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Vol. 38 No.7 • 11/2020



Blood Test Foresees Psychotic Disorders


round a quarter of young people who display mild, transitory psychotic symptoms at an early age ultimately go on to develop a serious psychotic disorder. Schizophrenia, for example, is generally not clinically diagnosed until a person reaches their twenties.

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Scoring System Predicts Severity of Infections in COVID-19 Patients

newly devised scoring system was designed to help doctors identify COVID-19 patients more likely to develop severe infections with potentially life-threatening complications. Investigators at the Royal College of Surgeons in Ireland (Dub-

lin, Ireland) evaluated the relationship between the ratio of interleukin (IL)-6 to IL-10 and subsequent clinical outcome in 80 patients hospitalized for COVID-19. They used their findings to create a simple five-point linear score predictor of clinical outcome, the

International Consortium to Standardize COVID -19 Tests

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Predicting Pre-Term Births in High-Risk Women


lobally, preterm birth is the leading cause of death in children under 5 years with 15 million babies being born before 37 weeks’ gestation each year. Spontaneous preterm birth is a syndrome, which can be precipitated by a variety of factors. The association between bacterial vaginosis (BV) detected using laboratory techniques and preterm labor has been recognized for

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US Centers for Disease Control and Prevention (CDC) and the Joint Research Centre of the European Commission (JRC) have entered into a collaboration with Siemens Healthineers toward developing a novel process for standardizing SARS-CoV-2 assays, thereby enabling all test manufacturers to develop analytically comparable tests based on common frames of reference. LabMedica’s COVID-19 Diagnostics Update section starts on page 4.



Instant Breath Test Detects COVID-19

nitial findings from a new study have shown how COVID-19 can be detected via a non-invasive breath test by identifying candidate biomarkers, providing almost instant results. The new study was conducted by Loughborough University (Leicestershire, UK; www.lboro.ac. uk) which is part of a consortium’s research team that has been able to identify candidate biomarkers present in the breath

World's Fastest PCR-Based COVID -19 Test Introduced


rapid new coronavirus test, which provides results for COVID-19 in just 39 minutes, is now available on the Vivalytic, a point of care platform brought to market by Randox Laboratories and Bosch Healthcare. The test for detection of the SARS-CoV-2


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COVID -19 Mass Screening Method Could Be Much Cheaper than Individual Testing

sing a new mathematical approach to screen large groups for COVID-19 could be around 20 times cheaper than individual testing, suggests a study by researchers at The University of Edinburgh (Edinburgh, UK; www. ed.ac.uk).

Applying a recently created algorithm to test multiple samples in one go reduces the total number of tests needed, lowering the cost of screening large populations for COVID-19, according to the researchers. This novel approach will make it easier to spot Cont’d on page 14

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COVID -19 Update . . . . . 4 Clinical News . . . . . . . . . 8 IFCC News . . . . . . . . . . 25 Product News . . . . 16-34 Events Calendar . . 46-47


International Federation of Clinical Chemistry and Laboratory Medicine

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COVID-19 Diagnostics Update



he report that follows provides a survey of news and advances for the month of October 2020. For a recap of earlier developments, the reader is invited to refer to previous issues of LabMedica. Roche Launches Quantitative Antibody Test for SARS-CoV-2

Roche Diagnostics (Basel, Switzerland; www. roche.com) has launched its Elecsys Anti-SARSCoV-2 S antibody test for markets accepting the CE Mark. The test targets antibodies against the spike protein and can quantitatively measure the level of antibodies against SARS-CoV-2 in patients who have been exposed to the virus. Roche plans to launch a high-volume SARSCoV-2 Antigen test as an aid in the diagnosis of SARS-CoV-2 infection by the end of 2020. The new Elecsys SARS-CoV-2 Antigen test will target markets accepting the CE Mark, though Roche also intends to file for Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA). Snibe Diagnostics’ Maglumi 2019-nCoV IgM/IgG Test Granted FDA EUA

Snibe Diagnostics (Shenzhen, China; www. snibe.com) has received Emergency Use Authorization from the US Food and Drug Administration for its SARS-CoV-2 antibody test. Snibe’s Maglumi 2019-nCoV IgM/IgG test comprises a capture chemiluminescence immunoassay for immunoglobulin M antibodies against SARSCoV-2 and an indirect chemiluminescence immunoassay for immunoglobulin G antibodies against the virus. The test uses human serum and serum in separating gel tube samples and runs on the company's Maglumi 2000 series fully automated chemiluminescence immunoassay analyzer. Menarini Diagnostics Launches New SARS-CoV-2 Antigen Test

A new COVID-19 test from A. Menarini Diagnostics (Florence, Italy; www.menarinidiag nostics.com) detects the presence of antigens can not only determine whether a patient is positive for COVID-19, as well as provides an indication of the viral load, allowing the most infectious and most at-risk patients to be identified immediately. These tests are unlike molecular biology tests because, although they also use nasopharyngeal swabs to take the sample, antigen tests do not search for the genetic material of the virus. Instead, they check for the presence of antigens and, therefore, for potential infection by searching for specific viral proteins.

Ortho Awarded BARDA Contract to Accelerate Development of SARS-CoV2 Antigen Test

Ortho Clinical Diagnostics (Raritan, NJ, USA; www.orthoclinicaldiagnostics.com) has been awarded USD 12,850,000 by the Biomedical Advanced Research and Development Authority (BARDA) to support the development of the company's SARS-CoV-2 antigen test and


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An enzyme-linked immunosorbent assay for mannosebinding lectin found that this molecule is associated with coagulopathy in severe COVID-19 patients (Photo courtesy of Getty Images).

continued regulatory pathway support for its total and IgG antibody tests. The tests offer greater choice in tracking, surveillance and patient management. The test results also can help aid in determining who may be eligible to donate a part of their blood called convalescent plasma, which may serve as a possible treatment for those who are seriously ill from COVID-19. World's First Patient-Controlled Nasopharyngeal Swab Robot for COVID-19 Testing

A new robot developed by Biobot Surgical Pte Ltd (Singapore; www.biobotsurgical.com) for automated COVID-19 swab test could provide a solution to protect and reduce the risk of exposure faced by healthcare workers to the SARS-CoV-2 virus. SwabBot, a robot for automated swab, is designed to address the challenges of COVID-19 swab test. In addition to protecting and reducing the healthcare workers’ risk of exposure to the novel coronavirus, SwabBot also standardizes the consistency of swabs taken while providing greater throughput of swab tests.

GK Pharmaceuticals’ Accu-Right SARSCoV-2 RT-PCR Kit Granted FDA EUA

GK Pharmaceuticals CMO (Manatí, Puerto Rico, USA; www.gkcmo.com) has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for the company’s GK ACCU-RIGHT SARS-CoV-2 assay. The assay is an in vitro diagnostic RT-PCR test intended for the qualitative detection of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in upper respiratory specimens (such as nasopharyngeal, oropharyngeal, midturbinate, and nasal swabs) collected from individuals suspected of COVID-19 by their healthcare provider.

New COVID-19 Antibody Assay Can Analyze Up to 40,000 Samples per Day

A new COVID-19 antibody assay can analyze up to 40,000 samples per day and is suitable for both serum and dried blood sampling. The new COVID-19 antibody has been developed by LGC's Immunogenicity Centre of Excellence (Cambridge, UK; www.lgcgroup.com) and uses serum or capillary blood collected remotely with the Mitra microsampling device from Neoteryx LLC (Torrance, CA, USA; www.neoteryx.com. Individuals can be tested for SARS-CoV-2 antibodies by visiting a blood draw center to provide a serum sample via phlebotomy, or by collecting their own blood sample at home using the Mitra device and a simple fingerstick method. Cont’d on page 5

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Four-In-One Test Kit for Detecting Influenza A/B, RSV and SARS-CoV-2 A new four-in-one test kit for detecting influenza A, influenza B, RSV and SARS-CoV-2 is set to be launched in the coming month of November before the flu season begins in the Northern hemisphere by Abacus Diagnostica (Turku, Finland; www.abacusdiagnostica.com). Abacus plans to seek CE IVD approval for the multiplexed assay detecting influenzas, RSV and SARS-CoV-2. New Test Enables Fast, Cheap and Accurate COVID-19 Diagnosis

A new method developed by researchers at the Karolinska Institutet (Stockholm, Sweden; www.ki.se) for fast, cheap, yet accurate testing for COVID-19 infection simplifies and frees the testing from expensive reaction steps. The method enables upscaling of the diagnostics, making it particularly attractive for places and situations with limited resources, for repeated testing and for moving resources from expensive diagnostics to other parts of the care chain.

COVID-19 Diagnostics Update ma and fingerstick whole blood. The test was first authorized for emergency use by certain labs in July 2020 to help identify individuals with antibodies to SARS-CoV-2, indicating recent or prior COVID-19 infection. The EUA has now been reissued to authorize the test for POC use using fingerstick blood samples. The latest authorization means that fingerstick blood samples can now be tested in POC settings like doctor’s offices, hospitals, urgent care centers and emergency rooms rather than having to be sent to a central lab for testing. New ABC Test for Influenza A, Influenza B, and COVID-19

A new ABC Test (Influenza A/Influenza B/COVID-19) being developed by Co-Diagnostics, Inc. (Salt Lake City, UT, USA; www.codi agnostics.com) is anticipated to be ready for launch to US CLIA laboratory customers the first

Neoteryx’s COVID-19 antibody assay can analyze up to 40,000 samples per day using serum or dried blood (Photo courtesy of Neoteryx LLC)

week of October 2020. The ABC multiplex test will initially be made available to CLIA labs that will be using it in their own laboratory developed tests, or LDTs, while the company proceeds with the FDA Emergency Use Authorization submission and CE marking registration.

Routine Blood Test Predicts Increased Mortality Risk in COVID-19 Patients

Investigators at the Center for Systems Biology at Massachusetts General Hospital (Boston, MA, USA; www.csb. mgh.harvard.edu) have discovered that a standard test to assess blood cells can identify which patients who are admitted to the hospital with COVID-19 face a high risk of becoming critically ill and dying. In their examination of 1,641 adults diagnosed with SARS-CoV-2 infection for complicated changes in circulating blood cells, the researchers found that patients who had red cell distribution width (RDW) values above the normal range when they were admitted to the hospital had a 2.7-times higher risk of dying, with a mortality rate of 31% compared with 11% in patients with normal RDW values. Also, a subsequent increase in RDW after admission was associated with an even higher risk of dying, indicating that RDW could be tracked during hospitalization to help determine whether patients are responding to treatment or getting worse. FDA Authorizes First POC Antibody COVID-19 Test

The US Food and Drug Administration (FDA Silver Spring, MD, USA; www.fda.gov) has issued an emergency use authorization (EUA) for the first serology (antibody) point-of-care (POC) test for COVID-19. The Assure COVID19 IgG/IgM Rapid Test Device is a lateral flow assay and is authorized for use with venous whole blood, serum, plas-


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COVID -19 Diagnostics Update

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FDA Authorizes First Nanopore Sequencing-Based Test for SARS-CoV-2 The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) to the Clear Dx SARS-CoV-2 novel descriptive diagnostic from Clear Labs (San Carlos, CA, USA; www.clearlabs.com), making it the first nanopore sequencing-based test for SARS-CoV-2 to receive EUA. Clear Dx offers a fully automated, nanopore-based NGS solution for simultaneous high-volume diagnosis of SARS-CoV-2 and deeper genomic characterization of the virus. At a price comparable to qPCR, Clear Dx simultaneously improves test accuracy while providing end-to-end results in hours, instead of days. Cepheid Four-in-One Combination Test for SARS-CoV-2, Flu A/B and RSV Granted FDA EUA

Cepheid (Sunnyvale, CA, USA; www. cepheid.com) has been issued an emergency use authorization (EUA) by the US Food and Drug Administration for its four-in-one combination test for SARS-CoV-2, Flu A, Flu B and RSV. The Xpert Xpress SARS-CoV-2/Flu/RSV four-inone test is expected to deliver qualitative detection of SARS-CoV-2, Flu A, Flu B and RSV from a single patient sample. The regulatory authorization will make the test available globally on its cartridge-based GeneXpert Systems, which features instruments that can be configured for both near patient point-of-care and high volume laboratory testing needs. New, Portable COVID-19 Saliva-Based Testing Device

Researchers at Arizona State University (ASU Tempe, AZ, USA; www.asu.edu) are developing a new, portable saliva-based testing device that will deliver results in as little as 20 minutes. The device will allow users to easily provide a saliva sample on a computer chip that will quickly detect whether the virus is present. If the virus is detected, a strong, green fluorescent signal is generated on the device.

Blood-Based Test Accurately Identifies SARS-CoV-2 Infection before Symptoms Develop

A team of scientists from the Duke University Health System (Durham, NC, USA; www. dukehealth.org) are conducting studies to determine the effectiveness of newly-identified biomarkers in detecting SARS-CoV-2. The biomarkers can accurately identify numerous viral infections across the clinical stages of disease, offering a potential new way to guide treatment, quarantine decisions, and other clinical and public health interventions in the setting of endemic and pandemic infectious diseases, such as COVID-19.

Dried Blood Spot Sampling Enables Inexpensive COVID-19 Antibody Testing

Using dried blood spot samples (DBS) is an accurate alternative to venous blood in detecting SARS-CoV-2 antibody tests, according to a new

study by immunology experts at the University of Birmingham (Birmingham, UK; www.birming ham.ac.uk). DBS sampling is simple, inexpensive and can be self-collected by the patient at home, using a simple finger prick. The sample can then be collected on a forensic grade card before being posted back to labs for processing. This offers exciting possibilities to widen access to antibody testing particularly in more resource limited countries. Hologic Granted FDA EUA for Asymptomatic COVID-19 Testing with Panther Fusion SARS-CoV-2 Assay

Hologic, Inc.’s (Marlborough, MA, USA; www.hologic.com) Panther Fusion SARS-CoV-2 assay has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for testing of individuals without symptoms or other reasons to suspect COVID-19 infection. The Panther Fusion SARS-CoV-2 test runs on Hologic’s fully automated Panther Fusion system, which can provide initial results in approximately three hours and process more than 1,000 coronavirus tests in 24 hours. Additionally, Hologic’s Aptima SARS-CoV-2 assay, which had initially received EUA from the FDA in May, has now been authorized for testing of individuals without symptoms or other reasons to suspect COVID-19 infection. In addition, the FDA has authorized the company’s pooling protocol for symptomatic testing with the Aptima SARS-CoV-2 assay. COVID-19 Saliva Tests Could Detect Silent Carriers

Scientists at Hokkaido University (Hokkaido, Japan; www.global.hokudai.ac.jp) have demonstrated a quick and effective mass testing approach using saliva samples to detect individuals who have been infected with COVID-19 but are still not showing symptoms. Testing self-collected saliva samples could offer an easy and effective mass testing approach for detecting asymptomatic COVID-19, according to the researchers. 120 Million COVID-19 Tests to Be Made Available to To Developing Countries

The Access to COVID-19 Tools (ACT) Accelerator has announced a set of agreements to make available affordable, high-quality COVID19 antigen rapid tests for low and middle-income countries (LMICs). The ACT Accelerator is a new, ground-breaking global collaboration launched by the World Health Organization (WHO), the European Commission, France and the Bill & Melinda Gates Foundation to accelerate the development production, and equitable access to COVID-19 tests, treatments, and vaccines. The Bill & Melinda Gates Foundation has executed separate volume guarantee agreements with rapid diagnostic test (RDT) producers Abbott (Lake Forest, IL, USA: www.abbott.com) and SD Biosensor (Korea; www.sdbiosensor. com). These two arrangements will make available to LMICs 120 million antigen rapid diagnostic tests (Ag RDTs) – priced at a maximum of USD 5 per unit – over a period of six months.

FDA Grants First Ever EUA to COVID-19 POC Antibody Test for Use with Fingerstick Blood Samples Adial Pharmaceuticals, Inc. (Charlottesville, VA, USA; www.adialpharma.com) has secured emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its Assure/FaStep COVID-19 IgG/IgM Rapid Test Device. This is the FDA’s first ever EUA for a serology (antibody) point-of-care (POC) test for COVID19 using fingerstick blood samples as compared with current approved tests that only utilize serum, plasma, or a venous blood draw. Machine Learning Based Rapid Diagnostic Predicts COVID-19 Severity Risk

Inflammatix (Burlingame, CA, USA; www. inflammatix.com) has been awarded USD 1.1 million by the Defense Advanced Research Projects Agency (DARPA) for further development of a rapid diagnostic named CoVerity COVID19 Severity Test. The rapid diagnostic reads the immune system to predict severe respiratory failure risk in COVID-19 patients and is being developed by Inflammatix to help physicians make better hospital admission and resourcing decisions for COVID-19 patients at hospital presentation.

BD Receives CE Mark for Portable, Rapid Point-of-Care COVID-19 Antigen Test

Becton, Dickinson and Company’s (BD Franklin Lakes, NJ, USA; www.bd.com) rapid, point-of-care, SARS-CoV-2 antigen test for use on the BD Veritor Plus System has been CE marked to the IVD Directive (98/79/EC). The new test delivers results in 15 minutes on an easy-to-use, portable instrument, which is a critical improvement in turnaround time for COVID-19 diagnostics, because it provides real-time results and enables decision-making while the patient is still onsite.

Portable Lab-On-A-Chip Identifies Concentration of COVID-19 Antibodies

Researchers from the University of Michigan (Ann Arbor, MI, USA; www.umich.edu) have developed a new, portable lab-on-a-chip that can identify the presence of COVID-19 antibodies in blood with greater speed and efficiency than the current standard “enzyme-linked immunosorbent assay” or ELISA technology. The researchers have demonstrated that the device can identify the concentration of COVID-19 antibodies in human blood in 15 minutes. That process normally takes between hours and a few days. Avacta Launches SARS-CoV-2 BAMS Research Assay Kit

Avacta Group plc (Wetherby, England; www. avacta.com) has announced that the BAMS assay to detect the SARS-CoV-2 virus has been launched as a research kit by its partner Adeptrix (Beverly, MA, USA; www.adeptrix.com) and the assay has been presented by Bruker Scientific (Billerica, MA, USA; www.bruker.com) in a new application note. Cont’d on page 7

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The bead-assisted mass spectrometry (BAMS) assay uses the Affimer reagents specific to the SARS-CoV-2 virus to capture the virus spike protein from the sample for rapid detection by mass spectrometry, using the installed base of these instruments in hospitals. ViveraLaunches Two COVID-19 Tests

Vivera Pharmaceuticals’ (Newport Beach, CA, USA; www.viverapharma ceuticals.com) Advanced Diagnostics Division has launched two new diagnostic tests for the detection of SARS-CoV-2 antigens in those with active infections from nasal or saliva specimens. Vivera's COVx-RDA Antigen Test Saliva Collection Kit and COVx-RDA Antigen Test Nasal Collection Kit for SARS-CoV-2 are designed for rapid detection in high volume environments requiring highly accurate test results. Vivera's new antigen tests are relatively easy to use and with results in 10 minutes, remove barriers to diagnosing acute infection. Diagnostic Tool Identifies COVID-19 Patients at Risk of Developing Cytokine Storm

COVID -19 Diagnostics Update Administration (FDA) for a new, high-throughput method that uses heat and technology to extract RNA from samples collected for COVID-19 molecular testing. The authorization will help the company improve the speed and efficiency of RT-PCR tests, considered the ‘gold standard’ for active infections. Quidel Receives FDA EUA for First Rapid Antigen Combination ABC Test

Quidel Corporation (San Diego, CA, USA; www.quidel.com) has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) to market its Sofia 2 Flu + SARS Antigen FIA. The rapid point-ofcare test is intended to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid, simultaneous qualitative detection and differentiation of the nucleocapsid protein antigens from SARS-CoV-2, influenza A and influenza B in direct nasopharyngeal (NP) and nasal (NS) swab specimens from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider within the first five days of the onset of symptoms. Cont’d on page 8

Researchers at Intermountain Healthcare (Salt Lake City, UT, USA; www.inter mountainhealthcare.org) have developed a new clinical tool to accurately identify and diagnose COVID-19 patients who are at high risk of developing a serious inflammatory condition that can damage the lungs and other organs. The new tool is a diagnostic clinical score that is used to determine whether patients with the virus are at increased risk of developing the condition, known as hyperinflammatory syndrome, also sometimes referred to as a “cytokine storm.” Beckman Coulter Granted FDA EUA for COVID-19 Inflammatory Response Immunoassay

Beckman Coulter Diagnostics (Brea, CA, USA; www.beckmancoulter.com) has received Emergency Use Authorization (EUA) for its Access Interleukin-6 (IL-6) assay from the US Food & Drug Administration (FDA). Access IL-6 is a fully automated immunoassay designed to detect IL-6 levels in serum and plasma which can be used to aid physicians identifying a severe inflammatory response and determining the risk of intubation with mechanical ventilation in COVID-19 patients. Beckman also received EUA from the FDA for its Access SARS-CoV-2 Immunoglobulin M (IgM) assay. The assay detects antibodies that recognize the receptor binding domain (RBD) of the spike protein which the SARS-CoV-2 virus uses to enter the human host cells, and demonstrates 99.9% specificity and 98.3% sensitivity.

