LabMedica International October 2023 by Globetech

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40 th

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ISSN 1068-1760

Vol.40 No.6 • 10/2023

DAILY CLINICAL LAB NEWS

Test Improves MS Management ultiple sclerosis (MS) is a complex ailment with considerable diversity, impacting each patient uniquely, which complicates diagnosis and prognosis. Effectively managing disease activity, which involves new neurological symptoms and re-

New STI Testing Guidelines to Render Low-Cost POC Diagnostics More Accessible

Method Eliminates Renal Biopsies

very day, over one million individuals contract new sexually transmitted infections (STIs), marking a significant global health concern. The COVID-19 pandemic saw a dip in STI prevention, testing, and treatment services in numerous countries,

resulting in a worldwide STI resurgence. Nations with robust STI surveillance like the US and UK have witnessed a rise in STIs. The emergence of infections such as mpox and the resurgence of neglected STIs challenge prevention and control efforts. There’s

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Antimicrobial Resistance: New Insights into Evolution Call for Shifts in Testing

upus (systemic lupus erythematosus, or SLE) is a serious autoimmune disease that has the potential to affect various organs and even result in death. A particularly severe complication of lupus is lupus nephritis (LN), which is a severe inflammation of the kidneys. This condition can be fatal, as it is a leading cause of death among lupus patients. Between 5% and 20% of the 60% Cont’d on page 11

Improved Malaria Detection in Blood very year, over 200 million individuals contract malaria, with more than half a million of these cases resulting in fatalities. The World Health Organization advocates for the use of parasite-based diagnosis prior to commencing treatment for the infectious disease caused by Plasmodium parasites. Various diagnostic techniques are available, including conventional light

latest study shows that patients often get co-infected by multiple clones of pathogens and that resistance arises from the selection of already resistant clones rather than new mutations.

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n automated, compact, and affordable fluorescent Immunoassay (FIA) solution is designed to transform the landscape of clinical point-of-care (POC) diagnostics. The innovative analyzer is capable of detecting a broad spectrum of analytes, such as hormones, enzymes, and infectious

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Rapid Blood Test Detects and Distinguishes 18 Infectious or Inflammatory Diseases nfectious and inflammatory diseases often bring children into hospitals and clinics for medical care. The challenge for healthcare professionals lies in accurately differentiating between potentially severe bacterial infections and less critical ailments, especially

when symptoms such as fever are common to many illnesses. As a result, many patients might receive broad-spectrum antibiotics as a precautionary measure until bacterial infection is ruled out. This overuse of antibiotics contributes to antimicrobial resisCont’d on page 15

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Test Improves MS Management Cont’d from cover

lapse rates, is central to improving outcomes. Historically, there have been no dynamic, quantifiable methods to track disease activity over time. This creates challenges in MS management and could lead to less-than-optimal utilization of disease-modifying therapies, which are essential for reducing disease activity, minimizing relapses, and slowing disease progression. Now, a new blood test has demonstrated potential for offering quantitative insights to enhance the care of MS patients and deliver a superior performance compared to the top-performing single-protein model. Octave Bioscience (Menlo Park, CA, USA; www.octavebio.com) has developed the Octave MSDA Test, which is the first and only multi-protein serum-based biomarker assay devised to quantitatively measure the disease activity of MS patients. This test can be used throughout a patient’s disease journey, enabling more informed clinical decisions for improved disease management. The Octave MSDA Test is part of the comprehensive Octave Precision Care Solution, which combines data from the test along with expanded imaging capabilities and clinical insights, providing a more comprehensive view of the patient. This solution equips the entire MS care ecosystem with the means to better gauge, monitor, and manage the disease. Octave has completed evaluating over 1,400 protein biomarkers using more than 3,000 patient samples. Advanced data science, machine learning, and feature extraction techniques were harnessed to select the top-performing and most pertinent 18 biomarkers for incorporation into a customized assay panel, developed using the Olink proteomics platform. These biomarkers were then integrated into an algorithm, generating four pathway scores that represent distinct disease processes in MS pathophysiology – immunomodulation, neuroinflammation, myelin biology, and neuroaxonal integrity. Additionally, the algorithm produces an overall disease activity score on a scale of 1.0 to 10.0. The Octave MSDA Test boasts numerous clinical applications throughout the care continuum. It aids in routine surveillance to better monitor disease activity, especially in patients with stable disease, and to track emerging or worsening symptoms. Furthermore, it can be used as an objective assessment of treatment response and tracks a patient’s disease activity level once a decision has been made with their clinician to scale back or discontinue their disease-modifying treatment. The Octave MSDA Test promotes shared decision-making between patients and their physicians while complementing standard radiographic imaging and clinical evaluation to offer more objective insights for enhanced MS care. In a recent study published in Clinical

LabMedica International October/2023

Immunology, the test was clinically validated relative to radiographic and clinical markers of disease activity and outperformed the top-performing single protein model. Presently, the Octave MSDA Test is available for commercial use and is being routinely utilized in leading practices across the United States, as well as in pharmaceutical studies. “We are encouraged that these results validate the performance of the Octave MSDA Test and demonstrate its ability to quantitatively and objectively measure disease activity of patients with MS,” said Ferhan Qureshi, Vice President of Biomarker Product Development at Octave. “The test interrogates multiple biological pathways important in MS pathophysiology with a

Image: The Octave MSDA Test is a multi-protein serum-based biomarker assay to measure disease activity of MS patients (Photo courtesy of Shutterstock)

diverse set of biomarkers to provide a highly sensitive, dynamic perspective of disease at the subclinical level. This provides an important complement to clinical evaluation of signs and symptoms of disease and MRI findings.”

POC Testing Update Ultra-Portable Rapid Test Platform Offers Complete Solution for Remote and Off-Grid Testing ReadyGo Diagnostics (Bath, UK; www. readygotest.com) is set to revolutionize low cost decentralized diagnostic testing with Geo, its ultra-portable isothermal molecular diagnostics system integrated with a patented device which combines sample collection and processing into a single, easy to use disposable. The rapid test platform, designed for small labs, pharmacies, and remote diagnostic needs, enables molecular tests to be run anywhere and delivers results in approximately 20 minutes. Geo uses ReadyGo’s Flex reagents which do not require cold-chain, making it a true off-grid, go-anywhere test platform. The platform also does not require a specialized operator or accurate pipetting thanks to its pre-measured reagents. ReadyGo has designed tests using recombinase polymerase amplification (RPA) and loop-mediated isothermal amplification (LAMP) for Geo’s isothermal amplification. Earlier this year, ReadyGo entered into an agreement with rapid diagnostics specialist Gemina Laboratories (Vancouver, BC, Canada; www.geminalabs.com) to develop a Mycobacterium tuberculosis (MTB) assay that will run on the Geo platform. The partnership aims to launch a MTB screening test in 2024 that will be capable of replacing smear microscopy by providing results within 30 minutes from a simple saliva sample.

a patient’s immune response, individually probing nearly a million blood cells. Immune Reveal generates one of the industry’s most powerful data sets that, when translated by artificial intelligence, can “read” immune responses to specific diseases even before the appearance of symptoms. This approach paves the way for a new era of integrated tests that can perform disease screening, confirmation testing, and precision treatment testing in minutes using the same card and sample. Immune IQ plans to commercialize sepsis detection as the initial test on the Immune Reveal platform.

Ultrafast Point-of-Care PCR Testing System Provides Central Lab Precision in 15 Minutes

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First-Ever POC Analyzer Reads Patient’s Immune System to Detect Diseases Before Symptoms Developed by Immune IQ (Minneapolis, MN, USA; www.immuneiq.com) in collaboration with Honeywell (Charlotte, NC, USA; www.honeywell.com), Immune Reveal is a first-of-its-kind point-of-care diagnostic platform that leverages the power of the human immune system to address two main challenges associated with sepsis: broad screening and rapid identification. Immune Reveal uses flow cytometry technology to rapidly decipher

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Nuclein’s (Austin, TX, USA; www.nuclein. com) DASH is a quantitative PCR system that takes testing out of the traditional laboratory environment by consolidating the entire PCR testing process (sample extraction and PCR). DASH (Diagnostic Analyzer for Specific Hybridization) is roughly the size of a cereal box, making it compact enough to fit on a countertop or desk. DASH delivers the same accuracy as other PCR tests in a portable platform that can be utilized by non-technical personnel at the point-of-care. It identifies infectious bacterial and viral pathogens in under 15 minutes, requiring less than a minute of hands-on time. DASH’s defining features are its user-friendly nature, quickness, and PCRlevel precision. DASH units can be linked together to deliver between 4 and 24 test Cont’d on page 5

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ISSN 1068-1760 Vol.40 No.6. Published, under license, by Globetech Media LLC; Copyright © 2023. All rights reserved. Reproduction in any form is forbidden without express permission. Opinions expressed are solely those of the authors, and do not represent an endorsement, or lack thereof, by the Publisher of any products or services. Teknopress Yayıncılık ve Ticaret Ltd. Şti. adına İmtiyaz Sahibi: M. Geren • Yazı işleri Müdürü: Ersin Köklü Müşir Derviş İbrahim Sok. 5/4, Esentepe, 34394 Şişli, İstanbul P. K. 1, AVPIM, 34001 İstanbul • E-mail: Teknopress@yahoo.com Baskı: Postkom A.Ş. • İpkas Sanayi Sitesi 3. Etap C Blok • 34490 Başakşehir • İstanbul Yerel süreli yayındır. Yılda sekiz kere yayınlanır, ücretsiz dağıtılır.

LabMedica International October/2023

POC Testing Update Cont’d from page 4

results per hour, making it an excellent choice for point-of-care testing in clinics, businesses, or community environments.

