriously unwell by reading the chemical signature in a person’s saliva. The

researchers found the test worked by detecting the body’s response to COVID-19 rather than just the virus itself – making it different from PCR and rapid antigen tests.

Thermo Fisher Introduces Low-Cost RT-LAMP Tests Thermo Fisher Scientific (Waltham, MA, USA; www.thermofisher.com) has launched two new reverse transcription loop-mediated isothermal amplification (RT-LAMP)-based solutions to support active research and surveillance of viral pathogens, including SARSCoV-2. While PCR remains the gold standard for diagnostic, lab-based testing, isothermal RT-LAMP nucleic-acid-based amplification provides a rapid and low-cost option for viral pathogen detection.

Next-Gen Graphene Biosensor Helps Diagnosis of Infectious Diseases GRIP Molecular Technologies,Inc. (St. Paul, MN, USA; www.gripmolecular.com) is developing a next-generation diagnostic technology that aims to simultaneously and accurately detect a wide variety of upper respiratory infection pathogens, including Influenza, COVID-19, RSV and other common diseases, with one sample and one test that takes minutes to perform. The new novel graphenebased electronic biosensor technology under development aims to provide rapid, simultaneous, lab-grade accuracy detection of an array of infectious diseases, anytime, anywhere, by any user. Image: Organic electrochemical transistor quantifies SARS-CoV-2 neutralizing antibodies (Photo courtesy of Unsplash). LabMedica International April/2022

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PRODUCT NEWS

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BIOCHEMISTRY & TURBIDIMETRY AUTOMATIC IMMUNOASSAY ANALYZER FLOOR ANALYZER LABTEST MACCURA BIOTECHOLOGY

The CS-400 is a biochemistry and turbidimetry floor analyzer that is fully automatic. The reaction fixed cycle allows performing of 400 photometric tests with maximum efficiency and enables automatic counting of reagents volume. LINKXPRESS COM

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The i 1000 fully automatic immunoassay analyzer uses multiple magnetic separation technology for high-efficient B/F separation and features a patented magnetic field design to strictly control the loss of mag-bind. LINKXPRESS COM

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3-PART DIFF HEMATOLOGY ANALYZER HUMAN

The HumaCount 30TS is a 3-part differential hematology analyzer that tests for 22 parameters at a throughput of 30 samples/hours. It features anti-clogging technology, a large color touchscreen and a builtin thermal printer. LINKXPRESS COM

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Blood Test Predicts Likely Progression to Alzheimer’s Up to 6 Years in Advance Cont’d from cover

development across much of the rest of the world. The accreditation follows the US Food and Drug Administration’s awarding of a Breakthrough Device Designation to AlzoSure Predict in January. AlzoSure Predict is a biomarker blood test that can identify with high accuracy whether individuals over the age of 50 with signs of cognitive impairment will or will not progress to Alzheimer’s disease up to six years before definitive symptoms are apparent. The company’s technology uses an analytical method that includes a proprietary and patented antibody developed by Diadem designed to bind to U-p53AZ and its target sequences. U-p53AZ is a conformational variant of the p53 protein that has been implicated in the pathogenesis of AD in multiple studies. AlzoSure Predict’s accreditation is supported

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by positive clinical data from a 482-patient longitudinal study showing that the test can identify whether individuals will or will not progress to full-fledged Alzheimer’s disease up to six years before the illness is apparent. Patients were aged 50 years or older at the start of the study and asymptomatic or at the early stages of AD or other dementias. The second phase of this study, which includes biobank data on more than 1,000 additional patients from Europe and the US, will be completed in the coming months. “This first regulatory approval for AlzoSure Predict is a signal event for our scientists whose insight and commitment have enabled us to achieve this milestone,” said Paul Kinnon, CEO of Diadem. “We believe it represents a significant advance for the millions of patients and their families in Europe at risk from Alzheimer’s disease. Earlier knowledge

will benefit those who are found to be not likely to advance to AD as well as those individuals found to be at risk, who can now take steps to slow the progression of the condition. We will be partnering with a variety of health providers to ensure wide access to AlzoSure Predict and expect the test to be available to physicians and patients in the EU in the coming months.” Image: AlzoSure Predict blood-based prognostic test for Alzheimer’s disease (Photo courtesy of Diadem Srl).

ELISA Blood Test for Heart Risk Prediction

assay) cardiovascular risk test could provide clinicians with a key tool for both more accurate risk prediction and patient management. The CardiNor SN assay from Cardinor AS (Oslo, Norway; www.cardinor.com) is a bloodbased cardiovascular risk test that detects SN, a small 33-amino acid neuropeptide detectable in the blood stream and produced by neuroendocrine and heart muscle cells. SN is the only biomarker shown to be associated with biological processes linked to cardiomyocyte handling and has been described as the “missing link biomarker” in CVD risk assessment. This unique biological function may explain why SN is an independent and strong predictor of mortality in all major patient cohorts tested, including patients with ventricular arrhythmia, acute heart failure, and acute respiratory failure

patients with CVD and severe sepsis. SN is thus addressing a vast and untapped market potential for CVD patient diagnosis, risk stratification and monitoring, complementary to BNP/NTproBNP and cardiac troponins. In addition to front line CVD testing, there is a potential major role for SN testing in patient selection for cardiac rhythm management. Current criteria both lack the desired sensitivity and specificity. As an example, as many as 70% of patients with an ICD (implantable cardioverter-defibrillator) will never need the device. Conversely, a large proportion of sudden cardiac death patients do not fulfill current criteria for ICD implantation. Thus, there is an urgent need to better target and select patients who will benefit from an ICD. CardiNor has a comprehensive clinical program to further strengthen and widening the

clinical documentation of its novel biomarker, and the SN test is being trialed in patient selection for cardiac rhythm management using ICD devices. The CardiNor SN assay has achieved CE marking according to IVDD and the company is now planning to expand its distribution network globally and preparing for its US market entry. “We are delighted to achieve CE marking on this important new biomarker and are now looking forward to expanding our distribution network globally and to prepare for US market entry,” said Dag Christiansen, CEO, CardiNor. “The COVID-19 pandemic has further highlighted the need for improved cardiovascular disease risk markers. The CardiNor Secretoneurin ELISA assay will provide clinicians with a key tool for both more accurate risk prediction and patient management.” LabMedica International April/2022

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PRODUCT NEWS

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HBA1C TEST

REAL TIME PCR PLATFORM

ESR ANALYZER

HbA1c Fast test kit is intended for the quantitative measurement of HbA1c in human whole blood samples. This test is used as an aid for monitoring glycemic control in diabetics.

The VIASURE V-Lab96 Real Time PCR Platform is an open platform for in vitro diagnostics that allows for the analysis of 96 samples simultaneously for qualitative and quantitative PCR.

The VES MATIC 5 is a fully automated modified Westergren method ESR system that determines the ESR directly on the hematocrit tube (190 samples/hour), using racks from the main cell counters.

GETEIN BIOTECH

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CERTEST BIOTEC

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DIESSE DIAGNOSTICA

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Test Predicts Recurrence of Oropharynx Cancer

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personalize treatment more quickly for patients whose cancer returns. Despite generally favorable outcomes, up to 20% of patients with human papillomavirus (HPV)-driven oropharyngeal squamous cell carcinoma (OPSCC) will experience recurrence within five years of curative-intent therapy; approximately half of recurrences present with distant disease. Currently, recurrence is detected primarily through imaging and physical exams, but there is wide variability in the use and frequency of these surveillance methods. There are indications that a biomarker test may detect recurrent disease earlier than imaging or other standard methods of post-treatment surveillance, allowing physicians to personalize treatment more quickly for patients whose cancer returns. Oncologists at the Dana-Farber Cancer Institute (Boston, MA, USA; www. dana-farber.org) and their colleagues demonstrated in large, multi-institutional study that a blood test to detect circulating tumor DNA can accurately predict recurrence of HPV-driven oropharyngeal cancer following treatment. In a retrospective clinical case series included 1,076 consecutive patients across 124 USA sites who were > 3 months post therapy for HPV-driven OPSCC and who had one or more circulating cell-free tumor tissue modified HPV DNA (TTMV-HPV DNA) test (NavDx, Naveris Laboratories, Natick, MA, USA; www.naveris.com) between 2/6/2020 and 6/11/2021. TTMV-HPV DNA for HPV subtypes 16, 18, 31, 33, and 35 was analyzed with ultrasensitive digital droplet PCR. Test results were compared to LINKXPRESS COM

