LabMedica International October 2021 by Globetech

NOV. 28 – DEC. 2

2021 MUNICH

Vol. 38 No.6 • 10/2021

ISSN 1068-1760

MRI-Based Prostate Cancer Blood Test

rostate cancer does not usually cause any symptoms until the cancer has grown large enough to put pressure on the tube that carries urine from the bladder out of the penis (urethra). Symptoms of prostate cancer can include: needing to urinate more

DAILY CLINICAL LAB NEWS

End-to-End Digital Health Platform Automates Diagnostic Testing Process

new end-to-end digital health platform automates and simplifies diagnostic testing experience by transforming connectivity between clinical labs, providers, and patients, thus creating a testing ecosystem. PreciseMDX (Palo Alto, CA,

USA; www.precisemdx.com) has launched a cloud-based solution that automates and simplifies the diagnostic testing experience, empowering labs to deliver a transformative journey to providers and patients. PreciseMDX dramatically improves connectivity between

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CRISPR Breakthrough Could Transform Antibody Testing

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Liquid Biopsy Detects Minute Brain Tumors

blood-based liquid biopsy approach enables detection of brain tumors that are so small and low-grade that the patient will often have few or no symptoms. Due to the non-specific symptoms of brain cancer, gliomas will often remain undetected until they are larger or at a higher grade, reducing the patient’s likelihood of a good clinical outcome.

here remains a substantial burden from infectious disease in low-resource rural communities, not least as a consequence of malaria. In infectious disease diagnosis, results need to be communicated rapidly to healthcare professionals once testing has been completed so that care pathways can be implemented. Diagnostic testing continues

Lead author, Karl Barber with a PICASSO microarray I

See article on page 17

Smartphone-Based DNA Test for Malaria

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n an advance that could lead to a whole new class of clinical diagnostics, scientists have repurposed CRISPR genetic modification technology toward identifying antibodies in blood samples.

V I S I T

WORLD’S CLINICAL LABORATORY NEWS LEADER

High-Throughput PCR System Can Test Up to 150,000 COVID-19 Samples per Day

new ultra-high-throughput PCR testing system for SARS-CoV-2 detection can test up to 150,000 patient samples per day. The proven molecular genomics testing platform with unmatched capacity that has been developed by LGC, Biosearch Technologies (Hertfordshire, UK; www.biosearchtech.com) is expected

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Driven by Evolution of New SARS-CoV-2 Strains, Antigen Testing Seen to Show Rapid Growth

he global COVID-19 antigen test market is witnessing increasing demand due to the evolution of new strains of the SARSCoV-2 virus and increasing spikes in the instances of new COVID-19 infections. These are the latest findings

of Transparency Market Research (Albany, NY, USA; www.trans parencymarketresearch.com), a next-generation market intelligence provider. Products in the global COVID19 antigen test market are expected to gain traction owing to Cont’d on page 13

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INSIDE

COVID-19 Update. . . . . 4 Clinical News. . . . . . . . . 7 IFCC News. . . . . . . . . . 29 Product News . . . . . 6-26 Industry News . . . . . . . 33 Events Calendar . . . . . 34

PUBLISHED IN COOPERATION WITH

International Federation of Clinical Chemistry and Laboratory Medicine

GLOBETECH >>> MEDIA <<<

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LabMedica International

he report that follows provides a selection of news and advances announced from August 1 to September 15, 2021. For a recap of earlier developments, the reader is invited to refer to previous issues of LabMedica or visit our website at www.LabMedica.com.

ing from a menu of over 50 assays designed to screen for different variants.

New CRISPR-Based Test That Is Much Faster and Easier to Deploy than qRT-PCR Diagnoses COVID-19 in 20 Minutes

A multidisciplinary team of researchers affiliated with various institutions and led by the University of São Paulo’s São Carlos Institute of Physics (IFSC-USP; São Paulo, Brazil; www.2.ifsc.usp.br) has developed an impedance analyzer connected to DNA biosensor that can be used to detect genetic sequence from SARSCoV-2. The device has already shown to be efficient in detecting SARS-CoV-2. The result of the analysis can be ready in 30 minutes, for a laboratory-scale cost of less than USD 1 per genosensor. The components of the impedance analyzer, a durable part of the device, cost less than USD 200.

In their efforts to develop a diagnostic test that is much faster and easier to deploy than qRT-PCR, scientists at the University of California, Berkeley (Berkeley, CA, USA; www. berkeley.edu) have combined two different types of CRISPR enzymes to create an assay that can detect small amounts of viral RNA in less than an hour. While the new technique is not yet at the stage where it rivals the sensitivity of qRTPCR, which can detect just a few copies of the virus per microliter of liquid, it is already able to pick up levels of viral RNA - about 30 copies per microliter - sufficient to be used to surveil the population and limit the spread of infections. Low-Cost Tabletop Device Detects SARS-CoV-2 Variants from Saliva Sample in an Hour Researchers at the Wyss Institute for Biologically Inspired Engineering at Harvard University (Boston, MA, USA; www.wyss. harvard.edu) and the Massachusetts Institute of Technology (MIT; Cambridge, MA, USA: www.mit.edu) have created an inexpensive, CRISPR-based diagnostic test that allows users to test themselves for SARS-CoV-2 and multiple variants of the virus using a sample of their saliva at home, with no extra instrumentation needed. The diagnostic device, called Minimally Instrumented SHERLOCK (miSHERLOCK), is easy to use and provides results that can be read and verified by an accompanying smartphone app within one hour. New Antibody Test Shows Body’s Response to COVID-19 Vaccine The cPass SARS-CoV-2 Neutralization Antibody Detection Kit developed by GenScript Biotech Corporation (Piscataway, NJ, USA; www.genscript.com) helps people understand their body’s response to the COVID-19 vaccine. The new antibody test has been awarded the Federal Drug Administration (FDA) Emergency Use Authorization. The cPass test has broad implications for the general public. Thermo Fisher Updates TaqMan SARS-CoV-2 Mutation Panel to Detect Delta and Lambda Variants Thermo Fisher Scientific Inc. (Waltham, MA, USA; www.thermofisher.com) has updated its Applied Biosystems TaqMan SARS-CoV-2 Mutation Panel to detect the Delta and Lambda strains. First launched in March 2021, the research panel features a customizable menu of verified real-time PCR assays for identification of SARS-CoV-2 mutations. The panel enables laboratories to track known mutations by select-

Impedance Analyzer Connected to DNA Biosensor Enables Ultra-Fast and Cheap Detection of SARS-CoV-2

New Faster COVID-19 Test Avoids RNA Degradation and Time-Consuming Extraction Scientists at the National Institutes of Health (NIH Bethesda, MA, USA; www.nih.gov) have developed a new sample preparation method to detect SARS-CoV-2 that bypasses extraction of the virus’ genetic RNA material, thereby simplifying sample purification and potentially reducing test time and cost. The team of scientists made their discovery by testing a variety of chemicals using synthetic and human samples to identify those that could preserve the RNA in samples with minimal degradation while allowing direct detection of the virus by using quantitative reverse transcription PCR (RT-qPCR). New Electrochemical COVID-19 Test Uses Pencil Lead to Deliver 100% Accurate Results from Saliva Samples A new electrochemical test developed by researchers at the University of Pennsylvania (Philadelphia, PA, USA; www.upenn.edu) uses electrodes made from graphite – the same material found in pencil lead – to address the challenges of cost, time and accuracy associated with current COVID-19 tests. These electrodes reduce the cost to USD 1.50 per test and require only 6.5 minutes to deliver 100% accurate results from saliva samples and up to 88% accuracy in nasal samples. Infra-Red Technology Based Test Can Rapidly Predict Severe COVID-19 Scientists at the QIMR Berghofer Medical Research Institute (Brisbane, Australia; www. qimrberghofer.edu.au) and the Indian Institute of Technology (Maharashtra, India; www.iitb. ac.in) have developed a way of using infra-red technology to rapidly test which patients are most at risk of becoming severely unwell from COVID-19. In a small pilot study of COVID-19 patients in India, the test performed with 85% accuracy. The researchers hope that the test could in future be used to triage patients in areas with large outbreaks of the disease. Cont’d on page 5

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EDITORIAL BOARD

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ISSN 1068-1760 Vol.38 No.6. 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 October/2021

COVID -19 Diagnostics Update Cont’d from page 4

Dipstick-Based Test Enables Rapid Genetic Fingerprinting of SARS-Cov-2 Variants A new dipstick-based, rapid test invented by ID Genomics (Seattle, Wash., USA; www.idge nomics.com) will enable the simultaneous identification of a large number of genetic variants of the SARS-CoV-2 virus. ID Genomics has received a National Institutes of Health (NIH) grant to expedite bringing this test to market. The test will ‘fingerprint’ at once all currently known COVID19 variants of concern or interest, including Alpha, Beta, Gamma, Delta, Delta-plus, Epsilon, Lambda, etc., and offers the potential to detect the emergence of novel variants. The entire test not only can be accomplished in two hours, but also will not require expensive instrumentation, and can be rapidly deployed across epidemiological surveillance labs globally.

University of Amsterdam (Amsterdam, Netherlands; www.uva.nl) have partnered with Accessible Genomics, a group of volunteering scientists from all around the world to implement a low start-up cost genomic sequencing platform for SARS-CoV-2 monitoring for laboratories in developing countries. Genomic data can be used to identify and track variants of the virus, which helps scientists and government officials make better decisions about quarantine measures and vaccine administration. However, not all countries have access to the equipment, chemicals, and know-how to perform enough genomic sequencing to sufficiently track SARS-CoV-2 variants. Testing Saliva as Reliable as Nasal Swab and Detects 93% of COVID-19 Infections, Finds Study

A real-world trial by researchers from Beth Israel Deaconess Medical Center (Boston, MA, USA; www.bidmc.org) has demonstrated that COVID-19 tests of self-collected saliva provided comparable results to tests performed by trained healthcare professionals using Nasopharyngeal (NP) swabs. Based on their analysis, the researchers concluded that saliva tests detect 93% of COVID-19 infections in an outpatient setting. The findings could help alleviate the testing bottlenecks that haveconstrained COVID-19 testing since early in the pandemic. Seegene Receives CE-IVD Mark for Use of Combo Swab with Four COVID-19 Diagnostic Tests Seegene, Inc. (Seoul, Korea; www.seegene. com) has obtained CE marking for the use of Cont’d on page 6

New Ultrarapid COVID-19 Test Gives Highly Accurate Results Faster than PCR and LAMP Tests Researchers at the University of Birmingham (Birmingham, UK; www. birmingham.ac.uk) have confirmed the speed, accuracy and simplicity of a novel, highly sensitive testing method for COVID-19 that can be deployed at entertainment venues, airport arrival terminals, and in remote settings where clinical testing laboratories are not available. The researchers used a three way comparison study to confirm that the Exponential Amplification Reaction (EXPAR) method is just as sensitive, but faster, than both PCR and LAMP tests which are currently used in hospital settings. The Birmingham COVID-19 test, called RTF-EXPAR, gives a sample-to-signal time of under 10 minutes, even for low viral levels where current lateral flow tests are less effective. Triple COVID-19 Antibody Testing Device Indicates Prior SARS-CoV-2 Infection and If Your Vaccine Worked Mantracourt Electronics Limited (Devon, UK; www.mantracourt.com) helped engineer a new seven-minute COVID-19 antibody testing device that was designed by Attomarker Ltd. (Exeter, UK; www.attomarker.com) and will tell people whether they have immunity against coronavirus and whether that immunity comes from developing antibodies after infection or the vaccine. Low Cost Portable Genomic Sequencing Platform to Help Labs in Developing Countries Track SARS-CoV-2 Variants Scientists at the Philippine Genome Center Mindanao (Davao, Philippines; www.pgc.upmin.edu.ph) and the

LabMedica International October/2021

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SARS-COV-2 (N1 + N2) RT PCR TEST CERTEST BIOTEC

GIARDIA/CRYPTOSPORIDIUM ANTIGEN TEST TECHLAB

AUTOMATED BODY FLUID CELL COUNT CONTROL STRECK LABORATORIES

The VIASURE SARS-CoV-2 (N1 + N2) Real Time PCR Detection Kit for BD MAX System is an automated real-time RT-PCR test designed for the qualitative detection of RNA from the SARS-CoV-2 in respiratory samples.

The GIARDIA/CRYPTOSPORIDIUM QUIK CHEK test is a rapid membrane enzyme immunoassay for simultaneous qualitative detection and differentiation of Giardia cyst antigen and Cryptosporidium oocyst antigen in a single test device.

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

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COVID -19 Diagnostics Update

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Advanced Lab-On-Chip Optical Biosensors Offer Fast, Efficient Point-Of-Care COVID-19 Testing

Combo Swab, a self-collection device with four diagnostic assays. Combo Swab is a user-friendly swab designed for efficient specimen collection at scale in which patients can easily collect specimen from their nasal and oral cavity under the supervision of a healthcare professional. With the CE-IVD mark, the Combo Swab can be now used with Seegene’s four COVID-19 diagnostic assays, including Allplex SARS-CoV-2 Assay, Allplex SARS-CoV-2 Master Assay, Allplex SARS-CoV-2 Variants I Assay, and Allplex SARSCoV-2/FluA/FluB/RSV

Advanced lab-on-a-chip optical biosensors can enable fast accurate point of care COVID-19 diagnosis, according to researchers from the University of Texas at Austin (Austin, TX, USA; www.utexas.edu) and Omega Optics Inc. (Austin, TX, USA; www.omegaoptics.com). The researchers investigated the opportunities and challenges in developing rapid COVID-19 sensing techniques. Without the prospect of herd immunity on the immediate horizon, speedy detection for COVID-19 remains imperative for helping to curb the pandemic. Point-of-care testing that can provide immediate results is an urgent need. One of the most promising solutions to accurate rapid testing is using optical biosensors.

