LabMedica International July 2021 by Globetech

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WORLD’S CLINICAL LABORATORY NEWS LEADER ISSN 1068-1760

Vol. 38 No.4 • 6-7/2021

DAILY CLINICAL LAB NEWS

LAMP Assay Diagnoses High HBV DNA Levels orldwide a population estimated at some 260 million is chronically infected with hepatitis B virus (HBV) and 887,000 annually die from cirrhosis or liver cancer. Since over 95% of HBV-infected people live in low and middle income countries

Comprehensive Genomic Profiling Test: Analytic Validation and Clinical Utilization ancer has a high clinical burden and oncology therapies are expensive. It is estimated that 1,898,160 new cancer cases will be diagnosed and over 608,570 deaths are projected to occur in the USA in 2021. The prevalence of cancer is expected to rise over

time, providing an expanding unmet need for genomic tests to help physicians treat patients in a more precise manner. Identification of genomic alterations by Next Generation Sequencing (NGS) has become an efficient clinical tool, particularly

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Antibody Test Screens for COVID -19 Vaccine Induced Blood Clots

Test for Risk of Urinary Uric Acid Crystallization ric acid (UA) kidney stones account for 10% to 11% of all kidney stones, and this percentage has increased over time. An accurate, rapid, simple, and low-cost test is needed to distinguish urine that is susceptible and resistant to the formation of UA crystals. Renal stone formation is a multifactorial process that is affected by urine composition and

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Test Offers Biopsy-Free Colon Cancer Diagnosis

newly developed liquid biopsy test detects persistent circulating tumor DNA (ctDNA) after curative surgery and can identify patients with minimal residual disease (MRD) who will ultimately relapse. Most ctDNA MRD assays require tumor sequencing to identify tumor-derived mutations and to facilitate ctDNA detection. This approach requires both a

he world’s first diagnostic testing menu for suspected vaccine induced immune thrombotic-thrombocytopenia (VITT) aims to aid physicians in managing suspected blood clots.

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new superfast, portable COVID-19 testing method detects the SARS-CoV-2 virus much faster than the currently available methods. Researchers from the University of Florida (Gainesville, FL, USA) and National Chiao Tung University (Hsinchu, Taiwan) have developed a rapid and sensitive testing method for COVID19 biomarkers. The researchers, who previously demonstrated detection of biomarkers relevant in

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PerkinElmer to Acquire IDS, Expanding Immunodiagnostics Range erkinElmer, Inc. (Waltham, MA; USA; www.idsplc.com) and Immunodiagnostic Systems Holdings PLC (IDS; Bol-don, Tyne and Wear, UK; www.perkinelmer.com) have reached an agreement whereby PerkinElmer will

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acquire IDS for approximately USD 155 million. IDS develops, manufactures, and markets innovative immunoassays and automated immunoanalyzer technologies to provide improved diagnostic outcomes for patients. IDS’s imCont’d on page 33

Clinical News . . . . . . . 10 IFCC News . . . . . . . . . 29 Product News . . . . 6-28 Industry News . . . . . . 30 Events Calendar . . . . 34 PUBLISHED IN COOPERATION WITH

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LabMedica International he report that follows provides a selection of news and advances announced from May 1 to June 15, 2021. For a recap of earlier developments, the reader is invited to refer to previous issues of LabMedica or visit our website at www. LabMedica.com.

Highly Accurate Chip-Based Technology Improves COVID-19 Testing and Tracing A team of researchers at The University of New Mexico (Albuquerque, NM, USA; www. unm.edu) has developed a chip that provides a simpler and more rapid method of genome sequencing for viruses like COVID-19. The scientists created a tiled genome array they had developed for rapid and inexpensive full viral genome resequencing and applied their SARS-CoV-2-specific genome tiling array to rapidly and accurately resequence the viral genome from eight clinical samples acquired from patients in Wyoming that tested positive for SARS-CoV-2. Ultimately, they were able to sequence 95% of the genome of each sample with greater than 99.9% accuracy. New Ultra-Fast Test for COVID-19 Antibodies Uses AI to Analyze and Confirm Results in Less Than Five Minutes The University of Utah (Salt Lake City, UT, USA; www.utah.edu), ARUP Laboratories (Salt Lake City, UT, USA; www.aruplab.com) and Techcyte Inc. (Orem, UT, USA; www. techcyte.com) have formed a partnership to develop the NanoSpot.AI rapid COVID-19 antibody test. The less than five-minute, easy-to-administer SARS-CoV-2 antibody test is estimated to be significantly less expensive to manufacture, creating the potential for the test to be considerably more affordable than currently available tests and making it possible to extend the test to every corner of the world. New COVID-19 ELISA Test Measures Levels of Neutralizing Antibodies against Six Common SARS-CoV-2 Variants A new ELISA test from AXIM Biotechnologies, Inc. (San Diego, CA, USA; www. aximbiotech.com) measures levels of neutralizing antibodies against six common variants of the SARS-CoV-2 virus. The new test measures levels of immune protection against each of the variants of SARS-CoV-2 in parallel fashion. The test takes less than two hours to complete and can provide an indication of relative risk of infection with each variant. Cheap COVID-19 Test Accurately Detects Antibodies against SARSCoV-2 from More than 1,000 Blood Samples at Once A group of scientists from Swiss Federal Institute of Technology Lausanne (EPFL; Lausanne, Switzerland; www.actu.epfl.ch), University of Geneva (UNIGE; Geneva,

Switzerland; www.unige.ch) and Hôpitaux Universitaires de Genève (HUG; Geneva, Switzerland; www.hug.ch) has developed a reliable and cheap COVID-19 antibody test that can analyze more than 1,000 samples at once and requires a small drop of blood, such as that from a finger prick. The highly accurate test can analyze hundreds of samples at the same time, using minute quantities of reagents and single drops of blood. Unique Antibody Test Screens for COVID-19 Vaccine-Induced Blood Clots A unique offering of new testing options from Versiti, Inc. (Milwaukee, WI, USA; www.versiti.org) aims to aid physicians in managing suspected blood clots following the administration of adenovirus-based COVID19 vaccines. Versiti has unveiled the first comprehensive diagnostic testing menu for suspected vaccine-induced immune thrombotic-thrombocytopenia (VITT) in the US. New Tools Enable Rapid Analysis of Coronavirus Sequences and Tracking of SARS-CoV-2 Variants A new tool developed by scientists at the UC Santa Cruz Genomics Institute (Santa Cruz, CA, USA; www.ucscgenomics.soe. ucsc.edu) allows researchers to quickly see how a new viral sequence is related to all other variants of SARS-CoV-2, crucial information for tracking transmission dynamics. Called Ultrafast Sample Placement on Existing Trees (UShER), this powerful tool identifies the relationships between a user’s newly sequenced viral genomes and all known SARS-CoV-2 virus genomes by adding them to an existing phylogenetic tree, a branching diagram like a family tree that shows how the virus has evolved in different lineages as it accumulates mutations. High-Throughput Microfluidic Nanoimmunoassay Detects Anti-SARSCoV-2 Antibodies in Serum or Ultra Low-Volume Blood Samples A team of researchers at Icahn School of Medicine at Mount Sinai (New York, NY, USA; www.icahn.mssm.edu) has developed a high-throughput microfluidic nanoimmunoassay (NIA) that can detect anti-SARSCoV-2 antibodies in serum or ultra low-volume blood samples. The NIA can detect anti-SARS-CoV-2 IgG antibodies in 1,024 samples per device. To enable decentralized blood sample collection, the method can detect antibodies in a small drop of blood obtainable by finger pricking, and the blood can be collected and shipped with a simple, low-cost blood glucose test strip. 3D Printing Paves Way for New Type of COVID-19 Lateral Flow Test with More Capabilities Researchers at KU Leuven (Leuven, Belgium; www.kuleuven.be) have developed a 3D printing technique that extends Cont’d on page 5

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ISSN 1068-1760 Vol.38 No.4. Published, under license, by Globetech Media LLC; Copyright © 2020. All rights reserved. Reproduction in any form is forbidden without express permission. Opinions expressed are solely those of the authors, and do not represent an endorsement, or lack thereof, by the Publisher of any products or services. Teknopress Yayıncılık ve Ticaret Ltd. Şti. adına İmtiyaz Sahibi: M. Geren • Yazı işleri Müdürü: Ersin Köklü Müşir Derviş İbrahim Sok. 5/4, Esentepe, 34394 Şişli, İstanbul P. K. 1, AVPIM, 34001 İstanbul • E-mail: Teknopress@yahoo.com Baskı: Postkom A.Ş. • İpkas Sanayi Sitesi 3. Etap C Blok • 34490 Başakşehir • İstanbul Yerel süreli yayındır. Yılda sekiz kere yayınlanır, ücretsiz dağıtılır.