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the results of subsequent clinical evidence of OPSCC, using nasopharyngolaryngoscopy and/or radiologic (CT, MRI, or PET-CT) evaluations and/or tissue biopsy. Glenn J. Hanna, MD, an Assistant Professor of Medicine and lead author of the study, said, “Most patients had no other evidence of disease or clinically indeterminate disease status at the time of their first positive biomarker test. Incorporating a test for TTMV-HPV DNA into routine post-treatment follow-up can enable physicians to detect recurrent cancers earlier and allow us to start recommended interventions more quickly to improve outcomes.” The authors concluded that their findzings demonstrated the clinical validity and utility of circulating TTMV-HPV DNA testing in daily clinical practice as an effective surveillance tool for identifying patients with active and occult recurrent HPV-driven OPSCC. To date the positive predictive value for recurrence or persistence of HPV-driven OPSCC is 95.0% (76/80), which may increase with additional follow-up of cases remaining in active surveillance. Notably, the presence of circulating TTMV-HPV DNA was the first indication of recurrence for 72.4% of cases. These data will help inform clinical and guideline-endorsed strategies concerning the inclusion of circulating TTMV HPV-DNA as a biomarker of molecularly detectable HPV-driven OPSCC in the setting of recurrence surveillance. The study was presented at the on February 24, 2022, at the 2022 Multidisciplinary Head and Neck Cancers Symposium held in Phoenix, AZ, USA. LabMedica International April/2022

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

LabMedica International

Microbiological Features of Mucormycosis Determined in Critically Ill Patients

ucormycosis is a rare invasive fungal infection with high mortality in patients with severe underlying predisposing factors causing immunosuppression. The exact incidence of mucormycosis and the optimal therapeutic approach is difficult to determine, especially in severe cases, due to the rarity of the disease. The causative pathogens are fungi of the order Mucorales, mainly Rhizopus spp., Mucor spp. and Lichtheimia spp., which are typically found on decaying organic material and soils. There are three ways humans can contract mucormycosis, by inhaling spores, by swallowing spores in food or medicines, or when spores contaminate wounds. Medical Microbiologists at the Technical University of Munich, School of Medicine (Munich, Germany; www.tum.de) conducted a retrospective analysis between February 2016 and February 2019. Patients were identified using the HyBase analysis system (epiNet AG, Bochum, Germany; www.epinet.de) and inclusion criteria were positive laboratory culture for Mucorales with consistent clinical presentation, intensive care treatment, and age >18 years. Proven mucormycosis was based on histopathological findings. Pulmonary mucormycosis was classified as probable as the diagnosis was mainly based on bronchoalveolar lavage (BAL) when patients did not undergo surgery. All samples were collected using aseptic techniques. Primary microbiological cultures were performed on Columbia agar, Schaedler agar, chocolate agar (prepared culture media, Becton Dickinson, Sparks, MD, USA; www.bd.com) and thioglycolate broth (Oxoid Thermo Fisher Scientific, Waltham, MA, USA; www.thermofisher.com). Colonies of Mucorales were subcultured on Sabouraud dextrose agar for macroscopic, microscopic and matrix-assisted laser desorption/ionization-time of flight (Bruker Daltronics GmbH, Leipzig, Germany; www. bruker.com) species identification. Molecular species identification via 28s rDNA polymerase chain reaction and sequencing was performed. Galactomannan detection (Platelia Aspergillus Ag, Bio-Rad Laboratories, Munich, Germany; www.bio-rad. com) was performed using BAL and serum samples. The investigators reported that they had found 15 critically ill patients with Mucorales detected between 2016 and 2019 and the

LabMedica International April/2022

crude mortality rate was 100%. At the time of diagnosis of mucormycosis, 80% of subjects had relevant medical immunosuppression and 53.3% of subjects had neutropenia. Manifestation of mucormycosis was pulmonary in 53.3% of subjects, rhino-orbital in 20% of subjects and disseminated in 26.7% of subjects. Rhizopus microsporus was isolated in nine of 15 (60%) cases, Lichtheimia corymbifera in four of 15 (26.7%) cases and Rhizopus arrhizus in two of 15 (13.3%) cases. Galactomannan antigen testing (serum and BAL) was performed regularly to identify a differential diagnosis or mixed invasive fungal infection (13/15, 86.7%), and yielded positive results for two patients, one of whom also had detectable fungal growth of Aspergillus

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fumigatus in two consecutive BAL samples. The authors concluded that for intensive care patients, the prognosis of mucormycosis was extremely poor. An aggressive strategy for diagnosis and treatment is essential for intensive care patients with mucormycosis. It should be noted that during the COVID-19 pandemic in India, the Indian government reported that more than 11,700 people were receiving care for mucormycosis as of 25 May 2021. The study was published on August 1, 2021 in the International Journal of Infectious Diseases.

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TB MOLECULAR DETECTION SYSTEM

BREAST CANCER TEST

SARS-COV-2 POOLING TEST

The HumaLoop T is intended for the sensitive and accurate molecular detection of Mycobacterium Tuberculosis bacterium complex on a consolidated platform in order to replace smear microscopy.

BRCAaccuTest and BRCAaccuTest PLUS are reagent kits for producing libraries for analyzing the BRCA1 and BRCA2 genes using the next generation sequencing method, which analyzes genomic DNA derived from blood or FFPE tissue.

The Vivalytic SARS-CoV-2 Pooling (COVID-19) is a rapid real time PCR test cartridge, providing clear results in a timely manner, direct at the point of care to enable the patient to quickly take the recommended safety precautions.

HUMAN

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NGENEBIO

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RANDOX LABORATORIES

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Dengue Patients’ Hemoglobin Concentrations Compared by POC and CBC

engue is a mosquito-borne viral infection that is mainly found in tropical and sub-tropical climates. The natural history of dengue has the unique characteristic of plasma leakage that results in hemoconcentration as well as vasculopathy and thrombocytopenia that result in bleeding. Hematocrit monitoring is a crucial tool to guide management in dengue patients. Microhematocrit adjunct with a complete blood count (CBC) to monitor dengue patients were traditionally performed to decrease the frequency of venipuncture. However, microhematocrit is currently less preferred to the point-of-care hemoglobin monitoring tools to measure red cells in other diseases. A team of medical scientists at the Ramathibodi Hospital (Bangkok, Thailand; www.rama.mahidol.ac.th) evaluated the relationship between hemoglobin measured by point-of-care hemoglobin (POC-Hb) testing and hematocrit measured by the automated method in adult dengue patients. A total of 44 dengue patients were enrolled. Twenty-nine patients (65.9%) were female, with a median age of 31 years (interquartile range 22–41). Of the enrolled patients, 30 (68.2%), 11 (25.0%), and three (6.8%) were classified as dengue without warning signs, with warning signs, and severe dengue, respectively. Seven patients (15.9%) had hemoconcentration, and five patients (11.3%) had bleeding.

The team measured a CBC by Mindray BC6800Plus (Mindray, Shenzhen, China; www. mindray.com) at Ramathibodi Hospital, and Sysmex XN-3000 (Sysmex, Kobe, Japan; www. sysmex.co.jp) at Chakri Naruebodindra Medical Institute. POC-Hb testing was performed on capillary blood and read by the HemoCue Hb 201+ (HemoCue AB, Ängelholm, Sweden; www.hemocue.com). POC-Hb testing was conducted by three physicians who were trained on the use of the device. Hemoconcentration was defined by an increase of ≥20% in hematocrit compared with a convalescent value. A total of 216 pairs of POC-Hb and CBC were evaluated. The investigators reported that the medians of hemoglobin and hematocrit at dengue presentation were 13.8 g/dL and 41.6%, respectively. The medians of mean corpuscular volume (MCV) and platelets were 87.0 fL and 98,500/mm3, respectively. The team found a significant positive correlation was observed between hemoglobin measured by POC-Hb testing and hematocrit measured by an automated CBC. Bland-Altman analysis between hemoglobin measured by POC-Hb testing and an automated CBC showed a bias of -0.43. Using the cutoff of POC-Hb ≥20% as a criteria for hemoconcentration, the sensitivity and specificity of hemoconcentration detected by POC-Hb device were 71.4% and 100.0%, respectively.

The authors concluded that hemoglobin measurement using POC-Hb testing adjunct with CBC monitoring can be used to monitor plasma leakage as well as hemorrhage in dengue patients. The use of POC-Hb testing is less invasive and requires less blood compared to venipuncture for CBC evaluation. The study was published on August 16, 2021 in the journal PLOS Neglected Tropical Diseases. Image: The HemoCue Hb 201+ System Analyzer has become a standard in hemoglobin point-of-care testing (Photo courtesy of HemoCue AB).