LabCorp’s Innovative SARS-CoV-2 RNA Extraction Method Secures FDA EUA

LabCorp Diagnostics (Burlington, NC, USA; www.labcorp.com) has become the first commercial laboratory to receive an Emergency Use Authorization (EUA) from the US Food and Drug


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New Sensor Rapidly Detects COVID-19 Infection Status

A new type of multiplexed test (a test that combines multiple kinds of data) with a low-cost sensor could enable diagnosis of a COVID infection through rapid analysis of small volumes of saliva or blood, without the involvement of a medical professional, in less than 10 minutes. Researchers at the California Institute of Technology (Caltech Pasadena, CA, USA; www.caltech.edu) have developed wireless sensors that can monitor conditions such as gout, as well as stress levels, through the detection of extremely low levels of specific compounds in blood, saliva, or sweat. The new version of the sensor, which has been named SARS-CoV-2 RapidPlex, contains antibodies and proteins that allow it to detect the presence of the virus itself; antibodies created by the body to fight the virus; and chemical markers of inflammation, which indicate the severity of the COVID-19 infection.

Automatic POC System Measures COVID-19 Antibodies with HbA1c, CRP, U-Albumin

DxGen Corp. (Korea; www.dxgen.vbweb.kr) has launched the Epithod AutoDx analyzer, a new automatic point-of-care system that measures COVID-19 antibodies along with HbA1c, glycated albumin, hemoglobin, C-reactive protein and U-Albumin within just three minutes. By providing medical professionals with various and valuable diagnostic information, the Epithod system can be effectively used not only for COVID19 diagnosis tests, but also for complication diagnosis tests and patient prognosis monitoring and treatment in various medical front lines.

US Labs Increase COVID-19 Testing Capacity But Face Shortage of Supplies

A survey of community and regional laboratories in the US by the National Independent Laboratory Association (NILA St. Louis, MO, USA; www.nila-usa.org) has revealed a potential collective increase in COVID-19 testing capacity, although difficulties persist in accessing the necessary testing supplies. The survey revealed shortages of test kits, reagents, and other materials, such as plastic pipette tips, without which they were unable to perform the promised number of tests. In spite of an increase in their COVID-19 testing capacity, these labs do not have access to the supplies and materials necessary to perform critical COVID-19 tests.

EKF Diagnostics’ PrimeStore MTM Evaluated for SARS-CoV-2 Inactivation

EKF Diagnostics’ (Cardiff, UK; www.ekfdiag nostics.com) novel viral transport media PrimeStore MTM (Molecular Transport Medium) has been successfully evaluated for effective SARSCoV-2 inactivation in a new study published by Public Health England (PHE). EKF’s PrimeStore MTM sample collection device allows COVID19 samples to be rapidly inactivated in the collection tube, avoiding contamination and preserving RNA without need for refrigeration.

Novel Rapid Antigen Assay Detects SARS-CoV-2 in Saliva in 10 Minutes Veravas, Inc. (Charleston, SC, USA; www. veravas.com) has developed its VeraTest SARSCoV-2 Rapid Antigen Assay, based on the company’s patent-pending VeraPrep technology and a proprietary novel antibody fragment with high specificity to the SARS-Cov-2 spike protein. The 10-minute assay is easily performed with a saliva sample, sample diluents and a single VeraPrepbased assay reagent. Qiagen Complements COVID-19 Testing Portfolio with Novel Kit

Qiagen N.V. (Venlo, Netherlands; www.qia gen.com) plans to launch a novel straightforward approach to viral RNA epidemiology that will significantly simplify and accelerate PCR analysis and remove key testing bottlenecks for SARSCoV-2 and other RNA viruses. QIAGEN’s innovative QIAprep&amp Viral RNA UM Kit combines a liquid-based sample preparation step completed in only two minutes with real-time PCR detection in a streamlined workflow that can be automated with standard lab equipment for any throughput, any assay and any reaction need from single to multiplex testing.

World’s First Assay Kit to Profile SARSCoV-2 sgRNA from Clinical Samples

Lucence (Singapore; www.lucence.com), a molecular diagnostics company, has launched the world’s first assay kit to directly profile SARSCoV-2 subgenomic RNA (sgRNA), a marker of active viral replication, from clinical samples. DeepMARK utilizes Lucence’s proprietary ultrasensitive next-generation sequencing (NGS) technology, AmpliMARK, to concurrently detect and analyze the genome and transcriptome of SARS-CoV2. Pinpointing sources of unlinked SARS-CoV-2 cases supports rapid public health response. New Dipstick Technology Could Offer Faster, Cheaper and Mobile COVID-19 Diagnosis

A new ‘dipstick’ technology developed by the University of Queensland (Queensland, Australia; www.uq.edu.au) helps to quickly extract and analyze genetic material could be used for cheap, accurate and mobile COVID-19 testing, including at airports and remote testing centers. The technology allows genetic material to be extracted in as little as 30 seconds, with a full molecular diagnosis in 40 minutes. The process can be used to extract genetic material from most living organisms, including people, livestock, bacteria and viruses.

Mast Awarded Tender for Supply of AST and AMR Discs

Mast Group Ltd. (Liverpool, UK; www.mast -group.com) has been awarded the Public Health England (PHE) tender for the exclusive supply of antibiotic susceptibility (AST) and antimicrobial resistance (AMR) discs. Mast, a leading European AST manufacturer, is constantly reviewing its portfolio of MASTDISC AST and continues to be

Blood-based test that accurately identifies viral infection before symptoms develop could help in early identification of SARS-CoV-2 (Photo courtesy of Duke University Health System)

at the forefront of development of new antimicrobial discs. As a major strategic partner for pharmaceutical companies, Mast works closely with those organizations on the launch of new compound AST discs, with two already launched this year and more to come in the near future.

Thermo Fisher’s OmniPath Total Antibody ELISA Test Gets FDA EUA

Thermo Fisher Scientific Inc.’s (Waltham, MA, USA; www.thermofisher.com) OmniPath COVID-19 Total Antibody ELISA Test for SARSCoV-2 has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA). Thermo Fisher has developed the test in collaboration with WuXi Diagnostics and the Mayo Clinic. The OmniPath COVID-19 Total Antibody ELISA Test is designed to detect immunoglobulin M, A, and G against SARS-CoV-2 in human serum. The assay uses a 96-well microplate and can be run either manually or with the fully automatic Dynex Agility ELISA system from Thermo Fisher. Thermo Fisher has launched two new SARSCoV-2 antibody tests: the Thermo Scientific OmniPATH COVID-19 Total Antibody ELISA test, and the Thermo Scientific EliA SARS-CoV-2-Sp1 IgG test. The new tests for detecting COVID-19 antibodies have expanded the company's SARSCoV-2 test portfolio, which ranges from molecular diagnostic tests and sample collection products, to personal protective equipment, to support of therapy and vaccine development and manufacturing. BioFire Diagnostics’ PCR-based SARS-CoV-2 Test Receives FDA EUA

BioMérieux’s (Marcy-l'Étoile, France; www. biomerieux.com) subsidiary, BioFire Diagnostics, has received Emergency Use Authorization by the US Food and Drug Administration for the BioFire Respiratory Panel 2.1-EZ which uses a syndromic approach to accurately detect and identify a wide range of pathogens, including SARS-CoV-2. The BioFire RP2.1-EZ Panel is designed to run on the CLIA-waived BioFire FilmArray 2.0 EZ Configuration System and identifies a menu of 19 respiratory targets in one multiplex PCR test, with results in about 45 minutes. Low-Cost, Simple-to-Use, Ultrafast Point-Of-Care COVID-19 Test

A new low-cost, simple-to-use, ultrafast pointof-care test for COVID-19 developed by Rover Diagnostics (New York, NY, USA; www.roverdx. com) and Columbia Engineering (New York, NY,


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USA; www.engineering.columbia.edu). Rover’s ultrafast, portable PCR technology is based on two breakthroughs in science and engineering and it meets all the conditions for successful point-of-care PCR. Furthermore, Rover will integrate HIPAAcompliant cloud access to allow for instant notification and large-scale data analysis. Algebraic Equations Enable Faster Processing of COVID-19 Tests

Dr. Usama Kadri, from the Cardiff University’s School of Mathematics (Cardiff, UK; www. cardiff.ac.uk) has developed a new method for processing large volumes of COVID-19 tests which he believes could lead to significantly more tests being performed at once and results being returned much quicker. Dr. Kadri’s technique uses simple algebraic equations to identify positive samples in tests and takes advantage of a testing technique known as ‘pooling’. Dr. Kadri believes the new technique could allow many more patients to be tested using the same amount of tests tubes and with a lower possibility of false negatives occurring. ACLA Opposes US FDA’s Decision to No Longer Review EUA Requests for COVID-19 LDTs

The US Food and Drug Administration (FDA Silver Spring, MD, USA; www.fda.gov) will no longer review emergency use authorization (EUA) requests for COVID-19 lab developed tests (LDTs). The FDA’s decision follows an announcement in August by the US Department of Health and Human Services that LDTs would not be required to undergo premarket review. However, the American Clinical Laboratory Association (ACLA Washington, DC, USA; www.acla.com) has opposed the FDA’s decision. GenMark’s Combination Test for COVID-19, Flu and Respiratory Illnesses Receives FDA EUA

GenMark Diagnostics, Inc. (Carlsbad, CA, USA; www.genmarkdx.com) has received the US Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) for the company’s ePlex Respiratory Pathogen Panel 2 (RP2 Panel). GenMark’s RP2 Panel provides results in less than two hours for more than 20 viruses and bacteria that cause common respiratory infections with similar symptoms, including COVID-19, flu, bronchitis and the common cold. New COVID-19 Test Uses Magnetic Beads to Detect SARS-CoV-2

A highly sensitive COVID-19 test, developed by researchers at the Norwegian University of Science and Technology (NTNU Trondheim, Norway; www.ntnu.edu), relies on magnetic nanoparticles to extract viral RNA. A key aspect of this made-in-Norway COVID-19 test is a specific combination of polar solvents, buffers, salts and other chemicals that do not damage the viral RNA molecule itself.

30-Second COVID-19 Breathalyzer Test Could Be Game-Changer

India and Israel are jointly developing a new rapid COVID-19 testing kit that will simply require an individual to blow into a tube and deliver results in less than a minute, making the test a real game-changer. The test would be extremely cheap to perform, as it would deliver results locally and eliminate logistics as well as the cost involved for sending samples to the laboratory. Holographic Imaging Based COVID-19 Test

A new method developed by scientists at New York University (New York, NY, USA; www. nyu.edu) to detect both viruses and antibodies uses holographic imaging and has the potential to aid in medical diagnoses and, specifically, those related to the COVID-19 pandemic. The scientists who have developed the new method base their test on holographic video microscopy, which uses laser beams to record holograms of their test beads. If fully realized, the proposed test could be done in under 30 minutes, is highly accurate, and can be performed by minimally trained personnel. Glucose Monitor Reconfigured for Use as SARS-CoV-2 Antibody Detector

A trio of scientists – a pharmacologist, a biomedical engineer, and a biophysicist – at the Johns Hopkins University (Baltimore, MD, USA; www.jhu.edu) has developed a system for using everyday glucose monitors to detect COVID-19 antibodies. The scientists are pooling their knowledge to design a device that can detect whether a person has antibodies linked to SARS-CoV-2, the virus that causes COVID-19. Peel-and-Sniff Cards Single Best Predictor of Being COVID-19 Positive

With mounting scientific evidence that anosmia, or loss of smell, is one of the most specific symptoms of COVID-19 infection, sensory scientists at the Pennsylvania State University (University Park, PA, USA; www.psu.edu) are developing peel-and-sniff cards to supplement other testing and surveillance efforts.

Nanopore Sequencing and Machine Learning Powered-Platform for High-Frequency COVID-19 Testing

A new nanopore sequencing and machine learning powered platform launched by Angstrom Bio, Inc. (Austin, TX, USA; www. angstrom.bio) enables high-accuracy, high-frequency, low-cost COVID-19 and respiratory pathogen testing, allowing businesses, educational institutions, and other points of frequent gathering to resume operations safely. The new AMPD platform leverages the extreme resolution and bandwidth of nanopore sequencing to provide the accuracy and volume necessary to detect the earliest stages of exposure to pathogens like SARS-CoV-2 and influenza.

Snibe Maglumi 2000 Immunology Analyzer (Photo courtesy of Snibe Diagnostic)

World's First Paper-Based COVID-19 Test

Researchers at the CSIR-Institute of Genomics and Integrative Biology (IGIB New Delhi, India; www.igib.res.in) have developed the world's first paper-based COVID-19 test that uses cuttingedge CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) technology for detection of genomic sequence of the novel coronavirus. The technology was conceived and developed under a sickle cell mission and utilizes an indigenously developed cutting-edge CRISPRCas9 technology to specifically recognize COVID-19 sequence in a sample. Siemens Launches New Rapid COVID-19 Antigen Test

Siemens Healthineers (Erlangen, Germany; www.siemens-healthineers.com) has launched a rapid and easy-to-use antigen test for the detection of SARS-CoV-2 that helps identify infected individuals in 15 minutes without using specialized laboratory personnel or instruments. The new CLINITEST Rapid COVID-19 Antigen Test from Siemens is a point-of-care cassette test that does not require laboratory instruments or specialized lab personnel to administer, and it delivers results in 15 minutes. New 1-Minute COVID-19 Antibody Test

A new one-minute antibody test for COVID19 launched by bioLytical Laboratories (Vancouver, BC, Canada; www.biolytical.com) in Europe is the only test of its kind to use innovative flowthrough technology to deliver results, making it far faster than other antibody tests currently available. The INSTI COVID-19 Antibody Test is a new one-minute test that detects total antibodies to SARS-CoV-2 and is the only one of its kind to use innovative flow-through technology to deliver results, making it far faster than other antibody tests currently available. Extremely Rapid COVID-19 Test

Scientists at the University of Oxford (Oxford, UK; www.ox.ac.uk) have developed an extremely rapid diagnostic test that can differentiate SARS-CoV-2 from negative clinical samples, as well as from other common respiratory pathogens such as influenza and seasonal human coronaviruses, with high accuracy in less Cont’d on page 11

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than five minutes. The scientists have worked with clinical collaborators to validate the assay on COVID-19 patient samples which were confirmed by conventional RTPCR methods. They now aim to develop an integrated device that will eventually be used for testing in sites such as businesses, music venues, airports etc., to establish and safeguard COVID-19-free spaces. New COVID-19 Test Uses Nanotube Based Electrochemical Biosensor

A new COVID-19 rapid test developed by engineers and virologists at the University of Nevada (Reno, NV, USA; www.unr.edu) uses a nanotube-based electrochemical biosensor and has shown successful lab results by detecting the SARS-CoV-2 virus in about 30 seconds. The novel COVID-19 testing approach is based on a similar technology used in the past for detecting tuberculosis and colorectal cancer as well as detection of biomarkers for food safety.

COVID-19 Diagnostics Update viduals who have never been exposed to the virus, and those who may develop short-lived antibodies after exposure to the virus. Plexision has been awarded a National Science Foundation (NSF) Phase 1 Small Business Innovation Research grant to develop the widely available version of PlexCOVID-19, its novel COVID-19 immunity test. Rapid Lateral Flow Antigen COVID-19 Testing Platform

A new rapid lateral flow antigen COVID19 testing platform from Apollo Medco (Atlanta, GA, USA; www.apollomedco.com) gives testers the ability to process an unprecedented 200-300 people each hour and report results within 15 minutes utilizing testing kits from Quidel, BD and Abbott. The COVID CleanPass system is a mobile app-linked, HIPAA compliant, cloud secure and data-backed COVID-19 testing platform

that is hassle-free, simple to operate, and compatible with worldwide power sources, enabling businesses across the globe to reopen and start growing with absolute peace of mind.

New Serology Assay Accelerates COVID-19 Research

Bio-Techne Corporation (Minneapolis, Minn., USA; www.bio-techne.com) has launched a new SARS-CoV-2 multi-antigen assay for Simple Western that offers quantitative characterization of patient serum or plasma derived human IgG antibodies reactive against recombinant Nucleocapsid protein (N), S1 receptor binding domain protein (RBD), S1 subunit full length, S2 subunit full length, and Spike (S1+S2) viral antigens within one 3-hour run. The SARS-

World’s Simplest High-Throughput RT-PCR Test for COVID-19

BioGX Inc. (Birmingham, AL, USA; www. biogx.com) has applied for Emergency Use Authorization (EUA) with the US Food and Drug Administration (FDA) for its extraction-free, direct sample addition RT-PCR test for the detection of SARSCoV-2 viral RNA in suspected COVID-19 patients. The Xfree COVID-19 Direct RTPCR test is a complete test in a single vial, lyophilized in the trusted BioGX Sample-Ready format and has the potential to increase testing capacity by millions per week. New Testing Process to Measure COVID-19 Antibody Levels

A team of US Army researchers collaborated with scientists at Houston Methodist (Houston, TX, USA; www. houstonmethodist.org), Pennsylvania State University (University Park, PA, USA; www.psu.edu) and the University of Texas (Austin, TX, USA; www. utexas.edu) to test alternative ways to measure COVID-19 antibody levels. Their efforts led to the development of a process that is faster, easier and less expensive to use on a large scale, and holds promise for accurately identifying potential donors who have the best chance of helping infected patients through convalescent plasma therapy.

Novel COVID-19 Immunity Test Predicts Infection Risk and Disease Severity

Plexision (Pittsburgh, PA, USA; www.plexision.com) is developing a novel immunity test for COVID-19 infection that measures cell-mediated immunity to the SARS-CoV-2 coronavirus can aid immunity assessments in indi-


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CoV-2 multi-antigen serology assay runs on Jess and Wes systems, enabling the processing of 23 patient samples in three hours. Lab Testing Procedure Specifically Identifies SARS-CoV-2 Neutralizing Antibodies

Scientists at The Ohio State University (Columbus, OH, USA; www. osu.edu) have developed a new lab testing procedure for the detection of antibodies against SARS-CoV-2 that gives results more quickly than existing assays and specifically identifies so-called “neutralizing” antibodies – those that protect by blocking infection of cells. The scientists have developed what is called a “pseudotype” virus neutralizing antibody assay, in which an HIV vector and core is coated with the SARSCoV-2 spike protein to detect antibodies against the coronavirus. Saline Oral Rinse COVID-19 RT-PCR Test Could Be Game-Changer

OralDNA Labs (Eden Prairie, MN, USA; www.oraldna.com) has been issued an amended Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for its OraRisk COVID-19 RT-PCR test, allowing testing from a saline oral rinse collection. This eliminates the need for a nasal swab and avoids the difficulty some individuals have in providing sufficient saliva for saliva direct testing, making oral rinse collection a game-changer for COVID-19 testing. ThermoGenesis’ Breakthrough Lateral Flow Immunoassay Test Reader

A new breakthrough lateral flow immunoassay test reader technology from ThermoGenesis Holdings, Inc. (Rancho Cordova, CA, USA; www.thermogen esis.com) aims to facilitate the widespread use of inexpensive, mass-produced, FDA-authorized SARS-CoV-2 lateral flow immunoassay (LFIA) tests to distinguish seropositive members of populations of concern (individuals who already have SARS-CoV-2 antibodies), who might be a lower priority for the earliest immunization. The ThermoGenesis Reader will enable the tracking of vaccine recipients' antibody response over time, both to presumptively confirm immune status and to determine when booster immunizations may be required by individuals whose initial vaccine responses are waning. CerTest Biotec and BD Secure CE Mark for Combination Test

CerTest Biotec (Zaragoza, Spain; www.certest.es), along with Becton, Dickinson and Company (BD Franklin Lakes, NJ, USA; www.bd.com), have announced that the VIASURE SARS-CoV-2 (N1 + N2) Real Time PCR Detection Kit adapted for the BD MAX System has been CE marked. The kit allows BD MAX System users to run a single module that tests concurrently for COVID-19 and Influenza (Flu) and Respiratory Syncytial Virus (RSV). New Technology Diagnoses COVID-19 Infection in 30 Minutes

A new one-pot diagnostic method developed by a joint research team from Pohang University of Science & Technology (POSTECH Gyeongbuk, Korea; www.postech.ac.kr) for detecting pathogenic RNAs with PCR-level sensitivity allows anyone to easily and quickly diagnose COVID-19 in just 30 minutes. The new SENSR (SENsitive Splint-based one-pot isothermal RNA detection) technology allows anyone to easily and quickly diagnose COVID-19 based on the RNA sequence of the SARS-CoV-2 virus in just 30 minutes, reducing the stress on one single testing location and avoiding contact with infected patients as much as possible.

