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WORLD’S CLINICAL LABORATORY NEWS LEADER
ISSN 1068-1760
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Vol. 39 No.4 • 6-7/2022
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World’s First Rapid Oral Cancer Test
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DAILY CLINICAL LAB NEWS
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Machine Learning Drastically Reduces Workload of Diagnostic Cell Counting
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ntil now there hasn’t been a perfect way to identify pre-malignant lesions that are likely to develop into mouth cancer. Without knowing definitively whether a lesion is cancerous, patients with pre-malignancy must be reviewed regularly over a long
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achine learning methods are increasingly spreading into the area of blood cell counting, until recently dominated by expensive and often less accurate traditional cell analyzers. However, due to the enormous amount of manual annotation work required,
training the machine learning model has so far proven highly labor-intensive. Now, researchers have developed an innovative training method that automates much of this activity. Researchers at Beihang University (Beijing, China; ev.buaa.edu.cn)
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Study Points to Crucial Gaps in Children’s Clinical Testing
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Point-of-Care Analyzer Performs Complete Blood Count in 5 Minutes
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orld’s first lab-quality portable plug-and-play Complete Blood Count (CBC) analyzer allows real-time blood testing to be performed by anyone, anywhere. By providing critical health data on the spot, the analyzer enables rapid diagnostic results and data-driven disease management decisions. Cont’d on page 10
P O R T A L
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esearchers have developed a rapid test for viruses that can deliver results as accurate as lab tests within 30 minutes. The technology can be applied to viruses that cause respiratory syncytial virus, influenza and COVID-19. A new study by researchers from the University of Texas at Dallas (Dallas, TX, USA; www. utdallas.edu) demonstrated the
he advent of next-generation sequencing (NGS) technology has enabled the diagnostic workup of patients suspected of having primary immunodeficiency disorders, which will have significant implications for not only their diagnosis and prognosis but also provide opportunities for targeted therapeutic management and family planning. Cont’d on page 14
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Next-Gen Sequencing for Immunodeficiencies
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breakthrough study by a research team affiliated with the AACC reveals significant inconsistencies in pediatric reference intervals that are critical to clinical testing, and calls for the development of reliable standards in the field.
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Two Industry Giants Combine to Form QuidelOrtho
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uidelOrtho Corporation (San Diego, CA, USA; www. quidelortho.com) announced completion of the merger uniting Quidel Corporation (San Diego, CA, USA) and Ortho Clinical Diagnostics (Raritan, NJ, USA), forging QuidelOrtho as a leading in vitro diagnostics concern.
Quidel acquired Ortho in December 2021, in a USD 6 billion transaction that aims to unite technologies and platforms to offer expanded access to clinical chemistry, immunoassay, molecular diagnostics, immunohematology, donor screening and, point-of-care diagnostic offerings. Cont’d on page 22
INSIDE
COVID-19 Update. . . . . 4 Clinical News. . . . . . 6-28 IFCC News. . . . . . . . . . 29 Product News . . . . . 6-28 Industry News . . . . . . . 33 Events Calendar . . . . . 34
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COVID -19 Diagnostics Update I
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he report that follows provides a selection of news and advances announced from May 1 to June 15, 2022. For a recap of earlier developments, the reader is invited to refer to previous issues of LabMedica or visit our website at www.LabMedica.com.
Saliva-Based Rapid Test Uses DNA Aptamer to Detect COVID-19 Achiko AG (Zurich, Switzerland; www.achiko. com) has launched an affordable, saliva-based rapid test that uses a DNA aptamer instead of an antibody to detect COVID-19 and is read by a UV Spectrophotometer. DNA aptamers are believed to offer a structural advantage over other enzyme-based approaches in sensitivity, specificity, quality of production, lower costs, test formats and other areas.
Blood Test Detects and Monitors Cell Death to Predict Disease Severity VolitionRx Limited’s (Austin, TX, USA: www. volition.com) Nu.Q NETs test detects neutrophil extracellular traps (NETs) in minute quantities. NETosis is a unique form of cell death that is characterized by the release of NETs. Elevated levels of NETs are a complicating factor associated with poor patient outcomes in a range of infectious and non-infectious diseases such as sepsis and COVID-19.
$12 PCR Testing’ Global Initiative to Help End COVID-19 Pandemic Seegene, Inc. (Seoul, Korea; www.seegene.com) has unveiled a global initiative designed to help people safely return to normalcy and contribute to global efforts to terminate COVID-19 and prevent future outbreaks. Seegene’s initiative dubbed ‘In-life PCR,’ entails asymptomatic testing for early virus detection, syndromic respiratory testing as anti-virus restrictions are eased, and boosting PCR test accessibility through affordable pricing.
Image: RHINOstic Automated Nasal swabs create hands-free diagnostics workflows (Photo courtesy of Rhinostics)
Automated Nasal Swab Creates Hands-Free Diagnostics Workflow The RHINOstic Automated Nasal Swab from Rhinostics, Inc. (Boston, MA, USA; www. rhinostics.com) allows laboratories to manage their staff, where COVID-19 surges will not require armies of temporary workers but instead, relies on robotics to manage the increase of samples during peak times while lowering per sample labor costs to roughly USD 0.50 per sample.
Researchers from the Kirby Institute at UNSW Sydney (Sydney, Australia; www.unsw.edu.au) have developed a methodology that speeds up the process for isolating and characterizing the risks posed by COVID-19 variants of concern. The methodology is highly cost-effective, automated, and can be used to measure the effectiveness of therapeutics and scaled to test thousands of samples.
Nasopharyngeal Swabs More Effective Than Saliva Tests at Detecting COVID-19 A new study by researchers at Cornell University (Ithaca, NY, USA; www.cornell.edu) has found that nasopharyngeal swabs – taken from far back inside the nostril – were more effective at detecting COVID-19 than saliva tests or swabs just inside the nostril or under the tongue. The study also found that detection rates were lower in asymptomatic patients, confirming the rationale for shortened isolation guidelines.
POC Diagnostic Respiratory Panel Tests for Multiple Viruses and Bacteria Genomtec SA’s (Wrocław, Poland; www. genomtec.com) ID RP5-PLEX diagnostic panel simultaneously detects the presence of Influenza A and B viruses, RSV (Respiratory Syncytial Virus), SARS-CoV-2 and the atypical bacteria Mycoplasma pneumoniae and Chlamydophila pneumoniae. The panel runs on the Genomtec ID Analyzer, one of the smallest portable genetic laboratories in the world, with which a reaction card (panel) is used along with a sample from a patient to perform a genetic test.
Swab with Unique Head Design Enables Accurate COVID-19 Test Results
Image: Allplex SARS-CoV-2 FluA/FluB/RSV Assay (Photo courtesy of Seegene)
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EDITORIAL BOARD
First Method for Rapid Isolation and Characterization of COVID-19 Variants
Image: AptameX DNA Aptamer-based COVID-19 rapid test has received CE Mark (Photo courtesy of Achiko)
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labmedica.com
Graham Beastall United Kingdom Hernán Fares Taie Argentina Bernard Gouget France Maurizio Ferrari Italy Jocelyn M. Hicks United States Tahir S. Pillay South Africa Andreas Rothstein Colombia Praveen Sharma India Rosa I. Sierra-Amor Mexico Peter Wilding United States Andrew Wootton United Kingdom
SARS-CoV-2 RT-PCR Test with 3-in-1 Media Pooling Strategy Increases Testing Throughput The ViroKey SARS-CoV-2 RT-PCR Test v2.0, developed by Vela Diagnostics (Singapore; www. veladx.com) for the detection of SARS-CoV-2, uses a three-in-one media pooling strategy to provide additional capability to be used for pooling. This pooling strategy can be done by combining sample media of up to three patients to be tested as one sample, thereby only using resources needed for a single test.
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Mawi DNA Technologies (Hayward, CA, USA; www.mawidna.com) has launched NextSWAB, a 100% medical-grade plastic swab that is designed for high efficiency collection without the possibility of Cont’d on page 5
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ISSN 1068-1760 Vol.39 No.4. Published, under license, by Globetech Media LLC; Copyright © 2022. 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 June-July/2022
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COVID -19 Diagnostics Update Cont’d from page 4
contamination from glue or fibers used in flock and cotton swabs that may inhibit PCR based assays. NextSWAB aims to resolve the commonly face problems in current sample collection methods for COVID-19 testing such as low recovery, high bacterial content, low quality DNA, and excessive resampling costs.
Next Generation COVID-19 Antigen Test to Offer Even Greater Sensitivity Alamar Biosciences (Fremont, CA, USA; www.alamarbio.com) and Mologic, Ltd. (Bedford, UK; www.mologic.co.uk) have entered into a collaboration to develop second generation tests with even greater sensitivity by leveraging the latest generation of engineered antibodies with ultra-high affinity and novel electronic lateral flow immunoassay (eLFIA)technology for SARS-CoV-2 diagnostics.
5-Minute SARS-CoV-2 Ag Test Aids Fast Clinical Decision-Making at POC The SARS-CoV-2 Ag Ultra Test from LumiraDx (London, UK; www.lumiradx. com) delivers results in just five minutes from sample application and aids in fast clinical decision-making at point of care (POC), helping to inform treatment decisions and prevent the further spread of infection, while also increasing testing throughput.
Image: Alamar’s Attobody TM platform produces highly diverse pool of antibodies (Photo courtesy of Alamar Biosciences)
Image: LumiraDx five-minute SARS-CoV-2 Ag ultra test has achieved CE marking (Photo courtesy of LumiraDx)
CE-Marked COVID/ Influenza Molecular Tests to Expand Global Testing LumiraDx (London, UK; www. lumiradx.com) has achieved CE Mark for two new Fast Lab Solutions molecular tests, including Dual-Target SARS-CoV-2 STAR Complete and SARS-CoV-2 & Flu A/B RNA STAR Complete. These high-sensitivity and high-throughput tests help to expand testing capabilities across the globe.
Rapid Antigen COVID-19 Tests Not Keeping Pace with Variants of Concern A new study by scientists at the Harvard T.H. Chan School of Public Health (Boston, MA, USA; www. hsph.harvard.edu) and Beth Israel Deaconess (Boston, MA, USA; www.bidmc.org) suggests that while rapid antigen tests remain a useful tool for the detection of COVID-19 infections, continuous assessment and updating is likely needed in the context of variants of concern.