Single Automated Analyzer to Bring Full Diagnostics Suite to Wherever Patients Are Vital Biosciences Inc. (Mississauga, ON, Canada; www.vitalbio.com) is developing a novel platform that delivers rapid results using minimal blood volumes and technology that facilitates automation and adaptable form factors outside centralized labs. The single automated device is designed to provide a comprehensive range of diagnostics directly to patients. With only 600 uL of blood, the platform can measure 50 of the most commonly requested biomarkers in primary care within 20 minutes, without compromising analytical performance. The instrument employs an automated microfluidic workflow to simultaneously run three subsystems: hematology, clinical chemistry, and immunoassays. The company aims to create a comprehensive menu that covers the vast majority of routine lab orders, thereby eliminating the need to send tests to a centralized lab. Patients would no longer need to travel to a draw site or ship their samples to a centralized laboratory, nor wait for days to discuss their results with their healthcare provider. Patients who are likely to require bloodwork can provide their sample at check-in and receive results during their initial appointment.

time, comprehensive view of a patient’s clotting status right in the emergency room. This device is unique in its ability to promptly and accurately assess clotting times across various types of anticoagulant medications, including DOACs. It requires only 14 microliters of whole blood and yields easyto-interpret clotting time results with lab-like precision in 3-8 minutes. This rapid diagnostic capability can significantly influence timely and accurate treatment decisions, setting a new benchmark for emergency care for patients at risk of bleeding. Its compact design and flexibility make it suitable for use not just in emergency departments and ambulances but also across various healthcare settings like hospitals, clinics, surgical centers, physician offices, and pharmacies.

Portable Rapid Assay Identifies Hemorrhaging Patients Using Small Blood Sample DioTeX Diagnostics (Baltimore, MD, USA; www.diotexdiagnostics.com), comprising a team of undergraduate biomedical engineers from Johns Hopkins University (Baltimore, MD, USA; www.jhu.edu), is developing a portable, dependable, and accessible internal hemorrhage diagnostic tool. Their approach involves using a specific biomarker associated with hemorrhage to create a rapid immunochemistry-based test. Using the device, critical diagnostic results can be obtained and interpreted by anyone, regardless of location. To utilize the device, a blood sample is collected from behind the ear of a patient who Cont’d on page 6

Designed for Modern Laboratories

Novel POC Coagulometer Could Revolutionize Coagulation Testing Perosphere Technologies (Danbury, CT, USA; www.perospheretech. com) is engaged in the further development and commercialization of a novel POC coagulometer, known as the Perosphere POC Coagulometer, which offers a real-

· Automated random access clinical chemistry analyzer · Throughput up to 640 tests/h incl. ISE · Modern software features

DiaSys. Confidence in Results. www.diasys-diagnostics.com

LabMedica International October/2023

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may be experiencing internal bleeding. This process employs DioTeX’s proprietary blood drawing mechanism. After approximately 5 minutes, users can interpret the test device’s reading. A single line indicates no hemorrhage, while two lines indicate the presence of bleeding. This test has the potential to revolutionize internal hemorrhage diagnosis, as it can be conducted accurately and consistently by individuals with minimal training.

ticles combined with specially engineered aptamers. Much like a 3D puzzle piece, the aptamers only fit to the surface of specific bacteria. As a result, the aptamer-gold nanoparticles get agglomerated on the surface of the target bacteria, generating a unique signature detectable by a UV-visible spectrophotometer. Importantly, this innovative prototype is not only specific to Klebsiella pneumoniae but is also adaptable to different types of bacteria, offering great potential for primary healthcare.

Groundbreaking POCT Device Detects UTI Causing Bacteria in Five Minutes

Innovative Device Measures Glucose in Saliva for More Convenient Diabetes Monitoring

Urinary tract infection (UTI) is a prevalent health concern globally, particularly affecting women during pregnancy. Researchers at the Indian Institute of Technology Guwahati (IIT Guwahati, Assam, India; www.iitg.ac.in) have made a significant breakthrough by creating a 3D printed photodetector device that can identify and quantify a UTI-causing bacteria known as Klebsiella pneumoniae in five minutes from a urine sample. This capability is highly significant, as Klebsiella pneumoniae is not only a common cause of UTI but is also linked to pneumonia and soft tissue infections. The prototype device utilizes gold nanopar-

Researchers at King Abdullah University of Science and Technology (KAUST, Saudi Arabia; www.kaust.edu.sa) have created a prototype sensor capable of measuring glucose levels in saliva. This innovation could eventually offer a simple, swift, and painless way for individuals to monitor their diabetes. The KAUST team devised a remarkably sensitive glucose detector built on a thin-film transistor. The transistor features thin layers of semiconductors, including indium oxide and zinc oxide, along with the enzyme glucose oxidase on top. When a saliva sample is applied to the sensor, the enzyme converts any glucose present into D-gluconolactone and hydrogen peroxide. The electrical oxidation of hydrogen peroxide generates electrons that enter the semiconductor layers and modify the current flowing through the semiconductors, a change that reflects the glucose concentration in the sample. The researchers evaluated their device using human saliva samples with varying glucose levels and analyzed saliva from fasting volunteers. The device proved to accurately measure a broad range of glucose concentrations in under a minute. Importantly, the sensor remained unaffected by other molecules in saliva, including sugar derivatives like fructose and sucrose.

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Mobile Diagnostic System Performs Instant Lab Quality Blood Analysis Anywhere A potentially groundbreaking diagnostic system is making waves in the point of care (POC) setting, offering the first mobile technology for instant blood analysis beyond the confines of a lab. The REVDX from EFA Technologies (Caesarea, Israel; www. revdxmedical.com) is a portable lab-quality device that incorporates advanced multi-channel technology. This handheld device can be used anywhere, eliminating the need for time-consuming preparations or specialized knowledge. It is capable of functioning without electricity or internet connectivity, while also being cost-effective. At present, the device can conduct a blood count, with plans for additional tests in the future. A simple finger prick is all that’s required, eliminating the need to visit a lab and delivering results in just minutes. The device aims to empower doctors and medical teams in diverse scenarios to make informed treatment decisions promptly, bypassing the wait time for blood tests and their subsequent results. LabMedica International October/2023

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LabMedica International

Antimicrobial Resistance: New Insights into Evolution Call for Shifts in Testing Cont’d from cover

A research study published in the journal Nature Communications has offered novel insights into the development of antimicrobial resistance (AMR) in patients suffering from bacterial infections. This could lead to more effective preventative strategies against AMR infections in susceptible individuals. Contrary to the conventional belief that infection typically occurs due to a single strain of bacteria that develops resistance through new genetic mutations, the study suggests that patients often get co-infected by multiple clones of pathogens. In these cases, resistance arises from the selection of already resistant clones rather than new mutations. In the study led by the University of Oxford (Oxford, UK; www. ox.ac.uk), the researchers utilized an innovative technique to examine genetic alterations and antibiotic resistance in Pseudomonas aeruginosa, a common hospital-acquired bacterium, particularly among immunocompromised and severely ill individuals. Samples were taken from 35 patients in intensive care units across 12 European hospitals. Approximately two-thirds of the patients were found to be infected by a single strain of Pseudomonas, in some of which AMR developed due to new mutations, as traditionally believed. However, in a surprising revelation, one-third of patients were infected by multiple strains of the bacteria. It was observed that patients with mixed-strain infections exhibited a roughly 20% higher increase in resistance when exposed to antibiotic treatment compared to those with single-strain infections. The spike in resistance was primarily attributed to the selection of pre-existing resistant strains that already existed prior to antibiotic therapy. Interestingly, the study also found that such resistance could decline rapidly under certain conditions. When samples from single-strain and mixed-strain infections were cultured without antibiotics, the growth rate of AMR strains was slower compared to non-AMR strains. This supports the idea that AMR genes carry fitness trade-offs and are negatively selected when antibiotics are absent. This effect was more pronounced in mixed strain populations, suggesting that a diverse bacterial environment could contribute to resistance loss in the absence of antibiotics. The findings suggest that strategies focusing on controlling bacterial transmission among patients, such as improved sanitation and infection control measures, might be more effective against AMR compared to efforts to prevent new resistance mutations. This is particularly important in settings with a high infection rate, like immunocompromised individuals. Additionally, the study calls for a shift in clinical testing,

Image: A study has revealed new mechanism for rapid evolution of multi-drug resistant infections in patients (Shutterstock)

emphasizing the importance of considering pathogen strain diversity instead of assuming a singular strain during infection assessments. This approach could aid in making more accurate predictions about antibiotic treatment effectiveness and improve patient outcomes, similar to the use of diversity measurements in cancer cell populations to predict chemotherapy success. "The diagnostic methods employed for assessing antibiotic resistance in patient samples have undergone slow evolution over time, and our findings highlight the significance of developing new diagnostic approaches that facilitate the assessment of pathogen population diversity in patient samples," said Professor Craig Maclean, the lead researcher from the University of Oxford's Department of Biology.

New Breast Cancer Susceptibility Genes Identified enetic tests for breast cancer currently focus on a limited number of genes, including BRCA1, BRCA2, and PALB2, but this scope only accounts for a small part of the overall genetic risk for the disease. This has led researchers to believe that other risk-associated genes are yet to be discovered. Now, a large-scale international collaborative study has identified new genes linked to breast cancer that could eventually be included in tests to detect women at an elevated risk of the disease. The study led by researchers from Université Laval (Québec, Canada; www.ulaval.ca) and the University of Cambridge (Cambridge, UK; www.cam.ac.uk) has found evidence for at least four new breast cancer risk genes, and possibly more. These newly-discovered genes deepen medical understanding of the genetic risk factors for breast cancer and could improve risk prediction. By identifying women with a higher likelihood of developing the disease, there is potential for improving breast screening methods, risk reduction strategies, and clinical management practices. In addition, the discovery of these new genes sheds light on the biological processes that lead to cancer development,

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New Breast Cancer Susceptibility Genes Identified Cont’d from page 7

possibly paving the way for new treatment options. The study, which was published on August 17, 2023 in the journal Nature Genetics, utilized extensive genetic data. The research included an examination of genetic changes across all genes in a sample of 26,000 women with breast cancer and 217,000 without the disease, encompassing participants from eight countries in Europe and Asia. The goal is to incorporate this newfound information into a comprehensive risk prediction tool that health professionals worldwide currently use. However, before these discoveries can be implemented

in a clinical environment, the researchers have recognized the need to validate the results with further datasets for which the team is presently undertaking a large-scale international effort. "Improving genetic counseling for high-risk women will promote shared decision-making regarding risk reduction strategies, screening and determination of treatment options," said Professor Jacques Simard of Université Laval. “Although most of the variants identified in these new genes are rare, the risks can be significant for women who carry them. For example, alterations in one of the new genes, MAP3K1, appear to give rise to a particularly high risk of breast cancer.”