LabMedica International June-July/2021

COVID -19 Diagnostics Update Cont’d from page 4

the possibilities of COVID-19 lateral flow tests and enable production of quick, cheap, and easy to use advanced diagnostic tests. Using a 3D printer, the bioengineers have fabricated a 3D version of a lateral flow test. The basis is a small block of porous polymer, in which ‘inks’ with specific properties are printed at precise locations. In this way, a network of channels and small ‘locks’ is printed that let the flow through or block it where and when necessary, without the need for moving parts. During the test, the sample is automatically guided through the different test steps. That way, even complex protocols can be followed. First Detailed Analysis of Which Antibodies Best Neutralize SARSCoV-2 in COVID-19 Patients Could Improve Serological Tests

with 90% accuracy and could extend reliable testing for SARS-CoV-2 to remote and disadvantaged areas. The fast and inexpensive diagnostic test, called RAPID 1.0 (Real-time Accurate Portable Impedimetric Detection prototype 1.0), is inexpensive and highly scalable in comparison to existing methods for COVID-19 detection, allowing the production of millions of units per week. Disposable Biosensor Platform to Enable COVID-19 Testing at Point of Care The Wyss Institute for Biologically Inspired Engineering at Harvard University (Boston, MA, USA; www.wyss.harvard.edu) is integrating GBS, Inc.’s (New York, NY, USA; www.gbs.inc) world-first Biosensor Platform technology with a specialized nanomaterial coating. This gel-like coating allows

the detection of IgM and/or igG antibodies which indicates a person’s current or previous exposure to the SARS-CoV-2 virus, and thus, a potential infection with COVID-19. Further development could result in a chewing-gum sized diagnostic ‘strip’ to be used as a diagnostic tool for COVID-19 testing at point of care. Novel X-Ray Imaging Technique Reveals Best SARS-CoV-2 Antibodies for Developing Reliable, Rapid COVID-19 Tests An imaging technique developed by researchers at Lawrence Berkeley National Laboratory (Berkeley, CA, USA; www.lbl. gov) that is helping reveal the best antibodies for COVID-19 detection could pave the way for reliable instant tests on the market. The Cont’d on page 6

Scientists at Fujita Health University (Aichi, Japan; www.fuji ta-hu.ac.jp) have performed the first detailed analysis of different antibodies produced by COVID-19 patients to various parts of SARS-CoV-2 and determined which of them had the strongest neutralizing activity against the novel coronavirus. The scientists undertook the first detailed investigation of how different antibodies (or antibody “isotypes”) interact with the various antigens produced by SARSCoV-2 in COVID-19 patients. Novel Chip-Based Antigen Test Provides Ultrasensitive Detection of SARS-CoV-2 and Influenza A A novel chip-based diagnostic technology developed by researchers at UC Santa Cruz (Santa Cruz, CA, USA; www.ucsc.edu) can detect individual viral antigens in nasal swab samples to identify the viruses that cause COVID-19 and flu with a single test. The novel chip-based antigen test can provide ultrasensitive detection of SARS-CoV-2 and influenza A, the viruses that cause COVID-19 and flu, respectively. The test is sensitive enough to detect and identify individual viral antigens one by one in nasal swab samples. This ultrasensitive technique could eventually be developed as a molecular diagnostic tool for point-of-care use. Rapid COVID-19 Diagnostic Test Delivers Results With 90% Accuracy within Four Minutes A low-cost, rapid diagnostic test for COVID-19 developed by researchers at Penn Medicine (Philadelphia, PA, USA; www.pennmedicine.org) provides results within four minutes

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SARS-COV-2/FLU/RSV RT-PCR TEST

SPUTUM MEDIUM

COAGULATION ANALYZER

The SARS-COV-2/FLU/RSV Real Time PCR kit uses real-time reverse transcription and amplification of nucleic acids in one step for the detection of SARS-CoV-2, Influenza A, Influenza B and RSV in respiratory samples.

The Puritan Sputum Medium with Sterile Transfer Pipette, 1 ml is used to liquify sputum specimens prior to streaking or the isolation of bacteria that cause respiratory tract infections.

The Xprecia Stride coagulation analyzer is a handheld device that tests PT/INR with lab accuracy and is ergonomically designed, with a large, intuitive touchscreen to enhance the user experience and simplify work flow.

VIRCELL

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PURITAN MEDICAL

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COVID -19 Diagnostics Update Cont’d from page 5

new research suggests that a highly sensitive lateral flow assay – the same type of device used in home pregnancy tests – could be developed using pairs of rigid antibodies that bind to the SARSCoV-2 nucleocapsid protein. Such a test would only require a small drop of mucus or saliva, could give results in 15 minutes, and could detect a COVID-19 infection one day before the onset of symptoms. New Microchip Real-Time Technology Platform for COVID-19 Testing Offers Alternative to Gold-Standard RT-QPCR Tests A microchip technology test kit for COVID-19 developed by Lumex Instruments (Mission City, BC, Canada; www.lumexinstru ments.com) and validated by investigators at Simon Fraser University (Burnaby, BC, Canada; www.sfu.ca) may facilitate point-of-care testing in remote locations, clinics, and airports while providing similar accuracy to the tube-based real-time PCR tests. The low-energy (100 watt), compact, lightweight microchip analyzer uses 10-fold less reagents compared to Centers for Disease Control and Prevention (CDC)-approved tube-based RT-PCR tests, and reports results in as little as 30 minutes. Its accuracy was 100% predictive in clinical samples, according to the investigators. Portable, Battery-Powered Device Combined with Rapid, Highly Sensitive and Accurate Assay Enables COVID-19 Testing Anytime, Anywhere A new coronavirus test developed by researchers at the University of Illinois at Urbana-Champaign (Champaign, IL, USA; www.illinois. edu) can get accurate results from a saliva sample in less than 30 minutes and detect as little as one viral particle per 1-microliter drop of fluid. Many of the components of the hand-held device used in this technology can be 3D-printed. Though it is still in the prototype stage, the device is estimated to cost less than USD 78 and the reagents and other materials needed for testing would amount to USD 6-7 per test, the researchers found. Using CLEIA for Screening and RT-PCR for Confirmation Increases Accuracy of COVID-19 Diagnosis, Finds New Study A team of scientists from Hokkaido University (Hokkaido, Japan;

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www.global.hokudai.ac.jp) used a novel antigen-based kit, Lumipulse SARS-CoV-2 Ag kit (Lumipulse), developed by Fujirebio Europe (Ghent, Belgium; www.fujirebio.com) to quantitatively measure the viral antigen in biological samples within 35 minutes. The team used the antigen kit to detect SARS-CoV-2 in saliva samples, and assess the efficiency and accuracy of the test compared to RT-PCR. Their findings show that the antigen detection kit, which is used to perform chemiluminescent enzyme immunoassay (CLEIA), can rapidly detect SARS-CoV-2 with good accuracy in these samples. Seegene Unveils Exclusive Diagnostic System for Diagnosing COVID-19 Variants Seegene, Inc. (Seoul, Korea; www.seegene.com) has introduced a unique system for diagnosing COVID-19 variants at the European Congress of Clinical Microbiology (ECCMID) 2021. Seegene’s Dr. Guy Willem Lee, Director of Marketing Strategy introduced the diagnostic system at ECCMID 2021under the theme of “SARS-CoV-2 and Variants ‘Full Screening’ Solution” using its latest COVID-19 variant diagnostic tests. The ‘Full Screening Solution’ is a one-step system that can verify whether an individual has contracted coronavirus wildtype or the virus variant with a single real-time PCR test. New Antigen-Based COVID-19 Rapid Test Format Analyzes 500 Samples per Hour and Detects SARS-CoV-2 Infection in 10 Minutes A new antigen-based detection technique developed by researchers at the University of Helsinki (Helsinki, Finland; www.hus.fi) could be used to analyze as many as 500 samples per hour and was able to diagnose a viral infection almost as accurately as PCR tests in a recently completed study. The researchers developed a new rapid assay principle for viral antigen detection, applying it to diagnosing SARS-CoV-2 infections. Next Generation Sequencing Testing Protocol for SARSCoV-2 Can Process Tens of Thousands of Samples in Less Than 48 Hours A new testing protocol for SARS-CoV-2 developed by researchers at the Vienna BioCenter (Vienna, Austria; www.viennabiocenter.org) can process tens of thousands of samples in less than 48 hours and could also be adapted to many more pathogens. The method, called SARSeq, or ‘Saliva Analysis by RNA sequencing’, achieves high sensitivity, specificity, and the power to process up to 36,000 samples in less than 48 hours. It could enable large groups to be tested for SARSCont’d on page 7 LabMedica International June-July/2021