Mass Spectrometry-Based Device Uses Breath Samples to Identify COVID-19

Scientists are leveraging mass spectrometry technology to develop a rapid, non-invasive device that will use breath samples to identify COVID-19 strains. BreathTech Corporation, a subsidiary of Astrotech Corporation, (Austin, TX, USA; www.astrotech.com), has signed a joint development agreement (JDA) with Cleveland Clinic (Cleveland, OH, USA; https://my.clevelandclinic.org) to explore leveraging Astrotech’s BreathTest-1000 mass spectrometer to rapidly screen for COVID-19 or related indicators.

DBS sampling is simple, inexpensive and can be self-collected by the patient at home, using a simple finger prick (Photo courtesy of University of Birmingham)

Rapid COVID-19 Antigen Tests less Effective in People with Low Virus Levels

Researchers from the Erasmus University Medical Center (Rotterdam, the Netherlands; www.erasmusmc.nl) have cautioned that not all rapid COVID19 antigen tests that provide results within 30 minutes may be equally effective at detecting the SARS-CoV-2 virus. Their suggestion was based on data gathered from drive through testing stations using rapid antigen detection tests (RDTs), RT-PCR and virus culture, with the aim of assessing the ability of RDTs to detect infectious cases. The researchers have recommended careful fit-for-purpose testing before implementation of antigen RDTs in routine testing algorithms as part of the COVID-19 response. Future COVID-19 Tests Could Be Based on Biomarkers and Molecular Profiles

A new study by scientists at the University of California, Riverside (Riverside, CA, USA; www.ucr.edu) and University of Southern California (Los Angeles, CA, USA; www.usc.edu) has shown how variations in SARS-CoV-2 host gene expression can be linked to variations in COVID-19 susceptibility and symptom severity. This could pave the way for better medical tests based on biomarkers and molecular profiles of individuals, to accommodate these variations in monitoring virus transmission and disease pathology, which helps guide mitigation and treatment options. Use of Genetic Sequencing to Track SARS-CoV-2 Mutations Can Improve Diagnostic Testing Accuracy

Scientists at the UNC School of Medicine (Chapel Hill, NC, USA; www. med.unc.edu) are tracking the SARS-CoV-2 virus that causes COVID-19 by sequencing the genome of virus samples collected from diagnostic testing. Using next generation sequencing on SARS-CoV-2 will help accurately diagnose the novel coronavirus, identify mutations and track its history which can help with transmission tracing, diagnostic testing accuracy and vaccine effectiveness. This type of virus monitoring is also important in diagnostic testing. New Cell-Free Test Rapidly Detects COVID-19 Neutralizing Antibodies

Dr. Stephen Smith of Seattle Children's Research Institute (Seattle, WA, USA; www.seattlechildrens.org) has developed a new way to quantify whether an individual has neutralizing antibodies that could prevent the SARS-CoV-2 virus from infecting cells using a method that is more broadly applicable than those currently available. The newly developed diagnostic could have a range of potential commercial applications from broad community testing to assessing vaccine responses and screening for convalescent plasmas that have particularly high levels of neutralizing antibodies as a potential treatment. Cutting Edge All-in-One Equipment Can Turn 60 sq. m. Room into COVID-19 Testing Lab

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COVID-19 Diagnostics Update

turn a 60 sq. m. room into a COVID-19 testing lab. Developed by scientists and technicians in partnership with Hamilton Company, Thermo Fisher, Grenova, and Premier Medical Laboratory Services, Lab in a Box enables a high capacity of onsite diagnostics for hospitals, expanding laboratories, schools, and large companies in need of quick and accurate testing results. The turnkey equipment that includes everything needed for professional laboratory level diagnostic is expected to radically change the landscape of COVID-19 testing. PerkinElmer’s Multianalyte SARS-CoV-2, Flu Test Receives CE Mark

PerkinElmer, Inc. (Waltham, MA; USA; www.perkinelmer.com) has received clearance for marketing its PKamp Respiratory SARS-CoV-2 RT-PCR Panel as an in vitro diagnostic (IVD) device in more than 30 countries by meeting the requirements of the European In Vitro Diagnostic Directive (IVDD). The test is currently under review by the US FDA for Emergency Use Authorization (EUA). COVID-19 Test to Identify SARS-CoV-2 Virus Particles in Exhaled Breath within Five Minutes

Imec (Leuven, Belgium; www.imec-int.com) is developing a SARS-CoV-2 test to identify positive cases and confirm whether someone is contagious in less than five minutes using a groundbreaking approach that will use virus particles in exhaled breath. The company has begun developing the groundbreaking SARS-CoV-2 test that will identify the virus particles in a person's exhaled breath, unlike the current approaches (using blood, saliva, or a nasopharyngeal swab). The solution promises accurate identification of a contagious case in less than five minutes, enabling faster, easier, more comfortable, and larger-scale testing. Finger-Prick Tests Show Antibody Response to SARS-CoV-2 Reduces over Time

Inflammatix’s machine learning-based rapid diagnostic reads immune system to predict covid-19 severity risk (Photo courtesy of Inflammatix)

among first responders and school-aged children. The pilot study aims to determine the best methods for using the inexpensive tests with the hope of supporting reopening efforts. Non-Invasive COVID-19 Test Identifies "Breath Signatures"

Initial findings from a new study conducted by Loughborough University (Leicestershire, UK; www.lboro.ac.uk) have shown how COVID-19 can be detected via a non-invasive breath test by identifying candidate biomarkers, providing almost instant results. Utilizing technologies which were developed earlier, the researchers demonstrated how these markers or ‘breath signatures’ can be used to rapidly distinguish COVID-19 from other respiratory conditions at point of need, such as an emergency department, a workplace or a care setting, with no laboratory support. New Technology Pulls Elusive COVID-19 Marker from Blood

McMaster University (Hamilton, ON, Canada; www.mcmaster.ca) in collaboration with SQI Diagnostics, Inc. (Toronto, ON, Canada; www.sqidiag nostics.com) has created a new technology that can detect an elusive protein bio-marker from human blood to measure the severity of COVID-19. The Cont’d on page 26

Scientists from the Imperial College London (London, UK; www.imperal. ac.uk) conducted an analysis of finger-prick tests to detect coronavirus antibodies in the blood on more than 365,000 people in the UK have found that the antibody response to the SARS-CoV-2 virus that causes COVID-19 wanes over time. These findings suggest that there may be a decline in the level of immunity in the population in the months following the first wave of the epidemic. DiaSorin Launches LIAISON SARS-CoV-2 Ag Antigen Test

DiaSorin (Saluggia, Italy; www.diasorin.com) has launched its new LIAISON SARS-CoV-2 Ag, a high-throughput antigen test available in markets accepting the CE Mark for quantitative detection of SARS-CoV-2 in symptomatic patients through nasal and nasopharyngeal swabs. The new highthroughput antigen test uses chemiluminescence immunoassay (CLIA) technology to determine the presence of SARS-CoV-2 Nucleocapsid protein antigen in nasal dry swabs and nasopharyngeal swabs eluted in Universal Transport Media for Virus (UTM/VTM), quantifying the viral load of the infection directly from individuals suspected of COVID-19 by their healthcare provider. Ortho Launches New VITROS SARS-CoV-2 Antigen Test

Ortho Clinical Diagnostics (Raritan, NJ, USA; www.orthoclinicaldiagnos tics.com) has received CE Mark for its second COVID-19 antibody test - the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test (COVID-19 IgG antibody test). Ortho’s COVID-19 IgG antibody test detects the IgG antibody and offers 100% specificity. It closely follows the introduction of Ortho’s COVID-19 Total test and the two tests offer greater choice in tracking and surveillance, patient management, and screening convalescent plasma.

Study to Examine Whether Rapid COVID-19 Antigen Tests Can Identify Infectious and Asymptomatic Individuals

Researchers at the University of Southern California (Los Angeles, CA, USA; www.usc.edu) are using rapid COVID-19 antigen tests in a study to examine their use among first responders and school-aged children, as well as understand whether these tests can identify infectious and asymptomatic individuals. The study will examine the use of coronavirus rapid antigen tests


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International Consortium to Standardize COVID-19 Tests

LabMedica International

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S Centers for Disease Control and Prevention (CDC; Atlanta, GA, USA; www.cdc.gov) and the Joint Research Centre of the European Commission (JRC; Brussels, Belgium; www.ec.europa.eu) have entered into a collaboration with Siemens Healthineers (Erlangen, Germany; www.siemens-healthineers.com) toward developing a novel process for standardizing SARS-CoV-2 assays, thereby enabling all test manufacturers to develop analytically comparable tests based on common frames of reference. Antibody tests differ among test manufacturers and currently cannot be analytically compared because they target different SARS-CoV-2 proteins. These include the spike protein, S1/S2, S1 RBD, and N protein, which are found in different parts of the SARS-CoV-2 virus. As the pandemic has evolved, antibody test results have progressed from qualitative positive/negative results to more recent assays capable of numerical measurements that gauge the level of IgG antibodies in a patient’s blood sample. The reportable numerical patient results of the current semiquantitative assays are expressed in units that are not actual concentrations of antibodies, but rather the antibody activity to the virus.

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Because comparing test results across manufacturers has not been possible, establishing immunity associated with these tests has been challenging. Siemens’ collaboration with the CDC and the JRC will develop a novel process for standardizing SARS-CoV-2 assays by anchoring each protein to a neutralization antibody titer – a level of antibody present to block virus from entering cells in laboratory experiments. The thresholds displayed in the standardized unit of measure for IgG – arising either from natural infection or vaccination – may likely contribute to a standardized interpretation of immunity through test results. Developing a standardized process will define which concentration confers neutralization for different manufacturers’ antigen targets. Each manufacturer currently standardizes their assays independently with internal standards that are not linked to a common reference. The results of this collaborative research project will support the JRC's production of a reference material. This reference material with assigned concentrations of antibody specific to each viral protein will allow manufacturers to refer to standardized values. With an international standard estab-

lished and adopted by manufacturers, clinicians would be positioned to track their patients' antibody concentrations, regardless of the test method or manufacturer used. This capability is expected to improve patient care by enabling long-term antibody level comparison - clinical information that is important for verifying natural immunity acquired by patient’s infection with the virus, as well as for determining the effectiveness of vaccines. "One barrier to antibody test adoption is we don't currently have an established process to determine immunity," said Deepak Nath, PhD, President of Laboratory Diagnostics, Siemens Healthineers. "Different SARS-CoV-2 antibody targets produce different levels of neutralization. Our R&D team recognized that if you could define a level at which neutralization is conferred for different targets, you could create a common ground to standardize assays—not just on antibody production, but their ability to provide immunity. Our collaboration with the CDC and JRC will develop the framework that all antibody test manufacturers would be expected to adopt moving forward for greater benefit to patient care as the pandemic evolves."

World's Fastest PCR-Based COVID-19 Test Unveiled

pathogen, is currently the fastest PCR test (the gold standard of test methods) worldwide, and is predestined for decentralized use in mobile test centers at service stations or in airports, so that people who take the test can obtain a reliable result while at the testing site. The advantages of the rapid SARS-CoV-2 test on Vivalytic lie not only in speedy analysis, but also in ease of use. A sample is taken from the nose or throat using a swab, and placed in the test cartridge. Then the cartridge, which contains all the

reagents required for the test, is inserted into the Vivalytic device for automated analysis. Available now in Europe, the CE-approved test, which has a sensitivity of 98% and a specificity of 100%, helps avoid time in quarantine, relieve laboratories, and make travel and work safer again. “Rapid and accurate testing plays a crucial role in identifying cases of Covid-19 – to contain any outbreaks and limit the spread of the virus,” said Dr. Heather McMillan, Molecular R&D Manager at Randox Biosciences (Crumlin, UK;

www.randox.com). “This new rapid test will be a game-changer in the coronavirus testing landscape by allowing patients to receive their results at the point of care faster than ever before.” “With our different coronavirus tests and variable analysis strategies, we open up a range of testing scenarios with a Vivalytic device from screening all the way to supporting differential diagnosis for similar symptoms,” added Marc Meier, president of Bosch Healthcare Solutions GmbH (Waiblingen, Germany; www. bosch-healthcare.com).

COVID-19 Mass Screening Method Could Be Much Cheaper than Individual Testing

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outbreaks early on. Initial research has shown that it is highly effective at identifying positive cases when most of the population is negative. The researchers developed the method – called the hypercube algorithm – and conducted the first field trials in Africa. Tiny quantities taken from individual swabs were mixed to create combined samples and then tested. The team showed that a single positive case could still be detected even when mixed with 99 negative swab results. If this initial test highlighted that the mixed sample contained positive cases, then researchers

used the algorithm to design a further series of tests. This enabled them to pinpoint individual positive swab results within the combined sample, making it easy to identify people who are infected. If the initial test results indicated that there were no positive cases in the mixed sample, then no follow-up action was needed. The new method is best suited to regular screening of a population – rather than testing individual patients – and may help to significantly lower testing costs, according to the researchers. “We hope our method will enable regular, cost-effective screening in multiple contexts. By doing so, it could be a game changer in

helping us to overcome the COVID-19 pandemic,” said the University’s inaugural Higgs Chair of Theoretical Physics, Professor Neil Turok. LabMedica International November/2020



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The Aerospray TB Series 2 automated slide stainer can stain acid-fast bacteria (AFB) using either carbol fuchsin or fluorescence reagents and provides a wide range of staining settings with multiple possible variables.

The NG-Test MCR-1 is a multiplex lateral flow immunoassay developed for detection of Colistin resistance with 100% sensitivity and 98% specificity. This test is rapid, sensitive, specific, easy to use, and costeffective.

The H560 is the latest 5-part differential hematology analyzer from Erba Mannheim, designed for ease of use and featuring a responsive 10.4-inch color touchscreen. The H560 reports 32 parameters from just 15µL of blood.


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Blood Test Foresees Psychotic Disorders

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The condition is known to present a number of signs and symptoms than can precede the full-blown psychotic episodes often needed for clinical diagnosis. This early pre-clinical phase of a psychotic disorder is often referred to as the prodromal stage. In the case of schizophrenia, prodromal symptoms appear in nearly three quarters of patients up to five years before the first episode of psychosis occurs. An international team of molecular psychiatrists led by the Royal College of Surgeons in Ireland (Dublin, Ireland) included in a study a prospective cohort of clinical high-risk (CHR) criteria enable identification of 344 participants recruited across 11 international sites. Protein depletion, digestion, and peptide purification were performed using baseline plasma samples. Prepared sample was injected on a Q Exactive Hybrid Quadrupole-Orbitrap Mass Spectrometer (Thermo Fisher Scientific, Waltham MA, USA) operated in data-dependent acquisition mode for label-free liquid chromatography mass spectrometry. Nine proteins in plasma samples from the same participants were assessed using enzyme-linked immunosorbent assay (ELISA).

A cohort of non-high risk individuals were included in the study. The team used machine learning machine learning, and homed in on a unique pattern of proteins that distinguished those who ultimately went on to develop a psychotic disorder. Ten particular proteins were identified as most predictive, and the test was subsequently validated in a separate dataset. Using the most accurate protein pattern, they were able to correctly determine which high-risk subjects would go on to develop a psychotic disorder by the age of 18 with a 93% accuracy. The test was less accurate in predicting those high-risk 12-year-olds that did not go on to develop a psychosis by the age of 18. However, considering only between 16% and 35% of young people considered at clinical high risk ultimately transition to a full psychotic disorder, even this low level of accuracy could be useful in stratifying those younger patients more likely to develop psychosis. David R. Cotter, PhD, a molecular psychiatrist and a senior author of the study, said, “Our study has shown that, with help from machine learning, analysis of protein levels in blood sam-

ultiple sclerosis (MS) is an immunemediated neurodegenerative disease of the central nervous system (CNS), with a highly variable inter-individual disease course. As a result, even if using existing clinical prognostic factors, the forecasting of long-term prognosis is often unreliable and imprecise. Neurofilaments provide structural support to axons as the main component of the neuronal cytoskeleton. Elevated levels of these proteins have been observed in several neurodegenerative diseases. In persons with MS, elevated CSF levels of neurofilament light chain (NfL) or heavy chain have been associated with brain atrophy and long-term outcome.

Neurologists at the Karolinska Institutet (Stockholm, Sweden; www.ki.se) and their associates investigated the association between plasma neurofilament light chain (pNfL) levels and the risk of developing sustained disability worsening. They enrolled 4,385 individuals with MS and randomly selecting 1,026 people matched for age and sex who did not have MS. The team used the highly sensitive Single Molecule Array (Simoa, Billerica, MA, USA; www.quanterix.com) NF-Light Advantage Kit, with antibodies from UmanDiagnostics (Umeå, Sweden; www.umandiagnostics.com). They assessed the impact of age-stratified pNfL



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ples can predict who is at truly at risk and could possibly benefit from preventive treatments. We now need to study these markers in other people at high risk of psychosis to confirm these findings.” The authors concluded that they had developed models incorporating proteomic data predicting transition to psychotic disorder in the CHR state. In a general population sample, several of the same proteins contributed to prediction of psychotic experiences. The study was published on August 26, 2020 in the journal JAMA Psychiatry. Image: Q Exactive Hybrid Quadrupole-Orbitrap Mass Spectrometer (Photo courtesy of Thermo Fisher Scientific).

