LabMedica International May 2022 by Globetech

WORLD’S CLINICAL LABORATORY NEWS LEADER ISSN 1068-1760

Vol. 39 No.3 • 5/2022

POC Test Speeds Up Sepsis Diagnostics

DAILY CLINICAL LAB NEWS

Painless Test Simplifies Diagnosis of Allergies and Predicts Success of Immunotherapy

epsis (blood poisoning) is a life-threatening condition that requires immediate medical attention. Early presentation and diagnosis is vital and can increase the chances of survival significantly. However, serious limitations in the current methods for

lthough allergies are widespread, their diagnosis is complex and, depending on the type of allergy, the prospects of success with therapy are not always clear. Skin tests so far have been unpleasant, time-consuming and associated with a certain risk

of triggering an allergic overreaction. Researchers have now developed a novel test that massively simplifies the diagnosis of allergies and can reliably predict the success of a therapy. The allergy test developed by researchers at the University of

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DNA Test Cuts Diagnosis Of Over 50 Genetic Diseases From Decades to Days

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here are about 50 million people suffering from dementia worldwide. Alzheimer’s disease is the most common form and accounts for 6070% of cases. At present there are no disease modifying treatments for Alzheimer’s, and therapies to treat symptoms are limited. The lack of Cont’d on page 12

BioMerieux Acquisition to Expand Offerings in Antimicrobial Susceptibility Testing

Antibody Test Diagnoses MS in 20 Minutes

ultiple sclerosis (MS) is a disease that affects the brain and spinal cord, and can lead to deterioration and permanent damage of the nerves. While its cause is unknown, the disease triggers the immune system to attack the protective coating on nerve fibers. This disrupts signals between the brain and spinal cord. Symptoms vary widely. These symptoms depend on the

Non-Invasive Blood Test Can Accurately Diagnose Alzheimer’s

ntimicrobial Resistance (AMR) is a global threat, with infections from antibiotic resistant pathogens being one of the leading causes of death around the world. For clinicians to save patients’ lives and rapidly optimize therapies, fast

Personalized Cancer Monitoring Platform

Image: Neuronal inclusions in Huntington’s disease (3D illustration).

See article on page 4

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new DNA test can screen a patient’s genome for a whole category of genetic neurological and neuromuscular diseases, including Huntington’s disease, muscular dystrophies and fragile X syndrome.

V I S I T

and accurate antimicrobial susceptibility test (AST) results and interpretation are critical. In addition to improving patient outcomes, rapid AST also reduces global AMR burdens by enabling the implementation of effective instiCont’d on page 22

ver the past several years, research has shown that minimal or molecular residual disease (MRD) monitoring can reliably identify lung cancer patients at high risk of relapse, detect post-surgical recurrence often earlier than standard imaging, assess therapy response, and potentially act as a surrogate for clinical trial endpoints. Now, a newly-available platform can help Cont’d on page 14

INSIDE

COVID-19 Update. . . . . 5 Clinical News. . . . . . 6-20 IFCC News. . . . . . . . . . 23 Product News . . . . . 4-20 Industry News . . . . . . . 21 Events Calendar . . . . . 26

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COVID -19 Diagnostics Update

he report that follows provides a selection of news and advances announced from March 15 to April 30, 2022. For a recap of earlier developments, the reader is invited to refer to previous issues of LabMedica or visit our website at www.LabMedica.com.

COVID-19. The proteins, known as ephrin ligands, could potentially serve as a biomarker to help doctors identify patients who are at risk for serious illness.

COVID-19 PCR Test Identifies All SARSCoV-2 Variants in Positive Patient Sample

KSL Diagnostics, Inc. (Buffalo, NY, USA; www. ksldx.com) has launched the COVID-19 Immune Index which can help monitor the effectiveness of COVID-19 virus protection through a simple blood test. The new assay is the first-of-its-kind antibody test that detects an individual’s immune response to COVID-19 and assesses the risk of infection if subsequently exposed by correlating COVID-19 virus neutralization against a person’s antibody levels.

A new PCR test developed by scientists at by Rutgers University (Newark, NJ, USA; www. rutgers.edu) uses molecular beacons not only to diagnose COVID-19 infection, but also to identify the specific SARS-CoV-2 variant causing that infection. The Rutgers-RP RT-PCR assay can detect mutations in SARS-CoV-2 that have been shown to increase immune escape, avoid neutralization, and increase transmissibility.

Urinary Proteome Analysis Predicts Transition from Moderate to Severe COVID-19

Antibody Test Measures Degree of Immunity from COVID-19

30-Second Coronavirus Test as Good as PCR Test Researchers at the University of Florida (Gaines-

Image: COVID-19 Immune Index monitors effectiveness of COVID-19 virus protection through a simple blood test (Photo courtesy of KSL Diagnostics)

ville, FL, USA; www.ufl.edu) in association with scientists at National Yang Ming Chiao Tung University (Taipei, Taiwan; www.en.nycu.edu.tw) have developed a COVID-19 testing device that can detect coronavirus infection in as little as 30 seconds as sensitively and accurately as a PCR.

Scientists at the National Center for Protein Sciences (Beijing, China; www.ncpsb.org.cn) have found that urine may provide a window for us to see what is happening inside the human body and predict the transition from moderate to severe disease in COVID-19 progression.

Saliva Testing for COVID-19 Preferred to Nasal Swabs A study by investigators at the University of Maryland (College Park, MD, USA; www. umd.edu) has found that genetic testing of saliva samples identifies the SARS-CoV-2 virus more quickly than testing of nasal swabs. The finding has implications for improving public acceptance of COVID-19 testing, reducing the cost of mass COVID-19 screening and improving the safety of healthcare workers who conduct testing.

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Sensor for Faster, Accurate COVID-19 Tests Could Revolutionize Virus Testing A COVID-19 sensor developed at Johns Hopkins University (Baltimore, MD, USA; www.jhu.edu) could revolutionize virus testing by adding accuracy and speed to a process that frustrated many during the pandemic. The sensor, which requires no sample preparation and minimal operator expertise, offers a strong advantage over existing testing methods, especially for population-wide testing.

Test for Proteins in Saliva Could Predict COVID-19 Severity Researchers at the University of Utah Health (Salt Lake City, UT, USA; www.healthcare.utah.edu) have identified a family of proteins that is significantly elevated in the saliva of patients hospitalized with

LabMedica International May/2022

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COVID -19 Diagnostics Update vaccination alone (SP antibodies only).

COVID-19 Breath Test Provides Results in Three Minutes

Image: The team of researchers that developed the Avicena Sentinel saliva sampling approach at Australia’s Perron Institute.

Swab-Based Rapid Test Uses UV Spectrometer to Detect All Variants A nanotechnology research group at the University of Georgia (Athens, GA, USA; www. uga.edu) has developed a swab-based rapid test that uses a UV spectrometer for detection of the spike protein of SARS-CoV-2 and will cover all COVID-19 variants, as well as any future variants.

Rapid, Saliva-Based SARS-CoV-2 Screening System 98% Accurate Researchers at the University of Western Australia Perron Institute (Perth, Australia; www. uwa.edu.au) have developed the Avicena Sentinel saliva sampling approach which involves sensitive molecular processes and ultra-high throughput technology for screening potentially infectious, asymptomatic carriers. A pilot project has validated the feasibility of the rapid, highly sensitive population screening platform for detecting viruses such as those causing COVID-19.

The US FDA has issued a EUA to InspectIR Systems, LLC (San Francisco, CA, USA; www.inspect-ir.com) for its InspectIR COVID-19 Breathalyzer, which is the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection and can provide results in less than three minutes.

COVID-19 Test Differentiates SARSCoV-2 Alpha Variant from Earlier Strains A point-of-care COVID-19 test developed by researchers at the University of Illinois at Urbana-Champaign (Champaign, IL, USA; www. illinois.edu) can detect and differentiate the alpha variant of the SARS-CoV-2 virus from earlier strains in saliva samples. The test uses a pointof-care amplification and testing process, called LAMP, which is more efficient than PCR because it does not require expensive thermal cycling machines.

Nucleic Acid Amplification Test Detects COVID-19 without Instrument Domus Diagnostics (Park City, UT, USA; www.domusdx.com) will soon begin clinical testing of its COVID-19 testing platform that

could significantly address the global need for accessible, rapid, Nucleic Acid Amplification Tests (NAAT) that can be used by an unskilled user anywhere in the world without the need for an instrument or electricity.

Novel Platform Detects Coronavirus Particles with “Slow Light” Scientists at the Gwangju Institute of Science and Technology (GIST, Gwangju, Korea; www. gist.ac.kr) 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.

Blood Test Detects Severe COVID-19 from Preeclampsia in Pregnant Women

SARS-CoV-2 Antibody Test Enables Personalized COVID-19 Assessment The PictArray SARS-CoV-2 assay from Pictor Limited (Auckland, New Zealand; www.pictordx. com) is a first of its kind test will enable high efficacy personalized COVID-19 assessments by detecting if a patient has antibodies from a previous infection of SARS-CoV-2 (from spike protein (SP) and nucleocapsid protein (NP) antibodies) or from

Image: Portable, POC COVID-19 test discerns alpha variant from earlier strains (Photo courtesy of Pexels)

Image: Each hairpin shaped molecular beacon has a specific color and fluoresces when it binds to its target genetic mutation (Photo courtesy of Rutgers University)

Researchers at the Josep Carreras Leukemia Research Institute (IJC, Barcelona, Spain; www. carrerasresearch.org) have identified indicators which enable differentiating between pregnant women who suffer from preeclampsia and asymptomatic COVID-19 or only have COVID-19 with no preeclampsia, thus paving the way for a more accurate diagnosis for both diseases and a better risk assessment. LabMedica International May/2022

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LabMedica International

DNA Test Cuts Diagnosis Of Over 50 Genetic Diseases from Decades to Days

single DNA test has been developed that can screen a patient’s genome for over 50 genetic neurological and neuromuscular diseases such as Huntington’s disease, muscular dystrophies and fragile X syndrome. The diseases covered by the test belong to a class of more than 50 diseases caused by unusually-long repetitive DNA sequences in a person’s genes that are known as ‘Short Tandem Repeat expansion disorders’. A short tandem repeat (STR) is a short DNA sequence motif, typically 2 to 6 base pairs (bp), repeated consecutively at a given position in the genome. Clinical Genomic Scientists from the Garvan Institute of Medical Research (Sydney, Australia; www.garvan.org.au) and their colleagues extracted high–molecular weight (HMW) genomic DNA from patient blood samples using the Qiagen Gentra PureGene Blood Kit (Qiagen, Hilden, Germany; www. qiagen.com) or the QIAsymphony DSP DNA Midi Kit and suspended in nuclease-free water. Before Oxford Nanopore Technologies (ONT) library preparations, the DNA was sheared to ~15-kb fragment size using Covaris G-tubes (Woburn, MA, USA; www.covaris. com) and visualized, after shearing, on an Agilent TapeStation (Santa Clara, CA, USA; www.agilent.com) and Nanopore sequencing libraries were prepared. Each sample was loaded onto an ONT MinION flow cell (R9.4.1) and sequenced on either an ONT GridION or ONT MinION device (Oxford Nanopore Technologies, Oxford Science Park,

UK; www.nanoporetech.com) with live target selection/rejection executed. The team reported that their approach enabled accurate, haplotype-resolved assembly and DNA methylation profiling of STR sites, from a list of predetermined candidates. This correctly diagnoses all individuals in a small cohort (n=37) including patients with various neurogenetic diseases (n=25). Targeted long-read sequencing solves large and complex STR expansions that confound established molecular tests and short-read sequencing and identifies noncanonical STR motif conformations and internal sequence interruptions. They observed a diversity of STR alleles of known and unknown pathogenicity, suggesting that long-read sequencing will redefine the genetic landscape of repeat disorders. They also showed how the inclusion of pharmacogenomic genes as secondary ReadUntil targets can further inform patient care. Ira W. Deveson, PhD, Head of Genomics Technologies and a senior author of the study, said, “‘We correctly diagnosed all patients with conditions that were already known, including Huntington’s disease, fragile X syndrome, hereditary cerebellar ataxias, myotonic dystrophies, myoclonic epilepsies, motor neuron disease and more. They are often difficult to diagnose due to the complex symptoms that patients present with, the challenging nature of these repetitive sequences, and limitations of existing genetic testing methods.” The study was published on March 4, 2022 in the journal Science Advances.

