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Vol. 39 No.7 • 11/2022
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Kit Detects Immunity to COVID-19 and Variants
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s the COVID-19 pandemic continues, countries around the world are switching toward vaccinations and boosters to combat the pandemic. However, waning immunity against SARS-CoV-2 wild-type (WT) and variants have been widely reported. Booster
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Study Urges Setting Up Reserve Lab Capacity for Future Pandemics
he lack of early COVID-19 PCR testing capacity had a knock-on effect on other health services in 2020. This included delaying the ability to make sure hospitals were COVID-secure and patients had surgery as safely as possible, and slowing down
the identification of people with COVID-19 in the community – which delayed contact tracing. The risk of another pandemic like COVID-19 happening is ever-present: there have been outbreaks of infectious disease throughout history. But nobody can say for
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MCED Tests Mark New Era in Early Cancer Detection
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First Test to Diagnose Acute Rheumatic Fever
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new project will look to identify and validate biomarkers for acute rheumatic fever (ARF), which initiates a slow but progressive process of heart valve damage dubbed rheumatic heart disease (RHD). These biomarkers will serve as a basis for the world’s first sensitive and specific diagnostic test for ARF. The collaborative network led by the Cincinnati Children’s
Rapid POC Test for Methicillin Resistance
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Image: 3-D depiction of cancer cell and lymphocytes
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merging multicancer early detection (MCED) blood tests can detect a common cancer signal from over 50 different types of cancer and predict the origin of the signal in the body.
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Blood Volume Test Cuts by Half Hospital Stay for Heart Patients
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ffective management of patients hospitalized for heart failure remains problematic despite advances in medical therapy. Hospitals and clinicians struggle with readmissions, mortality and wasted resources. There is a need for accurate, actionable data to allow clinicians to optimize treatCont’d on page 8
Liquid Biopsy Testing Platform Offers Unprecedented Sensitivity in MRD Detection
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urrent liquid biopsy assays are able to detect circulating tumor DNA (ctDNA) levels when tumor burden is high, but are not sensitive enough to detect minimal residual disease (MRD) when ctDNA levels are low. A significant portion of lymphoma patients even-
tually experience disease progression, and existing ctDNA assays fail to detect MRD in the majority of patients who will later relapse. Now, a novel liquid biopsy testing platform allows detection of MRD with up to a 100-fold improvement in sensitivity over existing assays. Cont’d on page 17
ethicillin-resistant (MRSA) is a major multi-resistant nosocomial pathogen worldwide with the WHO estimating that the mortality rate of patient infection rates is around 50% higher compared with patients who have been infected by non-resistant Staphylococcus aureus strains. Moreover, the extensive period of hospitalization, morbidity, and the associated medical costs inCont’d on page 18
INSIDE
COVID-19 Update. . . . . 4 Clinical News. . . . . . . . . 8 IFCC News. . . . . . . . . . 29 Product News . . . . . 6-24 Industry News . . . . . . . 33 Events Calendar . . . . . 34 PUBLISHED IN COOPERATION WITH
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COVID -19 Diagnostics Update
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he report that follows provides a selection of news and advances announced from September 1 to October 15, 2022. For a recap of earlier developments, the reader is invited to refer to previous issues of LabMedica or visit our website at www.LabMedica.com. PCR Test Simultaneously Detects COVID-19 and Quantitatively Measures Viral Load Levels The cobas SARS-CoV-2 Duo test from Roche Diagnostics (Basel, Switzerland; www.roche.com) is a first of its kind PCR test that simultaneously detects COVID-19 and quantitatively measures the viral load levels of COVID-19. It is the first automated, real-time RT-PCR assay for the in vitro qualitative and quantitative detection of SARS-CoV-2 RNA in nasal and nasopharyngeal swab specimens. The cobas SARS-CoV-2 Duo test combines the standard qualitative result of a traditional SARS-CoV-2 PCR test with a quantitative result, which measures the viral load of a patient suspected of COVID-19. The test aims to help the healthcare community with contact tracing, patient triage and the approach to medical care.
Vital Technological Breakthrough Could Help Diagnose Long-Term Effects of COVID-19 A new discovery by researchers at Murdoch University (Perth, Australia; www.murdoch.edu.au) will aid the diagnosis of debilitating symptoms that can include severe headaches, extreme exhaustion, heart palpitations and brain fog. The discovery comes in the form of a new diagnostic tool that could be easily deployed in medical practices across the world, at low cost. The technology uses a specially designed set of radio pulses to extract signals from highly specific biomarker signals (from inflammatory glycoprotein markers and fats bound to lipoproteins) that gives a rapid diagnosis in approximately a minute. The researchers believe that their findings represent a translational triumph that will ultimately benefit COVID-19 patients in clinics throughout the world, as well as have the possibility for application across many other diagnostic areas including cardiovascular disease.
First Diagnostic Test for Long COVID Provides More Than 90% Accuracy IncellDx (San Carlos, CA, USA; www.incelldx. com) has developed a simple blood test that can help to objectively diagnose patients suffering from Post-Acute Sequelae of COVID-19 (PASC), commonly known as long COVID. IncellDx’s test is the first diagnostic test designed to identify patients with long COVID and has received CE-IVD marking in Europe. The test was developed based on clinical studies published in the peer reviewed journal Frontiers in Immunology, which showed that IncellDx researchers generated credible, objective disease scores for long COVID using machine learning and artificial intelligence to measure and analyze sets of inflammatory markers called cytokines and chemokines. The studies also demonstrated that patients with previous COVID-19 infection and lingering symptoms were found to have a distinct immunologic profile characterized by patterns of inflammatory marker expression. In a subsequent publication, IncellDx found SARS CoV-2 S1 spike protein in monocytic reservoirs of long COVID patients up to 15 months after acute infection.
Finger-Prick Blood Test Identifies Immunity to COVID-19 A simple finger-prick test developed by ImmunoServ Ltd. (Cardiff, UK; www.immunoserv.com) in close collaboration with Cardiff University (Cardiff,
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UK; www.cardiff.ac.uk) that measures the presence of immune T cells which can recognize SARS-CoV-2 will help determine which individuals are most vulnerable, and who might need more focused interventions such as repeated booster vaccinations. Recent efforts to identify those least protected from COVID-19 reinfection have focused on quantifying antibodies recognizing the surface spike protein of SARS-CoV2. Although measuring antibodies on a larger scale in a population is relatively easy, the levels do not give the full picture of protection from re-infection, especially as variants of SARS-CoV-2 emerge. Over 300 volunteers were recruited from across the UK in early 2022 to assess the novel test which used a simple finger-prick blood sample collected at home and sent to a laboratory by post allowing anyone within the UK to be part of the study. Individuals with the largest T cell response to the virus were best protected from COVID-19 over the following three months, regardless of their levels of antibodies to the virus.
Guanidine-Free Molecular Transport Medium Improves COVID-19 Testing Safety MagBio Genomics, Inc. (Gaithersburg, MD, USA; www.magbiogenomics.com) has announced US FDA 510(k) clearance, CE Mark approval and global launch of its MagXtract Collection Tube which offers improved safety, stability and cost-effective sample collection and processing. Used for sample collection and processing, the MagXtract Collection Tube is the first guanidine-free molecular transport medium, FDA-cleared device available in the U.S. for COVID-19 testing. In Europe the MagXtract Collection Tube is versatile, available for testing both COVID-19 and Influenza. It is also validated for bacterial and fungal sample collection and stabilization in research studies. The MagXtract Collection Tube can stabilize DNA & RNA at ambient temperatures and contains a proprietary molecular transport medium which lyses and inactivates collected samples. Direct lysis of the sample effectively stabilizes the nucleic acids (DNA & RNA) making them available for capture without the need of an additional lysis step. Furthermore, direct pathogen lysis eliminates the need for sample processing in a containment, making it easier for laboratory staff to handle samples.
New Breakthrough Test Detects and Predicts COVID-19 Severity AMPEL BioSolutions (Charlottesville, VA, USA; www.ampelbiosolutions.com) has made a breakthrough in precision and personalized medicine that can detect and predict the severity of COVID-19 in patients while also determining the best treatment options for each specific case. AMPEL’s new genomic test, known as CovGENE, can be administered by drawing a patient’s blood to quickly ascertain whether a COVID-19 patient will have a mild, moderate, or severe outcome. After a patient tests positive, the CovGENE blood test will help determine the type of treatment and medicine needed in order to reduce the chances of hospitalization or a medical emergency. The company’s new approach, through a simple blood test, will ultimately accelerate the means of providing effective treatments to the right people at the right time and potentially stem the serious illness caused by SARSCoV-2 infection that can lead to lung damage or death.
Siemens Launches New Combination Tests for SARS-CoV-2 and Seasonal Respiratory Pathogens Siemens Healthineers (Erlangen, Germany; www. healthcare.siemens.com) has announced the release of its new CE-marked FTD SARS-CoV-2/FluA/FluB/ HRSV Assay, a PCR test, and the CLINITEST Rapid Cont’d on page 5
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ISSN 1068-1760 Vol.39 No.5. Published, under license, by Globetech Media LLC; Copyright © 2022. All rights reserved. Reproduction in any form is forbidden without express permission. Opinions expressed are solely those of the authors, and do not represent an endorsement, or lack thereof, by the Publisher of any products or services. Teknopress Yayıncılık ve Ticaret Ltd. Şti. adına İmtiyaz Sahibi: M. Geren • Yazı işleri Müdürü: Ersin Köklü Müşir Derviş İbrahim Sok. 5/4, Esentepe, 34394 Şişli, İstanbul P. K. 1, AVPIM, 34001 İstanbul • E-mail: Teknopress@yahoo.com Baskı: Postkom A.Ş. • İpkas Sanayi Sitesi 3. Etap C Blok • 34490 Başakşehir • İstanbul Yerel süreli yayındır. Yılda sekiz kere yayınlanır, ücretsiz dağıtılır.
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COVID -19 Diagnostics Update Cont’d from page 4
COVID-19 + Influenza Antigen Test. Validated on Siemens’ VERSANT kPCR Molecular System, the new FTD SARS-CoV-2/FluA/FluB/HRSV Assay is a combination PCR test that detects and differentiates between clinically relevant viruses: SARSCoV-2, Influenza A, Influenza B, and HRSV A/B. Preserving sensitivity via the separate detection of SARS-CoV-2 targets allows the company’s highly effective, proven FTD SARS-CoV-2 Assay to perform without any compromise to sensitivity, maintaining key features of the top-performing assay. The CLINITEST Rapid COVID-19 + Influenza A/B Antigen Test is a convenient 3-in-1 test that can be administered by a healthcare professional in virtually any medical setting, and provides reliable results in 15 minutes. With no instrumentation or equipment required, a single nasopharyngeal swab sample can differentiate between SARS-CoV-2, Influenza A, and Influenza B infections.
Low-Cost COVID-19 Platform Combines Sensitivity of PCR and Speed of Antigen Tests A new study by researchers at the University of Illinois at Urbana-Champaign (Champaign, IL, USA; www.illinois.edu) has shown that tiny nets woven from DNA strands can ensnare the spike protein of the SARS-CoV-2 virus that causes COVID-19, lighting up the virus for a fast-yet-sensitive diagnostic test – and also impeding it from infecting cells, thus opening a new possible route to antiviral Image: The scanning electron microscope image shows SARS-CoV-2 AIX1000_Nov22 IssueV2.pdf 2 04/10/2022 18:13:37 (Photo courtesy of NIAID-RML) treatment. The DNA nets were designed to bind to the coronavirus spike protein (yellow) – the structure that sticks out from the surface of the virus and binds to receptors on human cells to infect them. Once bound, the nets give off a fluorescent signal that can be read by an inexpensive handheld device in about 10 minutes. The researchers demonstrated that their DNA nets effectively targeted the spike protein and were able to detect the virus at very FULLY AUTOMATED RPR FOR SYPHILIS SEROLOGY low levels, equivalent to the sensitivity of gold-standard PCR tests that detect the virus’s genetic material but can take a day or ■ Runs screens and titers – up to 192 samples in 90 minutes more to return results from a clinical lab.