Blood Test Predicts Multiple Sclerosis Progression

levels above the 80th, 95th, and 99th percentiles among controls on the risk of Expanded Disability Status Scale (EDSS) worsening within the following year and reaching sustained EDSS scores of 3.0, 4.0, and 6.0 and conversion to secondary progressive multiple sclerosis (SPMS). The investigators reported that the participants were followed for a total of five years to see if they developed increased levels of disability. They also looked to see if individuals with high NfL levels developed secondary progressive multiple sclerosis (SPMS). MS patients had an average NfL level of 11.4 pg/mL compared Cont’d on page 27

LabMedica International November/2020


Tumor Mutation and Immune Microenvironment Revealed in Colorectal Cancer


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ost colorectal cancers are due to old age and lifestyle factors, with only a small number of cases due to underlying genetic disorders. Other risk factors include diet, obesity, smoking, and lack of physical activity. Dietary factors that increase the risk include red meat, processed meat, and alcohol. Immunotherapy for metastatic colorectal cancer (CRC) is effective only for mismatch repair-deficient tumors with high microsatellite instability that demonstrate immune infiltration, suggesting that tumor cells can determine their immune microenvironment. Immune checkpoint inhibitors have demonstrated impressive activity in patients with CRC and other solid tumors. An international team of scientists collaborating with the Sungkyunkwan University School of Medicine (Suwon, Korea; www.skkumed.ac.kr) used single-cell RNA sequencing, and profiled expression patterns in more than 91,100 individual cells from tumor samples. This included 23 Korean individuals with CRC and six CRC patients from Belgium, bringing in additional genome sequence and genotyping data to explore the relationships between immune or stromal cell features in the context of tumor mutation drivers, mutational signatures, and cell lineage patterns. At Katholieke Universiteit Leuven (Leuven, Belgium; www.kuleuv en.be), investigators used a similar strategy to take a look at the transcriptional profiles in almost 28,000 individual cells from the Belgian CRC patients, focusing on core tumor samples, samples bordering the tumor, and matched normal samples. The team reported that cancer cells displayed transcriptional features reminiscent of normal differentiation programs, and genetic alterations that apparently fostered immunosuppressive microenvironments directed by regulatory T cells, myofibroblasts and myeloid cells. Intercellular network reconstruction supported the association between cancer cell signatures and specific stromal or immune cell populations. The investigators noted that tumors classified in a consensus molecular subtype (CMS) called CMS2 often contained TP53 or APC driver mutations and had relatively low levels of immune cells and stromal cells, for example, along with gene expression signatures resembling absorptive cell lineages. Based on data for 91,103 unsorted single cells from patients in the two cohorts, the team teased out expression-based clusters representing cell types in the microenvironment, including stromal, epithelial, myeloid, and mast cells, along with T cells and B cells, in samples collected from different parts of the large intestine. The authors concluded that that the genetic alterations found in the tumors did not fully line up with molecular features in the samples,


LabMedica International November/2020

LabMedica International

suggesting still other environmental, microbiome, or molecular features contribute to such interactions. Once identified, these missing components would complete the translation of cancer cell signatures into a collective CRC landscape. The study was published on May 25, 2020 in the journal Nature Genetics. Image: Myeloid-derived suppressor cells in the tumor microenvironment have been observed in a variety of solid tumors (Photo courtesy of BMS Immuno-Oncology).


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The Elite 580 features ‘walkaway’ analysis for 60 samples and a responsive 22-inch color touchscreen, reporting 29 parameters from just 20µL of blood including 3D flow cytometry scatterplots.

The Multiplier is a computer-controlled, microplatebased, testing system that performs multiple chemiluminescent analyses simultaneously on a single sample in a single well. Intended for use with Multiplier SmartPLEX assays.

The TRAPIST V6 is a fully automated PCR & immunoassay system that performs rapid multiplex diagnostic testing and enables a wide range of molecular assays as well as immunoassays, delivering results within an hour.



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Immune Microenvironment Changes Contribute to early-Stage Multiple Myeloma

ultiple myeloma is a cancer that forms in a type of white blood cell called a plasma cell. Plasma cells help you fight infections by making antibodies that recognize and attack germs. Multiple myeloma causes cancer cells to accumulate in the bone marrow, where they crowd out healthy blood cells. Precursor states of multiple myeloma (MM) and its native tumor microenvironment need in-depth molecular characterization to better stratify and treat patients at risk. A new study suggests that immune microenvironment changes can contribute to early-stage multiple myeloma, appearing in precursor conditions that precede the blood cancer. A team of scientists collaborating with the Dana-Farber Cancer Institute (Boston, MA, USA; www.dana-farber.org) performed cell sorting and single-cell RNA sequencing on some 19,000 cells from bone marrow samples from seven newly diagnosed multiple myeloma

patients; 11 individuals with high- or low-risk "smoldering" multiple myeloma involving some altered plasma cells; and five individuals with a condition known as monoclonal gammopathy of unknown significance (MGUS) that sometimes progresses to multiple myeloma. The team's analyses uncovered expressionbased clusters representing nine types of immune cells including CD16+ or CD14+ monocytes, natural killer cells, B cells, and T cells. In the early stages of multiple myeloma, for example, the single-cell transcriptome data pointed to an uptick in natural killer cell representation in the immune microenvironment, together with chemokine receptor expression changes. The investigators also picked up other immune changes, from a decline in certain memory cytotoxic T cells and enhanced interferon signaling by multiple immune cell types to altered regulation of monocyte immune cells with effects on T cell activity. They went on to confirm some


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of the immune microenvironment changes in mouse models of early multiple myeloma, in vitro cell line experiments, and phenotyping profiles for bone marrow samples from more than a dozen individuals with or without multiple myeloma or a precursor condition. The scientists reported that major histocompatibility complex class II dysregulation in CD14+ monocytes, which results in T-cell suppression in vitro. These results provide a comprehensive map of immune changes at play over the evolution of premalignant MM, which will help develop strategies for immune-based patient stratification. The study was published on April 27, 2020 in the journal Nature Cancer.

Scoring System Predicts Severity of Infections in COVID-19

Cont’d from cover

Dublin-Boston score. The two interleukins are molecular messengers linked to the body's immune response to inflammation. In general, IL-6 is pro-inflammatory while IL-10 is anti-inflammatory. The investigators associated the IL-6:IL-10 ratio with (a) baseline biomarker levels, (b) change in biomarker level from day 0 to day two, (c) change in biomarker from day 0 to day four, and (d) slope of biomarker change throughout the study. Based on the changes in the ratio of the two biomarkers over time, the investigators formulated a point system where each one-point increase was associated with a 5.6 times increased odds for a

more severe outcome. "The Dublin-Boston score is easily calculated and can be applied to all hospitalized COVID-19 patients," said Dr. Noel G. McElvaney, professor of medicine, at the Royal College of Surgeons in Ireland. "More informed prognosis could help determine when to escalate or deescalate care, a key component of the efficient allocation of resources during the current pandemic. The score may also have a role in evaluating whether new therapies designed to decrease inflammation in COVID-19 actually provide benefit." The Dublin-Boston scoring system was described in the October 8, 2020, online edition of the journal EbioMedicine.

Image: Pro-inflammatory IL-6 is responsible for stimulating acute phase protein synthesis, as well as the production of neutrophils in the bone marrow. It supports the growth of B-cells and is antagonistic to regulatory T-cells (Photo courtesy of Wikimedia Commons)). LabMedica International November/2020



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Atellica® Data Manager leverages 20+ years of experience in digitalizing laboratory best practices to deliver open, scalable, next-generation software with powerful features and easy navigation.

The HumaLyte Plus5 ISE system is a cost-efficient solution for rapid (< one minute) electrolyte testing, including additionally calcium and pH in serum, plasma, whole blood or diluted urine.

The AMPLIRUN CORONAVIRUS RNA CONTROL comprises purified RNA of coronavirus used to control in vitro diagnosis techniques based in nucleic acids amplification. The non-infectious control allows for any sequence to be amplified.




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Phosphorylated Tau Protein Blood Test Distinguishes alzheimer’s Disease from Other Neurological Disorders

recently developed blood test has confirmed the hypothesis that elevated levels of circulating phosphorylated tau 181 (pTau181) protein correlate with Alzheimer's disease (AD) and distinguish it from other neurological disorders that may be misdiagnosed as AD. Since neurological disorders such as frontotemporal dementia are as common as AD among adults under 65 years of age, simple, widely available screening tests are needed to identify which individuals, with symptoms of cognitive or behavioral decline should be further evaluated for initiation of treatment. A blood-based test for AD would be a less invasive and less expensive screening tool than the currently approved cerebrospinal fluid or amyloid-beta positron emission tomography (PET) diagnostic tests. In an effort to develop a blood-based test for AD, investigators at the University of Gothenburg (Sweden; www.gu.se) examined whether plasma tau protein phosphorylated at residue 181 (pTau181) could differentiate between clinically diagnosed or autopsy-confirmed AD and other neurological disorders.


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For this purpose, the investigators adapted an assay based on measurement of pTau181 in ordinary blood samples using the extremely sensitive Single Molecule Array (Simoa) technique. The Simoa method can detect considerably lower levels of protein biomarkers than other analytical methods. The current study included four clinic-based prospective cohorts. The discovery cohort comprised 37 patients with Alzheimer's disease and age-matched controls. Two validation cohorts (226 in TRIAD and 763 in BioFINDER-2) included cognitively unimpaired older adults (mean age 63–69 years), participants with mild cognitive impairment (MCI), Alzheimer's disease, and frontotemporal dementia. In addition, TRIAD included healthy young adults (mean age 23 years) and BioFINDER-2 included patients with other neurodegenerative disorders. The primary care cohort comprised 1131 control participants from the community without a diagnosis of a neurological condition and patients referred from primary care physicians for specialist care. Results obtained with the Simoa assay revealed that in all cohorts, plasma pTau181 showed gradual increases along the Alzheimer's disease continuum, from the lowest concentrations in amyloid betanegative young adults and cognitively unimpaired older adults, through higher concentrations in the amyloid beta-positive cognitively unimpaired older adults and MCI groups, to the highest concentrations in the amyloid beta-positive MCI and Alzheimer's disease groups. Plasma pTau181 distinguished Alzheimer's disease dementia from amyloid beta-negative young adults and cognitively unimpaired older adults, as well as other neurodegenerative disorders (including frontotemporal dementia, vascular dementia, progressive supranuclear palsy, corticobasal syndrome, Parkinson's disease, or multiple systems atrophy). Furthermore, in the primary care cohort, plasma pTau181 discriminated Alzheimer's disease patients from young adults and cognitively unimpaired older adults but not from MCI. "We believe that, in the future, one very important use of our blood test will be for screening in primary care. We demonstrated this in one of the studies forming part of our article, in which we looked at patients in primary care with concerns about their failing memory," said senior author Dr. Kaj Blennow, professor of clinical neurochemistry at the University of Gothenburg. The phosphorylated tau 181 assay was described in the May 1, 2020, issue of the journal The Lancet. LabMedica International November/2020


New Monotest Diagnoses Risk of Invasive aspergillosis

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new monotest using chemiluminescence, meets the need for the immediate testing of individual samples for patients at risk of invasive aspergillosis, without resorting to batching, cumulating samples, or sending out to an external laboratory. Aspergillus sp. is one of the most ubiquitous of the airborne saprophytic fungi. With the increase in the number of immune-suppressed patients, there has been a dramatic increase in severe and usually fatal invasive aspergillosis or invasive candidiasis, now one of the most common mold infections worldwide. Invasive Aspergillus Infection (IAI) is an important life-threatening infection in immune-compromised patients, especially those with prolonged neutropenia, allogeneic hematopoietic stem cell transplant (HSCT) and solid organ transplant (SOT). In immune-competent hosts, IAI is involved in chronic obstructive pulmonary, Large Burned patients, cirrhosis, corticosteroid treatment, most of them located in Intensive Care Units. Diagnosis of IAI by conventional culture-based methods show clear deficiencies especially in sensitivity and speed: Confirmation with culture occurs in less than 50% of cases due to the frequent negative results of blood cultures and the difficulty of obtaining deep tissue samples or fluids ordinarily sterile. The availability of effective antifungal agents determines the need for rapid and accurate diagnosis. Therefore, it is essential to implement the diagnosis of invasive mycosis with non-culture-based techniques among which biomarkers are already an essential part. Currently, the most commonly biomarker used in the case of Aspergillus is the Galactomannan. Galactomannan is a useful diagnostic test for the investigation of invasive aspergillosis in patients with a suggestive clinic. It can be done not only in blood but also in CSF, BAL or peritoneal fluid. Its systematic and periodic use is not recommended in non-symptomatic hematological patients who have been receiving antifungal prophylaxis. However, the format currently marketed by a microtiter plate capture ELISA makes it very difficult to use the test with only one or a few samples. The ELISA method is useful when studying a large number of patients at risk of invasive aspergillosis in a systematic way. New formats are now needed to facilitate its use with a single sample. These new systems must be able to quantify the fungal load and be easy to carry out. One model would be the new immunochromatography based on â&#x20AC;&#x153;Lateral Flowâ&#x20AC;?, which is a very simple, but difficult to quantify technique. Now, the VirClia Aspergillus Galactomannan AG, a new mon-otest using chemiluminescence developed by Vircell S.L. (Granada, Spain; www.en.vircell.com), could respond to these new


LabMedica International November/2020

LabMedica International

diagnostic needs for testing individual samples immediately, without the need for batching, cumulating samples or sending out to an external laboratory. The VirClia Aspergillus Galactomannan AG has been successfully evaluated internally and externally against a commercially available ELISA reference assay and showed a 91% correlation.


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The VACUETTE Virus Stabilization Tube is a primary container for the safe transport and storage of swab specimens and is manufactured under Greiner Bio-One hygienic standard requirements.

The Vivalytic Viral Respiratory Tract Infection Array Detecting SARS-CoV-2 (COVID-19) can identify SARS-CoV-2 (COVID-19) and differentiate it from other respiratory infections with similar symptoms.

The qTOWER³ auto is a compact, automatable realtime PCR thermal cycler that allows even high sample numbers to be handled safely and cost-efficiently. It enables simple device integration and offers increased throughput.



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Predicting Pre-Term Births in High-Risk Women

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Cont’d from cover

many years. Its presence, detected in early pregnancy is associated with an increased risk of preterm labor. However, treatment of BV with antibiotics has not been demonstrated to prevent preterm birth. Gynecologists and Bioengineers at the Warwick University (Coventry, UK, www.warwick.ac.uk) carried out a prospective observational cohort of repeated sampling of 216 patients between 10 to 29 weeks of pregnancy (total 493 sets of swabs were taken, with at least two swabs per patient), from women attending the high-risk preterm prevention clinic at a tertiary level teaching hospital from January 2017-August 2018. The team initially analyzed volatile organic compounds (VOCs) present in the vagina for a condition called bacterial vaginosis, in which the bacteria of the vagina have become imbalanced. Vaginal swabs were taken during the second and third trimesters of pregnancy and the outcome of all pregnancies followed up. The technology they used works by separating the vapor molecules by combining two techniques that first pre-separates molecules based on their reaction with a stationary phase coating (a gas-chromatograph), followed by measuring their mobility in a high-electric field (an Ion Mobil-


ity Spectrometer). The odors/VOCs emanating from the samples were analyzed using a GC-IMS instrument (G.A.S., Dortmund, Germany), which is based on Gas Chromatograph – Ion Mobility Spectrometry principles (GC-IMS). Using machine learning techniques, the team 'trained' the technology to spot patterns of VOCs that were signs of bacterial vaginosis. The team reported that VOC analysis of vaginal swabs, taken in the mid-trimester, is a fair test (AUC 0.79) for preterm prediction, with a sensitivity of 0.66 (95%CI 0.56–0.75) and specificity 0.89 (95%CI 0.82– 0.94). Using vaginal swabs taken closest to delivery, VOC analysis is a good test (AUC 0.84) for the prediction of preterm birth with a sensitivity of 0.73 (95%CI 0.64–0.81) and specificity of 0.90 (95%CI 0.82– 0.95). Lauren Lacey, MD, an associate professor and lead author of the study, said, “We've demonstrated that the technology has good diagnostic accuracy, and in the future it could form part of a care pathway to determine who would deliver preterm. VOC technology is really interesting because it reflects both the microbiome and the host response, whereas other technologies look for a specific biomarker. It's the beginning of looking at the association of VOCs with preterm delivery. We want to develop this and look at whether these patterns could be implemented into a care pathway.” The authors concluded that this novel work has demonstrated that VOC analysis has the potential to be used as a predictive tool to support the prediction of preterm birth and aid personalized prevention strategies. The study was published on July 22, 2020 in the journal Scientific Reports. Typical GC-IMS output of a vaginal swab. Red spots indicate individual chemicals and machine learning identifies which of these chemicals hold discriminatory information (Photo courtesy of the University of Warwick).

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LabMedica International November/2020



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CD-Chex CD34 is a ready-to-use, positive procedural control for enumerating CD34 positive cells by flow cytometry. The whole blood control does not need to be diluted and offers 30-day open-vial stability.

VACUETTE Transport Boxes ensure safe transport of sample material from collection point up to analysis in the laboratory. The VACUETTE Transport Boxes can store 40 tubes, available with or without the HK0190 shipping box.

The SuperFlex™ Chemiluminescent Immunoassay System delivers ultra-sensitive detection of small biological molecules using labeled antibodies and antigens in serum, plasma and whole blood.



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Instant Breath Test Detects COVID-19

Cont’d from cover

of someone affected by COVID-19. Utilizing technologies which were developed earlier, the team has demonstrated how these markers or ‘breath signatures’ can be used to rapidly distinguish COVID-19 from other respiratory conditions at point of need, such as an emergency department, a workplace or a care setting, with no laboratory support. The IMSPEX Group which is also part of the consortium will be working alongside researchers to help develop and scale such technology. Its BreathSpec device has been a key tool used by researchers in the analysis of volatile organic compounds (VOCs) in human breath. For the feasibility study, the researchers recruited 98 patients, out of whom 31 had COVID-19. Other diagnoses included asthma, exacerbation of asthma and COPD, viral pneumonia, other respiratory tract infections, and cardiac conditions. In order to identify and diagnose COVID-19 from the samples, the team used Gas Chromatography (GC) - a procedure used for separating and analyzing compounds that can be vaporized without decomposition - and Ion Mobility Spectrometry (IMS) – an analytical technique used to separate and identify ionized molecules in the gas phase. The study participants gave a single breathsample for the analysis of VOCs by GC-IMS. The analysis identified alde-


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hydes (ethanal, octanal), ketones (acetone, butanone), and methanol that discriminated COVID-19 from other conditions. “We are hugely encouraged by these findings. Employing tried and tested techniques used during the TOXITriage project, suggests that COVID-19 may be rapidly distinguished from other respiratory conditions,” said Paul Thomas, Professor of Analytical Science from Loughborough’s Department of Chemistry. “To develop this technique further larger studies are required, together with complementary GC-MS studies, to build on the data collected so far. If shown to be reliable, it offers the possibility for rapid identification or exclusion of COVID-19 in emergency departments or primary care that will protect healthcare staff, improve the management of patients and reduce the spread of COVID-19.” Image: The BreathSpec device was used during field trials last year in Finland (Photo courtesy of Andrew Weekes)

Cont’d from page 13 researchers have created a surface that repels every other element of human blood except critical cytokine biomarkers like Interleukin-6 (IL-6), enabling timely and clear detection of critical "cytokine storm" progress of COVID-19 in individual patients. On-the-Go SARS-CoV-2 Testing Device for Rapid Reporting

Hoth Therapeutics, Inc. (New York, NY, USA; www.hoththerapeutics.com) is developing an in vitro diagnostic device that has the potential for testing by patients anywhere to allow public health professionals to immediately detect SARSCoV-2 via a mobile device as an aid in the diagnosis of COVID-19 infection. The On-the-Go SARS-CoV-2 Testing Device has the potential to provide results within minutes and the results can then be sent to healthcare professionals or public health databases using the app on the patient's mobile device. New Biomimicry Control for COVID Diagnostics


Researchers at the Centre for Biomedical Tuberculosis Research at Wits University (Johannesburg, South Africa; www.wits.ac.za) have developed a unique “control standard” that improves accuracy and safety of COVID-19 testing by using biomimicry as a safer alternative to incorporating the actual SARS-COV-2 virus. The researchers have used the biomimicry technique to engineer a control organism that mimics the genetic material of the virus, when used in diagnostic tests kits. If the tests work correctly, the genetically modified organism is identified as being SARS-CoV-2. lMI-11-20 126

LabMedica International November/2020


Certain Cytokines Not associated with Severity of COVID-19 Symptoms

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LabMedica International


he pandemic outbreak of coronavirus disease 2019 (COVID-19) is sharply spreading all over the world. The severity of a viral disease usually is positive association with immune-mediated inflammatory responses. The aggressive and persistent inflammatory response leads to high risk of multiorgan failure and death. . The overproduction inflammatory cytokines results in cytokine storm. Cytokine storm indicates excessive release of pro-inflammatory cytokines including C-reactive protein (CRP) and pro-inflammatory cytokines (IL-2, IL-4, TNF-α, IFN-γ). There is a body of evidences suggests that severe COVID-19 patients have cytokine storm. Scientists at the Harbin Medical University (Harbin, China; www. hrbmu.edu.cn) and their colleagues studied patients aged 39 to 85 years old, who were confirmed to be SARS-CoV-2 positive via nasopharyngeal swabs. Further, clinical characteristics and chest CT scans indicated that these patients had severe COVID-19. All patients were admitted in ICU with hypoxemic respiratory failure. Of these patients, five (20%) had hypertension and five (20%) had diabetes. All 25 patients were discharged from the ICU to the hospital ward before being discharged home. The scientists analyzed serum inflammatory cytokines and immune cells in these patients and found that CRP (range: 0.499-9.75 mg/L; reference value: 0-10 mg/L), IL-2 (range: 0.67-2.59 pg/L; reference value: 0.08-5.71 pg/mL), IL-4 (range: 0-2.27 pg/L; reference value: 0.1-2.8 pg/L), TNF-α (range: 0-1.86 pg/L; reference value: 0.1-2.31 pg/L) and IFN-γ (range: 0.51-3.24 pg/L; reference value: 0.16-7.42 pg/L) were in the normal value range compared to the reference value. These cases showed that IL-2, IL-4, TNF-α, IFN-γ and C reactive protein level is not associated with severe COVID-19 pathology. The investigators also reported that levels of IL-6 and IL-10 in some severe COVID-19 patients were over the reference values, indicating that these patients had severe clinical characteristics independent of circulating levels of IL-2, IL-4, TNF-α, IFN-γ and CRP. IL-6 levels in 16 patients were above the reference range of 1.18-5.3 pg/L, with levels of 036.3 pg/L recorded in all 25 patients. In addition, 14 patients had IL-10 levels above the reference range of 0.19-4.91 pg/L, with levels of 4.9612.44 pg/L observed across the 25 patients. The authors concluded that some reports had shown cytokine storm was correlated with severity and mortality of COVID-19 patients, but the correlation does not indicate causation. More viral replication also could drive consequent severity of COVID-19. The authors said that the hypothesis that blocking cytokine storm eases COVID-19 severity needs to be more carefully investigated based on their observation. The study was published on June 10, 2020 in the Journal of Medical Virology.