World’s First Bedside Genetic Test Identifies Susceptibility to Deafness in Newborn Babies

new bedside machine takes just 25 minutes to identify whether a critically ill baby admitted to intensive care has a gene that could result in permanent hearing loss if they are treated with a common emergency antibiotic. The world-first genetic test that could save the hearing of babies has been partly developed by The University of Manchester (Manchester, UK; www.manchester.ac.uk) and successfully piloted in the NHS (UK; www.nhs.uk). The new swab test technique would replace a test that traditionally took several days and could save the hearing of 180 babies in England alone every year. People admitted to intensive care are usually given an antibiotic called Gentamicin within 60 minutes. While Gentamicin is used to safely treat about 100,000 babies a year, one in 500 babies carry the gene that can make it cause permanent hearing loss. The new test means that babies found to

have the genetic variant can be given an alternative antibiotic within the ‘golden hour.’ The test is expected to save the NHS GBP 5 million every year by reducing the need for other interventions, such as cochlear implants. The idea for the test came five years ago, and trials started in 2020 with further adaptations and fine-tuning so that the current machine, which is called the Genedrive System, is now fully CE certified to be used in a clinical setting. The team had successfully transferred the accuracy of the machine in the lab to working effectively in a ward. At the same time, clinicians adapted quickly to incorporate the test into their routine care for very sick children in the neonatal ward. The test is now expected to be routinely used in all the hospitals’ neonatal units within weeks. “The successful trial of this bedside test is fantastic news for the hundreds of babies – and Cont’d on page 8

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ISSN 1068-1760

Vol.39 No.3. Published, under license, by Globetech Media LLC; Copyright © 2020. All rights reserved. Reproduction in any form is forbidden without express permission. Opinions expressed are solely those of the authors, and do not represent an endorsement, or lack thereof, by the Publisher of any products or services. Teknopress Yayıncılık ve Ticaret Ltd. Şti. adına İmtiyaz Sahibi: M. Geren • Yazı işleri Müdürü: Ersin Köklü Müşir Derviş İbrahim Sok. 5/4, Esentepe, 34394 Şişli, İstanbul P. K. 1, AVPIM, 34001 İstanbul • E-mail: Teknopress@yahoo.com Baskı: Postkom A.Ş. • İpkas Sanayi Sitesi 3. Etap C Blok • 34490 Başakşehir • İstanbul Yerel süreli yayındır. Yılda sekiz kere yayınlanır, ücretsiz dağıtılır.

LabMedica International May/2022

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Blood Products Use in Trauma-Related Hemorrhagic Shock Patients Questioned

reatment of hemorrhagic shock is now increasingly focused on the early use of hemorrhage control, tranexamic acid, and blood-based resuscitation with packed red cells and plasma. The improved survival from these and other strategies within streamlined trauma systems have been reported in the military and civilian settings, and have stimulated an interest in prehospital transfusion. Extending the use of both packed red blood cells (PRBC) and plasma for major hemorrhage into the prehospital environment might seem intuitive, but has implications for the transfusion and clinical communities. Transfusion specific concerns include sustaining the demand for universal blood products, blood product wastage, and regulatory compliance. Clinical scientists at the Queen Elizabeth Hospital (Birmingham, UK; www.uhb. nhs.uk) and their colleagues carried out a randomized controlled trial of resuscitation with pre-hospital blood products (RePHILL) is a multicenter, allocation concealed, open-label, parallel group, randomized, controlled, phase 3 trial done in four civilian prehospital critical care services in the UK. Eligible participants were randomly assigned to receive either up to two units each of packed red blood cells (PRBC) and LyoPlas or up to 1 L of 0.9% sodium chloride administered through the intravenous or intraosseous route. Sealed treatment packs which were identical in external appearance, containing PRBC–LyoPlas or 0.9% sodium chloride were prepared by blood banks and issued to participating sites according to a randomization schedule. From Nov 29, 2016 to Jan 2, 2021, prehospital critical care teams randomly assigned 432 participants to PRBC– LyoPlas (n=209) or to 0.9% sodium chloride (n=223). The scientists reported that the median follow-up was 9 days (IQR 1 to 34) for participants in the PRBC–LyoPlas group and 7 days (0 to 31) for people in the 0.9% sodium chloride group. Participants were mostly white (62%) and male (82%), had a median age of 38 years (IQR 26 to 58), and were mostly involved in a road traffic collision (62%) with severe injuries (median injury severity score 36, IQR 25 to 50). Before randomization, participants had received on average 430 mL crystalloid fluids and tranexamic acid (90%). Upon arrival to the hospital, the mean hemoglobin concentration was higher in the PRBC–LyoPlas group than in the 0.9% sodium chloride group (133 g/L versus 118 g/L). The composite primary outcome occurred in 128 (64%) of 199 participants

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LabMedica International May/2022

randomly assigned to PRBC–LyoPlas and 136 (65%) of 210 randomly assigned to 0.9% sodium chloride (adjusted risk difference –0.025%). The rates of transfusion-related complications in the first 24 hours after ED arrival were similar across treatment groups (PRBC–LyoPlas 11 [7%] of 148 compared with 0.9% sodium chloride nine [7%] of 137, adjusted relative risk 1.05. Serious adverse events included acute respiratory distress syndrome in nine (6%) of 142 patients in the PRBC–LyoPlas group and three (2%) of 130 in 0.9% sodium chloride group, and two other unexpected serious adverse events, one in the PRBC-LyoPlas (cerebral infarct) and one in the 0.9% sodium chloride group (abnormal liver function test). There were no treatment-related deaths. The authors concluded that the trial did

not demonstrate that PRBC–Lyoplas improved episode mortality or lactate clearance when compared with 0·9% sodium chloride for participants with trauma-related hemorrhagic shock. Based on current evidence, the decision to commit to routine prehospital transfusion in civilian practice will require careful consideration by all stakeholders. The study was published on April 1, 2022 in the journal The Lancet Hematology.

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POC Test Speeds Up Sepsis Diagnostics

detecting the causative pathogens in sepsis present a major obstacle to increasing the speed of diagnosis and thus improving patient outcomes in a condition that is time critical. Now, a bedside instrument for the rapid diagnosis of sepsis could deliver results within a two-hour time window to help the clinical team plan proper management. Great North Research & Innovation (GNRI, Newcastle Upon Tyne, UK; www.gnri-biomed. co.uk) is building a patient focused tool to assist clinicians in determining the causative pathogens in sepsis rapidly and accurately. GNRI’s work aims to improve patient outcomes, to enable optimal treatment pathways and to reduce healthcare costs. Globally, it is estimated that there are 28.5 million patients and 11 million deaths from sepsis each year, and the numbers are increasing at an average rate of 10% annually. Sepsis occurs when an infectious organism is present in large numbers in the blood stream, overwhelming the body’s immune system and leading to a generalized whole-body inflammatory response and shutting down of the vital organs. When a clinician suspects sepsis, several blood tests are carried out in order to reach a definitive diagnosis. The gold standard test for identifying the causative organisms

in Sepsis is currently blood cultures, which require a minimum of 48 hours and up to five days to provide results. Until the results are obtained, patients only receive supportive treatment in the form of oxygen, fluids and broad-spectrum antibiotics. A large proportion do not survive this delay and in many cases, patients become critically ill and die before the results of the tests become available to clinicians. In addition to the increased possibility of mortality and co-morbidities, delays to conclusive diagnosis in cases of sepsis lead to significantly increased costs for healthcare providers. Extended periods of emergency treatment for serious complications arising from infections contribute to an enormous cost burden on the healthcare system. The costs for ongoing care and treatment for recovered patients experiencing troublesome sequalae as a result of sepsis are considerable. Furthermore, the current practices of prescribing broad spectrum antibiotics cause an imbalance in the bacterial population of the body in already weakened patients, and contribute to the proliferation of antibiotic resistance. Thus, the need for an effective solution for the rapid diagnosis of sepsis has never been greater. The easy to use rapid and sensitive GNRI diagnostic system could identify bacteria or

fungi in a blood sample within a two-hour time frame at the patient’s bedside. Using a venous blood sample in a standard vacutainer, the system will handle all aspects of the process: from sample preparation to incubation, to reading and interpretation of results. The initial target is sepsis, but the utility of the system lends itself to multiple applications in other areas of healthcare. GNRI expects to develop a prototype of the device by the end of the year that would be about the size of a laser printer. The GNRI diagnostic system will be ideal for clinics, emergency rooms or high dependency wards and can also be used by non-laboratory personnel. Image: The GNRI diagnostic system is easy to use, rapid and sensitive (Photo courtesy of Unsplash)

World’s First Bedside Genetic Test Identifies Susceptibility to Deafness in Newborn Babies

Cont’d from page 6

their parents - who would otherwise lose their hearing when given this common antibiotic in intensive care situations,” said NHS national medical director Stephen Powis. “The trial demonstrated that you can deploy rapid genetic testing in a clinical setting, and that the tests can be carried out within the ‘golden hour’ when severely unwell babies should be treated with antibiot-

ics,” added Professor Bill Newman, a consultant in genomic medicine at Manchester University NHS Foundation Trust and Professor of Translational Genomic Medicine at the University of Manchester, who led the Pharmacogenetics to Avoid Loss of Hearing (PALoH) study. “Genomic medicine is transforming healthcare, and this is a powerful example of how genetic testing can now be done

extremely quickly and become a vital part of triage - not only in intensive care but across our services,” said Professor Dame Sue Hill, Chief Scientific Officer for England and Senior Responsible Officer for Genomics in the NHS. “It also shows the importance of thinking about how advances in technology can rapidly transform how we use genomics closer to care for our patients.” LabMedica International May/2022