Image: New genes associated with breast cancer could be included in tests to identify at-risk women (Photo courtesy of Freepik)

Bacteria Engineered to Detect Tumor DNA Could Seek and Destroy Gastrointestinal and Other Cancers umors release their DNA into their surrounding environment, a phenomenon known as shedding. While various technologies can analyze purified DNA in laboratory settings, they fall short in detecting DNA where it is released. Although bacteria have been engineered for diverse diagnostic and therapeutic tasks, they cannot recognize specific DNA sequences and mutations outside of cells. Now, researchers have engineered bacteria that can identify tumor DNA in a live organism. This innovation, which successfully detected cancer in the colons of mice, has the potential for the creation of new biosensors to identify infections, cancers, and other diseases. Under the new “Cellular Assay for Targeted CRISPR-discriminated Horizontal gene transfer,” or “CATCH,” strategy, scientists from the University of California San Diego (La Jolla, CA, USA; www.ucsd.edu) used CRISPR technology to engineer bacteria capable of assessing free-floating DNA sequences on a genomic level. The concept involved repurpos-

ing bacteria that are naturally present in the colon as biosensors, capable of detecting DNA released from colorectal tumors. The focus was on Acinetobacter baylyi, a bacterium in which the essential components for both acquiring DNA and utilizing CRISPR for analysis were identified. The researchers proceeded to design, construct, and assess Acinetobacter baylyi as a sensor for detecting DNA from the KRAS gene, which is frequently mutated in various cancers. They programmed the bacterium with a CRISPR system to differentiate between mutant and normal (non-mutated) variants of the KRAS gene. Consequently, only bacteria that had incorporated mutant KRAS forms, as present in precancerous growths and cancers, would survive to indicate or respond to the disease. This research builds upon the concept of horizontal gene transfer, a method by which genetic material is exchanged among organisms in a manner distinct from traditional genetic inheritance. While horizontal gene

transfer is commonly observed between bacteria, the researchers successfully adapted this concept from mammalian tumors and human cells into bacteria. The researchers are presently refining their bacteria-based biosensor strategy, exploring new circuits and various bacterial species for detecting and treating human cancers and infections. Researchers believe that in the future, cellular interventions will surpass traditional medicinal approaches. A living bacterium capable of detecting DNA within the gastrointestinal tract holds remarkable potential as a sentinel for identifying and combating gastrointestinal cancers, along with numerous other malignancies. “There is so much potential to engineer bacteria to prevent colorectal cancer, a tumor that is immersed in a stream of bacteria, that could help, or hinder, its progression,” said researcher Susan Woods. The research was presented in a study published on August 11, 2023 in the journal Science. LabMedica International October/2023

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Improved Malaria Detection in Blood Cont’d from cover

microscopy, rapid diagnostic tests, and PCR. Nevertheless, the established benchmark for malaria diagnosis is manual light microscopy, where a specialist examines blood samples under a microscope to verify the presence of malaria parasites. However, the result accuracy is heavily dependent on the expertise of the microscopist and can be affected by fatigue caused by workloads among the professionals conducting the tests. Due to the demanding nature of traditional diagnosis and the high workload, an international team of researchers undertook an investigation into the feasibility of employing a novel system that combines an automated scanning microscope with artificial intelligence (AI) for clinical diagnosis. The results indicated that this system identified malaria parasites with almost the same accuracy as experienced microscopists following standard diagnostic procedures. This advancement holds the potential to ease the burden of microscopists and increase the manageable patient caseload.

Researchers at The Hospital for Tropical Diseases at UCLH (London, UK; www.uclh. nhs.uk) tested a fully automated malaria diagnostic system comprising both hardware and software components. The automated microscopy platform scans blood samples, and algorithms for malaria detection process the images to detect the presence and quantity of parasites. The researchers analyzed more than 1,200 blood samples from travelers who had returned to the UK from regions where malaria is prevalent. The study evaluated the accuracy of the AI-microscope system in a true clinical setting under ideal conditions. The researchers compared the results obtained from both manual light microscopy and the AI-microscope system. Manually, 113 samples were identified as having malaria parasites, whereas the AI system accurately detected 99 positive samples, resulting in an 88% accuracy rate. Despite this commendable accuracy rate, the automated system also produced false positives, indicating 122 samples as positive when they were not, potentially

Image: New high-tech microscope uses AI to successfully detect malaria in returning travelers (Photo courtesy of Freepik)

leading to unnecessary administration of anti-malarial drugs to patients. “At an 88% diagnostic accuracy rate relative to microscopists, the AI system identified malaria parasites almost, though not quite, as well as experts,” said Dr. Roxanne ReesChanner, a researcher at The Hospital for Tropical Diseases at UCLH. “This level of performance in a clinical setting is a major achievement for AI algorithms targeting malaria. It indicates that the system can indeed be a clinically useful tool for malaria diagnosis in appropriate settings.”

New Method Aligns Data from Tissue Slices Virtually to Expand Possibilities for 3D Analysis hen it comes to studying biological tissue, whether from a patient or an animal, a common approach involves surgically removing a portion of the affected tissue for analysis. In laboratories across the globe, technicians meticulously slice the extracted tissue into thin sections, which are then examined under a microscope or subjected to tests that detect specific molecules. These molecular clues can aid in diagnosing conditions, guiding treatments, or even gauging the effectiveness of drugs. However, the process of analyzing each slice is resource-intensive in terms of time, money, and computational capacity.

Consequently, researchers and medical professionals are often constrained to studying only a limited number of slices from various parts of the tissue. Adding to the complexity, the act of cutting, processing, and analyzing tissue slices within a lab environment causes them to undergo physical distortions. As a result, accurately understanding how these slices align and fit into the three-dimensional structure of the original tissue becomes challenging. Now, a new method revolutionizes the ability to comprehend the three-dimensional composition of tissues, including tumors or other tissue using data from just a few slices, thus allowing for a

much deeper understanding of biological tissue samples. The new method, named Gaussian Process Spatial Alignment (GPSA) which has been developed by researchers at Gladstone Institutes (San Francisco, CA, USA; www.gladstone. org) has a scope extending beyond tumors, encompassing a wide array of tissues and data derived from tissue slices. This innovative method leverages a two-layer Gaussian process. In the first layer, it aligns the warped two-dimensional tissue slice onto a three-dimensional tissue model. The second layer attributes data collected from the slice, such as Cont’d on page 11 LabMedica International October/2023

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Cont’d from cover

Method Eliminates Renal Biopsies

of SLE patients who develop renal symptoms will progress to end-stage kidney disease within a decade. The current standard method for diagnosing LN is through a renal biopsy, a painful procedure involving the extraction and examination of kidney tissues. Unfortunately, this method has significant drawbacks, including low agreement among pathologists in determining classes and pathology indices. This inconsistency can result in misclassification of LN, leading to incorrect treatment and poor patient outcomes. Furthermore, renal biopsies only yield limited tissue samples, restricting the type and scope of analysis performed on a sample. A promising breakthrough has emerged from researchers at the University of Houston (Houston, TX, USA; www.uh.edu), who have pioneered the use of imaging mass cytometry (IMC) to study the kidneys of SLE patients and diagnose LN. IMC offers substantial advantages over traditional methods, providing a much more comprehensive analysis of the affected tissue. Unlike conventional approaches that examine only 1-3 distinct proteins within a specific tissue, IMC can detect the presence of up to 37 different proteins simultaneously. The use

of IMC is often combined with machine learning algorithms to characterize the cellular composition of the human kidney, differentiate cell types, and identify novel markers for disease. One of the major benefits of IMC is its ability to precisely pinpoint locations of tissues for more detailed investigation. During a study involving 21 patients, researchers utilizing IMC discovered both increased and decreased disease markers indicative of renal disease. Additionally, they found that glomeruli (an intricate network of blood vessels serving as the kidneys’ cleaning system) might be enlarged in some LN patients. These findings were published in a recent study in the journal Clinical Immunology. “Decreased expression of epithelial markers along with an increased expression of mesenchymal markers, also termed epithelial to mesenchymal plasticity (EMP) have been reported in kidney biopsies from patients with renal diseases, including LN,” said Chandra Mohan, Hugh Roy and Lillie Cranz Cullen Endowed Professor of biomedical engineering. “It is very likely that the parietal epithelial cells encircling the glomeruli may be an additional site of EMP in proliferative LN, though this needs to be verified using additional markers.

LabMedica International

Image: The Candida Auris diagnostic test has received FDA Breakthrough Device Designation (Photo courtesy of T2 Biosystems)

EMP could certainly affect additional cells in LN kidneys, but this needs to be systematically investigated.”