Image: This illustration reveals ultrastructural morphology exhibited by coronaviruses. Note the spikes that adorn the outer surface of the virus, which impart the look of a corona surrounding the virion, when viewed electron microscopically (Photo courtesy of Centers for Disease Control and Prevention).

Blood Test Predicts Multiple Sclerosis Progression

Cont’d from page 16

to 7.5 pg/mL in the non-MS patients. Overall, investigators determined that high plasma NfL correlated with sustained EDSS scores 3.0 and 4.0. MS patients were 40% to 70% more likely to have worsening disability during the following year and 50% more likely to reach a level of moderate disability that affected daily activities. The results reflect other variables that could affect the risk of poorer outcomes in the MS patients, such as rate of relapse and longevity of disease. A total of 525 MS patients (16%) reached the moderate level of disability, and 352 patients (9%) reached significant disability. Ali Manouchehrinia, PhD, an assistant professor and first author of the study, said, “These results suggest that elevated levels of these nerve proteins biomarkers measured early on in the course of the disease may help us to predict how the disease will develop and monitor how treatment is working. In a disease like MS that is so unpredictable and varies so much from one person to the next, having a noninvasive blood test like this could be very valuable, especially since treatments are most effective in the earliest stages of the disease.”


LabMedica International November/2020


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The OSOM® Ultra Plus Flu A&B Test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab and nasopharyngeal swab specimens obtained from patients.

The Access SARS-CoV-2 IgM Antibody Test targets antibodies that recognize the receptor binding domain (RBD) of the spike protein which SARS-CoV-2 uses to bind to a human cell receptor.

The GSD NovaPrime® SARS-CoV-2 (COVID-19) RTPCR is intended for the qualitative determination of SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2) genomic RNA extracted from human respiratory specimen types.



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Blood Biomarkers Help Diagnose Parkinson's Disease

he identification of circulating biomarkers that closely correlate with Parkinson’s disease (PD) has failed several times in the past. A conventional pipeline for biomarker discovery usually contemplates the collection of clinical samples, such as blood, and their analysis by mass spectrometry. However, clinical samples, in particular the case of plasma and serum, the primary source for biomarker discovery, are known to have a large dynamic range, which makes it difficult to reach the


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less abundant species. A translational approach has been conducted, allowing the evaluation of the plasma levels of two mitochondrial-related proteins, whose combination leads to a robust model with potential diagnostic value to discriminate the PD patients from matched controls. Interdisciplinary scientists from the University of Coimbra (Coimbra, Portugal; www.uc.pt) examined blood plasma samples from 31 Parkinson’s patients, ages 65 to 86 and being followed at the Centro Hospitalar Cova da Beira (Covilhã, Portugal; www. chcbeira.pt). They then compared these sample with 28 from matched controls, whose ages ranged from 55 to 83. The team started out by comparing proteins that are secreted by cells cultured in normal conditions, and in a setting of oxidative stress, an imbalance between the production and clearance of toxic reactive species that are harmful to cells, and which plays a key role in neurodegenerative diseases like Parkinson’s. In total, their analysis retrieved 23 mitochondrial-related proteins that were differentially secreted by cells under these two conditions, including 19 proteins whose levels were significantly increased in the presence of oxidative stress, and four proteins with significantly decreased levels in this setting. This approach yielded a total of 98 proteins that were significantly different between patients and controls, but a review of mitochondrial-related proteins retrieved only two candidates, clusterin and the vacuolar protein sorting-associated protein 35 (VPS35). Levels of these two mitochondrial-related proteins combined were better than each single protein at discriminating patients from controls, showing an accuracy of 82.1%. The rate of incorrectly classified patients also dropped significantly when people with more advanced disease were examined. Clusterin, VPS35, and GFP (the internal standard used in mass spectrometry analysis) levels were determined using ELISA commercial kits, namely Clusterin Human ELISA kit (Invitrogen, Carlsbad, CA, USA; www.thermofisher.com), Human Vacuolar protein sorting-associated protein 35 (VPS35) ELISA Kit (Abbexa, Cambridge, UK; www.abbexa.com) and GFP ELISA Kit (Abcam, Cambridge, UK; www.abcam.com), respectively. The authors concluded that an adaptation of a translational pipeline for biomarker selection was presented and transposed to neurological diseases. From the application of this adapted pipeline, two mitochondrial-related proteins were identified as potential candidates for Parkinson’s disease diagnosis. The study was published on April 3, 2020 in the journal Translational Neurodegeneration. LabMedica International November/2020



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The magnetic beads with unique separation function and buffer system can extract high purity disease virus DNA/RNA from sample rapidly with high sensitivity and efficiency.

The Mag-Bind PX Blood RNA 96 Kit provides a convenient and fast RNA extraction solution for samples stabilized in PreAnalytiX PAXgene or Applied Biosystems’ Tempus blood RNA tubes.

The SARS-CoV-2 Fluorescent PCR Kit (for the COVID-19 Coronavirus) is a qualitative assay that allows the detection of nucleic acids in samples from patients who meet COVID-19 clinical and/or epidemiological criteria.


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Genetic alterations analyzed in Pediatric low-Grade Glioma


ow grade gliomas are brain tumors that come from two different types of brain cells known as astrocytes and oligodendrocytes. They are classified as a grade 2 tumor making them the slowest growing type of glioma in adults. Pediatric low-grade gliomas (pLGG) are frequently driven by genetic alterations in the RAS-mitogen-activated protein kinase (RAS/MAPK) pathway yet show unexplained variability in their clinical outcome. Genetic alterations have been documented in this brain tumor subtype (pLGG) that correspond with better or worse patient outcomes. A large team of scientists led by those at the Hospital for Sick Children (Toronto, ON, Canada; www.sickkids.ca) used imaging, histology, targeted DNA sequencing, RNA sequencing, clinical, and other data for more than 1,000 children with pLGG, they narrowed in on two broad groups of tumors marked either by recurrent rearrangements or by single-nucleotide variants. Broadly speaking, they noted, rearrangement-rich tumors tended to turn up in relatively low-risk pLGG cases, while certain sets of single-nucleotide changes coincided with intermediate- or highrisk pLGG cases. Starting with data for 976 pLGG patients treated at the hospital between the mid-1980s and 2017, the investigators focused in on 477 cases that could be successfully profiled using methods such as RNA-seq, NanoString nCounter analyses (nanoString Technologies, Seattle, WA,USA; www.nanostring.com), array-based single nucleotide polymorphism (SNP) profiling, targeted DNA sequencing, droplet digital polymerase chain reaction (ddPCR), and immunohistochemistry. The scientists reported that 84% of cases harbored a driver alteration, while those without an identified alteration also often exhibited upregulation of the RAS/MAPK pathway and roughly two-thirds of the cases contained

BRAF or NF1 mutations, or KIAA1549-BRAF fusions. The team also drew prognostic insights from the kinds of mutations that occurred often in the pLGGs. For example, a cluster of 265 tumors appeared to have rearrangement-related drivers. Those tumors were overrepresented in children diagnosed with pLGG before the age of 10, the investigators noted, and some 88% were classified as having grade I histology. In those rearrangement-related cases, the 10-year overall survival rate reached nearly 98%. Cynthia Hawkins, MD, PhD, a neuropathologist and corresponding author of the study, said, “The pLGG morphological, imaging, clinical, and molecular profiling allowed us to comprehensively investigate the molecular underpinnings and provide comprehensive clinical insights for some of the rarest of pLGG molecular subtypes. These data can guide diagnostic protocols and treatment approaches, while aiding in expediting clinical trials for new, better-targeted therapies for these children in the near future.” The study was published on April 13, 2020 in the journal Cancer Cell. Image: The nanoString nCounter: This instrument provides a simple and cost-effective solution of direct digital quantification for multiplex analysis of up to 800 known RNA, DNA, or protein targets in one tube (Photo courtesy of the Crown Institute of Genomics). LabMedica International November/2020



large Proteomics Study Identifies New Fluid Biomarkers for Diagnosis of alzheimer’s Disease

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LabMedica International

recent study identified proteins and biological processes in brains from Alzheimer’s disease (AD) that may serve as diagnostic fluid biomarkers and potential therapeutic targets for the disease. Investigators at Emory University (Atlanta, GA, USA; www.emory.edu) and colleagues at the [U.S.] National Institute on Aging (Bethesda, MD, USA; www.nia.nih.gov) and other institutions used quantitative mass spectrometry and coexpression network analysis to conduct the largest proteomic study thus far on AD. For this study, the investigators analyzed patterns of protein expression in more than 2,000 human brain and nearly 400 cerebrospinal fluid samples from both healthy individuals and patients diagnosed with Alzheimer's disease. Brain tissue samples came from autopsy of participants in AD research centers and several epidemiological studies NE D ES W across the country. The brain collections IGN also contained samples from individuals with six other neurodegenerative disorders as well as samples representing normal aging. Cerebrospinal fluid samples were collected from study participants at WORlD’S MeDICal PRODUCT MaRkeTPlaCe the Emory University Goizueta Alzheimer's Disease Research Center. Results of the study pointed to a protein network module linked to sugar SIGN UP metabolism as being one of the modules FOR FREE! most significantly associated with AD pathology and cognitive impairment. This module was enriched in AD genetic risk factors and in microglia and astrocyte protein markers associated with an anti-inflammatory state, suggesting that the biological functions it represents serve a protective role in AD. Proteins from this module were found to be elevated in cerebrospinal fluid in early stages of the disease. "We have been studying the possible links between abnormalities in the way the brain metabolizes glucose and Alzheimer's-related changes for a while now," said contributing author Dr. Madhav Thambisetty, chief of the clinical and translational neuroscience section at the National Institute on Aging. "The latest analysis suggests that these proteins may also have potential as fluid biomarkers to detect the presence of early Connecting Buyers with disease." Suppliers Worldwide The Alzheimer’s disease proteomics Reach new sources of supply study was published in the April 13, Identify latest products and technologies 2020, online edition of the journal NaSend inquiries directly to suppliers ture Medicine. Receive latest product alerts Chat live with suppliers Image: Micrograph showing a human

astrocyte growing in cerebral culture. An elevation in astrocyte protein markers was associated with an anti-inflammatory state in brains of patients with Alzheimer’s disease (Photo courtesy of Wikimedia Commons)


LabMedica International November/2020

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The Allplex 2019-nCoV Assay is a multiplex Real-time PCR assay for the simultaneous detection of three target genes of SARS-CoV-2 in a single tube. The assay is designed to detect RdRP and N genes specific for SARS-CoV-2.

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The MBT STAR-Cepha IVD Assay detects resistances towards 3rd generation cephalosporins within just one hour after a positive blood culture alert. lINkXPReSS COM

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Human Nk Cells Identified by Single-Cell RNa Sequencing


atural killer (NK) cells are cytotoxic lymphocytes that are crucial for viral defense as well as detecting and killing cancer cells. This cell type is therefore of great interest for cancer immunotherapy. Human natural killer (NK) cells in peripheral blood perform many functions, and classification of specific subsets has been a longstanding goal. NK cells have also been implicated in a wide range of diseases: those caused by microbial pathogens, autoimmune diseases, reproductive complications, and transplantation. An international team of scientists led by those at the University of Manchester (Manchester, UK, www.manche ster.ac.uk) obtained peripheral blood samples from various sources. Peripheral blood mononuclear cells were isolated from fresh blood collected into EDTA-coated tubes by density gradient centrifugation (Ficoll-Paque Plus; Amersham Pharmacia Biotech, Piscataway NJ, USA; www.apbiotech.com) or from leukocyte reduction system chambers through Ficoll density centrifugation. Primary human NK cells were isolated by negative magnetic bead selection (Miltenyi Biotec, Bergisch Gladbach, Germany; www.miltenyibiotec.com) or (Stemcell Technologies, Vancouver, BC, Canada; www.stemcell.com) into medium. The NK cells were stained with diverse labeled antibodies and assessed by flow cytometry on a BD FACS Canto II flow cytometer (BD Biosciences, San Jose, CA, USA; www.bdbiosciences.com). Individually barcoded singlecell RNA sequencing (scRNA-seq) libraries were also prepared. The team identified three novel human blood NK cell populations: a population of

type I interferonâ&#x20AC;&#x201C;responding NK cells that were CD56neg; a population exhibiting a cytokine-induced memory-like phenotype, including increased granzyme B mRNA in response to IL-2. They als o identified a small population, with low ribosomal expression, downregulation of oxidative phosphorylation, and high levels of immediate early response genes indicative of cellular activation. Analysis of CMV+ donors established that CMV altered the proportion of NK cells in each subset, especially an increase in adaptive NK cells, as well as gene regulation within each subset. The authors summarized that NK cells within healthy individuals displayed an exquisite division of labor. The expansion, contraction, or alteration, of these subsets in pathological settings will give insight into NK cell responses during disease progression. The study was published on April 9, 2020 in the journal Blood Advances. Image: Diversity of peripheral blood human NK cells identified by single-cell RNA sequencing (Photo courtesy of University of Manchester). LabMedica International November/2020


Molecular Differences Discovered among Ovarian Cancer Subgroups

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LabMedica International


varian cancer is a highly diverse disease with a high rate of overall mortality. High-grade serous ovarian cancer (HGSC) is the most common and aggressive type of epithelial ovarian cancer, exhibiting high levels of tumor heterogeneity and variable clinical outcomes. The extent of residual disease following upfront cytoreductive surgery for HGSC is one of the strongest prognostic factors for progression-free and overall survival. Neoadjuvant chemotherapy (NACT) followed by interval cytoreductive surgery has been offered as an alternative approach, especially where full cytoreductive surgery is not feasible. A team of scientists led by the University of Texas MD Anderson Cancer Center (Houston, TX, USA; www.mdanderson.org) analyzed tumor biopsies from 30 women with HGSC, some of whom had no visual evidence of disease after surgery, some of whom responded well to neoadjuvant chemotherapy, and some of whom responded poorly to neoadjuvant chemotherapy. This analysis indicated that tumors that underwent full resection differed molecularly from the other subgroups and that some of these differences between cancer subgroups could be applied to predict disease response. The investigators collected primary tumor tissue and tissue from metastatic sites, which they analyzed using whole-genome sequencing to an average somatic coverage of 118× and to germline coverage of 38×. They also conducted targeted deep-sequencing, RNA sequencing, and proteomic and immune profiling on these samples. This analysis indicated that tumors that underwent full resection differed molecularly from the other subgroups and that some of these differences between cancer subgroups could be applied to predict disease response. The scientists reported that across all both primary and metastatic samples, the most frequently mutated gene was TP53. However, the types of mutations affecting TP53 varied by tumor subgroup. For instance, the subgroups that underwent neoadjuvant chemotherapy (NACT) were more likely to have nonsense TP53 mutations, while the complete gross resection (R0) group had missense mutations. Other alterations varied by subgroup. About 54% of R0 group tumors had copy number loss of NF1, while the NACT groups had much lower levels of NF1 loss, about 18%. NF1 mRNA and protein levels were similarly decreased in the R0 group as compared to the NACT groups.

NF1, they noted, could be a marker to predict R0 and NACT response. R0 subgroup tumors additionally exhibited a strong binding neoantigen signature, as compared to the NACT subgroups. This neoantigen signature, they noted, is associated with the increased infiltration of tumor immune cells. When they examined the immune profiles of the tumors, the researchers found the R0 group exhibited an increased number of infiltrated T cells, as compared to the NACT subgroups. The NACT subgroups, by contrast, had increased macrophages and B cells, as compared to the R0 group. Meanwhile, R0 subgroup tumors also had lower levels of chromothripsis than the other subgroups. Further, when chromothripsis did occur in those tumors, it was more likely to affect chromosomes 6 and 19. Chromothripsis in NACT subgroup tumors was, by contrast, more likely to affect chromosomes 8 and 17. The authors concluded that they had identified significant distinct molecular abnormalities and cellular changes and immune cell repertoire alterations between the groups, including a higher rate of NF1 copy number loss, and reduced chromothripsis-like patterns, higher levels of strong-binding neoantigens, and a higher number of infiltrated T cells in the R0 versus the NACT groups. The study was published on April 14, 2020 in the journal Cell Reports. Image: Schematic Diagram of the Molecular Analysis of Clinically Defined Subsets of High-Grade Serous Ovarian Cancer (Photo courtesy of MD Anderson Cancer Center).

early-Onset Preeclampsia Risk Reflected in Circulating Maternal Transcripts


reeclampsia is a poorly understood pregnancy-associated disorder. Often marked by hypertension, preeclampsia can lead to severe complications including internal bleeding, seizures, stroke, premature birth, and death. Preeclampsia can develop suddenly, and identifying who is at risk of the condition is difficult. Circulating RNA (C-RNA) is continually released into the bloodstream from tissues throughout the body, offering an opportunity to noninvasively monitor all aspects of pregnancy health from conception to birth. A team of scientists led by those at Illumina (San Diego, CA, USA; www.illumina.com) used transcriptome enrichment and sequencing to search for preeclampsia-related RNAs in blood samples collected over time from more than 100 pregnant women with or without early-onset preeclampsia, a condition linked to a rise in maternal and perinatal morbidity and mortality risk. They sequenced the circulating transcriptome from 40 pregnancies at the time of severe, early-onset preeclampsia diagnosis and 73 gestational age–matched controls. The investigators saw more than three-dozen suspicious transcripts with enhanced representation in blood plasma from the preeclampsia pregnancies, focusing in on 30 preeclampsia-related circulating transcripts with follow-up quantitative polymerase chain reaction (PCR) and


LabMedica International November/2020

validation analyses. The team brought in machine learning classifier clues, and they acquired a set of 49 circulating RNA transcripts that could pick up early-onset preeclampsia pregnancies with between 85% and 89% accuracy, on average, in another group of two dozen women with or without preeclampsia. The average accuracy of the circulating RNAbased classifier dipped to around 72% for women in the validation cohort experiencing late-onset preeclampsia. Differential expression analysis identified the 30 transcripts with gene ontology annotations and tissue expression patterns consistent with the placental dysfunction, impaired fetal development, and maternal immune and cardiovascular system dysregulation characteristic of preeclampsia. The authors concluded that they had detected molecular changes specific to the complex pathophysiology of early-onset severe preeclampsia at the time of diagnosis, supporting robust classification across cohorts. They noted that the altered circulating RNA transcripts identified represented contributions from maternal, placental, and fetal tissues, many of which would not be captured in studies focusing on placental tissues collected after delivery. The study was published on July 1, 2020 in the journal Science Translational Medicine.