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

LabMedica International

Liquid Biopsy Enables Early Cancer Detection in Li-Fraumeni Syndrome Patients

atients with Li-Fraumeni Syndrome (LFS) harbor germline pathogenic variants in the TP53 gene causing predisposition to many cancers from childhood through late adulthood and can accelerate the onset of cancer by more than 30 years. This aggressive clinical surveillance for early tumor detection is associated with improved survival, but is disruptive to quality of life. For some cancers, conventional screening methods may not be entirely effective. Detection and analysis of circulating tumor DNA (ctDNA) has seen a variety of uses in sporadic cancer including the detection of stages I and II cancers but has not been explored for hereditary cancer syndromes such as LFS. A team of medical scientists led those at the Princess Margaret Cancer Center (Toronto, ON, Canada; www.uhn.ca) collected more than 150 plasma samples from more than 100 LFS patients. The cohort includes both pediatric and adult patients. Each plasma sample underwent shallow genome sequencing (sGS, 1×), cell-free methylated DNA immunoprecipitation (cfMeDIP, 60M clusters), and targeted panel sequencing (20,000×), given sufficient DNA. To date, 53 targeted panel, 96 sGS, and 96 cfMeDIP samples have been sequenced. The team reported that the known germline TP53 variants were identified in 49/53 samples which included exon-level deletions and non-canonical splicing mutations. Using an error suppression method (ConsensusCruncher) and a variant calling pipeline, somatic TP53 mutations were identified in 3/15 cancer positive and 4/38 cancer negative samples. Somatic copy number alterations and tumor fraction were predicted using ichorCNA (Broad Institute, Cambridge, MA, USA; www.broadin stitute.org). Positive predicted tumor fractions were detected in 30/96 samples (12/18 cancer positive). In several cancer positive cases where no somatic TP53 mutation was found, ichorCNA was able to detect copy number alterations and predict positive tumour fraction. The investigators used sGS, and also evaluated DNA fragmentation as previous studies have highlighted the shorter length of ctDNA. On a global scale, they observed an increased proportion of short DNA fragments in LFS samples, regardless of cancer status, and an even greater increase in cancer positive LFS samples compared to non-LFS healthy controls. On a genome-wide scale, LFS patients also consistently exhibited abnormal fragmentation

LabMedica International May/2022

profiles compared to non-LFS healthy controls. Derek Wong, PhD, a postdoctoral fellow and a senior author of the study, said, “Li-Fraumeni is a good proving ground for the “cfDNA in hereditary and high-risk malignancies” (CHARM) consortium due to the overall high risk of developing a variety of cancer types and multiple cancers over the patients’ lifetime. The most common cancers include breast, brain, bone, adrenal, and soft tissue sarcoma, and despite our advances in treatment and understanding of these cancers, early detection is often the best prognostic indicator for survival.” The authors concluded that their approach demonstrated that each individual assay, while sensitive, is not comprehensive. However, in synthesis, targeted panel sequencing, sGS, and

cfMeDIP are capable of accurately and sensitively detecting ctDNA. Their method presents a novel approach to the management of patients with LFS that is both comprehensive, non-invasive, and sensitive. The study was presented at the American College of Medical Genetics and Genomics annual meeting, held March 22-26, 2022 in Nashville TN, USA. Image: Li-Fraumeni Syndrome: a) Highgrade invasive ductal carcinoma with p53 overexpression; b) mutant pattern in a patient with a germline TP53 missense mutation (Photo courtesy of Brigham and Women’s Hospital)

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AUTOMATIC HEMATOLOGY ANALYZER

FLUORESCENT IMMUNOASSAY SYSTEM

ACUTE CORONARY SYNDROME PANEL

PROKAN

SD BIOSENSOR

BIOMERIEUX

The PE-9000 fully automatic 5-part hematology analyzer has a throughput of 60 samples per hour and features a 50 tubes autoloader. It comes with a 10.4-inch touch screen display and one-button automatic analysis.

STANDARD F2400 is a fluorescent immunoassay system designed for easy and reliable measuring of diverse items. It provides LIS connectivity to the majority of existing information systems in hospitals.

The VIDAS Acute Coronary Syndrome (ACS) panel offers three complementary tests for the assessment of myocardial injury - VIDAS Troponin I Ultra, VIDAS CK-MB and VIDAS Myoglobin, performed on instruments of the VIDAS family.

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Antibody Test Diagnoses MS in 20 Minutes

amount of nerve damage and which nerves are affected. Symptoms can be temporary or long-lasting. While no cure for MS has been found, treatments can speed recovery from attacks and manage symptoms. Researchers at Mayo Clinic (Rochester, MN, USA; www. mayoclinic.org) have now validated a new antibody test to diagnose MS that measures kappa immunoglobulin free light chains in cerebrospinal fluid. An antibody typically consists of two immunoglobulin heavy chains and two light chains. There are two types of light chains: kappa and lambda. The validated test measures kappa immunoglobulin free light chains in cerebrospinal fluid. The researchers conclude the test is a valid alternative to a commonly used test to detect oligoclonal bands in cerebrospinal fluid. Oligoclonal bands are proteins that indicate inflammation of the central nervous system. The diagnostic test that detects oligoclonal bands in cerebrospinal fluid requires about four hours of analytical processing. This test is labor-intensive and involves subjective visual interpretation. The Mayo study validates a di-

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agnostic value of 0.1 milligrams per deciliter to measure kappa free light chains. The study’s results are comparable to diagnostic values from tests measuring oligoclonal bands. The study analyzed serum samples from a retrospective cohort of 702 Mayo patients to determine a diagnostic value for measurement of kappa free light chains. Samples from a prospective cohort of 657 Mayo patients were used to validate that value. Of the more than 1,300 patients, 12% were diagnosed with MS. The study estimates a significant cost savings for the new test. Better yet, results are available in about 20 minutes. “Among the advantages of kappa measurement is that it’s a much easier test to run in the laboratory,” says Ruba Saadeh, a research fellow in neuroimmunology in Mayo Clinic’s Department of Laboratory Medicine and Pathology, and the study’s first author. “Our findings represent a cost savings as well as an automated alternative to the arsenal of tests used to diagnose multiple sclerosis.” “The laboratory technologist training can be standardized because of the automation involved in this process, and the subjective visual

interpretation of bands and personnel involvement is substantially reduced,” added Maria Alice Willrich, Ph.D., a Mayo Clinic pathologist and the study’s senior author. Image: Researchers have validated a new antibody test to diagnose multiple sclerosis (MS) (Photo courtesy of Mayo Clinic)

Blood Test Identifies Stillbirth, Placentitis in Women with COVID-19

ecent reports have identified an increased risk of stillbirth in pregnant people infected with SARS-CoV-2. Perinatal pathologists have identified specific placental pathology, termed COVID placentitis, associated with a high risk of stillbirth and poor neonatal outcome. COVID placentitis, characterized by histiocytic intervillositis, increased perivillous fibrin deposition, and villous trophoblast necrosis, has been associated with direct viral infection of the syncytiotrophoblast layer of the placenta. A blood test may identify pregnant

women with COVID-19 who are at higher risk for stillbirth and placentitis. Clinical Scientists at the Northwestern University Feinberg School of Medicine (Chicago, IL, USA; www.feinberg.northwest ern.edu) and their colleagues identified six patients diagnosed with COVID placentitis on pathologic examination and with maternal plasma samples collected and 12 matched controls that had SARS-CoV-2 infection without COVID placentitis. The control cases were matched for gestational age at birth and time between SARS-CoV-2 infection and

delivery. COVID placentitis was diagnosed based on the presence of histiocytic intervillositis confirmed with immunohistochemical staining for CD68 and increased perivillous fibrin deposition in the context of maternal SARS-CoV-2 infection. The percentage of villous parenchyma involved was estimated using both gross and microscopic evidence of involvement. Viral RNA was extracted from clinical specimens utilizing the QIAamp Viral RNA Minikit (Qiagen, Hilden, Germany, Cont’d on page 14 LabMedica International May/2022

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Cervicovaginal DNA Virome Alterations Associated with Genital Inflammation

ervical cancer is one of the most common cancers among women. In 2021, more than 600,000 cases and 340,000 deaths were reported worldwide. In addition to infection with the human papillomavirus (HPV), known risk factors for cervical cancer include immunodeficiency, smoking and oral contraceptive use. The healthy vaginal bacterial microbiome is dominated by Lactobacillus species. Bacterial vaginosis, characterized by low Lactobacillus abundance and overrepresentation of anaerobes, including Gardnerella, Prevotella, Atopobium, Sneathia, Megasphaera, and others, has been associated with HPV infection and cervical intraepithelial neoplasia. Medical Scientists at the Arizona State University (Temple, AZ, USA; www. asu.edu) included in a study a subset of 28 premenopausal, non-pregnant women. Vaginal swabs and cervicovaginal lavage (CVL) samples were collected by a physician. The first vaginal swab was collected using an Eswab collection system with Amies transport medium (Copan Diagnostics, Murrieta, CA, USA; www.copanusa.com) and used for HPV genotyping and 16S rRNA sequencing analyses. CVL samples were collected using 10 mL of sterile 0.9% saline and used for multiplex cytokine and virome analyses. Women were classified as HPV negative or positive. HPV status was determined with a linear array HPV genotyping test (Roche Diagnostics, Indianapolis, IN, USA; www. diagnostics.roche.com), which detects 37 anogenital HPV genotypes. Vaginal bacterial microbiome analysis was performed previously by 16S rRNA gene sequencing using DNA extracted from vaginal swabs and sequenced for 250 cycles on the MiSeq platform (Illumina, San Diego, CA, USA; www.illumina.com). A multiplex cytokine assay was performed using Milliplex MAP human cytokine/ chemokine and Th17 magnetic bead panels (Millipore, Burlington, MA, USA; www.merckmillipore.com). The investigators reported that specific virome alterations were associated with features of the local microenvironment related to HPV persistence and progression to cervical cancer. Cervicovaginal viromes clustered distinctly by genital inflammation state. Genital inflammation was associated with decreased virome richness and alpha diversity and an increased abundance of Anelloviridae species from the genus Alphatorquevirus. Lactobacillus bac-

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teriophages were closely associated with increased Lactobacillus abundance, consistent with phage-host relationships. Interestingly, bacteria-bacteriophage transkingdom interactions were linked to genital inflammation and showed specific interactions with bacterial vaginosis-associated bacteria, including Gardnerella, Prevotella, and Sneathia. The authors concluded that they had identified associations between cervicovaginal DNA virome composition and bacterial microbiome and genital inflammation. Both vaginal Lactobacillus relative abundance and genital inflammation were associated with changes in the cervicovaginal virome. Anelloviridae species, including Alphatorquevirus species, were also associated with genital inflamma-

tion. Additionally, they observed distinct bacteria-bacteriophage transkingdom interactions between established disease-associated bacteria and bacteriophages. The study was published on March 28, 2022 in the journal mSystems. Image: The cobas 4800 HPV test and the cobas HPV test for use on cobas 68/8800 systems are clinically validated and FDA approved (Photo courtesy of Roche Diagnostics)

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At SEKISUI Diagnostics, what matters to you matters to us. Our whole purpose is to partner with you to provide intelligent solutions that enable you to make a timely difference. Because we both understand that there is a patient behind every answer—and that’s what matters most.