COVID -19 Diagnostics Update Cont’d from page 6

CoV-2 with the same sensitivity as regular PCR tests. Ortho Launches First Quantitative COVID-19 IgG Spike Antibody Test and New Nucleocapsid Antibody Test Ortho Clinical Diagnostics (Raritan, NJ, USA; www.orthoclinicaldiagnostics.com) has launched the first quantitative COVID-19 IgG antibody test in addition to a total COVID-19 nucleocapsid antibody test. Ortho is the only company that offers laboratories in the US a quantitative test in combination with a nucleocapsid test. Both tests help health care teams differentiate the cause of antibodies against SARS-CoV-2 and are processed on Ortho’s trusted VITROS Systems. Ultrafast, On-Chip PCR that Detects SARS-CoV-2 in Only 8 Minutes Could Speed COVID-19 Diagnosis

dzne.de), the University of Bonn (Bonn, Germany; www.uni-bonn.de) and Hewlett Packard Enterprise (HPE; Houston, TX, USA; www.hpe.com) have trained artificial intelligence (AI) algorithms to detect blood cancer, lung diseases and COVID-19 in data stored in a decentralized fashion. This approach has advantages over conventional methods since it inherently provides privacy preservation technologies, which facilitates cross-site analysis of scientific data. Swarm learning could thus significantly promote and accelerate collaboration and information exchange in research, especially in the field of medicine. New, Fast, Portable Saliva Screening Test Uses Infrared Light Technology to Confirm SARS-CoV-2 Infection New research led by scientists at Monash University (Melbourne, Australia; www. monash.edu) and the Peter Doherty Institute

for Infection and Immunity (Melbourne, Australia; www.doherty.edu.au) has achieved a proof of concept for a new, fast, portable saliva screening test that uses an infrared light technology to confirm infection with SARS-CoV-2. The new diagnostic approach involving the use of a portable infrared instrument to detect the SARS-CoV-2 virus in saliva could pave the way for safer and more efficient COVID-19 testing. COVID-19 Rapid Antigen Test Provides End-To-End Digital Screening Solution A new COVID-19 antigen test from iXensor (Taipei, Taiwan; www.ixensor.com) provides a full end-to-end digital screening solution to prevent further outbreaks. The iXensor’s PixoTest solution, which has received the CE-IVD mark, comprises a palm-sized

Researchers at Korea Advanced Institute of Science and Technology (KAIST; Daejeon, Korea; www.kaist. ac.kr) have developed a plasmofluidic chip that can perform PCR in only about eight minutes, which could speed COVID-19 diagnosis during current and future pandemics. The tiny PCR chip can amplify DNA much more quickly than conventional, benchtop PCR systems and could provide many opportunities for rapid point-of-care diagnostics during a pandemic, according to the researchers. New Electronic-Based ‘Nose’ Detector Sniffs out COVID-19 Infected People in 80 Seconds A proof of concept by scientists at the Weizmann Institute of Science (Rehovot, Israel; www.weizmann. ac.il) with an electronic nose has suggested that an optimized detector may allow effective real-time diagnosis of SARS CoV-2 infection, which would provide for extensive relief in the COVID-19 pandemic. The team successfully deployed a mobile eNose platform that can smell SARS CoV-2 infection at a drive-through testing station. The team applied a deep learning classifier to the eNose measurements, and achieved real-time detection of SARS CoV-2 infection at a level significantly better than chance, for both symptomatic and non-symptomatic participants. AI with Swarm Intelligence Detects COVID-19 in Data Stored in Decentralized Fashion Using a principle called “swarm learning” experts from the German Center for Neurodegenerative Diseases (DZNE; Bonn, Germany; www.

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COVID-19 SELF-TEST

HEMATOLOGY ANALYZER

CHEMILUMINESCENT ANALYZER

The COVID-19 Antigen Test Kit (Colloidal Gold) is a SARS-CoV-2 antigen detection self-test that is fast, convenient and cost-effective. Designed for home use, the CE Marked personal test gives accurate results in 15 minutes.

Sight OLO is a compact hematology analyzer for complete blood count that provides lab-grade results with 19 parameters and 5-part differential. Results are ready in minutes on touchscreen interface, printout and email.

The ALTA CLIAlyzer is an intuitive bench-top chemiluminescent analyzer used for the quantitative determination of concentrations of various analytes found in serum, whole blood, or plasma specimens.

SINGUWAY BIOTECH

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COVID -19 Diagnostics Update Cont’d from page 7

analyzer that reads test results accurately, a digital health pass App, an Admin App, and a HIPAA-grade health management web portal. The fully digitized testing and reporting design shortens the test-to-report time to 15 minutes. Rapid Blood Test Could Confirm COVID-19 Vaccination in Minutes Researchers at the Johns Hopkins University (JHU; Baltimore, MD, USA; www. jhu.edu) have developed a rapid blood test that can confirm in minutes if a person has been vaccinated for SARS-CoV-2, the virus that causes COVID-19. The rapid blood test could confirm a person has been vaccinated while they wait to board a plane or enter a sporting event. Immunocompromised patients, who studies have shown don’t always respond to the COVID-19 vaccine, could test their antibody level and see if the vaccine is working for them, according to the researchers.

SIGHT DIAGNOSTICS

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New Method for Rapid, Accurate Detection of Viruses Could Speed Up COVID-19 Testing Researchers from Critical Analytics for Manufacturing Personalized-Medicine (CAMP), an Interdisciplinary Research Group (IRG) at the Singapore-MIT Alliance for Research and Technology (SMART; Singapore; www.smart.mit.edu) have developed a method for rapid, accurate detection of viruses that is four times faster than conventional PCR methods, is highly specific, sensitive, and resistant to inhibitors and could speed up COVID-19 testing. The molecular rapid testing methodology, called RApid DIgital Crispr Approach (RADICA) for rapid and accurate detection of viral nucleic acids marks a breakthrough that can be easily adapted to detect different DNA/RNA targets in viruses like the coronavirus. Handheld RT-PCR System Combined with Saliva-Based Test Brings Mobility to COVID-19 Testing and Reduces Cost COVID-19 testing has been made easier and more accessible with the US FDA emergency use authorization (EUA)

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of the combination of SalivaDirect developed by Yale School of Public Health (New Haven, CT, USA; www.publichealth.yale. edu) with Ubiquitome Limited’s (Auckland, New Zealand; www.ubiquitomebio.com) handheld Liberty16 mobile real time-PCR. Collecting saliva samples, analyzing them in the Liberty16 and getting the result spelled out on the iPhone app, allows for outbreaks to be identified anywhere there is cell phone reception, by labs with SalivaDirect authorization. CRISPR-Based COVID-19 Rapid Test Accurately Detects Coronavirus in as Little as One Minute Researchers at Montana State University (Bozeman, MT, USA; www.montana.edu) have repurposed a CRISPR system to make a rapid, accurate COVID-19 test that can accurately detect even relatively small amounts of coronavirus in patient samples in less than 30 minutes and sometimes in as little as one minute. The technology, which could also be used against other viruses such as Zika and Ebola, is based on a Type III CRISPR system, which, in bacteria, monitors for viral invasion.