AIX1000®
Quick Test Kit Determines Immunity against COVID-19 and its Variants A team of scientists from the Singapore-MIT Alliance for Research and Technology (SMART, Singapore; https:// smart.mit.edu), and Nanyang Technological University (NTU, Singapore; www. ntu.edu.sg) has developed a quick test C kit that can tell if a person has immunity M against COVID-19 and its variants, based on the antibodies detected in a blood samY ple. Different from ART test kits – which look for the presence of viral proteins CM produced during a COVID-19 infection MY to determine if a person is infected – this rapid point-of-care test kit is a serology CY test that measures antibodies made by the CMY patient. It requires a drop of blood and takes just 10 minutes to show results, as K compared to the 24 to 72 hours required for conventional laboratory testing. The test kit detects the levels of neutralizing antibodies against SARS-COV-2, the virus causing COVID-19, and its variants such as Delta and Omicron, and can be easily adapted for new variants of concern and other diseases in the future. The test paves the way for personalized vaccination strategies, where people are only given vaccinations and booster shots when necessary, depending on their variance in antibody levels and immune response.
Blood Test Performed During Initial Infection Predicts Long COVID Risk A blood test taken at the time of COVID-19 infection could predict who is
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■ New universal slide-in rack system to ease sample loading ■ Full sample traceability ■ Proprietary image recognition algorithm gives objective results ■ Reduced labor overhead: reduced TAT and hands on ■ Improved Database Management ■ FDA cleared and CE-IVD marked
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Cont’d on page 6 LabMedica International November/2022
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RDE (Receptor Destroying Enzyme) (II) is used in the haemagglutination test (HI test) for the influenza virus in order to eliminate non-specific haemagglutination inhibitors existing in a serum specimen.
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most likely to develop long COVID, suggests a new small-scale study by researchers at University College London (London, UK; www.ucl.ac.uk). The study analyzed proteins in the blood of healthcare workers infected with SARS-CoV-2, comparing them to samples from healthcare workers who had not been infected. Usually protein levels in the body are stable, but the researchers found a dramatic difference in levels of some of the proteins up to six weeks following infection, suggesting disruption to a number of important biological processes. Using an artificial intelligence (AI) algorithm, they identified a “signature” in the abundance of different proteins that successfully predicted whether or not the person would go on to report persistent symptoms a year after infection. The researchers say that, if these findings are repeated in a larger, independent group of patients, a test could potentially be offered alongside a polymerase chain reaction (PCR) test that could predict people’s likelihood of developing long COVID.
Testing for SARS-CoV-2 Blood Antigen Levels Can Predict Clinical Outcomes of COVID-19 Patients The amount of SARS-CoV-2 antigen measured in the blood of patients hospitalized with COVID-19 is associated with illness severity and other clinical outcomes, according to a new study by researchers from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH, Bethesda, MD, USA; www.nih.gov). The researchers analyzed levels of SARS-COV-2 antigen in blood samples taken from study participants and assessed the association of those levels with disease progression. Higher levels of viral antigen in the blood, which could indicate ongoing SARSCoV-2 replication, correlated with more severe disease. The researchers suggest that SARS-CoV-2 antigen levels hold promise as a biomarker, or a measurable substance, to predict which patients hospitalized with COVID-19 have a higher risk of worse outcomes.
One-Time Blood Test Predicts Which Hospitalized COVID-19 Patients Will Grow Worse A one-time test could predict which people hospitalized with COVID-19 are likely to worsen LINKXPRESS COM
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significantly during their stay, even if they were admitted with relatively mild symptoms, according to a study of more than 2,500 people led by researchers at Stanford Medicine (Stanford, CA, USA; www.stanford.edu). The test measures patient blood levels of a protein on the virus that causes COVID-19. High levels of the protein correlated strongly with an increased need for respiratory support five days later, regardless of the patient’s disease severity when the test was conducted, the researchers found. People whose levels were high were also likely to be hospitalized significantly longer than those with lower levels. The findings of the study suggest that the virus may continue to replicate in a subset of hospitalized patients, and that those patients might benefit from antiviral treatments like monoclonal antibodies or remdesivir. Such antiviral treatments are now primarily used in outpatient settings after previous clinical trials showed they did not benefit hospitalized patients.
Health Care Professionals Showed Increased Interest in POC Technologies during Pandemic, Finds Study A new study by researchers at UMass Chan Medical School (Worcester, MA, USA; www. umassmed.edu) and UMass Lowell (Lowell, MA, USA; www.uml.edu) suggests that interest among health care professionals in point-of-care technologies (POCTs) increased during the pandemic, with perceived applications of easy-to-use athome, mobile or bedside devices in a broader range of diseases. Health care professionals also viewed the adoption of POCTs as facilitating the humanization of epidemiology - in other words, sharing control of disease diagnosis and management with patients, rather than continuing to be provider-driven. Prior to the COVID-19 pandemic, health care professionals identified 18 medical condition categories for which POCTs could be used to diagnose a disease. Endocrine disorders, including diabetes mellitus, featured prominently among these, followed by infectious disease, cardiovascular and hematology conditions. Following COVID-19’s designation as a pandemic, health care professionals identified 20 medical conditions for which POCTs could be used to diagnose a disease. Infectious disease and cardiovascular-related medical conditions rose to the center of this network, followed by endocrine, respiratory and hematology conditions. LabMedica International November/2022
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Blood Volume Test Cuts by Half Hospital Stay for Heart Patients Cont’d from cover
ment plans and individualize care, thereby improving outcomes and reducing duration and cost of care. Now, new data has validated the benefits of a diagnostic blood test in reducing hospital length of stay (LOS) for heart failure patients. Daxor Corporation’s (Oak Ridge, TN, USA; www.daxor.com) BVA-100 (Blood Volume Analyzer) is the first diagnostic blood test cleared by the FDA to provide safe, accurate, objective quantification of blood volume status and composition compared to patient-specific norms. Over 60,000+ tests have been performed at leading hospital centers across the U.S., enhancing hospital performance metrics in a broad range of surgical and medical conditions, including significantly reducing mortality and readmissions in heart failure and critical care. Daxor has several ongoing multicenter trials in the areas of COVID-19 and heart failure treatment. A recent study titled “Length of Stay After Blood Volume Analysis in Hospitalized Heart Failure” compared both hospital admission and discharge dates, allowing the calculation of pre- and post-BVA LOS for all patients. Those who received BVA-guided treatment on the day of admission to the hospital had a highly significant (p <0.001) lower total LOS than controls (2.04 vs. 4.56 days) and significantly improved outcomes (lower 30-day readmissions and 365-day mortality). “This important study shows that BVA has the ability to help clinicians treat patients more effectively so that they get out of the
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Image: New data shows heart failure treatment guided by Daxor’s BVA-100 lowers hospital length of stay by 55% (Photo courtesy of Daxor)
hospital faster and have better results in terms of mortality and readmission when compared to those who did not receive BVA-guided care. Annual costs for HF treatment are estimated at USD 30.7 billion and expected to grow to nearly USD 70 billion by 2030 if we fail to improve on current treatment outcomes. Notably, in-hospital care comprises the majority of costs across all HF categories, averaging USD 14,000 per admission,” stated Michael Feldschuh, CEO and President of Daxor Corporation. “The clinical evidence continues to demonstrate that our innovative BVA-100 blood test uniquely allows physicians to understand underlying HF blood volume derangements, providing them with accurate, actionable data to individualize treatment plans in both the inpatient and outpatient settings - improving outcomes and reducing the total cost of care,” added Jonathan Feldschuh, Chief Scientific Officer of Daxor Corporation. LabMedica International November/2022
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LabMedica International
MCED Tests Mark New Era in Early Cancer Detection
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ancer doctors, care providers and pay- if they had cancer and it took a bit longer if they ers need to get ready for a major shift did not have cancer primarily because physiin early cancer detection that will cians opted to perform imaging studies and then affect almost every stage of cancer diagnosis repeat them a second time several months later and treatment. Researchers have presented new to investigate the possibility of a cancer diagnodata supporting the accuracy of multi-cancer sis,” explained study senior author Deb Schrag, early detection (MCED) blood testing that could Memorial Sloan Kettering Cancer Center. have major implications for future cancer care “An important finding was that few parprovision. New MCED tests in development can ticipants with a false positive screening test detect a common cancer signal from over 50 dif- required multiple invasive procedures such ferent types of cancer and predict where the sig- as endoscopies and biopsies. This finding nal has come from in the body. The signal arises should help to allay concerns that these tests from small sequences of circulating tumor DNA could cause harm by generating unnecessary (ctDNA) in the blood which have some different procedures in people who are well,” added methylation patterns from non-tumor DNA. Schrag. In the PATHFINDER study presented Image: New tests can detect common cancer at the ESMO Congress 2022, organized by signal across over 50 types of cancer from tuthe European Society for Medical Oncology mor DNA in blood (Photo courtesy of Pexels) (ESMO, Lugano, Switzerland; www. esmo.org), an MCED test detected a cancer signal in 1.4% of 6621 people VISIT US AT aged 50 years and over who were not known to have cancer, and cancer was confirmed in 38% of those with a positive test. Of 6290 people who 2022 were cancer free, 99.1% received Hall 3 • F80 a negative test result. Among those with a positive test result, the time to achieve diagnostic resolution (i.e. to find cancer or decide there was no evidence of malignancy requiring further investigation) was a median of 79 days. Among participants with a positive screening test, diagnostic resolution was achieved within three months for 73%. The study reported at the ESMO Congress 2022 is the first prospective investigation to show that an MCED test can detect cancer in patients with undiagnosed cancer, as previous studies used tests only in patients already known to have cancer. A number of further studies are now underway including a major randomized clinical trial enrolling 140,000 NOW asymptomatic people in England to Dedicated kits for DiaSys respons® ABLE L I investigate the clinical effectiveness A V A and BioMajesty® JCA-BM6010/C of MCED testing on cancer outcomes. However, the researchers have stressed the importance of continued standard screening for tumors, such as breast and colorectal cancer, Particle enhanced immunoturbidimetric assay while MCED tests are being refined and validated for cancers such as High precision at clinical cut-offs pancreatic, small bowel and stomach cancer where there are currently no Outstanding onboard and calibration stability screening options. Dedicated calibrators & controls “The results are an important first step for early cancer detection tests because they showed a good detection rate for people who had cancer and an excellent specificity rate for those DiaSys. Total confidence in patient results. who did not have cancer. In people www.diasys-diagnostics.com with a positive test, it took less than two months to confirm the diagnosis
Procalcitonin FS
The reliable alternative, when time matters in sepsis management
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LabMedica International November/2022
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Immune Regulators Predict Severity of Plasmodium Vivax Malaria