New Method Aligns Data from Tissue Slices Virtually to Expand Possibilities for 3D Analysis Cont’d from page 10

activated genes, to each point in the three-dimensional model. This intelligent approach effectively reverses the warping effect, resulting in a precise alignment of the slices. During this process, the GPSA model extrapolates data to fill the gaps between slices, generating a comprehensive three-dimensional “atlas” of the tissue. A key advantage of GPSA is its versatility. Researchers can construct tissue atlases using

data from slices of varying sizes, generated by diverse technologies, and captured at different scales and resolutions. Unlike previous techniques that demanded a predefined three-dimensional framework, GPSA derives this framework solely from the two-dimensional slices when an initial framework isn’t available. Additionally, GPSA has the capability to merge multiple types of tissue-slice data, such as genetic activity and cellular structure, into a unified atlas. Furthermore, when applied

LabMedica International October/2023

to slices taken from the same tissue at different time points, GPSA can generate atlases that predict how each location within the tissue evolves over time. This feature could deepen our insights into aging, disease progression, and the development of different tissues within growing organisms. Presently, researchers are engaged in further analyses to further demonstrate the tool’s flexibility. For instance, they have devised an approach that budget-conscious labs can use to determine the minimum number of tissue slices required and the precise cutting locations needed for GPSA to build an informative tissue atlas. “Say you have four slices from different locations in a person’s breast cancer tumor, and for every point on each slice you know which of 20,000 genes are turned on or off,” said Gladstone Senior Investigator Barbara Engelhardt, PhD, senior author of the study. “GPSA creates a fully query-able 3D atlas where, for any single ‘x, y, z’ coordinate, for any of the 20,000 genes, we can dive in and ask: What genes are on and off at this position in the tumor? And how certain are we in this estimate?” Image: Barbara Engelhardt and her colleagues have developed a new tool to align data from tissue slices virtually, expanding possibilities for 3D analysis (Photo credit: Michael Short/Gladstone Institutes) LINKXPRESS COM

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Rapid Sepsis Test Uses Magnetic Nanoparticles to Detect Bacterial Pathogens hen it comes to life-threatening blood poisoning caused by staphylococcus bacteria, quick identification of the bacteria in the bloodstream is vital to begin life-saving treatment. This urgency stems from the fact that staphylococcal sepsis results in fatality for up to 40% of cases. The infection, triggered by spherical bacteria, might initially manifest as a local skin ailment or pneumonia. However, when staphylococci infiltrate the bloodstream during sepsis, severe complications can emerge. In such critical scenarios, prompt identification of pathogens and selection of suitable antibiotics are vital. This is especially crucial as Staphylococcus aureus strains can exhibit resistance to multiple antibiotics. Researchers have now developed “sepsis sensors” using magnetic nanoparticles that enable rapid detection of bacterial pathogens and identification of appropriate antibiotic candidates. Researchers at Empa (Dübendorf, Switzerland; www.empa.ch), along with their colleagues from ETH Zurich (Zürich, Switzerland; www.ethz.ch), looked for a way to bypass the lengthy intermediate step of first cultivating the bacteria in a blood sample for a diagnostic procedure. They developed a method utilizing magnetic nanoparticles that are capable of binding to staphylococci. Consequently, these bacteria can be identified through the application of a magnetic field. Subsequently, antibiotic sensitivity is assessed using a chemiluminescence technique. If antibiotic-resistant bacteria are present in the sample, it emits light. Conversely, if the bacteria can be eradicated with antibiotics, the reaction vessel remains dark. Another problematic bacterial entity is Pseudomonas aeruginosa, a rod-shaped bacterium capable of causing various illnesses, including urinary tract infections via catheterization during hospital stays. Such infections can develop into sepsis, and these pathogens are often resistant to numerous antibiotics. In such cases, magnetic nanoparticles offer the distinct advantage of versatility. The approach can be customized for different bacteria types, similar to a modular system. This adaptability enabled the researchers to design a rapid “sepsis sensor” leveraging magnetic nanoparticles. In samples containing synthetic urine, this method reliably identified bacterial species and gauged potential antibiotic resistance through chemiluminescence reactions. So far, the researchers have assessed their magnetic nanoparticle toolkit for sepsis and urinary tract infections using laboratory samples. In the coming

Image: Magnetic nanoparticles (red) bind specifically to the spherical bacteria (yellow) (Photo courtesy of Empa)

phase, the team plans to validate the sepsis tests alongside their clinical partners by analyzing patient samples. “All in all, the sepsis test takes around three hours – compared to several days for a classic cultivation of bacterial cultures,” said Empa researcher Fei Pan.

Blood Test Identifies Pregnant Women at Higher Risk of Preeclampsia reeclampsia, a serious pregnancy complication affecting 1 in 40 pregnant women, is characterized by elevated blood pressure. Left untreated, it can lead to organ damage and, in rare instances, maternal or fetal death. As the exact cause remains uncertain, identifying high-risk patients is complex. Now, researchers have discovered that DNA analysis can identify women at higher risk of developing severe preeclampsia during later pregnancy stages. Detecting high-risk patients early will allow for administering preventive medication, significantly reducing the risk of severe preeclampsia. Around 1 in 8 cases involve early-onset preeclampsia, manifesting between 20 and 34 weeks of pregnancy. Preterm births, often induced due to preeclampsia, require neonatal intensive care and can lead to serious complications. Promptly identifying women with an elevated risk of early preeclampsia is essential for initiating appropriate and preventive treat-

Cont’d on page 13

LabMedica International October/2023

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LabMedica International

New STI Testing Guidelines to Render Low-Cost POC Diagnostics More Accessible Cont’d from cover

growing concern over treatment-resistant strains of gonorrhea, particularly a Neisseria gonorrhea clone resistant to ceftriaxone, found in several countries. Diagnosing STIs in low- and middle-income countries is further complicated due to limited access to diagnostic tests. To tackle these challenges, the World Health Organization (WHO, Geneva, Switzerland; www.who.int) has shared its latest guidance on sexually transmitted infections (STIs) at the STI & HIV 2023 World Congress which took place in Chicago, US, on 24-27 July 2023. Given the rising STI numbers, WHO has emphasized the need for improved testing and diagnostic services. During the congress, WHO shared its latest research on STIs and antibiotic resistance in gonorrhea. The new guidance includes target product profiles (TPPs) for point-of-care diagnostic technologies for diagnosing syphilis (treponema pallidum), Chlamydia trachomatis, Neisseria gonorrhea, and Trichomonas vaginalis, which intend to aid the development of quality STI diagnostics. TPPs can ensure that products are developed and produced to fulfill the clinical needs of populations at risk and are “fit-for-use” – in other words, that they are safe, effective, and adapted to the use environment. Point-of-care tests can reduce healthcare costs, minimize waiting times, expedite initiation of and enhance the accuracy of treatment, and improve patient follow-up. The new fourth edition of the Laboratory and Point-of-Care Diagnostic Testing Guide for STIs, including HIV, offers the latest details on STI isolation, detection, and diagnosis. The guide has been expanded to include information about molecular testing, rapid on-the-spot tests, and

Blood Test Identifies Pregnant Women at Higher Risk of Preeclampsia Cont’d from page 12

ment, reducing both preeclampsia and potential premature birth risks. Current screening methods are often complex, time-consuming, and unreliable. In order to understand the pivotal role of the placenta, researchers from KU Leuven (Leuven, Belgium; www.kuleuven.be) compared placental DNA in 498 women with and without early preeclampsia. Normal pregnancy brings changes in placental DNA structure through DNA methylation. However, the researchers found that women developing early preeclampsia exhibited a distinct DNA methylation pattern. While the cause of this difference remains unknown, it can allow physicians to identify high-risk women and initiate treatment before symptoms emerge. The new test offers a significant advantage: it can be conducted using DNA from a simple blood sample taken around the 12th week of pregnancy. Given that blood samples are routinely taken for non-invasive prenatal testing (NIPT) to identify fetal chromosomal abnormalities, additional placental samples or cells are not necessary. "In time, our analysis can be carried out simultaneously with the NIPT test,” said Professor Bernard Thienpont who led the research. “But first, we will focus on implementing our new method on a larger scale, optimizing and validating it. We also want to investigate whether certain women would benefit more from preventive screening, for example, in the case of a first pregnancy."

LabMedica International October/2023

Image: WHO has released new guidance to improve testing and diagnosis of STIs (Photo courtesy of Freepik)

diagnostic test quality management. A new product on the Diagnostics Landscape for Sexually Transmitted Infections (STIs) highlights diagnostics available to support scale-up of screening for syphilis, chlamydia, gonorrhea, trichomoniasis, mycoplasma, and human papillomavirus (HPV), specifically catering to the rising demand for tests in low-to-middle income countries. “New models of STIs services need to be resilient and adaptive to current and future threats”, said Dr. Meg Doherty, Director of WHO’s Global HIV, Hepatitis and Sexually Transmitted Infections Programs. “Recent scientific advances in STIs treatment and technologies, and innovative service delivery methods, provide an important opportunity to end STIs as a public health concern by 2030. However, large variations in investment, maturity and performance of STI surveillance systems between countries continues to be a challenge”.

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Handheld Immunoassay Analyzer Offers POC Testing Breakthrough Cont’d from cover

diseases, making it a versatile diagnostic tool. Its compact design, lasting battery life, and user-friendly interface make it a practical for diverse environments. Introduced by Anbio Biotechnology (Frankfurt, Germany; www.anbio.com), the new AF100S FIA Solution offers a compact, handheld solution for point-of-care immunodiagnostic needs that delivers rapid, accurate, and reliable results. The device employs fluorescently labeled antibodies or antigens to identify specific biomolecules in a patient’s sample. When a sample is combined with these labeled antibodies or antigens, the biomolecule, if present, binds to these labeled molecules, creating a complex that releases a fluorescent signal. This signal is then measured and compared with a recognized standard to ascertain the biomole-

cule’s concentration in the sample. This small yet efficient FIA analyzer can perform up to 240 tests per hour, making it a good fit for high-volume settings. It is powered by a lithium battery that supports up to 800 tests per charge or offers 20 days of device standby time. Its user-friendly interface, shown on a large color touchscreen, simplifies operation. The compact size of the AF-100S, measuring just 195x100x70mm, makes it an optimal choice for various medical settings such as private clinics, urgent care centers, emergency departments, and ambulances. “The Anbio AF-100S is set to transform the field of clinical diagnostics, empowering healthcare providers with a cost-effective and comprehensive solution,” said Sa Jiang, Chief Marketing Officer at Anbio. “Our FIA solution is small, yet powerful point-of-care immunodi-

Image: The AF-100S automated, compact, and affordable fluorescent Immunoassay (FIA) solution (Photo courtesy of Anbio)

agnostic solution that provides rapid, accurate, and reliable results for a wide range of analytes to provide faster diagnosis and better prognosis to patients.”