New Microchip-Based Diagnostic System Rapidly Measures Amount of SARS-CoV-2 Antibodies in Blood

First Ever COVID-19 Portable Sweat Test Device Delivers Results in 30 Seconds

Researchers at the RIKEN Center for Emergent Matter Science (CEMS; Saitama, Japan; www.riken.jp) have developed a diagnostic system that can rapidly and sensitively measure the amount of antibodies in the blood that can protect us from SARS-CoV-2, the virus that causes COVID-19. The diagnostic system for on-site measurement of antibodies against the COVID19 virus is expected to enable efficient and precise testing of SARS-CoV-2 vaccine efficacy at medical facilities.

Researchers at Chulalongkorn University (Bangkok, Thailand; www. chula.ac.th) have successfully developed, for the first time, a quick and easy-to-use portable sweat test device for COVID-19 to detect specific scents in sweat caused by bacteria. Sample collection only takes 15 minutes per person, and the results can be obtained in 30 seconds. The sweat test is now being used in community screening. The test is based on the success of the “COVID-19 Sniffer Dogs” project that uses sweat sniffer dogs to detect asymptomatic COVID-19 cases in the community.

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Rapid SARS-CoV-2 T-Cell Test Reveals Full Picture of Body’s Immune Response to COVID-19 Researchers from the Duke-NUS Medical School (Singapore; www.dukenus.edu.sg) have discovered a simple and rapid method to measure the T-cell immune response to the SARS-CoV-2 virus, which causes COVID-19. The test to show the full picture of body’s immune response to COVID-19 offers a rapid way to track an elusive part of the immune system, paving the way for better vaccine strategies. Global COVID-19 Saliva-Based Screening Market to Continue Growing due to Ease of Use and Shorter Test-To-Result The global COVID-19 saliva-based screening market was valued at over USD 1.7 billion in 2020 and is gaining traction, as it is patient-friendly, easy to use, and has a shorter test-to-result timeline. However, the market for COVID-19 saliva-based screening products is expected to gradually decline over the years due to increasing focus on vaccination across countries, support from developing countries to supply vaccinations to underdeveloped countries, and the population attaining herd immunity. These are the latest findings of Persistence Market Research (New York City, NY, USA; www. persistencemarketresearch.com), a market research company.

COVID-19 Test Combines Label-Free Microscopic Imaging and AI to Deliver Fast and Accurate Results A new COVID-19 test developed by researchers from the Beckman Institute for Advanced Science and Technology at the University of Illinois at Urbana-Champaign (Champaign, IL, USA; www.illinois.edu) combines label-free microscopic imaging with artificial intelligence (AI) to quickly detect and classify the SARS-CoV-2 virus. The researchers paired microscopy with AI to develop the new COVID-19 test that is fast, accurate, and cost-effective. First Instrument-Free COVID-19 RT-PCR Test Granted FDA EUA for Pooled Samples The first instrument-free PCR test from Visby Medical (San Jose, CA, USA; www.visbymedical.com) to detect the SARS-CoV-2 virus can now be used to pool up to five patient samples using a single test. Visby Medical’s instrument-free Reverse Transcription (RT)-Polymerase Chain Reaction (PCR) COVID-19 test has been granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for testing pooled patient samples in high-complexity Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories. LabMedica International October/2021

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LabMedica International

Circulating Adipokine Possible Biomarker for Severity of Interstitial Lung Disease

circulating adipokine (a cytokine chemical messenger produced by adipose tissue) has been identified as a possible biomarker associated with the severity of systemic sclerosis-associated interstitial lung disease. While interstitial lung disease (ILD) is the leading cause of morbidity and mortality in systemic sclerosis (SSc), few predictive markers have been discovered, which can be used to assess progression of the disease. Based on previous studies demonstrating that adipose tissue metabolism and adipokine homeostasis was dysregulated in Ssc, investigators at the University of Michigan (Ann Arbor, USA; www. umich.edu) sought to determine the association and predictive ability of the novel adipokine C1qTNF-Related Protein 9 for Ssc-ILD. C1qTNF9, also known as CTRP9, is one of several adiponectin/ Acrp30 paralogs which comprise the C1q and TNF-related protein family. All family members share a modular organization comprising a short variable region, a collagenous domain, and a C1q-like globular domain. CTRP9 is a 40 kiloDalton glycoprotein that contains multiple hydroxylated proline residues in its collagenous region. It circulates as a homotrimer and higher order multimers as well as in heterotrimers with adiponectin. It is preferentially expressed in adipose tissue and plays a role in glucose homeostasis. For this retrospective study, the investigators analyzed data from 110 patients with interstitial lung disease and scleroderma. They determined serum levels of CTRP9 and collected clinical and lung function data every 12 months over a four-year period. Results indicated that elevated circulating CTRP9 was associated with worse lung function, but that low CTRP9 levels identified patients with stability of lung disease with reasonable accuracy. These findings suggest that CTRP9 may be a potential biomarker in SScassociated ILD. “Despite interstitial lung disease being the leading cause of death among scleroderma patients, there are very few markers that predict progression of the disease,” said senior author Dr. John Varga, chief of the division of rheumatology at the University of Michigan. “CTRP9 is an entirely novel biomarker that has never been implicated in scleroderma. It will help physicians predict the course of the disease and identify those patients who would not need to be on aggressive treatment for their lung disease.” “The results from the new study add to the collection of biomarkers that could help for classification and treatment prediction for peo-

LabMedica International October/2021

ple living with scleroderma-associated lung disease,” said Dr. Varga. “We look forward to future studies that validate and expand upon this work.” The study was published in the July 12, 2021, online edition of the journal Arthritis Care & Research.

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THIRD PARTY IMMUNOASSAY QC

LANCING DEVICE

GLASSWARE WASHER

The Multichem IA Plus is a consolidated third party immunoassay QC material that consolidates over 90 analytes into a single product. It increases laboratory efficiencies by reducing handling time and lot evaluation time.

The Autolet Plus is an intuitive lancing device that is comfortable and easy for the user. It automatically primes during lancet insertion and has a mechanism for quick release of the lancet to simplify the lancing process.

FlaskScrubber Vantage Series Glassware Washers have specialized features for contamination-sensitive research. They are designed to wash and dry narrow-neck and general purpose glassware.

TECHNOPATH CLINICAL DIAGNOSTICS

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OWEN MUMFORD

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Liquid Biopsy Detects Minute Brain Tumors

Cont’d from Cover

Earlier detection and diagnosis of brain tumors is vital to improve patient outcomes, leading to safer surgeries and earlier treatments. In this regard, investigators at the University of Strathclyde (Glasgow, United Kingdom; www.strath.ac.uk) and the biotech company Dxcover Limited (Glasgow, United Kingdom; www.dxcover.com) developed a Multi Cancer Early Detection (MCED) Platform based on a spectroscopic liquid biopsy approach for detection of small and low-grade gliomas. This approach combined attenuated total reflection (ATR)-Fourier transform infrared (FTIR) spectroscopy coupled with supervised learning methods and machine learning algorithms for the analysis of dried blood samples. The current study was carried out on a cohort of 177 patients (90 patients with high-grade glioma (glioblastoma (GBM) or anaplastic astrocytoma), or low-grade glioma (astrocytoma, oligoastrocytoma, and oligodendroglioma). Tumor volumes were calculated from magnetic resonance imaging (MRI) investigations and patients were split into two groups depending on MRI parameters. Combining the spectroscopy technology with supervised learning methods and machine learning algorithms, 90 tumor patients were stratified against 87 control patients who displayed no symptomatic indications of cancer, and were classified as either glioma or non-glioma. Results revealed that sensitivities, specificities, and balanced accuracies were all greater than 88%, the area under the curve (AUC) was 0.98, and cancer patients with tumor volumes as small as 0.2 cubic

centimeters were correctly identified. Senior author Dr. Matthew Baker, chief technical officer of Dxcover Limited, said, “This breakthrough is a watershed moment in the development of early cancer detection. The study demonstrates the effectiveness of our Dxcover Brain Cancer Liquid Biopsy at detecting even the smallest brain tumors, which is great news for the care of future brain cancer patients, increasing treatment options and potentially extending life expectancy. Clinical tests like this are a crucial part of Dxcover’s journey to develop and commercialize a widely accepted Multi-Cancer Early Detection platform to help save lives.” The liquid biopsy for early glioma detection was described in the July 30, 2021, online edition of the journal Cancers. Image: Highly effective early diagnostic tests could revolutionize cancer detection. Here, a sample is dropped onto a disposable Dxcover Slide and dried for analysis. (Courtesy of Dxcover Limited)

Insulin Resistance and T2D Associated with Gut Microbial Diversity

ype 2 diabetes (T2D) is a common complex metabolic disorder. Currently, more than 380 million people live with type 2 diabetes globally, and this number is expected to increase to more than 550 million by 2030. Differences in gut microbiome composition with T2D status may comprise pathways on how dietary and other environmental factors affect development of insulin resistance and T2D. Patients with T2D have a lower overall α diversity of gut microbiome composition than healthy people.

A multidisciplinary international team of scientists led by those at the Erasmus University Medical Center (Rotterdam, the Netherlands; www.erasmusmc.nl) examined associations of gut microbiome composition with insulin resistance and T2D in a large population-based setting controlling for various sociodemographic and lifestyle factors. The team carried out a cross-sectional analysis included 2,166 participants from two Dutch population-based prospective cohorts. The investigators used an automated stool DNA isolation kit (Diasorin, Saluggia, Italy;

www.diasorin.com) to isolate bacterial DNA. The V3 and V4 hypervariable regions of the bacterial 16S ribosomal RNA gene were amplified and sequenced on the MiSeq platform (Illumina, San Diego, CA, USA; www.illumina. com). Serum insulin was measured by electrochemiluminescence immunoassay technology. In one study, glucose levels were measured by hydrogen 1 nuclear magnetic resonance, and serum insulin was measured on an architect system (Abbott Laboratories, Lake Forest, IL, USA; www.abbott.com). Associations Cont’d on page 18 LabMedica International October/2021

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POC ANALYZER

YELLOW FEVER IGG/IGM ASSAY

POCT ANALYZER

The Epithod 616 is a semi-automatic analyzer for point-of-care testing to measure HbA1c, Glycated Albumin, CRP, Hemoglobin, μ-Albumin, COVID-19 Antibody (IgM/IgG), and Antigen.

The yellow fever IgG/IgM is a chromatographic immunoassay kit for rapid, qualitative, and differential determination of yellow fever IgG/IgM. It requires serum, plasma, whole blood specimen, with testing time of 5 to 10 minutes.

HUBI-TAS is a POCT analyzer based on Humasis' proprietary technology that can simultaneously and quantitatively analyze up to six markers within 15 minutes using a small amount of blood in the field.

DXGEN

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HUMASIS

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MRI-Based Prostate Cancer Blood Test Cont’d from Cover

frequently, often during the night needing to rush to the toilet. Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man’s blood. Stockholm3 is a blood test that combines protein markers, genetic markers and clinical data with an advanced algorithm in order to detect aggressive prostate cancer at an early stage. Medical Scientists at the Karolinska Institutet (Stockholm, Sweden; www.karolinska.se) carried out a prospective, population-based, randomized, open-label non-inferiority trial that included 12,750 men ages 50 to 74. Of these, 2,293 were considered to have an elevated risk of prostate cancer (i.e., a PSA level ≥3 ng/mL or a Stockholm3 score ≥0.11) who were randomized 2:3 to either the standard group (systematic prostate biopsies) or the experimental group (biparametric MRI followed by MRI-targeted and systematic biopsy in MRI-positive men). The investigators found that the area under the receiver-operating characteristic curve for detection of clinically significant prostate cancer was 0.76 for Stockholm3 and 0.60 for PSA. In the experimental group, a Stockholm3 of 0.11 or higher was non-inferior to a PSA of 3 ng/ mL or higher for detection of clinically significant prostate cancer (227 versus 192; relative proportion [RP] 1.18, and also detected a similar number of low-grade prostate cancers (50 versus 41; RP 1.22) and was associated with more MRIs and biopsies. Compared with PSA of 3 ng/mL or higher, a Stockholm3 of 0·15 or higher provided identical sensitivity to detect clinically significant cancer, and led to fewer MRI procedures. Compared with screening using PSA and systematic biopsies, a Stockholm3 of 0.11 or higher combined with MRI-targeted and systematic biopsies was associated with higher detection of clinically significant cancers (227 [3.0%] men tested versus 106 [2.1%] men tested; RP 1.44, lower detection of low-grade cancers (50 [0.7%] versus 73 [1.4%]; RP 0.46, and led to fewer biopsy procedures. Martin Eklund, PhD, an Associate Professor and a co-author of the study, said, “Compared with the traditional PSA-based diagnostic strategy, we showed that the novel strategy of combining the Stockholm3 test and an MRI-targeted biopsy approach is associated with a 69% reduction in the rate of overdetection, while maintaining the sensitivity to detect clinically significant prostate cancer.” The authors concluded the Stockholm3 test can inform risk stratification before MRI and targeted biopsies in prostate cancer screening. Combining the Stockholm3 test with an MRI-targeted biopsy approach for prostate cancer screening decreases over-detection while maintaining the ability to detect clinically significant cancer. The study was published on August 12, 2021in the journal Lancet Oncology. LINKXPRESS COM

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CENTRIFUGE EPPENDORF

MOLECULAR & IMMUNOASSAY DIAGNOSTIC ANALYZER RANDOX

D-DIMER ELISA KIT MONOBIND

The Centrifuge 5910 Ri is a refrigerated benchtop Centrifuge featuring a 7-inch VisioNize touch interface with an intuitive user experience that provides fast and error-free operation, ensuring efficient and reproducible runs.