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LabMedica International June-July/2022
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PRODUCT NEWS
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Study Points to Crucial Gaps in Children’s Clinical Testing
Cont’d from cover
To correctly interpret clinical test results for pediatric patients, physicians must evaluate results within the context of reference intervals - the range of normal test values appropriate for the age, stage of development, ethnicity, and gender of a child. Now, a groundbreaking study has demonstrated significant inconsistencies with pediatric reference intervals, which are essential to high quality pediatric medical testing. The study completed by laboratory medicine experts at the American Association for Clinical Chemistry (AACC, Washington, DC, USA; www. aacc.org) identifies some of the most pressing issues in this area, thereby paving the way for the medical community to develop more reliable pediatric reference intervals and vastly improve children’s medical care. The pediatric reference intervals in use today are highly inconsistent for a broad range of common clinical laboratory tests, a problem that puts children at risk for inappropriate or even harmful medical care. For example, imprecise reference intervals can lead to a physician missing that a child has a serious medical condition and failing to administer treatment in time. With this in mind, a team of AACC scientists analyzed the reference intervals for several common and important pediatric tests. These reference intervals included those for free thyroxine, thyrotropin, ferritin, hemoglobin, and IGF-1, all of which are crucial for early identification and treatment of various disorders that impact pediatric cognitive and physical development; cystatin C, which is used to predict end-stage kidney disease in children; estradiol (a form of estrogen); and testosterone.
The researchers examined the numerous reference intervals for each of these tests that are published in the scientific literature, as well as those developed and used by individual clinical labs. From this, the team found that many of these pediatric reference intervals are inappropriate for assessing a child’s health or monitoring treatment. The reference intervals for free thyroxine, thyrotropin, ferritin, cystatin C, estradiol, and testosterone were particularly inconsistent, especially during developmental stages where children undergo rapid biochemical changes. As just one example, some pediatric reference intervals for free thyroxine and thyrotropin fail to capture the surge in these two hormones that occurs in the first few days of life, which could lead to incorrect diagnoses of thyroid diseases in newborns. Inconsistencies such as this are due, in part, to the high variability in the age groups used to represent certain life stages during pediatric reference interval development - a finding that is essential to improving these reference intervals in the future. “There is a need to correctly describe the biochemistry of child development, as well as to identify strategies to develop accurate and consistent pediatric reference intervals for improved pediatric care,” said Hubert W. Vesper, PhD, an AACC member and director of clinical standardization programs at CDC, who led the team of AACC scientists. “Continued communication and collaboration between clinicians and their laboratory colleagues ensures appropriate clinical test interpretation and patient assessment and remains essential to effective implementation of common pediatric reference intervals.”
AST Automation System Rapidly Diagnoses Blood Stream Infection for Early Treatment Initiation
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very year, 30 million people worldwide get affected by a blood stream infection, pathologies often caused by antibiotic-resistant bacteria and characterized by up to 30% mortality. In these patients, reducing the time to diagnosis is not simply a good service, as the rapidity of appropriate treatment initiation may decrease their short-term mortality. Thus, any slight improvement in the complex and multitasked workflow that interposes between a blood sample collection and diagnosis can be life-saving. Now, a new antimicrobial susceptibility testing (AST) automation system guarantees the shortest four hours incubation time for positive blood culture samples, thereby reducing the incubation time for blood stream infection patients to allow for early intervention with a targeted antimicrobial therapy. Copan Group’s (Brescia, Italy; www.copangroup.com) Radian is an integrated module of the company’s full lab automation ecosystem that already eases the AST tasks of healthcare professionals by automating antibiotic disks application on WASPLab streaked plates, followed by automated incubation, digital imaging, and interpretation to derive
antibiotic susceptibility results. Disk diffusion is the only antibiotic susceptibility testing that provides a true image of bacterial growth, enabling microbiologists to detect culture purity, heterogeneous growth or colony morphology, as well as antibiotic interactions, to adapt antimicrobial treatment more rapidly.With Radian, automation gets rid of the disadvantages linked to manual disk diffusion while maintaining at the same time its original advantages. Copan has now pushed Radian even further to develop Radian BC. Integrating EUCAST Rapid AST Rules (R-AST) into the automated workflow, Radian BC is the first platform to provide accurate therapy indications for blood stream infection patients with just a four hour incubation period. Like no other AST automation available today, Radian BC guarantees the shortest four hours incubation time for positive blood culture samples. By reducing the incubation time for blood stream infection patients to a quarter, Radian BC ensures to specialists unparalleled rapid diagnostic assessment, directing each patient towards an early intervention with a targeted antimicrobial therapy. LabMedica International June-July/2022
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*Heparinized. GEM, Premier and iQM are trademarks of Instrumentation Laboratory Company and/or one of its subsidiaries or parent companies and may be registered in the United States Patent and Trademark Office and in other jurisdictions. The Werfen logo is a trademark of Werfen and may be registered in the Patent and Trademark Offices of jurisdictions throughout the world. ©2021 Instrumentation Laboratory. All rights reserved.
PRODUCT NEWS
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World’s First Rapid Oral Cancer Test Cont’d from cover
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period of time, even if they’re at low risk, creating anxiety and disruption for the patient, as well as increase in health service costs. On the other hand, if a “mild” case develops into cancer, the patient may have already been discharged from hospital, so they often delay seeking treatment because they don’t think they have cancer. As a result of this delay, treatment is more aggressive, costly and less likely to succeed. Now, researchers have developed the world’s first PCR test for mouth cancer that may improve the early detection of oral cancer. The test developed by researchers at Queen Mary University of London (London, UK; www.qmul.ac.uk) has been named Quantitative Malignant Index Diagnosis System (qMIDS) and has now been proved with patients from China, India and the UK. The test is quick and easy. It only needs the PCR machine used in COVID testing and a technician to operate it. It could be rapidly rolled out around the world at very little extra cost. A tiny sample (the size of half-a-grain of rice) is taken from the suspicious area in the patient’s mouth and the test only takes 90 minutes after reaching the technician – similar to a COVID PCR test. qMIDS diagnostic accuracy would mean that 90% of low-risk patients could be discharged from hospital to go back to their dentist or GP for review. Or they might be tested in the dentist’s surgery and only referred to secondary care if they were high risk. High-risk cases could also be detected in the pre-cancer period and treated definitively, thereby saving the patient’s life with minor surgery, better cure rates and quality of life, as well as a huge reduction in health service costs. The test process is largely automated, removing the need for expensive pathologists. There’s also no need for invasive biopsies. The tests can be carried out on multiple sites when patients have lesions affecting large areas throughout the mouth. “qMIDS dramatically improves our management of mouth cancer and its pre-cancerous state, saving lives and healthcare costs. Surgeons and dentists anywhere in the world can use this test for minimally invasive tissue samples because all it needs is a PCR machine and the technician who operates it,” said Professor Iain Hutchison, co-study lead. “qMIDS will help us identify patients with pre-malignancies that will never transform to cancer, so they can be reassured and discharged from hospital review. Patients with highrisk premalignancy can have minor surgery to remove the lesion before it has transformed to cancer, thereby curing the patient and saving them major surgery, which in turn reduces health service costs. It is a powerful tool especially when used in conjunction with conventional histopathology assessment.” LabMedica International June-July/2022
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To view this issue in interactive digital magazine format visit www.LabMedica.com
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Lipid Measurements Show Potential as Alzheimer’s Disease Biomarkers
rain changes accompanying ageing are varied and can include pathologies that lead to cognitive impairment, the commonest of which is Alzheimer’s disease (AD). Identifying bloodbased signatures of brain health and preclinical pathology may offer insights into early disease mechanisms and highlight avenues for intervention. Previous studies have identified associations between several metabolite classes and imaging markers related to neurodegeneration, including particular lipids and amino acids. Blood metabolites may also present as potential candidates for these associations. Due to their proximity to core biological processes, they are uniquely placed to capture real-time physiological changes and may allow insights into the processes associated with emergence of disease. A team of medical scientists led by the University College London group (London UK; www.ucl.ac.uk) enrolled at age 69-71, 502 participants in Insight 46, the neuroscience sub-study. Accompanying MRI and amyloid-PET imaging data were present for 437 participants. Blood samples were collected by trained research nurses. Samples were stored at - 80° C. Following quality control, concentrations of 1,019 metabolites, detected with liquid chromatography-mass spectrometry, were available for 1,740 participants at age 60-64. The scientists used Ultrahigh Performance Liquid Chromatography-Tandem Mass Spectrometry (UPLC-MS/MS), concentrations of 1,401 metabolites were detected and measured by Metabolon Inc (Durham, NC, USA; www.metabolon.com) among participants. Metabolites were assigned to nine families (lipids, amino acids, xenobiotics, peptides, nucleotides, cofactors and vitamins, carbohydrates, energy and partially characterized molecules) and further organized into pathways. Unknown metabolites were assigned to an “Unknown” family and pathway and denoted by a number prefixed by an “X”; these were included in all analyses. The investigators reported that in the fully adjusted model, three lipid modules were associated with a brain volume measure: one enriched in sphingolipids, one in several fatty acid pathways, and another in diacylglycerols and phosphatidylethanolamines. Twenty-two hub metabolites were
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LabMedica International June-July/2022
associated with an imaging outcome. Some nominal associations were reported for amyloid-β, and with an AD PRS in the genetic analysis, but none survived multiple testing corrections. The authors concluded that their findings highlight relationships between groups of lipids and structural brain measures, as well as key metabolites within these that are likely to be driving associations. Future work should be directed towards understanding if these metabolites associate with longitudinal changes in brain volumes, and whether relationships are causal; this could advance our understanding of brain health and neurodegeneration, and reveal possible targets of intervention. The study was pre-published on April 29, 2022 in the journal medRxiv.
Image: The analysis pipeline used to investigate associations between blood metabolites, later life brain imaging measures, and genetic risk for Alzheimer’s disease (Photo courtesy of University College London)
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PRODUCT NEWS
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MOLECULAR DIAGNOSTIC SYSTEM
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Panther Trax is the latest addition to the Panther Scalable Solutions (PSS) portfolio of products, offering the ultimate in lab automation by physically linking multiple Panther instruments into a single, powerful workcell.
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The Pocketchem BA PA 4140 is a portable blood ammonia analyzer that can measure blood ammonia from whole blood sample anytime and anywhere. It requires a sample of only 20ul of whole blood and uses exclusive reagent strips.
HOLOGIC DIAGNOSTICS
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Multi-Virus Test Offers Results in 30 Minutes Cont’d from cover
method, called DIgitAl plasMONic nanobubble Detection (DIAMOND). The technology is 150 times more accurate than traditional rapid tests and matches the accuracy of polymerase chain reaction (PCR) tests. The new strategy paves the way for much faster results than PCR tests, which often take a day or more for results to be determined. In addition, the tests are inexpensive and do not require complex liquid handling or extensive sample preparation. DIAMOND involves attaching gold nanoparticles to antibodies against the virus being tested. These combination molecules are then mixed with a patient sample from a nasal swab. If the sample contains a virus, the antibodies labeled with gold nanoparticles will bind with proteins on the virus’s surface. The researchers use a syringe to pump the sample into a tube called a microchannel, which is as narrow as a strand of thin spaghetti. The microchannel is mounted on a glass slide placed on a surface. As the liquid flows through the microchannel, it passes through the light of two lasers in a process similar to the way luggage moves on a conveyor to be scanned at an airport.