Electrochemical Enzyme-Based Blood ATP and Lactate Sensor Monitors Disease Severity

cientists have developed a prototype sensor that could help doctors rapidly measure adenosine triphosphate (ATP) and lactate levels in blood samples from patients, aiding in the rapid assessment of the severity of diseases. The biosensor developed by scientists at Hokkaido University (Hokkaido, Japan; www. global.hokudai.ac.jp) can detect levels of ATP

and lactate in blood with great high sensitivity in as little as five minutes. ATP is a molecule found in every living cell that stores and carries energy. In red blood cells, ATP is produced by a biochemical pathway called the Embden–Meyerhof pathway. Severe illnesses such as multiple organ failure, sepsis and influenza reduce the amounts of ATP produced by red blood cells. As such, the severity of

these illnesses could be gauged by monitoring the amounts of ATP and lactates in a patient’s blood. The new biosensor follows a straightforward process. Chemicals are added to a blood sample to extract ATP from red blood cells. Enzymes and substrates are then added to convert ATP and lactate to the same product Cont’d on page 14 LabMedica International April/2022

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HAEMOSTASIS ANALYZER

MICROPLATE READER

URINE ANALYZER

The Haema TX haemostasis analyzer enables fully-automated whole blood analysis by using “Thromboelastography” technology to provide physiological and comprehensive insights into patients’ haemostasis process.

The KC-100 microplate reader is an 8-channel optical measuring system that performs optional single/ double wavelength analysis and extensive onboard data analysis, featuring a large touch-screen LCD and storage of 2,500 results.

The ComboStik R-50 urine analyzer has a throughput of 45 tests (max 120 tests) per hour and simultaneously tests up to 10 strips. It has a 128x64 LCD screen, built-in printer, LIS connection and memory for storing 2,000 results.

MEDCAPTAIN

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CARETIUM

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DFI CO.

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PD-L1 Expression in Circulating Tumor Cells Investigated for NSCLC

n non-small cell lung cancer (NSCLC), analysis of programmed cell death ligand 1 (PD-L1) expression in circulating tumor cells (CTCs) is a potential alternative to overcome the problems linked to the tumor biopsy spatiotemporal heterogeneity. However, the prognostic significance of PD-L1-positive [PD-L1(+)] CTCs remains controversial. Circulating tumor cells (CTCs) might better reflect the tumor heterogeneity than tissue biopsies because they arise from different tumor sites. Furthermore, as CTCs are collected using a minimally invasive method (blood sampling), they can be analyzed longitudinally as liquid biopsies, and might provide information on the different mechanisms of treatment resistance. Oncologists and colleagues at the University Medical Centre of Montpellier (Montpellier, France; www.umontpellier.fr) prospectively enrolled between June 2016 and June 2018 patients older than 18 years of age with histologically confirmed stage III or IV NSCLC. Blood sampling was performed at diagnosis, before the first treatment (n = 9), or later, at progression, before the next therapeutic line (n = 45). Blood was drawn from the arm vein in specific 10 mL CellSave tubes (Menarini Silicon Biosystems, Bologna, Italy; www. siliconbiosystems.com) for CTC detection. Blood samples were processed immediately with the CellSearch system (Huntington

Valley, PA, USA; www.cellsearchctc.com). PD-L1 expression in CTCs was evaluated with the antihuman B7-H1/PD-L1 fluorescein isothiocyanate-conjugated antibody (R&D System, Minneapolis, MN, USA; www. rndsystems.com). The investigators reported that they detected CTCs and PD-L1(+) CTCs in 43.4% and 9.4% of patients with NSCLC. PD-L1 expression concordance between tumor tissue and CTCs was low (54%). The presence of PD-L1(+) CTC correlated with the absence of gene alterations in tumor tissue and with poor prognosis-related biological variables (anemia, hyponatremia, increased lactate dehydrogenase). In univariate analysis, absence of gene alterations, number of metastatic sites, prior systemic therapies, and presence of CTCs and PD-L1(+) CTCs were associated with worse overall survival, whereas PD-L1 expression in tumor tissue was not. In multivariate analysis, squamous cell carcinoma histology, number of prior systemic treatments, and the presence of CTC were significantly associated with overall survival. Survival was worse in patients with PD-L1(+) CTCs than in patients with PD-L1negative CTC or without any CTC. The authors concluded that their data confirmed the feasibility of PD-L1 detection on CTCs in patients with advanced NSCLC, using the CellSearch technology, and suggest a neg-

ative prognostic impact of the PD-L1(+) CTC subpopulation. The weak concordance between PD-L1 expression on the tumor tissue and CTCs and the finding that only PD-L1 expression on CTCs predicted the clinical outcome suggest that tissue biopsy and CTCs are two complementary tools. The study was published on August 6, 2021 in the journal Clinical Chemistry. Image: The CellSearch Circulating Tumor Cell Kit is intended for the enumeration of circulating tumor cells of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+ and PD-L1) in whole blood (Photo courtesy of CellSearch/Menarini Silicon Biosystems).

Electrochemical Enzyme-Based Blood ATP and Lactate Sensor Monitors Disease Severity

Cont’d from page 12

that can be detected by specially modified electrodes on a sensor chip. The intensity of the current generated at the electrodes depends on the amount of by-product present in the sample. The team conducted parallel tests and found that other components present in blood, such as ascorbic acid, pyruvic acid, adenosine

diphosphate (ADP), urate and potassium ions, don’t interfere with the ability of the electrodes to accurately detect ATP and lactate. They also compared their sensor with those currently available and found it allowed for the relatively simple and rapid measurement of the two molecules. The researchers next aim to simplify the measurement process even further by inte-

grating an ATP extraction method into the chip itself. They also plan to make their sensor system even more compact. “We hope our sensor will enable disease severity monitoring and serve as a tool for diagnosing and treating patients admitted to intensive care units,” said Hokkaido University applied chemist, Akihiko Ishida. LabMedica International April/2022

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

LabMedica International

Epigenetic Biomarker Signature Predicts the Likelihood of Premature Birth

esearchers have identified an epigenetic biomarker signature for preterm birth that can be used in a clinical setting to predict the likelihood that a pregnant woman might deliver prematurely. Preterm birth (earlier than 37 weeks) is the major cause of newborn and infant mortality affecting nearly one in every ten live births. Many premature infants face a number of health issues, including cognitive disabilities and cardiovascular problems. Preterm birth has been linked to risk factors such as a twin or multiple pregnancy and preclampsia. Yet, many early births are unexpected, and having a diagnostic test in the first-term of pregnancy could allow caregivers to take steps to delay or prevent a preterm birth. A study carried out by investigators at Washington State University (Pullman, USA) was designed to develop an epigenetic biomarker for susceptibility of preterm birth using buccal cells from the mother, father, and child (triads). An epigenomewide association study (EWAS) was used to identify differential DNA methylation regions (DMRs) using a comparison of control term birth versus preterm birth triads. Cheek swabs were obtained from two groups of mother-father-infant triads shortly

after the babies were born. In one set of 19 triads, the infants were born prematurely and in another group of 21 triads, the babies were carried to full term. DNA was isolated from the buccal cell collections and analyzed with a methylated DNA immunoprecipitation (MeDIP) procedure to obtain methylated DNA for subsequent sequencing (Seq) for an MeDIP-Seq protocol. This procedure provides a genome-wide assessment of greater than 90% of the genome, compared to approximately 50–70% for bisulfite sequencing, or less than 1% for array analysis. Epigenetic DMR associations with preterm birth were identified for both the mother and father that were distinct and suggested potential epigenetic contributions from both parents. The mother (165 DMRs) and female child (136 DMRs) had the highest number of DMRs and were highly similar, suggesting potential epigenetic inheritance of the epimutations. The male child had negligible DMR associations. Clearly the female infants’ epigenetic biomarker signature was not used to predict potential preterm birth, but could potentially be used to assess later life disease susceptibility in the individual. "The signature we found was present in all the parents we analyzed," said senior author

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Dr. Michael Skinner, professor of biological sciences at Washington State University. "This is likely to lead eventually to a very useful test. We used buccal cells, which are collected by a cheek swab. It is very non-invasive and easy to do. Although we may not be able to fix the problem, if we know that it is going to develop because of these diagnostics, we can treat it. This could help with the transition from reactionary medicine to preventive medicine." The study was published in the March 1, 2022, online edition of the journal Scientific Reports. Image: A premature baby being monitored in a neonatal intensive care ward.

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BENCHTOP RECAPPING & SAMPLE ACUTE KIDNEY INJURY TEST MANAGEMENT SYSTEM GLOBE SCIENTIFIC BIOMERIEUX

NEPHROCHECK is an innovative test that detects kidney stress prior to actual damage, when intervention can still make a difference. It is intended to be used as a risk assessment test, in conjunction with clinical evaluation.

CapTrack is the world’s first and only benchtop recapping and sample management system. Available in three models, CapTrack is the solution for increased efficiency, sample integrity and safety in blood processing laboratories. LINKXPRESS COM

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AUTOMATIC HEMATOLOGY ANALYZER GETEIN BIOTECH

BHA-5000 is a 5-part differential automatic hematology analyzer with 25 reportable parameters that uses laser-based flow cytometry to count white blood cells in blood samples.