ytokines and chemokines are immune response molecules that display diverse functions, such as inflammation and immune regulation. In Plasmodium vivax infections, the uncontrolled production of these molecules is thought to contribute to pathogenesis and has been proposed as a possible predictor for disease complications. Severe clinical manifestations described for P. vivax infections include neurological conditions, especially coma or successive seizures, and impaired consciousness; hematological conditions, in particular anemia, severe thrombocytopenia and hemoglobinuria; systemic symptoms, such as circulatory collapse, vital organ damage, including respiratory dysfunction and acute respiratory distress syndrome, acute kidney failure, splenic rupture, liver dysfunction, and jaundice. Tropical Disease Specialists at the Universidad de Córdoba (Montería, Colombia; www.unicordoba.edu.co) and their colleagues enrolled 156 participants in a study and classified them into three groups: 50 patients with severe malaria (SM), 56 non-severe malaria (NSM) and 50 healthy controls (HC), all from an endemic area. After confirming the diagnosis of P. vivax malaria by microscopy and molecular techniques; biochemical, hematological and parasitological parameters were determined. Patients were classified as severe malaria if they met the criteria for any of the following complications: Hemoglobin concentration
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lower than 7 mg/dL was considered severe anemia, platelet concentration lower than 50.000 platelets/μL was considered severe thrombocytopenia, hypoglycemia (glucose < 60mg/dL), creatinine concentration higher than 1.3 mg/dL was considered indicative of renal dysfunction, Glutamic-pyruvic transaminase (GPT), Glutamic-oxaloacetic transaminase (GOT) concentration higher than 40 u/L was considered hepatic dysfunction. IL-4, IL-2, CXCL10 (IP-10), IL-1β, TNF-α, CCL2 (MCP-1), IL17A, IL-6, IL-10, IFN-γ, IL-12p70, CXCL8 (IL-8), and active TGF-β1 determination was performed in plasma, using the Human Essential Immune Response Panel kit (13-plex) (Biolegend, San Diego, CA, USA; www.biolegend.com). Samples were run in duplicates in a FACSCalibur (Becton Dickinson, Franklin Lakes, NJ, USA; www.bd.com). The scientists reported that the levels of several cytokines and chemokines, CXCL10, IL-10, IL-6, IL-4, CCL2 and IFN-γ were found to be significantly higher in severe, compared to non-severe P. vivax malaria patients. Severe thrombocytopenia was positively correlated with IL-4, CXCL10, IL-6, IL-10 and IFN-γ levels; renal dysfunction was related to an increase in IL-2, IL-1β, IL-17A and IL-8, and hepatic impairment with CXCL10, MCP-1, IL-6 and IFN-γ. A Lasso regression model suggests that IL-4, IL-10, CCL2 and TGF-β might be developed as biomarkers for severity in P. vivax malaria. The authors concluded that their study showed that there is a differential concentration of some cytokines and chemokines between patients with non-severe malaria and severe P. vivax malaria; and that there are associations between these molecules with manifestations that occur in severe malaria. Four molecules with potential to become biomarkers of severity were identified. The study was published on September 30, 2022 in the journal PLOS Neglected Tropical Diseases. LabMedica International November/2022
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LabMedica International
Rapid Diagnostic Tool to Revolutionize Diagnosis of Tick-Borne Diseases
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ick-borne illnesses have ballooned in recent years. Tick-borne pathogens can be passed to humans by the bite of infected ticks. Those ticks can carry bacteria, viruses or parasites. Now, a team of biomedical engineers is working to ramp up and reimagine how medical professionals diagnose tick-borne infections such as Lyme disease. Scientists at West Virginia University (Morgantown, WV, USA; www.wvu.edu) are developing a tool that more quickly detects tickborne diseases via a blood sample on a single chip. Their model aims to detect disease within one to two weeks after the onset of an infection, whereas existing approaches rely on a symptom-based questionnaire – which might ask if a person has a fever or a rash – and tests that aren’t reliable until at least a few weeks after infection. Their project was recently awarded USD 1.2 million as a joint initiative between the National Science Foundation and the National Institutes of Health. The research will involve cross-disciplinary use of microfluidics, sensors and machine-learning. Those factors will enable improved diagnosis of tick-borne infections via a non-invasive, affordable, quick and user-friendly tool. After collecting a blood sample from a patient, the tool will analyze the cells. All cells have a set of dielectric properties like permittivity and conductivity that are unique for cell membrane and cell cytoplasm. Those properties are heavily dependent on the state of the cell, such as whether it is normal or abnormal. The unique properties depend on the shape and size of the cell; if the membrane is rough, smooth or leaky; and what is happening within the cell interior. Once a few drops of blood enter the device, an electric field will sort them based on the state, size and shape of the cells. The sorted cells will have a baseline value of capacitance that will show up by the sensor and thus we can conclude the type of infection. What makes the project more unique is its ability to detect multiple tick-borne infections at once, and in a timely fashion. “Most tests available currently are symptom-based and symptoms develop four to six weeks after a tick bite,” said Soumya Srivastava, assistant professor at the Benjamin M. Statler College of Engineering and Mineral Resources, who is leading the team. “Our platform can detect these diseases early on, within one to two weeks, in under 30 minutes using a portable diagnostic tool. If successful, this tool may be useful for a variety of health applications beyond tick-borne diseases. Rapid detection could reduce the risk of hospitalization, doctor’s visits and prevent the disease from progressing into a chronic, life-long condition.”
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Image: A new tool could more quickly detect tick-borne diseases via blood sample on single chip (Photo courtesy of Pexels)
Digital Microscopy and AI Clinical and Research Applications
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NONINVASIVE PRENATAL TEST SYSTEM
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The OsmoPRO MAX automated osmometer offers automation, ease of use, and workflow flexibility. Built for labs of all sizes, it features automated pipetting, continuous loading of primary tubes and integrated barcode scanners.
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AI Algorithm Uses Pathology Images to Diagnose Rare Diseases
R
are diseases are often difficult to diagnose and predicting the best course of treatment can be challenging for clinicians. Modern electronic databases can store an immense amount of digital records and reference images, particularly in pathology through whole slide images (WSIs). However, the gigapixel size of each individual WSI and the ever-increasing number of images in large repositories, means that search and retrieval of WSIs can be slow and complicated. As a result, scalability remains a pertinent roadblock for efficient use. To solve this issue, researchers have now developed a deep learning algorithm that can teach itself to learn features which can then be used to find similar cases in large pathology image repositories. Known as SISH (Self-Supervised Image search for Histology), the new tool developed by investigators at Brigham and Women’s Hospital (Boston, MA, USA; www.brighamandwomens.org) acts like a search engine for pathology images and has many potential applications, including identifying rare diseases and helping clinicians determine which patients are likely to respond to similar therapies. The algorithm teaches itself to learn feature representations which can be used to find cases with
Image: New model acts as search engine for large databases of pathology images (Photo courtesy of Brigham and Women’s Hospital)
analogous features in pathology at a constant speed regardless of the size of the database. In their study, the researchers tested the speed and ability of SISH to retrieve interpretable disease subtype information for common and rare cancers. The algorithm successfully retrieved images with speed and accuracy from a database of tens of thousands of whole slide images from over 22,000 patient Mail: inquiry@medtl.com Phone: 86 29 8268 2132 Url: www.tlgenetech.cn cases, with over 50 different disease types and over a dozen anatomical sites. The speed of retrieval outperformed other methods in many scenarios, including disease subtype retrieval, particularly as the image database size scaled into the thousands of images. Even while the repositories expanded in size, SISH was still able to maintain a constant search speed. The self-teaching algorithm, however, has some limitations including a large memory requirement, limited context awareness within large tissue slides and the fact that it is limited to a single imaging modality. Overall, the algorithm Sample Collection Nucleic Acid Extraction PCR Detection demonstrated the ability to efficiently retrieve and Pre-processing images independent of repository size and in Why choose Tianlong: diverse datasets. It also demonstrated proficiency * One-stop PCR lab products supplier, lower your sourcing cost; in diagnosis of rare disease types and the ability to serve as a search engine to recognize certain * Verified compatibility of instruments and reagents, more reliable results; regions of images that may be relevant for di* CE/FDA/MHRA registered, more accessible & quality guaranteed ; agnosis. This work may greatly inform future * Trusted by reputed brand, such as Seegene, Takara,Linear, AIT, Kogene; disease diagnosis, prognosis, and analysis.
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The PCRplus Solution comprises a flexible delivery platform such as the GeneXpert system and 31 Xpert CE-IVD test cartridges that combine accuracy, speed, flexibility, quality and simplicity.
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First Test to Diagnose Acute Rheumatic Fever Cont’d from cover
Hospital Medical Center (CCHMC, Cincinnati, OH, USA; www.cincinnatichildrens.org) is dubbed the Acute Rheumatic Fever Diagnosis Collaborative (ARC) Network and comprises experts from six continents who specialize in bacterial pathogenesis, immunology, genetics, system biology, bioinformatics, and epidemiology as well as clinicians living and working in low- and middle-income countries across four continents where RHD remains endemic. These investigators have a strong track record of successful and productive collaboration, with more than 150 co-authored publications on ARF and RHD. ARC expects their discoveries over the next five years to modernize ARF diagnosis and establish a robust platform for future research into the disease. These discoveries will ensure higher quality epidemiological surveillance, inform vaccine
safety and trials, and help innovate new strategies for ARF prevention and treatment. “Despite the high burden of rheumatic heart disease in most low and middle-income countries, rheumatic fever has been incredibly challenging to diagnose,” said Andrea Beaton, MD, pediatric cardiologist at Cincinnati Children’s and lead researcher for this project. “The symptoms of ARF overlap with other common childhood illnesses and lack of a single, easy-to-deploy diagnostic test further hampers diagnosis.” “The ARC Network brings together an incredible group of global experts who will utilize modern scientific methods to identify a diagnostic test for rheumatic fever,” said Beaton. “Our work has the potential to transform the way we diagnose rheumatic fever globally and to help uncover new targets for prevention and treatment.”
Image: A single, easy-to-deploy test could identify and validate biomarkers for acute rheumatic fever (Photo courtesy of Pexels)
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Cont’d from page 12
“We show that our system can assist with the diagnosis of rare diseases and find cases with similar morphologic patterns without the need for manual annotations, and large datasets for supervised training,” said senior author Faisal Mahmood, PhD, in the Brigham’s Department of Pathology. “This system has the potential to improve pathology training, disease subtyping, tumor identification, and rare morphology identification.” “As the sizes of image databases continue to grow, we hope that SISH will be useful in making identification of diseases easier,” added Mahmood. “We believe one important future direction in this area is multimodal case retrieval which involves jointly using pathology, radiology, genomic and electronic medical record data to find similar patient cases.” LabMedica International November/2022
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MCHC Mean corpuscular hemoglobin concentration (MCHC) provides insight into chronic low grade blood loss and autoimmune hemolysis.
novabiomedical.com References 1. Cardacio C et al. Multiple Electrolyte and Metabolic Emergencies in a Single Patient. Case Reports 4. Kobayashi M et al. Prognostic Value of Estimated Plasma Volume in Heart Failure in Three Cohort in Nephrol Vol 2017;Article ID 4521319:1-6. Studies; Clin Res Cardiol 2019;108(5): 549-561. 2. Alabi FO et al. Multiple electrolyte imbalances and mixed acid-base disorder posing a diagnostic 5. Metkus T et al. Estimated Plasma Volume is Associated with Mortality in Acute Respiratory Distress dilemma: a case report. J of Med Case Reports 2020;14(15):1-5. Syndrome. Crit Care Explorations 2021;3(9):1-9. 3. Hypomagnesemic hypokalemia and hypocalcemia: clinical and laboratory Characteristics. Elisaf M 6. Mandelbaum T et al. Outcome of critically ill patients with acute kidney injury using the AKIN et al. Miner Electrolyte Metab 1997;23(2):105-112. criteria. Crit Care Med 2011;39(12):2659-2664
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POC HEMOGLOBIN/HEMATOCRIT ANALYZER NOVA BIOMEDICAL
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The Hemosure iFOB one-step fecal occult blood test is a qualitative, sandwich dye conjugate immunoassay that employs a unique combination of monoclonal and polyclonal antibodies to selectively identify in human feces.