The first laser activates the gold nanoparticles, which absorb the laser’s energy and expand. If the expansion is strong enough, the nanoparticle will boil the surrounding water, generating vapor bubbles. The size of the nanobubbles is what determines the test result. Large nanobubbles signal the presence of a virus. While the current study focused on respiratory syncytial virus (RSV), Qin said the technology can be applied to other viruses, such as those that cause influenza and COVID19. Researchers also aim to use the platform to identify cancer biomarkers. The technology would need to receive approval from the Food and Drug Administration before it could be made available to the public. The researchers aim to bring the technology to hospitals, labs, drive-thru pharmacies and, eventually, home tests. “If we can detect pathogens earlier, we should be able to save lives,” said Dr. Haihang Ye, research associate in mechanical engineering and co-corresponding author of the study. “Our detection is quick, accurate and sensitive.” Image: Rapid virus test delivers results as accurate as lab tests within 30 minutes (Photo courtesy of University of Texas at Dallas)
Point-of-Care Analyzer Performs Complete Blood Count in 5 Minutes Cont’d from cover
PixCell Medical Technologies, Ltd.’s (Yokne’am Illit, Israel; www.pixcell-medical.com) HemoScreen hematology analyzer is the only 5-part differential CBC analyzer that is FDAcleared, CE-marked and TGA-approved for point-of-care use, offering clinically proven lab-accurate readings of 20 standard blood count parameters within five minutes, with just one finger-prick of blood. PixCell’s HemoScreen delivers lab-accurate diagnostic information that allows healthcare professionals to make
rapid and clinically reliable decisions supported by real-time data. The portable point of care hematology analyzer combines flow cytometry and digital imaging in a single platform for CBC and WBC 5-part differential. HemoScreen employs a patented, disposable cartridge preloaded with all necessary reagents. This reduces reagent waste and eliminates the need for maintenance and calibration, providing CBC results as well as comprehensive abnormal cell flagging for earlier detection of infection and certain cancer
types. “PixCell has transformed routine blood testing by combining novel microfluidics, machine learning and AI into a point-of-care instrument that anyone can operate,” said Dr. Avishay Bransky, co-founder and CEO of PixCell Medical. “Our breakthrough technology is allowing lab-grade testing to become independent from central laboratories and highly skilled experts, putting data in the hands of the medical staff who need it most, when they need it and where they need it.” LabMedica International June-July/2022
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Meet CellaVision at AACC
This year, we are proud to introduce our NEW and complete workflow solution for low-volume hematology laboratories. We will also display solutions for high-volume labs, designed to automate and simplify the process of performing blood and body fluid differentials. Launch event! Make sure to drop by the CellaVision booth for some refreshments and a presentation of our new workflow solution on July 27 at 2PM!
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AUTOMATED URINALYSIS CHEMISTRY ANALYZER BECKMAN COULTER
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The DxU 810c Iris fully automated urinalysis chemistry analyzer features continuous strip loading capability and high throughput with fast turnaround time, bringing a high-capacity urine chemistry analyzer to laboratories.
The LifeTouch gene amplification device uses advanced thermoelectric refrigeration technology and new TAS technology for swifter cooling, accuracy of temperature control, smaller appearance volume, and quieter operation.
PATHFAST is a fully automatic immunoassay analyzer, which combines progressive chemiluminescence technology with the patented Magtration technology to process small patient samples with high accuracy and precision.
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ELISA STRIP READER Awareness Technology, Inc. has updated the design of our popular Stat Fax 4700 microwell strip reader. The update includes a new processor and graphical user interface with a capacitive touchscreen. Improved input response, increased capacity for stored tests, user-friendly icons similar to those found on smartphones and tablets, the same reliability and accuracy you have come to depend on. Instrument QC checks are also available.
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or many parts of the world that do not have access to high-tech labs found in hospitals, detecting viruses such as hepatitis C (HCV) – could save millions of preventable deaths worldwide. Now, scientists have developed a method to detect viruses in very small volumes. The work follows a successful Innovate UK project developing graphene for use in biosensors – devices that can detect tiny levels of disease markers. Biosensors such as this could be used at the point-of-care - opening effective healthcare in difficult-to-reach settings. What makes the detection of viruses in such small volumes possible is the use of a material called graphene. Graphene is extremely thin - only one atom thick - making it very sensitive to anything that attaches to it. By carefully controlling its surface, scientists at Swansea University (Swansea, UK; www.swansea.ac.uk) were able to make the surface of graphene sensitive to the HCV virus. In the future, it is hoped that multiple biosensors can be developed onto a single chip – this could be used to detect different types of dangerous viruses or disease markers from a single measurement. “Highly sensitive and simplistic sensors have never been more in demand with regards point-of-care applications,” said Ffion Walters, Innovation Technologist at Swansea University’s Healthcare Technology Centre. “This collaborative project has allowed us to realise proof-of-concept real-time sensors for HCV, which could be especially beneficial in resource-limited settings or for difficult-to-reach populations.” “At Swansea University, we have now developed graphene-based biosensors for both Hepatitis B and C. This is a major step forward to a future single point of care test,” added Professor Owen Guy, Head of Chemistry at Swansea University. Image: Graphene device chip attached to an electrical connector with two 5 μL HCVcAg samples (Photo courtesy of Swansea University) LabMedica International June-July/2022
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LabMedica International
Wearable Lab on the Skin Simultaneously Monitors Glucose, Alcohol, Lactate in Real-Time
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ost commercial health monitors, such as continuous glucose monitors for patients with diabetes, only measure one signal, thereby leaving out information that could help people with diabetes, manage their disease more effectively. Monitoring alcohol levels is useful because drinking alcohol can lower glucose levels. Knowing both levels can help people with diabetes prevent their blood sugar from dropping too low after having a drink. Combining information about lactate, which can be monitored during exercise as a biomarker for muscle fatigue, is also useful because physical activity influences the body’s ability to regulate glucose. Now, engineers have developed a prototype of a wearable that can continuously monitor several health stats – glucose, alcohol, and lactate levels – simultaneously in real-time. The device developed by researchers at UC San Diego (La Jolla, CA, USA; www.ucsd.edu) is about the size of a stack of six quarters. It is applied to the skin through a Velcro-like patch of microscopic needles, or microneedles, that are each about one-fifth the width of a human hair. Wearing the device is not painful - the microneedles barely penetrate the surface of the skin to sense biomolecules in interstitial fluid, which is the fluid surrounding the cells beneath the skin. Different enzymes on the tips of the microneedles react with glucose, alcohol and lactate in interstitial fluid. These reactions generate small electric currents, which are analyzed by electronic sensors and communicated wirelessly to an app developed by the researchers. The results are displayed in real time on a smartphone. An advantage of using microneedles is that they directly sample the interstitial fluid, and research has shown that biochemical levels measured in that fluid correlate well with levels in blood. The microneedle patch, which is disposable, can be detached from the electronic case for easy replacement. The electronic case, which is reusable, houses the battery, electronic sensors, wireless transmitter and other electronic components. The device can be recharged on any wireless charging pad used for phones and smartwatches. Integrating all these components together into one small, wireless wearable was one of the team’s biggest challenges. It also required some clever design and engineering to combine the reusable electronics, which must stay dry, with the microneedle patch, which gets exposed to biological fluid. The wearable was tested on five volunteers, who wore the device on their upper arm, while exercising, eatC
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ing a meal, and drinking a glass of wine. The device was used to continuously monitor the volunteers’ glucose levels simultaneously with either their alcohol or lactate levels. The glucose, alcohol and lactate measurements taken by the device closely matched the measurements taken respectively by a commercial blood glucose monitor, Breathalyzer, and blood lactate measurements performed in the lab. The researchers plan to further develop the technology for commercialization. Next steps include testing and improving upon how long the microneedle patch can last before being replaced. The researchers are also excited about the possibility of adding more sensors to the device to monitor medication levels in patients and other health signals. advert_LabMedica_June-July2022_EN.pdf 3 30/05/2022 17:20:34 “This is like a complete lab on the skin,” said center director Joseph Wang, a professor of na-
noengineering at UC San Diego. “It is capable of continuously measuring multiple biomarkers at the same time, allowing users to monitor their health and wellness as they perform their daily activities.” “We’re starting at a really good place with this technology in terms of clinical validity and relevance,” said Patrick Mercier, a professor of electrical and computer engineering at UC San Diego. “The beauty of this is that it is a fully integrated system that someone can wear without being tethered to benchtop equipment.”
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AUTOMATED NUCLEIC ACID EXTRACTION SYSTEM BODITECH
URINE SPECIMEN PREPARATION SYSTEM
ELECTROLYTE ANALYZER
NuActor is an automated nucleic acid extraction system, used with a ready-to-use cartridge that can be stored at room temperature. It can extract concentrated high-purity nucleic acids from a small volume of samples.
The MAST URI PREP instrumentation allows urine samples to be dispensed independently, enabling simultaneous reading and validation on MAST URI SYSTEM, leading to significant increase in throughput capacity and workflow convenience.
The K-Lite 5 Series electrolyte analyzer offers detection and calculation of various parameters such as K+, Na+, Cl-, Ca2+, pH. The liquid distribution valve is automatically segmented and flushed throughout the whole process.
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Next-Gen Sequencing for Immunodeficiencies Cont’d from cover
NGS parallelization of DNA sequencing reactions generates hundreds of megabases to gigabases of nucleotide sequence reads in a single instrument run. This has enabled a drastic increase in available sequence data and fundamentally changed genome sequencing approaches in the biomedical sciences. Primary immunodeficiency disorders (PIDs) are a group of heterogeneous disorders caused by germline variants in a large number of genes that are involved in or control immune responses. More than 450 PIDs have been described, and this number is continuing to increase. Despite major advances in the molecular and genetic characterization of PIDs over the last 20 years, timely and accurate diagnosis of PID remains a challenge. This is particularly evident for the more common types of PID, such as common variable immunodeficiency (CVID), where there is a wide spectrum of clinical manifestations and late onset of symptoms. CVID, which affects males and females equally, is the most common of the known PID syndromes, affecting approximately one in 25,000 individuals. It is an immune disorder
characterized by recurrent infections and low antibody levels, specifically in immunoglobulin (Ig) types IgG, IgM, and IgA. Generally symptoms include high susceptibility to foreign invaders, chronic lung disease, and inflammation and infection of the gastrointestinal tract. The intent of a recently published study was to highlight the importance of NGS in the diagnostic workup of patients suspected of having PID. To do this, investigators at the University of Western Australia (Perth, Australia; www. wa.gov.au) recruited 22 unrelated patients with CVID. The subjects all met the formal European Society for Immunodeficiencies–PanAmerican Group for Immunodeficiency diagnostic criteria for CVID and had at least one of the following additional criteria: disease onset at age less than 18 years, autoimmunity, low memory B lymphocytes, family history, and/or history of lymphoproliferation. DNA samples were tested and processed with a next-generation sequencing panel containing 120 different immune genes. Results of NGS analysis identified likely pathogenetic variants in six of the 22 patients (27%). In an additional four patients, variants of unknown
significance (VOUS) were identified. VOUS are genetic variants whose clinical significance is not clear at this stage but might cause the disease. Overall, genetic abnormalities were found in nearly half of the subjects. “Genetic testing was costly to perform and was mostly targeted to DNA sequencing of a single or very small number of genes. Therefore, a genetic diagnosis was limited for many patients with PIDs,” said senior author Dr. Lloyd J. D’Orsogna, senior lecturer in pathology and laboratory medicine at the University of Western Australia. “Recent advances in genetic technology allow affordable testing of multiple genes from the same individual. We can therefore identify a specific gene that may lead to frequent infections in patients. An earlier and more accurate diagnosis may improve the patient outcome and prevent complications. I hope the new age of genetic medicine enables earlier and more accurate diagnosis, likely leading to better treatment and outcomes for all.” The study was published in the May 12, 2022, online edition of The Journal of Molecular Diagnostics.