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Genomics Approach Links ABO Blood Type to Inflammatory and Cardiovascular Diseases

genomics approach that supplements classical blood typing procedures connects blood type phenotype to a large set of common inflammatory and cardiovascular diseases. Previous studies have primarily focused on identifying associations between ABO blood groups and diseases risk. To expand this work, investigators at the University of Uppsala (Sweden; www.uu.se) sought to test for association between ABO genotypes (OO, OA, AA; OB, BB, and AB) and a large set of common inflammatory and cardiovascular diseases as well as disease-related protein biomarkers. For this work, materials were obtained from The UK Biobank, which is a prospective observational study of approximately 500,000 volunteers aged 40 to 69 years who were recruited from 22 sites across the United Kingdom between 2006 and 2010. The investigators tested for association by conducting a likelihood ratio test, examining whether ABO status contributed significantly to the risk for 24 diseases, and 438 plasma proteins. Results confirmed previous findings of a strong association between ABO and cardiovascular disease, identified associations for both type

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I and type II diabetes, and provided additional evidence of significant differences between heterozygous and homozygous allele carriers for pulmonary embolism, deep vein thrombosis, but also for von Willebrand factor levels. In addition, the results indicated an additive effect between genotypes, even between the two most common A subgroups, A1 and A2. The investigators also found that ABO contributed significantly to 39 plasma proteins, of which 23 had never been linked to the ABO locus before. “There is a large difference for the risk for blood clots, depending on if someone has one or two genetic variants of the blood groups A, AB, or B. Simply put, there is twice the risk of suffering from blood clots if you have two variants of A or B rather than just one,” said first author Julia Höglund, a doctoral student in immunology, genetics, and pathology at Uppsala University. “This is not detected in a regular blood test since both A and B mask the O gene. A person’s genetic variants play a big role in the risk for cardiovascular diseases. If this was the standard method used with patients, it would significantly improve the ability to find high-risk patients. Our findings show that by making it standard to determine the patient’s blood group and the blood group’s genetics, we would be able to discover and begin treating diseases at an early stage, which can prevent or delay serious complications.” The ABO genomics study was published in the July 30, 2021, online edition of the American Journal of Hematology. Image: Blood type is determined, in part, by the ABO blood group antigens present on red blood cells (erythrocytes) (Photo courtesy of Wikimedia Commons). LabMedica International April/2022

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5-PART HEMATOLOGY + CRP ANALYZER

CARDIAC PANEL

SARS-COV-2 RRT-PCR TEST

The DF50CRP is a 5-part hematology + CRP analyzer combined in one machine with a built-in three reagents smart room and reagent cooling system. It offers testing of three sample modes and has a throughput of up to 60 tests for CBC.

The Triage Cardiac Panel is a rapid, point of care fluorescence immunoassay used with the Triage MeterPro. This test is designed to determine the level of creatine kinase MB (CK-MB), myoglobin and troponin I.

Revogene SARS-CoV-2 is a real-time rRT-PCR qualitative test run on the Revogene instrument for the detection of SARS-CoV-2 nucleic acid from nasopharyngeal, oropharyngeal, anterior nasal, and mid-turbinate nasal swab specimens.

DYMIND BIOTECHNOLOGY

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MERIDIAN BIOSCIENCE

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‘Fingerprint’ Machine Learning Technique Identifies Various Bacteria in Seconds

Cont’d from cover

treatments. By teaching a deep learning algorithm to identify the “fingerprint” spectra of the molecular components of various bacteria, the researchers could classify various bacteria in different media with accuracies of up to 98%. Bacteria-induced illnesses, those caused by direct bacterial infection or by exposure to bacterial toxins, can induce painful symptoms and even lead to death, so the rapid detection of bacteria is crucial to prevent the intake of contaminated foods and to diagnose infections from clinical samples, such as urine. Raman spectroscopy sends light through a sample to see how it scatters. The results reveal struc-

tural information about the sample - the spectral fingerprint - allowing researchers to identify its molecules. Surface-enhanced Raman spectroscopy (SERS) places sample cells on noble metal nanostructures that help amplify the sample’s signals. However, it is challenging to obtain consistent and clear spectra of bacteria due to numerous overlapping peak sources, such as proteins in cell walls. To parse through the noisy signals, the researchers have implemented an artificial intelligence method called deep learning that can hierarchically extract certain features of the spectral information to classify data. They specifically designed their model, named the dual-branch wide-kernel net-

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work (DualWKNet), to efficiently learn the correlation between spectral features. Such ability is critical for analyzing one-dimensional spectral data, according to the researchers. The researchers now plan to use their platform to study more bacteria and media types, using the information to build a training data library of various bacterial types in additional media to reduce the collection and detection times for new samples. “We developed a meaningful universal platform for rapid bacterial detection with the collaboration between SERS and deep learning,” said Professor Sungho Jo from the School of Computing. “We hope to extend the use of our deep learning-based SERS analysis platform to detect numerous types of bacteria in additional media that are important for food or clinical analysis, such as blood.” Image: Schematics of the general process of Raman data collection and analysis (Photo courtesy of KAIST). LabMedica International April/2022

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

LabMedica International

Globotriaosylsphingosine Levels Measured in Fabry Disease Patients

abry disease (FD) is caused by an inborn error of glycosphingolipid metabolism, a genetic defect resulting in partial or complete deficiency of the lysosomal hydrolase alpha-galactosidase A (alpha-Gal A). This enzyme is responsible for breaking down glycolipids such as globotriaosylceramide and its deacylated derivative, globotriaosylsphingosine (LysoGb3). In males, the classical Fabry phenotype generally arises in the pediatric age with acroparesthesia, hypo- or anhidrosis, angiokeratoma, corneal opacities (typically cornea verticillata) and microalbuminuria. Recently, LysoGb3 was found to be a useful biomarker in confirming FD diagnosis even in symptomatic females with normal or borderline leukocyte enzyme activity due to the effect of X-chromosome inactivation. Clinical Scientists at the Meyer Children Hospital (Florence, Italy; www.meyer.it) and their colleagues carried out a prospective observational study enrolling 104 FD patients, 39 males and 65 females between the ages of 4 and 75 years from six clinical centers in Italy. Venous blood was collected. A portion was spotted onto filter paper (DBS) and another portion separated to obtain plasma. The LysoGb3 concentrations in DBS and plasma were determined by highly sensitive electrospray ionization liquid chromatography tandem mass spectrometry. The data were obtained using an API 5500 QTRAP mass spectrometer (AB SCIEX, Concord, ON, Canada; www.sciex.com) equipped with Turbo Ion

Image: The AB SCIEX QTRAP 5500 System is a high sensitivity, bench top hybrid triple quadrupole-Linear Accelerator trap mass spectrometer designed for LC/MS/MS analyses (Photo courtesy of SCIEX).

Capillary and Venous Blood Sampling Compared for Coagulation Assays

linical laboratories offer a wide range of coagulation assays used in the diagnosis and management of patients with hemostatic disorders, preoperative screening, or anticoagulation therapy monitoring. The request from clinicians for capillary blood collection for other routine coagulation test, such as International Normalized Ratio, prothrombin time, activated partial thromboplastin time, and thrombin time, remains significant in particular from those involved in pediatrics. Capillary sampling offers a less invasive method for blood collection than venipuncture, which makes it more suitable for neonates, young children as well as for adult patients with poor venous access or severe anxieties concerning blood sampling. Diagnostic Laboratorians at the University Medical Center Utrecht (Utrecht, The Netherlands; www.umcutrecht.nl) performed a method comparison between capillary and venous blood sampling for routine coagulation assays. Both venous and capillary (finger stick) blood samples were collected from 188 healthy volunteers and patients. In citrate plasma, International Normalized Ratio (INR), prothrombin time (PT), activated partial

Spray source and operating in MRM positive ion mode. Chromatographic separation was achieved using an Agilent 1290 Infinity UHPLC capillary system (Agilent Technologies, Santa Clara, CA, USA; www.agilent.com). The scientists reported that the method using DBS was validated by evaluating its precision, accuracy, matrix effect, recovery, and stability. Mean (±SEM) plasma and DBS levels of LysoGb3 in the 30 males with classical FD were 45.6 ± 9.2 and 40.6 ± 9.0 nmol/L, respectively, while in the nine males with late-onset FD, they were 9.2 ± 3.2 and 7.9 ± 2.4 nmol/L, respectively. Mean LysoGb3 levels in 54 females with a GLA variant associated with classical FD were 7.1 ± 0.6 (plasma) and 6.4 ± 0.5 nmol/L (DBS), while in the nine females with a GLA variant associated with late-onset FD LysoGb3 levels were 1.9 ± 0.7 (plasma) and 1.8 ± 0.5 nmol/L (DBS). There was a strong correlation between plasma and the corresponding DBS LysoGb3 concentrations, with few exceptions. Discrepancies were observed in anemic patients with typically low hematocrit levels compared to the normal range. The authors concluded that the method proved to be efficient for the rapid analysis of LysoGb3. DBS provides a convenient, sensitive, and reproducible method for measuring LysoGb3 levels for diagnosis, initial phenotypic assignment, and therapeutic monitoring in patients with FD. The study was published on August 26, 2021 in the journal Clinical Chemistry and Laboratory Medicine.