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The Creatinine (Crea) Gen.2 (Sarcosine Oxidase Method) is a groundbreaking solution for antidrug interference that efficiently eliminates the interferences of calcium dobesilate and etamsylate in the sample.

The 2019-nCoV IgG/IgM Rapid Antibody Test Cassette from AllTest intended for SARS-COV-2-specific IgM/IgG antibody detection is an ideal complement to nucleic acid detection.

The Ion GeneStudio S5 systems are designed to enable a broad range of targeted next-generation sequencing (NGS) applications. Five Ion S5 chips enable a sequencing throughput range of 2M to 130M reads per run.




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Urea Dissociation Test Reduces SaRS-CoV-2 IgM False-Positives

t present, the diagnosis of COVID-19 is mainly based on epidemiological history inquiry, laboratory testing, and chest radiology examination. Among these examinations, the detection of nucleic acid from SARS-CoV-2 is the direct evidence for COVID19 diagnosis. The detection of serum-specific IgM and IgG, especially the former, is routinely used in clinical laboratories to evaluate the acute phase infection of pathogens in the serum. In many infections, IgM can be detected as early as one week after infection. When the level of IgM reaches the detection limit of the assay kit, the detection of IgM can avoid false-negative results owing to sampling. Medical Laboratory Scientists at the Affiliated Hospital of North Sichuan Medical College (Nanchong, China; www.nsmc.edu.cn) used


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gold immunochromatography assay (GICA) and enzyme-linked immunosorbent assay (ELISA) to detect SARS-CoV-2 IgM in 86 serum samples, including five influenza A virus (Flu A) IgM-positive sera, five influenza B virus (Flu B) IgM-positive sera, five Mycoplasma pneumoniae IgM-positive sera, five Legionella pneumophila IgM-positive sera, six sera of HIV infection patients, 36 rheumatoid factor IgM (RF-IgM)-positive sera, five sera from hypertensive patients, five sera from diabetes mellitus patients, and 14 sera from novel coronavirus infection disease (COVID-19) patients. The interference factors causing false-positive reactivity in the two methods were analyzed, and the urea dissociation test was employed to dissociate the SARS-CoV-2 IgM-positive serum using the best dissociation concentration. The IgM against Flu A and B, M.

pneumoniae, and L. pneumophila were detected by indirect immunofluorescence assay (Respiratory tract 8 joint detection kit; Euroimmun, Inc.; LĂźbeck, Germany; www.euroimmun.com). Rheumatoid Factor (RF-IgM) was detected by rate nephelometry assay (IMMAGE800; Beckman Coulter, Inc.; Brea, CA, USA; www.beckmancoulter.com). HIV combi PT was detected by electrochemiluminescence assay (Cobas E602, Roche, Mannheim, Germany; www.roche.de). GICA and ELISA were used for SARS-CoV2 IgM detection kit provided by Beijing Hotgen Biotechnology Co. (Beijing, China; www.hotgen.com.cn). Optical density in ELISA plates was measured using a PHOMO Microplate Reader (Autobio Diagnostics Co., Zhengzhou, China; www.autobio.com.cn). Urea dissociation tests of GICA and ELISA were also performed. The team reported that both GICA and ELISA detected positive SARS-CoV-2 IgM in 22 middle-high level RF-IgM-positive sera and in all the 14 sera from the patients with COVID-19 patients. The other 50 sera were negative. When urea dissociation concentration was 6 mol/L, SARS-CoV-2 IgM was positive in one middle-high level RF-IgM-positive sera and in the 14 COVID-19 samples detected using GICA. When urea dissociation concentration was 4 mol/L and the avidity index (AI) lower than 0.371 was set to negative, test results were positive for SARS-CoV-2 in 3 middle-high level RFIgM-positive sera, as well as the 14 COVID-19 sera detected using ELISA. The authors concluded that middle-high level of RF-IgM could lead to false-positive reactivity of SARS-CoV-2 IgM detected using GICA and ELISA, and urea dissociation tests would be helpful in reducing false-positive results of SARS-CoV2 IgM. The study was published on April 10, 2020 in the Journal of Clinical Microbiology. LabMedica International November/2020


Important Genetic Mechanism Behind Inflammatory Bowel Disease Revealed

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LabMedica International


he two main forms of Inflammatory Bowel Disease (IBD), Crohn's disease and ulcerative colitis, have an important genetic component. More than 240 genetic regions have been identified that associate with IBD, more than any other pathological condition that has been studied. The exact cause of IBD is unknown, but IBD is the result of a defective immune system. A properly functioning immune system attacks foreign organisms, such as viruses and bacteria, to protect the body. In IBD, the immune system responds incorrectly to environmental triggers, which causes inflammation of the gastrointestinal tract. Scientists at the Children's Hospital of Philadelphia (Philadelphia, PA, USA; www.chop.edu) and their colleagues used a variety of assays and state-of-the-art sequencing methods. The study team sought to characterize the single nucleotide polymorphism (SNP) rs1887428, which is located on the promoter region of the Janus kinase 2 (JAK2) gene. The protein coded by this gene is responsible for controlling the production of blood cells. Mutations of JAK2 have been linked to various blood cancers. The team identified proteins known as transcription factors, which regulate gene expression, that were associated with this particular single nucleotide polymorphism (SNP). Two transcription factors in particular, RBPJ and CUX1, can recognize the DNA sequence altered by the rs1887428 SNP. Additionally, they found that while the SNP only has a very modest influence on JAK2 expression, the effect was amplified by other proteins in the JAK2 pathway. Hakon Hakonarson, MD, PhD, a Professor of Pediatrics and senior INTeRaCTIVe author of the study, said, “Using DIGITal eDITION this method, we believe we have added an important tool to our arsenal of SNP-to-gene assignment methods, allowing us to pinpoint disease-driving genetic mutations that have previously been difficult to properly assign risk. This study in particular also provides evidence that drugs targeting JAK2 may provide some benefit for those patients suffering from IBD who carry mutations that upregulate the JAK2 pathway, though such precision-based approaches would need to be validated in clinical studies.” The authors concluded that despite the absence of a consensus transcription factor-binding motif or expression quantitative trait locus, they have used improved methods to characterize a putatively causal SNP to yield insight into inflammatory bowel disease mechanisms. The study was published on April 9, 2020 in the Journal of Crohn's and Colitis.

Image: Histological photomicrograph of a colonic biopsy showing a crypt abscess, a classic finding in ulcerative colitis (Photo courtesy of KGH).






LabMedica International November/2020

Sensitive Separation Device enables Diagnostic analysis of Cancer exosomes

LabMedica International

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novel separation technique that combines isotachophoresis with paperbased lateral flow chromatography was used to isolate and characterize cancer exosomes and exosome biomarkers in serum samples. Exosomes derived from cancer cells/tissues have great potential for early cancer diagnostic use, but their clinical potential has not been fully explored because of a lack of cost-effective multiplex approaches capable of effectively isolating and identifying specific exosome populations and analyzing their content biomarkers. Exosomes are cell-derived vesicles that are present in many and perhaps all biological fluids, including blood, urine, and cultured medium of cell cultures. The reported diameter of exosomes is between 30 and 100 nanometers, which is larger than low-density lipoproteins but much smaller than red blood cells. Exosomes, which contain RNA, proteins, lipids, and metabolites that are reflective of the cell type of origin, are either released from the cell when multivesicular bodies (MVBs) fuse with the plasma membrane, or they are released directly from the plasma membrane. Exosomes have specialized functions and play a key role in coagulation, intercellular signaling, and waste management. Investigators at Washington State University (Pullman, USA; www.wsu.edu) sought to


overcome the technical barriers hindering the diagnostic applications of cancer exosomes by developing a paper-based isotachophoresis (ITP) technology capable of 1) rapid isolation and identification of exosomes from both malignant and healthy cells and 2) multiplex detection of selected exosomal protein biomarkers of the target exosomes. While generally not achieving the resolution of other forms of electrophoresis, ITP has been successfully employed for difficult samples, such as very small peptides, not amenable to traditional techniques. ITP has also shown great promise for the analysis of complex mixtures of molecules of different classes. Although, technically, isotachophoresis separates samples by electrophoretic mobility, the layers of sample molecules move at the same speed. The novel technology described in the current study combined the focusing power of ITP with the multiplex capability of paper-based lateral flow to achieve on-board separation of target exosomes from large extracellular vesicles, followed by electrokinetic enrichment of the targets. This created an ultrasensitive platform for comprehensive exosome analysis. For a proof of concept, the technology platform was tested with human serum samples spiked with exosomes derived from healthy human serum and a prostate cancer cell line. Results revealed that under anionic ITP conditions, the device showed superior performance

in simultaneous detection of the cancer exosomes and normal exosomes with an observed limit of detection more than 30-fold better than that of enhanced ELISA. In a subsequent step, the technology was shown to be capable of the rapid profiling of a selected protein biomarker panel associated with the target exosomes. "This has the potential to become a technique capable of concentrating samples by orders of magnitude in minutes," said senior author Dr Wenji Dong, associate professor of chemical engineering and bioengineering at Washington State University. "Exosomes provide a unique opportunity as a cancer marker." The exosome concentration device was described in the May 15, 2020, online edition of the journal Biosensors and Bioelectronics. Image: Image of the paper-based isotachophoresis (ITP) device that isolates, enriches, and detects exosomes from a prostate cancer cell line (Photo courtesy of Washington State University)

Cord Blood Transplants May Outperform Matched Sibling Donors

hen a cancer patient needs a bone marrow transplant, there are four common donor sources: A matched related donor (sibling), a matched unrelated donor (from a donor database), a half-matched


donor, or umbilical cord blood. There are advantages and disadvantages to each approach, but consensus has generally ranked a matched sibling first, followed by a matched unrelated donor, with cord blood and

half-matched donors reserved for patients without either of the first two options. Hematologists at the University of Colorado Anschutz Medical Campus (Aurora, CO, USA; www.cuanschutz.edu) compared outcomes among adult matched related donor (MRD) patients undergoing peripheral blood stem cell transplantation and adult patients undergoing double unit cord blood transplantation (CBT), between 2010 and 2017. A total of 190 CBT patients were compared with 123 MRD patients. Median follow-up was 896 days (range, 169-3,350) among surviving CBT patients and 1,262 days (range, 249-3,327) among surviving MRD patients. For MRD donors, median infused cells were 6.07 Ă&#x2014; 106 CD34/kg (range, 2.99-9.66). The scientists reported that in the comparison of 190 patients receiving cord-blood transplants with 123 patients receiving transplants from the "gold standard" of matched sibling donors showed no difference in survival outcomes between these two approaches, with significantly fewer complications due to chronic graft-versus-host disease in patients receiving transplants from cord blood. In addition to showing a decrease in the chance of Contâ&#x20AC;&#x2122;d on page 45

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LabMedica International


acetylated Tubulin Is a Biomarker for Severe Depression

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recent study suggested that the structural protein tubulin could serve as a novel diagnostic biomarker for severe depression. The molecular mechanisms involved in the development of depression, which in its severest form may lead to suicide, are only poorly understood. It is known that post-translational modifications of the structural protein tubulin alter microtubule dynamics and play a role in mood disorders. Furthermore, tubulin interacts closely with G-alpha-s, the G-protein responsible for activation of adenylyl cyclase. This enzyme catalyzes the production of cAMP, a molecule necessary for quick messaging in the brain. Investigators at the University of Illinois at Chicago (USA; www.uic.edu) examined the amount of modified (acetylated) tubulin present in the brains from people who were not depressed as well as those from people with depression who died by suicide or by other causes. For this study, the investigators evaluated

tubulin acetylation in whole tissue homogenates and in plasma-membrane and lipidraft membrane domains in tissue from normal control (NC) subjects, depressed suicides, and depressed non-suicides (human males/females). Lipid rafts are areas within the plasma membranes of cells, which contain combinations of glycosphingolipids, cholesterol, and protein receptors organized into glycolipoprotein lipid microdomains. Results sited in the current study tissue indicated that tissue homogenates showed no changes in tubulin acetylation between controls, depressed suicides, and depressed non-suicides. However, plasma-membrane associated tubulin showed significant decreases in acetylation from depressed-suicides and depressednon-suicides compared to controls. No change was seen in expression of the enzymes responsible for tubulin acetylation or de-acetylation. The investigators said that these results suggested that during depression, tubulin localized in the membrane maintained a lower acetyla-

-cell acute lymphoblastic leukemia (BALL) is characterized by the accumulation of abnormal immature B-cell precursors (BCP) in the bone marrow (BM) and is the most common pediatric cancer. Among the different subtypes known in BALL, the most common one is characterized by the presence of a higher number of chromosomes than in healthy cells and is called High hyperdiploid B-ALL (HyperD-ALL). This genetic abnormality is an initiating oncogenic event affiliated to childhood B-ALL, and it remains poorly characterized. A large team of hematologists at the Josep

Carreras Leukaemia Research Institute (Barcelona, Spain; www.carrerasresearch. org) and their colleagues used 54 primary pediatric B-ALL samples to characterize the cellular-molecular mechanisms underlying the mitotic/chromosome defects predicated to be early pathogenic contributors in HyperDALL. The team reported that HyperD-ALL blasts are low proliferative and show a delay in early mitosis at prometaphase, associated to chromosome alignment defects at the metaphase plate leading to robust chromosome segregation defects and non-modal

tion state, permitting increased sequestration of G-alpha-s in lipid-raft domains, where it was less likely to couple to adenylyl cyclase for cAMP production. Imaging studies have shown that depressed individuals have less cAMP in their brains, which is remedied by successful treatment. The study was published in the April 13, 2020, online edition of the Journal of Neuroscience. Image: Representation of the molecular structure of tubulin protein (Photo courtesy of Wikimedia Commons)

Physiological Mechanisms Underlying Prevalent Pediatric leukemia Discovered



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karyotypes. The main proteins and processes leading to fatal error were a malfunctioning of the condensin complex, a multiprotein complex responsible for helping condense the genetic material correctly into chromosomes. The protein Aurora B kinase (AURKB), that is responsible for a correct chromosome attachment to the spindle poles, thus ensuring proper chromosome segregation; and the mitotic checkpoint, or Spindle Assembly Checkpoint (SAC), the cell machinery involved in controlling that chromosomes are correctly separated to each pole of the cell that is dividing. Ă&#x201C;scar Molina, PhD, the first author of the study, said, â&#x20AC;&#x153;We knew already that HyperDALL arises in a BCP in utero. However, the causal molecular mechanisms of hyperdiploidy in BCPs remained elusive. As faithful chromosome segregation is essential for maintaining the genomic integrity of cells, and deficient chromosome segregation leads to aneuploidy and cancer, we wanted to observe and deepen on what is happening in chromosomes' segregation in HyperD-ALL, because we suspected that by studying cell division in these cells we would find an explanation to this oncogenic process.â&#x20AC;? The authors concluded that chromosome structure/condensation defects and hyperdiploidy were reproduced in healthy CD34+ stem/progenitor cells upon inhibition of AURKB and/or SAC. Collectively, hyperdiploid B-ALL is associated to defective condensin complex, AURKB and SAC. The study was published on April 22, 2020 in the journal Blood. LabMedica International November/2020


Urine Testing Method Developed for Ureterolithiasis

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LabMedica International


reterolithiasis (nephrolithiasis or kidney stones) is a disease affecting the urinary tract. Kidney stones occur due to buildup of certain salts and minerals that form crystals, which in turn stick together and enlarge to form a hard mass in the kidneys. The stones move into the urinary tract and can cause blood in the urine, considerable pain and blockages in the urinary system. Metabolic testing of a kidney stone patient’s urine to identify metabolites such as minerals and solutes that cause stones to form is key for preventing future ones. This testing is currently done by requiring the patient to collect their urine over a 24-hour period in a large container. The container is then sent to a laboratory for analysis and the results normally come back in 7 to 10 days. Scientists from the Pennsylvania State University (University Park, PA, USA; www.psu.edu) and their colleagues developed SLIPS-LAB (Slippery Liquid-Infused Porous Surface Laboratory), a droplet-based bioanalysis system, for rapid measurement of urinary stone–associated analytes. The ultra-repellent and antifouling properties of SLIPS, which is a biologically inspired surface technology, allow autonomous liquid handling and manipulation of physiological samples without complicated sample preparation procedures and supporting equipment. The team used enzymatic and colorimetric assay kits to measure metabolic profiles in urine. The uric acid assay was obtained from BioAssay Systems (Hayward CA, USA; www.bioassaysys. com). Calibration experiments were performed using SLIPS-LAB and a FlexStation 3 microplate reader (Molecular Devices, San Jose, CA, USA; www.moleculardevices.com). The performance of SLIPS-LAB for a spot urine test was compared with manual procedures in 96-well plates. A validation study was performed using SLIPS-LAB for detecting urine samples from patients with urinary stones. The six-plex SLIPS-LAB device was designed for metabolic evaluation of urinary stone disease. The device conducts colorimetric and enzymatic assays in parallel for detecting calcium, citrate, uric acid, oxalate, and pH, which are among the most clinically relevant urinary analytes to assess stone risk and treatment response. The urinary stone–associated analytes of 24-hour urine samples from 15 individuals were examined using SLIPS-LAB. To study the metabolic profiles, the data were normalized to typical physiological values of 24-hour urine. The test results can then be read using a scanner or a cell phone, and the scanned image can then be analyzed using a computer algorithm. All these steps, according to the authors, would take approximately 30 minutes in a physician’s office. An added benefit, they said, is that SLIPS-LAB is more cost-effective than regular, 24-hour testing. Pak Kin Wong, PhD, professor of biomedical engineering and the principal investigator of the study, said, “We demonstrated that SLIPS-LAB enables the reagent and sample to move themselves and perform the reactions for us. It means the technology doesn’t require a technician to run any test machinery, so it is possible to do the test in non-traditional settings, like a physician’s office or even the patient’s home.” The authors concluded that SLIPS-LAB will allow detection in a timely and cost-efficient manner and provide actionable diagnostic information and personalized treatment suggestions to individuals with urinary stone disease. The study was published on May 22, 2020 in the journal Science Advances. Image: FlexStation 3 Microplate Reader measures absorbance, fluorescence intensity, fluorescence polarization, luminescence, and time-resolved fluorescence (Photo courtesy of Molecular Devices).


LabMedica International November/2020



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Increasingly efficient Serological Tests Developed with electrochemiluminescence

LabMedica International


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iagnostic markers, or biomarkers, are biomolecules (e.g., enzymes, proteins, peptides, and hormones) that can be measured accurately and reproducibly and can precisely predict relevant clinical outcomes or diseases in various populations. In fact, biomarkers represent a powerful aid in clinical diagnostic and therapeutic monitoring. Therefore, detection, identification, and quantification of such molecules can translate into the development of sophisticated methods and instrumentations for analyzing clinically useful biomarkers. Medical Chemists at the University of Bologna (Bologna, Italy; www.unibo.it) and their colleagues discovered an unexpected but

highly efficient mechanistic path for electrochemiluminescence (ECL) generation close to the electrode surface (signal enhancement, 128%) using an innovative combination of ECL imaging techniques and electrochemical mapping of radical generation. The team used through the combination of ECL and microscopy and the use of labeled microbeads, they mapped ECL generation close to the electrode surface (≤1 µm), thus revealing the contribution of an additional pathway to ECL generation, which was unobserved to date. This additional mechanism exhibits a very high efficiency, i.e., 10 times more intense than the signals measured at larger distances (>1 µm). The scientists identified a family of alternative coreactants/additives, namely branched amines, which may lead to an advantageous overall signal enhancement. In particular, the use of N-dipropyl isobutyl amine (DPIBA) enhances the ECL signal by a maximum of 47% in a commercial immunoassay system for the quantification of several biomarkers, such as thyroid stimulating hormone (TSH), cardiac troponin T, ferritin, and immunoglobulin (Ig)M antibodies against Toxoplasma gondii (Toxo IgM) and hepatitis A (A-HAV IgM). A series of commercially



lMI-11-20 140

available Elecsys assays (Roche Diagnostics, Indianapolis, IN, www.diagnostics.roche.com) for the detection of those specific biomarkers was used on a Roche cobas e 801 immunoassay analyzer to evaluate the effect of DPIBA on the assay performance. Alessandra Zanut, PhD, a Physical Chemist and first author of the study, said, “From these results, we managed to identify highly efficient reactants that are able to enhance the sensitivity of this technique way beyond that currently employed for serological tests. With this technique, we obtained an ECL signal enhancement up to 128% compared to current techniques.” The study was published on May 29, 2020 in the journal Nature Communications. Image: Schematic representation of the remote electrochemiluminescence (ECL) mechanism (Photo courtesy of University of Bologna).