Paper-Based Sensor Strip Rapidly Detects Sodium in Urine and Blood at POC
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iabetes and kidney sufferers are vulnerable to sodium imbalance, which might create several issues such as nausea, complications, fatigue, reminiscence loss, muscle weak spot, cramps, seizures, and cardiac pain. So, early and straightforward detection of sodium imbalance can be a life-saver. Now, a team of researchers has developed nanotechnology-based paper sensor strips to detect sodium focus in urine and blood serum that could revolutionize scientific analysis. Researchers from the Central University of Kerala (Kerala, India; www.cukerala.ac.in)
spent four years in creating the sodium testing equipment in their lab which specializes in biosensors, web of issues sensors, magnetic area sensors, optical, UV and infrared sensors. The sodium sensor was made by inserting curcumin, a chemical derived from turmeric, on prime of three to nine nanometres-thick copper particles. The curcumin coating protects the nano-copper from getting oxidized. The end synthesized product is an ink-like solution called quantum dots which is used to print the paper strips. The strip reacts with the sodium in urine or blood serum and produces a novel
color by relying on the sodium focus. For urine, the reading must be above 20 mili-equvalence per litre (mEq/ l) and for blood serum, it must be between 135 and 145 mEq/ l, while a reading below 125 could be problematic. Sodium focus detection strategies involving ion-selective electrodes and ion chromatography produce correct outcomes, although their high prices, advanced technology and excessive pattern requirement hamper their utilization on a large scale. However, paper-based dipsticks are cost-effective and user-friendly alternatives that produce rapid results. LabMedica International June-July/2022
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ANTI-DENGUE VIRUS IGM ASSAY
PROLACTIN ELISA TEST
CHEMISTRY ANALYZER
The Chorus DENGUE IgM Capture assay sensitized with human anti-IgM monoclonal antibodies uses the enzyme immunoassay method for the qualitative determination of anti-Dengue virus IgM class antibodies in human serum.
The Prolactin Enzyme-Linked Immunosorbent Assay (ELISA) kit provides materials for the quantitative measurement of prolactin in human serum.
The new BS-600M chemistry analyzer offers high throughput along with industry-leading small footprint, advanced automated sample loading, whole blood HbA1c testing as well as improved ISE with lower consumption.
DIESSE DIAGNOSTICA SENESE
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Smart Diaper Could Provide Quick and Painless Bedside Urinalysis
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he concentration of certain compounds in urine can provide information about many different conditions, including kidney disease, urinary tract infections and electrolyte deficiencies. Though many people with diabetes monitor their glucose levels with blood tests, glucose levels in their urine can also reveal spikes or dips. To analyze urine, however, physicians typically must order a urinalysis from a hospital lab, which takes time, or use paper test strips, which aren’t very sensitive. Neither system can deliver fast, bedside analyses. Now, researchers have designed a flexible sensor that fits in a diaper, measures multiple components in urine and can share those results over Bluetooth to provide real-time bedside analyses for incontinent, elderly or infant patients. Urine can reveal a lot about a person’s health. But physicians don’t currently have a convenient or fast way of tracking the concentration of important compounds in their patients’ urine. Some researchers have explored wearable devices to monitor health markers—like electrolyte and sugar content in sweat. Researchers at the Sun Yat-Sen University (Guangzhou, China; www.sysu.edu.cn) wanted to design a similar type of wearable device that could accurately and sensitively measure the concentration of multiple health markers in urine and give real-time feedback to care providers. The team first fabricated a flexible electrode array about the size of a U.S. quarter. They included five different electrodes on the array that were designed to specifically detect potassium ions, sodium ions, hydrogen peroxide, uric acid or glucose, which are biomarkers for various conditions. Then they connected the array to a circuit board that had a Bluetooth module and lithium-ion battery power source. When the array was exposed to urine samples from three volunteers, it performed as well as a commercial urine test system. Next, the researchers incorporated the array into a diaper and found that, when urine was present, they could get readable signals for the biomarkers. However, they anticipate that in a real-world setting, where dry diapers become slowly saturated with urine, the electrode array would have to take multiple measurements to get stable readings. So, with optimization, this “smart” diaper could be a way to provide quick and painless urinalysis with wearable device technology, according to the researchers. Image: Smart diaper is designed for bedside urine testing (Photo courtesy of Unsplash) LINKXPRESS COM
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LabMedica International
Combining RDTs Determines Dengue Immune Status
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engue is an emerging arboviral infectious disease (DENV), transmitted through the bite of an Aedes mosquito that burdens much of the urbanized tropical and subtropical world. Current dengue diagnostics are primarily concerned with capturing active infections, thus no such method exists for determining primary or post-primary DENV infections, at the point of care. By assaying for changes in both DENV IgM and IgG antibodies, a rise in IgM titers coupled with high and low convalescent IgM: IgG ratios indicate active primary and secondary infections, respectively. Scientists have investigated how combining different rapid diagnostic tests (RDTs) can be used to accurately determine the primary and post-primary DENV immune status of reporting patients during diagnosis. A team of scientist specializing in tropical medicine and led by those at the London School of Hygiene and Tropical Medicine (London, UK; www.lshtm.ac.uk) collected serum from cross-sectional surveys of acute suspected dengue patients in Indonesia (N:200) and Vietnam (N: 1,217) and were assayed using dengue laboratory assays and RDTs. The team used logistic regression modeling, and determined the probability of being DENV NS1, IgM and IgG RDT positive according to corresponding laboratory viremia, IgM and IgG ELISA metrics. Samples were assayed for the presence of DENV1-4 viremia using the CDC fourplex, real-time polymerase chain reaction (RT-PCR) test. The presence of DENV IgM and IgG antibodies was performed using Panbio capture ELISAs (Abbott, East Princeton, NJ, USA; www.globalpointofcare. abbott). The assays detect IgM/G antibodies specific to all serotypes and provide plate-calibrated titer outputs termed ‘panbio units’. Additional RDTs used in the study included DENV NS1 RDT (Bio-Rad, Hercules, CA ,USA; www.bio-rad.com). Among samples from Indonesia, patient serum samples were tested for DENV NS1 using both Abbott’s NS1 capture ELISAs) and NS1 RDTs (SD Biosensor, Suwon, Korea; www.sdbiosensor.com). The investigators reported that combining NS1, IgM and IgG RDTs captured 94.6% (52/55) and 95.4% (104/109) of laboratory-confirmed primary and post-primary DENV cases, respectively, during the first 5 days of fever. Laboratory test predicted, and actual, RDT outcomes had high agreement (79.5% (159/200)). Among patients from the Philippines, different combinations of estimated RDT
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LabMedica International June-July/2022
outcomes were indicative of post-primary and primary immune status. Overall, IgG RDT positive results were confirmatory of post-primary infections. In contrast, IgG RDT negative results were suggestive of both primary and post-primary infections on days 1–2 of fever, yet were confirmatory of primary infections on days 3–5 of fever. The authors concluded that they had described methods for estimating the primary and post-primary immune status of dengue patients at the point of care, using a combination of simple-to-use rapid diagnostic tests. Using all three NS1, IgM and IgG RDTs, they demonstrated how at certain stages of infection health care workers and surveillance operations could confidently determine types of dengue infections. The study was published on May 4, 2022 in the journal PLOS Neglected Tropical Diseases.
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Image: The Panbio Dengue IgM Capture ELISA is used to detect IgM antibodies to dengue antigen in serum as an aid to clinical laboratory diagnosis of patients with clinical symptoms consistent with dengue fever (Photo courtesy of Abbott)
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URINE ANALYZER
PHOTOMETER
CHEMILUMINESCENCE ANALYZER
The R-600S urine analyzer offers outstanding accuracy, easy operation with colorful touch screen, continuous and fast processing with urine test strips, self-system check, auto-calibration, and connectivity.
The DTN-405 photometer offers single and double wavelength test modes and also makes flow-cell and cuvette mode possible. It features an LCD screen that offers real-time-reaction curve display.
The Diazyme DZ-Lite 3000 Plus chemiluminescence analyzer is an FDA 510k cleared user-friendly system that determines reaction mode and determines sensitivity, accuracy and precision of reagents.
DFI CO.
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Machine Learning Drastically Reduces Workload of Diagnostic Cell Counting
Cont’d from cover
have developed the new scheme for training a convolutional neural network (CNN) - a type of machine learning that mirrors the connection structure of the human visual cortex. The number and type of cells in the blood often play a crucial role in disease diagnosis, but the cell analysis techniques commonly used to perform such counting of blood cells - involving the detection and measurement of physical and chemical characteristics of cells suspended in fluid - are expensive and require complex preparations. Worse still, the accuracy of cell analyzer machines is only about 90% due to various influences such as temperature, pH, voltage, and magnetic field that can confuse the equipment. In order to improve accuracy, reduce complexity and lower costs, much research into alternatives has lately focused on the use of computer programs to perform “segmentation” on photographs of the blood taken by a high-definition camera connected to a microscope. Segmentation involves algorithms that perform pixel-by-pixel labeling of what appears in a photo, in this case, what parts of the image are cells and which are not - in essence, counting the number of cells in an image. For images in which only a single type of cell appears, such methods achieve a decent level of accuracy, but they perform poorly when confronting images with multiple types of cells. So in recent years, in attempts to solve the problem, researchers have turned to CNNs. For the CNN to perform this task, it must first be “trained” to understand what is and is not a cell on many thousands of images of cells that humans have manually labeled. Then, when fed a novel, unlabelled image, it recognizes and can count the cells in it. The researchers at Beihang University developed a new scheme for training the CNN, in this case, U-Net, a fully convolutional network segmentation model that has been widely used in medical image segmentation since it was first developed in 2015. In the new training scheme, the CNN is first trained on a set of many thousands of images with only one type of cell (taken from the blood of mice). These single-cell-type images are “preprocessed” automatically by conventional algorithms that reduce noise in the images, enhance their quality, and detect the contours of objects in the image. They then perform adaptive image segmentation. This latter algorithm calculates the various levels of gray in a black and white image, and if a part of the image lies beyond a certain threshold of gray, the algorithm segments that out as a distinct object. What makes the process adaptive is that rather than segmenting out parts of the image segments according to a fixed gray threshold, it does this according to the local features of the image.