The Randox Discovery is a molecular & immunoassay diagnostic analyzer capable of consolidating the normal workload of multiple laboratories, into one compact benchtop platform. It uses Randox patented Biochip Technology.

The D-Dimer AccuBind ELISA Kit is intended for the quantitative determination of D-Dimer concentration in human plasma or serum by a microplate enzyme immunoassay, colorimetric for disease monitoring, including DVT, PE and COVID-19.

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End-to-End Digital Health Platform Automates Diagnostic Testing Process

Cont’d from Cover

clinical labs, providers, and patients during every step of the diagnostic testing process for any type of test. The first-of-its-kind platform enables labs of any size to quickly and seamlessly set up rapidly scalable, personalized, digital experiences that providers and patients expect in this post-pandemic era where consumer adoption of virtual care has skyrocketed. The unexpected volume of COVID-19 testing has exposed the costs and risks associated with manual data management. PreciseMDX replaces manual data entry with an automated flexible end-to-end solution that works seamlessly with any LIS or LIMS, allowing labs to scale their business and streamline workflow, resulting in significant time and cost savings. PreciseMDX is designed to eliminate complexity for all users - from scheduling and check-in to coordinating on-site or at-home testing to results notification and reporting. Labs receive step-by-step user onboarding, and easily customizable test orders management software - all from the cloud, allowing for deployment in days, not weeks or months. The PreciseMDX solution supports any type of diagnostic test, including: women’s & men’s health (fertility, prenatal, cancer, testosterone), sexual health (STIs, HPV, UTI), wellness/nutrition (nutrition DNA kit, food allergy/intolerances), COVID-19 testing, respiratory, nail fungal wound panels, and vaccines. “The scramble to ramp up testing during COVID-19, exposed a need

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in the healthcare industry for an automated diagnostic testing experience so that labs can scale rapidly, patients can have control over the process and receive results quickly, and providers can treat patients quicker with a faster, more connected system,” said Mark Dorner, co-Founder & Chief Executive Officer of PreciseMDX. “We saw this need and created a technology to completely transform the diagnostic testing experience to one that is automated, simple, and user friendly. Today, this is what patients expect.”

Smartphone-Based DNA Test for Malaria

to underpin control and prevention strategies, primarily through the use of rapid, point-of-care, lateral flow immunoassays, which are affordable, sensitive, specific, user-friendly, rapid and robust, equipment-free and deliverable devices. This represents a particular challenge when testing in remote, low-resource rural communities, in which such diseases often create the largest burden. Bioengineers at the University of Glasgow (Glasgow, UK; www.gla. ac.uk) and their colleagues developed a smartphone-based end-to-end platform for multiplexed DNA diagnosis of malaria. The diagnostic platform comprises both hardware and software. The hardware includes a three-dimensional (3D) printed mobile heater for loop-mediated isothermal amplification (LAMP)-based diagnostics as well as a mobile phone and a low-cost disposable sensor cartridge, while the software includes an Arduino program, an Android app and a Hyperledger blockchain network. The team field tested the platform on blood samples collected from 40 school children from Uganda, and compared their results with the

gold-standard PCR assay. The team also used malaria rapid immunodiagnostic tests (RDT) for comparison. The scientists reported that of the 28 tests that were correctly assigned and valid, 16 were true positives (positive for the manually recorded test, the blockchain records and real-time PCR), six were true negatives, three were false negatives and three were false positives (with respect to the gold standard). The blockchain implementation ensured the security of transactions, opening up the possibility for integration into surveillance databases, while maintaining the required safety around data privacy. The authors concluded that the smartphone-based end-to-end platform they had developed for multiplexed DNA-based lateral flow diagnostic assays that can be used in remote, low-resource settings. Their decision support tool provides automated detection of the results and their analysis, supporting human expertise, and transactions involved in data handling are secured, trusted and endorsed using blockchain technology. The study was published on August 2, 2021 in the journal Nature Electronics. LabMedica International October/2021

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LabMedica International

Zika IgM Antibody Found in West Nile Virus Patients

est Nile virus (WNV) and Zika virus (ZIKV) are mosquito-borne viruses in the family Flaviviridae. Residents in, and travelers to, areas where the viruses are circulating are at risk for infection, and both viruses can cause an acute febrile illness. In the contiguous USA, WNV disease is the most commonly reported arboviral disease, with about 2,000 to 6,000 reported cases each year. WNV disease presentations range from mild febrile illness to severe neuroinvasive disease. Almost all ZIKV disease cases in the continental USA are travel associated. Vector Borne Disease experts at the Centers for Diseases Control and Prevention (CDC, Fort Collins, CO, USA; www.cdc. gov) included serum samples from 153 persons with confirmed recent WNV infection in their analysis. The median age of patients was 59 years (range 10–92 years) and 53 (35%) were female. Samples were collected at a median of seven days (range 0–40 days) after symptom onset. Serum samples were tested for the presence of ZIKV IgM antibody with CDC’s envelope protein antigen-based ZIKV IgM antibody capture-ELISA (Zika MAC-ELISA). A P/N value <2.0 was interpreted as negative, a P/N from 2.0 to <3.0 was equivocal, and a P/N ≥ 3.0 was positive.

The scientists reported that among 153 sera from patients with acute WNV infection, the ZIKV IgM antibody result was positive in 56 (37%; 95% confidence interval [CI] 29–44%) and equivocal in 28 (18%; 95% CI 13–25%). With 55% of samples having cross-reactive antibodies, it is important for health care providers to request appropriate testing based on the most likely cause of a patient’s possible arboviral infection considering their clinical symptoms and signs, travel history, and place of residence. Patients were significantly more likely to have a ZIKV IgM antibody-positive or equivocal result if their sample had both WNV and St. Louis encephalitis virus (SLEV)-neutralizing antibodies, compared with patients with samples with only WNVneutralizing antibodies (relative risk = 2.1), and this association was not modified by nor required adjustment for sex. The authors concluded that for cases where the epidemiology does not support the preliminary IgM findings, confirmatory neutralizing antibody testing should be performed. These measures will avoid an incorrect diagnosis of ZIKV infection, based on cross-reactive antibodies, in a person truly infected with WNV. The study was published on July 22, 2021 in the journal Vector-Borne and Zoonotic Diseases.

Image: The Zika IgM antibody-capture, enzyme-linked immunosorbent assay (Zika MAC-ELISA) for antibody testing (Photo courtesy of the Centers for Diseases Control and Prevention).

Driven by Evolution of New SARS-CoV-2 Strains, Antigen Testing Seen to Show Rapid Growth Cont’d from Cover

their benefits such as shorter test-to-result timeline, as well as their patient-friendly and easy-to-use nature. Furthermore, scalability and timeline challenges regarding PCR testing for the SARS-CoV-2 virus are among the major factors resulting in increased uptake of products in the global COVID-19 antigen test market. Moreover, the emergence of several COVID-19 variants in countries such as Brazil, the UK, and South Africa has intensified the requirement for enhanced and rapid testing products, thus fueling the growth of the global COVID-19 antigen test market. Increasing concerns over the frequency as well as spread of these variants are also anticipated to favor the expansion of the global COVID-19 antigen test market. Furthermore, increased demand for low cost rapid test kits for conducting large scale testing in order to control the spike in COVID-19 cases in various underdeveloped economies is also expected to favor the expansion of the global COVID-19 antigen test market over the coming years. Additionally, the rising number of product approvals as well as emergency use authorizations by regulatory bodies, coupled with various technological collaborations between several operating entities, is expected to intensify the competitive landscape of the

LabMedica International October/2021

global COVID-19 antigen test market, going forward. Geographically, Asia Pacific is anticipated to account for the largest share of the global COVID-19 antigen test market in terms of revenue, mainly due to the strong presence of various regional and local players who are actively innovating newer antigen tests, as well as the introduction of various new products by several up and coming start-ups in the region.

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NOVEL CORONA VIRUS (SARS-COV-2) AG RAPID TEST KIT BIOPERFECTUS

AUTOMATED HEMATOLOGY ANALYZER TECO DIAGNOSTICS

SARS-COV-2 VARIANTS ASSAY SEEGENE

Bioperfectus Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasopharyngeal swabs.

The TC-Hemaxa 1000 is a fully automated three-part differential hematology analyzer that checks for 19 parameters + 3 histograms and has a throughput of 60 samples per hour.

The Allplex SARS-CoV-2 Variants II Assay is intended for the simultaneous detection of four mutation sites in S gene for identification of SARSCoV-2 variants.

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Blood-Based Liquid Biopsy Combined with Machine Learning Diagnoses Early Lung Cancer

novel liquid biopsy that collects fragments of circulating tumor DNA combined with advanced machine learning technology was able to detect over 90% of lung cancers in samples from nearly 800 individuals with and without the disease. Investigators at Johns Hopkins Medicine (Baltimore, MD, USA; www. jhmi.edu) debuted the field of fragmentomics as the basis for lung cancer diagnosis. Fragmentomics studies the physical properties of circulating cell-free DNA fragments. DNA is packaged abnormally in cancer cells, resulting in abnormal fragment patterns when cancer cells die and release their DNA into the bloodstream. Cell-free DNA fragments in the blood can indicate the presence of cancer and suggest its likely location in the body. Advanced machine learning (artificial intelligence) technology was used to compare an individual’s cell-free DNA patterns against populations with and without cancer. The technology, called DELFI (DNA evaluation of fragments for early interception), used millions of data points to identify both the presence of cancer and its tissue of origin. For the current study, the investigators, working with colleagues in

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Denmark and the Netherlands, first performed genome sequencing of cell-free DNA in blood samples from 365 individuals participating in a seven-year Danish study called LUCAS. They validated the cancer detection model using the DELFI approach on an independent cohort of 385 Cont’d on page 23

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AUTOMATED PROCALCITONIN (PCT) TEST FUJIREBIO

SARS-COV-2 MULTIPLEX REAL-TIME RT-PCR ASSAY EUROFINS

URINE STRIP READER BIOTRON DIAGNOSTICS

Lumipulse G BRAHMS PCT immunoreaction cartridges are for in vitro diagnostic (IVD) use with a two-step sandwich immunoassay method on the LUMIPULSE G system for the quantitative determination of procalcitonin (PCT).

The CE-marked GSD NovaPrime Plus SARS-CoV-2 is intended for the qualitative detection of SARS-CoV-2 and the simultaneous discrimination of B.1.1.7 (Alpha), B.1.351 (Beta), and B.1.1.248 (P.1) (Gamma) lineages in one reaction.

UROFAST-720 is a semi-automated and CLIA-waived urine strip reader that can do 500 tests per hour with 2000 test memory. The space-saving design features patient ID, LIS capability, flip screen, and 110/220 volt compatibility.

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Molecular Assays Compared for MRD Detection in B-ALL

-cell precursor acute lymphoblastic leukemia (B-ALL) is the most common malignancy in children, and it may be associated with gene alterations that regulate B-cell development. The prognostic significance of minimal residual disease (MRD) in children with acute lymphoblastic leukemia (ALL) has been demonstrated. Two quantitative polymerase chain reaction (qPCR) based-methods, for clonal immunoglobulin or T-cell receptor gene (Ig/TCR) rearrangements and for fusion transcripts, are widely used for the measurement of minimal residual disease (MRD) in patients with B-precursor acute lymphoblastic leukemia (B-ALL). A large team of Hematology Oncologists at Chang-Gung Memorial Hospital (Taipei, Taiwan; www.chang-gung.com) and their colleagues collected bone marrow samples at diagnosis and at different time points after therapy from patients with B-ALL. The diagnostic bone marrow (BM) mononuclear cells (MNC) were immediately enriched by FicollHypaque density gradient centrifugation, subjected to RNA extraction by using Trizol reagent (Invitrogen Corporation, Carlsbad, CA, USA; www. thermofisher.com), and then followed by using RT-PCR assays to detect the major fusion transcripts for diagnostic work up and risk stratification. The MRD of bone marrow samples from 165 patients carrying the

three major fusion transcripts including 74 BCR-ABL1, 54 ETV6-RUNX1, and 37 TCF3-PBX1 were analyzed by using the two qPCR-based methods. Complementary DNA (cDNA) was synthesized by using the Invitrogen Superscript II Rnase H2 reverse transcriptase kit with random hexamer. RT-qPCR with TaqMan assay for the measurement of the three major fusion transcripts was performed with ABL1 gene as internal control on the ABI 7700 (before 2009) or 7900 (after 2009) (Applied Biosystems, Foster City, CA, USA; www.thermofisher.com). BIOMED-2 consensus primers for heteroduplex analysis were used to amplify the Ig or TCR locus on gDNA. The coefficient correlation of both methods was good for TCF3-PBX1, and BCR-ABL1 (ALL and moderate for ETV6-RUNX1). The concordance was perfect for TCF3-PBX1 ALL (97.2%), substantially concordant for ETV6-RUNX1 ALL (87.1%), and only moderate for BCR-ABL1 ALL (70.6%). The discordant MRD, positive for only one method with a difference greater than one log, was found in four of 93 samples (4.3%) with ETV6-RUNX1, 31 of 245 samples (12.7%) with BCR-ABL1, and none of TCF3-PBX1 ALL. None of the eight non-transplanted patients with BCRABL1-MRD (+)/Ig/TCR-MRD (-) with a median follow-up time of 73.5 months had hematologic relapses. The authors concluded that their results demonstrated that each fusion transcript had a trend of specific VH usage. Excellent MRD concordance between the two qPCR-based methods in TCF3-PBX1 ALL indicated that RT-qPCR is the most cost-laboriousness-effective method for TCF3-PBX1 ALL whereas Ig/TCR-qPCR is a more reliable method to guide MRDadapted therapy in BCR-ABL1 ALL. The study was published on July 25, 2021 in The Journal of Molecular Diagnostics Image: The SuperScript III Reverse Transcriptase (RT) kit provides increased specificity with gene-specific primers (GSPs) and the highest cDNA yield of all RTs (Photo courtesy of Thermo Fisher Scientific).