Fluorescent Carbon Nanotubes Accurately Detect Bacteria and Viruses n interdisciplinary research team that comprised scientists from Ruhr University Bochum (RUB, Bochum, Germany; www.ruhr-uni-bochum.de), the Fraunhofer Institute (Duisberg, Germany; www.ims.fraunhofer.de) and ETH (Zurich, Switzerland, ethz.ch) has developed an innovative method to construct modular optical sensors capable of identifying viruses and bacteria. The team utilized fluorescent carbon nanotubes attached to a novel type of DNA anchors which serve as molecular handles. These anchor structures can be utilized to conjugate biological recognition units such as antibodies aptamers to the nanotubes, enabling interaction with bacterial or viral molecules. This interaction impacts the fluorescence of

the nanotubes, causing their brightness levels to increase or decrease. The research team utilized tubular nanosensors composed of carbon, each with a diameter of less than one nanometer. When irradiated with visible light, these nanotubes emit near-infrared light, a spectrum invisible to the human eye but ideal for optical applications due to the significant reduction of other signals within this range. Previously, the team had successfully manipulated the nanotubes’ fluorescence to detect vital biomolecules. Their latest effort involved customizing carbon sensors for easy detection of various target molecules. This breakthrough was achieved with the help of DNA structures with guanine quantum defects. This process involved linking DNA

Image: 3D printed model of a carbon nanotube (Photo courtesy of RUB)

bases to the nanotube in order to introduce a defect into the nanotube’s crystal structure. Consequently, the nanotubes’ fluorescence underwent a quantum-level change. In addition, the defect functioned as a molecular handle, Cont’d on page 15

LabMedica International October/2023

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LabMedica International

Rapid Blood Test Detects and Distinguishes 18 Infectious or Inflammatory Diseases Cont’d from cover

tance and an uptick in drug-resistant infections. Traditional diagnostic tests typically focus on identifying specific pathogens, like SARS-CoV-2, HIV, or Influenza through lateral flow tests (LFTs), or bacteria and yeast through blood cultures. However, these methods have their limitations. LFTs can only confirm or deny a specific cause, while blood cultures may take up to 72 hours or more for reliable results. But now, a promising blood test that can rapidly diagnose the cause of a child’s illness is being hailed as ‘transformative’. An international team, led by researchers at Imperial College London (London, UK; www.imperial.ac.uk) has developed and validated a diagnostic method that can simultaneously detect and differentiate between 18 infectious or inflammatory diseases, such as group B Streptococcus (GBS), respiratory syncytial virus (RSV), and tuberculosis. Unlike current tests that can take hours, days, or even weeks, this approach is designed to yield results in under an hour. The innovative test uses a single blood sample to diagnose the cause of fever by recognizing specific patterns of genes that are activated or deactivated by the body in response to particular illnesses. The finding builds on over a decade of research that seeks to detect and diagnose illnesses through gene expression patterns. In the latest study that was published on August 18, 2023 in Cell Press Med, the researchers analyzed the pattern of gene expression in blood in response to various infections and inflammatory conditions. They collected data from thousands of patients, including over 1000 children suffering from 18 infectious or inflammatory diseases, to identify the key genes that were switched ‘on’ or ‘off’. Utilizing machine learning, the team identified a panel of 161 genes for 18 conditions that corresponded to specific disease areas and pathogens. To further validate the panel, the researchers assessed a group of 411 pediatric patients hospitalized with sepsis or severe infections. Gene expression from blood analysis was compared to diagnoses made using existing clinical methods. As introducing new diagnostic tests in a clinical setting can have severe consequences if misdiagnoses occur, the team applied a ‘cost-sensitive’ measure, consulting a panel of five clinical experts to ensure the test could accurately avoid misdiagnoses where the consequences would be most significant. While still in the proof-of-concept stage, the researchers are hopeful that a diagnostic test centered on patients’ gene expression could markedly enhance the diagnosis of childhood diseases. This breakthrough could minimize delayed or missed diagnoses and make a substantial difference in healthcare, especially in regions with limited resources. “This body of work has enabled us to identify the molecular signature of a wide range of diseases based on 161 genes, out of thousands of genes in the human genome. By distinguishing between many diseases at the same time within the same test, we have developed a more comprehensive and accurate model that aligns with the way clinicians think about diagnosis,” said Dr. Myrsini Kaforou, Senior Lecturer within Imperial’s Department of Infectious Disease. “A future diagnostic test based on this approach could help provide the right treatment, to the right patient, at the right time, while optimizing antibiotic use, and reducing lengthy time to diagnosis for inflammatory diseases.”

Fluorescent Carbon Nanotubes Accurately Detect Bacteria and Viruses

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enabling the addition of a detection unit that could be adjusted to the respective target molecule to identify a specific viral or bacterial protein. In a study published in the Journal of the American Chemical Society, the team demonstrated the new sensor concept by targeting the SARSCoV-2 spike protein. Researchers used aptamers that bind to the SARSCoV-2 spike protein, following which the fluorescent sensors reliably indicated the protein’s presence. Notably, the selectivity and stability of sensors featuring guanine quantum defects surpassed those of sensors without such defects, especially when in solution.

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Simple Mouth Rinse Test Provides Early Cardiovascular Disease Warning Signs eriodontitis, a widespread oral health issue involving infected gums, has been linked to cardiovascular disease. In a new study, scientists explored the inflammation leading to periodontitis and examined whether the levels of white blood cells (a sign of gum inflammation) in the saliva of healthy adults could signal potential cardiovascular issues. Specifically, they looked at whether high levels of these cells correlated with compromised flow-mediated dilation, an early sign of arterial problems. Scientists at Mount Royal University (Calgary, AB, Canada; www.mtroyal.ca) set out to investigate the link among young adults without any known periodontal problems to see if even minor levels of oral inflammation might have clinical significance for heart health. They selected two measures, pulse-wave velocity (to gauge artery stiffness) and flow-mediated dilation (to assess how well arteries expand to allow increased blood flow), as key indicators of cardiovascular risk. Both of these measurements directly relate to arterial health, and issues with

either can increase the risk of heart disease. The study involved 28 non-smoking participants aged 18 to 30, with no underlying health conditions, medications that might affect cardiovascular risk, or history of periodontal disease. Before visiting the laboratory, they were instructed to fast for six hours, although water intake was allowed. Upon arrival, they rinsed their mouths with water, followed by saline, which was then collected for analysis. Participants subsequently underwent an electrocardiogram while lying down, and remained in that position for additional tests, including blood pressure, flow-mediated dilation, and pulsewave velocity measurements. The findings revealed that high levels of white blood cells in the saliva were significantly linked to poor flow-mediated dilation, indicating a heightened risk of cardiovascular disease in these individuals. Interestingly, there was no connection between white blood cells and pulse-wave velocity, suggesting that the long-term effects on artery health were

not yet evident. Scientists have proposed that the inflammation from the mouth, possibly seeping into the vascular system, could affect the arteries’ ability to produce nitric oxide, which aids in responding to changes in blood flow. Elevated levels of white blood cells might further exacerbate this vascular dysfunction, although the levels detected in the study participants are generally not seen as clinically significant, indicating that even minor inflammation could have broader health implications. “We are starting to see more relationships between oral health and risk of cardiovascular disease,” said Ker-Yung Hong, first author of the study. “If we are seeing that oral health may have an impact on the risk of developing cardiovascular disease even in young healthy individuals, this holistic approach can be implemented earlier on.” “The mouth rinse test could be used at your annual checkup at the family doctors or the dentist,” said Dr. Michael Glogauer, a co-author of the study. “It is easy to implement as an oral inflammation measuring tool in any clinic.”