Image: New training method allows machine learning to more accurately count blood cells (Photo courtesy of Pexels)
After the single-cell-type training set is presented to the U-Net model, the model is fine-tuned using a small set of manually annotated images of multiple cell types. In comparison, a certain amount of manual annotation remains, and the number of images needed to be labeled by humans drops from what was previously many thousands to just 600. To test their training scheme, the researchers first used a traditional cell analyzer on the same mouse blood samples to do an independent cell count against which they could compare their new approach. They found that the accuracy of their training scheme on segmentation of multiple-cell-type images was 94.85%, which is the same level achieved by training with manually annotated multiple-cell-type images. The technique can also be applied to more advanced models to consider more complex segmentation problems. As the new training technique still involves some level of manual annotation, the researchers hope to go on to develop a fully automatic algorithm for annotating and training models. LabMedica International June-July/2022
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AUTOMATIC CLINICAL CHEMISTRY ANALYZER DIRUI INDUSTRIAL
5-PART HEMATOLOGY ANALYZER SINGUWAY BIOTECH
SARS-COV-2 REACTIVE & NON-REACTIVE CONTROLS RANDOX LABORATORIES
The CS-2000 automatic clinical chemistry analyzer features an intelligent and flexible modular design and has a throughput of 2000 T/H for single module colorimetric throughput and combined four ISE units up to 9600 T/H.
The Cellcount-60 is a 5-part hematology analyzer featuring dual detecting channels, a 10.4-inch full color touchscreen and a throughput of 60 samples per hour. Open sample loading design enables instant initial screening.
Qnostics SARS-CoV-2 Typing are reactive and non-reactive controls intended for use with in-vitro assays for the determination of spike antibodies to SARS-CoV-2. These controls can be used on various analyzers.
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Raman Spectroscopy Based Method Detects Infections in Cystic Fibrosis Patients in Minutes
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ystic fibrosis is an inherited condition that causes sticky mucus to build up in the lungs and digestive system. This causes lung infections and problems with digesting food. Treatments are available to help reduce the problems caused by the condition. Yet recurring infections still dramatically reduce the quality and length of life. The current methods for diagnosing immediate (acute) and longer-term (chronic) infections are complex and time-consuming in the laboratory. For biofilm infections, it can take days from collecting and processing a patient’s sample to achieving a result. This delays effective treatments and impacts patient outcomes. Now, a multi-disciplinary team of researchers has set out to develop a diagnostic tool that would be rapid, accurate and simple-to-use for doctors. Researchers from the University of Southampton (Southampton, UK; www. southampton.ac.uk) have developed a new chemical analysis technique called multi-excitation Raman spectroscopy. This non-invasive method emits a scattering of multiple colors of light into a patient’s sample. The technique has the potential to detect infections in cystic fibrosis patients in minutes rather than days. In future, the simple analysis could be performed on hospital wards to deliver faster and more effective treatment. The approach could also be expanded to target a variety of diseases and counter anti-microbial resistance. Long term infections in the lungs of people with cystic fibrosis are extremely hard to treat. There is evidence that the Pseudomonas aeruginosa bacteria exists as biofilms in the body, protecting the bacteria from antibiotic action and driving antimicrobial resistance. This increases the Booth: 1006 LINKXPRESS COM
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Image: Prototype of the new spectroscopy instrument to detect infection in cystic fibrosis (Photo courtesy of University of Southampton)
urgency for rapid and effective treatment. The Southampton research showed 99.75% accuracy at identifying Pseudomonas aeruginosa and Staphylococcus aureus across all studied strains. This included 100% accuracy for drug-sensitive and drug-resistant Staphylococcus aureus. “Our new Raman spectroscopy based method offers many advantages over resource-intensive, culture-based methods, allowing rapid and label-free analysis,” said Prof Sumeet Mahajan, Head of Chemical Biology and the Associate Director of Institute for Life Sciences at the University of Southampton. “It is reagentless and avoids complex sample-preparation steps with sophisticated equipment. Here, we have developed a method that is highly accurate yet rapid and neither requires nanoscale materials for enhancing signals nor fluorophores for detection.” LabMedica International June-July/2022
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Novel Surrogate Marker Described for Pancreatic Neuroendocrine Tumors
umors of the endocrine pancreas are a collection of tumor cell types collectively referred to as PanNETs. These tumors originate in islet cells. Although they may be similar or identical in histologic appearance to carcinoid tumors of the gastrointestinal tract, differences in their underlying biology and likely differences in response to therapeutic agents suggest that they should be treated and investigated as a distinct entity. Pancreatic neuroendocrine tumor (PanNET) is the second most common solid neoplasm of the pancreas, accounting for 3% to 4% of all pancreas neoplasms. The incidence of this tumor has increased owing to advances in various imaging techniques and increasing awareness. Surgical resection is the main treatment option for localized PanNETs, both functioning and nonfunctioning, without distant metastasis. Pathologists at the University of Ulsan College of Medicine (Seoul, Republic of Korea; http://en.ulsan. ac.kr) assessed the significance of tumor border, a well-known prognostic indicator in other cancers, in the PanNETs. They evaluated the macroscopic growth pattern (expansile [Exp] versus infiltrative [Inf]) and the microscopic tumor border (pushing [Pus] versus Inf) of 203 surgically resected PanNETs and compared them with other clinicopathologic factors. Growth pattern and tumor border were evaluated at the junctions between tumor and normal pancreatic parenchyma or between tumor and other adjacent organs by both gross and microscopic examination. First, macroscopic growth pattern was evaluated in PanNET cases with available gross images of the cut surface of the PanNETs and was classified as expansile or infiltrative pattern. Expansile growth pattern was defined when the tumor had well-delineated margin from adjacent parenchyma. Microscopic tumor border was categorized as pushing or infiltrative. When the tumor boundary was well circumscribed under microscopic examination, this was referred to as a pushing border. Tissue microarray (TMA) was constructed from archived, formalin-fixed, paraffin-embedded tissue blocks with a manual tissue microarrayer (UNITMA Co Ltd, Seoul, Korea; www.unitma.com). The scientists reported that based on macroscopic growth pattern, 83 cases had Exp patterns whereas 84 had Inf patterns. According to microscopic tumor border, 122 PanNETs had Pus borders whereas 81 had Inf borders. Combining macroscopic
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LabMedica International June-July/2022
growth pattern and microscopic tumor border, 65 PanNETs had Exp/Pus, 34 had Inf/Pus, 18 had Exp/Inf, and 50 had Inf/Inf status. PanNETs with Inf/Inf status were associated with higher tumor grade, pT classification, and American Joint Committee on Cancer stage grouping; lymph node metastasis; and lymphovascular and perineural invasion.. Patients with PanNET having Inf/Inf status had significantly shorter overall survival (OS) and recurrence-free survival (RFS). Further, using multivariate analysis, Inf/Inf status was identified as an independent poor prognostic factor of OS and RFS. The authors concluded that the combined Inf/Inf status was observed in approximately 25% of PanNETs and was associated with ag-
gressive biological behavior and short OS and RFS. Therefore, assessing combined macroscopic growth pattern and microscopic tumor border can provide additional information regarding survival and recurrence in PanNET patients. The study was published on May 9, 2022 in the journal Archives of Pathology and Laboratory Medicine. Image: Photomicrograph of histology of pancreatic neuroendocrine tumor (Photo courtesy of Nephron)
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The NT-proBNP-CHECK-1 quantitative antigen test is an in vitro diagnostic (IVD) immunochromatographic rapid test for detection of amino terminal fragment of the Brain Natriuretic Peptide (NT-proBNP) to assess cardiac disorders.
Biossays C8 is an automatic biochemistry analyzer with a high single module throughput of 1600 T/H, two reagent compartments with 72 positions each and a total of 300 sample positions.
The Bioperfectus Monkeypox Virus Real Time PCR Kit is based on real-time PCR technology. Specific primers and probes are based on F3L gene areas of the Monkeypox virus. The kit also contains a housekeeping gene (RNase P) as an IC.
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Two Industry Giants Combine to Form QuidelOrtho
QuidelOrtho’s comprehensive product portfolio covers a wide range of point-of-care tests for infectious diseases, critical cardiac health and autoimmune biomarkers, and a host of clinical and at-home products to detect COVID-19. QuidelOrtho’s core competencies and capabilities include immunoassay development, automated manufacturing, monoclonal antibody characterization and development, molecular assay development, lab-based in vitro diagnostics, blood bank solutions and transfusion pre-screening. QuidelOrtho’s current products fall generally into these categories: (1) visually-read lateral flow, with expertise in infectious disease and reproductive health; (2) direct fluorescent
antibodies (DFA), with expertise in infectious disease and virology; (3) micro-titer production, with a focus on bone and complement pathway markets; (4) fluorescent immunoassay products (Sofia); (5) molecular diagnostic products including the flagship Savanna, an integrated molecular diagnostic system; (6) immunodiagnostics, clinical chemistry and integrated testing systems to serve diagnostic labs of all sizes (VITROS Systems); (7) immunodiagnostic donor screening systems and services that drive blood safety (Ortho Summit/VERSEIA/ VITROS Systems); (8) pre-transfusion testing that automates blood bank workload (VITROS 3600) with software to standardize operations, simplify tasks, and improve productivity
(ORTHO CONNECT); and (9) a combination of service, expertise, technology and data-driven solutions to drive effective, efficient labs (Ortho Care Services & Informatics). “We are very excited to bring together the talented and experienced teams of both Quidel and Ortho who share a commitment to the employees, customers, patients, and the communities we serve,” said Douglas Bryant, Chairman and Chief Executive Officer of QuidelOrtho. “There is a lot of important work ahead of us to deliver on our targeted synergies and new product introductions and we are energized and poised to excel in our combined mission to deliver advanced diagnostics to improve human health.”