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AUTO HEMATOLOGY ANALYZER WITH ESR

URINE ANALYZER

FLUORESCENCE IMMUNOASSAY ANALYZER

MINDRAY IN-VITRO DIAGNOSTICS

URITEST MEDICAL ELECTRONIC

WONDFO

The BC-700 hematology analyzer series, including two open vial models BC-700/BC-720 and two autoloader models BC-760/BC-780, incorporates both complete blood count (CBC) and erythrocyte sedimentation rate (ESR) tests.

The URIT 560 urine analyzer has a throughput of up to 600 tests per hour and can measure 14 parameters including Cr, Ma, Ca, VitC and ACR. It features CIS detectors for faster, more accurate results and comes with touchscreen.

The Finecare FIA Meter is a fluorescence immunochromatographic analyzing system which helps diagnose conditions such as inflammation, diabetes, cardiovascular diseases, renal injury and cancers, and others.

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Blood Test for Skin Cancer May Help Avoid Invasive Skin Biopsies

elanoma is one of the most aggressive skin cancers due to its potential to metastasize widely in the body. The risk of metastasis is increased with later detection and increased thickness of the primary lesion, thus early identification/ surgical removal is critical for higher survival rates. Recent advances in liquid biopsy have proposed less-invasive alternatives for cancer diagnosis and monitoring using minimal invasion at sample collection, and circulating tumor cells (CTCs) have been considered a promising blood-based surrogate marker of primary tumors. Now, new research indicates that testing an individual’s blood can reveal the presence of CTCs. Such tests

may allow patients to forego invasive skin biopsies to determine whether they have skin cancer. For applications in treatment monitoring, researchers at the University of Michigan (Ann Arbor, MI, USA; www.umich.edu) investigated melanoma CTC quantification and molecular profiling using a novel microfluidic device, MelanoBean (MB) chip. The MB chip is a newly optimized platform of the previously reported OncoBean microfluidic device for melanoma. The researchers showed that the test, which uses the Melanoma-specific OncoBean platform conjugated with melanoma-specific antibodies, can be used not only to diagnose melanoma

but also to evaluate whether all cancer cells have been successfully removed after skin cancer surgery. "This is the first comprehensive study of circulating tumor cells - or CTCs - to evaluate the efficacy of surgery using microfluidic systems in melanoma, including changes in the number of CTCs, CTC cluster configuration, and gene expression profiling,” said first author, Yoon-Tae Kang, PhD. “CTCs have the potential to pinpoint treatment resistance and recurrence, and can be a valuable biomarker to non-invasively monitor for disease progression,” added corresponding author Sunitha Nagrath, PhD.

Non-Invasive Blood Test Can Accurately Diagnose Alzheimer’s

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accurate, accessible and affordable diagnostic tools is a major contributor to the absence of effective treatments for this devastating condition. Now, the first non-invasive bloodbased test for the diagnosis of Alzheimer’s disease and other dementias has shown potential to accurately diagnose the disease. Diadem srl (Milan, Italy; www.diademdx. com) has presented data showing that its new AlzoSure Confirm blood test can accurately identify patients with Alzheimer’s disease. AlzoSure Confirm has been developed on the same technology platform that underlies AlzoSure Predict, Diadem’s prognostic blood test that can accurately predict whether or not an individual with early cognitive changes will progress to Alzheimer’s disease up to six years before the condition is fully manifested. The new assay is based on the same U-p53AZ integrative biomarker - a conformational variant of p53 - which has been associated with the pathogenesis of AD in more than 400 studies, with documented interactions with amyloid,

tau and other factors associated with patients’ progression to AD. Diadem’s patented technology has been developed using its U-p53AZ platform. In the latest study presented by Diadem, researchers used a subset of samples from a longitudinal database of almost 500 patients exhibiting different stages of cognitive decline to investigate the full sequence of post-translational modifications (PTMs) of U-p53AZ over the course of the continuum that culminates in Alzheimer’s disease. They discovered that specific PTM “fingerprints,” or signatures, were characteristic of different stages of the progression to AD. AlzoSure Confirm uses the PTM signature characterizing full-fledged Alzheimer’s disease to provide a blood-based biomarker test potentially capable of diagnosing the disease. In the early clinical validation data Diadem presented at AD/PD22, this PTM signature was able to reliably detect patients with Alzheimer’s disease and to distinguish them from patients with other

dementias. “At Diadem, we are committed to developing widely accessible prognostic and diagnostic blood tests capable of accurately identifying individuals who either have Alzheimer’s disease or who will progress to AD in the coming years,” said Paul Kinnon, CEO of Diadem. “Our AlzoSure Predict prognostic blood test has already been validated in large longitudinal clinical studies and will be available in the EU later this year. We are also very excited about our new AlzoSure Confirm test, which has the potential to accurately and specifically diagnose Alzheimer’s disease using a simple blood test. The lack of timely, accurate and affordable diagnostics has hindered progress in developing more effective treatment options for AD patients, and we look forward to working with a variety of partners to produce and report more confirmatory data on AlzoSure Confirm.” LabMedica International May/2022

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

LabMedica International

Deep Sequencing of CD34+ Cells Detects Measurable Residual Disease in AML

onitoring of measurable residual disease (MRD) in patients with acute myeloid leukemia is predictive for disease recurrence and may identify patients who benefit from treatment intensification. Current MRD techniques rely on multicolor flow cytometry or molecular methods, but are limited in applicability or sensitivity. For patients with hematological malignancies such as acute myeloid leukemia (AML) or high risk myelodysplastic syndrome (MDS), the application of allogeneic stem cell transplantation (alloHSCT) often remains the only curative treatment option. Nevertheless, relapse after SCT occurs in 30% to 70% of AML patients and is the major cause of treatment failure, with dismal prognosis and a two-year survival of <20%. Hematologists at the University Hospital Carl Gustav Carus TU Dresden (Dresden, Germany, www.tu-dresden.de) and their colleagues retrospectively analyzed 429 peripheral blood (PB) and 55 bone marrow (BM) samples of 40 AML and high-risk MDS patients, with/without molecular relapse based on CD34+ donor chimerism (DC), in complete remission after alloHSCT. The team evaluated the feasibility of a novel approach for MRD detection in PB, which combines immunomagnetic pre-enrichment and fluorescence-activated cell sorting (FACS) for isolation of CD34+ cells with error-reduced targeted next-generation sequencing (NGS). The investigators reported that enrichment of CD34+ cells for NGS increased the detection of mutant alleles in PB ~1000-fold (median Variant Allele Frequency [VAF] 1.27% versus 0.0046% in unsorted PB). Although a strong correlation was observed for the parallel analysis of CD34+ PB cells with NGS and DC, the combination of FACS and NGS improved sensitivity for MRD detection in dilution studies ~10-fold to levels of 10-6. In both assays, MRD detection was superior using PB versus BM for CD34+ enrichment. Importantly, NGS on CD34+ PB cells enabled prediction of molecular relapse with high sensitivity (100%) and specificity (91%), and significantly earlier (median 48 days, range 0-281) than by CD34+ DC or NGS of unsorted PB, providing additional time for therapeutic intervention. Moreover, panel sequencing in CD34+ cells allowed the early assessment of clonal trajectories in hematological complete remission. The authors have proposed a novel, easily accessible and robust method for ultra-sensitive MRD detection in peripheral blood, which is applicable to the vast majority of AML patients. First results demonstrate the feasibility of targeted deep sequencing on CD34+ cells for early relapse prediction in clinical settings, with superior sensitivity and specificity as compared to chimerism-based MRD assessment or the use of unsorted PB for NGS. The study was published on March 23, 2022 in the journal Blood Advances.

Image: The BD FACSAria III cell sorter is equipped with 4 lasers and the instrument enables multicolor analysis of up to 15 parameters (Photo courtesy of BD Biosciences)

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AUTOMATED HEMATOLOGY ANALYZER

AUTOMATED SAMPLE PROCESSOR

FLOW CYTOMETER

RAYTO LIFE AND ANALYTICAL SCIENCES

HOLOGIC

LUMINEX CORPORATION

The Hemaray 51 is a 5-part differential, 30 parameter automated hematology analyzer that has a throughput of 60 samples per hour. It features a compact design, integral PC, touch screen, printer, and a reagent management system.

The ThinPrep 5000 Processor frees up operators to focus on other tasks with continuous, hands-free processing of the ThinPrep Pap test, ThinPrep Non-Gyn and ThinPrep UroCyte samples with up to 45 minutes of walkaway time.

The Guava easyCyte Flow Cytometers are dynamic and flexible benchtop systems powered by intuitive software that provides greater sensitivity and optional highthroughput capabilities.

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Personalized Cancer Monitoring Platform

detect MRD in patients with solid tumors. Invitae Corporation (San Francisco, CA, USA; www.invitae.com) has announced full access to its Personalized Cancer Monitoring (PCMTM) platform to help detect MRD in patients with solid tumors. Invitae PCM is a pan-cancer, tumor-informed liquid biopsy assay, uses a next generation sequencing (NGS) to analyze DNA (ctDNA) in a patient’s plasma. Invitae PCM uses a novel set of personalized assays based on a patient’s tumor to detect circulating tumor ctDNA in blood, offering the ability to perform risk stratification, response assessment to treatment and detection of cancer recurrence, based on recent studies. In order to identify MRD at an earlier stage than conventional methods before patients clinically relapse, the technology must be sensitive enough to detect ctDNA at very low levels. Additionally, an MRD test with high specificity is also needed to reduce the likelihood of false positive results. The PCM test utilizes advanced technologies to arrive at high levels of sensitivity and specificity, detecting tumor DNA at very low levels of concentrations in peripheral blood. Validation studies demonstrate greater than 99.9% sensitivity

in detecting ctDNA at a 0.008% variant allele frequency. Each assay is custom designed to detect a patient’s unique tumor signature, allowing for personalized results to guide treatment decisions. Invitae PCM requires both blood and tumor tissue samples from the patient to conduct tumor-normal whole exome sequencing (WES). Based on the results, Invitae’s proprietary algorithm selects 18-50 tumor-specific variants to include on the patient’s custom-designed ctDNA panel. This range of variants allows for a balance of highly sensitive and specific MRD detection in cancers that have lower or higher mutational burdens. If an MRD-positive result is obtained at any point in a cancer patient’s journey, the clinician and patient can discuss the implications of the result and the most appropriate treatment or clinical trial options. “Relapse risk stratification is a clinical need for many patients undergoing treatment for solid tumors and is best served by up-to-date molecular tools to complement and improve upon the standard of care methods for recurrence detection,” said Robert Nussbaum, M.D., chief medical officer, Invitae. “The

PCM platform complements current monitoring methods, and has the ability to determine a cancer therapy’s effectiveness earlier than those methods for many patients, allowing clinicians the opportunity to refine treatment options.” “We are excited about PCM availability globally, as this is an evolving area where we have invested over the last year and we believe has the potential to give patients the information needed to understand their recurrence risk to fight and beat the disease,” said Sean George, Ph.D., co-founder and CEO of Invitae. Image: A new liquid-based personalized cancer monitoring platform can help detect disease earlier (Photo courtesy of Invitae Corporation)

Blood Test Identifies Stillbirth, Placentitis in Women with COVID-19

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www.qiagen.com). Testing for SARSCoV-2 presence was performed by qRTPCR with the CDC 2019-nCoV RT-PCR Diagnostic Panel utilizing the N1 probe in SARS-CoV-2 and RNASE P probe for sample quality control. All replicates were amplified and on-target amplification was verified by TOPO cloning (CloneJET PCR Cloning Kit, Thermo Fisher Scientific, Waltham, MA, USA; www.thermofisher. com) and Sanger sequencing of the N1 qPCR product.