Allplex MTB/XDRe Detection is a multiplex real-time PCR assay that detects Mycobacterium tuberculosis (MTB) with Ct value and identifies 13 mutations associated with extensively drug-resistant TB (XDR-TB) simultaneously.
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Washing Techniques Compared for Preparation of Autologous Blood Transfusions
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ell salvage is the process by which blood lost in surgery is collected and washed or filtered to produce autologous blood for re-transfusion to the patient. Cell salvage aims to reduce the need for donor blood. Centrifugal cell salvage washing technique is a preferred medical treatment in order to retain lost red blood cells (RBCs) without contaminants. Although this technology very efficiently collects and washes shed blood, it is costly and often impractical or unavailable, especially in middle – or low – income countries. A team of clinical scientists working with the Sanquin Blood Bank (Amsterdam, the Netherlands; www.sanquin.nl) collected a total of nine whole blood units, 500 mL ± 10% in quadruple, and used bottom-and-top collection systems containing 70 mL of citrate-phosphate-dextrose (CPD, Fresenius Kabi, Emmer Compascuum, the Netherlands; www.freseniuskabi.com) at the Sanquin Blood Center to allow their temperatures to adjust to 20 to 24ºC. The processing of the whole blood with the devices was initiated at around 16 hours after collection. The laboratory study was designed to compare the centrifugation (autoLog, Medtronic, Eindhoven, the Netherlands; www.medtronic.com), microfiltration (HemoClear BV, Zwolle, The Netherlands) and coarse filtration (Hemafuse, Sisu Global Health, Baltimore, MD, USA; www.sisuglobal. health) techniques in their ability to remove non-cellular components and recover and concentrate the blood cells. Hematological parameters (cell count, hemoglobin concentration, hematocrit and mean corpuscular volume (MCV)) were obtained using an Advia 2120 hematology analyzer (Siemens Healthcare Nederland; www.siemens-healthineers.com). The hematology team reported that the centrifugal technology confirmed its efficacy to remove potentially harmful solutes and capture red blood cells. The microfiltration technology (HemoClear) reached comparable levels of removal of solutes, with a potential advantage over centrifugal technology in the ability to also recover platelets. The coarse filtration technology (Hemafuse) had no washing capacity but, like the microfiltration technology, has the advantage of recovering platelets. Both filtration-based technologies recovered a significantly greater amount of platelets, with the coarse filtration having the highest recovery of platelets, 92% versus 67% with microfiltration. The mean-free hemoglobin concentration before processing was 11 ± 10 mg/L. The centrifugation procedure significantly increased mean-free hemoglobin concentration to 207 ± 22 mg/L. The authors concluded that innovative filtration devices represent an alternative to centrifugal technology in the preparation of autologous Cont’d on page 17
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LabMedica International
Liquid Biopsy Testing Platform Offers Unprecedented Sensitivity in MRD Detection
Cont’d from cover
Foresight Diagnostics, Inc.’s (Aurora, CO, USA; www.foresight-dx. com) MRD platform is based on the Phased variant Enrichment and Detection Sequencing (PhasED-Seq) technology. PhasED-Seq lowers the error profile of mutation detection in sequencing data by requiring the concordant detection of two separate non-reference events in an individual DNA molecule. By detecting more than one mutation, PhasED-Seq can more accurately distinguish tumor-derived cell free DNA (i.e., ctDNA) from healthy cell free DNA – enabling detection of ctDNA at levels below one part-per-million (<0.0001%). PhasED-Seq has been extensively validated in thousands of patient samples. Foresight has been granted a patent by the U.S. Patent and Trademark Office (USPTO) or the detection of MRD using its personalized phased variant detection platform. The granted patent covers Foresight’s PhasED-Seq technology and the workflow behind the Foresight Solid Tumor Recurrence Test, an assay used to detect MRD from the plasma of cancer patients using DNA sequencing. The test is custom designed for each patient to track phased variants identified from tumor tissue samples using whole genome sequencing. The test offers unprecedented sensitivity for MRD detection, enabling a limit of detection below one part per million. “Ultra-sensitive MRD tests are essential to detect residual disease and recurrence following completion of curative intent therapies,” said Dr. Ash Alizadeh, MD/PhD, co-founder and Chief Medical Advisor at Foresight. “PhasED-Seq has been used in more than 20 different clinical studies, and can predict cancer relapse when tumor burden is low and patients are more likely to favorably respond to anti-tumor therapy. Sensitivity for MRD detection is important for all types of cancer and is particularly critical for cancers that shed relatively small amounts of circulating tumor DNA (ctDNA) into the bloodstream such as lung and breast cancer.”
Image: The PhasED-Seq MRD testing platform with increased sensitivity could dramatically improve patient outcomes (Photo courtesy of Foresight Diagnostics)
Washing Techniques Compared for Preparation of Autologous Blood Transfusions Cont’d from page 16
blood for reinfusion. The HemoClear technology for the first time enables the recovery of washed platelets and red blood cells. Washing of blood cells with saline is necessary to remove non-cellular components and enable safe reinfusion. Both the centrifugation (autoLog) and microfiltration (HemoClear) technologies have a washing feature and effectively reduce the various non-cellular solutes. The study was published on September 30, 2022 in the Journal of Blood Medicine.
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ADVANCED STAINING SYSTEM
SARS-COV-2, INFLUENZA A/B TEST
RAPID DIAGNOSTIC TEST ANALYZER
The Tissue-Tek Genie Advanced Staining System is the first fully automated, true random access stainer for immunohistochemistry (IHC) and in situ hybridization (ISH) that features 30 completely independent staining stations.
REALQUALITY ABFlu-Cov-2 is an IVD kit for the identification of the respiratory viruses SARS-CoV-2, Influenza A and Influenza B. It is useful in the clinical diagnosis of patients presenting symptoms during seasonal epidemics.
BUDDI is a smart rapid diagnostic test analyzer that evaluates the line signal intensities on the test device, helping clarify decision making of unclear test line, and minimizes possible errors in results by visual detection.
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Rapid POC Test for Methicillin Resistance
Cont’d from cover
crease significantly with an MRSA infection. The treatment on the front line today looks at increasing empirical antibiotic prescribing and increasing drug-resistant outbreaks. Speed is key here - since the result of diagnostics with culture sampling, which is the current traditional method for MRSA testing is only available after one to three days. Now, a new test for the quick diagnosis of MRSA at the point of the care not only provides rapid RT-PCR results in 53 minutes but differentiates whether the bacterial strain is MRSA or methicillin-sensitive (MSAA) which promotes targeted therapy. The new MRSA/SA rapid test on Vivalytic by Bosch Healthcare Solutions GmbH (Waiblingen, Germany; www.bosch-healthcare. com), a point of care platform brought to the market by Randox Laboratories (Crumlin, UK; www.randox.com), delivers reliable results in under an hour directly at the point of care and is therefore, particularly suitable for use in accident and emergency units. Since the result of diagnostics with cultures is only available after one to three days, this PCR test for the point of care is ideal as an additional tool when speed is of the essence.
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Image: Vivalytic test MRSA/SA provides quick diagnosis of methicillin resistance at POC (Photo courtesy of Bosch)
The quick and reliable diagnosis of whether the bacteria strain is MSSA or MRSA-resistant is also important in emergency situations. Waiting times for operations can, on the one hand, be reduced, while on the other enabling a decision on effective antibiotic treatment on this basis. This ability contributes to preventing contamination, breaking the chain of infection, and avoiding other resistances, which can, in turn, positively impact the treatment procedure and costs. Last but not least, unnecessary isolation measures, which are not only complex and expensive, but also put patients under even more pressure, can be avoided. The advantages of PCR rapid tests administered with the aid of Bosch’s Vivalytic platform lie not only in the quick analysis time, but also in the ease of handling. The Vivalytic system is a fully automated, cartridge-based platform capable of both Hi-Plex and Lo-Plex infectious disease testing. Each easy-to-use cartridge contains all necessary reagents, is fully-sealed to minimize risk and can be conveniently stored at room temperature. The Vivalytic consolidates the full molecular workflow into a small benchtop platform, capable of extraction, PCR amplification and detection. It follows an easy four step process from sample entry to results and with the gold standard PCR testing. With most up to date technology, the Vivalytic has wireless connectivity, with no peripherals required, making a unique space saving and hygienic solution. Handling and utilization are simple and medical professionals require only minimal training. LabMedica International November/2022
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PORTABLE MOLECULAR WORKSTATION
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HEMATOLOGY QUALITY CONTROL
iPonatic III is a portable molecular workstation that offers fully automated rapid testing process and “sample-in-result-out” system, with test results available in as short as eight minutes.
AccuRa-32 is a real-time fluorescent quantitative PCR system specially designed for rapid nucleic acid testing needs in applied fields such as clinical, food, environmental and research. It can detect 32 samples at the same time.
Cal-Chex A Plus is a whole blood product manufactured for calibrating multi-parameter hematology analyzers and assigned values are derived from replicate analysis on whole blood calibrated hematology analyzers.
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Ultra-Rare Set of Blood Groups Identified
he two primary blood group systems, the ABO and Rh- systems are known to the majority of individuals. There are other additional blood group systems, each with a unique range of reaction risk. Additionally, different blood group antigens exist within each blood group system. Despite the identification of the high incidence red cell antigen Era nearly 40 years ago, the molecular background of this antigen, together with the other two members of the Er blood group collection, has yet to be elucidated. The mechanosensory ion channel Piezo1 is the carrier molecule for the Er red cell antigens, establishing a new blood group system. A team of Transfusion Medicine Specialists led by those at the NHS Blood and Transplant, (Bristol, UK; www.nhsbt.nhs.uk) performed Whole exome and Sanger sequencing of individuals with serologically defined Er alloantibodies and identified several missense mutations within the PIEZO1 gene, encoding amino acid substitutions within the extracellular domain of the Piezo1 mechanosensor ion channel. Confirmation of Piezo1 as the carrier molecule for the Er blood group antigens was demonstrated using immunoprecipitation, CRISPR/Cas9-mediated gene knockout and expression studies in an erythroblast cell line.
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The team described the molecular bases of five Er blood group antigens. They recognized Era, Erb and Er3 antigens; and two novel high incidence Er antigens, described as Er4 and Er5, establishing a new blood group system. The clinical significance of antibodies against Er4 and Er5 is poorly understood due to a lack of data, but two cases of severe hemolytic disease of the fetus and newborn have been reported in women with these antibodies. Er was recognized as a blood group collection by the International Society of Blood Transfusion in 1990 and promoted to a blood group in 2022. Missense mutations in PIEZO1, encoding the Piezo1 mechanosensor protein, defines the Er red blood cell antigens. Nicole M Thornton, PhD, Head of Red Cell Reference at NHSBT’s International Blood Group Reference Laboratory, said, “Most people will have what we consider to be the ‘regular’ form of Er but a small number of rare individuals have altered forms, including the new ones we identified in this study. Discovering the genetic basis of blood groups allows us to develop new tests to identify those with uncommon blood groups, with the aim of providing the best possible care for even the rarest of patients. The more we know about such rare blood group variations, along with
Image: The mechanosensory ion channel Piezo1 is the carrier molecule for Er red cell antigens, establishing a new blood group system (Photo courtesy of University of Bristol)
the ability to be able to test for and identify them, the better care we are able to offer to such patients in the future.” The authors concluded that demonstration of Piezo1, present at just a few hundred copies on the surface of the red blood cell, as the site of a new blood group system highlights the potential antigenicity of even low abundance membrane proteins and contributes to our understanding of the in vivo characteristics of this important and widely studied protein in transfusion biology and beyond. The study was published on September 19, 2022 in the journal Blood.