Novel Platform Detects Coronavirus Particles with “Slow Light”
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xisting methods for detecting and diagnosing COVID-19 are either expensive and complex or inaccurate. Now, scientists have developed a novel biosensing platform to detect and quantify viral particles using a simple optical microscope and antibody proteins. Their versatile approach, based on slowing down light, could pave the way to new diagnostic tools and next-generation detection platforms that are fast, accurate, and low-cost. Scientists at the Gwangju Institute of Science and Technology (GIST, Gwangju, Korea; www. gist.ac.kr) have developed a new technique to easily visualize viruses using an optical microscope. A key element of their detection platform, called the Gires-Tournois immunoassay platform (GTIP), is the Gires-Tournois "resonance structure," a film made from three stacked layers of specific materials that produce a peculiar optical phenomenon called "slow light." Because of how incident light rebounds inside the resonant layers before being reflected, the color of the platform seen through an optical microscope appears very
uniform. However, nanometer-sized virus particles affect the resonance frequency of GTIP in their immediate vicinity by slowing down the light that gets reflected around them. The "slow light" manifests as a vivid color change in the reflected light so that, when viewed through the microscope, the virus particle clusters look like "islands" of a different color compared to the background. To ensure that their system only detects coronavirus particles, the researchers coated the top layer of GTIP with antibody proteins specific to SARS-CoV-2. Interestingly, not only did the system enable the detection of viral particles, but, by using colorimetric analysis techniques, the researchers could even effectively quantify the number of virus particles present in different areas of a sample depending on the color of the light reflected locally. The overall simplicity of the design is one of the main selling points of GTIP. Given that optical microscopes are available in most laboratories, the method developed by the group could become a valuable and ubiquitous diagnostic and virus research tool. Furthermore,
GTIP is not limited to detecting viruses or strictly dependent on antibodies; any other binding agent works as well, helping visualize all kinds of particles that interact with light. "Compared to existing COVID-19 diagnostic methods, our approach enables rapid detection and quantification of SARS-CoV-2 without needing extra sample treatments, such as amplification and labeling," explained Professor Young Min Song at GIST who led the research group. "Our strategy can even be applied for a dynamic monitoring of target particles sprayed in the air or dispersed on surfaces. We believe that this approach could be the basis for next-generation biosensing platforms, enabling simple yet accurate detection." LabMedica International June-July/2022
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MGISP-Smart 8 is a professional automated pipetting robot, equipped with an independent 8 pipetting channel and a pipetting volume range from 1 μL to 1000 μL. It is adaptable to microplates as well as reservoirs and tubes.
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Autoantibodies Combined With Tumor Markers Detect Lung Cancer
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ung cancer (LC) is one of the most common cancers in the world and is the primary cause of cancer-related death. According to the pathological type, LC can be categorized into small cell LC (SCLC) and non-small cell LC (NSCLC). NSCLC includes squamous cell carcinoma (LSC), adenocarcinoma (LAC), and large cell cancer. Gene mutation and recombination occur in cells in the early stage of disease, and related antigens are released. These antigens are recognized by the immune system, which produces antibodies against the antigen as autoantibodies for lung cancer. The autoantibodies can be detected in the blood during the first five years of imaging diagnosis of LC due to the sensitivity and stability of the immune system. Medical Laboratory Scientist at the Ningbo Medical Center (Ningbo, China; www.nbu.edu.cn) included in a study 780 patients with pulmonary nodules: 633 patients diagnosed with LC and 147 patients with benign lung disease. Among 633 patients with LC, 314 were male with an average age of 60 years (range, 17–83 years), and 319 were female with an average age of 59 years (range, 25–85 years).
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ELISA was used to detect the levels of the autoantibodies (TAAbs), and chemiluminescence immunoassay was used to test the levels of the tumor markers. The diagnostic efficacy of the TAAbs combined with the tumor markers for lung cancer was evaluated by receiver operating characteristic (ROC) curves. Seven TAAbs were detected using assay kits (Hangzhou Cancer probe Biotech Company, Hangzhou, China; http://en.biotests. com.cn) and the levels of the TAAbs were measured with Microplate Reader (ST360, Shanghai Kehua Biotechnology Co., Ltd., Shanghai, China; www.skhb.com). The three tumor markers were detected using Unicel DxI800 (Beckman Coulter, Brea, CA, USA; www.beckmancoulter. com). The team reported that the positive rate of the combined detection of seven TAAbs and three tumor markers in lung cancer (37.8%) was higher than that in the other three groups. The positive rates of SOX2, GAGE7, MAGE A1, CAGE, CYFRA21-1, and SCCA had differences among the four groups. Compared with the benign lung disease group, only GAGE7, CYFRA21-1, and SCCA differed among the groups. The combined sensitivity of the TAAbs was 29.1% (AUC, 0.594), the combined sensitivity of all the markers was 37.8% (AUC, 0.660), and Youden's index was 0.196. In the lung cancer group, CYFRA21-1 had a significant difference in age and sex, and SOX2, MAGE A1, CYFRA21-1, NSE, and SCCA were significantly different in pathological type and tumor–node–metastasis (TNM). In contrast, p53 and GBU4-5 showed no significant differences in age, sex, pathological type, and TNM. The authors concluded that the combination of these seven TAAbs and three tumor markers could be useful in early diagnosis of LC, and the efficiency of combined detection was better than that of individual detection. The study was published on May 21, 2022 in Journal of Clinical Laboratory Analysis. LabMedica International June-July/2022
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BIO-FLASH is a fully automated, random access chemiluminescent analyzer that runs a broad menu of autoimmune assays to provide precise quantification and a wide analytical measuring range (AMR).
The Natch 48 nucleic acid extraction system uses advanced magnetic beads technology. It has a sample type volume of 1-96 tests/batch, extraction time of 10-60 minutes per batch and a working volume of 30-2000uL.
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Tear-Based Method Detects Breast Cancer
ith advances in screening techniques, and adjustment of recommended screening guidelines, mortality rates due to breast cancer continue to decline. Despite the estimated waning in mortality rates, breast cancer still remains the highest cancer diagnosis of women globally. With continued advancement in biomarker identification techniques, there is increasing interest in finding markers of disease in non-traditional biological fluids. Breast cancer associated biomarkers have been identified in urine, nipple fluid aspirate, as well as breast milk. Tear fluid is one of the most underrated biofluids that has been gaining interest in recent years. Scientist at the Namida Lab Inc (Fayetteville, AR, USA; www.namidalab.com) and their medical colleagues examined the ocular proteome to identify protein biomarkers with altered expression levels in women diagnosed with breast cancer. They collected tear samples from 273 participants using Schirmer strip collection methods. Following protein elution, proteome wide trypsin digestion with liquid chromatography/
tandem mass spectrometry (LC-MS/MS) was used to identify potential protein biomarkers with altered expression levels in breast cancer patients. MS/MS analysis using collision-induced dissociation on an LTQ Orbitrap Velos mass spectrometer (Thermo Fisher Scientific, Waltham, MA, USA; www.thermofisher.com). MS data was acquired using the FTMS analyzer in profile mode at a resolution of 60,000 over a range of 375 to 1500 m/z. Selected biomarkers were further validated by enzyme linked immunosorbent assay (ELISA). Standard sandwich ELISA procedures using DuoSets ELISA kits (R&D Systems, Minneapolis, MN, USA; www.rndsystems.com) were used to evaluate the expression level of S100A8 (SA8), S100A9 (SA9), and Galectin-3Binding Protein (LG3BP) in tear samples. The investigators reported that a total of 102 individual tear samples (51 breast cancer, 51 control) were analyzed by LC-MS/MS which identified 301 proteins. Spectral intensities between the groups were compared and 14 significant proteins were identified as potential biomarkers in breast cancer patients. Three bio-
markers, S100A8, (7.8-fold increase), S100A9, (10.2-fold increase), and Galectin-3 binding protein ( 3.0-fold increase) with an increased expression in breast cancer patients were selected for validation using ELISA. Validation by ELISA was conducted using 171 individual tear samples (75 Breast Cancer and 96 Control). Similar to the observed LC-MS/MS results, S100A8 and S100A9 showed significantly higher expression in breast cancer patients. However, galectin-3 binding protein had increased expression in the control group. The authors concluded that their results provided further support for using tear proteins to detect non-ocular systemic diseases such as breast cancer. The work provided crucial details to support the continued evaluation of tear samples in the screening and diagnosis of breast cancer and paves the way for future evaluation of the tear proteome for screening and diagnosis of systemic diseases. The study was published on April 26, 2022 in the journal PLOS ONE.
Inexpensive Diagnostic Tool Enables Rapid Microbial Identification for Positive Blood Cultures
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newly commercialized rapid microbial identification system fully automates the sample preparation steps for reporting phenotypic antibiotic susceptibility results in approximately seven hours direct from positive blood cultures, thereby reducing the time clinicians must wait to determine the most optimal antibiotic therapy for deadly infections. Accelerate Diagnostics, Inc. (Tucson, AZ, USA; www.acceleratediagnostics.com) has announced the commercialization of Accelerate Arc system, which includes its new Accelerate Arc Module and blood culture (BC) kit, having completed IVD registration with the FDA. The Accelerate Arc system unlocks the path to automated, rapid microbial ID for positive blood cultures across the large installed base of MALDI
system users. It can cut hours of wait time, eliminate laborious hands-on sample prep, and offer significant cost savings for healthcare facilities compared to current methods. Designed or labs with MALDI platforms, the Accelerate Arc Module and BC kit is a novel application of inline centrifugation and automated sample prep techniques, which together with the BC kit, provides a suspension of cleaned microbial cells for direct transfer to a MALDI spotting plate. The simple load-and-go workflow eliminates the need for batching multiple specimen tests, cutting hours off the wait for microbial ID results for positive blood cultures. The Accelerate Arc Module requires just 2-3 minutes of hands-on time to run and is simple enough to be used on all shifts, by any laboratory technician, freeing up valuable
technician time by automating the MALDI workflow. Further, this automated, rapid workflow that the Accelerate Arc system avails is the perfect companion to the Accelerate PhenoTest BC kit AST configuration enabling laboratories to report identification and antimicrobial susceptibility test results directly from positive blood cultures days earlier than current standard-of-care methods. "Arc in its early days of commercialization has already generated numerous evaluations and inbound interest from potential commercial partners. Using our system, the total cost to rapidly identify organisms from positive blood cultures is significantly less than what laboratories are paying today for a rapid molecular ID solution," said John Meduri, Chief Strategy Officer for Accelerate Diagnostics. LabMedica International June-July/2022
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LabMedica International
Different Subtypes Defined in Small Cell Lung Cancer
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mall cell lung cancer (SCLC) is a malignant disease associated with a particularly high mortality rate. SCLC is a particularly aggressive cancer that typically occurs in smokers, exhibiting rapid growth and a high propensity for metastasis. Recent studies suggest that SCLC may be differentiated into specific molecular subtypes. However, due to the significant lack of tumor material and the problem of tumor heterogeneity, this information could not be effectively validated in a clinical setting. A large international team of clinical scientists led by the Medical University of Vienna (Vienna, Austria; www.meduniwien.ac.at) examined 386 Central European cases, one of the largest cohorts of surgically treated patients to date. The expression of subtype-specific transcription factors and P53 and RB1 proteins were measured by immunohistochemistry (IHC) in the surgically resected SCLC samples. Signal amplification was performed using Novolink Polymer Detection System kit (Leica Biosystems, Wetzlar, Germany; www. leicabiosystems.com). Correlations between subtype-specific proteins and in vitro efficacy of various therapeutic agents were investigated by proteomics and cell viability assays in 26 human SCLC cell lines. The team also comprehensively profiled protein expression using mass spectrometry-based proteomics in SCLC cell lines to assess the therapeutic relevance of each SCLC subtype. The nLC-MS/MS analysis was performed on an Ultimate 3000 RSLC nano pump (Thermo Fisher Scientific, Waltham, MA, USA; www.thermofisher.com) coupled to a Q-Exactive HF-X mass spectrometer equipped with an EASYSpray ion source. The investigators reported that besides SCLC-A (ASCL1-dominant), SCLC-AN (combined ASCL1/ NEUROD1), SCLC-N (NEUROD1dominant) and SCLC-P (POU2F3dominant), IHC and cluster analyses identified a quadruple-negative SCLC subtype (SCLC-QN). No unique YAP1subtype was found. The highest overall survival rates were associated with non-neuroendocrine subtypes (SCLC-P and SCLC-QN) and the lowest with neuroendocrine subtypes (SCLC-A, SCLC-N, SCLC-AN). In univariate analyses, high ASCL1 expression was associated with poor prognosis and high POU2F3 expression with good prognosis. Notably, high ASCL1 expression influenced survival outcomes independently of other variables in a multivariate model. High POU2F3 and YAP1 protein abundances correlated with sensitivity and resis-
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tance to standard-of-care chemotherapeutics, respectively. Specific correlation patterns were also found between the efficacy of targeted agents and subtype-specific protein abundances. Zsolt Megyesfalvi, MD, a Thoracic Surgeon and first author of the study, said, “In contrast to the increasingly personalized approaches observed in non-small cell lung cancer, SCLC is still considered to be a homogeneous clinical picture and is treated in a standardized way both in hospitals and laboratories. We are now showing that differential expression of key transcriptional regulators clearly distinguishes five major SCLC subtypes.” The author concluded that they have investigated the clinicopathological relevance of SCLC molecular subtypes in a large cohort of surgically resected specimens. Differential IHC
expression of ASCL1, NEUROD1 and POU2F3 defines SCLC subtypes. No YAP1-subtype can be distinguished by IHC. The study was published on April 30, 2022 in The Journal of Pathology.