The investigators reported that among the patients with placentitis, one had asymptomatic SARS-CoV-2 infection, four had mild infections and one had moderate infection. There was one stillbirth in the placentitis group. Two women with placentitis were viremic, including the patient who had a stillbirth, while viremia was not detected in the group without placentitis. Cloning and Sanger sequencing of the qRTPCR products confirmed specific on-target amplification of SARS-CoV-2 in two samples.

Leena B. Mithal, MD, an assistant professor of pediatric infectious diseases and the lead author of the study, said, “Right now, we don’t know if there’s placentitis until after delivery. We’re laying groundwork for further studies so that in the future, people who are diagnosed with COVID during pregnancy may be able to get a test that will help identify pregnancies that may be at higher risk of stillbirth or fetal distress.” The study was published in the April, 2022 issue of the journal Placenta. LabMedica International May/2022

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Novel System to Accelerate Development of New Diagnostic Tests

nlike polymerase chain reaction, or PCR, tests, which require access to sophisticated labs operated by trained staff, isothermal tests like loop-mediated DNA amplification (LAMP) can offer quick, accurate results by creating interactions between chemicals and the DNA strands contained in patient samples and delivering rapid results at the point of care. However, in many cases, those rapid tests are designed and developed for a specific purpose, which can introduce unnecessary complexity and make it difficult for one test to be easily adapted for use in a different diagnosis. Researchers have now developed a more generalizable approach to the creation of new tests, building a software tool capable of turning the reaction graphs into suggestions as to how chemical primers and reactions could be used to create the desired diagnostic results. The software which helps speed up the process of creating new diagnostic tests could help combat future pandemics, its developers say. The system, developed by a team of bioengineers and chemists from the University of Glasgow (Scotland, UK; www.gla. ac.uk) and Shanghai Jiao Tong University (Shanghai, China; www.en.sjtu.edu.cn), suggests new reaction pathways to accelerate the design and development of new diagnostic assays. It is freely available for other researchers around the world to investigate, adapt and use, can also be used to identify the early stages of non-infectious diseases like cancer, which could help patients receive more timely treatment. The researchers first began by developing reaction graphs – representations of the biomechanical processes which enable rapid diagnostic tests like cross priming amplification (CPA) and LAMP. They probed the effectiveness of the software by using it to design the chemical primers and reactions for four different diagnostic tests – three for infectious diseases and one for cancer, a non-communicable disease. The researchers successfully created a multiplexed test for a form of HIV with high levels of sequence variations, a highly sensitive test for tuberculosis, and a study for analyzing patient clinical samples for the presence of hepatitis B. The team also developed an assay to detect short miRNA sequences relevant in the diagnosis and prognosis of cancers, including oral squamous cell carcinoma, breast cancer and glioma. They used their newly-designed diagnostic assays to test patient-derived samples from clinical laboratories in China. Then, the researchers confirmed their results using separate PCR tests. They tested their results against LAMP diagnostics for the same diseases, finding that their results were more specific and reproducible than

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LabMedica International May/2022

the LAMP tests. “Our programmable system automates a lot of the early trial-and-error work that goes into the development of new tests, and we’ve shown that it can be used to reliably diagnose a useful cross-section of communicable and non-communicable diseases. It’s an exciting discovery, and suggests many potential applications in medicine,” said Professor Jon Cooper, of the University of Glasgow’s James Watt School of Engineering, who is the paper’s lead author. “Our programmable system offers one new route to supporting that kind of fast diagnostic development,” added Dr Julien Reboud, a co-author of the paper from the University of Glasgow. “We’re keen to make it as accessible as possible

to other researchers around the world, so we’ve made all our graphs and data freely available online. We hope that it will be of real use to researchers and clinicians across a wide range of applications, and we look forward to seeing the new applications they will find for the system.” Image: New method of developing diagnostic tests could help tackle future pandemics (Photo courtesy of Pexels)

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URINE SPECIMEN PREPARATION SYSTEM

3-DIFF HEMATOLOGY ANALYZER

MOLECULAR DIAGNOSTIC ANALYZER

MAST GROUP

SFRI

CEPHEID

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 COUNTENDER 20+ is a 3-part differential hematology blood cell counter that uses float discriminators to ensure top performance and provide accurate platelet count at very low levels. It has a throughput of 60 tests per hour.

GeneXpert Infinity-48s is an automated, multimode molecular diagnostic analyzer for on-demand access processing of real-time PCR-based clinical diagnostics. It has a throughput of 1,300 tests per day.

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Double-Antigen Sandwich ELISA Detects Antibodies to Trypanosoma Cruzi

hagas disease (CD), also known as American trypanosomiasis, is a potentially life-threatening vector-borne tropical zoonosis caused by the protozoan parasite Trypanosoma cruzi. The estimated prevalence of CD in 21 Latin American countries where it is considered endemic exceeds five million individuals; CD accounts for approximately 7,500 deaths annually. Indirect immunoassays are the recommended method for chronic Chagas disease diagnosis and its performance relies on the employed antigen preparation. Chimeric antigens have been successfully utilized for chronic CD in vitro diagnosis and efficiently address commonly encountered hurdles arising from the use of recombinant and native antigens. A team of Medical Scientists at the Oswaldo Cruz Foundation (Rio de Janeiro, Brazil; www.portal.fiocruz.br) and their colleagues developed and evaluated four chimeric antigens from T. cruzi (IBMP-8.1, IBMP-8.2, IBMP-8.3 and IBMP-8.4) using a double-antigen sandwich ELISA (DAgSELISA) as the diagnostic platform. To overcome any limitation, peroxidase-labeled (HRP) antigens can be utilized, diagnosing either acute or chronic infection, in a species and immunoglobulin class-independent manner. The team obtained a total of 412 sera from 207 T. cruzi-positive and 205 T. cruzi-negative individuals. Additionally, to evaluate cross-reactivity, 68 sera from individuals with unrelated diseases, as previously defined by parasitological or serological diagnosis, were acquired. The investigators reported that in the phase I study, the areas under the curve of IBMP-8.1, IBMP-8.2, IBMP-8.3 and IBMP-8.4 were 98.7%, 99.5%, 98.6% and 98.8%, respectively. Among the positive samples, IBMP-8.1 antigen classified 53 (25.6%) as false negative, IBMP-8.2, 27

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(13%), IBMP-8.3, 24 (11.6%) and IBMP-8.4, 43 (20.8%), giving sensitivities of 74.4%, 87%, 88.4% and 79.2%, respectively. The only antigen that did not reach 100% specificity was IBMP-8.3, with 96.6%. IBMP-8.3 was also the only molecule to show cross-reactivity with Human T-cell lymphotropic virus (HTLV). The authors concluded that that IBMP-DAgS-ELISA is suitable for the detection of anti-T. cruzi antibodies in areas of co-endemicity with Leishmania spp. The findings also demonstrate the notable capability of all four IBMP proteins to distinguish between T. cruzi-positive and -negative samples. The specificity attained under DAgS-ELISA reached 100% using three of the four chimeric antigens evaluated, IBMP-8.1, IBMP-8.2 and IBMP-8.4. The study was published on March 11, 2022 in the journal PLOS Neglected Tropical Diseases.

BDNF Risk Variant Linked to Brain Inflammation in RRMS Patients

ultiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS) that is nowadays representing one of the main causes of disability in young people. The clinical course of MS is highly variable and reflects the complex pathogenesis characterized by inflammation and neurodegeneration already detectable in the initial stages of the disease. Pro-inflammatory cytokines and chemokines released by autoreactive lymphocytes and activated resident immune cells drive neuroinflammation and the formation of demyelinating white matter lesions. Gray matter involvement in MS is not merely a consequence of chronic axonal damage; it has been proposed that inflammation may play a causal role, a process defined as inflammatory neurodegeneration. Neurologists at the Neuromed Research Institute (Pozzilli, Italy; www. reteneuroscienze.it) and their colleagues explored whether the Brain

Derived Neurotrophic Factor (BDNF) Val66Met polymorphism could influence the inflammatory response in MS. They analyzed the associations between this SNP and the CSF levels of a large set of pro-inflammatory and anti-inflammatory molecules in a group of relapsing–remitting (RR)-MS patients at the time of diagnosis. A group of 218 consecutive RR-MS Italian patients from Central and Southern Italy were enrolled in a study and 71.1% of whom were female, with a median age of 34 years. These patients had been diagnosed a median of three months earlier. Genotyping for BDNF SNP Val66Met was performed on all enrolled patients. Genomic DNA was isolated from peripheral blood leukocytes according to standard procedures using the QIAamp DNA Blood Mini Kit, (QIAGEN LLC, Germantown, MD, USA; www.qiagen.com). The BDNF region containing the Val66Met polymorphism was analyzed with a TaqMan Validate SNP Genotyping Assay using the ABI-Prism 7900HT Cont’d on page 17

LabMedica International May/2022

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LabMedica International

Diabetic Kidney Disease and Risk of Incident Stroke

therosclerotic cardiovascular disease (ASCVD) is a significant cause of morbidity and mortality among people with type 2 diabetes (T2D). The huge burden of ASCVD in T2D, mainly coronary artery disease (CAD) and stroke, constitutes a major public health problem in this population and accounts for significant disability and healthcare costs. Diabetes mellitus is associated with a 3-fold greater age-adjusted risk of stroke and a higher post-stroke mortality. The increased burden of stroke in individuals with T2D is driven in large part by the high prevalence of the metabolic syndrome components in this population. However, accruing evidence suggest that other factors such as diabetes-related microvascular complications might play a roll. Indeed, diabetic retinopathy was found to be associated with higher risk of stroke in people with T2D. A team of medical scientists collaborating with those at SOVAH Health (Danville, VA, USA; www.sovahhealth.com) included in their study a total of 9,170 participants; mean age: 62.8 ± 6.6 years, 38.2% women, 62.9% white. Of the entire sample, 62.2% of participants had no chronic kidney disease (CKD); 13.3%, CKD G1; 14.1%, CKD G2; and 10.5%, CKD G3. Urine albumin-to-creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR) were assessed at baseline. Urine microalbumin was assayed on spot urine by immunonephelometry on a BN II nephelometer (Siemens Healthineers, Erlangen, Germany; www.siemens-healthineers.com). Urinary albumin excretion was estimated as the urine albumin-to-creatinine ratio (UACR) in mg albumin/g of creatinine. eGFR was calculated in mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. Serum and urine creatinine was measured via enzymatic methods on a Roche Double Modular P Analytics automated analyzer (Roche Diagnostics, Indianapolis, IN , USA; www.diagnostics.roche.com). The scientists reported that over a median follow-up of 4.9 years, 156 participants developed a stroke (incidence rate 3.6/1000 person-years. After adjusting for relevant confounders, higher UACR and lower eGFR were each associated with increased risk of stroke. Compared to UACR < 30 mg/g, moderate albuminuria and severe albuminuria were associated with increasing hazards for stroke (HR 1.61 and 2.29 respectively). Compared to eGFR of ≥ 60 mL/min/1.73 m2, decreased eGFR (eGFR < 60 mL/min/1.73 m2) was associated with higher risk of stroke (HR 1.50). Compared to no CKD, worsening CKD stage was associated with an increasing risk of stroke (HRs of 1.76 for CKD G1, 1.77 for CKD G2,

and 2.03 for CKD G3). The authors concluded that in a large and diverse cohort of adults with type 2 diabetes, higher UACR, decreased eGFR, and worsening CKD stages were associated with increased risk of stroke, independently of other stroke risk factors. The study was published on March 29, 2022 in the journal BMC Medicine. Image: The BN II System is an easy-to-use, reliable nephelometric analyzer that offers a broad range of protein assays (Photo courtesy of Siemens Healthineers) RS TO LY IBU APP R T O DIS ED T IT INV