LabMedica International April/2022

Image: The ACL-TOP 750 LAS coagulation analyzer (Photo courtesy of Werfen).

thromboplastin time (APTT), thrombin time (TT), fibrinogen, and D-dimer were measured according to routine protocols using the ACL-TOP 750 LAS (Werfen, Bedford, MA, USA; www.werfen.com) coagulation analyzer. Regression analysis was performed and the mean relative difference between capillary and venous sampling was reflected to the total allowable error. The scientists reported that there was a strong correlations and acceptable variations, using the total allowable error (TEa) as decision limit, were found for INR, PT, TT, fibrinogen, and D-dimer between capillary and Cont’d on page 20 LINKXPRESS COM

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2019-NCOV RAPID ANTIGEN SELF TEST

TRILEVEL HEMATOLOGY CONTROL

AUTOMATIC CHEMISTRY ANALYZER

The XABT 2019-nCoV Antigen Rapid Test Cassette is a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in anterior nasal swab.

The Liquichek Hematology-16 Control is a trilevel control specifically designed for use on most hematology analyzers that measure up to 16 parameters and 3-part white blood cell differentials.

The PF-810 is a fully automatic chemistry analyzer with a throughput of 800 tests per hour, 90 reagent positions, 120 sample positions and 160 reaction cups. It features a 24 hour cooling system for keeping reagents at 2~8 °C.

XABT

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BIO-RAD QUALITY SYSTEMS DIVISION

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PROKAN

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Detecting Pancreatic Cancer in High-Risk Individuals

Cont’d from cover

Signs and symptoms of the most-common form of pancreatic cancer may include yellow skin, abdominal or back pain, unexplained weight loss, light-colored stools, dark urine, and loss of appetite. Usually, no symptoms are seen in the disease’s early stages, and symptoms that are specific enough to suggest pancreatic cancer typically do not develop until the disease has reached an advanced stage. An international team of gastroenterologists led those at University of Pittsburgh Medical Center (Pittsburgh, PA, USA; www.upmc.com) examined serum samples from 586 adults: 167 with pancreatic ductal adenocarcinoma (PDAC) (median age 70 years, 58% male), 203 at high-risk for familial PDAC from a clinical trial (median 59 years, 36% male), and a control group of 216 healthy adults (median 49 years, 51% male). Histologically confirmed PDAC blood samples were collected for processing prior to surgery or adjuvant treatment, and laboratory personnel were blinded to the identity of the serum samples. Samples were collected at eleven sites in the USA and Europe, using standard protocols with storage conditions of -80 °C and thawed for analysis within two years of collection. The scientists used the multiplex IMMray PanCan-d assay (Immunovia, Marlborough, MA, USA; www.immunoviainc.com) which distinguished 56 PDAC stages I & II versus high-risk individuals with 98% specificity and 85% sensitivity, and distinguished PDAC stages I – IV versus high-risk individuals with 98% specificity and 87% sensitivity. They identified samples with a CA19-9 value of 2.5 U/mL or less as probable Lewis null (le/le) individuals. Excluding these 55 samples from the analysis increased the IMMray PanCan-d test sensitivity to 92% for 157 patients with PDAC stages I-IV versus 379 controls while maintaining specificity at 99%; test sensitivity for PDAC stages I & II increased from 85% to 89%. IMMray PanCan-d combines eight serum

biomarkers with CA19-9 to generate a risk-level signature. The biomarkers are a combination of immunoregulatory and tumor biomarkers. Andrew Hendifar, MD, an Assistant Professor at Cedars-Sinai Medical Center in Los Angeles, who was not involved in the study, said, “The high specificity is promising and proof of principle that biomarker assays could be used to help clinical decision-making in identifying early pancreatic cancer.” The authors concluded that their results demonstrate the IMMray PanCan-d blood test can detect PDAC with high specificity (99%) and sensitivity (92%). The key to improve survival is early detection during a potentially curable stage. Low or negative CA19-9 expression in individuals who are genotypically Lewis antigen null (i.e., le/le with mutations in both copies of the FUT3 gene) further limits the reliability of this biomarker for PDAC detection.” The study was published on February 14, 2022 in the journal Clinical and Translational Gastroenterology.” Image: Schematic diagram of the IMMray PanCan-d assay that relies on the IMMray microarray technology, where single chain fragment antibodies are printed onto a slide in a measured amount as a microarray of different antibody biomarkers (Photo courtesy of Immunovia).

Capillary and Venous Blood Sampling Compared for Coagulation Assays

Cont’d from page 19

venous sampling, However, capillary sampling resulted in significant shorter APTT values when using the standard APTT-SP Liquid reagent with a mean bias of −10.4%.. The mean relative difference of TT and fibrinogen was −1.7% and −3.7%, respectively, but were considered acceptable variations using the TEa as a decision limit. D-dimer showed a mean relative difference of 1.2%], which fell within the range of acceptable variation. The authors concluded that strong correlations and acceptable

variations were found for INR, PT, TT, fibrinogen, and D-dimer between capillary and venous sampling. However, capillary sampling resulted in significantly shorter APTT values when using the standard APTT-SP Liquid reagent. Based on these results, capillary blood sampling proved to be an alternative blood withdrawal method for routine coagulation assays, with the exception of APTT, if a venipuncture is unavailable. The study was originally published online on February 3, 2022, in the journal Clinical Biochemistry. LabMedica International April/2022

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

Urinary VEGFA and Renal Pathology Evaluated for IgA Nephropathy Patients

mmunoglobulin A (IgA) nephropathy (IgAN) is the most common primary glomerulonephritis and is the leading cause of end-stage renal disease (ESRD) in China. Renal biopsy remains the golden standard for diagnosing and monitoring IgA nephropathy (IgAN). Vascular endothelial growth factor-A (VEGFA) is an essential angiogenic cytokine and found to be crucial for the survival, differentiation and structure maintaining of these glomerular cells. VEGFA is therefore, pivotal for maintaining the glomerular filtration barrier function. The relationship of urinary and renal VEGFA in IgAN patients are still not clear. Nephrologists at the Sun Yat-sen University (Guangzhou, China; www. sysucc.org.cn) recruited a total of 85 IgAN patients and 71 healthy controls without microscopic hematuria, proteinuria, hepatic disease and with normal serum creatinine. Samples of IgAN patients were obtained at the day of renal biopsy. Serum and morning urine collected from each subject were transferred to a separate vial after centrifuge and stored at −80 °C until assayed. Serum levels of VEGFA were measured by ELH-VEGF-1 ELISA (RayBiotech, Peachtree Corners, GA, USA; www.raybiotech.com), and urine VEGFA levels were measured by ELISA from R&D Systems (Minneapolis, MN, USA; www. rndsystems.com). Absorbance was measured at 450 nm using the SpectraMax Plus 384 Microplate reader (Molecular Devices, San Jose, CA, USA; www.moleculardevices. com). Renal biopsies of 27 IgAN patients were randomly selected from enrolled 85 IgAN patients and used for VEGFA testing by immunohistochemistry analysis. The expression levels of VEGFA and Glyceraldehyde 3-phosphate dehydrogenase (GAPDH) were quantified by real-time PCR using Taqman with a fluorescence detection monitor 7900 Real-time PCR system (Applied Biosystems, Waltham, MA, USA; www.thermofisher.com). The investigators reported that compared with healthy controls, urinary VEGFA level was elevated in IgAN patients (76.19 ± 63.67 pg/ mg Cr versus 146.67 ± 232.71 pg/ mg Cr), and not correlated with serum VEGFA level. Baseline urinary VEGFA was significantly associated with gender and tubular atrophy/ interstitial fibrosis by stepwise multivariate regression analysis. Urinary VEGFA was higher in male patients

LabMedica International

LabMedica International April/2022

accompanied with higher serum creatinine, larger proportion of hypertension and recurrent hematuria than in female patients. In the kidney of IgAN patients, VEGFA were robustly expressed in the parietal epithelial cells, podocytes, mesangial cells and tubular epithelial cells. After a follow-up duration of 38.53 ± 27.14 months, IgAN patients with higher urinary VEGFA level were found to have a poorer renal outcome of renal replacement therapy. The authors concluded that increased urinary VEGFA might reflect certain renal pathology and, although not fully specific, still could be served as a valuable noninvasive indicator in predicting renal progres-

sion of IgAN. The study was published on September 8, 2021 in the Journal of Clinical Laboratory Analysis. Image: The SpectraMax Plus 384 Microplate Reader can run both standard spectrophotometer and microplate reader applications on the same instrument (Photo courtesy of Molecular Devices).