Novel Capsule-Based Smell Test Diagnoses Neurological and Respiratory Diseases o aid in diagnosing diseases where loss of the sense of smell is a symptom, such as in chronic neurological conditions like Parkinson’s and Alzheimer’s diseases and in acute respiratory infections such as that caused by COVID-19, a team of researchers at Queen Mary University of London (United Kingdom; www.qmul.ac.uk) developed a novel smell testing kit based on capsules of aromatic oils placed between two strips of single-sided tape. This smelling test was made up of aromatic oil capsules that were prepared by a fabrication technique, which enabled full control over the capsule size, the shell thickness, and the volume

of the encapsulated oil. The technique generated capsules by concentrically dripping oil/alginate droplets from a coaxial nozzle into an oppositely charged ionic liquid. After formation, liquid capsules were left to dry and form a solid crust surrounding the oil. The prototype test used in the current study consisted of placing a standardized number of capsules between adhesive strips that users crushed and pulled apart to release the smell. In addition, a simple mathematical model was developed to predict the volume of encapsulated oil within the capsule in terms of the flow rate Cont’d on page 12 LabMedica International June-July/2021

COVID -19 Diagnostics Update

Antibody Test Screens for COVID-19 Vaccine Induced Blood Clots unique offering of new testing options aims to aid physicians in managing suspected blood clots following the administration of adenovirus-based COVID-19 vaccines. Versiti, Inc. (Milwaukee, WI, USA; www.versiti.org) has unveiled the first comprehensive diagnostic testing menu for suspected vaccine-induced immune thrombotic-thrombocytopenia (VITT) in the US. Cases of patients developing clots (thrombosis) with low platelet counts (thrombocytopenia) have been reported following administration of adenovirus-based COVID-19 vaccines. VITT is considered to be a rare side effect of the adenovirus vector-based vaccines for COVID-19. Per reports in the medical literature, cases of VITT have been reported between 3 and approximately 20 days post vaccination. Versiti’s unique test offering determines the presence and function of platelet-activating antibodies in patients’ blood. Published communications in the medical literature have identified the presence of these antibodies as being a key finding following the development of these life-threatening clots in individuals receiving specific COVID vaccines. These antibodies are similar to those seen in Heparin Induced Thrombocytopenia (HIT). Once a patient has these antibodies, physicians and providers must implement alternate anticoagulation therapies to care for the individual. “Accurate assessment of VITT is critical to guiding appropriate drug selection and management of patients with blood clot side effects,” said Dr. Ruchika Sharma, associate medical director of Versiti’s platelet immunology laboratory. “Patients receiving incorrect therapies could be at risk for serious bleeding complications or, in some cases, worsening of their existing blood clot(s). This testing menu leverages Versiti’s decades of experience in immune platelet disorders, to provide physicians with the necessary tools to aid in the care and management of patients with suspected VITT.”

Image: Unique Antibody Test Screens for COVID-19 Vaccine Induced Blood Clots (Photo courtesy of Versiti, Inc.)

LAMP Assay Diagnoses High HBV DNA Levels cont’d from cover

(LMICs) and only 12-25% of infected people are eligible for anti-HBV therapy. Loop-mediated isothermal amplification (LAMP) assay is a nucleic acid test (NAT) using DNA polymerase with high auto-cycling strand displacement activity and six specially designed primers. LAMP has the following characteristics allowing its use as a rapid, reliable and inexpensive pointof-care test in LMICs with a high amplification efficiency enabling rapid detection of nucleic acids. A large team of medical scientists associated with the Pasteur Institute (Paris, France) designed Pan-genotypic primer sets on conserved HBV gene regions. Accuracy of LAMP to identify highly viremic patients was evaluated in 400 and 550 HBV-infected people in France and Senegal, respectively. Analytical validation was performed using real-time turbidimetric LAMP (Loopamp LA-500, Eiken Chemical, Japan). Viral loads were quantified using an AMPLIX real-time PCR (Biosynex, Illkirch-Graffenstaden, France). The team reported that their primers successfully detected eight major HBV genotypes/sub-genotypes (A1/2/3/B/C/D/E/F) with a detection limit ranging between 40-400 IU/mL. In France, the area under the receiver operating characteristic curve (AUROC), sensitivity and specificity of bead-based extraction and real-time turbidimetric LAMP were 0.95, 91.1% and 86.0%, respectively, to diagnose HBV DNA ≥20,000 IU/mL; and 0.98, 98.0% and 94.6% for ≥200,000 IU/mL. The performance did not vary by viral genotypes. In Senegal, using a field-adapted method, reagent-free boiland-spin extraction and inexpensive end-point fluorescence detection, the AUROC, sensitivity and specificity were 0.95, 98.7% and 91.5%, respectively, to diagnose HBV DNA ≥200,000 IU/mL. The assay was not adapted to discriminate low-level viremia. The authors concluded that they had developed a simple, rapid (60 minutes), and inexpensive (USD 8/assay) alternative to PCR to diagnose high viremia ≥200,000 IU/mL. HBV-LAMP may contribute to eliminating HBV mother-to-child transmission by identifying high-risk pregnant women eligible for antiviral prophylaxis in resource-limited countries. The study was published on April 7, 2021 in the journal Clinical Microbiology and Infection.

LabMedica International June-July/2021

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PRODUCT NEWS PCR ANALYZER HANGZHOU BIOER TECHNOLOGY

The BioFlux automatic PCR analysis system is designed to meet the demand for automation of PCR detection. The technology involves "sample pre-treatment + nucleic acid extraction + fluorescence quantitative PCR". LINKXPRESS COM

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ANTIBIOTIC SUSCEPTIBILITY TESTING PLATFORM SHANGHAI FOSUN

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Urinary Interleukin-8 May Be the Ultimate Bladder Cancer Biomarker recently published study established that the urinary protein interleukin-8 (IL-8) not only distinguished bladder cancer from controls, it also discriminated high grade from low grade disease, and the successive clinical stages of bladder cancer. The potential usefulness of this biomarker was determined by investigators at the University of Houston (Texas, USA; www. uh.edu). These investigators had set out to identify novel urine protein biomarkers of bladder cancer using a Luminex (Austin, TX, USA; www.luminexcorp.com) based screening platform. For this study, the investigators analyzed urine samples from 66 subjects, comprised of 31 urology clinic controls and 35 bladder cancer patients, using a Luminex based screening platform. ELISA validation was carried out for the top four prospective urine biomarkers using an independent cohort of 20 urology clinic controls and 60 bladder

cancer (BC) subjects. Results revealed that of the 16 proteins screened by the Luminex platform, 10 showed significant elevation in BC compared to the controls. Eight of these urine proteins were able to differentiate BC from control urine with AUC values exceeding 0.70 with specificity values exceeding 0.9. Upon ELISA validation, urine IL-1alpha, IL-1ra, and IL-8 were able to distinguish control urine from urine drawn from various bladder cancer stages, with IL-8 being the best discriminator. Overall, IL-8 displayed the highest significance in discriminating between controls and BC patients and discriminating highly advanced stages/grades of BC from less advanced stages/grades of BC. Senior author Dr. Chandra Mohan, professor of biomedical engineering at the University of Houston, said, “Bladder cancer (BC) is the sixth most common cancer diagnosis in the United States and is over four times more

common in men than women. Urine biomarkers could potentially provide preliminary confirmation of low-grade BC before invasive procedures are performed and facilitate surveillance of BC.” The Luminex-based study was published in the April 13, 2021, online edition of the journal Oncotarget. Image: A platform for multiplexing up to 100 analytes such as proteins in a single well of a microtiter plate (Photo courtesy of Luminex Corporation)

Cryptococcal Antigen Screening Evaluated Among People Living with HIV ryptococcosis is a potentially fatal fungal disease caused by a few species of Cryptococcus (most often Cryptococcus neoformans or Cryptococcus gattii). Cryptococcosis is believed to be acquired by inhalation of the infectious propagule from the environment. Most people in the USA who develop cryptococcal infections are HIV-positive. However, occasionally persons with no apparent immune system problems develop cryptococcosis. Cryptococcosis remains a leading cause of meningitis and mortality among people living with HIV (PLHIV) worldwide. An international team of scientists led by the University of Washington (Seattle, WA, USA; www.washington.edu) evaluated laboratory-based cryptococcal antigen (CrAg) reflex

testing and a clinic-based point-of-care (POC) CrAg screening intervention for preventing meningitis and mortality among PLHIV in South Africa. The team included 3,105 (39.4%) of 7,877 people screened were HIVpositive, of whom 908 had CD4 ≤200 cells/ mm3 and were included in the analyses. The laboratory and clinical teams performed serum CrAg by enzyme immunoassay and lateral flow assay (Immy Diagnostics, Norman, OK, USA; www.immy.com). The investigators reported that Lab reflex and clinic-based testing significantly increased CrAg screening and diagnosis of CrAg-positive PLHIV. As compared to clinician-directed testing, clinic-based CrAg testing increased the number of PLHIV diagnosed with cryptococcal Cont’d on page 13

Image: The CrAg LFA (lateral flow assay) can detect cryptococcal antigens in the blood of asymptomatic patients prior to development of cryptococcal meningitis enabling pre-emptive treatment of CrAg positive patients (Photo courtesy of Immy Diagnostics) LabMedica International June-July/2021

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Comprehensive Genomic Profiling Test: Analytic Validation and Clinical Utilization cont’d from cover

for oncology as molecular markers can guide personalized treatment. Currently available options for tumor profiling include immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), and, more recently, small panel next-generation sequencing (NGS). Scientists at the Ashion Analytics, LLC, (Phoenix, AZ, USA) developed and analytically validated their comprehensive genomic profiling assay, GEM ExTra. The assay is for patients with advanced solid tumors that and uses Next Generation Sequencing to characterize whole exomes employing a paired tumor-normal subtraction methodology. The test was utilized in over 1,400 patient samples during a period of April 2018 and December 2019 across cancer centers to detect multiple actionable alterations in a variety of cancer types. The assay detects single nucleotide variants (SNV), indels, focal copy number alterations (CNA), TERT promoter region, as well as tumor mutation burden (TMB) and microsatellite instability (MSI) status.