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BDNF Risk Variant Linked to Brain Inflammation in RRMS Patients

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Sequence Detection System (Applied Biosystems, Foster City, CA, USA; www.thermofisher.com). In 210 MS patients, the CSF concentrations of inflammatory cytokines were analyzed using a Bio-Plex multiplex cytokine assay (Bio-Rad Laboratories, Hercules, CA, USA; www.bio-rad.com). The scientists reported that among the patients, 12 had two copies of Val66Met (5.5%) and 70 had one copy (32.1%). The remaining 136 people had no copies of this variant (62.4%). Using a machine-learning algorithm that examined the levels of 27 inflammatory molecules, the team found that a combination of several molecules, including TNF, IL-8, and MCP-1, was significantly higher in people with either one or two copies of the variant (called Met carriers). Specifically, median TNF levels in Met carriers was 2.8 pg/mL compared with 1.95 pg/mL for non-carriers. IL-8 levels were a median of 23.8 pg/mL for Met carriers and 19.4 pg/mL for non-carriers, while MCP-1 levels rose from a median of 120.8 pg/ mL in non-carriers to 139.4 pg/mL in carriers. The authors concluded that for the first time an association between the BDNF Val66Met polymorphism and central inflammation in MS patients at the time of diagnosis. The findings suggest a role for this polymorphism in both inflammatory and neurodegenerative processes and may contribute to explaining its complex influence on the MS course. The study was originally published on February 10, 2022 in the journal Genes.

LabMedica International May/2022

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Painless Test Simplifies Diagnosis of Allergies and Predicts Success of Immunotherapy

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Bern (Switzerland; www.unibe.ch) not only greatly simplifies diagnosis, but can also reliably predict the success of immunotherapy. Type I allergy occurs when the body produces immunoglobulin E (IgE) class antibodies in response to allergens. The IgE antibodies are bound by IgE receptors on the surface of specialized immune cells in the body called mast cells. Subsequent contact with the same allergens then leads to activation of the mast cells and therefore to the release of inflammatory mediators such as histamine or leukotrienes, which are responsible for the allergic symptoms. For their novel allergy test, the researchers developed a new in vitro cell culture which, with the help of a few molecular biological techniques, can generate almost any desired

number of mature mast cells – and this within a few days. These mast cells contain IgE receptors on their surface and behave very similarly to mast cells in the human body when they are exposed to IgE and allergens. In the test, these mast cells are brought into contact with blood serum from allergic individuals – thereby binding the IgE antibodies from the serum to the cells – and then stimulated with the allergens to be tested. At this point, the activation of the cells can be quantified very easily and quickly using so-called flow cytometry. In order to be able to perform a large number of tests, the researchers have developed a high-throughput approach in which up to 36 conditions can be measured in a single test tube. This makes possible the testing of either multiple allergens with one blood serum or

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multiple sera together for the same allergen. In addition to the initial diagnosis of allergies, the researchers hope the test will have other major applications. According to the researchers, the test also has great potential for monitoring therapeutic success and the duration of action for new allergy medications in clinical trials, as well as for determining possible allergic reactions and for quality control of food products. “We are confident that with our test we will be able to measure within a few months after the start of an immunotherapy whether the therapy is effective and to what extent,” said Thomas Kaufmann from the Institute of Pharmacology at the University of Bern. “This would be an important aid in the decision-making process for the allergologist treating the patient, whether it makes sense to continue the therapy or not.” “Another important advantage is that the test works with serum, which is very stable and can be stored frozen for a long time, which also allows retrospective tests and studies. In contrast, other comparable tests use whole blood, which cannot be stored and must be processed within hours,” added Alexander Eggel from the Department for BioMedical Research (DBMR) at the University of Bern and the Department of Rheumatology and Immunology, Inselspital, Bern University Hospital. Image: Novel test simplifies diagnosis of allergies (Photo courtesy of Pexels) LabMedica International May/2022

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

LabMedica International

Rapid Test Predicts Sepsis Soon After Infection and Before Organ Damage

epsis is among the leading causes of death in hospitals. In the clinic, sepsis is diagnosed by a symptom-based approach that may include kidney or liver failure, blood clotting or bleeding - which often occurs well after permanent organ damage. Thus, molecular diagnostics that detect infection at early stages of disease to minimize host injury are sorely needed. In a potential paradigm change for sepsis diagnostics, a new test predicted sepsis soon after infection in mice - well before blood clotting and organ failure - enabling early antibiotic treatment and markedly increased survival. The findings of the collaborative study led by scientists from UC Santa Barbara (Santa Barbara, CA, USA; www.ucsb.edu) provide a platform to develop rapid and easy-to-perform clinical tests for early sepsis detection and clinical intervention in human patients. The team succeeded in detecting a catastrophic shift in blood protein abundance soon after infection that can predict sepsis well before disease symptoms and organ damage arise. To carry out the test, a small amount of blood was collected and analyzed for an increase in coagulation proteins that are induced but inactive at early stages of infection. Such detection enabled early antibiotic treatment - well before activated coagulation proteins induced blood clotting - resulting in markedly increased survival in mice. The technology is open source and freely accessible to all. The study also demonstrated that antibiotics

are less effective after blood proteins increase in response to infection. Treatment failure may be due to host injury triggered by excessive blood clotting, providing insight into why delays in antibiotic treatment in human sepsis are associated with increased risk for death. The researchers demonstrated that the changes in blood proteins soon after infection observed in mice were similar to that reported for human sepsis. Thus, they are optimistic that these findings are translatable for the early detection and treatment of sepsis in humans. “The key finding was identifying proteins in the blood that arise very soon after infection - well before overt disease symptoms,” said professor Michael Mahan of UC Santa Barbara, who led the project. “Early detection is critical for clinical intervention to increase survival in sepsis patients.” “The future plan is to identify a biopanel of early sepsis blood proteins for incorporation into existing blood tests, enabling sepsis prediction well before excessive blood clotting and permanent organ damage,” explained UCSB scientist Douglas Heithoff who was a part of the research team. “Currently, one in four patients die of sepsis, with many survivors experiencing lifelong debilitation with cognitive decline,” added UCSB scientist Scott Mahan who participated in the project. “We hope technologies like this offer new ways of delivering state-of-the-art molecular diagnostics that predict sepsis before permanent injury occurs.”

Image: New test predicts sepsis soon after infection — well before blood clotting and organ failure (Photo courtesy of Unsplash)

Automated Systems Compared for Vancomycin MIC Values for MRSA Bacteremia

taphylococcus aureus bacteremia is associated with significant morbidity and mortality. Compared with methicillin-susceptible isolates, methicillin-resistant Staphylococcus aureus (MRSA) increases hospital length of stay (LOS), hospital costs, duration of bacteremia, and mortality. Variability in minimum inhibitory concentration (MIC) with automated susceptibility testing instruments may influence methicillin-resistant Staphylococcus aureus (MRSA) treatment. A large meta-analysis of 22 studies reported that elevated vancomycin MICs ≥1.5 mg/L were independently associated with reduced treatment response, specifically higher mortality and treatment failure. Cliical Scientists at The Medical Center at The University of Texas (Austin, TX, USA; www.uthealthaustin.org) evaluated the difference in vancomycin MIC values and the impact on vancomycin alternative therapy utilization for patients with MRSA bacteremia using the MicroScan from May 2013 to December 2016 (Beckman Coulter, Brea, CA, USA; www.beckman.com) and VITEK 2 from June 2017 to February 2020 (bioMérieux, Hazelwood, MO, USA; www.biomerieux-usa. com) automated systems. The team carried out a retrospective multicenter cohort study

LabMedica International May/2022

of adult patients with MRSA bacteremia. Adult patients ≥18 years old were included if they had ≥1 positive blood culture for MRSA, received vancomycin within 48 hours of first positive blood culture, and received ≥72 hours of MRSA therapy with in vitro activity and patients were stratified by susceptibility testing. The investigators reported that a total of 193 patients were included for analysis: 89 in the MicroScan group and 104 in the VITEK 2 group. Vancomycin alternative therapy use was higher in the MicroScan group than the VITEK 2 group (56.2% versus 20.2%). Median MIC value was 2 mg/L and 1 mg/L for MicroScan and VITEK 2, respectively. Median hospital LOS was shorter in the VITEK 2 period (16 versus 12 days). Thirty-day mortality (10.1% versus 7.7%; and 90-day readmission (34.8% versus 29.8%) did not significantly differ between MicroScan and VITEK 2 groups. The authors concluded that implementation of VITEK 2 from MicroScan resulted in lower vancomycin MRSA MIC and less use of vancomycin alternatives. Length of hospitalization was also decreased in the VITEK 2 cohort. The study was published in the April 2022 issue of the International Journal of Infectious Diseases. LINKXPRESS COM