Patch-Based Ebolavirus Diagnostic Can Quickly Identify and Treat Infected Individuals groundbreaking diagnostic that combines a patch-based blood collection device with a sensitive and rapid immunoassay for ebolavirus into a single device will allow community health workers to quickly identify and treat infected individuals in remote settings. The novel, single-use, rapid ebolavirus diagnostic will combine Satio, Inc.’s (Boston, MA, USA; satiopatch.com) patch-based blood collection device with an ebolavirus immunoassay from Institut Pasteur de Dakar (Dakar, Senegal; www.pasteur.sn). Satio is working on a suite of patch-based platforms, including SatioDot optimized for dried blood spots, and SatioDraw

designed for comprehensive whole blood collection, which can cater to an extensive array of lab-based tests. These platforms employ a lancet to gather blood from the upper arm, channeling it into the patch. Satio is now accelerating the development of an integrated blood draw and diagnostic platform with the potential to extend its capabilities for identifying other critical bloodborne pathogens, such as HIV and syphilis. Satio's groundbreaking designs, covered by patent protection, provide patients with access to simple and cost-effective blood collection options. These solutions facilitate blood extraction, reagent mixing, and the identification of an array of pathogens, all achieved through

a patch affixed to the arm. In a remarkable extension, Satio's patch technology also holds the potential for the painless administration of drugs and vaccines. Consequently, this innovation holds the promise to mitigate or even eliminate the necessity for needles and medical professional intervention. By doing away with conventional fingerstick blood samples and the associated external blood sample manipulation, Satio's trailblazing innovation reduces exposure to bloodborne pathogens. Simultaneously, it offers an exceptional, budget-friendly diagnostic tool for easy deployment at the point of need, thereby advancing patient outcomes and restricting the spread of ebolavirus. LabMedica International October/2023

NEWS

Edited by Katherina Psarra, MSc, PhD IFCC members may send news to Email: enews@ifcc.org

MESSAGE FROM THE PRESIDENT By Khosrow Adeli • President, IFCC

y warmest greetings to everyone at IFCC. I hope you all are enjoying the arrival of the Fall season. To start, I am delighted to inform you that the IFCC Organization is experiencing significant growth in its membership base. We have received applications from several new societies and countries seeking to become full or affiliate members, and we have welcomed numerous new corporate members in just the past few months. Pending ratification by the IFCC Council, we anticipate having 98 national societies as full members, more than 20 affiliate members, and 58 corporate members. This remarkable achievement breaks all previous records across all membership categories, underscoring the heightened visibility, influence, and global reach of the IFCC organization. Later this year, we will be publishing a special feature article in the eNews, highlighting all the new IFCC national societies, affiliates, and corporate members that have joined IFCC over the past three years. Additionally, there is a growing interest in IFCC membership from societies and entities in various specialties within laboratory medicine, extending beyond clinical chemistry. The IFCC Executive Board is enthusiastic about recommending an expansion of the IFCC’s membership scope, aiming to encourage participation from all areas of clinical laboratory diagnostics and clinical laboratory medicine. To align with this vision, we will be proposing amendments to the IFCC statutes, facilitating the inclusion of other specialties within the IFCC organization. Furthermore, the IFCC Executive Board is advocating for changes in the election process for Executive Board members to foster a more inclusive opportunity for individuals within the IFCC community to contribute to the board. The proposed amendments suggest that no individual should serve in the same position on the Executive Board for more than six years in total. Additionally, individuals cannot be nominated for more than one position in the same year or election cycle. Stay tuned for forthcoming updates! A ballot will be initiated, and all IFCC Full Member Societies will be invited to vote on the proposed revisions to the IFCC statutes, ensuring the continued growth and success of the IFCC Organization. I’m also thrilled to announce the formal launch of the new IFCC initiative on Laboratory Medicine Practice Guidelines. The IFCC Executive Board has granted approval for an innovative program aimed at encouraging IFCC functional units, including committees, taskforces, and working groups, to create and share best practice recommendations and guidelines across all facets of clinical laboratory medicine. This program is dedicated to facilitating the implementation of these recommendations in clinical laboratories worldwide. Under this program’s umbrella, the IFCC will develop various types of guidance documents, encompassing best practice recommendations, position papers, and comprehensive evidence-based and graded practice guidelines. These documents will be made widely and freely available, serving as valuable resources for laboratory professionals. Their purpose is to provide guidance, establish standards, and promote best practices within the field of laboratory medicine. Undoubtedly, these resources will contribute significantly to enhancing the quality of laboratory practices worldwide, with a particular focus on benefiting developing countries. To oversee and drive this program forward, we

LabMedica International October/2023

are in the process of forming an IFCC Taskforce on Laboratory Medicine Practice Guidelines (TF-LMPG). This taskforce will serve as a steering group, providing program oversight, and will also act as a review panel to evaluate proposals submitted by various functional groups. Stay tuned for further updates and contributions from this exciting initiative. Finally, in partnership with MZ Events, the Arab Federation of Clinical Biology, the Saudi Society of Clinical Chemistry, and the UAE Genetics Association, IFCC is diligently working on preparations for our upcoming flagship scientific event, the IFCC WorldLab Congress, scheduled to take place in the fabulous city of Dubai from May 26 to May 30, 2024. More information to follow in future editions of the eNews. As always, feel free to email me at president@ifcc.org with your feedback, questions, or concerns.

Cheers, Khosrow 

NEWS

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

EDITORIAL By Katherina Psarra, MSc, PhD Dear Colleagues, It is already the 1st of October. The fall is here and most of us have begun forgetting their summer vacations. It is a good time for IFCC because many more national societies are joining and even laboratory societies of different disciplines than purely Clinical Chemistry. You will find out a lot about these activities in the President’s message, where you will also learn about the progress in the guidelines concerning several methods and the new Working Group

created to support this activity. And then, there is a very interesting interview of Prof. Christa Cobbaert, Chair of the IFCC Scientific Division. You will read about the activities and plans of the Scientific Division, a very important division, the backbone of all the events that take place, like the WorldLab to be held on May 2024 in Dubai. The history of the IFCC SD is there not to forget to mention its future. The fall is here, dear colleagues, and I am sure that a lot of congresses take place in your countries, congresses of your national societies of Clinical Chemistry, as well as other laboratory societies. Have a look at the falling leaves of the trees, let the autumn mood relax you and write a report for the IFCC eNews. We are looking forward to them. And don’t forget to propose your candidates for the IFCC awards in Dubai. You can read about them in this issue also. Think the best of the best!

Educational Opportunity to Learn About Global Trends in Healthcare

nnovation. Best Practices. Transformational Healthcare. Better Outcomes. Increased Quality. We are all united in this quest to improve healthcare. No matter your role, title, or education, opportunities exist to make measurable differences in care delivery, and ultimately, patient outcomes. Often, those opportunities start with an idea, a spark to enable change. How that change occurs can vary, but one such avenue can often start with education. With this in mind, the UNIVANTS of Healthcare Excellence program (www.UnivantsHCE. com) is proud to host the inaugural Executive Leadership Exchange (ELX) (www. healthcareELX.com). The ELX forum is an inspiring and engaging educational event for all healthcare professionals, including laboratorians, clinicians, administrators and industry professionals. With a goal to

maximize value, identify solutions that resolve care gaps and promote wellness, this must-see program features a diverse agenda, where top leaders across healthcare share best practices, insights and opportunities for measurably better healthcare. With more than 30 diverse and worldrenown speakers, ELX is designed to bring insights directly to you. Registration, which includes full access to plenary sessions, educational workshops and hot topics is NOW OPEN. Access for registered attendees is available until December 31st. Registered attendees can also obtain up to 15.25 ACCENT®

continuing education credits. Additionally, and available now for ondemand viewing are two complementary sessions, including a brilliant plenary talk by Michael Dowling, President & CEO, Northwell Health. As one of the foremost CEOs in US healthcare, Mr. Dowling shares key trends and insights from the viewpoint of leadership. To view this complimentary session now, please visit here. Also available for on-demand viewing is a short and dynamic conversation between Dr. Colleen Strain, Scientific Leadership, Abbott and Paul Epner, Vice Chair, Sepsis Alliance, where they discuss becoming power users of laboratory medicine. To view this complimentary session now, please visit here. To learn more, to watch the complimentary sessions and to register, please visit www.healthcareELX.com.

IFCC Welcomes Armenia as New Full Member

he IFCC welcomes the Association of Medical Laboratory Diagnostics Specialists (AMLA) – Armenia. The “Association of Medical Laboratory Diagnostics Specialists – Armenia” is now the 96th Full Member within the IFCC. Best wishes for a long and fruitful participation in IFCC activities and projects for advancing excellence in Laboratory Medicine for better healthcare worldwide.

LabMedica International October/2023

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

NEWS

IFCC Distinguished Awards for IFCC WorldLab Dubai 2024: Call for Nominations by Maurizio Ferrari Chair, IFCC Awards Committee

s you are aware, the IFCC confers several Distinguished Awards to scientists and clinicians who work in clinical chemistry and laboratory medicine or related disciplines. These Awards are the highest honours that our Federation can bestow to colleagues worldwide in recognition of their outstanding achievements, to publicize their exceptional research and other li-Lanzi at the IFCC Office as follows: collilanzi@ifcc.org. contributions that have improved medical and healthcare, and A more detailed description of them, including names of forto stimulate and encourage other scientists to accelerate their mer honorees, can be found on the IFCC website. efforts in advancing clinical chemistry and laboratory medicine. For the 6 (six) Dubai Awards, the closing date for receipt of On behalf of IFCC and its Awards Committee, I am pleased nominations is 31st December 2023. to call for nominations for the following IFCC Distinguished Please do not hesitate to write to Ms Colli Lanzi or me if you Awards for presentation at the IFCC Congress in May 2024, have any queries. Dubai (UAE). 1. IFCC Howard Morris Distinguished Clinical Chemist Award (since 2020) - IFCC Distinguished Clinical Chemist Award (1967- 2017): Sponsored by Yashraj Biotechnology Ltd. 2. IFCC Award for Significant Contributions in Molecular Diagnostics: Sponsored by Abbott Laboratories. 3. IFCC Distinguished Award for Laboratory Medicine and Patient Care. 4. IFCC Distinguished Award for Contributions to the Cardiovascular Diagnostics: Sponsored by HyTest. 5. IFCC-Gérard Siest Young Scientist Award for Distinguished Contributions in Pharmacogenetics: Sponsored by Biologie Prospective. 6. IFCC Distinguished Women Scientist Award for Contribution to In Vitro Diagnostics: Sponsored by Yashraj Biotechnology Ltd. Please note: Each country/society can only nominate candidates for a maximum of 2 awards. This rule allows a better distribution of awards to scientists from various regions around the world. Nominations: Welcome from the President CALL FOR PROPOSALS or National Representative of the nominees’ Making your mark in the world of laboratory medicine national society, which should be a member requires bold thoughts and actions. Every observation, of the IFCC. Each nomination should contain: hypothesis and innovation stretches the potential of our 1) A statement as to the reasons for nomprofession and improves patient outcomes. This is your ination, opportunity to showcase your hard work to inspire curiosity 2) A full CV of the nominees including a and discovery in the global community that will gather in bibliography, and Chicago next July. 3) Other letters of support (optional). Ready to show us what you’re made of? Submit your They should be sent by email to Silvia Colproposal for the 2024 edition of ADLM University, Roundtables and Scientific Sessions.