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CRISPR Breakthrough Could Transform Antibody Testing

cientists at Harvard Medical School (Boston, MA, USA; www.hms.har vard.edu) and Brigham and Women’s Hospital (Boston, MA, USA; www. brighamandwomens.org) have repurposed the genetic modification technology CRISPR to identify antibodies in patient blood samples in a move that could inspire a new class of medical diagnostics in addition to a host of other applications. The technology involves customizable collections of proteins which are attached to a variant of Cas9, the protein at the heart of CRISPR that will bind to DNA but not cut it as it would when used for genetic modification. When these Cas9-fused proteins are applied to a microchip sporting thousands of unique DNA molecules, each protein within the mixture will

High-Throughput PCR System Can Test Up to 150,000 COVID-19 Samples per Day

Cont’d from Cover

to redefine large-scale COVID-19 testing. For labs ready to scale to support mass testing, the company is offering the ultra-high-throughput (uHTP) end-point PCR testing system for SARS-CoV-2 detection. The Biosearch Technologies workflow combines the Nexar industrial scale, automated end-point PCR testing platform with our robust, high-quality testing reagent components. UgenTec’s FastFinder software seamlessly integrates with the company’s instrumentation to provide full traceability of the sample down to individual wells on the Array Tape consumable, which allows the user to easily pull up a sample’s status. Biosearch Technologies’ SARS-CoV-2 testing workflow can expand testing capacity to as many as 150,000 samples per day with minimal need for additional staff, instrumentation, or lab space. Biosearch Technologies’ SARSCoV-2 testing system is good for screening symptomatic and asymptomatic individuals. It is compatible with anterior nares specimens self-collected in a non-medical setting or by a healthcare professional within a healthcare setting. The system features an easy dry swab collection device that is safe for handling, better for shipping, and automation-friendly. Biosearch Technologies’ SARS-CoV-2 testing workflow features an extraction-free process without compromising sensitivity of a 250 cp/swab limit of detection (LoD).

LabMedica International

LabMedica International October/2021

self-assemble to the position on the chip containing its corresponding DNA sequence. The researchers have called this technique ‘PICASSO’, short for peptide immobilization by Cas9-mediated self-organization. By then applying a blood sample to the PICASSO microarray, the proteins on the microchip that are recognized by patient antibodies can be identified. The research team has demonstrated that the technology works to assemble thousands of different proteins, suggesting that it could be readily adapted as a broad-spectrum medical diagnostic tool. They used the technique to detect antibodies binding to proteins derived from pathogens, including SARS-CoV-2, from the blood of recovering COVID-19 patients.

“In this work, we demonstrated the application of PICASSO for protein studies, creating a tool that we believe could be quickly adapted for medical diagnostics,” said Dr. Karl Barber, a 2018 Schmidt Science Fellow. “Our protein self-assembly technique could also be harnessed for the development of new biomaterials and biosensors just by attaching DNA targets to a scaffold and allowing Cas9-linked proteins to bind.” “This technology has the potential to be used as a medical diagnostic tool that could, one day, provide doctors with a way to quickly determine the diagnosis and best course of treatment for each individual patient,” added Dr. Megan Kenna, Executive Director of Schmidt Science Fellows.

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SARS-COV-2/FLU A/B & RSV TEST

AUTOMATED IMMUNE ANALYZER

MOLECULAR DIAGNOSTIC SYSTEM

RespiBio Panel 3 (RBRP3) is intended for the simultaneous testing of SARS-CoV-2, Flu A/B & RSV in one simple and easy to use test. The assays are freeze dried and ready to use with inbuilt internal controls.

The UNION automated immune analyzer features a ready-to-use cartridge with a patented design and tests for more than 80 reagent parameters, including the characteristic test AMH.

The Singuway 9600 Pro molecular diagnostic system is specially designed for rapid nucleic acid testing needs in applied fields such as clinical, food, environmental and research. It can detect 16 samples at the same time.

SEROSEP

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SHENZHEN YHLO BIOTECH

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SINGUWAY BIOTECH

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Early T-Cell Precursor Lymphoblastic Lymphoma Characterized

- cell lymphoblastic lymphoma (TLLy) is an aggressive neoplasm of immature T-cell precursors and represents 25% to 30% of childhood non-Hodgkin lymphoma. Early T-cell precursor phenotype acute lymphoblastic leukemia (ETP-ALL) is a subtype of T-cell acute lymphoblastic leukemia (T-ALL) with a unique immunophenotype and genetic abnormalities distinct from conventional T-ALL. Medical Scientists at the University of Utah School of Medicine (Salt Lake City, UT, USA; https://medicine.utah.edu) assessed the incidence of ETP-LLy among a large cohort of T-LLy patients treated on the Children’s Oncology Group (COG) trial, and compared the copy number profiles of ETP-LLy and nonETP T-LLy using DNA isolated from archival formalin-fixed, paraffin-embedded (FFPE) samples. The investigators reviewed the immunophenotyping data of 218 T-LLy patients. Hematoxylin and eosin stained slides was reviewed on each case to verify at least 80% tumor cells in sections. FFPE tissue from 10 slides per case was scraped into tubes, and DNA was isolated. Genomic microarray hybridization was performed using OncoScan FFPE molecular inversion probe

single-nucleotide polymorphism assay (MIP SNP, Affymetrix/ThermoFisher, Santa Clara, CA, USA; www.affymetrix.com). Cases were considered ETP if they were CD1a−, CD8−, CD5− or weak, and expressed at least one of the following stem/myeloid markers: CD34, CD13, CD33, CD117. Non-ETP T-LLy cases selected for comparison were required to express CD1a, CD5, and CD8. The team performed single-nucleotide polymorphism array profiling on nine ETP-LLy and 15 non-ETP T-LLy cases. The scientists reported that compared with non-ETP T-LLy, ETP-LLy showed less frequent deletion of 9p (CKDN2A/B), more frequent deletion of 12p (ETV6) and 1p (RPL22), and more frequent absence of biallelic T-cell receptor γ deletions. Recurrent abnormalities previously described in ETP-ALL such as deletions of 5q and 13q and gain of 6q were not observed in ETP-LLy cases. There were no failures of therapy among the ETP-LLy subtype with a 4-year event-free survival of 100%. The authors concluded that they had established an incidence of ETP-LLy of 4% and demonstrated that ETP-LLy exhibit distinct features from non-ETP T-LLy at the genomic level including less frequent 9p deletion including CDK2A/B and more frequent

12p deletion including ETV6. They identified RPL22 deletion on 1p as a recurrent finding in ETP-LLy suggesting ribosomal biogenesis dysfunction may play a role in the pathogenesis of some ETP-LLy. Finally, the MIP SNP array may have clinical utility for assessment of T-LLy specimens, especially when only fixed tissue is available. The study was published on July 23, 2021 in the journal Blood Advances. Image: Bone marrow aspirate from a patient with Precursor T-cell Acute Lymphoblastic Leukemia (Photo courtesy of Dr. Peter Maslak, MD).

Insulin Resistance and T2D Associated With Gut Microbial Diversity

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among α diversity, β diversity, and taxa with the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and with type 2 diabetes were examined. The investigators reported that lower microbiome Shannon index and richness were associated with higher HOMA-IR (e.g., Shannon index, −0.06; 95% CI, −0.10 to −0.02), and patients with type 2 diabetes had a lower richness than participants

without diabetes (odds ratio [OR], 0.93; 95% CI, 0.88-0.99). The β diversity)was associated with insulin resistance. A total of 12 groups of bacteria were associated with HOMA-IR or type 2 diabetes. There were five taxa whose higher abundance was tied to lower prevalence of T2D:Clostridiaceae 1, Peptostreptococcaceae, Clostridium sensu stricto 1, Intestinibacter, and Romboutsia. There were seven taxa whose greater abundance was associated with lower

HOMA-IR including Christensenellaceae and Marvinbryantia. The authors concluded that higher microbiome α diversity, along with more butyrate-producing gut bacteria, was associated with less T2D and with lower insulin resistance among individuals without diabetes. These findings could help provide insight into the etiology, pathogenesis, and treatment of T2D. The study was published on July 29, 2021 in the journal JAMA Network Open. LabMedica International October/2021

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RAPID PCR DIAGNOSTIC SYSTEM

LIPID PROFILE ANALYZER

SARS-COV-2 IGG ANTIBODY TEST

The Accula System is a sample-to-answer nucleic acid PCR amplification platform for just-in-time testing, with the simplicity, convenience, and procedural familiarity of traditional rapid immunoassays.

The CLIA-waived Cholestech LDX Analyzer offers efficient and economical point of care testing for cholesterol and related lipids, and blood glucose toward immediate risk assessment and monitoring of heart disease and diabetes.

The Epithod AutoDx SARS-CoV-2 IgG test kit is in vitro diagnostic (IVD) test for the semi-quantitative detection of IgG antibody to SARSCoV-2 in human whole blood, serum, and plasma that is produced after virus infection.

THERMO FISHER SCIENTIFIC

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Exhaled Nitric Oxide and Eosinophil Count Diagnose Eosinophilic Asthma

osinophilic asthma is now recognized as an important subphenotype of asthma based on the pattern of inflammatory cellular infiltrate in the airway. Eosinophilic asthma can be associated with increased asthma severity, atopy, late-onset disease, and steroid refractoriness. Asthma is characterized by recurrent respiratory symptoms and a variable expiratory-airflow limitation, affecting approximately 334 million people worldwide. Tests to identify reversible airflow limitation are important in asthma diagnosis, but they are time-consuming and it may be difficult for patients to cooperate. Respiratory Medicine specialists at the Daping Hospital, Army Medical University (Chongqing, China; https://cqhmaen.com) conducted a retrospective cohort study on 2,349 suspected asthma cases between January 2014 and December 2019. Fractional exhaled nitric oxide (FeNO) was evaluated with an online measurement technique using a Nano Coulomb nitric oxide analyzer. FeNO results were reported as parts per billion (ppb), and FeNO measurements were performed prior to spirometry, the methacholine challenge test, and the reversibility test. The investigators took peripheral venous blood samples, and blood eosinophils (B-Eos) and leukocytes were counted using a Sysmex XN-9000 Hematology

Image: Blood film showing eosinophilic leukocytes (single cell arrowed) surrounded by red blood cells. About 50% of people with severe asthma may have elevated levels of eosinophils in their blood (Photo courtesy of Jane Liesveld, MD)

Analyzer (Sysmex, Kobe, Japan; www.sysmex.co.jp), a multifunctional automatic hematology analyzer and leukocyte classifier. B-Eos counts were reported along with other leukocyte subpopulations, and the percentage of each subpopulation was calculated. Baseline spirometry, the bronchial-provocation and bronchodilation test (BPT, BDT) were performed using a Jaeger spirometer (Erich Jaeger GmbH, Würzburg, Germany; www.erich-jaeger.com). The scientists reported that the main study population included 897 males and 1,452 females, of whom 824 patients were diagnosed with asthma. Asthmatic patients had significantly higher white blood cell counts (7.24 versus 7.05 × 109/L), B-Eos counts (306 versus 105 cells/μL), B-Eos percentages (4.5% versus 1.8%), Cont’d on page 26 LabMedica International October/2021

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LabMedica International

Automated Assays Evaluated for High-Sensitivity Thyroglobulin Measurement

hyroglobulin (Tg) is a tumor marker for differentiated thyroid carcinoma (DTC) originating from thyroid follicular cell and is an important tumor marker for therapy control. Over the past decade, assays for highly sensitive Tg measurement have become increasingly established. Differentiated thyroid carcinoma, namely papillary and follicular thyroid carcinoma, makes up about 94% of these cases. Despite the generally good prognosis of thyroid carcinoma, about 5% of patients will develop metastatic disease which fails to respond to radioactive iodine, exhibiting a more aggressive behavior. Clinical Laboratorians at the University Hospital of Essen (Essen, Germany; www.uk-essen.de) and their associate determined Tg values of 166 sera from subjects without thyroid diseases and of more than 500 sera of well-defined DTC patients. Histologically diagnosed papillary, follicular, oncocytic (Hürthle cell), or poorly differentiated thyroid carcinomas are referred to as thyroid follicular cell-derived differentiated thyroid carcinomas (DTC). The study groups were divided in separate cohorts and sub-groups. To measure the Tg the investigators compared three different assays. The Medizym Tg Rem assay (Medipan, Blankenfelde-Mahlow, Germany; www. medipan.de), which is a manual two-step sandwich immunoenzymometric assay (IEMA) with two monoclonal antibodies directed against different epitopes of the Tg molecule. For the measurement of Tg values that are above the functional measuring range of the Tg Rem assay, they used in the Medipan SELco Tg assay, a manual immunoradiometric assay (IRMA) with two monoclonal antibodies. The team also compared the Elecsys Tg II (Roche, Basel, Switzerland; www.roche.com) which is an electrochemiluminescence immunoassay (ECLIA) for the Cobas automated system which uses biotinylated monoclonal Tg-specific antibodies and monoclonal Tg-specific antibodies labeled with a ruthenium complex that form a sandwich complex with Tg molecules in the sample. The other assay was the LIAISON Tg II Gen assay was run on a LIAISON XL analyzer (DiaSorin, Saluggia, Italy; www. diasorin.com). The LIAISON XL analyzer is a fully automated chemilumi-

Image: The LIAISON XL is a fully automated chemiluminescence analyzer, performing complete sample processing as well as measurement and evaluation (Photo courtesy of DiaSorin)