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Pediatric Antiphospholipid Syndrome Diagnosis Methods Reassessed

ntiphospholipid syndrome (APS) is a systemic autoimmune disease characterized by thrombotic events and/or pregnancy morbidity in the setting of persistently positive antiphospholipid antibodies (aPL). APS is rare in children and known to cause inflammation and recurring, potentially fatal, blood clots. Two-thirds of children with the autoimmune disease experienced additional symptoms not formally associated with APS, including low platelet counts, hemolytic anemia and livedo reticularis, a rash indicating abnormal blood flow to the skin. Rheumatologists at the University of Michigan (Ann Arbor, MI, USA; www.umich.edu) and their colleagues conducted a retrospective review of pediatric APS at a tertiary referral center. The electronic medical record system was queried from 2000 through 2019, and 21 cases were included. Antiphospholipid antibody (aPL, [anti-β2GPI and anti-cardiolipin]) were measured at by the QUANTA Lite ELISA (Werfen, Bedford, MA, USA; www.werfen.com) prior to 2015. Since 2015, aPL has been quantified via a multiplex assay using the BioPlex 2200 System (Bio-Rad Laboratories, Hercules, CA, USA; www.biorad.com). The team also captured positivity of other autoantibodies where available. The antinuclear antibody test (ANA) was done by immunofluorescence assay (IFA) with a positive result at a titer of 1:80 or greater. Anti-double-stranded-DNA was done via chemiluminescent immunoassay. Anti-Sm and anti-chromatin testing was done via an extractable nuclear antibody panel for which the test methodology is a multiplex flow immunoassay. Also included was the lupus anticoagulant panel that included prothrombin time (reference range 9.4 – 12.2 s) with INR, partial thromboplastin time (reference range 21.0–29.0 s), dilute Russell’s viper venom test (DRVVT). The phosphatidylserine/prothrombin antibody IgG and IgM panel was a Werfen ELISA. The scientists reported that 21 patients were included with a median age at diagnosis of 16 years and median follow-up of 5.8 years. Secondary APS was slightly more common than primary APS (11 versus 10 cases) and was primarily diagnosed in the context of systemic lupus erythematosus. Two thirds of patients (67%) also had “non-criteria” manifestations of APS including thrombocytopenia, autoimmune hemolytic anemia, and livedo reticularis/racemosa. Almost half of patients (43%) had recurrent thrombosis, typically when patients were sub-therapeutic or non-adherent with anticoagulation. Damage Index

in Patients with Thrombotic APS (DIAPS) scores indicated a chronic burden of disease in both primary and secondary APS patients. Jacqueline Madison, MD, a Rheumatologist and lead author of the study, said, “Beyond clots, there is not one definitive feature of this rare disease in children; rather, there is a constellation of symptoms we found among these patients. If we can prove these symptoms are related to the condition, then physicians should be able to test for APS sooner and diagnose the disease earlier to prevent potentially catastrophic clots.” The authors concluded that with regards to laboratory testing for APS, anti-PS/PT could be considered as an additional aPL lab test in patients for whom clinical suspicion of APS is high. ANA may not be positive in APS, particularly primary APS, and so it should not be used as a screening test for APS in pediatric patients. The study was published on February 22, 2022 in the journal Pediatric Rheumatology. Image: Livedo Reticularis: this is one of the most important physical signs in Antiphospholipid syndrome (APS) and is felt by many physicians to be an additional risk factor for the risk of APS clinical events, over and above the presence of antiphospholipid antibody (Photo courtesy of Graham Hughes and Shirish Sangle) LabMedica International May/2022

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

Industry News

Roche and Bristol Myers Squibb to Collaborate On Digital Pathology and Cancer Diagnostics

dvances in computation and artificial intelligence (AI) in digital pathology are showing promise to meet the demand for more accurate and comprehensive assessment of pathology results to enable improved patient outcomes. Whole slide imaging, combined with modern AI-based image analysis tools, have the potential to transform the practice of pathology. The use of AI and deep learning methods to interpret whole slide images in digital pathology enables pathologists to derive novel and meaningful diagnostic insights from tissue samples. AI-based image analysis automates quantitative tasks and enables fast, repeatable evaluation of information-rich tissue images that are sometimes difficult to interpret manually. AI-based image analysis uncovers aspects that are invisible to the human eye and reduces the risk of human error. Patients, whose tissue samples are analyzed using AI-based image analysis, can benefit from a faster and more accurate diagnosis. The insights gained from these analyses can help pathologists determine the best treatment option for cancer patients. Now, a new collaboration builds on commitment to advance personalized healthcare by helping to improve access to new treatment options for patients with solid tumors. Roche (Basel, Switzerland; www.roche. com) has entered into a collaboration with Bristol Myers Squibb (BMY, New York, NY, USA; www.bms.com) to support the advancement of two assays for use in clinical trials with the development and deployment of two new digital pathology algorithms. Roche is delivering an end-to-end digital pathology solution from tissue staining to producing high-quality digital images that can be reliably assessed using automated clinical image analysis algorithms. Roche offers two deployment options for its uPath software: an on-premise solution and a cloud solution, marketed as NAVIFY Digital Pathology. The VENTANA DP 200 slide scanner and Roche uPath enterprise software are CE-IVD marked for in-vitro diagnostic use. In the first project under this collaboration, Roche Digital Pathology is creating an AI-based image analysis algorithm to aid pathologists in interpreting the on-market VENTANA PD-L1 (SP142) Assay. BMY Squibb will use this algorithm to generate biomarker data from clinical trial samples. In the second project, Roche will leverage its recently announced Open Environment collaboration with PathAI to integrate a PathAI-developed algorithm for CD8 biomarker analysis into the NAVIFY Digital Pathology workflow software. The AIpowered algorithm will be used by BMY to analyze clinical trial samples that have been stained with Roche’s CD8 assay and generate quantitative spatial biomarker data. Data from both projects will be used to aid in cancer diagnosis and to advance personalized healthcare treatment options, with the aim of improving outcomes for patients. Pathology imaging tools based on AI can help to support

LabMedica International May/2022

clinical trials in the investigation of targeted therapy options. Expanding access to these innovative imaging tools through the Roche Digital Pathology Open Environment can potentially enable more precise diagnoses, improved clinical decision-making and lead to more personalized treatment strategies. “The Bristol Myers Squibb and PathAI collaborations are among the first examples where AI technology and digital pathology applications are playing a role in developing treatments for patients. By using our NAVIFY Digital platform to interpret tissue based assays and AI algorithms, pathologists are better able to identify targeted therapy options, ultimately improving patient care,” said Jill German, Head of Roche Diagnostics Pathology Customer Area. “We believe digital methods will bring significant improvements in standardisation and interpretation of tissue-based assays and will

enable broader access to tissue based assays. The ability to more deeply interrogate images will present opportunities to better understand disease biology, potentially leading to expanded and improved drug development options and ultimately highly effective patient selection strategies,” said Sarah Hersey, Vice President, Translational Sciences and Diagnostics, Bristol Myers Squibb. “We are pleased to be part of this collaboration that is using leading edge technology to enable improved patient outcomes.”

Industry News

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Siemens Enters Digital Pathology Field with Proscia’s Concentriq Dx Platform

he demand for digital pathology has surged as systemic challenges long threatening the traditional laboratory model centered around pathologists and microscopes in physical spaces have intensified in the pandemic and post-pandemic era. Mounting pressures created by a shrinking pathologist population, rising biopsy volume, and industry consolidation have been exacerbated by the pandemic-driven shift to remote work. Laboratories are now rapidly seeking to modernize their pathology operations, but legacy software systems lack the necessary enterprise-wide capabilities, preventing labs from achieving true digitization. In line with this trend, Siemens Healthineers (Erlangen, Germany; www.siemens-healthineers.com) and Proscia (Philadelphia, PA, USA; www.proscia.com) have entered into a multi-year OEM agreement under which Siemens will expand its Enterprise Imaging offering towards the global digital pathology market using Proscia’s Concentriq Dx platform. With Proscia’s Concentriq Dx platform, Siemens is entering the digital pathology market to satiate the rampant demand and expand its Enterprise Imaging offering with industry-leading technology to realize the full value of digital pathology operations. The agreement with Proscia enables Siemens to expand into one of the few remaining areas of healthcare that has just started to experience the full benefits of digitization. Proscia’s Concentriq is a singular, scalable platform that enables laboratory networks to unify pathology operations and eliminate the geographic silos to realize a truly connected and collaborative global practice. The platform sits at the lab’s center of gravity, connecting a diverse ecosystem of hardware and software into a single solution. Concentriq’s pathologist-centric design was developed by and for pathologists to deliver an interface that feels natural, is highly responsive, supports real-time collaboration for consults and second opinions, and makes digital image viewing as smooth as possible. The platform’s future-proof design is ready now for pathology’s computationally driven future, with an integration layer capable of supporting plug-and-play adoption of AI applications. Siemens’ Syngo Carbon Enterprise Imaging Solution offers a wide range of possibilities with image interpretation, reporting, AI implemen-

tation, data management, archiving and migration, including unique access to innovation platforms through seamless integration. Proscia’s Concentriq Dx in combination with Syngo Carbon offers a best-ofbreed solution for digitizing pathology operations at scale alongside diagnostic radiology imaging for healthcare enterprises. “Healthcare’s rapid digital transformation has emphasized the value of data in reshaping the way clinicians and researchers understand, diagnose, and fight disease,” said Christian Zapf, Head of Imaging Software & IT at Siemens Healthineers. “The traditional practice of pathology is on the verge of the biggest transformation the field has seen since the introduction of light microscopy, and we’re excited to accelerate pathology’s digital transformation and pioneer breakthroughs with a strong partner complementing our core strength in enterprise reading and reporting resulting in higher efficiency and improved patient outcomes.”

BioMerieux Acquisition to Expand Offerings in Antimicrobial Susceptibility Testing cont’d from cover

tutional Antimicrobial Stewardship (AMS) programs. bioMérieux (Marcy-l’Étoile, France) has further strengthened its commitment to fight AMR with the acquisition of Specific Diagnostics (San Jose, CA, USA) which focuses on fast AST solution. Specific has developed a rapid AST system that delivers phenotypic AST directly from positive blood cultures. The SPECIFIC REVEAL Rapid AST system has been developed based on the company’s unique, patented metabolomic signature technology and offers an easy-to-use instrument with a targeted menu, small footprint, and modular design for adaptable throughput, well-suited to address the needs of clinical laboratories. The SPECIFIC REVEAL Rapid AST system provides actionable results for Gram-negative bacteria directly from positive blood cultures in an average of five hours. This helps clinicians to address the challenge of bloodstream infections, allowing either timely de-escalation to

a focused, more appropriate, and lower-cost therapy, or life-saving rapid escalation to more effective therapy where a multidrug-resistant (MDR) infection is present. SPECIFIC REVEAL seamlessly integrates with bioMérieux’s Sepsis Solution, including BACT/ALERT VIRTUO, VITEK MS PRIME, BIOFIRE BCID2, VIDAS PCT and VITEK2. With the addition of SPECIFIC REVEAL Rapid AST, the bioMérieux Sepsis Solution allows same-day AST results for Gram-negative bacteria to enable more targeted therapy and improve patient outcomes. “This acquisition reinforces our long-standing commitment to sustain antibiotic efficacy for future generations,” said Alexandre Mérieux, Chairman and CEO, bioMérieux. “With the addition of Specific Diagnostics’ REVEAL Rapid AST system into our microbiology portfolio, bioMérieux further supports clinicians and laboratories in further improving patient outcomes and enhancing antimicrobial stewardship, leveraging our extensive distribution network.”

Global Point-of-Care Testing (POCT) Market to Surpass USD 55 Billion by 2030

he global point of care testing (POCT) market was valued at USD 29.47 billion in 2020 and is expected to grow at a CAGR of 6.5% from 2021 to 2030 to reach USD 55.27 billion by 2030, driven by a rise in the prevalence of chronic diseases such as diabetes, rheumatism, and cancer and several supportive initiatives implemented by government and non-government organizations. However, stringent government regulations for the approval of POCT devices and reimbursement issues are expected to restrain the market growth. On the other hand, technological advancements in POCT devices and the advent of home-based POCT devices will present new growth opportunities in the coming years.