Two Serodiagnostic Tests Compared for loiasis in Non-endemic area

oiasis, the disease caused by the infection with the filarial nematode Loa loa, is transmitted through the bite of tabanid flies of the genus Chrysops. It is endemic in Central and West Africa where, according to the most recent estimates, about 10 million people are infected. There is a scarcity of convenient, commercial diagnostics for L. loa. Microscopy requires trained personnel and has low sensitivity, while the serodiagnosis is currently not standardized. Individual case management is also important in non-endemic countries to treat migrants, expatriates and tourists. Scientists at the Sacro Cuore Don Calabria Hospital (Verona, Italy; www.sacrocuore.it) retrospectively compared the performance of an Antibody Rapid Test (RDT) and a commercial ELISA pan-filarial test on 170 patients, 65 with loiasis [8 with eyeworm, 29 with positive microfilaremia, 28 with neither microfilaremia nor history of eyeworm but eosinophilia and history of Calabar swelling (probable loiasis)], 95 with other common parasitic infections and no previous exposure to L. loa (37 with M. perstans, one with Brugia sp., 18 with strongyloidiasis, 20 with schistosomiasis, five with hookworm, four with Ascaris lumbricoides infection, 10 with hyper-reactive malarial splenomegaly), and 10 uninfected controls. The Loa Antibody Rapid Test (RDT, Drugs & Diagnostics for Tropical Diseases, San Diego, CA, USA; www.ddtd.org) detects human IgG against a 148-aminoacid sequence of Ll-SXP-1, a protein

with 51–53% sequence identity with Wuchereria bancrofti and Onchocerca volvulus, the two most clinically relevant filarial species. The commercial ELISA kit uses Acanthocheilonema viteae antigens (Bordier Affinity Products, Crissier, Switzerland; www.bordier.ch) and this test is not specific for single filarial species, and detects IgG against various filarial nematodes affecting humans. The investigators reported that the sensitivity of the RDT and of the ELISA were 93.8% (61/65) and 90.8% (59/65), respectively. For the RDT, most of the cross-reactions were observed in patients with M. perstans: 7/37 (18.9%), followed by 1/10 (10%) with hyper-reactive malarial splenomegaly and 1/20 (5%) with schistosomiasis. None of the 27 subjects infected with intestinal nematodes was found positive with this test. The ELISA is meant to be a pan-filarial assay, and reacted extensively with cases of M. perstans (95%), as expected, and also in 11/18 (61.1%) patients with strongyloidiasis and in 3/5 (60%) with hookworm infection. The authors concluded that the novel lateral flow RDT has proven to be an accurate and userfriendly tool for the diagnosis of L. loa infection. While some cross-reactivity with M. perstans should be taken into account when considering its potential application as a screening tool in endemic areas, on the other hand this new test appears to be promising in the of non-endemic setting, where it could be included in a management algorithm. The study was published on May 26, 2020 in the journal PLOS Neglected Tropical Diseases. LabMedica International November/2020


Edited by Katherina Psarra MSc, PhD IFCC members may send news to: Prof. Katherina Psarra IFCC Office, Via C. Farini 81 20159 Milano, Italy. E-mail: enews@ifcc.org


Update from the IFCC Committee on Point-of-Care Testing By Dr Adil I. Khan, Chair, IFCC Committee on Point-of-Care Testing (C-POCT)

020 started like any other year – flurries of e-mails discussing plans for upcoming conferences and future ones. In the background however, a viral outbreak was unfolding that would become the COVID-19 pandemic and change how we socially interact both at scientific and non-scientific levels. The first IFCC victim was the World Lab Congress planned to be held in May 2020 and the associated venues including the Point-of-Care Testing Satellite Meeting.The main World Lab meeting and POCT Satellite Meeting in Seoul has now been postponed to June 26-30th May 2022.The POCT Satellite Meeting had been organized such that in addition to an array of interesting and relevant topics, there would also be an industry session where vendors would talk about their latest POC instrumentation. We had obtained good industry support and it is hoped that we will be able to muster this support again in June 2022. Due to the POCT explosion not only in hospitals but in out-of-hospital settings the Committee on Mobile Health and Bioengineering in Laboratory Medicine (Emerging Technology Division), the Committee on Point-of-Care Testing, (Education and Management Division), and the Critical and Point-of-Care Testing Division (American Association of Clinical Chemistry) have partnered and put together a program (“POCT: Making the Point”) to be held at the University of Tor Vergata, in Rome, Italy for March 15-16, 2021. COVID-19 caused this to be moved to August/September of 2021 and most likely it will be a hybrid meeting with inperson and virtual meetings format. On other fronts, the C-POCT members have been active in writing articles related to POCT for Practical Laboratory Medicine (Guest Editor, Dr. Julie Shaw) and Archives of Pathology and Laboratory Medicine (Guest Editor Dr. Adil Khan) in addition to finalizing a position paper on POCT in settings outside the hospital. As technology improves, POC testing is becoming more prevalent in environments outside the hospital. This position paper will address responsibilities of vendors as well as laboratories in guiding healthcare workers as well as the consumer as they use POCT instruments to test for and monitor disease. It has been a very challenging year not only for healthcare workers but for everyone since COVID-19 directly impinges on our social interactions. However, humankind’s innate motivation to adapt to challenges and move forward has allowed us to use more extensively and creatively video conferencing technology that already existed, but was associated with a certain inertia to use it profusely. This pandemic has pushed us “over the brink” as it were to, and heralded an era where improved virtual meetings or hybrid in-person /virtual meetings is allowing a greater audience to reach and is pushing forward the IFCC goals of best laboratory practices and knowledge of laboratory medicine and instrumentation.



LabMedica International November/2020

Adil I. Khan, MSc, PhD, is an Associate Professor of Pathology at the Lewis Katz School of Medicine, Temple University, in Philadelphia and the Director for Point-of-Care Testing and Clinical Chemistry for the Temple University Health System. He is also the Chair of the IFCC Committee on Point-of-Care Testing.


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


By Katherina Psarra, MSc, PhD

Dear colleagues, hope you are all well. Cold winter has arrived in many countries making people to stay indoors, making it harder to meet friends and relatives in the middle of the “second wave” of the epidemic. I have seen beautiful photos of yellow and red leaves from all over the world and perhaps, as I said before, “lonely” walks in the woods or by the rough sea may be the solution.Well, I am looking forward to the time when my editorial won’t begin with a phrase about COVID-19...


News from the IFCC Committee for Evidence-Based Laboratory Medicine (C-EBLM)

he IFCC C-EBLM submitted an application to present a symposium at the 2020 Joint Conference of the Canadian College of Medical Geneticists (CCMG) and the Canadian Society of Clinical Chemists (CSCC) which was due to be held in Winnipeg, Canada in June 2020. This was accepted and they were due to present on 20 June 2020. However, because of global travel restrictions, the conference was cancelled. Instead, the session was presented online on 30 July 2020. The following talks were presented: 1. Application of EBLM in the Age of Pre-



In this issue our president Prof Khosrow Adeli is presenting the complete IFCC educational program about laboratories and COVID-19. Let us all register and participate in the IFCC Global Conference on COVID-19 Diagnostic Testing on February 15-17, 2021. In his interesting and moving article about the COVID-19 toll on the elderly Dr Bernard Gouget stresses the need for “solidarity and protection” and talks about the ethics concerning this unprecedented situation. IFCC committees for Evidence-based Laboratory Medicine and on Point-of care Testing present their recent work in this issue. Better times will come, and we will all meet in committees, in working groups, in conferences. Till then, stay healthy and keep solidarity in mind!

cision Medicine – Annalise Zemlin (chair IFCC C-EBLM) 2. Guidelines Implementation – Andrew Don-Wauchope (member C-EBLM) 3. Evidence for implementing point of care testing – Karina Rodriguez-Capote (member C-EBLM) 4. Stopping tests and starting new test: Application of EBLM – Seema Bhargava (member C-EBLM) 5. Appropriate Stewardship in the Laboratory; Cut Out the Noise and Bring on Reflective Testing – Manal Elnenaei (CSCC member topic submitted as a roundtable discussion)

These talks were well received by over 100 on-line participants and led to interesting discussion. The questions were addressed and written up for the CSCC October newsletter. Hopefully, there will be future collaboration and face to face meetings between the C-EBLM and CSCC / CCMG.

By Prof Annalise E Zemlin, Chair, IFCC Committee on Evidence-Based Laboratory Medicine (C-EBLM); Chemical Pathology, Faculty of Medicine and Health Sciences, Stellenbosch University and NHLS Tygerberg Hospital, Cape Town - South Africa


Education at the Times of Pandemic: The Malawi Association of Medical Laboratory Scientists (MAMLS) Recipe By: Elias Chipofya IFCC National Representative for MAMLS

aboratory Medicine professionals in Africa have acknowledged even prior to the pandemic that increased access to online meetings is necessary to bring down costs as well as keeping members in touch. Prof. Tahir Pillay from the Department of Chemical Pathology at the University of Pre-

toria reported that he has been using Zoom for a number of years in his department in IFCC e-news of September 2020. COVID19 accelerated the need of online meetings and during the lockdown, the South African Association for Clinical Biochemistry and Laboratory Medicine (SAACB) adopted on-

line meetings to manage professional activities as well as supporting each other through this difficult times. The lesson from SAACB’S experience of Zoom is Zoom’s crucial importance as far as online meetings are concerned in Africa. Malawi Association of Medical Laboratory Scientists (MAMLS) adopted Zoom meetings by launching leadership seminar series. Our first seminar was on 9th September 2020 and Dr. Graham Beastall (UK) presented a talk on “leadership for changing world of laboratory medicine”. In our recent seminar, we hosted Prof. Rajiv Erasmus (South Africa) and Dr. Ashlin Rampul, a member of the IFCC Young Scientist Task Force. We extended our invitation to the undergraduate students, postgraduate students and young scientists from South Africa. A total of 50 participated in the session. Prof Erasmus spoke on “Ethical leadership” and Dr. Rampul introduced the IFCC Young Scientist programme and made a presentation on “Conducting research as a young scientist”. Both programmes were well received and MAMLS plans further zoom seminars. We are grateful to the speakers for their time and the fascinating topics they presented. MAMLS Website: www.mamls.mw LabMedica International November/2020


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


irstly, I would like to say that I hope you, your family and your friends are safe and well during these tough times. The IFCC Executive Board is aware of the many challenges faced by laboratory professional across the globe and has been activity supporting the membership. Despite the pandemic, the IFCC organization has been very busy deProf. Khosrow Adeli, PhD, veloping new programs to enFCACB, DABCC, FAACC sure continued progress on a number of fronts, including development of guidelines on laboratory management of COVID-19, a new live webinar series to provide e-learning opportunities to members and non-members around the world, as well as new programs in Global Newborn Screening and Global Laboratory Quality. An important new development is the new IFCC Global Conference on COVID-19 Diagnostic Testing on February 15-17, 2021. The conference will bring together scientific and industry leaders from around the world to present on the latest advances in COVID-19 diagnostics as well as public health authorities and medical experts to present on rapidly growing list of therapeutics and vaccines. The preliminary program was announced a few weeks ago and the online sites for registration and abstract submission will be open in a few days. I would like to invite you all to consider registering for this conference and participating in this important virtual congress. We have kept the cost very low for all regular attendees from academia or industry and have arranged for free registration for all young scientists and trainees under 40 years of age. Symposium and workshop proposals are welcome from regional federations, national societies, and corporate members. I am also pleased to remind you of the recently published IFCC Testing Guidelines on Covid-19: Four guideline documents have been developed by the IFCC Taskforce and have been published in a recent special issue of Clinical Chemistry and Laboratory Medicine (CCLM). Here are PUBMED links to all four publications:

IFCC live Webinar Series: Fall 2020

Value and Impact of laboratory Medicine in Patient Care: Developing the evidence – Nov. 25, 2020 Presentations will include: • Critical role of the clinical laboratory in healthcare delivery: What is the Evidence? • The Essential Need for New Retrospective and Prospective Outcome Studies • A New IFCC Strategy to Develop the Evidence in Key Areas of Clinical Medicine Details for this webinar will be available in due time. IFCC Webinars on: • COVID-19 Guidelines on Molecular, Serological and Biochemical/Hematological Testing,


LabMedica International November/2020

was broadcast on 23rd September 2020; On Demand content is available by clicking on this link. • Advancing Internal and External Quality Assurance on Global Scale available on-demand was broadcast on 15th October 2020; On Demand content is available by clicking on this link. • Expanding Newborn Screening Globally: Reducing Infant Mortality Through Early Diagnosis was held on 4th November 2020; On Demand content will be soon available. Registrants will be informed via email.



By khosrow adeli

President, IFCC

Editorial and Executive Summary: https://pubmed.ncbi.nlm.nih.gov/33027045/ IFCC Guidelines on Molecular Testing of SARS-CoV-2 Infection: https://pubmed.ncbi.nlm.nih.gov/33027042/ IFCC Guidelines on Serological Testing of Antibodies against SARS-CoV-2 Infection: https://pubmed.ncbi.nlm.nih.gov/33027043/ IFCC Guidelines on Biochemical & Hematological Monitoring of COVID-19 patients: https://pubmed.ncbi.nlm.nih.gov/33027044/ These guidelines provide practical recommendations on the intended use, selection, evaluation and implementation of laboratory tests used in the diagnosis of SARS-CoV-2 infection and management of COVID-19. Links to these new testing guidelines have also been added to the IFCC websites. I hope you all benefit from these new evidence-based guidelines. I am also hoping all of you register to participate in the Global conference on Covid-19 being organized by IFCC in February and contribute to a very successful and well-attended virtual event. Feel free to email me at: president@ifcc.org with your feedback, questions, or concerns.

• •

Till next time ☺ Khosrow



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

lockdown 2.0 and Curfew: Unspoken Toll on the elderly

by Dr. Bernard Gouget


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

OVID-19 sheds a harsh light on global demographic reality. According to the United Nations report "World Population Ageing 2019", the worldwide population included 703 million people age 65 and above in 2019. This number should reach 1.5 billion in 2050. This section of the population has grown from 6% of the total in 1990 to 9% in 2019 and should reach 16% in thirty years, or one out of every six people. There’s something strange about this coronavirus pandemic. Even after months of extensive research by the global scientific community, many questions remain open. We heard many explanations for the widely differing spread trajectories over the past nine months—weather, prior immunity, herd immunity, and elderly populations—but none of them explains the timing of the widespread rises and how to control this pathogenic virus. The coronavirus also infects young people, but from the first signs of the epidemic, the population in the crosshairs as the most vulnerable remains those aged 65 and over. They are the ones who most often succumb to the epidemic, who make up the most severe cases and who increase the cohort of ICU patients and drive the rising gruesome death toll. The mortality curves are explicit. The majority of affected countries emphasize senior fragility. In France, treating seniors differently was even considered, envisaging targeted confinement, a discrimination that was quickly dropped in the face of general outcry. This senior fragility vis-à-vis COVID-19 means that they will be at greater risk of contracting the coronavirus than other population categories. The older people or those with preexisting comorbidities are far more likely to have severe complications or die from the disease. It is important to highlight the important role of demography. This science of population may help to understand how the age structure of a population explain differences in fatality rates across countries and how transmission unfolds in populations with similar population sizes but different age structures, showing a dramatically higher burden of mortality in countries with older versus younger populations. The powerful interaction of demography and current age-specific mortality for COVID-19 suggests that policies to slow transmission should consider the age composition of local and national contexts as well as the estimated extent of human-to-human contact, intergenerational interactions and the level of restriction to which each country was subjected, factors that influence R0. Also, It is essential for countries to provide case and fatality data disaggregated by age and sex to determine age group susceptibility more definitively, but above all to improve real-time targeted forecasting of hospitalization and critical care needs. Cultural and institutional reasons may explain the deviation in fatality rate between countries . South Korea for example has been practicing sustained vigilance-with massive testing , tracing, and isolating regime. The country whose population is aging, has recorded in the beginning fewer deaths in this section of society. One hypothesis would be that in those above age 75, South Korea has a recorded rate of seasonal flu vaccination close to 75%, a rate nearly identical in Germany and England, while in France, this rate drops to 48%. If such flu vaccination coverage could partially explain lower mortality, this would mean that immune systems spared by the flu can therefore resist coronavirus a little better. This is encouraging in these times of COVID-19 for influenza vaccination awareness campaigns: “Protected together, Vaccines works!”


Via Carlo Farini 81, 20159 Milan, ITALY Tel: (39) 02-6680-9912 • E-mail: ifcc@ifcc.org • Web: www.ifcc.org Office Hours: 8.30-13.00 and 13.30-17.30 Staff Members: Paola Bramati, Silvia Cardinale, Silvia Colli-Lanzi

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.