Circadian Rhythm Genes Are Biomarkers for Predicting Risk of Preterm Birth

revious studies have observed an association between maternal circadian rhythm disruption and preterm birth. However, the underlying molecular mechanisms and the potential of circadian clock genes to serve as predictors of preterm birth remain unexplored. Investigators at Michigan State University (East Lansing, USA; www. msu.edu) examined the association of 10 core circadian transcripts in maternal blood with spontaneous preterm births versus full term births using a nested case-control study design. For this study, maternal blood was sampled in trimesters two-three from women with spontaneous preterm births (n = 51) and full term births (n = 106), matched for five demographic variables. Results revealed that in second trimester maternal blood, only CLOCK and CRY2 transcripts were significantly lower in spontaneous preterm births versus full term. In addition, the investigators identified 98 common pathways that were negatively or positively correlated with CLOCK and CRY2 expression. CLOCK is a gene encoding a basic helix-loop-helix-PAS transcription factor that is believed to affect both the persistence and period of circadian rhythms. The CLOCK gene plays a major role as an activator of downstream elements in the pathway critical to the generation of circadian rhythms. In mammals, the proteins coded by the CRY1 and CRY2 genes act as light-independent inhibitors of CLOCK-BMAL1 components of the circadian clock. “We were excited to discover lower mRNA levels in the CRY2 and CLOCK genes,” said senior author Dr. Hanne Hoffmann, assistant professor of animal science at Michigan State University. “Preterm births are common. If we know the mother is at risk for a preterm birth, her doctor can monitor her more closely. If we could measure women’s mRNA levels and tell them for their second or third pregnancies that

nescence analyzer that adopts a “flash” chemiluminescence technology (CLIA) with paramagnetic microparticle solid phase. TgAb determinations were performed on the Immulite 2000XPi Immunoassay system (Siemens Healthineers, Eschborn, Germany; www.siemens-healthineers.com). The scientists reported that Tg reference values from healthy subjects were up to 37.93 ng/mL (women) and 24.59 ng/mL (men) with the LIAISON Tg II Gen assay. Tg values showed good correlations in healthy subjects and patients with active tumorous disease. In contrast, Tg values in the very low range from cured thyroidectomized patients were poorly comparable between the three assays, while clinical differences between the cohorts were correctly reflected by all assays. The authors concluded that the data from their study demonstrated that with the new LIAISON Tg II Gen assay another assay running on an automated laboratory platform for measurement of Tg values ranging from the highly sensitive up to a pronounced increased level is available. In TgAb sera of DTC patients depicted different results between assays indicating different interferences of TgAb’s with assay antibodies. The study was published on July 27, 2021 in the journal Practical Laboratory Medicine

LabMedica International October/2021

they are not at risk for a preterm birth because their levels are higher (in a normal/healthy range), that would be such a comfort to the mothers who previously had a preterm birth. If I can help one baby make it to full term who was not supposed to, that would make my day.” The preterm birth study was published in the June 18, 2021, online edition of the Journal Biology of Reproduction.

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Serum YKL-40 Levels Measured in Antisynthetase Syndrome Patients

ntisynthetase syndrome (ASSD) is a rare systemic autoimmune myopathy characterized by muscle, joint, and pulmonary involvement, as well as by the presence of fever, “mechanic’s hands,” and Raynaud’s phenomenon. The protein chitinase-3-like-1 (YKL-40) is a glycoprotein secreted by inflammatory cells, including macrophages and neutrophils. YKL-40 is associated with several physiological processes, such as inflammation, cell proliferation, angiogenesis, tissue fibrosis, and tissue remodeling. Rheumatologists at the Universidade de Sao Paulo (Sao Paulo, Brazil; https://www5.usp.br) carried out a cross-sectional single-center study that took place from 2017 to 2019 and included 66 adult patients with ASSD followed up at the outpatient clinic. The patients’ mean age was 44.8 ± 11.8 years, and median disease duration

was 1.5 (0.0–4.0) years. These patients were predominantly female (82.8%) and Caucasian (73.4%). Most patients had stable disease. Muscle involvement was defined as the presence of progressive and proximal limb muscle weakness, increased serum levels of muscle enzymes, such as creatine phosphokinase (CPK), myopathic pattern on electroneuromyography, and muscle biopsy compatible with inflammatory myopathy. The scientists used a commercially available line blot test kit, the Myositis Profile Euroline Blot test kit, (Euroimmun, Lübeck, Germany; www.euroimmun.com) to identify anti-aminoacyl-tRNA synthetase autoantibodies (anti-Jo-1, anti-EJ, anti-OJ, anti-PL-7, anti-PL-12, and anti-Ro-52). The YKL-40 quantification was performed using a specific kit (Human CHI3L1 ELISA kit, RayBiotech, Peachtree Corners, GA, USA; www.raybiotech.com). The interferon

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gamma (IFN-γ) and TNF-α tests were performed using the LUMINEX 100/200x xMAP technology (Millipore, Burlington, MA, USA; www.merckmil lipore.com). Additionally, the YKL-40 expression and location were assessed in muscle tissues of three patients with ASSD, whose biopsies were taken from the vastus lateralis muscle upon diagnosis. The investigators reported that the median YKL-40 serum level was significantly higher in patients with ASSD when compared to the healthy individuals: 538.4 (363.4–853.1) pg/mL versus 270.0 (201.8–451.9) pg/mL, respectively. However, YKL-40 serum levels did not correlate with any clinical, laboratory, disease status, or therapeutic parameters, except tumor necrosis factor alpha (TNF-α) serum levels. YKL-40 was highly expressed by inflammatory cells found in muscle biopsy specimens. The authors concluded that there were high YKL-40 serum levels in patients with ASSD, and these correlated positively with TNF-α serum levels. Although other studies have shown the expression of YKL-40 in lungs of patients with various systemic autoimmune myopathies, they have shown high YKL-40 levels in inflammatory muscle tissue cells. The study was published on July 5, 2021 in the journal Advances in Rheumatology . Image: Antisynthetase Syndrome Patients with positive immunohistochemistry reaction of (A) YKL-40, (B) YKL-40 (higher magnification); (C), a specimen from a patient with antisynthetase syndrome, but without infiltrate inflammation; (D) CD68, (E) CD4, and (F) CD8 (Photo courtesy of Universidade de Sao Paulo) LabMedica International October/2021

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LabMedica International

Point-of-Care Diagnostic for G6PD Deficiency Evaluated

lucose-6-phosphate dehydrogenase (G6PD) deficiency is an inherited condition in which patients are excessively susceptible to the development of hemolytic anemia. Affected people lack the ability to tolerate biochemical oxidative stress, and red cell hemolysis is the most important clinical consequence. People with G6PD deficiency are at risk of hemolysis when exposed to certain medications, including 8-aminoquinoline drugs used to treat Plasmodium vivax malaria. The diagnosis of G6PD deficiency is made by a quantitative spectrophotometric analysis or, more commonly, by a rapid fluorescent spot test detecting the generation of NADPH from NADP. The test is positive if the blood spot fails to fluoresce under ultraviolet light. Scientists specializing in Tropical Medicine from the Amazonas State University (Manaus, Brazil; www.uea. edu.br) and their international colleagues collected venous samples were from 1,662 participants, and capillary samples were available from 1,693 participants. Microscopic examinations of thick blood slides were conducted to determine malaria diagnosis. The performance of the semi-quantitative point-of-care G6PD test, STANDARD G6PD Test (SD Biosensor, Suwon, Republic of Korea; www.sdbiosen sor.com). Both capillary and venous specimens were compared to matching G6PD values from venous specimens tested with a spectrophotometric reference assay normalized by hemoglobin. The quantitative G6PD reference assay was run in duplicate using the Pointe Scientific reagent kit (Pointe Scientific, Canton, MI, USA; www.dnb.com) on a Shimadzu UV-1800 six-cell temperature-regulated manual spectrophotometer

(Kyoto, Japan; www.shimadzu.com). Each specimen was also tested using the Trinity qualitative G6PD FST kit (G-6-PDH Screen by Spot Test, Trinity Biotech, Bray, Ireland; www.trinitybiotech.com). Hemoglobin concentration was determined within 24 hours using a KX-21N automated hematology analyzer (Sysmex, Kobe, Japan; www. sysmex.co.jp) and the HemoCue 201+ test (HemoCue AB, Ångelholm, Sweden; www.hemocue.com) and run on aliquoted venous blood in the laboratory within 24 hours of sample collection. The scientists reported that in comparison to spectrophotometry, the STANDARD G6PD Test performed equivalently in determining G6PD status in venous and capillary specimens under varied operating temperatures. Using the manufacturer-recommended reference value thresholds, the test’s sensitivity at the <30% threshold on both specimen types was 100%. Specificity was 98.6% on venous specimens and 97.8% on capillary. At the 70% threshold, the test’s sensitivity was 96.9% on venous specimens and 94.3% on capillary. Specificity was 96.5% and 92.3% on venous and capillary specimens, respectively. The authors concluded that their data showed that the STANDARD G6PD Test performed well in comparison to the spectrophotometric reference standard. The STANDARD G6PD Test is a promising tool to aid in the identification of G6PD deficiency in Brazil. The availability of this test represents an important opportunity to improve management of P. vivax malaria cases in resource-limited settings, where reliable alternatives to quantitative spectrophotometry are needed to expand access to radical cure. The study was published on August 12, 2021 in the journal PLOS Neglected Tropical Diseases.

Image: The STANDARD G6PD Test is a handheld device that delivers results in two minutes and provides a quantitative measure of G6PD activity, including in heterozygous women (Photo courtesy of SD BIOSENSOR/ PATH)

Blood-Based Liquid Biopsy Combined with Machine Learning Diagnoses Early Lung Cancer

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non-cancer individuals and 46 lung cancer patients. Results revealed that combining fragmentation features, clinical risk factors, and CEA (carcinoembryonic antigen) levels, followed by CT imaging, detected 94% of patients with cancer across stages and subtypes, including 91% of stage I/II and 96% of stage III/IV, at 80% specificity. Genome-wide fragmentation profiles across nearly 13,000 ASCL1 transcription factor binding sites distinguished individuals with small cell lung cancer from those with non-small cell lung cancer with high accuracy. “It is clear that there is an urgent, unmet clinical need for development of alternative, noninvasive approaches to improve cancer screening for high-risk individuals and, ul-

LabMedica International October/2021

timately, the general population,” said first author Dr. Dimitrios Mathios, a postdoctoral researcher at Johns Hopkins Medicine. “We believe that a blood test, or liquid biopsy, for lung cancer could be a good way to enhance screening efforts, because it would be easy to do, broadly accessible and cost-effective.” A national clinical trial of the DELFI approach is being carried out by the biotech company Delfi Diagnostics (Baltimore, MD, USA; https://delfidiagnostics.com). This trial is using the technique to evaluate 1,700 participants in the United States, including healthy participants, individuals with lung and other types of cancers. The DELFI lung cancer study was published in the August 20, 2021, online edition of the journal Nature Communications. LINKXPRESS COM

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Fluorescent Lymphocytes and Smudge Cells Explored in Infectious Mononucleosis

nfectious mononucleosis (also known as Glandular fever) is an infection most commonly caused by the Epstein-Barr virus (EBV), which is a human herpes virus. Glandular fever is not particularly contagious. It is spread mainly through contact with saliva, such as through kissing, or sharing food and drink utensils. The mono test is 71% to 90% accurate and may be used as an initial test for diagnosing infectious mononucleosis (IM). However,

the test does have a 25% false-negative rate due to the fact that some people infected with EBV do not produce the heterophile antibodies that the mono test is designed to detect. Atypical lymphocytes appear, but the heterophilic agglutination test is negative. Clinical Laboratorians at the Peking University Third Hospital (Beijing, China; (www.puh3.net.cn) enrolled in a study 62 IM patients, 67 healthy controls, 84 patients with upper respiratory tract virus infection, and 35 patients with malignant lymphoid diseases, to explore the diagnostic value of high fluorescent lymphocytes (HFLC) and smudge cells for infectious mononucleosis (IM). The complete blood counts and leukocyte differential counts were tested, and the smudge cells were manually counted. Complete blood counts including red blood cells (RBC), hemoglobin (HGB), white blood cells (WBC), and leukocyte differential count, platelet (PLT), and HFLC percentage (HFLC%) were investigated with the Sysmex XN 9000 (Sysmex Corporation, Kobe, Japan; www.sysmex.com). Manual leukocyte classification and smudge cells were counted by Sysmex DI-60. A total of 200 nucleated cells were read on each slide. The number of smudge cells seen per 100 nucleated cells was counted, and the blood smears were observed by two experienced technicians under an optical microscope. The investigators reported that the value of HFLC% and smudge cells of the IM group were significantly higher than those of healthy controls and disease controls, and the HFLC% value of IM patients was positively correlated with the number of reactive lymphocytes. When the cutoff value of HFLC% was 0.4%, and of IM was high (AUC = 0.995). When the smudge cells >2/100 nucleated cells, the diagnostic value was further enhanced (AUC = 1.000). When the cutoff value of the HFLC% was 1.2%, it effectively distinguished IM patients from upper respiratory tract virus infection patients (AUC = 0.934). When smudge cells >16/100 nucleated cells, it also has high differential diagnosis value (AUC = 0.913). The combination HFLC% and smudge cells for the differential diagnosis can be increased to 0.968. The authors concluded that HFLC% and smudge cells can be used as effective indicators in the early diagnosis and differential diagnosis of IM. HFLC% assists the diagnosis of IM with the following advantages: first, this indicator has high specificity and sensitivity for the diagnosis of IM, which can effectively avoid missed diagnosed; second, HFLC%, as one of the blood routine indicators, can be obtained directly from the automatic blood analyzer. The study was published on August 17, 2021 in the Journal of Clinical Laboratory Analysis. LabMedica International October/2021

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LabMedica International

Donor-Linked Biomarker Predicts Likelihood of Liver Transplant Success

recent paper identified a biomarker linked to the organ donor that predicts the likelihood that a transplanted liver will be accepted or rejected by the recipient of the organ. Compatibility between donor and recipient depends on the similarity of the HLA (human leukocyte antigen) proteins expressed by both. A measure of this similarity is the HLA evolutionary divergence (HED), a continuous metric that quantifies the peptidic differences between two homologous HLA alleles, reflecting the size of the immunopeptide region resented to T-lymphocytes. In this recent paper, investigators at Assistance Publique, Hôpitaux de Paris, (France; www.aphp.fr) sought to assess the potential effect of donor or recipient HED on liver transplant rejection. For this study, they accessed the medical records of 1154 adults and 113 children who had a liver transplant between 2004 and 2018. Liver biopsies were done one, two, five, and 10 years after the transplant and in case of liver dysfunction. Donor-specific anti-HLA antibodies (DSAs) were measured in children at the time of biopsy. The HED was calculated using the physicochemical Grantham distance for class I (HLA-A or

HLA-B) and class II (HLA-DRB1 or HLADQB1) alleles. Grantham’s distance depends on three properties: composition, polarity and molecular volume. According to Grantham’s distance, the most similar amino acids are leucine and isoleucine and the most distant are cysteine and tryptophan. The influence of HED on the incidence of liver lesions was analyzed through the inverse probability weighting approach based on covariate balancing, generalized propensity scores. Data obtained during the study showed that in adults, class I HED of the donor was associated with acute rejection, chronic rejection, and ductopenia of 50% or more but not with other histologic lesions. In children, class I HED of the donor was also associated with acute rejection independent of the presence of DSAs. There was no effect of either donor class II HED or recipient class I or class II HED on the incidence of liver lesions in adults and children. Thus, HED calculated from the HLA alleles of the donor had a much stronger influence on liver transplant success than HLA compatibility. The higher the HED of a donor of liver graft, the more frequent rejection, and this was completely independent of the HLA compatibility of donors and recipients.