Additionally, the assay incorporates whole transcriptome sequencing of the tumor sample that allows for the detection of gene fusions and selects special transcripts, including AR-V7, EGFR vIII, EGFRvIV, and MET exon 14 skipping events. The assay has a mean target coverage of 180× for the normal (germline) and 400× for tumor DNA including enhanced probe design to facilitate the sequencing of difficult regions. The team found that found that 83.9% of tumor samples harbored at least one clinically actionable alteration (defined as positive) and the rest defined as negative, with a total of 1,267 positive and 242 negative reports (Detection Rate: 2018 = 76.4%, 2019 = 86.4%). Overall, 3,535 clinically actionable mutations were identified in the cohort (1,864 unique mutations), with a median of two clinically actionable alterations per tumor (mean = 2.93 ± 2.37) showing extensive variation across cancer types. Tumors with highest number of actionable mutations included skin (4.9 ± 2.2), endometrial (4.5 ± 3.9),

and colorectal (4.1 ± 3.5). These results generally agree with previous estimates of driver events per patient in these tumor types. This is somewhat lower than previously reported in a pan-cancer study (4.6/ tumor) of whole genomes, which also included driver copy number alterations which are not called out as actionable with GEM ExTra. Mean coding SNVs (i.e., missense, nonsense, stop codon) was 1.9 ± 1.4 per tumor which is within the range of predicted driver mutations in cancer. The scientists concluded that they had developed and analytically validated a comprehensive genomic profiling assay with a 14-day turnaround time that can be adapted to all future tumor profiling needs due to combined DNA and RNA analysis. The GEM ExTra assay not only uses WES for tumor DNA profiling, but also identifies clinically actionable transcript variants and fusion genes through RNA sequencing, both of which ensure that GEM ExTra will be comprehensive in the future. The study was published on April 13, 2021 in the journal Oncotarget.

Novel Capsule-Based Smell Test for Diagnosis of Neurological and Respiratory Diseases Cont’d from page 8

ratio and the nozzle size. In this preliminary study, a small group of eight patients with Parkinson’s disease were instructed to crush the capsules between their fingers and then peel back the tape strip to release the aroma contained within the capsules. The participants reported that the smells from the tests were detectable and remarked on the relative ease of rupturing the capsules, particularly for those with tremors, compared to the standard scratch and sniff smell test available on the market. First author Dr. Ahmed Ismail, a lecturer of fluid dynamics at Queen Mary University

of London, said, “Most of the smell tests on the market depend on using paperboard items treated with a fragrant coating called scratch and sniff, in which you need to scratch a card to release the odor. The problem with this approach is that the amount of odor released depends on the extent to which the individual scratches, something that might affect the outcome of the test. Our capsule-based smell test does not have this problem because the amount of odor released is controlled by the amount of oil precisely encapsulated. The mass-production of our new test would also be cheaper than a scratch and sniff test. Dr. Ismail said, “Our capsule-based smell

test can assist in the rapid diagnostic of various diseases linked to the loss of smell. These include chronic neurological conditions such as Parkinson’s and Alzheimer’s disease, as well as COVID-19, which is known to affect the sense of smell. Being non-invasive and less stressful, the capsule-based smell test has benefits over the nose swab in diagnosing COVID-19. This is an advantage for testing children in particular, as they are typically horrified if they need to do a nose swab, and the test can be done in the comfort of their own home.” The capsule-based smell test was described in the April 28, 2021, online edition of the journal Royal Society Interface. LabMedica International June-July/2021

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Serial SARS-CoV-2 Rapid Antigen Testing Evaluated During Outbreaks erial, facility-wide testing for SARSCoV-2 can help identify cases in outbreak settings, allowing for rapid implementation of transmission-based precautions and infection prevention and control strategies. Although real-time reverse transcription polymerase chain reaction (RT-PCR) testing performed in a laboratory has the highest sensitivity, its prolonged turnaround time can delay quarantine and isolation implementation. Antigen tests are easy to use and produce results in minutes, facilitating rapid action, particularly during outbreaks in congregate settings. Medical Scientists at the Centers for Disease Control and Prevention (CDC, Atlanta, GA, USA; www.cdc.gov) carried out a prospective study that included 532 specimens from 234 available residents and staff at a nursing home experiencing a SARSCoV-2 outbreak to evaluate the performance of antigen testing when used during an emerging outbreak. Two specimens were collected from all residents and staff three times over a 13-day period. Trained laboratory scientists tested one swab onsite using a rapid antigen test and the other was sent to the CDC for RT-PCR and virus culture reference testing. The percentage of positive agreement (PPA) and percentage of negative agreement (PNA) for BinaxNOW COVID-19 Ag Cards (Abbott Laboratories, Abbott Park, IL, USA; www.abbott.com) compared with RT-PCR using the CDC Influenza SARSCoV-2 (Flu SC2) Multiplex Assay on the Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument (Thermo Fisher Scientific, Waltham, MA, USA; www.thermofisher. com) and virus culture was done using Vero

CCL-81 cells. The team reported that BinaxNOW PPA with virus culture, used for detection of replication-competent virus, was 95%. However, the overall PPA of antigen testing with RTPCR was 69%, and PNA was 98%. When only the first positive test result was analyzed for each participant, PPA of antigen testing with RT-PCR was 82% among 45 symptomatic people and 52% among 343 asymptomatic people. Compared with RT-PCR and virus culture, the BinaxNOW test performed well in early infection (86% and 95%, respectively) and poorly in late infection (51% and no recovered virus, respectively). The authors concluded that although their data suggest that nearly a third of RTPCR-positive infections were missed overall, the antigen test was able to identify 86% of infections when testing was done during early infection when people are more likely to be infectious. Previous work has shown

that people can continue to test positive for SARS-CoV-2 by RT-PCR for weeks after they are no longer infectious. Thus, comparisons of antigen testing with virus culture might provide a more accurate measure of antigen test performance for identifying infectious people. The study was published on April 27, 2021 in the journal Annals of Internal Medicine. Image: BinaxNOW COVID-19 Ag Cards (Photo courtesy of Abbott Laboratories)

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Cont’d from page 10

meningitis (4.5% compared to 1.5%), initiation of fluconazole pre-emptive therapy (7.2% compared to 2.5%), and initiation of ART (96.8% compared to 91.3%). Comparing clinic-based testing to lab reflex testing, there was no significant difference in the cumulative incidence of cryptococcal meningitis (4.5% compared to 4.1%) or mortality (8.1% compared to 9.9%). The authors concluded that Lab reflex and clinic-based CrAg testing facilitated diagnosis of HIV-associated cryptococcosis and fluconazole initiation, but did not reduce cryptococcal meningitis or mortality. In this non-randomized cohort, clinical outcomes were similar between lab reflex testing and clinic-based point-of-care CrAg testing. The study was published on May 10, 2021 in the Journal of Acquired Immune Deficiency Syndromes.

LabMedica International June-July/2021

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The Agilent Bravo is a flexible liquid handling platform that automates sample preparation for screening applications such as compound management, cell-based assays, and biochemical assays.

GOLDSITE DIAGNOSTICS

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Portable COVID-19 Test Detects SARS-CoV-2 Within One Second cont’d from cover

epidemics and emergencies, such as the Zika virus, heart attacks, and cerebral spinal fluid leaks, leveraged their expertise to develop a sensor system that provides detection within one second, which is far faster than current COVID-19 detection methods. Detecting the presence of the virus requires amplifying the numbers of the biomarker, such as the copies of viral ribonucleic acid in the common polymerase chain reaction technique for COVID-19 detection, or amplifying the binding signal for a target biomarker. The group’s method amplifies the binding signal for a target biomarker. During measurement, sensor strips are connected to a circuit board via a connector, and a short electrical test signal gets sent between the gold electrode bonded with COVID antibody and another auxiliary electrode. This signal is then returned to the circuit board for analysis. While the system’s sensor strips clearly must be discarded after use, the test circuit board is reusable which means that the cost of testing may be greatly reduced. “This could alleviate slow COVID-19 testing turnaround time issues,” said Minghan Xian, an author and a chemical engineering doctoral candidate at the University of Florida. “Our biosensor strip is similar to commercially available glucose test strips in shape, with a small microfluidic channel at the tip to introduce our test fluid. Within the microfluidic channel, a few electrodes are exposed to fluid. One is coated with gold, and COVID-relevant antibodies are attached to the gold surface via a chemical method.”