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Potential Biomarker Found for Sudden Infant Death Syndrome
he term Sudden Unexpected Death in Infancy (SUDI) covers both explained and unexplained deaths. The unexplained deaths are termed Sudden Infant Death Syndrome (SIDS). Despite intensive studies over the past decades, the mechanisms which lead to SIDS remain elusive. It is currently believed that SIDS is not due to a single factor, but is multi-factorial in origin. Acetylcholine (ACh) is a major neurotransmitter of the autonomic nervous system and the principal neurotransmitter of the parasympathetic nervous system. It is hydrolyzed at cholinergic synapses by two enzymes, Acetylcholinesterase (AChE), and Butyrlycholinesterase (BChE) (also known as pseudocholinesterase). Clinical Scientists at the Children’s Hospital at Westmead (Westmead, Australia; www.schn.health.nsw.gov.au) analyzed 722 dried blood samples (DBS) including 67 DBS (58% male) from SUDI infants (26 SIDS and 41 Non-SIDS), and 655 date of birth- and gender-matched controls: SIDS cases, mean age-at death 15.7 (± 8·1) weeks, (4-35 weeks), 54% male and Non-SIDS cases, mean age at death 31.7 (± 30) weeks, (1-103 weeks), 64% male. Total BChE for each sample was quantified using the DetectX Butyrylcholinesterase Fluorescent Activity Kit (Arbor Assays, Ann Arbor, MI, USA; www.arborassays.com) and the signal was read at 510nm with excitation at 390nm. Total protein in each sample was quantified using the BCA (Bicinchoninic acid) Dual Range Protein Detection Kit (Arbor Assays). The specific activity of BChE (BChEsa) was calculated by dividing BChE activity (mU/mL) by the total protein content (µg/ml) giving BChEsa in mU/µg. Results were reported in U/mg. The investigators reported that conditional logistic regression showed that in groups where cases were reported as “SIDS death” there was strong evidence that lower BChE specific activity (BChEsa) was associated with death (OR=0.73 per U/mg, 95% CI 0.60-0.89), whereas in groups with a “Non-SIDS death” as the case there was no evidence of a linear association between BChEsa and death (OR=1.001 per U/mg, 95% CI 0.89-1.13). The authors concluded that BChEsa, measured in dried blood spots taken 2-3 days after birth, was lower in babies who subsequently died of SIDS compared to surviving controls and other Non-SIDS deaths. They concluded that a previously unidentified cholinergic deficit, identifiable by abnormal-BChEsa, is present at birth in SIDS babies and represents a measurable, specific vulnerability prior to their death. The study was published on May 06, 2022 in the journal EBioMedicine. LabMedica International June-July/2022
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News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information
NEWS
EuroMedLab Munich Serves as International Venue for Young Scientists By Dr. Jakob Adler, “Prof. Schenk / Dr. Ansorge & Colleagues” Medical Laboratory for Clinical Chemistry, Microbiology, Infectious Diseases and Genetics, Magdeburg, Germany
E
uroMedLab 2021, originally scheduled for May 2021, was twice postponed due to the SARS-CoV-2 pandemic and finally took place in Munich on April 10-14, 2022. Despite some remaining COVID-19 related constraints, the rescheduled event was a resounding success, featuring a rich scientific program and an attendance of more than 4,500 delegates from over 120 countries, plus some 800 industry-affiliated participants. The congress, also provided an exciting venue for groups of young scientists from the German Society for Clinical Chemistry Photo: The EuroMedLab Munich congress was a resounding and Laboratory Medicine (DGKL), EFLM, and IFCC to meet and success, with over 4,500 delegates participating in a rich conduct discussion rounds. The aim was to enter into a joint ex- scientific program and extensive international exhibition. change regarding their own activities for young scientists.
Photo: IFCC President Adeli addressing the plenum at EuroMedLab Munich Dr. Jakob Adler introduced the "Young Laboratory" section of the DGKL. In addition to a mentoring program, which gives new young members of the DGKL the opportunity to find a suitable mentor for further career planning, the section maintains a cooperation with the Trillium Academy. Here, young scientists can participate in Trillium Academy courses including, Digitalization in Laboratory Medicine with Reference Interval Review (Basic Course and Advanced Course) and Laboratory Data Standardization, with DGKL covering a large portion of the costs. In May 2021, the working group "Digital Competence" was founded under the leadership of Dr. Jakob Adler. This working group aims to strengthen the digital competence of young laboratory physicians by training algorithmic thinking, developing programming skills in R and explaining typical IT buzzwords in a 5-10 minute IT buzzword bingo.
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NEWS
News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information
IFCC Celebrates 70th Anniversary!
O
ver the past decades many outstanding achievements, many important milestones have been accomplished contributing to the IFCC’s mission of “Advancing excellence in laboratory medicine for better healthcare worldwide”. These achievements have not only contributed to the growth of the IFCC but have had an important impact on advancing the science of laboratory medicine and in vitro diagnostics around the world. The future holds considerable promise for the IFCC and its family of national societies and corporate members. The strong foundation built by thousands of IFCC officers over the past decades will ensure the IFCC’s continued journey towards global leadership in laboratory medicine, contributing to its most valuable mission of improving clinical decision making and better healthcare worldwide.
EuroMedLab Munich Serves as International Venue for Young Scientists
Cont’d from page 29
Tara Rolic reported on the EFLM Task Force Young Scientists (TFYS), which was discussed in a kick-off meeting in June 2021 and established in January 2022 to create a communication network for young scientists, residents and young professionals. This network will be used to promote scientific exchange between young scientists. For this purpose, virtual and face-to-face social, scientific and educational meetings will be organized. In the future, the networking of the young scientists of the IFCC and the groups of the National Societies will be strengthened. Dr. Santiago Fares Taie presented the IFCC TF-YS and their programs. To highlight some of them, he mentioned the Professional Scientific Exchange Programme (PSEP) that gives economic support to YS that plan to venture in an exchange programme, the webinar se- Photo: Participants at the Young Laboratory meeting Cont’d on page 32 during EuroMedLab Munich in group photo.
Le rassemblement Francophone de la Biologie Médicale
Pa l a is des congrès
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5èmes journées francophones
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News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information
NEWS
1st IFCC Young Scientists FORUM Held Ahead of WorldLab Seoul 2022
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By Tomris Özben, IFCC TF-YS FORUM Consultant, and Santiago Fares Taie, IFCC TF-YS, Chair
he First IFCC Young Scientists FORUM was held successfully on June 25-26, 2022, just ahead and in conjunction with the WorldLab Congress in Seoul, South Korea. The FORUM was originally planned for 2020, but due to the Covid-19 pandemic, it had been postponed to June 2022. Hence, the participants were happy to finally see the realization of the first IFCC YS-FORUM. The enthusiasm shown by young scientists (YSs), the active participation and the exchange of opinions and experiences during and after the FORUM Photo: Participants at the 1st IFCC Young Scientists FORUM held ahead clearly certifies that it has been a complete achieve- of WorldLab Seoul 2022, in group photo with IFCC President Adeli. ment. Constant evolution and dynamism are two adjectives that well describe our profession, Laboratory Medicine. Young Scientists are the future leaders, but they need to be trained and encouraged to succeed in their role, ideally with the support of experienced leaders. To make this feasible, YSs must have activities that encourage their participation, offer opportunities for training, and improve communication and networking. In order to achieve these aims, JULY 24-28 / CHICAGO, IL / USA in 2019 the IFCC Executive Board (EB) approved the TFYS EB Liaison’s proposal to initiate and hold an “IFCC Young Scientists FORUM” in conjunction with WorldLab congresses. The program of the FORUM was planned in a interactive way, triggering discussion and exchange of ideas. For this, we invited YSs to present a specific topic in 10 slides. The YS presenting these topics were selected according to their experience REGISTER EARLY AND SAVE or training. After each presentaWe are beyond excited to welcome you to Chicago for the tion, session moderators trig2022 AACC Annual Scientific Meeting & Clinical Lab Expo. gered a discussion. For five dynamic days, the 2022 AACC Annual Scientific Regarding to the program, Meeting will align leading scientific minds with curated Ashlin Rapmul (South Africa) topics and more. Experience 250+ educational opportunities including plenary presentations, scientific sessions, and and Udara Senarathne (Sri Lanroundtables. Expand your mind with 275+ expert speakers ka) coordinated the first session and 700+ exhibitors showcasing 200+ product categories. under the theme “The Future Register at meeting.aacc.org Transformation of Lab Medicine In person and digital options available. in a Time of Disruptive Innovations”. During this session we had the interesting lectures of Tara Rolić (Croatia), Mohammed Al Haddad (Palestine), Yunika Puspa Dewi (Indonesia), Ashlin Erwin Garcia, PhD Diagnostics R&D Scientist II, Labcorp Rampul and Udara Senarathne.