Fragile X Syndrome Mutations Found With Comprehensive Testing Method
ragile X syndrome (FXS), the most common form of inherited intellectual disability and monogenic cause of autism spectrum disorders, is mainly caused by the expansion of CGG trinucleotide repeats in the 5′ untranslated region of FMR1 gene. Individuals with a premutation allele are at risk for fragile X-associated tremor/ataxia syndrome, fragile X-associated primary ovarian insufficiency, and fragile X-associated neuropsy-
chiatric disorders. The premutation allele can expand to a full mutation allele during female germline transmission, thus being transmitted to the offspring with FXS. Medical Geneticists at the Central South University (Changsha, China; https://en.csu. edu.cn) and their associates retrospectively enrolled a total of 62 genomic DNA samples from 21 families with a history of FXS from the diagnostic laboratory in Hunan Jiahui Genetics Hospital, including 57 samples from
peripheral blood and five from chorionic villus sampling. All 21 families had members with FMR1 variants identified by in-house triplet repeat-primed – PCR (TP–PCR) assay, Southern Blot Analysis (SBA), Sanger sequencing, and Gap-PCR. TP–PCR and gene-specific PCR (GS-PCR) were performed using AmplideX PCR/CE FMR1 Reagents from Asuragen (Austin, TX, USA; www.asuragen.com) and analyzed on 3130 Cont’d on page 22
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LabMedica International
Study Urges Setting Up Reserve Lab Capacity for Future Pandemics
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sure when it will happen. Now, researchers have suggested that a system of reservist lab scientists should to be set up now to provide surge capacity that will help respond faster – and more effectively – to future outbreaks of infectious disease. They considered a number of options for providing scientific surge capacity and concluded that the best scenario would be a mix of highly skilled paid reservists, and volunteers who could be called on when required and trained rapidly. In their report, published in the journal The BMJ, researchers at University of Cambridge (Cambridge, UK; www.cam.ac.uk) suggest that effective preparation for the next pandemic includes recruiting a relatively small number of highly skilled scientists, who would be paid on retainer, to help in the initial phases of an emergency. It would Image: Researchers have suggested effective preparation for the next panalso involve a large reserve of volunteer staff to provide essential test- demic (Photo courtesy of Cultura RM Exclusive/Matt Lincoln) ing capacity; these people would not need to have specialist skills but could be trained quickly in an emergency VISIT US AT and paid only when needed. Those working in sectors of the economy likely to close during a pandemic – 2022 such as entertainment and hospitality Hall 1 • A64 – would be ideal candidates as voluntary reserves, the researchers say. In their paper the scientists compare COVID-19 with other large-scale emergencies including war, where the military has a system of reservists for built-in surge capacity. But they say that unlike the military where reservists serve to deter warfare, having an ‘always-on’ capacity to deal with public health emergencies wouldn’t do anything to deter a new pandemic from emerging – and that’s why there has always been a pressure to close labs and streamline public health services. Their suggested solution does not require sustained, crossparty political will to fund so is more likely to succeed; the researchers acknowledge there are many other pressures on the UK economy that must take priority. They recommend that other countries should consider their requirements for surge capacity based on their own circumstances. “There’s an extent to which the emergence of an infectious disease is a random process, but a pandemic like COVID-19 is guaranteed to happen again at some point,” said Dr Jordan Skittrall in the University of Cambridge’s Department of Pathology and first author of the report. “In the UK we’re in the privileged position of having the right scientific skills to respond to the next big outbreak. But we need to make sure that we have these people ready, so that when something does happen they can hit the ground running.”
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Fragile X Syndrome Mutations Found With Comprehensive Testing Method Cont’d from page 20
ABI Genetic Analyzer (Applied Biosystems, Waltham, MA, USA; www.thermofisher.com). PCR and Sanger sequencing of FMR1 exons and exon-intron boundaries were performed to analyze rare intragenic variants. Gap-PCR and Sanger sequencing were performed to determine the breakpoints of microdeletions. Comprehensive analysis of FXS (CAFXS) assay included two reactions for comprehensive analysis of FMR1 variants. Southern Blot Analysis of digested genomic DNA was also performed. The investigators reported that CAFXS accurately detected the number of CGG repeats in the range of 93 to at least 940 with mass fraction of 0.5% to 1% in the background of normal alleles, which was 2–4-fold analytically more sensitive than TP–PCR. All categories of mutations detected by control methods, including full mutations in 30 samples, were identified
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by CAFXS for all 62 clinical samples. CAFXS accurately determined AGG interruptions in all 133 alleles identified, even in mosaic alleles. CAFXS successfully identified two rare intragenic variants including the c.879A > C variant in exon 9 and a 697-bp microdeletion flanking upstream of CGG repeats, which disrupted primer annealing in TP–PCR assay. In addition, CAFXS directly determined the breakpoints of a 237.1-kb deletion and a 774.0-kb deletion encompassing the entire FMR1 gene in two samples. The authors concluded that long-read sequencing-based CAFXS represents a comprehensive assay for identifying FMR1 CGG expansions, AGG interruptions, rare intragenic variants, and large gene deletions, which greatly improves the genetic screening and diagnosis for FXS. The study was published on September 29, 2022 in the journal Clinical Chemistry.
Image: AmplideX PCR/CE FMR1 Reagents are for the detection of CGG repeats in the fragile X mental retardation (FMR1) gene. These reagents provide a PCR-only approach based on Triplet Repeat Primed PCR (TP-PCR) design to reliably amplify and detect all alleles including Full Mutations (Photo courtesy of Asuragen)
Genetic Prognosis Explored for Pediatric Dilated Cardiomyopathy
ilated cardiomyopathy (DCM) in children is a disease in which, due to abnormalities in the muscle, one or both ventricles in a child’s heart become enlarged and contract poorly. A variety of processes that result in myocardial damage can lead to dilated cardiomyopathy and coronary artery disease. Genetic DCM was initially thought to be primarily caused by variants in genes encoding cytoskeletal and sarcomeric proteins. However, recent advances in sequencing and array-based technologies have increased our understanding of the genetic basis of DCM. In addition to genes encoding sarcomeric and cytoskeletal proteins, genes coding for transcription factors, ion channels, the nuclear membrane, and mitochondrial proteins are now also known to be involved in isolated DCM.
Pediatric Cardiologists at the Erasmus University Medical Center (Rotterdam, The Netherlands; www.erasmusmc.nl) and their colleagues performed a multicenter observational study in children diagnosed with dilated cardiomyopathy, from 2010 to 2017. The team originally included 144 children. Initial diagnostic categories were idiopathic dilated cardiomyopathy in 67 children (47%), myocarditis in 23 (16%), neuromuscular in seven (5%), familial in 18 (13%), inborn error of metabolism in four (3%), malformation syndrome in two (1%), and “other” in 23 (16%). The genetic data collected were obtained retrospectively and reflect the genetic evaluation that was common practice at that time: single gene testing (e.g., Sanger sequencing of MYH7), targeted next-generation sequencing
(NGS) of a gene panel (range 28-70 genes), exome sequencing (ES) with analysis of genes related to cardiomyopathy or open exome analysis. Additional genetic testing (e.g., SNParray) was performed in a subset of patients in whom a malformation syndrome was suspected. The team defined two groups: patients with a likely pathogenic (LP) or pathogenic (P) variant (class 4 or 5) and patients without a pathogenic variant, including patients with one or more variants of unknown significance (VUS, class 3). The investigators reported that they found a likely pathogenic or pathogenic variant in 38 children (36%), most often in MYH7 (n = 8). In one patient initially diagnosed with myocarditis, a pathogenic LMNA variant was Cont’d on page 24
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Genetic Prognosis Explored for Pediatric Dilated Cardiomyopathy
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found. During the study, 39 patients (27%) reached study endpoint (SE: all-cause death or heart transplantation). Patients with a likely pathogenic or pathogenic variant were more likely to reach SE compared with those without (hazard ratio 2.8; 95% CI 1.3–5.8), while transplant-free survival was significantly lower. Clinical characteristics at diagnosis did not differ between the two groups. The authors concluded that genetic testing is a valuable tool for predicting prognosis in children with dilated cardiomyopathy, with carriers of a likely pathogenic or pathogenic variant having a worse prognosis overall. Genetic testing should be incorporated in clinical work-up of all children with dilated cardiomyopathy regardless of presumed disease pathogenesis. The study was published on September 30, 2022 in the journal Circulation: Genomic and Precision Medicine.
Troponin Testing Could Improve Timing of Heart Surgery and Survival Rate
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roponin is a protein involved in muscle contraction that is released into the bloodstream after a heart attack. The higher the troponin levels, the more damaged the heart is. Clinicians use troponin levels, along with other tests, to determine whether a patient is having a heart attack and to decide on treatment options such as coronary artery bypass graft (CABG) surgery - a surgical procedure used to treat coronary heart disease. The optimal time to perform surgery following a heart attack remains unclear. Previous reports have suggested that carrying out surgery in the first few days following a heart attack is associated with a higher risk of surgical complications and death due to not giving enough time for the heart to recover. As a result, following a heart attack, many patients who need bypass surgery wait for more than 10 days before surgery is performed. Now, a new study has found that some patients who have lower levels of troponin would benefit from having earlier surgery. However, the researchers show that patients with very high troponin levels should have surgery postponed, as their risk of dying was higher if surgery was performed within 10 days of their heart attack. There was no benefit in delaying surgery for those with low levels of troponin, according to the findings. The researchers suggest that early surgery for heart attack patients with lower troponin levels would reduce overall length of stay and ease pressure on resources such as staff. Cont’d on page 27
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Kit Detects Immunity to COVID-19 and Variants Cont’d from cover
vaccinations have shown to be able to increase immunological protection against new variants; however, the protection observed appears to decrease quickly over time suggesting a second booster shot may be appropriate. Moreover, heterogeneity and waning of the immune response at the individual level was observed suggesting a more personalized vaccination approach should be considered. To evaluate such a personalized strategy, it is important to have the ability to rapidly evaluate the level of neutralizing antibody (nAbs) response against variants at the individual level and ideally at a point of care setting. Now, scientists have developed a quick test kit that can tell if a person has immunity against COVID-19 and its variants, based on the antibodies detected in a blood sample. Different from antigen rapid test (ART) kits – which look for the presence of viral proteins produced during a COVID-19 infection to determine if a person is infected – this rapid point-ofcare test kit developed by a team of scientists from the Singapore-MIT Alliance for Research and Technology (SMART, Singapore; https:// smart.mit.edu), and Nanyang Technological University (NTU, Singapore; www.ntu.edu.sg) is a serology test that measures antibodies made by the patient. It requires a drop of blood and takes just 10 minutes to show results, as compared to the 24 to 72 hours required for conventional laboratory testing. The test kit detects the levels of neutralizing antibodies against SARSCOV-2, the virus causing COVID-19, and its
variants such as Delta and Omicron, and can be easily adapted for new variants of concern and other diseases in the future. Using a paper-based assay that is coated with chemicals that bind to antibodies in the blood sample, the test kit is low-cost, fast and has up to 93% accuracy. The test paves the way for personalized vaccination strategies, where people are only given vaccinations and booster shots when necessary, depending on their variance in antibody levels and immune response. Having an accurate and rapid serology test can enable governments and healthcare organizations to effectively manage limited vaccine resources, and address vaccine hesitancy, particularly concerning multiple booster doses. To address vaccine hesitancy and efficacy of vaccination against novel variants, a personalized vaccination approach could be more effective, one which offers booster doses to individuals assessed to be more at risk, such as healthcare workers and the elderly. For a personalized approach to be effective, healthcare workers need to be able to quickly evaluate the level of NAb response against variants at the individual level, using an easy-to-use point-of-care test kit in clinics, hospitals or vaccination centers. “Our team’s work in the development of a rapid test kit has given us valuable insights into vaccine effectiveness and protection longevity,” said Professor Peter Preiser, Co-Lead Principal Investigator at SMART AMR and Associate Vice President for Biomedical and Life Sciences at NTU Singapore. “Our study proves that our
Image: COVID-19 antibodies test kits (right) and the digital reader device (left in black) (Photo courtesy of NTU Singapore)
new test kit can be a powerful tool, allowing healthcare organizations to screen people and determine their vaccination needs, especially against the current and upcoming variants. This will help allay some people’s fears that they will be ‘over-vaccinated with a booster’, since the results will inform them accurately if they are well-protected against COVID-19 or not.” “Over the course of the pandemic, several large studies have shown that NAb levels against the dominant variant at the time of the study are a reliable indicator of protection from infection,” added Dr. Hadley Sikes, SMART AMR Principal Investigator, Associate Professor at MIT. “Some segments of the population have low tolerance for risk of infection. The test kit we developed can provide valuable, individualized information about how quickly or how slowly a person’s antibodies levels have fallen, allowing them to stay informed of their health and, whenever required, get a necessary booster dose to protect themselves.”