Test for Risk of Urinary Uric Acid Crystallization cont’d from cover

other factors, such as structural and pathological features of the kidneys, which include the presence of renal cavities with low urodynamic efficiency that retain urine for long periods, and alterations of the epithelial cells that cover the renal papillae. Urology Scientists at the University of Balearic Islands (Palma de Mallorca, Spain) and their colleagues collected urine samples from 20 healthy adult volunteers and 54 active formers of UA stones. Three samples were collected from each participant, with at least seven days between each collection. The main lithogenic parameters for UA stones were determined, and the risk of UA crystallization (RUAC test) was performed in all urine samples. The team reported that the ROC analysis indicated the area under the curve (AUC) was 0.881 (95% CI: 0.831 to 0.932), the sensitivity was 78.5%, the specificity was 92.4%, and the Youden index was 0.709. Based on this analysis, the optimum cutoff value was five

positive wells. The diagnostic specifications of RUAC test data, when considering that a urine is lithogenic with respect to UA when its SS is greater than 2 and the RUAC test is positive when crystals formed in five or more wells. A total of 61% of basal urine from UA stone formers were positive in the RUAC test, but only 19% of healthy volunteers were positive in the basal urine. Furthermore, among UA stone formers, the percentage of patients with a positive RUAC test decreased from 61% to 40% after treatment with theobromine. However, among healthy volunteers, the decrease after treatment with chocolate powder was not significant. The authors concluded the RUAC test has high diagnostic accuracy and low cost, and is also rapid and simple. This test can therefore be used as a screening tool in clinics and reference laboratories, in locations with limited laboratory infrastructure, and by community health workers with minimal training. This test demonstrates that the value of uric acid supersaturation in a urine, would also be a useful parameter, since for SS>2, the urine would be lithogenic for uric acid. The study was published on May 6, 2021 in the journal Clinica Chimica Acta. LabMedica International June-July/2021

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Picus Nxt electronic pipette comes with added features like user customizable protocols, password protection, and calibration reminders as well as added certification and safety features.

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Immunoassay Predicts Benefits of Anti-PD-1 Therapy in NSCLC ung cancer is the most common cause of cancer-related deaths worldwide. However, current targeted therapies and immunotherapies have gradually improved patient survival. Anti-programmed cell death-1 (PD-1) antibodies (Abs) are key drugs in non-small-cell lung cancer treatment; however, clinical benefits with anti-PD-1 monotherapy are limited. Notably, anti-programmed cell death-1 (PD1) and anti-PD-ligand1 (PD-L1) antibodies (Abs) as immune-checkpoint inhibitors prolong overall survival in non-small-cell lung cancer (NSCLC), which accounts for approximately 80% of lung cancer. However, clinical benefits with anti-PD-1/PD-L1 monotherapy are limited with only 20%–30% overall response rate. Oncologists at the Kawasaki Medical School, Okayama, Japan (https://m.kawasaki-m.ac.jp) and their colleagues obtained sera from advanced NSCLC patients, who received anti-PD-1 monotherapy as standard therapy in a first-line or later setting. Sera were collected within two months before anti-PD-1 monotherapy and were serially done after anti-PD-1

therapy, then frozen and stored at −80 °C until use. ESO-1 and XAGE1 antigen in tumor tissues were immunohistochemically stained in a previous study. The team developed a fully automated detection system for NY-ESO-1/XAGE1 Abs using an HISCL series (Sysmex, Kobe, Japan; www. sysmex.co.jp), which performs a chemiluminescent sandwich immunoassay. Sera were diluted 400 times with appropriate solution and reacted with magnetic beads coated with recombinant NY-ESO-1 protein or synthetic XAGE1 peptide (GL Biochemistry, Shanghai, China; http:// glbiochem.com). The investigators also determined serum Abs stability, performed analysis of interfering substances and antigen absorption tests. The scientists reported that the HISCL system detected specific serum NY-ESO-1/XAGE1 Abs, where levels in ELISA and HISCL were highly correlated. The Ab levels in HISCL were stable at four temperatures, five freeze/thaw cycles, and long-term storage; the levels were not interfered by common blood components. The Abs levels in 15 NSCLC responders to anti-PD-1

monotherapy were significantly higher than those in non-responders and healthy donors. The AUROC was the highest (0.91) in combinatory prediction with NY-ESO-1/XAGE1 Abs. The authors concluded that they had developed a fully automated immunoassay system, HISCL, measuring serum NY-ESO-1/XAGE1 Abs that can predict clinical benefits with anti-PD-1 monotherapy in NSCLC. Their serum biomarkers measured using HISCL are clinically meaningful, as the serum Abs obtained noninvasively were relatively stable at various conditions and could be measured easily and rapidly. The study was published on April, 15, 2021 in the journal Clinica Chimica Acta. Image: The HISCL-5000 is a fully automated immunoassay system designed for fast, highly sensitive and reliable immunoassay testing (Photo courtesy of Sysmex)

Holographic Histopathology Enables Fast, Precise Diagnostics icroscopic assessment of biopsied and resected tissues is central to understanding the underlying pathophysiology and clinical states of many patients. Because most microscopic specimens are translucent to visible light, conventional histological methods achieve image contrast using exogenous labels. Optical diffraction tomography is a microscopy technique for reconstructing the refractive index of a tissue sample from its scattered field images obtained with various illumination angles. It enables label-free high contrast visualization of transparent samples. The complex scattered field transmitted through the sample is first retrieved using off-axis holography, then

the scattered fields obtained with various angle of illuminations are mapped in the Fourier space enabling the reconstruction of the sample refractive index. Bioscientists at the Korea Advanced Institute of Science and Technology (Daejeon, Republic of Korea; www.kaist.ac.kr) and their colleagues developed label-free volumetric imaging of thick-tissue slides, exploiting refractive index distributions as intrinsic imaging contrast. The present method systematically exploited label-free quantitative phase imaging techniques, volumetric reconstruction of intrinsic refractive index distributions in tissues, and numerical algorithms for the seamless stitching of multiple

three-dimensional tomograms and for reducing scattering-induced image distortion. The scientists demonstrated label-free volumetric imaging of thick tissues with the field of view of 2 mm × 1.75 mm × 0.2 mm with a spatial resolution of 170 nm × 170 nm × 1,40 0 nm. The number of optical modes, calculated as the reconstructed volume divided by the size of the point spread function, was ∼20 giga voxels. They have also demonstrated that different tumor types and a variety of precursor lesions and pathologies can be visualized with the present method. The team demonstrated the capacity of Cont’d on page 17 LabMedica International June-July/2021

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LabMedica International

Hematological and Molecular Parameters Defined for CCUS and MDS atients with clonal cytopenia of undetermined significance (CCUS) have low blood counts and a normal bone marrow examination, but more advanced genetic testing shows the presence of a genetic mutation that is likely causing the low counts. Myelodysplastic syndromes (MDS) are clonal hematopoietic stem cell disorders, conditions that can occur when the blood-forming cells in the bone marrow become abnormal. This leads to low numbers of one or more types of blood cells. MDS is considered a type of cancer. Hematologists at the Mayo Clinic (Rochester, MN, USA; www.mayoclinic.org) and their colleagues included in a study a total of 187 patients: 75 (40%) with CCUS and 112 (60%) with Lower-risk MDS (LR-MDS), with a median age of 66 years (63% male). In the CCUS group, 59 (78%) patients had ≥1 somatic mutation, eight (11%) had clonal cytogenetic abnormalities only, and eight (11%) patients had both somatic mutations and clonal cytogenetic abnormalities. Sixty-seven (92%) patients had ≥1 somatic mutation, with 45 (61%) having >1 mutation. Common mutations in CCUS included TET2 (30%), SRSF2 (20%), DNMT3A (13%), and ASXL1 (11%) with 17 (23%) patients being red cell transfusion dependence (TD) and 10 (13%) being platelet TD at diagnosis. The scientists reported that in comparison with patients with CCUS, LRMDS patients were more likely to have higher white blood cell counts (WBC), higher absolute neutrophil counts (ANC), higher platelet counts, be red cell TD, have bone marrow (BM) ring sideroblasts (RS), have higher BM blast%,

Holographic Histopathology Enables Fast, Precise Diagnostics Cont’d from page 16

their novel method by imaging a variety of different cancer pathologies: pancreatic neuroendocrine tumor, intraepithelial neoplasia, and intraductal papillary neoplasm of bile duct. They imaged millimeter-scale, unstained, 100-µm-thick tissues at a subcellular 3D resolution, which enabled the visualization of individual cells and multicellular tissue architectures, comparable to images obtained with traditional chemically processed tissues. YongKuen Park, PhD, a professor and senior author of the study, said, “The images obtained with the proposed method enabled clear visualization of different morphological features in the various tissues allowing for recognition and diagnosis of precursor lesions and pathologies. We expect optical diffraction tomography to provide faster and more precise diagnostics in histopathology and intraoperative pathology consultations.” The study was published on April 29, 2021 in the journal Advanced Photonics.