THE LAB BEYOND
2022 AACC ANNUAL SCIENTIFIC MEETING + CLINICAL LAB EXPO
Cont’d on page 32
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LabMedica International June-July/2022
NEWS
News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information
IFCC, IFCC-Roche, COLABIOCLI Scholarships Awarded at Latin American Regional Congress
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Leon, Mexico (March 30 - April 2, 2022)
he first group of 2022 Scholarship recipients were selected to attend the XXV Congreso Latinoamericano de Bioquímica Clínica COLABIOCLI, that was held in León (MX), from March 30 to April 2, 2022. These Scholarships are a valuable way to allow young scientists from selected countries to participate in relevant international scientific congresses and conferences. In Leon several scholarships were generously offered by Roche, IFCC and COLABIOCLI. IFCC-Roche Scholarships to: Jhenny Arenas Cordova (Bolivia) and Veronica Isabel Acosta Baruja (Paraguay). IFCC Scholarships to: José Antonio Tesser Poloni (Brazil), Katherine Montoya (Chile), Maria del Rosario Benesperi (Argentina), Romina Medeiros (Uruguay), Eliana Oyuela Aldana (Colombia). COLABIOCLI Scholarships to: Sara Benegas (Paraguay), Isabel Rodriguez Martin (Spain).
Photo: The group of Scholarships recipients at COLABIOCLI Congress In the middle, Dr David Kinniburgh, IFCC Secretary, and Dr. Ana María Lena Rodríguez, COLABIOCLI EB Representative.
1st IFCC Young Scientists FORUM Held Ahead of WorldLab Seoul 2022 Cont’d from page 31
Claudia Imperiali (Spain) and Giulia Sancesario (Italy) coordinated Session 2 under the theme “Training in our profession worldwide and networking”. Speakers selected for this session were Claudia Imperiali, Josep Miquel Bauça (Spain), Udara Senarathne (Sri Lanka) and Elodie Lebredonchel (France). The differences in training programs of each region created an exceptional atmosphere for discussion, permitting us to learn from other colleagues’ experience and pursue for improvements. Session 3 consisted of a visit to a local laboratory. Thanks to the congress organization, the YSs attending the FORUM had the opportunity to visit GC Labs and the laboratory of the SNUH (Seoul National University Hospital). This experience always enriches our knowledge on laboratory organization, sample manipulation, technology, innovation, and laboratory profession. Moreover, this experience always gives us new ideas to implement in our own laboratories. Tamar Ramishvili (Georgia), Othaniel Philip Balisan (Philippines), Sedef Yenice (Turkey), Prasenjit Mitra (India) and Intan W. Masfufa (Indonesia) were the selected speakers for Session 4 coordinated by Santiago Fares Taie (Argentina) and Sean Campbell (USA) under the theme “Laboratory
EuroMedLab Munich Serves as International Venue for Young Scientists
Cont’d from page 30
ries, mentorship interviews and the research booklet. Also, the LAB-SURFING project that builds bridges among YSs from all around the world and improves networking. To conclude, he presented the next Leadership Workshop that will take place virtually in the second semester of 2022. Further to the scientific program of EuroMedLab 2021, more than 60 young scientists met for a social event in the heart of Munich to exchange ideas, get to know each other better and to network. We are curious to see which cooperations will grow out of this in the future. In any case, the first technical questions were discussed internationally and across borders during this evening.
Management, Leadership & Teamwork”. The final session was coordinated by Intan W. Masfufa and Udara Senarathne with the theme “Empowering Evidence-Based Medicine Through Clinical Laboratory Research – Best Practices for Today’s Laboratory Scientists”. Selected speakers for this session were Sean Campbell, Prof Tomris Özben (Turkey), Thumeka Jalavu (South Africa), Antigoni Poulopoulou (Greece) and Mundllamudi Prasad (India). We would like to extend our gratitude and thanks to all those who have made it possible for this FORUM to become a reality. Special thanks to the IFCC President Prof. Khosrow Adeli, who followed the FORUM enthusiastically and made valuable comments. Thanks to the IFCC for its financial support, bringing together young scientists from all over the world and providing them with IFCC-YS grants for travel and accommodation. Thanks to the WorldLab Seoul Congress Organization for waiving the WorldLab registration fees for FORUM participants and providing the FORUM meeting room and its facilities free of charge. Special and heartful thanks to Silvia Colli-Lanzi, along with Smeralda and the entire IFCC team. She has spent a great time and effort since the beginning for the realization of the FORUM. One of the objectives of the IFCC YS FORUM was to foster the creation of an opportunity to establish professional and scientific links/bridges among the YSs. The spirited participation of YS during all sessions and the level of the selected speakers exceeded our expectations. This perfect response and feedback motivate us to quickly start planning our second YS FORUM for the next IFCC WorldLab congress.
IFCC OFFICE
Address: Via Carlo Farini 81, 20159 Milan, ITALY Web: www.ifcc.org Tel: (39) 02-6680-9912 • E-mail: ifcc@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 June-July/2022
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To view this issue in interactive digital magazine format visit www.LabMedica.com
BD to Access Mayo Clinic's Clinical Data Resources
B
ecton, Dickinson and Company (BD, Franklin Lakes, NJ, USA; www. bd.com) has entered into a collaboration with Mayo Clinic Platform (Rochester, MN, USA; www.mayoclinicplatform.org) to access de-identified patient data from Mayo Clinic Platform_Discover to perform detailed postmarket surveillance on its products to fuel innovation and unlock a faster, more efficient path to market, with the ultimate goal of improving patient care. Mayo Clinic Platform_Discover, an enabling product of Mayo Clinic Platform, represents one of the most robust de-identified data sets available from 10 million patients, including both structured and unstructured data, images, 1.2 billion lab test results, three million echocardiograms and more than 640 million clinical notes. Using data mining, next generation artificial intelligence (AI) and machine learning tools, BD will analyze the real-world data - which provides information outside what is typically gathered in a clinical trial - to generate deeper insight into the patient experience that will help the company accelerate and enhance innovation around both existing products and unmet needs.
F
Fujirebio’s Belgian Acquisition Targets Neurodegenerative Diagnostics
ujirebio Holdings, Inc. (Tokyo, Japan; www.fujirebio.com) has announced the acquisition of ADx NeuroSciences (Gent, Belgium; www. adxneurosciences.com) for EUR 40 million in a deal that is expected to close in July 2022, pending the satisfaction of customary closing conditions. Following the completion of the acquisition, ADx NeuroSciences will become a wholly owned subsidiary of Fujirebio Europe NV. ADx NeuroSciences specializes in generating tailor-made antibodies and developing assays for pharma and in vitro diagnostics (IVD) companies. As part of Fujirebio, ADx NeuroSciences will continue to serve its current partners and customers in their diagnostic biomarker development and will continue to expand its portfolio of biomarkers and antibodies to help detect neurodegenerative diseases such as Alzheimer’s disease and Parkinson’s disease. Its current pipeline encompasses, next to several phospho-tau specific antibodies for measurement in plasma, biomarkers targeting synaptic degeneration supporting prognosis of these devastating diseases. Fujirebio will combine the know-how and biomarker portfolio of ADx NeuroSciences with both its own experience in bringing IVD products to the market and its strategic CDMO partnerships that make testing solutions available to the diagnostics industry. The acquisition also concentrates considerable additional know-how, expertise, and resources in the Fujirebio Neuro Center of Excellence.
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Meridian Acquisition Expands Recombinant Protein Capabilities
eridian Bioscience, Inc. (Cincinnati, OH, USA; www.meridianbioscience. com) has acquired, through its subsidiary Meridian Life Science, Inc., substantially all of the assets of EUPROTEIN Inc. (North Brunswick Township, NJ, USA; www.euprotein.com). EUPROTEIN offers custom development and production of high-quality bioresearch reagents, with a particular focus on human and other mammalian proteins and recombinant monoclonal antibodies. The acquisition will help Meridian accelerate its pipeline of new immunological reagents while expanding recombinant capabilities. “We are excited to welcome EUPROTEIN into thse Meridian family,” said Jack Kenny, Meridian Bioscience Chief Executive Officer. “We already extensively work with EUPROTEIN on projects with our Life Science R&D team, and they are well-positioned to help us accelerate our pipeline of new immunological reagents.” “The EUPROTEIN team is delighted to join Meridian,” added Guangli Wang, Ph.D., Founder, and CEO of EUPROTEIN. “Combining our products and capabilities with Meridian’s global reach and stellar reputation for providing the highest quality reagents furthers our vision of making a lasting impact on global healthcare.”
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LabMedica International June-July/2022
Industry News
Qiagen Acquires Polish Enzyme Provider
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IAGEN N.V. (Venlo, Netherlands; www.qiagen.com) has signed agreements to acquire a 96% majority ownership stake in BLIRT S.A. (Gdansk, Poland; www.blirt.eu), a manufacturer of recombinant enzymes for the life science industry. BLIRT develops, manufactures and commercializes standardized and customized solutions for proteins and enzymes as well as molecular biology reagents. Its offering includes proteins and enzymes that are critical to the life sciences industry and diagnostic kit manufacturers, especially for non-COVID-19 applications. QIAGEN is a global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. QIAGEN’s sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. “The addition of BLIRT to QIAGEN brings highly complementary capabilities that will create additional growth prospects for our enzymes and reagents business,” said Thomas Schweins, Senior Vice President and Head of QIAGEN’s Life Sciences Business Area. “BLIRT will also widen our geographic presence, add new sales channels, strengthen our production and R&D capacities and safeguard our supply chains. This acquisition will further strengthen our sample technologies business, one of our five pillars of growth. And it also supports our strategy to focus on attractive growth opportunities in the life science and molecular diagnostic markets and our disciplined approach to value-creating acquisitions.”
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AACC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Awareness Technology, Inc.. . . . . . . . . . . . . 12 Bioperfectus. . . . . . . . . . . . . . . . . . . . . . . . . . 20 Cellavision. . . . . . . . . . . . . . . . . . . . . . . . . . . 11 DiaSys Diagnostic Systems. . . . . . . . . . . . . . . 9 EUROIMMUN. . . . . . . . . . . . . . . . . . . . . . . . . . 8 Feather. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Gold Standard Diagnostics . . . . . . . . . . . . . . 13 IFCC EuroMedLab 2023 . . . . . . . . . . . . . . . . 29 JFBM 2022. . . . . . . . . . . . . . . . . . . . . . . . . . . 30 LabMedica International. . . . . . . . . . . . . . . . . 27 Mast Group . . . . . . . . . . . . . . . . . . . . . . . . . . 24 MedicalSystem Biotechnology. . . . . . . . . . . . 17 Nova Biomedical . . . . . . . . . . . . . . . . . . . . . . 36 Quantimetrix. . . . . . . . . . . . . . . . . . . . . . . . . . 23 Randox. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Sekisui Diagnostics . . . . . . . . . . . . . . . . . . . . 19 Singuway. . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Snibe Diagnostics . . . . . . . . . . . . . . . . . . . . . . 3 Veda Lab. . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Vicolab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Vircell. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 WASPaLM 2022 . . . . . . . . . . . . . . . . . . . . . . 33 Werfen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Werfen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Provided as a service to advertisers. Publisher cannot accept responsibility for any errors or omissions.
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