Thrombocytopenia Prevalence in Acute Cancer-Associated Thrombosis Patients
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enous thromboembolism (VTE) is a common complication in patients with cancer, with thrombosis being the second leading cause of death among outpatients undergoing chemotherapy. Thrombocytopenia is also a common complication in patients with cancer, either due to the underlying malignancy or toxicity of cancer-directed therapy. Due to the unique risk profile of cancer patients, management of cancer-associated thrombosis (CAT) requires special considerations as compared to VTE in non-cancer patients. Clinical decision-making in patients with cancer who develop both thrombosis and thrombocytopenia is challenging as thrombocytopenia increases the risk of bleeding without conferring protection against thrombosis. Hematologists at the Beth Israel Deaconess Medical Center (Boston MA, USA; www. bidmc.org) evaluated the prevalence of thrombocytopenia among patients with acute CAT. A retrospective cohort analysis of adult cancer patients was conducted between 2010 and 2021 with CAT (acute VTE within six
months after new diagnosis of malignancy). VTE included acute deep vein thrombosis (DVT), pulmonary embolism (PE), abdominal or thoracic venous thrombosis, and cerebral sinus thrombosis (CST). The lowest platelet count within two weeks of (before or after), the index VTE event, was identified to assess the frequency and grade of concurrent thrombocytopenia. The overall cohort was comprised of 47% females, with mean age 65.7 ± 12.8 years. The scientists identified 3,635 patients with CAT (79.8% solid tumors, 17.8% hematologic malignancies, and 2.4% multiple concurrent cancer diagnoses). Thrombocytopenia (defined as platelet count <100,000/µL) occurred in 22% (95% CI 21%-24%) of patients with CAT with solid tumors diagnoses and 47% (95% CI 43%-51%) of patients with CAT and hematologic malignancies. Severe thrombocytopenia (platelet count <50,000/µL) occurred in 7% (95% CI 6%-8%) of patients with solid tumors and 30% (95% CI 27%-34%) of patients with hematologic malignancies. The authors concluded that their study highlights the high co-prevalence of throm-
Image: A blood film from a thrombocytopenic patient that is almost devoid of platelets (Photo courtesy of Professor Erhabor Osaro, FIBMS, PhD)
bocytopenia and CAT. Approximately 1 in 5 patients with solid tumors and 1 in 2 patients with hematologic malignancies with a diagnosis of VTE have concurrent thrombocytopenia. These point estimates serve to better define the scope of the problem and serve as justification for additional clinical trials addressing appropriate anticoagulation for acute CAT with thrombocytopenia. The study was published on September 28, 2022 in the journal Blood Advances. LabMedica International November/2022
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LabMedica International
Troponin Testing Could Improve Timing of Heart Surgery and Survival Rate Cont’d from page 24
The large study led by Imperial College London (London, UK; www.imperial.ac.uk) is the first multicentre study to investigate the interaction between the extent of heart damage, as indicated by troponin levels, and the optimal time to wait for surgery in a large series of heart attack patients. The study reviewed patients who had a type of heart attack called a non-ST segment elevation myocardial infarction (NSTEMI) due to a blockage to their coronary arteries - which supply blood to the heart – who required a CABG. This is a procedure that uses veins, usually from the legs, or arteries from the chest or arm to bypass the blockage and restore blood flow and oxygen to heart muscle. Around 20% of NSTEMI patients have a CABG. However, the optimal timing for CABG surgery in patients with uncomplicated NSTEMI has been unclear. Prior to the new research, some studies had suggested that early surgery was associated with higher mortality post operation. This has led to a tendency for CABG to be delayed if a patient’s condition remains stable. However, other studies had reported similar mortality rates after early versus late surgery, concluding that delaying surgery in all patients after uncomplicated NSTEMI is not warranted and does not improve outcomes. No previous study had investigated in a large group of patients whether there was an association between the extent of heart damage (as measured by troponin levels) and the wait for surgery on survival. In the new study, the team analyzed data from the NIHR HIC of 1746 patients with NSTEMI and unstable angina (UA) - a condition in which the heart doesn’t get enough blood and oxygen, leading to a heart attack. The cohort consisted of 1684 patients with NSTEMI and 62 with UA. The average age of the group was 69 and 21% were female. They underwent CABG within 90 days at five different cardiac centers before their surgery between 2010 and 2017. The researchers compared patients’ troponin levels, wait between surgery and outcomes after surgery within the first 30 days and over a period of five years. They found that the pre-operative troponin level was a strong predictor of early mortality, and this was significantly influenced by the interval to surgery. The average wait for patients with high troponin levels to surgery was nine days. Sixty patients died within 30
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days after surgery and another 211 patients died over a period of five years following surgery. They found that for those who had troponin levels of less than 100 times the normal upper limit, delaying surgery to after 10 days was not associated with lower survival. For patients with higher troponin levels, early survival increased progressively with a longer time to surgery – survival was highest in those who had surgery after day 10. The effect of troponin levels pre-operation on survival was limited to the first 30 days after surgery. Late survival was determined by other risk factors, such as age and other co-morbidities such as hypertension. The team says more work is needed in
the form of prospective trials to assess the impact of troponin and timing of surgery on survival following a heart attack. “For patients with troponin levels of under 100 times the normal upper limit, extending the waiting time or surgery did not improve early survival,” said Dr. Amit Kaura, lead author of the research. “This finding is particularly significant as two-thirds of patients presenting with troponin levels of under 100 are waiting on average 12 days for surgery after being admitted to hospital. There are potential cost saving implications with our research by performing earlier surgery in this group of patients with lower troponin levels.”
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Biosensor Detects Brain Tumors With Less than a Drop of Blood
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espite significant advances, mortality from brain tumors remains high with five-year survival rates of 36%. More accurate diagnoses might improve the situation. To effectively treat brain cancer, physicians need to not only confirm the presence of a malignant tumor but also identify whether it originated there (primary tumor) or moved to the brain (secondary tumor) from other organs. Physicians also need to know where in the organ the tumor is located. However, tissue biopsies are invasive and can miss important information about a tumor’s make-up. Imaging-based methods, meanwhile, do not offer sufficient sensitivity and resolution. Now, researchers have developed a biosensor that could help physicians precisely diagnose brain cancer from a minute blood sample. In order to develop a noninvasive test using a tiny amount of serum that would avoid surgery or a painful spinal tap, researchers at the Institute for Biomedical Engineering, Science and Technology (I BEST, Toronto, Canada; www.ibestresearch.ca) used high-intensity laser beams
to form 3D nickel-nickel oxide nanolayers on a nickel chip. This process resulted in an ultrasensitive biosensor that allowed them to detect minute amounts of tumor-derived materials, such as nucleic acids, proteins and lipids, that made it through the blood-brain-barrier into the circulation. The sensor detected these components using a method known as surface-enhanced Raman spectroscopy, which generated molecular profiles, or fingerprints, for each sample. The researchers then analyzed these profiles with a DEEP neural network to find evidence of a brain tumor and define its type, as well as predict its location within the brain. Using the liquid biopsy platform, the researchers could detect brain cancer from just five microliters of blood serum, and they could distinguish it from breast, lung and colorectal cancer with 100% specificity and sensitivity. They had similar success distinguishing primary brain tumors from secondary tumors that had metastasized to the brain from the lung or breast. Profile analysis also allowed the researchers to determine in which of nine brain compartments the tumor resided with 96% accuracy. The noninvasive nature of the test should allow healthcare specialists to monitor cancer development over time so they can make better treatment decisions, the researchers say.
Simple Blood Draw Could Revolutionize Early Breast Cancer Detection VISIT US AT
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reast cancer is the most prevalent form of cancer in the world, affecting one in eight women over their lifetime. Since 1976 when the American Cancer Society endorsed mammography X-rays, the technique – along with a tissue biopsy – has become the standard way for doctors to check patients for breast cancer. But mammography is not 100% accurate and its detection can be impeded by healthy dense tissue. A tissue biopsy is also not a foolproof method. Although it can reveal information about the tumor, it has limitations. Doctors can sample only a small area and may fail to capture the full extent of the tumor. A tissue biopsy is also invasive and painful. Combined, the drawbacks for diagnosis with mammograms and tissue biopsies mean some patients are not diagnosed until the cancer has grown and spread. Now, scientists have found indications that a special blood test called a liquid biopsy could determine whether a patient has breast cancer at its early stage and if that cancer is unlikely to return. The high-definition comprehensive liquid biopsies are conducted using a standard blood draw from the arm of a patient in a doctor’s office. Once in the laboratory, the sample is examined for signs of cancer. The results of the study demonstrating the liquid biopsy results for early breast cancer detection was led by led the University of Southern California (USC, Los Angeles, CA, USA; www.usc.edu) and raise hopes that one day doctors could detect breast cancer in patients with a simple blood draw. For the study, the team worked with 100 breast cancer patients – some early and some late stage – and 40 patients without breast cancer from April 2013 through January 2017. The team tested a theory that the high-definition liquid biopsy could detect multiple cancer biomarkers, including the so-called “oncosomes” – nano-sized, membraned cargo carriers that enrich the body’s environment for cancer growth. These oncosomes are secreted by cancer cells as the group has shown previously. “The news here is that we found the vast majority of early-stage breast cancer patients have these oncosomes at very robust levels,” said Peter Kuhn, a USC cancer physicist. “They’re about 5-10 microns in diameter, about the size of a cell. We first identified these large vesicles in prostate cancer about a year-and-a-half ago and showed that they are related to the cancer. They are hiding in plain sight.” If further studies produce similar results, it could mean that the next generation high-definition liquid biopsy may become a diagnostic tool for early breast cancer detection and other cancers, he said. The test also could inform patients who have been treated for cancer that they will most likely remain cancer-free. “It’s an amazing opportunity to change how early breast cancer detection is being done with a simple blood draw, but it’s only a research outcome at this point and we still need to demonstrate clinical benefit,” said Kuhn. LabMedica International November/2022
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News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information
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NEWS
Prof. Tomris Ozben of Turkey Elected Next President of the IFCC
he International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) is happy to announce the election of Prof. Tomris Ozben, representing the Turkish Biochemical Society (TBS), as its President Elect. Her term in office starts on January 2023 and is scheduled to end on December 2026. In the election, Prof. Ozben received 45 votes (58%) from the 77 member societies that voted, out of a total of 89 member societies. Other candidates in the election were Prof. Michael Neumaier (German Society for Clinical Chemistry and Laboratory Medicine; DGKL) and Prof. Tahir Pillay (South African Association for Clinical Biochemistry and Laboratory Medicine; SAACB). Prof. Ozben, EuSpLM, Ph.D., D.Sc., and Specialist in Clinical Biochemistry, currently serves as President of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM). She has been Chair or a Member in many Federations, Scientific Organizations, Societies, Committees and Councils. She is the Past-IFCC Treasurer, Past-Chair of the IFCC Congress and Conference Committee, Past-President of the Balkan Clinical Laboratory Federation (BCLF), and Board Member of the IFCC Foundation for Emerging Nations (FEN). Over her tenure at Akdeniz University (Antalya, Turkey), Prof. Ozben has served as Vice Rector, Director of Research Funds, Chair of the Dept. of Clinical Biochemistry, and Founding Director of Central Laboratory at Akdeniz University Hospital. She worked for more than 10 years in the Ethical Committee of Akdeniz University Hospital and Medical Faculty on themes concerning drug research in clinical trials. She served as Commission Member of the Turkish Ministry of Health for restructuring Medical Education and Teaching, as well as Member-Elect of the Turkish High Educational Council for four years. Prof. Ozben’s own research interests include identification of early markers for diagnosis and prognosis of cancer, cardiovascular and chronic kidney diseases, diabetes, liquid biopsy, proteomics, oxidative stress and antioxidants in health and disease, impact of apoptosis in cancer therapy, multidrug resistance, nanoparticles, therapeutic drug monitoring, development and validation of new tests, analytical techniques, quality control and management, teaching, mentoring, research, and laboratory management. Prof. Ozben serves as mentor to numerous graduate students and takes part at Post-Graduate Education Programs (Specialty and PhD) at Akdeniz University, PhD program “Clinical Experimental Medicine” at University of Modena and Reggio Emilia and External Examiner for Post-graduate education at University of Zimbabwe. She has received several awards including Akdeniz University “Outstanding Service” and “Science” awards, AACC Van Slyke Society and AACC TDM/Toxicology Division and AACC’s National Academy of Clinical Biochemistry (NACB) awards. Prof. Ozben is on the Editorial Board of several scientific journals, and a reviewer for several journals, and scientific projects evaluator for the Italian Ministry for University Education and Research (MIUR; CINECA), Ministry of Science and Environmental Protection of Republic of Serbia, Israel Science Foundation, and the Scientific and Technological Research Council of Turkey (TUBITAK). She has taken part in the organization of several WorldLabs, EuroMedLabs, IFCC General Conference, and FEBS-IUBMB Advanced Courses, Workshops and Young Scientists FORUMs. She has published over 250 manuscripts; several book chapters; edited books published by international publishers, and attended as an invited speaker to more than 300 international conferences.