The diseases that increase mortality rates in COVID-19 patients are precisely those diseases that are common in seniors such as cardiovascular disease, diabetes, chronic respiratory disease, hypertension and cancer. Moreover, the body's immune response changes with age. The lungs, the primary organs affected by coronavirus, are less flexible and resistant at advanced age. To understand why and to identify biomarkers to predict which patients with chronic disease will progress to a severe form of COVID-19 requiring ICU care is therefore a research priority to better manage these patients and increase their chances of survival. Today, more than ever, Laboratory medicine specialists are organizing and coordinating to address mass screening. Testing is a non-optional problem. Tests permit us to do the most basic task in disease control: Identify the sick, and separate them from the well. When tests are abundant, they can dispel the fear of contagion. The only thing that makes a difference in public health is testing. PCR tests identify RNA segments of the coronavirus in samples from nasal swabs—like looking for its signature. Such diagnostic tests are measured on two different dimensions: Are they good at identifying people who are not infected (specificity), and are they good at identifying people who are infected (sensitivity)? PCR tests are highly accurate for both dimensions. However, PCR tests are also slow and expensive, and they require a long, uncomfortable swab up the nose at a "medical" facility. The slow processing times means that people don’t get timely information when they need it. Testing strategies with the new generation of antigen tests are becoming more agile. These antigen tests work by detecting a coronavirus protein via an antigen-antibody action. Their use, according to Prof. Bruno Lina, international center for infectiology research-Lyon (FR) , is not superposable with RT-PCR testing. They are much faster, but with a decreased sensitivity. They are read on a strip that contains two bands of antibodies: one which serves as the control with ubiquitous antibodies and the second with antibodies (Ab) directed against the coronavirus protein; if the proteins are carried along by migration on the strip, there is a color reaction to detect the viral protein. Elder care facilities in France are once again in the spotlight, with the appearance of new clusters and a rapid increase in the number of positive cases since the beginning of fall, combined with a resumption of mortality. Antigen testing may be useful to perform triage in patients in elder care facilities in situations at high risk of positivity or can be used, for example, in longitudinal surveillance when populations must be monitored regularly, such as athletes or caregivers, with RT-PCR testing remaining necessary for confirmation. To the extent that infections are increasing again along with fears of health crises, new coronavirus restrictions such as curfew have been introduced in several countries. This does not happen without some confusion and isolation in the elderly is an issue to be addressed with a great deal of care and respect. Binding, connecting, bonding and relating are all variations that should be preserved to form a human community animated by a sense of common responsibility, faced with the challenges of the disease. How can we ignore the fact that only networks of new solidarities will allow society to withstand the shock and resist entropy, this force of disintegration? The forces of disconnection exist and they are not negligible but they are not irresolvable either. It is up to us to oppose them with a willingness to work for the unity of society and, more broadly, the unity of the one human family that we form. The ability to connect and share appears to be the condition of our future. Shock videos in France, Spain and the Canary Islands have been and are being broadcast to educate the population about preventative measures. The videos show various events of daily life, at the office, at school or at home, where the protagonists do not consistently apply preventative measures and in which a family birthday turns to drama. However, there is some concern about these messages, which force us to be accountable through the reasonable and reasoned fear of being contaminated and of causing contamination. This fear certainly encourages mask-wearing and preventative measures, but also leads to making family members feel guilt about putting the elderly in mortal danger. This is a prevention message certainly, but also a direct intrusion into everyone's most private life. Catherine Ollivet of France Alzheimer and president of the center for ethical reflection, emphasized in a recent forum that it is no longer a particular event bringing together various, and perhaps too many, family members and friends, but indeed intrusion into simple everyday life. A single message, she writes, pervades people's minds today: love kills, family kills, human and emotional bond kills, friendship kills. It is therefore appropriate from now on to stop loving, to refrain from loving, since its obvious corollaries. Seeing, touching, smiling can make you guilty of killing. Preventative measures to "protect" residents in senior care facilities from their loved ones have never been greater, and there are good arguments for making the Cont’d on page 45 LabMedica International November/2020



LabMedica International

Presenilin1 Gene Characteristics Used as alzheimer's Disease Biomarker To view this issue in interactive digital magazine format visit www.LinkXpress.com

lzheimer's Disease manifests as a familial disease with monogenic inheritance and early onset (Early Onset AD: EOAD), or as a sporadic, multifactorial, late-onset disease (Late Onset AD: LOAD). The latter accounts for more than 90% of all cases and its causes are unknown. The Presenilin1 (PSEN1) gene encodes the catalytic peptide of the γ-secretase complex, a key enzyme that cleaves the amyloid-β protein precursor (AβPP), to generate the amyloid-β (Aβ) peptides, involved in Alzheimer’s Disease (AD). Other substrates of the γ-secretase, such as E-cadherin and Notch1, are involved in neurodevelopment and hematopoiesis. A team of international scientists working with the Sapienza University of Rome (Rome, Italy; www.uniroma1.it) analyzed patterns of DNA modification that affect the expression of the PSEN1 gene during brain development and during the progression of Alzheimer's in mice. They checked the results in humans by analyzing post-mortem human brain tissue from Alzheimer's patients and from prenatal and

postnatal babies and adolescents. To see whether changes to DNA methylation could be detected in human blood, they analyzed blood samples from 20 patients with late-onset Alzheimer's disease, comparing the results to 20 healthy controls. Assessment of CpG and non-CpG DNA methylation was performed by bisulphite DNA modification and genomic sequencing using nonCpG Methylation-Insensitive Primers (MIPs), previously described (HSPS1BisF1 and HSPS1BisR1 for the human DNA, MMPS1BisF1). Sequencing reactions of purified plasmid DNA were performed by the cycle sequencing method using the ABI PRISM 3130xl genetic analyzer (Applied Biosystems, Foster City, CA, USA; www.ther mofisher.com). Total RNA was extracted using the QIAGEN RNeasy Lipid Tissue mini kit and the QIAcube Connect instrument (QIAGEN, Hilden, Germany; www.qiagen.com). The results from post-mortem human brain tissue found upregulation of the PSEN1 gene in Alzheimer's patients. In both sexes, there was a significant inverse relationship between the extent of gene expression and DNA methylation.

The analysis of blood samples was able to detect lower PSEN1-related DNA methylation in Alzheimer's patients compared to controls. The difference was significant, although not as large as in brain samples. As lower methylation was detectable in the blood, and is associated with higher expression of PSEN1, it could offer a new way to diagnose Alzheimer's early, and less invasively, than sampling brain tissue. Andrea Fuso, PhD an assistant professor and senior author of the study, said, “We've detected an early sign of the disease in a DNA modification, or epigenetic marker, that was previously overlooked, and that could even provide a starting point for developing new therapies, as well as earlier diagnosis. Our results offer an exciting new area of investigation, deploying the methods we used to study DNA methylation so that modifications won't be missed. If found to be causal, our findings would provide a starting point for developing epigenetic therapies.” The study was published on February 5, 2020 in the journal Epigenetics.

Cord Blood Transplants May Outperform Matched Sibling Donors

Cont’d from page 36

graft-versus-host disease, which develops when a transplanted blood system attacks a patient's tissues, the study shows a slightly lower rate of relapse in these patients undergoing transplant with cord blood. Jonathan A. Gutman, MD, CU Cancer Center investigator and director of the allogeneic stem cell transplantation program and senior author of the study, said, “It turns out that for adults, it's very hard to find a single cord

lockdown 2.0 and Curfew: Unspoken Toll on the elderly

Cont’d from page 44 conditions for a normal relationship with their family difficult, if not impossible, to achieve. How many residents can be displaced from their rooms and find themselves disoriented and forced to go into a COVID unit without this leading to further behavioral disturbances and further devastating anxieties and heartache? She reminds us that the AIDS years, more than 30 years ago, have since shed light on so many other ethical paths, relating not only to the duties in professional healthcare practices of humanity and respect for the people treated, but also to these same duties for the whole of society. In a few months of the pandemic spreading as a result of disorderly health communication and rivalries between medical and health specialists, between predictive epidemiologists and politicians, but always under the "all-seeing" eye of cameras magnifying media positions, it seems that these values of humanity and respect have been swallowed up so that we no longer know and recognize distrust of oneself and of others, the fear for oneself and for others. The term “lockdown” has done a lot of damage. It exacerbated the false binary between shutting down and opening up. The pandemic grew huge in scope, entangling every aspect of society, and maxing out our capacity to deal with complexity. The grand challenge now is, how can we adjust our thinking to match the problem before us? We are living unprecedented moments in global society, raising fundamental questions about how we are living as individuals, and collectively. Will an ageing population mean people experience longer periods of good health and wellbeing, or will it be associated with a higher burden of illness and dependence on others? COVID-19 needs to be also understood as a wake-up call to ensure adequate care for the elderly. The principle of solidarity and protection applies which is employed in social health care insurance schemes also applies to the coronavirus pandemic. More emphasis and adequate solutions with a focus on the elderly in these times of pandemic is needed. In the meantime, one of the characteristics, among many others, of this health crisis, will have been to show us under a harsh and cruel light, something that was already evident: “The worst abuse is believing that you are benevolent” (Hannah Arendt,1906-1975, bequeathing us her ethics of thought).


LabMedica International November/2020

blood unit that meets the parameters we know need to be met in terms of size. To overcome this barrier, we often use two units from different sources. We think there are important advantages of cord blood, especially with respect to graft-versus-host disease. Previously, we've taken a position recommending cord blood over matched unrelated donors, and now we show that cord blood may even out-compete the gold standard of matched sibling donors.” The study was published on May 22, 2020 in the journal Blood Advances.

ATTENTION: Due to the CORONAVIRUS PANDEMIC, many events are being rescheduled for a later date, converted into virtual venues, or altogether cancelled. Please check with the event organizer or website prior to planning for any forthcoming event

Events Calendar

For a free listing of your event or a paid advertisement in this section contact:

International Calendar LabMedica International E-mail: info@globetech.net


Analytica China 2020. Nov 16-18; Shanghai, China; Web: www.analyticachina.com

MEDICA 2020. Nov 16-19; Virtual Venue; Web: www.medica-tradefair.com

AMP 2020 – Annual Meeting & Expo of the Association for Molecular Pathology. Nov 16-20; Virtual Venue; Web: amp20.amp.org

Annual General Meeting of the Malaysian Association of Clinical Biochemists (MACB). Nov 26-28; Virtual Venue; Web: www.macb.org.my DECEMBER 2020

6th Annual Conference of the Saudi Society for Clinical Chemistry (SSCC). Dec 1-4; Virtual Venue; Web: sscc.med.sa

62nd Annual Meeting & Exposition of the American Society of Hematology (ASH). Dec 5-8; Virtual Venue; Web: www.hematology.org

32nd Congress of the European Society of Pathology (ESP). Dec 6-8; Virtual Venue; Web: www.espcongress.org

Zdravookhraneniye 2020. Dec 7-11; Moscow, Russia; Web: www.zdravo-expo.ru

JIB 2020 – Journées de l’innovation en biologie.

India; Web: www.medicalfair-india.com

Dec 8-11; Virtual Venue; Web: jib-innovation.com

India Lab Expo & Analytica Anacon India. Dec 911; Virtual Venue; Web: www.analyticaindia.com

MARCH 2021

64th Congress of the German Society for Endocrinology. Mar 3-5; Berlin, Germany; Web: www.endokrinologie.net

36th International Congress of the International Society of Blood Transfusion (ISBT). Dec 12-16; Virtual Venue; Web: isbtweb.org

Pittcon 2021. Mar 6-10; New Orleans, LA, USA; Web: pittcon.org

72nd AACC Annual Scientific Meeting & Clinical Lab Expo – American Association for Clinical Chemistry. Dec 13-17; Virtual Venue; Web: www.aacc.org

USCAP 110th Annual Meeting - United States & Canadian Academy of Pathology. Mar 13-18; Virtual Venue; Web: www.uscap.org

LABWorld China 2020 (CPhI & P-MEC China). Dec 16-18; Shanghai, China; Web: www.pmecchina.com/labworld

KIMES 2021. Mar 18-21; Seoul, Korea; Web: www.kimes.kr

ITCC 2020 – 16th International Thyroid Congress. Dec 16-20; Virtual Venue; Web: www.itc2020.org

Arab Lab 2021. Mar 22-24 Dubai, UAE; Web: www.arablab.com

31st National Biochemistry Congress of the Turkish Biochemical Society. Dec 18-20; Virtual Venue; Web: www.biyokimyakongresi.org

APRIL 2021

India Lab Expo & Analytica Anacon India. Apr 1516; Mumbai, India; Web: www.analyticaindia.com


Fertility 2021 – Joint Conference of the UK Fertility Societies. Jan 6-10; Virtual Venue; Web: fertilityconference.org

EAHP-SH 2021 – 20th Meeting of the European Association for Haematopathology. Apr 24-29; Dubrovnik, Croatia; Web: www.eahp-sh2021.com


ISLH 2021 – International Society of Laboratory Hematology. May 7-9; New Orleans, LA, USA; Web: www.islh.org

MAY 2021

SLAS 2021 – Society of Laboratory Automation and Screening. Jan 25-27; Virtual Venue; Web: www.slas.org

ESPE 2021 – 59th Annual Meeting of the European Society of Paediatric Endocrinology. May 79; Liverpool, UK; Web: www.eurospe.org

IFCC Global Conference: Critical Role of Clinical Laboratories in COVID-19 Pandemic. Feb 15-17; Virtual Venue: Web: www.ifcc.org

ICE 2021 – 19th International Congress of Endocrinology. Feb 24-28; Virtual Venue; Web: icevirtualcongress.com

Immunology 2021 – Annual Meeting of the American Association of Immunologists (AAI). May 12-16; Philadelphia, PA, USA; Web: www.immunology2021.org

Medical Fair India 2021. Feb 25-27; New Delhi,


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ECE 2021 – 23rd European Congress of Endocrinology. May 22-25; Prague, Czech Republic; Web: www.ese-hormones.org

AFCB Congress 2021 – Arab Federation for Clinical Biochemistry and Laboratory Medicine. May 2729; Beirut, Lebanon; Web: www.ifcc.org JUNE 2021

31st Regional Congress of the International Society of Blood Transfusion (ISBT). Jun 6-9; Milan, Italy; Web: isbtweb.org

FOCIS 2021 – Annual Meeting of the Federation of Clinical Immunology Societies. Jun 8-11; Boston, MA, USA; Web: www.focisnet.org

Virtual Pathology Days 2021 – German Society for Pathology. Jun 8-12; Virtual Venue; Web: www.pathologie-dgp.de

26th Annual Congress of the European Hematology Association (EHA). Jun 10-13; Vienna, Austria; Web: ehaweb.org

ESGH 2021 – European Human Genetics Conference. Jun 12-15; Glasgow, UK; Web: www.eshg.org

BIO International Convention 2021 Jun 14-17; Boston, MA, USA; Web: convention.bio.org

47th CBAC – Congress of the Brazilian Society of Clinical Analysis. Jun 20-23; Fortaleza, Brazil; Web: www.sbac.org.br

SLAS Europe 2021 Conference & Exhibition – Society of Laboratory Automation and Screening. Jun 22-25; Vienna, Austria; Web: www.slas.org

81st Scientific Sessions of the American Diabetes Association. Jun 25-29; Washington, DC, USA;

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LabMedica International November/2020

ATTENTION: Due to the CORONAVIRUS PANDEMIC, many events are being rescheduled for a later date, converted into virtual venues, or altogether cancelled. Please check with the event organizer or website prior to planning for any forthcoming event

Web: professional.diabetes.org/scientific-sessions

ESHRE 2021 – 37th Annual Meeting of the European Society of Human Reproduction and Embryology. Jul 27-30; Virtual Venue; Web: www.eshre.eu/ESHRE2021

Medlab Middle East 2021. Jun 28 - July 1; Dubai, UAE; Web: www.medlabme.com JULY 2021

ECCMID 2021 – 31st European Congress of Clinical Microbiology & Infectious Diseases. Jul 9-12; Vienna, Austria; Web: www.eccmid.org

EAACI Hybrid Annual Congress 2021 – European Academy of Allergy and Clinical Immunology. Jul 10-12; Krakow, Poland; Web: www.eaaci.org

FEMS 2021 – 9th Congress of European Microbiologists. Jul 12-14; Virtual Venue; Web: fems2021.org

Analytica Lab Africa 2021. Jul 13-15; Johannesburg, South Africa; Web: www.analyticaafrica.com

IAS 2021 – 11th International AIDS Society (IAS) Conference on HIV Science. Jul 18-21; Berlin, Germany; Web: ias2021.org

ASV 2021 – 40th Annual Meeting of the American Society of Virology. Jul 19-23; Virtual Venue; Web: asv.org/asv2021

73rd AACC Annual Scientific Meeting & Clinical Lab Expo – American Association for Clinical Chemistry. Jul 25-29; Anaheim, CA, USA; Web: www.aacc.org AUGUST 2021

11th African Congress of Immunology – Federation of African Immunological Societies. Aug 1-5; Lilongwe, Malawi; Web: www.faisafrica.com


IFBLS 2021 – International Federation of Biomedical Laboratory Science. Aug 24-28; Copenhagen Denmark; Web: ifbls2021.org SEPTEMBER 2021

FIME 2021 – Florida International Medical Expo. Sep 1-3; Miami, FL, USA; Web: www.fimeshow.com

ECI 2021 – 6th European Congress of Immunology. Sep 1-4; Belgrade, Serbia; Web: iuis.org

43rd Annual Meeting of the European Thyroid Association (ETA). Sep 4-7; Milan, Italy; Web: www.eurothyroid.com

MSACL 2021 EU – The Association for Mass Spectrometry & Advances in Clinical Lab. Sep 12-16; Salzburg, Austria; Web: www.msacl.org

ESCV – 23rd Annual Meeting of the European Society for Clinical Virology. Sep 15-18; Manchester, UK; Web: www.escv.eu

ExpoMedical 2021. Sep 22-24; Buenos Aires, Argentina; Web: www.expomedical.com.ar

AFCC Congress 2021 – African Federation of Clinical Chemistry. Sep 23-25; Lusaka, Zambia; Web: www.ifcc.org

India Lab Expo & Analytica Anacon India. Sep 2325; Hyderabad, India; Web: www.analyticaindia.com

IMPE 2021 – 11 International Meeting of Pediatric Endocrinology. Sep 25-28; Buenos Aires, Argentina; Web: www.impe2021.org

CAP21 – Annual Meeting of the College of American Pathologists. Sep 25-28; Chicago, IL, USA; Web: www.capannualmeeting.org

EUROTOX 2021 – 56th Congress of the European Societies of Toxicology. Sep 26-29; Copenhagen, Denmark; Web: eurotox-congress.com










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LabMedica International November/2020

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Events Calendar

58th Annual Scientific Conference of the Australasian Association for Clinical Biochemistry and Laboratory Medicine (AACB). Sep 28-30; Brisbane, Australia; Web: www.aacb.asn.au

53rd National Congress of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC). Nov 3-5; Bari, Italy; Web: www.sibioc.it

Analitica Latin America 2021. Sep 28-30; Sao Paulo, Brazil; Web: www.analiticanet.com.br

32nd Regional Congress of the International Society of Blood Transfusion (ISBT). Nov 13-16; Brisbane, Australia; Web: isbtweb.org

EASD 2021 – 57th Annual Meeting of the European Association for the Study of Diabetes. Sep 27 - Oct 1; Stockholm, Sweden; Web: www.easd.org

90th Annual Meeting of the American Thyroid Association (ATA). Sep 29 - Oct 3; Scottsdale, Arizona; Web: www.thyroid.org OCTOBER 2021

ECC 2021 – 43rd European Congress of Cytology. Oct 3-6; Wroclaw, Poland; Web: cytology2021.eu

4èmes Journées Francophone de Biologie Médicale (JFBM). Oct 6-8; Rennes, France; Web: www.jfbm.fr

Analytica Vietnam 2021. Oct 7-9; Ho Chi Minh City, Vietnam; Web: www.analyticavietnam.com

46th ISOBM Congress - International Society of Oncology and Biomarkers. Oct 7-10; Bled, Slovenia; Web: www.isobm2020.net

German Congress for Laboratory Medicine 2021 – German Society for Clinical Chemistry and Laboratory Chemistry (DGKL). Oct 14-15; Mannheim, Germany; Web: laboratoriumsmedizin2020.de

ASCP 2021 – Annual Meeting of the American Society for Clinical Pathology. Oct 27-29; Boston, MA, USA; Web: www.ascp.org NOVEMBER 2021

ALACI 21 – 13th Latin American and Caribbean Congress of Immunology. Nov 1-5; Varadero, Cuba; Web: iuis.org/events/alaci-2021

61st Annual Academic Assembly of the Japan Society of Clinical Chemistry. Nov 5-7; Fukuoka, Japan; Web: jscc-jp.gr.jp

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

WASPaLM 2021 – 31st World Congress of the World Association of Societies of Pathology and Laboratory Medicine. Nov 25-28; Punta del Este, Uruguay; Web: www.waspalm.com

EuroMedLab 2021 – 24th IFCC-EFLM European Congress of Clinical Chemistry and Laboratory Medicine. Nov 28 - Dec 2; Munich, Germany; Web: www.euromedlab2021munich.org DECEMBER 2021

WSPID 2021 – 12th World Congress of the World Society for Pediatric Infectious Diseases. Dec 1-4; Cancun, Mexico; Web: wspid2021.com


Labquality Days 2021 – International Congress on Quality in Laboratory Medicine. Feb 10-11; Helsinki, Finland; Web: www.labqualitydays.fi

IFCC WorldLab Seoul 2022 – 24th International Congress of Clinical Chemistry and Laboratory Medicine. Jun 26-30; Seoul, Korea; Web: www.ifcc.org

APFCB 2022 – 16th Congress of the Asia-Pacific Federation of Clinical Biochemistry and Laboratory Medicine. Oct 15-18; Sydney, Australia; Web: apfcbcongress2022.org

Advertising Index

Vol. 38 No.7 11/ 2020 Page

AACC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Alcor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Biohit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 Biohit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Bio Rad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Buhlmann . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Coris . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Dynex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Diasys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 ELI Tech Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Euromedlab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Erba Mannheim . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Erba Mannheim . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Euroimmun . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 ICE 2020 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 Instrumentation Laboratory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Instrumentation Laboratory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 Labex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 LabMedica . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Mast Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Mayo Clinic Laboratories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Nova . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Quantimetrix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Seegene . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24-25 Serosep . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Singuway . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Snibe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Snibe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 TradeMed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Veda Lab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Vicolab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Vircell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Xunda . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 Provided as a service to advertisers. Publisher cannot accept responsibility for any errors or omissions.


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