Image: A healthy human liver. A biomarker linked to the organ donor predicts the likelihood that a transplanted liver will be accepted or rejected by the recipient of the organ (Photo courtesy of Wikimedia Commons)

Key Factors Signal Infection Risk in Alcoholic Hepatitis

lcohol-associated hepatitis (AAH) is a severe form of liver injury with mortality as high as 30%-40% at 90 days. As a result of altered immune function in AAH, bacterial infections are common and are associated with poor outcomes. Severe cases of AAH are characterized by new onset jaundice. Infections are common in severe AAH, with approximately 25% of patients presenting with community-acquired infection and a similar percentage found to develop nosocomial infections. The high rates of sepsis observed in AAH may be explained by the impact of alcohol excess on the immune system. Gastroenterologists and their colleagues at the Mayo Clinic Rochester (Rochester, MN, USA; www.mayoclinic.org) performed a retrospective study of consecutive patients admitted with a diagnosis of AAH at two independent tertiary centers from 1998 to 2018 (test cohort, n = 286) who developed infections following hospitalization. The cohort was 66% men, and the median age was 48 (range: 21-83) years. Corticosteroids were used in 32% of all patients with AAH. Patients were diagnosed with AAH based on the clinical criteria and laboratory data including aspartate aminotransferase (AST) >50, aspartate aminotransferase/alanine aminotransferase (ALT) ratio >1.5, AST/ALT <400 IU/L, and serum bilirubin (total) >3.0 mg/dL. When the diagnosis of AAH remained unclear, a liver biopsy was obtained for confirmation. Types of infection were categorized as a urinary tract infection (UTI), bloodstream infection (BSI), pneumonia (PNA), spontaneous bacterial peritonitis (SBP), and Clostridium difficile (C. diff). The scientists reported that the overall incidence of infection in the cohort was 36% (n = 102). They then excluded those who presented to the hospital with community-acquired infection, which was 12% (n = 34) of patients. The most common sources of infection at presentation were UTI (12), BSI (10), lower respiratory (6), SBP (3), and C. diff (3), and the most commonly identified organisms included Escherichia coli (8) and Staphylococcus aureus (6). Of those who developed an infection while hospitalized (31/286), the most common infection sources included lower respiratory tract infections (10), BSI (7), SBP (6), UTI

These findings allowed the investigators to conclude, “Class I HED of the donor predicts acute or chronic rejection of liver transplant. This novel and accessible prognostic marker could orientate donor selection and guide immunosuppression.” The study was published in the August 24, 2021, online edition of the journal Annals of Internal Medicine.

LabMedica International October/2021

(6), and C. diff (2). Daniel Penrice, MD, a co-author of the study, said, “Our hope is that future studies can evaluate whether targeted prophylactic antibiotics for patients at high-risk for infection can improve survival. Our prediction model can likely be strengthened by the inclusion of novel biomarkers such as circulating serum bacterial DNA, endotoxin, or bacterial 16S ribosomal DNA.” The authors concluded that in this multicenter cohort study of patients hospitalized with AAH, MELD score, ascites, WBC count, and use of corticosteroids were identified as significant predictors of the development of bacterial infection. They created a novel predictive equation that may be used to aid in the identification of patients with AAH at high risk of infection. The study was published on July 28, 2021 in the journal Hepatology Communications. Image: Histopathology shows extensive liver cell damage resulting from alcoholic hepatitis (Photo courtesy of The Johns Hopkins University)

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Genomes of Advanced Neuroendocrine Neoplasms Unveil Subtypes

etastatic and locally-advanced neuroendocrine neoplasms (aNEN) form clinically and genetically heterogeneous malignancies, characterized by distinct prognoses based upon primary tumor localization, functionality, grade, proliferation index and diverse outcomes to treatment. A clinical distinction is made between the poorly differentiated neuroendocrine carcinomas (NEC) and the more differentiated neuroendocrine tumors (NET), the latter are further subdivided based on their primary site in pancreas (pNET), gastro-intestinal tract or lung. Medical Oncologists at the Erasmus Medical Center Cancer Institute (Rotterdam, the Netherlands; www.erasmusmc.nl) and their colleagues sequenced the genomes of biopsy samples from 85 individuals with locally advanced or metastatic neuroendocrine neoplasms, including 70 samples taken from metastatic lesions and 15 samples representing the patients’ primary tumor. A dozen samples came from cases with unknown primary tumor sites. DNA was isolated with an automated workflow using the QiaSymphony DSP DNA Midi kit for blood and DSP DNA Mini kit for tumor samples (Qiagen, Hilden, Germany; www.qiagen.com). DNA concentration was measured by Qubit fluorometric quantitation (Invitrogen, Life Technologies, Carlsbad, CA, USA; www.thermofisher.com). DNA libraries for Illumina sequencing were generated from 50–100 ng of genomic DNA and subsequently whole-genome sequenced in a HiSeq X Ten system (Illumina, San Diego, CA, USA; www.illumina.com) using the paired-end sequencing protocol (2 × 150bp) for both the biopsy and matched blood sample. The team observed relatively high tumor mutational burdens (TMB) in neuroendocrine carcinoma (average 5.45 somatic mutations/Mb) with TP53, KRAS, RB1, CSMD3, APC, CSMD1, LRATD2,

TRRAP and MYC as major drivers versus an overall low TMB in neuroendocrine tumors (1.09). Furthermore, they observed distinct drivers which are enriched in somatic aberrations in pancreatic (MEN1, ATRX, DAXX, DMD and CREBBP) and midgut-derived neuroendocrine tumors (CDKN1B). Finally, 49% of aNEN patients reveal potential therapeutic targets based upon actionable (and responsive) somatic aberrations within their genome; potentially directing improvements in aNEN treatment strategies. The authors conclude that their study underscores that whilst the number of genetic aberrations is increased, the inventory of somatic drivers does not significantly change between primary and metastatic NEN. The major advantages of characterizing the genomic landscape of metastatic NEN lie within the identification of potentially actionable targets and treatment-induced (resistance-) mechanisms within the late-stage disease. The study was published on July 29, 2021 in the journal Nature Communications. Image: The QiaSymphony DSP DNA Midi kit (Photo courtesy of Qiagen).

Exhaled Nitric Oxide and Eosinophil Count Diagnose Eosinophilic Asthma

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and FeNO levels (52 versus 5 ppb). The percentage of blood neutrophils, forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), and FEV1/FVC ratio of asthmatic patients were significantly lower (59.3% versus 61.9%, 94.4% versus 96.2%, 79.7% versus 92.4%, and 68.5% versus 80.2%), respectively. The odds ratio for having asthma increased progressively with a gradual increase in FeNO or B-Eos count.

The authors concluded that there was no difference in diagnostic accuracy for asthma between FeNO and B-Eos count, and the combination of these two biomarkers could slightly improve diagnostic efficacy. Patients with moderately elevated biomarkers (FeNO > 40 ppb and B-Eos > 300 cells/μL) could be diagnosed with asthma and avoid objective tests when such tests are not feasible. The study was published on August 9, 2021 in the journal BMC Pulmonary Medicine. LabMedica International October/2021

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LabMedica International

Molecular Characterization of Microbiota in Cerebrospinal Fluid Using WGA

ydrocephalus is a common cause of neurological disability in children. Cerebrospinal fluid (CSF) shunt placement allows children with hydrocephalus to survive and avoid ongoing brain injury. Understanding the etiology of cerebrospinal fluid shunt infections and reinfections requires detailed characterization of associated microorganisms. Traditionally, identification of bacteria present in the CSF has relied on culture methods, but recent studies have used high throughput sequencing of 16S rRNA genes. Neurosurgeons at the Seattle Children’s Hospital (Seattle, WA, USA; www.seattlechildrens.org) and their colleagues enrolled in a study a subset of children who failed treatment for CSF shunt infection (i.e. had CSF shunt reinfection) and had CSF collected both near the beginning and end of both infection episodes. All samples were tested by routine CSF aerobic culture in hospital-certified laboratories. DNA was extracted and purified from CSF samples using the AGOWA mag Mini DNA isolation kit (AGOWA, LGC Genomics, Berlin, Germany; www.lgcgroup.com) and CSF microbiota amplicon library construction was carried out using a one-step PCR amplification targeting the V4 region of the bacterial 16S rRNA gene. Sequencing of the pooled libraries was carried out for 600 cycles on an Illumina MiSeq desktop sequencer using the MiSeq Reagent Kit v3 (Illumina, San Diego, USA; www.illumina.com). Whole genome amplification (WGA) of DNA purified from CSF samples and two mock community samples was carried out using the REPLI-g Mini Kit (Qiagen, Hilden, Germany; www.qiagen. com) and sequenced on the Illumina HiSeq 2500 platform to produce 96-bp paired-end reads. Taxonomic assignments of sequences from WGA and 16S were compared with one another and with conventional microbiological cultures. While classification of bacteria was consistent among all the INTERACTIVE approaches, WGA provided additional inDIGITAL EDITION sights into sample microbiological composition, such as showing relative abundances of microbial versus human DNA, identifying samples of questionable quality, and detecting significant viral load in some samples. One sample yielded sufficient non-human reads to allow assembly of a high-quality Staphylococcus epidermidis genome, denoted CLIMB1, which we characterized in terms of its multilocus sequence typing (MLST) profile, gene complement (including putative antimicrobial resistance genes), and similarity to other annotated S. epidermidis genomes. The authors concluded that they had demonstrated that WGA directly applied to CSF is a valuable tool for the identification and genomic characterization of dominant microorganisms in CSF shunt infections, which can facilitate molecular approaches for the development of better diagnostic and treatment methods. The study was published on August 20 2021 in the journal Frontiers in Cellular and Infection Microbiology.

Image: The MiSeq benchtop sequencer enables targeted and microbial genome applications, with high-quality sequencing, simple data analysis, and cloud storage (Photo courtesy of Illumina)

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LabMedica International October/2021

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CSF Biomarkers Compared for Down Syndrome and Inherited Alzheimer’s

lthough most people with Down’s syndrome will experience brain changes as they age, not everyone will develop Alzheimer’s disease or another type of dementia. Whilst having Down’s syndrome does put a person at increased risk, estimated at 1 in 3 people in their 50s, and closer to 2 in 3 aged over 60, it is not inevitable for all. Due to trisomy of chromosome 21 and the resultant extra copy of the amyloid precursor protein gene, nearly all adults with Down syndrome develop Alzheimer’s disease pathology by the age of 40 years and are at high risk for dementia given their increased life expectancy compared with adults with Down syndrome in the past. A large team of Neuroscientists led by those at Washington University School of Medicine (St. Louis, MO, USA; www.wustl. edu) and their colleagues carried out a cross-sectional study that included 341 individuals (178 [52%] women, 163 [48%] men, aged 30–61 years). Participants were 41 adults with Down syndrome, similarly aged carriers of autosomal dominant Alzheimer’s disease mutations (n=192), and non-carrier siblings (n=108). Participants with baseline cerebrospinal fluid (CSF), available clinical diagnosis, and apolipoprotein E genotype as of January 31, 2019, were included in the analysis. CSF samples obtained from adults with Down syndrome, similarly aged carriers of autosomal dominant Alzheimer’s disease mutations, and non-carrier siblings (aged 30–61 years) were analyzed for markers of amyloid β (Aβ1–40, Aβ1–42); tau phosphorylated at threonine 181-related processes; neuronal, axonal, or synaptic injury (total tau, visinin-like protein 1, neurofilament light chain [NfL], synaptosomal-associated protein 25); and astrogliosis and neuroinflammation (chitinase-3-like protein 1 [YKL-40]) via immunoassay. The team reported that individuals with Down syndrome had patterns of Alzheimer’s disease-related CSF biomarkers remarkably similar to carriers of autosomal dominant Alzheimer’s disease mutations, including reductions in Aβ 1-42 to Aβ 1-40 ratio and increases in markers of phosphorylated tau-related processes; neuronal, axonal, and synaptic injury; and astrogliosis and neuroinflammation, with greater degrees of abnormality in individuals with dementia. Differences included overall higher concentrations of Aβ and YKL-40 in Down syndrome and potential elevations in CSF tau and NfL in the asymptomatic stage (i.e., no dementia symptoms). The study was published in the August edition of the journal Lancet Neurology.