These are the latest findings of Allied Market Research (Dublin, Ireland; www.alliedmarketresearch.com), a full-service market research and business-consulting firm. Owing to surge in the prevalence of COVID-19 infection across the world, there has been an increase in the demand for POCT kits such as COVID-19 rapid kits for the detection of coronavirus, thereby driving the growth of the POCT market during the pandemic. There were increased development activities of various testing and monitoring kits during this period. However, lockdown restrictions and supply chain disruptions posed distribution challenges and created a supply-chain gap. LabMedica International May/2022

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

NEWS

MESSAGE FROM THE PRESIDENT By Khosrow Adeli

•

President, IFCC

reetings to you all in the IFCC family! It was wonderful to see so many of you at the EuroMedLab 2022 in April. After a long wait due to the COVID-19 pandemic, it was apparent how happy and excited all of us were to finally gather in person again. As we hoped, the conference was a huge success, with over 4100 attendees, exhibitors, and visitors from countries all around the world. I would like to thank the Scientific Program Committee for delivering an excellent scientific program, along with our participants, chairs and speakers, as well as corporate sponsors for taking part in this premier scientific event. Some of the many highlights of the conference included the lively industry exhibition, educational workshops, and poster presentations, alongside the beautiful city of Munich. Now that the EuroMedLab has wrapped up, I would like to remind everyone of our next upcoming event, taking place in Seoul, South Korea from June 26-30: WorldLab 2022! The Korean government has eased many restrictions, including removing quarantine requirements for vaccinated travelers, making it much easier for us to attend this important event in person. Additionally, we have confirmed that individuals from most countries do not require a special visa to visit South Korea. Given this great news, I urge you all to register and take advantage of the strong scientific program, which is packed full of interesting plenary lectures, educational workshops, satellite meetings, and poster sessions. This year’s WorldLab also presents a unique opportunity for attendees to travel to Seoul, the cultural, economic, and political centre of South Korea that not only has a very rich history and culture but many notable attractions. I am looking forward to this conference and meeting you all there in person. Aside from this upcoming event, I would also like to highlight the official launch of the IFCC Global MEDLAB Week, which we inaugurated in Munich on April 10 IFCC OFFICE

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 May/2022

and celebrated during the Lab Week from April 18-24. Many national societies and regional federations participated in this celebration and we had over 30,000 lab professionals and others around the world joining in the Social Media Campaign in support of the Global MEDLAB Week. It is crucial that we continue to recognize and celebrate the Vital Impact of Laboratory Medicine and the Critical Role of Laboratory Professionals in Public Health & Patient Care around the world. This includes laboratory technicians, managers, scientists, clinicians, and so many more individuals, as we all play an important part in the delivery of laboratory medicine. To find out more about this initiative and get involved in our campaign, visit our website: www.globalmedlabweek.org As always, feel free to email me at president@ifcc. org with your feedback, questions, or concerns. Till next time, Khosrow

NEWS

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

First Post-Covid Face-to-Face COLABIOCLI Congress Held Successfully in Leon, Mexico By Rosa Sierra-Amor, PhD; Secretary International Scientific Committee XXV COLABIOCLI Congress Leon 2022; IFCC Nominations Committee member; and eNews WG member.

The 25th COLABIOCLI Congress and the 2nd Mexican Congress of Clinical Laboratory Sciences were jointly held at Mexico’s charming provincial capital of Leon, on March 30 to April 2. Organized by the Mexican Association of Clinical Laboratory Sciences (CMCLabC) as the biannual congress of the Latin American Confederation of Clinical Biochemistry (COLABIOCLI), as well as a regional congress of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), the event also included the participation of the Spanish Society of Clinical Laboratory (AEFA), the Italian Society of Clinical Biochemistry (SIBIOCLI), the National Collegue of QFB México (CNQFB), and Mexico’s National College of Clinical Chemistry and Laboratory Medicine (CONQUILAB). The gathering also included post-congress activities organized by the Asian Pacific Federation of Clinical Biochemistry (APFCB) and the American Association for Clinical Chemistry Global Lab Quality Intiative (AACC LAWG). In a very open and safe venue, the Poliforum Leon, the congress took place with participation of the majority of the national societies afiliated with COLABIOCLI: Argentina, Brazil, Bolivia, Colombia, Chile, Dominican Republic, Ecuador, Guatemala, Honduras, Panama, Mexico, Nicaragua, Paraguay, Uruguay, and Spain. At the opening ceremony, COLABIOCLI president, Dr. Alvaro Justiniano-Grosz awarded a plaque to Prof. Stella Raymondo (Uruguay), Dr. Luiz Fernando Barcelos (Brazil) and Dr. Rosa Sierra-Amor (Mexico) for their contributions to advancing the profession in the Latin American region. The Mexican Association of Clinical Laboratory Sciences presented awards to Julio LaraRiegos, PhD, and Israel Parra-Rodriguez, MSc, for research in clinical biochemistry, and services to the profession, respectively. The COLABIOCLI Young Profesionals Forum lead by Santiago Fares-Taie (Argentina), Jorge Hernandez-Bello (Mexico), JJ Carrillo Ballesteros (Mexico), Sofia Duarte (Guatemala), and Alvaro Justiniano-Cortez (Bolivia), was joined by the Young Scholars from Latin America, contributing to the new generation of scientists. On March 30th, several courses were organized on different

Photo: Awardees (from left to right) Israel Parra, Rosa Sierra-Amor, and Julio Lara-Riegos.

Photo: Left. Opening Ceremony chaired by Jezabel Vite-Casanova, ME and Dr Avaro Justiniano-Grosz. topics, including: Leadership under the auspices of COLABIOCLI; Bioethics by the COLABIOCLI Working Group; Covid-19 within auspices of the University of Guadalajara; Forensic Medicine organized in conjunction with the Latin American Society of Forensic Medicine; POCT and accreditation within the auspices of the Italian Society of Clinical Biochemistry SIBioC; Molecular Diagnostics as part of the IFCC VLP program lecture; Traceability course with the support of COLABIOCLI and the Mexican Association of Clinical Laboratory Sciences; Board Certifica tion; Cost analysis; Blood banking; and Clinical Bacteriology. IFCC-Abbott Visiting Lecturer Program: Prof. Patricia Esperon (Uruguay) delivered a pre-congress course on “The

Photo: To incentivize young professionals, there were several scholarships: IFCC-Roche to: Jhenny Arenas Cordova (Bolivia) and Veronica Isabel Acosta Baruja (Paraguay). IFCC to: José Antonio Tesser Poloni (Brazil) Katherine Montoya (Chile), Maria del Rosario Benesperi (Argentina), Romina Medeiros (Uruguay), Eliana Oyuela Aldana (Colombia) and COLABIOCLI to: Sara Benegas (Paraguay) and Candelaria Rodríguez Matus (Argentina). fundamental concepts of oncogenetics” and a Plenary Conference on “Cancer Therapy guided by genomic data”. Dr. Victor Silva (Chile) participated in a Symposium on Vector dis eases entitled “Relevance of Early Identification in Mycology”. Prof. Nilda Fink (Argentina) coordinated a pre-congress course on Bioethics, as well as chairing two symposia on Ethics and Bioethics of Laboratory Personnel and on Bioethics in Laboratory Medicine. COLABIOCLI VLPs were for Dr. Juana Ortellado de Canese from Paraguay, who lectured on Emerging Diseases and Vigilance Antimicribial Networks; and Dr Raul Girardi from Argentina who spoke on the importance of traceability in Laboratory Medicine. From IFCC C-MHBLM, Dr Bernard Gouget spoke about “Artificial Intelligence in Lab Medicine: Hype vs Reality”. The rich scientific program included an opening keynote lecture by JF Muñoz-Valle on Vitamin D and COVID-19, and a keynote lecture at the closing ceremony by JM Gabastou on “The Role of Laboratory Medicine During the COVID-19 Pandemic”. There were four plenaries, five conferences, 29 symposia, and seven industry workshops. Topics included diabesity and nutrition, renal disease, tumor markers, blood bank, homeostasis LabMedica International May/2022

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

and coagulation, thyroid disease, quality management, accreditation, infectious diseases, metrology traceability, proficiency testing programs, applied molecular biology, clinical immunology, POCT, and Artificial Intelligence. There were round table discussions with laboratory experts that renewed the face-to-face interaction. Simultaneously COLABIOCLI Working Groups held closed meetings on: Accreditation Management; Pre-analytical Phase; Blood Bank; Bioethics; and the Commission on Education Management. Some were hybrid sessions, others face-to-face meetings. By invitation of the president of the congress, Jezabel Vite-Casanova, ME, the IFCC WG-IANT chaired by Raul Girardi organized a hybrid meeting that had the participation of the majority of its members. The winner of the Wiener Lab-COLABIOCLI Dr. Miguel Rojkín 2022 Award was Jose-Javier Morales-Nuñez from the University of Guadalajara, Jalisco, Mexico, for his research study on clinical biochemistry entitled: “Differences in the neutralizing antibodies generation against SARSCoV-2 individuals immunized by COVID-19 vaccines based on different platforms: CoronaVac, BTN162b, and Ad5-nCo”. Abstract presentations winners: First place to Raul-Eduardo Loredo-Puerta with the paper on “Molecular detection of carbapenemasases in clinical isolates of Pseudomonas spp., resistant to carbapenemics”. Second place went to: “Frequency of B-cell subpopulations and expression of IL-10 and IL-17 receptors in patients with rheumatoid arthritis: Association with clinical disease activity” by Jose-Javier Morales-Nuñez. Third place was: “Evaluation of the T-peripheral helper cellular population and its association with the BAFF System in patients with Generalized Lupus Erythematosus” by Nefertari Sagredo-Fabela. The In Vitro Diagnostics (IVD) companies that participated at the Laboratory Expo included: SNIBE, BD, INOCHEM, THERMO FISHER, DIAC, UNIPARTS, WIENER LAB, SUNBIO, PNCQ, NOVA BIOMEDICAL, RANDOX BIOSCIENCES, SENTINEL DIAGNOSTICS, LABORATORIOS RUIZ, and ZEISS. No doubt that meeting in person was essential. A face-to-face meeting in Leon helped to open the dialogue among professionals, enjoying meeting old friends, making new ones, keeping in mind that we´ll meet again in 2024 in Cartagena de Indías, Colombia, to celebrate another successful COLABIOCLI congress.

LabMedica International May/2022

NEWS

Photo: Renewal of the MoU agreement between COLABIOCLI and IFCC. On behalf of IFCC EB, Dr. David W. Kinniburgh and Dr. Alvaro Justiniano-Grosz, president COLABIOCLI accompanied by COLABIOCLI EB members and COC members.

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Vol. 39 No. 3 5/2022

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Bioperfectus. . . . . . . . . . . . . . . . . . . . . . . . . . 19

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IFCC WorldLab 2022. . . . . . . . . . . . . . . . . . . 23

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Vicotex. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

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