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Hematology Analyzer Offers Integrated CBC and ESR Testing Cont’d from cover

However, there is a need for integrated testing for CBC and ESR. Now, the first all-in-one hematology solution that combines 5-part differential with ESR analysis yields both CBC and ESR results with just one test in merely 1.5 minutes, significantly improving workflow and testing efficiency while benefiting patients with quicker blood test reports. Mindray (Shenzhen, China; www.mindray. com) has launched the new BC-700 Series, a revolutionary hematology analyzer series that incorporates both complete blood count (CBC) and erythrocyte sedimentation rate (ESR) tests. The BC-700 Series, including two open vial models BC-700/BC-720 and two autoloader models BC-760/BC-780, is designed to empower medium-volume labora-

tories with advanced diagnostics technologies that are applied in the premium products. Striving to benefit more laboratories worldwide, the BC-700 Series adopts Mindray’s core hematology technology of SF Cube 3D analysis and is built from the same platform as its high-end BC-6000 Series, but in a smaller footprint. In SF Cube technology, target cells are subject to a 3D analysis using bi-angular laser scatter signals and fluorescence. The 3D scattergrams generated with the cellular information can help clinical experts to identify and differentiate cell populations, in particular abnormal clusters, providing a more reliable result to the doctor. Powered by the SF Cube analysis technology, Mindray has developed many useful hematology parameters. With the new param-

eter, PLT-H, the BC-700 Series can more easily address the challenges that were previously inadequately met by conventional hematology analyzers, providing an accurate optical platelet count result in every CBC and DIFF test. By using patented reagents with cutting-edge technology, the BC-700 Series also allows the platelet clumps to be de-aggregated, offering laboratories a complete solution for reliable platelet analysis. “We designed and built this analyzer series, because Mindray believes all labs matter. Every laboratory needs solutions that empower trust and accurate results, and this is what drives us to develop technologies and innovations that go above and beyond your requirements,” said Shane Wan, Director of International IVD Product Line, Mindray.

Saliva-Based Liquid Biopsy Detects HPV-Caused Head and Neck Cancers

saliva-based liquid biopsy assay was developed that might eventually play an essential role in the detection and management of head and neck cancers caused by high-risk human papillomaviruses. High-risk human papillomavirus (HR-HPV) infection is a major risk factor of head and neck cancers (HNCs). These cancers constitute 3–5% of all malignancies worldwide and there are approximately 600,000 newly diagnosed cases annually. Patients are usually diagnosed at an advanced stage, since in the early stages, these cancers are difficult to locate with imaging studies or physical examination. Furthermore, the oropharynx is difficult to access, and detection is complicated if these smaller lesions are hidden in the crevices of the tonsils. Importantly, these cancers can metastasize at an early stage, even when the primary cancer is still undetectable in size. Despite the rising prevalence of HPVdriven HNC (HPV-HNC) and closely associated oropharyngeal cancers (OPC), biomarkers for detection, prognostication, and disease monitor-

ing are lacking. Investigators at Queensland University of Technology (Brisbane, Australia; www.qut.edu. au) performed a study to evaluate the potential use of salivary HR-HPV DNA as a biomarker of HPV-HNC. For this study, they employed quantitative real-time PCR and the Agena Bioscience (San Diego, CA, USA; www.agenabio.com) MassARRAY system to analyze saliva samples obtained from 491 patients at the time of first diagnosis of HNC and 10 patients with recurring HNC. An additional group of OPC patients was monitored for a period of up to five years. Results revealed that of the primary-HNC cohort, 43.2% were positive for salivary HRHPV DNA, with most having OPC. Salivary HR-HPV DNA was detected in 81.4% of tumor p16–positive OPC patients at diagnosis. Salivary HR-HPV–positive patients had a clear survival advantage over their salivary HR-HPV–negative counterparts. The median event-free survivals were 205 months for HR-HPV–positive patients, compared to 82 months for HR-HPV–negative

patients. “Despite the upsurge in HPV-driven HNC, there are no early detection methods or screening strategies for this cancer type, unlike cervical cancer, which is caused by the same virus. Biomarkers enabling early detection, monitoring, and disease prognostication are warranted to combat the rising incidence of HPV-driven OPC,” said senior author Dr. Chamindie Punyadeera, associate professor of biomedical sciences at Queensland University of Technology. “When the noninvasive nature and convenience of the collection are considered, salivary HR-HPV testing is an ideal mode of screening asymptomatic individuals and the long-term monitoring of HPV-driven HNC patients. Our findings indicate that in the near future, salivary HR-HPV testing will become part of routine clinical management for HPV-driven OPC patients.” The saliva-based biopsy was described in the July 26, 2021, online edition of The Journal of Molecular Diagnostics. LabMedica International April/2022

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

Two Circulating Biomarkers Predict Cardiovascular Disease Risk in Psoriasis Patients

lood levels of the protein biomarkers cardiac troponin I (cTnI) and N-terminal pro-brain-type natriuretic peptide (NT-proBNP) in patients with psoriatic disease (PsD) were found to be associated with carotid plaque burden and the development of cardiovascular disease (CVD) independent of traditional CVD risk factors. Individuals with psoriasis and psoriatic arthritis, collectively known as psoriatic disease, are more likely to develop cardiovascular disease than others in the general population. In order to discover whether these people carry biomarkers that could help predict their risk of developing CVD, investigators at the University of Toronto (Canada) measured

AI-Powered Pathology to Drive Insight in Cancer Diagnosis

riven by the economic and clinical benefits, leading laboratories are increasingly looking to adopt AI in routine practice. Powerful computational applications have highlighted the role that AI could play in improving diagnosis for an increasingly large portion of lab volume. However, a key barrier to deriving the full value of AI is the lab’s ability to seamlessly integrate this diverse range of applications into routine operations. Now, a strategic partnership will deliver integrated AI-enabled solutions that aim to improve clinical decision making for cancer care. Proscia (Philadelphia, PA, USA; www. proscia.com) and Visiopharm (Hoersholm, Denmark; www.visiopharm.com) have now joined forces to deliver a unified solution that combines Visiopharm’s suite of CE-IVD clinical AI applications – including breast IHC markers, breast metastasis detection, and colon metastasis detection – with Proscia’s CE-IVD Concentriq Dx platform for image-based data and workflow management. Users of Concentriq Dx can now leverage the full suite of Visiopharm’s AI applications directly in the routine workflow, helping pathologists quantify the expression of biomarkers aiming to accelerate treatment decisions for patient care. This marks an expansion of the companies’ existing collaboration integrating AI-enabled solutions which have successfully driven breakthroughs in translational research and advance precision medicine for life sciences companies. “We are excited about expanding our successful partnership in the research market to include the clinical market,” said Michael Grunkin, CEO of Visiopharm. “With Visiopharm’s commitment to AI-driven Precision Pathology, and Proscia’s commitment to interoperability and digital workflow solutions for pathology labs, this integrated solution combines efficient workflows and support for optimal treatment decisions to our clinical customers.”

LabMedica International April/2022

carotid total plaque area (TPA), cTnI, and NT-proBNP in 358 patients within a group of 1000 patients with PsD. For more than 15 years cTnI has been known as a reliable marker of cardiac muscle tissue injury. In addition, NT-proBNP levels in the blood are used for screening, diagnosis of acute congestive heart failure, and may be useful to establish prognosis in heart failure, as this marker is typically higher in patients with worse outcome. The plasma concentrations of NT-proBNP is also typically increased in patients with asymptomatic or symptomatic left ventricular dysfunction and is associated with coronary artery disease and myocardial ischemia. Results obtained in the current study showed that cTnI and NT-proBNP were associated with TPA. After adjusting for CV risk factors, the association remained statistically significant for cTnI but not NT-proBNP. Among 1,000 patients with PsD assessed for CV risk prediction, 64 patients had incident CV events. “Our study provides new insights regarding

the pathophysiology of cardiovascular diseases in psoriasis and psoriatic arthritis. However, at this time, ordering tests of cardiac biomarkers is not recommended for risk stratification of asymptomatic patients with psoriatic disease,” said senior Dr. Lihi Eder, associate professor of medicine at the University of Toronto. The study was published in the March 8, 2022, online edition of the journal Arthritis & Rheumatology.