Image: Representative example of amyloid-β plaques (Aβ1-42; brown staining; arrowheads) and neurofibrillary tangles (PHF1 antibody; blue staining; arrow) in the frontal cortex of a 46-year-old person with Down syndrome and end-stage Alzheimer disease. (Photo courtesy of University of California, Irvine).

LabMedica International October/2021

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

NEWS

IFCC Launches Annual Townhalls Starting this Fall

he IFCC Townhalls are a new initiative aimed to significantly enhance internal communications within the IFCC organization and between the IFCC Board and all IFCC member societies and Regional Federations. The Townhalls aim to: • Update the membership on current and upcoming IFCC programs and new initiatives globally or in specific regions; • Provide a platform for an open communication forum between the IFCC board members and the board members of IFCC regional federations and national societies, as well as all laboratory professional and scientists in each region; • Receive feedback from the membership on IFCC programs particularly the new initiatives planned to directly contribute to advancing excellence in laboratory medicine towards a better healthcare worldwide. There will be a three-hour Interactive Virtual LIVE event that will be held in different time zones around the world. The first Townhall was held on Sept. 15 in the Central European Time Zone and the IFCC Executive Board invited the Executive Board members and National Society Presidents of AFCB, AFCC and EFLM to join us. It was a unique opportunity to bring everyone together in these regions and allow for exchange of ideas and free communication between various organizations.

EFLM, AFCC, and AFCB Regional Federations and National Societies in these Regions showed high interest and participated in this open communication forum that significantly enhanced communication within our laboratory medicine community. Many participants asked questions in the Discussion Forum via chat. Participants in the IFCC Town Hall panel included: Prof. Khosrow Adeli, IFCC President; Dr. David Kinniburgh, IFCC Secretary; Dr. Alexander Haliassos, IFCC Treasurer; Mr. Joe Passarelli, IFCC Corporate Representative; Dr. Osama Najjiar, AFCB President; Prof. Rajiv Erasmus, AFCC President; Prof. Ana-Maria Šimundić, EFLM President. Above panel members gave brief presentations to update the membership on current and upcoming IFCC programmes and new initiatives globally or in specific regions.

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 October/2021

NEWS

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

Editorial

By Katherina Psarra, MSc, PhD

Dear colleagues, Was it really such an unbearable summer with Delta, fires, heat wave–as Dr. Gouget explains in his very interesting article in this issue? It is true that for the first time all these consequences of the climate crisis, in addition to the Delta variant, were present at the same time in many places around the world. We all witnessed this unprecedented summer. But at the same time, thanks to the vaccines, we had the chance

to enjoy some moments of real holidays, the countryside, the sun, the sea, meeting with friends (not big gatherings, of course)–to enjoy peaceful moments. Within the IFCC there is a lot to anticipate during the coming months. The Townhalls, the new meetings, where our voices can be heard, are explained and presented by our president in this issue. We are all looking forward to EuroMedLab in Munich at the end of November and we hope to attend in person after a period of “untouchable” meetings. Let’s hope that we will have a peaceful fall and winter waiting for us.

IFCC Professional Scientific Exchange Program (PSEP):

My internship at the Auto-Inflammatory Disease Unit of Arnaud de Villanueve Hospital, Montpellier, France By: Natalia Mª García Simón Residente Laboratorio Bioquímica Clínica Hospital Universitario Puerta de Hierro Majadahonda - Madrid

was granted with the IFCC Professional Scientific Exchange Programme to do my international rotation at the Auto-Inflammatory Disease Unit of Arnaud de Villanueve Hospital, in Montpellier (France), during my residency at the Puerta de Hierro Majadahonda University Hospital (Spain). The unit works as a National Reference Centre for the diagnosis of hereditary systemic auto-inflammatory diseases from a genetic point of view. The main tool they use is massive sequencing from blood samples, although they also perform Sanger sequencing and can use other type of samples such as tissue or saliva. The aim of my stay was to learn about next generation sequencing (NGS), from library preparation to interpretation of the results. Luckily, while I was there, they were trying different kits to prepare the libraries, so I learned to do so using three different kits, both manually and semi-automatically. They taught me about possible types of errors during the preparation and the ways to prevent and control them in the different steps.

Furthermore, they showed me how to prepare and introduce the samples in the sequencing machine and the technology it was based on. Finally, once the data was available, they taught me how to read and interpretate the results, and how to elaborate a report with the final conclusions. The project I was requested to do was to compare the current software they were using to interpretate the results with a new one they wanted to implement. One of the most positives aspects during my stay in this unit was that they have their own bioinformatics team and do their own data analysis, so I was able to follow the data from its raw origin to the final presentation that was handed to the biologists. During my project, I could detect and resolve mistakes and loss of data that can happen during the processing affecting the

final conclusions and, therefore, the diagnosis of the patients and their relatives. From a personal point of view, I am very happy with my stay at the hospital, and I would do it again without hesitation. They made me feel as part of the team and everyone was very kind and always willing to teach and answer all my questions. It has been a very positive experience, because, apart from the new techniques I have learned, I have acquired new knowledge of the techniques I was already familiar with, which I can introduce in my laboratory to improve and make it more efficient. Moreover, I have seen other ways of working, organising, and managing a laboratory which have broaden my views. For all that, I would like to thank Dr Guilaine Boursier, who took me under her guidance, and Dr Guillaume Sarrabay, both supervisors of the laboratory, and Professor Isabelle Touitou, head of the laboratory for accepting me in her team. Secondly, I would like to thank my supervisors at my hospital who encouraged me to do the rotation, especially the head of the laboratory, Dr Francisco Bernabeu, who helped me along the way and made this possible. Finally, I would like to thank the IFCC for the help and support they have given me that made the process a lot easier.

IFCC Townhall for Corporate Members: Recording Available Online

September 21, 2021 9 am-12:00 pm (Eastern Standard Time (EST) – New York)

he IFCC Executive Board invited all IFCC Corporate Members to join in into the IFCC Townhall for Corporate Members. It was a unique opportunity to hear directly from the IFCC leadership on those areas of most interest to all of our member companies. The EB answered questions, discussed topics,

burning issues, how the IFCC could enhance the collaboration with its corporate members, etc… It was a great opportunity to bring everyone together and allow for exchange of ideas and free communication between the Executive Board and Corporate Membership. Agenda: • The Town Hall began with

introductions and presentations from a briefing panel comprised of the IFCC President, Treasurer, and Corporate Representative to the Executive Board and all attendees on video. • Following the briefing panel presentations, the moderator (Mr Passarelli, Corporate Representative to the IFCC Executive Board) began the discussion period with a brief introduction of the topics to be discussed and corresponding time limits.

• The moderator then invited participants to ask their questions and/or provide their comments. • At the end of the discussion period, the IFCC President concluded the Town Hall. A feedback survey will be sent to participants. Two other Townhalls are planned in October for the Americas (NAFCC and COLABIOCLI) as well as Asia-Pacific (APFCB) in their own time zones. LabMedica International October/2021

NEWS

Edited by Katherina Psarra, MSc, PhD

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

MESSAGE FROM THE PRESIDENT By Khosrow Adeli

•

President, IFCC

y sincere greetings to you all. I hope everyone has had an enjoyable summer and a great time with family and friends. Here at IFCC, we are very excited for the Fall, with many important events planned. First, I am delighted to announce a new strategy to enhance internal communications within the IFCC community, the annual IFCC Regional Town Halls, starting this fall in regions around the world. The first IFCC Regional Town Hall will take place virtually on September 15th at the European, African, and Middle Eastern time zones and all regional federations and national societies affiliated with EFLM, AFCC, and AFCB have been invited to participate. Two other IFCC Regional Town Halls are planned on October 6 for the Americas (NAFCC & COLABIOCLI) and on October 20 for Asia-Pacific (APFCB). More detailed information will be circulated soon to IFCC Regional Federations and National Societies by the IFCC Office. These regional IFCC Annual Town Halls aim to bring the IFCC community together, including the Executive Board, IFCC Office Staff, Regional Federation Executive Board Members, National Society Presidents, and all Society Members, for the purpose of improving internal communication within IFCC. More specifically, the new IFCC Town Halls will: • Inform the IFCC community about ongoing and emerging plans that are vital to the organization, • Prepare the IFCC community to take action with respect to ongoing and emerging plans, • Give the IFCC community a voice and a chance to connect with the organization • Allow us to plan for the future together with input from all stakeholders across the organization Hopefully, by increasing internal communication, we can increase confidence and trust in the IFCC organization, boost motivation and morale in the IFCC community, and reinforce the IFCC’s mission, cur-

rent goals, and future directions. Each regional IFCC Annual Town Hall will take place over 3 hours, starting with 1 hour of presentations from the IFCC President/Board and Regional Federation Presidents. The remaining 2 hours will serve as an open forum for discussion. I encourage all members to participate and sincerely look forward to your questions and comments. Alongside the regional IFCC Annual Town Halls, there will be a special IFCC Town Hall for Corporate Members on September 21, 2021. The corporate IFCC Annual Town Hall will include the Executive Board, IFCC Office, Taskforce on Corporate Members (TF-CM), and representatives from all 49 Corporate Members, with the same aims mentioned above. Similarly, the corporate Town Halls will be scheduled for 3 hours, with one hour of presentations by the IFCC President/Board, IFCC Corporate Representative, and Chair of TF-CM to start and 2 hours of open forum discussion thereafter. More detailed information will be circulated to all corporate members soon by the IFCC Office. In addition, I would like to remind everyone of the 24th IFCC-EFLM European Congress of Clinical Chemistry and Laboratory Medicine (EuroMedLab 2021), which will be taking place in Munich from November 28th to December 2nd. I encourage all IFCC members to participate in this important scientific conference and hope to see many of you there in person. For those who are worried about travel restrictions due to the ongoing pandemic, considerations are being made regarding a virtual option to allow remote attendance. Of note, the XV International Congress of Pediatric Laboratory Medicine is also planned as a satellite meeting, taking place from November 26th to 28th. You will not want to miss out on the excellent scientific programmes for both this satellite meeting and main EuroMedLab 2021, which will surely set the tone for a wonderful week of presentations from global experts from Europe and around the world. With these exciting opportunities, I hope we can look forward to a lively and active Fall season. Should you have any feedback, questions, or concerns, please feel free to email me at president@ifcc.org.

Till next time ☺ Khosrow

The New IFCC Code of Ethics and Published Resources on Clinical Laboratory Ethics By Professor Nilda Fink Chair, IFCC Taskforce on Ethics

ince the 1970s, ethical issues have been a topic of concern in clinical laboratory practice that have been reflected in several pioneering publications (e.g., AACC, Guide to Ethics Governing the Conduct of Clinical Chemistry, 1975; Editorial, Brit Med J 1984; McQueen M. Clin Chem 1990;36:1404-1407). In different regions of the world, individual professional organizations were raising awareness of ethics-related dilemmas among their members. It became clear that there was a need at the international level to create a structure for ethical issues in Laboratory Medicine. Thus, during the term 1997-1999, the Executive Board of the IFCC accepted the task of establishing an Ethics Committee. Since then, several documents have been produced addressing some of the key ethical issues. • IFCC Position Paper. Report of the IFCC Taskforce on Ethics: Introduction and framework. Clin Chem Lab Med 2007;45:1098-1104. • IFCC Guideline. Ethics in Science: Background and Resources on Publication Ethics. November 2012.

LabMedica International October/2021

• Variability of ethics education in laboratory medicine training programs: Results of an international survey. Clin Chim Acta 2015;442:115-118. • IFCC Report. Ethical Considerations in Clinical Chemistry and Laboratory Medicine. January 2016. • IFCC Taskforce on Ethics (TF-E). TF-E Toolkit: A list of topics and articles related to Ethics in Laboratory Medicine. March 2019 (Updated frequently). • IFCC Report. A survey of extant Ethics Policies. April 2020. • Ethics in Laboratory Medicine. EJIFCC 2020;31:260-325. • IFCC Taskforce on Ethics (TF-E). IFCC Code of Ethics 2021. August 2021.

IFCC CODE OF ETHICS 2021: https://www.ifcc.org/media/479114/ifcc-code-ofethics_2021.pdf In 2021, Members of the Task Force on Ethics (TF-E) developed the IFCC Code of Ethics. This document was then edited and approved by the IFCC Executive Board and subsequently published in August 2021 on the IFCC website. The IFCC Code of Ethics 2021 contains a pre-

amble and three targets (Patients, Colleagues, and Profession and Society), with duties fundamentally based on the principles delineated in the Belmont Report created in 1978 by the then U.S.A. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. All stakeholders involved in the development and publication of the IFCC Code of Ethics 2021 endorse principles of ethical conduct in laboratory medicine profession, including laboratory procedures, research and development, teaching, management, and other forms of professional service. Clinical laboratory organizations have a responsibility to promote and anticipate the interest of their members; however, the IFCC mission and vision state that the organization’s main goal is to benefit the health and well-being of the patients and communities we work for. The recent approval of this Code of Ethics clearly shows the commitment of IFCC as an international organization to support laboratory professionals regarding Ethical standards. The aforementioned documents should also be useful to organizations that would like guidance on how to develop Ethics documents in the field of laboratory medicine.