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NEWS
News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information
EDITORIAL
By Katherina Psarra, MSc, PhD
Dear Colleagues, Our warmest congratulations from the eNews team to Prof. Tomris Ozben for her election as the new President-Elect. Well, IFCC is 70 years old, but it is so young, so vibrant and full of energy, as you will see in this issue of the eNews. Our President, Prof. Khosrow Adeli, in his message describes all this activity in the divisions, committees, working groups, task forces of our society. He describes the current IFCC strategic
IN MEMORIAM
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Prof. Jean-Paul Chapelle
rof. Jean-Paul Chapelle was born in the surroundings of Liège, Belgium, on November 6th, 1946. He graduated as a Pharmacist from the University of Liège in 1969 and defended his doctoral thesis in 1976. The same year, he started his career in the Clinical Chemistry Department of the University of Liege led by Prof. Heusghem. Jean-Paul Chapelle quickly became involved in the field of myocardial biomarkers and he notably highlighted the role of haptoglobin polymorphism as an independent risk factor for myocardial infarction. He published the results of this finding as first author in the New England Journal of Medicine in 1984. His research career has been very fruitful, notably thanks to his work on creatine kinase isoenzymes, on the very early markers of myocardial infarction, and on troponin I and T, for which he was recognized a key opinion leader. Prof. Chapelle has been nominated Head of the Clinical Chemistry Department of the CHU de Liège in 2004 until his retirement in 2012. It was under his leadership that the laboratories of the Department became pioneers in quality management, first by being accredited according to ISO 17025 in 2000, then according to ISO 15189 in 2005. Prof. Chapelle has largely contributed to the transmission
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plan and the program of the IFCC General Conference that was held in Brussels at the end of the month. Go through his message to learn everything about it. The IFCC-PSEP educational visit shows the importance of the IFCC contribution in the lab medicine professionals’ education all over the world. Very educational for all of us is late Prof. Jean Paul Chapelle’s life as presented in memoriam in this issue. I hope I persuaded you again that IFCC may be 70 years old but is more active and younger with every passing year. Stay tuned to the IFCC, stay tuned to the eNews, dear colleagues!
of his knowledge in clinical chemistry through the numerous courses in pharmaceutical sciences and biomedical sciences that he has given at the University of Liège. He has also been very active in various national and international scientific societies. He was notably Past-President of the Belgian Society of Clinical Chemistry (which later became the Royal Belgian Society of Laboratory Medicine) and Belgian National Representative to the International Federation of Clinical Chemistry (IFCC) for many years. Jean-Paul Chapelle was also known among his peers as a very nice and kind person, a polite and friendly colleague who was always listening, soft spoken but very much to the point. During all the years I have personally been working with him, I will never thank him enough for the confidence and freedom he gave and for his wise advice. Prof. Chapelle passed away on September 26th, 2022, leaving behind his beloved wife and two children who followed his path and successfully pursued a medical career.
Contributed by Etienne Cavalier, Prof. of Clinical Chemistry, University of Liège, CHU de Liège; President of the Royal Belgian Society of Laboratory Medicine
2021 UNIVANTS of Healthcare Excellence Award Winner: Croydon University Hospital is One Step Closer to HIV Elimination
s we prepare for world AIDS day on December 1, it’s important to recognize and celebrate healthcare teams who have improved outcomes related to HIV and AIDS. At Croydon University Hospital in the UK, Drs Ian Cormack, Clinical Lead HIV Medicine, and Linda Vaccari, Sexual Health Registrar, had a vision for getting AIDS to zero at their institution. With the help of their integrated clinical care team, they implemented an opt-out HIV screening program in emergency department (ED) to enable earlier diagnosis and treatment of those with HIV. Through this transformative program they were able to identify unsuspecting patients earlier, leading to a reduction in AIDS defining illnesses in newly diagnosed HIV patients from 78% to 4%. They also reduced unnecessary admissions (from 31% to 0%) while substantially reducing mortality for newly diagnosed HIV patients from 23% to 0%. This impressive initiative has achieved a sustained 97% testing rate for all eligible patients presenting to the ED which is
the highest rate ever recorded. Their program has enabled the diagnosis of 25 patients with newly identified HIV, representing a 3-fold increase compared to the three years before. Their ED is now responsible for diagnosing more new HIV cases than all other HIV testing centers combined. Due to the widespread success of their initiative, it is now being implemented in EDs across the nation with the hope of eliminating new HIV infections in the UK by 2030. For their commitment to healthcare excellence and outstanding outcomes the integrated clinical care responsible for this initiative was awarded one of the top 3 honors of the 2021 UNIVANTS of Healthcare Excellence awards. Congratulations Ian Cormack, Linda Vacarri, Mike Bell, Leslie Perry, Sarah Horne and Andrew Widdowson! To learn about this integrated clinical care initiative and others, please visit www.UnivantsHCE.com. LabMedica International November/2022
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NEWS
News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information
MESSAGE FROM THE PRESIDENT By Khosrow Adeli
I
•
President, IFCC
IFCC: 70 Years of Global Leadership in Laboratory Medicine
FCC has reached a major milestone this year, celebrating its 70th anniversary with seven decades of contributions to scientific and educational advances in the field of laboratory medicine around the world. Over the past 70 years, IFCC has undergone drastic transformation to expand its reach around the globe and become a pillar of the laboratory medicine community. Today, IFCC is the largest international organization in the field of laboratory medicine, linking 96 full member societies/countries, 20 affiliate member societies, 6 regional federations, and 52 corporate members worldwide. The organization represents an important facilitator of education and international scientific exchange in the field and is known for its contributions to development of standards in laboratory diagnostics. The current IFCC strategic plan (2020-2023) aims to continue advancing excellence in laboratory medicine for better healthcare worldwide through four main pillars: 1) directly impacting healthcare and patient outcomes, 2) directly contributing to global lab quality, 3) developing evidence on the value and impact of lab medicine in healthcare, and 4) expanding eLearning/distance learning programs worldwide. Main themes that support these pillars include encouraging and supporting a culture of innovation as well as enhancing functional unit productivity. Several Task Forces have been developed in recent years to tackle these objectives, working diligently toward IFCC’s new vision. Alongside Task Forces, IFCC Divisions should also be recognized for their achievements that have not only contributed to the growth of the IFCC organization but have also had significant impact on advancing the science of laboratory medicine and in vitro diagnostics around the world. These include the Scientific, Education and Management, Communications and Publications, and Emerging Technologies Divisions. Other great accomplishments in the last few years include the first-ever IFCC virtual conference held in early 2021, which brought together leading experts on a global virtual platform to present the latest advances in COVID-19 diagnostics and therapeutics as well as discuss the critical role of clinical laboratories in the COVID-19 pandemic. IFCC also held the first-ever Annual Town Halls to bring the IFCC community together for the purpose of improving internal communication. IFCC Officers, Members of Committees and Taskforces, Corporate Members, Special Guests including all past presidents of IFCC as well as Presidents of National Societies and Regional Federations have been invited to celebrate this milestone at the General Conference in Brussels, Belgium, from October 28-31, 2022. A special gala dinner will set the perfect backdrop to celebrate the 70th Anniversary of IFCC, recognizing 70 years of global leadership in laboratory medicine and celebrating our contributions to advancing excellence in laboratory medicine for better healthcare worldwide. Attendees can also look forward to a Symposium on the Central Role of Lab Medicine in Patient Care & Public Health (with expert presentations from AACC, WHO, and others), an Industry Forum on the Future of IVD over the Next Decade, Presentations from Past Presidents and Regional Federation Presidents, as well as Progress Reports from IFCC functional groups. As we reflect on 70 years, it is important to recognize the many milestones that IFCC has accomplished, of which there
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LabMedica International November/2022
are too many to list here. Moving forward, I strongly believe that the future holds considerable promise for the IFCC organization and its family of national societies and corporate members. I would like to thank all of our community members for your dedication and contributions to the IFCC organization over the years, aiding significantly in our progress towards the IFCC vision, which we will most certainly continue for years to come! Let’s come together and celebrate this major momentous achievement for the IFCC Organization at all events and conferences throughout the year and continue this long tradition of global leadership in laboratory medicine and in vitro diagnostics.