IFCC OFFICE Via Carlo Farini 81, 20159 Milan, ITALY Tel: (39) 02-6680-9912 E-mail: ifcc@ifcc.org • Web: www.ifcc.org Staff Members: Paola Bramati, Silvia Cardinale, Silvia Colli-Lanzi, Elisa Fossati, Sofia Giardina, Smeralda Skenderaj The views and positions expressed in the IFCC News section are those of the IFCC or the individual authors, and do not necessarily represent the views or positions of LabMedica magazine or its publishers.

LabMedica International October/2023

Visit meeting.myadlm.org for a complete list of submission guidelines and session categories. Deadline for submissions is November 3.

ZAHRA SHAJANI-YI PHD, DABCC (CC), FAACC

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Blood-Based Molecular Cancer Test Delivers Unsurpassed Accuracy and Specificity Levels he absence of an accurate blood biomarker in neuroendocrine tumor (NET) disease has hampered its effective management. The progress made in genomic medicine and the emergence of molecular biomarkers have paved the way for the adoption of liquid biopsy as a solution to allow for real-time management. Now, a blood-based neuroendocrine cancer diagnostic test can be used to help diagnose, recommend treatment, and then monitor progress for NET or neuroendocrine neoplasia (NEN) patients in real time. The NETest from Wren Laboratories (Branford, CT, USA; www. wrenlaboratories.com) assesses mRNA gene expression analysis to diagnose NETs. By focusing on mRNA, Wren achieves real-time evaluation of the disease state in NET or NEN patients through the interpretation of molecular signals released by cells related to neuroendocrine cancer activity found in a blood sample. The rapid and non-invasive liquid biopsy test enables results to be shared within 48 hours of receiving a blood sample. Upon arrival of the sample at Wren’s CAP and CLIA-certified laboratory, a quantitative polymerase chain reaction (qPCR) technique is employed to quantify the expression levels of 51 genes linked to neuroendocrine cancer. Subsequently, Wren employs multianalyte algorithmic analyses (MAAA) to calculate the likelihood of a patient having a NET or NEN. The resultant probability or risk score is then made available. The NETest outperforms any other available testing method in terms of sensitivity, specificity, and accuracy. It surpasses other NET diagnostics in robustness, boasting a remarkable 98% sensitivity that translates to minimal false negative results. It also exhibits an 86% accuracy in determining disease status (distinguishing between stable and progressive disease), a level of precision unmatched by other diagnostic methods. The results from the NETest offer insights into the tumor’s state, the presence of residual disease, and the potential for recurrence. The NETest demonstrates an impressive 99% accuracy in diagnosing post-treatment recurrences. Due to its exceptional accuracy in recurrence determination, the test reduces the need for imaging in nearbvly half of the patients, thereby mitigating radiation exposure. Furthermore, it assesses the tumor’s response to treatment. This comprehensive information aids oncologists and patients in enhancing treatment management and monitoring, facilitating swift detection

Image: A liquid biopsy neuroendocrine tumor diagnostic can help oncologists better manage NETs (Photo courtesy of Wren Laboratories)

of disease recurrence. Additionally, Wren offers a companion prognostic tool to the NETest, referred to as PPQ, designed to evaluate the efficacy of peptide receptor radionuclide therapy (PRRT). The PPQ exhibits 94% accuracy in measuring the response to PRRT, far surpassing current predictive diagnostic methods such as somatostatin receptor expression and morphological imaging or chromogranin A (CgA) measurement. “Our NETest uses the cellular messaging system of the human body mRNA to detect tumor activity in the bloodstream, often before a tumor can be seen,” said Mark Kidd, Ph.D., laboratory and scientific director. “As the NETest panel includes 51 genes, we employ machine learning, also called AI, to analyze this incredibly dense molecular information about a patient’s tumor status.” “NETest puts patients in the best position possible to understand their disease and, specifically, how they are responding to treatment,” added Dan Buck, general manager. “This blood-based assay provides invaluable information delivered in a simple manner that helps oncologists and patients better understand where they are in their cancer journey.”

LabMedica International October/2023

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

Industry News

MEDICA 2023 to Host Laboratory Medicine Forum his year, the MEDICA LABMED FORUM will once again be a part of the international medical trade fair MEDICA (Düsseldorf, Germany; www.medica-tradefair.com) scheduled for 13-16 November 2023. The forum aims to cover a wide range of topics including cancer, heart diseases, infections, new anti-bacterial substances, and the role of digital technology and artificial intelligence (AI) in medicine. Over the years, the forum has gained significant attention as an integral part of the trade fair. Despite the complexity of the subjects for discussion, all presentations have been designed to be concise, clear, and understandable, and can be continued further in panel discussions. The inaugural day of MEDICA will dive into two particularly controversial subjects that are stirring up the laboratory medicine community: the “In-Vitro Diagnostics Regulation” (IVDR) and its implications for smaller IVD companies and specialized labs, as well as the growing role of AI with its potential and pitfalls. There will be an in-depth discussion on how to navigate the challenges brought about by new EU guidelines for diagnostic test quality assurance. This will be followed by an engaging discussion on how AI technologies, such as machine learning, are poised to transform lab work, particularly in automating the evaluation of microscopic images and complex data, like those used in leukemia diagnosis. The second day will focus on a discussion of groundbreaking advancements in the fields of oncology and cardiology. Recent research has highlighted the powerful diagnostic capabilities of blood tests in cancer treatment and management. Circulating tumor cells and nucleic acids, for example, are emerging as secondary but vital methods, providing new angles beyond traditional tissue examinations in oncology. Meanwhile, molecular diagnostic tests are reshaping cardiology, offering enhanced risk assessments for arteriosclerotic cardiovascular diseases. Additionally, genetic tests are gaining significance in the treatment of congenital heart defects, and new concepts like thromboinflammation are coming into play. The third day of the Forum is traditionally allocated to the next scientific generation in the field of laboratory medicine. Every year, young participants are invited to report on their current research and give an outlook on the future of the scientific field. The leitmotif for 2023 is “data sciences,” which captivates young minds, particularly due to the intelligent analysis of huge lab data sets. Presentation subjects will range from AI-enabled image evaluations to the analysis of complex lab data and automated generation of diagnostic reports. The discussions will also include the subject of practical applications in healthcare settings and the diagnostics industry. The final day of the MEDICA LABMED FORUM will kick off with an overview of diagnostic techniques that significantly cut down the time required to detect pathogens, thus allowing timely and effective treatment strategies. There will be a special focus on the rapid identification of the bacteria causing sepsis and targeted antibiotic usage. Moving beyond traditional antibiotic treatments, innovative ways to combat resistance will be explored. This includes discussions on alternative approaches like using small molecules against bacterial toxins or exploring phage therapy. To wrap up the event, there will be a deep dive into “Next Generation Sequencing” (NGS) and bioinformatics, with a spotlight on characterizing the microbiomes of newborns, a notably vulnerable patient group. Another traditional feature of MEDICA is the forward-looking presentations related to future trends in

LabMedica International October/2023

Image: Trade fair audience in the Laboratory Equipment & Diagnostics theme area (Photo courtesy of Constanze Tillmann/ Messe Düsseldorf)

diagnostics and life sciences, with a special focus this year on infectious diseases and antibiotic resistance, recognized as an escalating health crisis. The forum has steadily grown over the years, with last year’s MEDICA and its parallel event COMPAMED drawing a crowd of over 80,000 professionals, 75% of whom were from international backgrounds.

Events Calendar For a free listing of your event or a paid advertisement contact: LabMedica International Calendar E-mail: info@globetech.net

2023 OCTOBER ECC 2023 – 44th European Congress of Cytology. Oct 1-4; Budapest, Hungary; cytology2023.eu EASD 2023 – 59th Annual Meeting of the European Association for the Study of Diabetes. Oct 3-6; Hamburg, Germany; easd.org 16th Argentinian National Congress of Biochemistry. Oct 5-7; Mendoza, Argentina; cubra.org.ar ADLM (Formerly AACC) Middle East 2023. Oct 7-8; Dubai, UAE; aaccme.com CAP23 – Annual Meeting of the College of American Pathologists. Oct 7-10; Chicago, IL, USA; cap.org DKLM 2023 – Annual Congress of the German Society for Clinical Medicine and Laboratory Medicine (DGKL). Oct 10-12; Mannheim, Germany; dgkl.de JFBM 2023 – Journées Francophones de Biologie Médicale. Oct 11-13; Antibes, France; jfbm.fr CELME 2023 5th Symposium: Cutting Edge of Laboratory Medicine in Europe. Oct 12-13; Prague, Czech Republic; celme2023.cz 21st CNB International Congress 2023 – Colombian National College of Bacteriology. Oct 12-15; Medellín, Colombia; congresocnb.com 60th Annual Scientific Conference of the Australasian Association of Clinical Biochemistry and Laboratory Medicine (AACB). Oct 16-19; Brisbane, Australia; aacb.asn.au ASHI 2023 – 49th Annual Meeting of the American Society for Histocompatibility and Immunogenetics. Oct 16-20; San Antonio, TX, USA; ashi-hla.org MedLab Africa 2023. Oct 17-19; Johannesburg, South Africa; africahealthexhibition.com ASCP 2023 – Annual Meeting of the American Society for Clinical Pathology. Oct 18-20; Long Beach, CA, USA; ascp.org LABCLIN 2023 – 17th National Congress of the