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Microbiome and Metabolome Features Characterized for the Cardiometabolic Disease Spectrum

cientists have already discovered that the gut microbiome is altered in people with chronic heart disease. They subsequently identified compounds that are produced by the diseased microbiome, for instance a bacterial compound called trimethylamine (TMA) that after modification in the liver of the human host causes arteriosclerosis. The human gut contains trillions of bacteria, collectively called the gut microbiome, which may have positive and negative effects on human health. When in balance they function as an inner chemistry factory producing numerous compounds that promote good health. However, an unhealthy lifestyle can disrupt the balance, leading the microbiome to instead produce compounds that may trigger multiple non-communicable chronic disorders in people at high genetic risk, including myocardial infarction, angina or heart failure. Scientists have already discovered that the gut microbiome is altered in people with chronic heart disease. A large team of international scientists including those at the University of Copenhagen (Copenhagen, Denmark; www.ku.dk) recruited 1,241 middle-aged people from Denmark, France and Germany including healthy individuals, individuals with obesity and type 2 diabetes, but lacking a diagnosis of heart disease, and patients with either myocardial infarction, angina pectoris or heart failure. Fasting plasma glucose, total and HDL cholesterol, triglycerides, creatinine and HbA1c levels were measured using standard enzymatic methods. Alanine aminotransferase, aspartate aminotransferase and γ-glutamyltransferase were measured by enzyme-coupled kinetic assays. Ultra-sensitive C-reactive protein was measured using an Image Automatic Immunoassay System (Beckman Coulter, Brea, CA. USA, www.beckman.com). Microbial loads of fecal samples were processed and analyzed using a C6 Accuri flow cytometer (BD Biosciences, San Diego, CA, USA; www.bdbiosciences.com). The scientists found that about 75% of microbiome and metabolome features that distinguish individuals with ischemic heart disease (IHD) from healthy individuals after adjustment for effects of medication and lifestyle are present in individuals exhibiting dysmetabolism, suggesting that major alterations of the gut microbiome and metabolome might begin long before clinical onset of IHD. They further categorized microbiome and metabolome signatures related

to prodromal dysmetabolism; specific to IHD in general or to each of its three subtypes or related to escalation or de-escalation of IHD. At higher microbiome architecture levels, there was a significant shift from the Bacteroides 1 and Ruminococcus enterotypes toward the low bacterial cell-count-associated Bacteroides 2 as the disease worsened. Oluf Borbye Pedersen, MD, A Clinical Professor and a senior author of the study, said, “We found that about half of these gut bacteria and blood compounds were modified by drug treatment and not directly related to heart disease or the early disease stages like diabetes or obesity occurring prior to diagnosis of heart disease. Among the remaining half, about 75% of the disturbances of the gut microbiome occurred in the early disease stages of overweight and type 2 diabetes, many years before patients noticed any symptoms of heart disease.” The authors concluded that at prodromal dysmetabolic stages and at both early and late clinical manifestations of IHD, multiple de-confounded microbiome and metabolome alterations are present, reflecting distinct metabolic pathways. Several of these are modifiable and might be targets for future mechanistic studies and clinical trials aiming at IHD prevention. The study was published on February 17, 2022 in the journal Nature Medicine. Image: The BD Accuri C6 Plus Flow Cytometer (Photo courtesy of BD Biosciences). LabMedica International April/2022

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

NEWS

MESSAGE FROM THE PRESIDENT By Khosrow Adeli

•

President, IFCC

y warmest greetings to everyone at IFCC. I hope you all are enjoying the arrival of Spring. To start, I would like to honour the late Professor Howard Morris, Past President of IFCC, on the third anniversary of his untimely and unfortunate passing. As a distinguished scientist, world traveler, and active service member of IFCC for over 20 years, he made many significant contributions to our organization and the field of laboratory medicine. In his memory, let us continue to carry his vision and energy forward by promoting the value of laboratory medicine in the effort to improve patient outcomes and safety in healthcare as well as public health. On that note, I am excited to remind you all of an exciting new IFCC program, the Global MedLab Week which is aimed at promoting and celebrating the value of laboratory medicine and laboratory professionals in both public health and patient care. This year’s theme will focus on the Laboratory’s Vital Role in the Global Fight against the COVID-19 Pandemic. Together, we will create global awareness among various stakeholders, including healthcare colleagues, governmental bodies, and the public, of the value of our profession in healthcare delivery. Increasing the visibility of laboratory medicine will help to increase funding to support innovation and sustainability, thereby improving both public health and patient care. The exciting new Global MedLab Week will officially launch this month at EuroMedLab 2022 in Munich from April 10-14. We are expecting thousands of registered participants, alongside our invited speakers and exhibitors, who we welcome to join us for this celebration, which will include presentations, an interactive booth, and more. Alongside this celebration, 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. Excellent social opportunities have also been organized for attendees to network while enjoying many attractions around the city. You will not want to miss this leading educational event, which will mark the first in-person meeting of this size since the beginning of the pandemic and is sure to bring together leading experts from around the world to enable meaningful scientific exchange. I look forward to seeing you there! Following the EuroMedLab 2022, I invite you all to join us at the IFCC WordLab 2022, which is taking place from June 23-30 in Seoul: the cultural, economic, and political centre of South Korea that not only has a very rich history and culture but many notable attractions. IFCC is pleased to partner with the Asia-Pacific Federation of Clinical Biochemistry (APFCB) to bring you an exciting and informative scientific program, including plenary lectures, ed-

LabMedica International April/2022

ucational workshops, satellite meetings, and poster sessions. As of April 2022, the Korean government will be removing quarantine requirements, making it easier for us all to attend this important conference. Given this great news, I urge you to register and look forward to meeting in person. A special late breaking abstract submission will also open soon to allow for submission of new presentations to the conference. As always, please feel free to email me at president@ifcc.org with your feedback, questions, or concerns.

Till next time, Khosrow

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

NEWS

Editorial By Katherina Psarra, MSc, PhD Dear colleagues, e are at the beginning of spring, but we don’t yet see it, neither in the weather, although trees and wildflowers have already blossomed, nor in spirit as the war has prevented it. But spring is here for the IFCC. The division chairs have met with the Board for the new strategic plan. A formidable, a springly plan full of activities, full of energy, has been prepared for IFCC and its members. Our president, Prof

Khosrow Adeli, is introducing it to us in his message. In this issue we learn about new and older IFCC Task Forces, Committees and WGs: Working Group on Flow Cytometry (WGFC), Committee on Kidney Disease (C-KD), Working Group on Metabolomics (WG-M), Task Force for Young Scientists (TF-YS), introduce themselves and their members, and present their plans or their recent work. It is important to be in touch with them, as new opportunities and ideas and perhaps new collaborations may arise. This issue is full of energy and photos. Welcome to the IFCC spring, dear colleagues!

IFCC to Hold Young Scientist Forum On June 25-26, Prior to WorldLab Seoul 2022 By: Dr Santiago Fares Taie; Chair, IFCC Task Force for Young Scientists Laboratorio Bioquímico, Mar del Plata, Argentina; E-mail: sfarestaie@hotmail.com

oung Scientists (YS) are the future of laboratory medicine and make up the majority of the workforce of laboratory professionals. The YS’s participation has been increasing during the last years due to increased support and visibility within the IFCC organization. Future leaders need to be trained and encouraged to succeed in their role, ideally with the support of experienced leaders. To make this feasible, YS must have activities that encourage their participation, offer opportunities for training, and improve communication and networking. For the first time, the IFCC TF-YS is organizing a Young Scientist Forum to be held as a satellite meeting one day before the IFCC WorldLab Seoul. One of the TF-YS main activities is to organize sessions or symposiums during the congresses to promote YS participation and exchange. In this opportunity, we are going one step further organizing a one-and-a-halfday activity before the start of the WorldLab congress. This activity is designed as a FORUM to encourage the participation and exchange of YS in a completely different way. Participants will have the opportunity to interact between each other and with the speakers, having open discussions about the following themes:

• The future transformation of Lab Medicine in a Time of “ Disruptive Innovations ”; • Training in our profession worldwide and networking; • Laboratory Management, Leadership & Teamwork; • Clinical Research – Best Practices for Today's Laboratory Scientists.

Each theme will have YS speakers giving lectures with TF-YS-designed activities to promote participation and debate among attendees for free and rapid exchange of ideas. Moreover, we will be scheduling virtual laboratory visits to highlight different practices of laboratory medicine worldwide and to emphasize the themes that will be discussed in the FORUM. Finally, we will have the opportunity to enrich ourselves with an onsite visit to a local laboratory in Seoul, so we can gain some perspective about different laboratory workflows and the larger role the clinical laboratory plays within the South Korean healthcare system. This is an enriching activity that has always had an excellent impact on our participants by serving as an inspiration for new ideas. We believe that this FORUM is the perfect setting to create an environment for YS to exchange experiences, learn from other colleagues, and participate in the ongoing TF-YS activities & opportunities that improve networking. We are confident it will be an unforgettable experience for all the attending YS.