LabMedica International June-July/2021

and have SF3B1 mutations, whereas CCUS patients were more likely to have higher absolute monocyte counts (AMC). The team observed higher WBC/ANC and platelet counts in MDS patients in comparison with CCUS patients, largely because of the fact that 50% of the MDS cohort comprised of patients with MDS-RS- single lineage dysplasia (SLD), where the dysplasia is largely limited to the erythroid lineage, sparing granulocyte and megakaryocyte development and maturation. The authors concluded that their data, among others, have led to operational classification criteria for the diagnosis of CCUS that includes the presence of myeloid-relevant somatic mutations with a variant allele frequency (VAF) ≥20%, without overt bone marrow (BM) dysplasia (<10% dysplastic cells). They strongly urge the academic community to consider including

CCUS, especially CCUS-HighVAF (≥20%), as a MDS subtype in the next iteration of the WHO classification system. The study was published on April 27, 2021 in the journal Blood Advances. Image: Bone marrow smear from a patient with refractory anemia (MDS) with ring sideroblasts. Classic appearance of ring sideroblasts shows iron deposition in a “necklace” around the nucleus using Perls stain (Photo courtesy of University of Pavia)

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Monocent SARS-CoV2 Antigen Rapid test is a qualitative and immunochromatographic in vitro assay for the detection of SARS-CoV2 virus from nasal swab or nasopharyngeal swab obtained from the patient.

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pproximately one million children develop tuberculosis (TB) and 205,000 die of TB-related causes each year. Eighty percent of these deaths occur in children < 5 years old, with the majority (96%) of deaths occurring among children who did not receive treatment, where missed diagnoses are likely responsible for undertreatment. Children with TB, particularly infants, frequently have paucibacillary TB, exhibit non-specific symptoms, and are likely to rapidly progress to disseminated or extrapulmonary TB in the absence of appropriate treatment. This clinical presentation, combined with difficulty obtaining respiratory samples, makes it challenging to diagnose pediatric TB and monitor treatment responses using standard sputum-based methods. A multidisciplinary team of medical scientists led by Tulane University School of Medicine (New Orleans, LA, USA; https:// medicine.tulane.edu) used a small blood sample that can be easily obtained from children of any age to detect a specific protein (CFP-10) that the bacteria secrete to maintain the infection that develops into TB. Since this protein is present at very low levels in the blood, the assay uses an antibody specific for this protein to enrich it from other proteins in blood and a mass spectrometer to detect it with high sensitivity

Image: Computer-generated Mycobacterium tuberculosis bacteria, Ziehl-Neelsen stain. The reagents used are carbol fuchsin, acid alcohol, and methylene blue counterstain Acid-fast bacilli stain red and the background is blue (Photo courtesy of microbiologyinpictures)

and accuracy. The team used this test to screen stored blood samples collected from 284 HIV-infected and 235 children without the virus who participated in a large clinical trial conducted from 2004 to 2008. Serum CFP-10pep was analyzed using a nanoparticle-based immunoenrichment assay read by matrix assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF-MS) (Bruker Microflex LRF, Bremen, Germany; www.bruker.com) that detects Mtb-specific CFP-10pep from trypsin-digested serum or EDTA plasma samples. The group found their test identified children diagnosed with TB by the current gold-standard TB tests with 100% accuracy. The assay also detected 83.7% of TB cases that were missed by these tests, but that were later diagnosed Cont’d on page 22 LabMedica International June-July/2021

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LabMedica International

Familial Hypercholesterolemia Tends to Slip Past Genetic Tests amilial hypercholesterolemia is a genetic disorder characterized by high cholesterol levels, specifically very high levels of low-density lipoprotein (LDL), in the blood and early cardiovascular disease. The most common mutations diminish the number of functional LDL receptors in the liver. Familial hypercholesterolemia (FH) is the most common inherited cardiovascular disease and carries significant morbidity and mortality risks. Genetic testing can identify affected individuals, but some array-based assays screen only a small subset of known pathogenic variants. FH is an autosomal dominant disorder most frequently associated with variants in the LDL receptor (LDLR) gene. Molecular Biochemists at the Geisinger Genomic Medicine Institute (Danville, PA, USA; www.geisinger.edu) and their colleagues carried out a cross-sectional study and compared comprehensive genetic test results for clinically significant variants associated with FH with results for a subset of 24 variants screened by a limited-variant array. Data were deidentified next-generation sequencing results from indication-based or proactive gene panels. Individuals receiving next-generation sequencing–based genetic testing, either for an FH indication between November 2015 and June 2020 or as proactive health screening between February 2016 and June 2020 were included. Genes were targeted with oligonucleotide baits to capture the exons ±10 base pairs of adjacent intronic sequence and certain noncoding regions of clinical interest. Targeted regions were sequenced to a mean depth of 350× read coverage (minimum 50×). All primary sequencing was performed on Illumina HiSeq or NovaSeq instruments (Illumina, San Diego, CA, USA; www. illumina.com). The number of pathogenic or likely pathogenic (P/ LP) variants were identified. The study included 4,563 individuals who were referred for FH diagnostic testing and 6,482 individuals who received next-generation sequencing of FH-associated genes as part of a proactive genetic test. Among individuals in the indication cohort, the median (interquartile range) age at testing was 49 (3261) years, 55.4% (2,528 of 4,563) were female, and 63.6% (2,902 of 4,563) were self-reported White/Caucasian. The cohorts were tested for more than 2,000 possible variants in four FH-associated genes: LDLR, APOB, PCSK9, and LDLRAP1. The team reported that in the indication cohort, the positive detection rate would have been 8.4% (382 of 4,563) for a limited-variant screen compared with the 27.0% (1,230 of 4,563) observed with the next-generation sequencing–based comprehensive test. As a result, 68.9% (848 of 1,230) of individuals with a P/LP finding in an FH-associated gene would have been missed by the limited screen. The potential for missed findings in the indication cohort varied by ancestry; among individuals with a P/LP finding, 93.7% (59 of 63) of self-reported Black/African American individuals and 84.7% (122 of 144) of Hispanic individuals would have been missed by the limited-variant screen, compared with 33.3% (4 of 12) of Ashkenazi Jewish individuals. In the proactive cohort, the prevalence of clinically significant FH variants was approximately 1:191 per the comprehensive test, and 61.8% (21 of 34) of individuals with an FH-associated P/LP finding would have been missed by a limited-variant screen. The authors concludes that limited-variant screens may falsely reassure the majority of individuals at risk for FH that they do not carry a disease-causing variant, especially individuals of self-reported Black/African American and Hispanic ancestry. The study was published on May 26, 2021 in the journal JAMA Cardiology.

Image: The NovaSeq 6000 performs whole-genome sequencing (Photo courtesy of Illumina)

LabMedica International June-July/2021

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Genesig COVID-19 3G is a CE-Marked three-gene assay to detect the ORF1ab, M gene, and S gene targets of SARS-CoV-2, enabling fulfillment of certain international testing requirements.