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Spanish Societies for Clinical Laboratory (AEBM-ML, AEFA & SEQCML). Oct 18-20; Zaragoza, Spain; labclin2023.es EndoBridge 2023. Oct 19-22; Antalya, Turkey; endobridge.org 26th Congress of the Society of Medical Laboratory Technology of South Africa (SMLTSA). Oct 19-22; Johannesburg, South Africa; smltsa.org.za 45th Annual ACBI Conference – Association of Clinical Biochemists in Ireland. Oct 20-21; Dublin, Ireland; acbi.ie 7th ESPT Congress – European Society for Pharmacogenomics and Personalised Therapy. Oct 25-27; Copenhagen, Denmark; esptcongress.org 5th International Congress & 14th National Congress of the Ecuadorian Society of Clinical Biochemistry. Oct 26-28; Cuenca, Ecuador; congresosebiocliecuador2023.com 63rd Annual Academic Assembly of the Japan Society of Clinical Chemistry (JSCC). Oct 27-29; Toyama, Japan; jscc-jp.gr.jp 34th National Congress of the Turkish Biochemical Society. Oct 29 - Nov 1; Fethiye, Turkey; biyokimyakongresi.org

NOVEMBER 53rd Mexican National Congress of Clinical Pathology. Nov 1-4; Aguascalientes, Mexico; fempac.org.mx ASHG 2023 – Annual Meeting of the American Society of Human Genetics. Nov 1-5; Washington, DC, USA; ashg.org 44th Annual Meeting of the American College of Toxicology (ACT). Nov 12-15; Orlando, FL, USA; actox.org MEDICA 2023. Nov 13-16; Dusseldorf, Germany; medica-tradefair.com AMP 2023 – Annual Meeting & Expo of the Association for Molecular Pathology. Nov 16-18; Salt Lake City, UT, USA; amp.org 71st Annual Scientific Meeting of the American Society of Cytopathology (ASC). Nov 15-19; Austin, TX, USA; cytopathology.org 2023 Annual RBSLM Meeting - Royal Belgian Society of Laboratory Medicine. Nov 17; Brussels,

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Belgium; rbslm.be JIB 2023 – Journées de l’innovation en biologie. Nov 17-18; Paris, France; jib-innovation.com 34th Regional Congress of the International Society of Blood Transfusion (ISBT). Nov 18-21; Cape Town, South Africa; isbtweb.org 4th Congress of the Chilean Medical Society of Clinical Laboratory. Nov 23-24; Santiago, Chile; Web: smlc.cl IUIS 2023 – International Union of Immunological Societies. Nov 27 - Dec 2; Cape Town, South Africa; iuis2023.org

DECEMBER ASI 2023 – 51st Annual Scientific Meeting of the Australian and New Zealand Society for Immunology. Dec 4-8; Auckland, New Zealand; asi2023.org 65th Annual Meeting & Exposition of the American Society of Hematology (ASH). Dec 9-12; San Diego, CA, USA; hematology.org ASLM2023 - 6th Biennial Conference of the African Society for Laboratory Medicine. Dec 12-15; Cape Town, South Africa; aslm2023.org

2024 FEBRUARY SLAS 2024 – International Conference & Exhibition of the Society of Laboratory Automation and Screening. Feb 3-7; Boston, MA, USA; slas.org Medlab Middle East 2024. Feb 5-8; Dubai, UAE; medlabme.com Labquality Days 2024 – International Congress on Quality in Laboratory Medicine. Feb 8-9; Helsinki, Finland; labqualitydays.fi 3rd International Congress of Laboratory Diagnosis 2024. Feb 15-18; Virtual; ldcongress.com Pittcon 2024. Feb 24-28; Philadelphia, PA, USA; pittcon.org

MARCH ICE 2024 – 21st International Congress of Endocrinology. Mar 1-3; Dubai, UAE; isendo.org China Lab 2024. Mar 5-7; Guangzhou, China;

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Events Calendar chinalabexpo.com MASCL 2024 – Congress of the Association for Mass Spectrometry & Advances in Clinical Lab. Mar 17-22; Monterey, CA, USA; msacl.org USCAP 113th Annual Meeting – United States & Canadian Academy of Pathology. Mar 23-28; Baltimore, MD, USA; uscap.org

APRIL Analytica 2024. Apr 9-12; Munich, Germany; analytica.de India Lab Expo & Analytica Anacon India. Apr 15-17; Mumbai, India; analyticaindia.com Korea Lab 2024. Apr 23-26; Seoul, Korea; korealab.org ExpoMED Eurasia 2024. Apr 25-27; Istanbul, Turkey; expomedistanbul.com ECCMID 2024 – 34th European Congress of Clinical Microbiology and Infectious Diseases. Apr 27-30; Copenhagen, Denmark; eccmid.org

MAY Immunology 2024 – Annual Meeting of the American Association of Immunologists (AAI). May 3-7; Chicago, IL, USA; immunology2024.aai.org AACE Annual Meeting 2024 – American Association of Clinical Endocrinology. May 9-11; New Orleans, LA USA; pro.aace.com ECE 2024 – 26th Annual Congress of the European Society of Endocrinology. May 11-14; Stockholm, Sweden; ese-hormones.org ASRI 2024 – 43rd Metting of the American Society for Reproductive Immunology. May 18-22; Houston, TX, USA; theasri.org Hospitalar 2024. May 21-24; Sao Paulo, Brazil; hospitalar.com 107th Annual Meeting of the German Society for Pathology. May 23-25; Munich, Germany; pathologie-dgp.de IFCC WorldLab 2024 – 26th International Congress of Clinical Chemistry and Laboratory Medicine. May 26-30; Dubai, UAE; dubai2024.org SLAS Europe 2024 Conference and Exhibition - Society of Laboratory Automation and Screening. May 27-29; Barcelona, Spain; slas.org ISLH 2024 – International Society for Laboratory Hematology. May 30 - Jun 1; Nantes, France; islh. org EAACI 2024 – Annual Congress of the European Academy of Allergy & Clinical Immunology. May 31 - Jun 3; Valencia, Spain; eaaci.org

JUNE ESHG 2024 – European Human Genetics Conference. Jun 1-4; Berlin, Germany; eshg.org UKMedLab24 – National Meeting of the Association for Clinical Biochemistry and Laboratory Medicine. Jun 10-12; Brighton, UK; acb.org.uk 9th International Symposium on Critical Care Testing and Blood Gases. Jun 13-14; Saint-Malo, France; criticalcaretesting-saintmalo2024.eu ASM Microbe 2024 – American Society for Microbiology. Jun 13-17; Atlanta, GA, USA; asm.org 49th CBAC – Congress of the Brazilian Society of Clinical Analysis. Jun 16-19; Natal, Brazil; sbac. org.br FOCIS 2024 – Annual Meeting of the Federation of Clinical Immunology Societies. Jun 18-21; San Francisco, CA, USA; focisnet.org

LabMedica International October/2023

FIME 2024 – Florida International Medical Expo. Jun 19-21; Miami, FL, USA; fimeshow.com ISTH 2024 Congress – International Society on Thrombosis and Haemostasis. Jun 22-26, Bangkok, Thailand isth2024.org ASV 2024 – 43rd Annual Meeting of the American Society of Virology. Jun 24-28; Columbus, OH, USA; asv.org ECB 2024 – European Congress on Biotechnology. Jun 30 - Jul 3; Maastricht, The Netherlands; ecb2024.com

JULY ESHRE 2024 – 40th Annual Meeting of the European Society of Human Reproduction and Embryology. Jul 7-10; Amsterdam, Netherlands; eshre.eu MedLab Asia 2024. Jul 10-12; Bangkok, Thailand; medlabasia.com 2024 ADLM Annual Scientific Meeting & Clinical Lab Expo. Jul 28 - Aug 1; Chicago, IL, USA;

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AUGUST COLABIOCLI 2024 - 26th Latin American Congress of Clinical Biochemistry. Aug 28-31; Cartagena, Colombia; colabiocli.com

SEPTEMBER ECP 2024 – 35th Congress of the European Society of Pathology. Sep 7-11; Florence, Italy; esp-congress.org Thailand LAB International 2024. Sep 11-13; Bangkok, Thailand; thailandlab.com ESVC 2024 – Annual Meeting for the European Society for Clinical Virology. Sep 17-21; Frankfurt, Germany; escv.eu

OCTOBER APFCB Congress 2024 – Asia Pacific Federation for Clinical Biochemistry and Laboratory Medicine. Oct 31 - Nov 3; Sydney, Australia; apfcbcongress2024.org

Today’s Critical Care Test Menu Must Include iMg ePV Urea Creat/eGFR Prime Plus provides the most clinical value of any blood gas/critical care analyzer profile by adding essential tests for electrolyte balance (iMg), plasma volume (ePV), and kidney function (Urea, Creatinine, eGFR).

Ionized Magnesium (iMg)

Hypomagnesemia is a frequent finding in critically ill patients.1 Magnesium therapy guided by real time ionized magnesium monitoring has been shown to improve outcome in these patients.2

Estimated Plasma Volume (ePV)

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Urea, Creatinine and eGFR

Over 50% of patients admitted to the ICU develop some degree of acute kidney injury.6 Creatinine, eGFR, and Urea monitoring provides early indication of changes in kidney function and helps guide therapy to prevent AKI.

novabiomedical.com References 1. Soliman HM. Development of ionized hypomagnesemia is associated with higher mortality rates. Crit Care Med 2003;31(4):1082-7. 2. Wilkes NJ et al. Correction of ionized plasma magnesium during cardiopulmonary bypass reduces the risk of postoperative cardiac arrhythmia. Anesth and Analg 2002;95(4) 828-834. 3. Kobayashi M et al. Prognostic Value of Estimated Plasma Volume in Heart Failure in Three Cohort Studies; Clin Res Cardiol 2019;108(5): 549-561.

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