NEWS

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

VIEWPOINT

The Unbearable Summer with Delta

By Bernard GOUGET; Chair-IFCC Committee on Mobile Health and Bioengineering in Laboratory Medicine (C-MHBLM), co-Chair IFCC-TF on History, SFBC-International Committee, President-Human Health Care Committee-Cofrac, President-National Committee for selection of the French Reference Laboratories, Ministry of Health

e thought the summer would be quieter, but new epidemic flares are clearly still with us. Delta variant has snuffed out the optimism we had in the spring and disturbed the summer reveries. COVID-19 is not going away so quickly, and the pandemic situation could get worse. At the same time, disastrous environmental events are converging like never: extreme heat, out-of-control wildfires, droughts, flood. The climate catastrophes are just part of the weather now. The crisis is becoming routine. Finding happiness under fraught circumstances can be challenging and ruminating over what might have been and what might happen just deliver unhappiness. COVID-19 deaths are on the rise once again. The number of cases is rising quickly due to the Delta variant. This variant exhibits two characteristics: a higher infectiousness and mutations of some of the antibody binding sites on the spike protein, which can be associated with immune escape. Some projections are cold-sweat inducing and impel a new turn of the screw in the face of the variant in the most affected areas. A continued arms race against the virus is inevitable. Governments are passing legislation to adapt their tools to the evolution of the health crisis. Nonessential sectors are operating remotely, and new travel restrictions are reappearing. Health control measures are imposed with the implementation of the “pass sanitaire” as in France and vaccine requirements for some occupations, with potential sanctions for those who refuse. The engagement of everyone is a vital component to be able to live as normally as possible after experiencing the trials of curfew and lockdown. The pandemic continues to shake up our lives, our relationship to freedom, our conception of civic duty. If the epidemic becomes out of control again, all economic and social activity will be disrupted again. A more vaccinated world creates a more hostile global environment for SARS-CoV-2. Mutations will still occur, but fewer of them will be of consequence. Globally, it is a race between vaccine delivery and virus transmission. These two sides are interconnected. The untrammeled spread of COVID-19 through large, vulnerable populations worldwide increases the risk that new variants will emerge. Every new variant carries with it the possibility of a devastating turn in the pandemic‚ a mutation that further weakens the efficacy of the vaccines, or that causes the disease to be more severe in children and young adults. Vaccines are still beating the variants, but the unvaccinated world is being pummeled. While several measures have boosted vaccination, we must not forget the hesitant minority not yet convinced by this almost civic obligation to get vaccinated, while there is a strong demand in low-income countries where populations have not been vaccinated much. Given a more contagious virus, pharmaceutical companies and medical laboratories are mobilizing. The idea of a third dose would certainly have a positive effect regardless of the vaccine, insofar as it would strengthen the protection of individuals who have already been vaccinated by cross immunity. It has become difficult to say if herd immunity can be attained. It has become a very ambitious challenge; vaccination in the name of the community remains completely relevant. In the meantime, even highly vaccinated countries should continue investing in other measures that can control COVID 19 but

have been inadequately used : improved ventilation, widespread rapid tests, smarter contact tracing, better masks, places in which sick people can isolate, and policies like paid sick leave. Such measures will reduce the spread of the virus among unvaccinated communities, creating fewer opportunities for an immune-escape variant to arise. Vaccines remains our most powerful tools. Immunization against diseases is among the most successful global health efforts of the modern era, and substantial gains in vaccination coverage rates have been achieved worldwide. The COVID-19 vaccine is one of the most spectacular embodiments of this scientific, technical and political progress thanks to which we have a better quality of life today than ever before in human history. Even as many countries do not yet have sufficient access to the vaccines, antivaccine crusades strangely resemble medieval witch hunts with the same references to absolute evil, the same fear of hybrid beings seeking to alter nature. It is characteristic of great crises to accelerate the march of progress while mixing hope and horror. The success of the messenger RNA vaccines reminds us that catastrophes stimulate human ingenuity, and necessity dissolves the most deeply entrenched beliefs. How can we not be amazed by the discoveries of genetics, a very young discipline! The RNA currently dominating the news is called messenger RNA but is also a messenger of hope! This amazing molecule deserves recognition of its potential, and scientists have been thoroughly inspired. The superiority of mRNA is due to its ability to rapidly adjust to virus mutations. The work around RNA is a saga populated with anonymous researchers who have ploughed forward come what may. A chance meeting in front of a photocopier, a beautiful analogy for RNA, which copies DNA sequences, allowed Katalin Kariko to meet her partner, Drew Weissman. Together and with their team, they succeeded in removing the obstacles that prevented messenger RNAs from triggering adequate immune responses. While the race for vaccines, the main weapon against COVID-19, already has its champions, the race for treatment is still looking for its winners. There is no shortage of candidates. Researchers, biotech companies and major pharmaceutical companies have all been mobilized. There are still more than 1600 clinical trials underway worldwide. One of the difficulties is that, due to the number of clinical trials in progress, the chance of finding patients lengthens the time for developing treatments. The therapeutic arsenal is still meager in the treatment market that directly addresses the virus. However, research is progressing, and we are hopeful that several drugs will arrive in the coming months. Treatments are an additional tool that can serve to anticipate the next crises. The stakes are not trivial, because while vaccines have so far provided an effective shield, nothing excludes new, more dangerous variants from escaping their protective net in the future. It is also a matter of protecting immunocompromised patients for whom vaccination is less effective and who are at greater risk of developing a severe form of the disease. The competition is vigorous on the monoclonal antibody and antiviral market, in which big pharma is well positioned. We can see that the magic of the precious ribonucleic acid molecule is not limited to COVID. This technique makes it possible to hope that our cells will learn how to make effective shields against other serious diseases themselves. An extraordinary leap has taken place over the past two years. It has been demonstrated that knowledge of living organisms at the level of molecules and DNA-RNA relationships could prove to be fundamental in the fight against certain diseases. However, RNA should not be seen as a miracle drug; in biology nothing is won in advance and treatments Cont’d on page 33 LabMedica International October/2021

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

Mesa Laboratories to Acquire Molecular Diagnostics Tool Developer

esa Laboratories, Inc. (Lakewood, CO, USA; www.mesalabs.com) has entered into a definitive agreement to acquire Agena Bioscience, Inc. (San Diego, CA, USA). Mesa is a global leader in the design and manufacturing of critical quality control solutions for the pharmaceutical, healthcare, and medical device industries. Mesa offers products and services through four divisions (Sterilization and Disinfection Control, Biopharmaceutical Development, Instruments, and Continuous Monitoring) to help its customers ensure product integrity, increase patient and worker safety, and improve the quality of life. Agena is a leading molecular diagnostics tools company that develops, manufactures, and supplies highly sensitive, low-cost, high-throughput, genetic analysis solutions to clinical labs and development

The Unbearable Summer with Delta Cont’d from page 32

do not always work. mRNA technology could become an additional weapon in the field of cancer treatment. One of the projects operates in a way very close to the method for COVID vaccines. It consists of introducing mRNA into cancer cells and having them produce a protein that will be recognized very efficiently by the immune system. By injecting mRNA that codes for tumour neoantigens, cells can produce them. In reaction, the immune system specifically attacks tumour cells that produce these neoantigens, and therefore the tumour mass. The strength of these new technologies is their potential action against all types of cancer. In addition, they allow personalized care. Mutated proteins are specific to each tumour and each patient. By means of a biopsy it is possible to sequence its genome, identify the mutations present and rapidly produce the corresponding mRNA. The potential of mRNA in oncology is not limited to immunotherapy. These new technologies could also make it possible to induce cells to produce the drug proteins they need themselves. It is vital to instill trust in innovation. Progress needs us as much as we need it. It must be supported by science education, appropriate communication and refined legal devices. Saving lives is urgent. The world has a moral obligation to do so, and solidarity is needed more than ever. No one is safe until everyone is.

Industry News

LabMedica International October/2021

partners globally. The company’s highly sensitive and cost-effective mass spectrometry-based platform, the MassARRAY System, is used globally in diverse research fields such as cancer profiling for solid tumors and liquid biopsies, inherited genetic disease testing, pharmacogenetics and clinical research. “Agena brings an innovative approach to the challenges of clinical genomics. Their MassArray system is a proven platform which integrates the best of mass spectroscopy and multiplex PCR; providing a unique combination of sensitivity, cost effectiveness, fast turnaround time, ease of use, and flexibility,” said Gary Owens, President and Chief Executive Officer of Mesa. “These benefits strongly address the needs of clinicians to apply patient specific genomic information to make personalized treatment and monitoring decisions. We

believe that The Mesa Way approach to continuous improvement will help the Agena team to continue to rapidly scale both commercially and operationally.” “We are proud of our track record in bringing the power of genomics to the clinical setting in hereditary diseases, pharmacogenomics, oncology, infectious disease and sample integrity testing,” added Peter Dansky, Chief Executive Officer of Agena, who will join Mesa to lead the new Clinical Genomics Division. “Our robust technology platform along with deep customer partnership has been the foundation of our success. We built our company based on a strong team-oriented values system, and we see a great fit with the Mesa culture. We look forward to working with the Mesa team to expand the applications we deliver and innovate new technologies for clinical genomics.”

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

2021 OCTOBER ECC 2021 – 43rd European Congress of Cytology. Oct 3-6; Wroclaw, Poland; cytology2021.eu 4th Journées Francophone de Biologie Médicale (JFBM). Oct 6-8; Rennes, France; jfbm.fr BSACI 2021 – Annual Conference of the British Society for Allergy and Clinical Immunology. Oct 7-9; Harrogate, UK; bsacimeeting.org 7th Russian Congress of Laboratory Medicine (RCLM). Oct 17-19; Moscow, Russia; congress.fedlab.ru

Germany; icplm2021.org

ASCP 2021 – Annual Meeting of the American Society for Clinical Pathology. Oct 27-29; Boston, MA, USA; ascp.org 32nd Congress of the Turkish Biochemical Society. Oct 27-30; Gaziantep, Turkey; biyokimyakongresi.org NOVEMBER 61st Annual Academic Assembly of the Japan Society of Clinical Chemistry. Nov 5-7; Fukuoka, Japan; jscc-jp.gr.jp Labclin 2021 – 15th Spanish Clinical Laboratory Congress. Nov 7-13; Virtual Venue; labclin2021.es AFCC Congress 2021 – 7th Regional Conference of the African Federation of Clinical Chemistry Nov 1113; Lusaka, Zambia; ifcc.org. 53rd National Congress of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC). Nov 11-13; Virtual Venue; sibioc.it

MEDLAB Asia Pacific 2021. Oct 2022; Virtual Venue; medlabasia.com

42nd Annual Meeting of the American College of Toxicology (ACT). Nov 14-17; Virtual Venue; actox.org

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

Arab Lab 2021. Nov 15-17; Dubai, UAE; arablab.com

SIOP 2021 – Annual Congress of the International Society of Paediatric Oncology (SIOP). Oct 21-24; Virtual Venue; siop-congress.org

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

Thailand LAB International 2021. Oct 27-29; Virtual Venue; thailandlab.com

ICPLM 2021 – 15th International Congress of Pediatric Laboratory Medicine. Nov 26-28; Munich,

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EuroMedLab 2021 – 24th IFCC-EFLM European Congress of Clinical Chemistry and Laboratory Medicine. Nov 28 - Dec 2; Munich, Germany; euromedlab2021munich.org Analitica Latin America 2021. Nov 30 - Dec 2; Sao Paulo, Brazil; analiticanet.com.br

Labquality Days 2022 – International Congress on Quality in Laboratory Medicine. Feb 10-11; Helsinki, Finland; labqualitydays.fi

DECEMBER JIB 2021 – Journées de l’innovation en biologie. Dec 1-2; Paris, France; jib-innovation.com

WSPID 2022 – 12th World Congress of the World Society for Pediatric Infectious Diseases. Feb 22-24; Virtual Venue; wspid2022.com

Zdravookhraneniye 2021 – Russian Health Care Week. Dec 6-10; Moscow, Russia; zdravo-expo.ru/en

MARCH Pittcon 2022. Mar 5-9; Atlanta, GA, USA; pittcon.org

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

KIMES 2022. Mar 10-13; Seoul, Korea; kimes.kr

ACBICON 2021 - 47th Annual Conference of Association of Clinical Biochemists of India. Dec 13-15; Virtual Venue; acbicon2021.com LABWorld China 2021 (CPhI & PMEC China). Dec 16-18; Shanghai, China; pmecchina.com/labworld

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

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

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

Medlab Middle East 2022. Jan 2427; Dubai, UAE; medlabme.com

China Lab 2022. Mar 31 - Apr 2; Guangzhou, China; chinalabexpo.com

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

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– AACC 2021 . . . . . . . . . . . . . . . . . . . . . . . . . . 33 110 Absology . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 123 Alcor Scientific. . . . . . . . . . . . . . . . . . . . . . . . 23 121 Bioperfectus Technologies. . . . . . . . . . . . . . . 21 – COLABIOCLI 2022. . . . . . . . . . . . . . . . . . . . . . . . . . . 28 107 DiaSys Diagnostic Systems. . . . . . . . . . . . . . . 7 – EuroMedLab 2021. . . . . . . . . . . . . . . . . . . . . 29 113 GenBody . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 – ICPLM 2021. . . . . . . . . . . . . . . . . . . . . . . . . . 17 109 Mayo Clinic Laboratory . . . . . . . . . . . . . . . . . . 9 115 Nova Biomedical . . . . . . . . . . . . . . . . . . . . . . 15 111 Randox. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 119 Randox. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 116 Rayto. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 114 Serosep. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 122 Singuway. . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 102 Snibe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 120 Vicotex. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 105 Vircell. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 – WASPaLM 2022 . . . . . . . . . . . . . . . . . . . . . . 24 103 Werfen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 136 Werfen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Provided as a service to advertisers. Publisher cannot accept responsibility for any errors or omissions.

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