Cheers, Khosrow
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IFCC Professional Scientific Exchange Program
Educational Visit to the Hormone Laboratory at Oslo University Hospital
I
By Vivek Pant, MBBS, MD, Samyak Diagnostic Pvt, Ltd, Kathmandu, Nepal
had an opportunity of visiting the hormone laboratory at Oslo University hospital, kindly supported by the International Federation of Clinical Chemistry and Laboratory Medicine, Professional Scientific Exchange Program. The purpose of this educational visit was to improve my capacity of applying the advanced technology, particularly Liquid Chromatography Mass Spectrophotometry (LC-MS), in diagnosis and monitoring of congenital adrenal hyperplasia. The routine analysis of steroid hormones is critical in understanding the function of metabolic pathways that impact sexual characteristic particularly in patients with congenital adrenal hyperplasia and disorder of sex development. LC-MS/MS is a robust emerging technique in steroid analysis due to the advantages it provides over immunoassay. These benefits include improvements in analytical sensitivity and selectivity, and the capability of multi-analyte quantitative detection in a single run. I spent most of my time at the LC-MS lab learning the analysis of steroids in blood sample. I observed and I was explained in detail about the whole process of sample preparation to interpretation of mass spectra. Sample preparation is the most important part to learn during LC-MS analysis of steroids. It is essential to remove proteins and other constituents that may
Oslo University Hospital - Hormone laboratory is in building no 23
precipitate when injected into the liquid chromatography (LC) mobile phase, to avoid clogging the chromatography column and improve chromatographic performance. The volume, pH, organic solvent, buffer and aqueous composition of the liquid injected into the LC have a profound effect on chromatography, modifying LC peak shapes, peak separation and retention times. This ultimately affects the quantitation limits, selectivity and robustness of the assay. I had one to one sessions with professor Per Medbøe Thorsby, the quality manager Stine Rødmyr, research scientist Alexander Bauer Westbye and Sandra Rinne Dahl, Dr. Finn Erik Aas and Dr. Oskar Kelp. The hormone laboratory at Oslo university hospital has validated the use of serum samples for multi-steroid profiling by LC-MS/MS technology. This laboratory uses an in house LC-MS/MS method developed for determination of serum concentrations of testosterone, androstendione, 17-hydroxyprogesterone, 21-deoxycortisol, 11-deoxycortisol, deoxycortisosterone, corticosterone, cortisone and cortisol.
Photo: Dr. Vivek Pant (Left) with Prof. Per Medbøe Thorsby (Right).
The optimized use of these analytes in research will allow us to gain further insight into the steroid metabolism in patients with congenital adrenal hyperplasia. While rotating in the laboratory I was provided with the opportunity to present about my workplace and my scientific publications. Also, I had the opportunity to visit the newborn screening laboratory where LC-MS technique was in use for analysis of various compounds other than steroid. Dr. Ingjerd Saeves explained about the analysis of different analytes by LC-MS in first and second tier methods that were either developed in-house or adopted from the literature. In newborn dried blood spot samples, the amino acids, acylcarnitines and succinylacetone were quantified by flow injection analysis with ultra-performance LC-MS. The in-house developed LCMS/MS method was also used to measure homocysteine, methylmalonic acid and methylcitric acid and to differentiate pivaloylcarnitine from isovalerylcarnitine. The faculties and staff at the hormone laboratory made me feel as a part of the team and everyone was very kind and always willing to answer all my queries. I also got to know the new things about the techniques and quality control management I was already familiar with, which I can introduce in my laboratory to improve and make it more efficient. Moreover, I have seen best possible ways of working, organizing, and managing a LC-MS laboratory which has broaden my views. I am very impressed by the collegial environment, state-ofthe-art research facilities and the egalitarian structure in the Oslo university hospital. I must extend my heartfelt gratitude to Prof. Per Medbøe Thorsby, who believed in me and provided his facilities at the hormone laboratory for my learning process. I am grateful and indebted to Prof. Bharat Jha and assistant Prof. Ram Vinod Mahato representing Nepalese Association for Clinical Chemistry (NACC). Finally, I would like to thank the IFCC that offers this wonderful opportunity to the young researchers and brings together the researchers and laboratory personnel around the globe.
IFCC OFFICE
Via Carlo Farini 81, 20159 Milan, ITALY Web: www.ifcc.org Tel: (39) 02-6680-9912 • E-mail: ifcc@ifcc.org Staff Members: Paola Bramati, Silvia Cardinale, Silvia Colli-Lanzi, Smeralda Skenderaj The views and positions expressed in the IFCC News section are those of the IFCC or the individual authors, and do not necessarily represent the views or positions of LabMedica magazine or its publishers. LabMedica International November/2022
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Industry News
To view this issue in interactive digital magazine format visit www.LabMedica.com
Beckman Coulter Acquisition to Expand AI-Based Clinical Decision Support Offerings
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eckman Coulter, Inc. (Brea, CA, USA; www.beckmancoulter. com) has acquired StoCastic, LLC (Towson, MD, USA; www. stocastic.com), an artificial intelligence (AI) company that provides evidence-based decision support for hospital emergency departments (EDs). StoCastic’s TriageGo will be a cornerstone of Beckman Coulter’s AI enabled Clinical Decision Support (CDS) portfolio, a growing field that aims to further improve patient care by leveraging data-driven insights for clinicians and optimize clinical decision making. StoCastic’s TriageGo decision support tool seamlessly integrates Electronic Health Record systems and routine ED workflow. The purpose of ED triage is to differentiate patients’ criticality, yet 60-70% of all patients in the U.S. are triaged to an ambiguous Emergency Severity Index Level 3, meaning the projected course of care is uncertain. TriageGo has been shown to reduce decision making times in the ED, including decreasing door-to-clinical decision time by
Sebia Acquires Autoimmune and Infectious Disease Diagnostics Concern in the US
S
ebia (Lisses, France; www.sebia.com), a global specialty diagnostic company providing innovative solutions for screening and diagnostics in oncology, metabolic diseases, genetic disorders and autoimmune diseases, has acquired Zeus Scientific, Inc. (Branchburg, NJ, USA; www.zeusscientific.com), an In Vitro Diagnostic (IVD) company specialized in autoimmune and infectious diseases technologies. The financial terms of the agreement were not disclosed. Sebia is a world-leading provider of clinical protein electrophoresis equipment and reagents, a technology used for in vitro diagnostic testing. Its systems analyze proteins in order to screen and monitor various diseases and conditions; primarily oncology (multiple myeloma) and metabolic disorders such as diabetes, also hemoglobinopathy and rare pathologies. Following the acquisition of Orgentec, Corgenix and Arotec in 2021, Sebia now develops and markets innovative solutions for autoimmunity diagnostics. Zeus is a global company focusing on the development, production and marketing of in vitro diagnostic tests to detect autoimmune and infectious diseases, available in several different technology applications. Clinical areas include inflammatory rheumatic diseases, serological detection of autoimmune vasculitis, thyroid diagnostics, gastroenterology and a number of infectious diseases, with a strong focus on Lyme disease. Zeus will provide synergies and expand Sebia’s capabilities and product portfolio in autoimmunity, with a strong footprint in the U.S. “Through this acquisition, we will be able to expand Sebia’s capabilities to provide high-value solutions to our customers and patients,” said Jean-Marc Chermette, Sebia’s president and CEO. “Zeus Scientific has developed a strong expertise in autoimmunity and infectious diseases. There are many parallels in our respective R&D programs, as well as benefits for the development of our global commercial network. With this acquisition, Sebia is reinforcing its operations and footprint in the United States, the largest IVD market. I am very pleased to welcome Zeus Scientific associates to the Sebia Group and look forward to a strong collaboration to accelerate innovation and global growth.” “We are extremely pleased to join the Sebia team,” said Scott Tourville, CEO of Zeus Scientific. “Its world-leading position in clinical protein electrophoresis and in vitro diagnostic testing makes Sebia the ideal company to continue to build on Zeus Scientific’s 46-year legacy of diagnostic innovation.”
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20-30 minutes, door-to-ICU times by 40-80 minutes and door-to-ED departure for those having emergency surgery by 30-60 minutes. “We are thrilled to be joining Beckman Coulter Diagnostics,” said Eric Hamrock, Senior Director, CDS Service, Beckman Coulter Diagnostics and former CEO, StoCastic LLC. “Beckman Coulter will bring world-class market understanding and customer experience leadership, in addition to their commitment to supporting and building upon StoCastic’s customers’ success, making this a perfect fit for our organization.” “With the StoCastic acquisition, we combine Beckman Coulter Diagnostics biomarkers with TriageGo’s evidence-based CDS to generate advanced decision support insights. This will enable clinicians to make informed decisions sooner and further improve patient outcomes,” said Kelly Sager, Vice President and General Manager, CDS Solutions at Beckman Coulter Diagnostics. S OR UT PLY RIB O AP T S DI ED T IT INV
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SEPTEMBER Thailand LAB International 2023. Sep 6-8; Bangkok, Thailand; thailandlab.com ECP 2023 - 35th Congress of the European Society of Pathology. Sep 9-13; Dublin, Ireland; esp-congress.org EUROTOX 2023 – 57th Congress of the European Societies of Toxicology. Sep 1013; Ljubljana, Slovenia; eurotox2023.com India Lab Expo & Analytica Anacon India. Sep 14-16; Hyderabad, India; analyticaindia.com ESPE 2023 – 61st Annual Meeting of the European Society for Paediatric Endocrinology. Sep 21-23; The Hague Netherlands; eurospe.org Analitica Latin America 2023. Sep 26-28; Sao Paulo, Brazil; analiticanet.com.br 92nd Annual Meeting of the American Thyroid Association (ATA). Oct 29 - Sep 1; Washington, DC, USA; thyroid.org
OCTOBER ECC 2023 – 44th European Congress of Cytology. Oct 1-4; Budapest, Hungary; cytology2023.eu
Events Calendar EASD 2023 – 59th Annual Meeting of the European Association for the Study of Diabetes. Oct 3-6; Hamburg, Germany; easd.org CAP23 – Annual Meeting of the College of American Pathologists. Oct 7-10; Chicago, IL, USA; cap.org JFBM 2023 - Journées Francophones de Biologie Médicale. Oct 11-13; France; jfmb.fr 85th Annual Meeting of the Japanese Society of Hematology. Oct 13-15; Tokyo, Japan; jshem.or.jp 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 ASCP 2023 – Annual Meeting of the American Society for Clinical Pathology. Oct 18-20; Long Beach, CA, USA; ascp.org 63rd Annual Academic Assembly of the Japan Society of Clinical Chemistry (JSCC). Oct 27-29; Toyama, Japan; jscc-jp.gr.jp
NOVEMBER MEDICA 2023. Nov; Dusseldorf, Germany; medica-tradefair.com IUIS 2023 – International Union of Immunological Societies. Nov 27 - Dec 2; Cape Town, South Africa; iuis2023.org
Advertising Index Page
Inq.No.
Vol. 39 No. 7 11/2022
Inq.No.
Advertiser
Advertiser
– 128 116 108 109 114 – 106 105 125 – 110 118 117 115 113 103 102 124 107 112 121 133 119 123 136 111
AACC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 AB Analitica. . . . . . . . . . . . . . . . . . . . . . . . . . 28 Awareness Technology, inc. . . . . . . . . . . . . . 16 Bioperfectus. . . . . . . . . . . . . . . . . . . . . . . . . . . 8 DiaSys Diagnostic Systems. . . . . . . . . . . . . . . 9 Dymind. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 EuroMedLab 2023 . . . . . . . . . . . . . . . . . . . . 29 Getein Biotech. . . . . . . . . . . . . . . . . . . . . . . . . 6 Gold Standard . . . . . . . . . . . . . . . . . . . . . . . . . 5 Hemosure. . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 LabMedica. . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Life Real. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Mast Group . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Medical System. . . . . . . . . . . . . . . . . . . . . . . 17 Nova Biomedical . . . . . . . . . . . . . . . . . . . . . . 15 Quantimetrix. . . . . . . . . . . . . . . . . . . . . . . . . . 13 Randox. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Sekisui. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Singuway. . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Snibe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Tianlong. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Vedalab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Vicotex. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Vircell. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Werfen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Werfen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 West Medica . . . . . . . . . . . . . . . . . . . . . . . . . 11 Provided as a service to advertisers. Publisher cannot accept responsibility for any errors or omissions.
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