LabMedica International April/2022

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

NEWS

THE WORLD OF IFCC

Second Egyptian Cytometry Workshop Held in Cairo By Dr Claude Lambert (FR); Chair, IFCC Working Group on Flow Cytometry

he second Egyptian workshop on cytometry was held on December 8-9, 2021, under the umbrella of the IFCC and Al-Azhar Faculty of Medicine in Cairo (Egypt). Organized by Dr Reham Hammad from Al-Azhar Faculty of Medicine, the course addressed the basic principles of cytometry as well as few applications like phenotyping of T-cells, apoptosis and cell death, cell cycle and proliferation, diagnosis of lymphoproliferative disorders and acute leukemia. The workshop included formal lectures in the morning and practical work in the afternoon. Lectures were conducted by Reham Hammad of Al-Azhar Faculty of Medicine as well as Eman Kandil (National Cancer Institute, Egypt) and new young talented biologists Doaa Aly and Samar Mohammed (AlAzhar Univ.), Randa Osman (NCI, Egypt). Practicals included alternatively cell labelling and analysis on a cytometer in the lab with the precious help of Ebrahim Ali. The other part included fluorochrome spectra analysis with compensation calculation and electronic data analyses on video projector. The number of participants was limited to render practical work possible especially in the context of the pandemic risk and the need to keep social distancing. Twenty-six participants came from different university hospitals in Egypt including the Russian Egyptian university and Assuit from far south of Egypt. Few were experienced in cytometry diagnosis while others were beginners. The workshop was very friendly and highly participative. Lectures raised lots of questions and discussions. After the end of the workshop attendees expressed their deep satisfaction and their regret it was too short. Next annual workshop is planned at the end of 2023 and will last longer.

LabMedica International April/2022

EGYPT

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

NEWS

IFCC Committee on Kidney Disease (C-KD): An Update Prepared by Chair: Dr. Joe El-Khoury

aboratory testing for kidney diseases is rapidly evolving. In 2021 alone, we saw two major changes affecting how we use laboratory testing to detect and diagnose Chronic Kidney Disease (CKD) and Acute Kidney Injury (AKI). In the US, new race-free equations to estimate glomerular filtration rate (eGFR) have been developed and endorsed by the National Kidney RS TO LY IBU APP R T O DIS ED T IT INV

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Foundation and the American Society of Nephrology. Medical centers nationwide are facing increased pressure to move away from the traditional equations that use race (mainly Black vs Non-Black) that have been demonstrated to cause racial inequities in access to advanced care. The effect on the rest of the world remains unclear, with some countries already using race-specific coefficients that were developed by their own scientists. The new race-free equations present an opportunity to standardize laboratory practice worldwide, as long as the equations perform well in other populations. On the AKI front, the AACC Academy released a new guidance document titled “The Laboratory Investigation of Acute Kidney Injury” providing 13 key recommendations to physicians and clinical laboratories involved in AKI testing. Of these, the recommendation to implement a new definition for AKI, called AACC AKI 20/20 (for 20 umol/L or 20% change), is most significant. This definition, based on biological and analytical variation data and correlated with poor clinical outcomes, directly challenges the existing consensus-based KDIGO definition. In addition, the emergence of structural AKI biomarkers, like TIMP2.IGFBP7, NGAL and L-FABP, receiving regulatory approvals in various countries presents a major paradigm shift, one that clinical laboratories worldwide are not ready for. All of these developments provide opportunities for the IFCC Committee on Kidney Disease (C-KD) to advise on and to support the international laboratory medicine community via the expertise of our membership. The IFCC C-KD’s primary aim is to promote, support and co-ordinate international activities related to laboratory testing in Kidney Diseases. This international committee is newly chaired by Dr. Joe El-Khoury (US) and consists of four members: Drs. Joris Delanghe (Belgium), Michele Mussap (Italy), Pradip Datta (US), and the newly appointed Graham Jones (Australia), a WASPaLM Nominee: Dr. John Eckfeldt (US), and a consultant: Dr. Flavio Alcantara (Brazil). The committee also has 22 corresponding members, of which 20 are nominated by their National Societies, and 2 are nominated by Corporate Members. The committee is pleased to welcome Dr. Aparna R. Bitla, from the Association of Medical Biochemists of India, as our newest corresponding member. More detailed information about our corresponding members and committee objectives can be found on the IFCC committee’s website: www.ifcc.org/ifcc-education-division

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 April/2022

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

LabMedica International

Blood Plasma Biomarkers Could Improve Diagnostic Tests for Alzheimer’s

lzheimer’s disease is the most common form of dementia, with the African American population at the greatest risk for developing the disease. The findings of the first study to focus on RNA molecules in plasma as biomarkers for Alzheimer’s disease in African Americans could lead to the development of improved diagnostic tests for the disease. Previous research has identified genetic risk factors for Alzheimer’s disease and established that RNA molecules in blood plasma could potentially be used as biomarkers. Now, researchers at Mayo Clinic (Jacksonville, FL, USA; www.mayoclinic.org) have pinpointed specific molecules in plasma that could serve as biomarkers to confirm a diagnosis of Alzheimer’s disease in the African American population. In their study, the researchers examined blood plasma messenger RNA molecules in 151 African Americans diagnosed with Alzheimer’s disease and 269 African Americans diagnosed as cognitively unimpaired with Clinical Dementia Rating scale scores of zero. The researchers found that when the plasma levels of six messenger RNA molecules - encoded by genes CLU, APP, CD14, ABCA7, AKAP9 and APOE - were accounted for in their statistical models, they improved their ability to accurately identify participants with an Alzheimer’s diagnosis by 8%. Researchers explain this is an improvement, compared to statistical models that account for only the presence of known risk factors, such as age and sex, and whether the person is a carrier of the APOE-e4 allele - a gene known to increase the risk of Alzheimer’s disease. The researchers predict this discovery could lead to more accurate Alzheimer’s disease screening for everyone, particularly for the people and communities at greatest risk. The researchers also predict that this discovery could contribute to the development of more accessible, minimally invasive screening options, enabling improved disease management. The researchers indicate that future research will focus on identifying additional genetic biomarkers in blood plasma that may improve the accuracy of Alzheimer’s disease diagnostic tests. “Having a comprehensive panel of biomarkers for use in screening will help with early detection of Alzheimer’s disease, and it will also contribute to intervention strategies that can delay and mitigate the onset of the disease,” said Joseph Reddy, Ph.D., a Mayo Clinic quantitative health sciences researcher and first author. “This could be especially relevant for African Americans - a population underrepresented in Alzheimer’s disease research - who were the focus of this study.” “Many screening tests for Alzheimer’s disease may not be accessible to all patients due to cost or lack of availability at health care

LabMedica International April/2022

facilities in their area,” added Minerva Carrasquillo, Ph.D., a Mayo Clinic neurogeneticist and senior author. “Some tests rely on complex imaging techniques, or on obtaining a sample of cerebrospinal fluid from the patient. Obtaining a plasma sample only

requires a blood draw, which is a routine procedure in most clinical settings.” Image: Plasma biomarker screening could improve accuracy of Alzheimer’s disease diagnosis (Photo courtesy of Pexels).

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

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

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

2022 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 EuroMedLab 2021 – 24th IFCCEFLM European Congress of Clinical Chemistry and Laboratory Medicine. Apr 10-14; Munich, Germany; euromedlab2021munich.org

MAY

105th Annual Meeting of the German Society for Pathology. Jun 9-11; Muenster, Germany; pathologie-dgp.de

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 ESPID 2022 – 40th Annual Meeting of the European Society for Paediatric Infectious Disease. May 9-13; Athens, Greece; espidmeeting.org

EHA 2022 - Annual Congress of the European Hematology Association. Jun 9-12; Vienna, Austria; ehaweb.org

74th AACC Annual Scientific Meeting & Clinical Lab Expo – American Association for Clinical Chemistry. July 24-28; Chicago, IL, USA; meeting.aacc.org

ESHG 2022 – European Human Genetics Conference. Jun 11-14; Vienna, Austria; eshg.org

FIME 2022 – Florida International Medical Expo. Jul 27-29; Miami, FL, USA; fimeshow.com

ENDO 2022 – Annual Meeting of the Endocrine Society. Jun 11-14; Atlanta, GA, USA; endocrine.org

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

KoreaLab 2022. Jun 14-17; Seoul, Korea; korealab.org

ECE 2022 – 24th European Congress of Endocrinology. May 21-24; Milan, Italy; ese-hormones.org

47th CBAC – Congress of the Brazilian Society of Clinical Analysis. Jun 19-22; Fortaleza, Brazil; sbac.org.br

ASRI 2022 – 41st Annual Meeting of the American Society for Reproductive Immunology. May 22-26; Nashville, TN, USA; theasri.org

Analitica Latin America 2022. Jun 21-23; Sao Paulo, Brazil; analiticanet.com.br Analytica 2022. Jun 21-24; Munich, Germany; analytica.de

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Inq.No.

Vol. 39 No. 2 4/2022

Inq.No.

Advertiser

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