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Intraoperative Frozen Section Detects Acute Invasive Fungal Rhinosinusitis cute invasive fungal rhinosinusitis (AIFRS) is a potentially lethal and rapidly progressive disease. It primarily affects immunocompromised or diabetic patients, in whom organisms that are ubiquitous, but usually harmless can invade mucosa and rapidly disseminate to the orbit and cranial cavity. Diagnostic delay is a factor that has consistently been associated with poor outcome in AIFRS, and this, in part, is related to the fact that AIFRS remains a histopathologic diagnosis. The clinical features are nonspecific, and sinus computed tomography is limited by lack of sensitivity for early AIFRS and poor specificity thereafter. Medical Laboratorians at the UT Health San Antonio (San Antonio, TX, USA; www.uthscsa.edu) retrospectively reviewed all cases of clinically suspected AIFRS during a 10-year period. Frozen-section samples were received fresh from the operating room, embedded in optimal cutting temperature medium, and allowed to freeze within a cryostat at an approximate temperature of −20 °C. Biopsies were entirely embedded when size permitted. Sections were prepared using a Leica Biosystems cryostat (Nussloch, Germany; www.leicabiosystems.com), at a thickness of approximately 5 µm, across two different levels. These were stained with hematoxylin and eosin (H&E) and interpreted by the general surgical pathologist on-call for frozen sections. The frozen-section results were compared with the final permanent sections as well as the tissue fungal culture results, following which the accuracy of frozen section was determined. The team reported that 48 patients with 133 frozen-section evaluations for AIFRS were included in the study. Thirty of 48 patients and 61 of 133 specimens were positive for AIFRS on final pathology. Of 30 positive patients, 27 (90%) had at least one specimen diagnosed

as positive during intraoperative consultation; among the 61 positive specimens, 54 (88.5%) were diagnosed as positive during intraoperative consultation. Of 72 negative specimens, all were interpreted as negative on frozen section. Thus, frozen sections had a sensitivity of 88.5%, specificity of 100%, positive predictive value of 100%, and negative predictive value of 90.6%. The authors concluded that the decision to undertake surgical debridement in patients with AIFRS requires definitive histopathologic diagnosis, for which intraoperative consultation with frozen section may be requested. Their analysis has demonstrated overall high accuracy of frozen sections in this scenario, and this information may be valuable in the surgical management of these patients. The study was published in the June, 2021 issue of the journal Archives of Pathology and Laboratory Medicine. Image: (A) Mucormycetes demonstrated broad hyphae with wavy, nonparallel walls and few septa. (B) Nonmucormycetes, which were predominantly Aspergillus species by culture, demonstrated thin delicate hyphae with parallel walls and frequent septa. (C and D) Candida species were distinctive for a mixture of yeasts and pseudohyphae (Photo courtesy of UT Health San Antonio)

Serum Based Antigen Test Detects Childhood Tuberculosis Cont’d from page 20

by a standard checklist employing an array of other information collected by each child’s physician (unconfirmed TB cases). The test also detected CFP-10 in 77% of the blood samples that were collected 24 weeks before children were diagnosed with TB by other methods, indicating its strong potential for early TB diagnosis. The biomarker from some positive cases can be detected as early as 60 weeks before their TB diseases were confirmed. Tony Y. Hu, PhD, a Professor of Biochemistry and Molecular Biology and senior author of the study, said, “This is a breakthrough for infants with tuberculosis because we don’t have this kind of

screening technology to catch early infections among those youngest groups who are most likely to be undiagnosed. I hope this method can be pushed forward quickly to reach these children as early as possible.” The authors concluded that their results suggest that serum CFP10pep signal could improve TB diagnosis in children, as it exceeds the WHO-specified sensitivity requirements for new non-sputum diagnostics, and exhibits similar performance for all TB manifestations, including culture-negative TB, HIV/TB co-infection, and extrapulmonary TB, which are normally challenging to diagnose. The study was published on May 18, 2021 in the journal BMC Medicine. LabMedica International June-July/2021

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LabMedica International

Point-of-Care Testing Evaluated for Early Coagulopathy Diagnosis emorrhage and coagulopathy are particularly relevant complications and are often connected to injuries, surgical interventions, serious diseases, anticoagulant medication or pregnancy/delivery. Acute bleeding requires fast and targeted therapy and therefore, knowledge of the patient’s potential to form a clot is crucial. Treating bleeding complications, rapid hemostatic optimization (interventional, surgical, mechanical or medication) and targeted therapy are therapeutic goals and are therefore equivalent to those of coagulopathy treatment. The earlier a coagulopathy is diagnosed, the earlier a targeted therapy can be initiated. The international normalized ratio (INR) value is of particular importance for the diagnosis and therapy of coagulopathy. Intensive Care Physicians at the University Hospital Frankfurt (Frankfurt, Germany; www.kgu.de) and their colleagues included in a study, one group that included hemorrhagic patients from the department of obstetrics (obstetric group = OG), and another group comprising patients admitted to the emergency department (emergency group = EG). The primary outcome measure was the difference between two INR results of one blood sample determined by point-of-care testing (POCT) and standard laboratory testing (SL). After blood sampling, a drop of blood was applied immediately to the test stripe of the POCT device, CoaguChek Pro II (Roche Diagnostics GmbH, Mannheim, Germany; www.roche.com). The CoaguChek Pro II is

a portable device requiring an 8-µl sample volume. It measures the international normalized ratio (INR) based on an electrochemical reaction. Samples for SL analysis were sent to the central laboratory via a pneumatic dispatch system (EG) or personal-based transport (OG) for automated analysis with an ACL TOP 700 Hemostasis testing System, (Werfen GmbH, Munich, Germany; www.werfen.com) in combination with PT Re Combiplastin 2G reagents. The team reported that INR results between POCT and SLA showed a high and significant correlation. POCT results were reported significantly more quickly (EG: 1.1 versus 39.6 minutes; OG: 2.0 versus 75 minutes) and required less time for analysis (EG: 0.3 versus 24.0 minutes; OG: 0.5 versus 45.0 minutes) compared to SLA. The time for transportation with the pneumatic tube was significantly shorter (8.0 versus 18.5 minutes) than with the personal-based transport system. The estimated blood loss was between 800 mL and 1300 mL. The authors concluded that strip-based test systems may be suitable methods for the emergency diagnosis of hemorrhagic patients because their measurement results are available significantly more quickly and seem to support the use of point-of-care INR-devices to rule out pathological INR-values in bleeding patients. The test strip-based methods can be used as diagnostic elements in hemotherapy algorithms to implement fast and targeted hemotherapy that can positively impact the

clinical outcomes of patients. The study was published on May 23, 2021 in the journal Practical Laboratory Medicine. Image: The CoaguChek Pro II Coagulation Meter and CoaguChek PT Test Strips (Photo courtesy of Roche Diagnostics)

Low-Density Lipoprotein Cholesterol Associated with Insulin Secretion yslipidemia is characterized by low levels of high-density lipoproteins (HDLs), hypertriglyceridemia, high total and low-density lipoprotein (LDL) cholesterol concentrations, as well as an increased proportion of small dense lipoproteins. Type 2 diabetes is characterized by insulin resistance and impaired insulin secretion from pancreatic β cells. Insulin resistance alone is insufficient to cause type 2 diabetes, as long as the β cell remains able to compensate for the increased demand for insulin. Once this compensatory mechanism reaches its physiological limits, glucose levels increase and patients progress toward overt type 2 diabetes. Doctors specializing in Diabetes from the University of Tübingen (Tübingen, Germany; https://uni-tuebingen.de) and their colleagues investigated the relationship between LDL cholesterol concentrations and insulin secretion and glucagon levels. A total of 3,039 individuals without cholesterol-lowering therapy, but with increased risk for diabetes, underwent routine blood tests and a 5-point oral glucose tolerance test (OGTT). Glucagon concentrations, insulin secretion, and insulin clearance

LabMedica International June-July/2021

Image: The YSI 2300 STAT Plus Glucose & Lactate Analyzer (Photo courtesy of YSI Life Science)

indices were derived from the OGTT. Plasma glucose was measured using an YSI 2300 glucose analyzer (YSI Life Science, Yellow Springs, OH, USA; www.ysi.com). Serum insulin and C-peptide were determined by immunoassay with the ADVIA Centaur XP Immunoassay System (Siemens Healthcare Diagnostics, Erlangen, Germany; www.siemens-healthineers.com). Total, HDL, LDL cholesterol, and triglycerides were measured on the Siemens Healthcare Diagnostics ADVIA Cont’d on page 24 LINKXPRESS COM

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COVID-19 TEST READER

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The COVID-19-CHECK-1 EASY READER+ can be used in combination with immunochromatographic rapid tests for the quantitative detection of anti-spike (S1) IgM and IgG antibodies to the SARS-CoV-2 virus.

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Vircell’s TRANSPORT MEDIUM-2 is intended for collection and preservation of SARS-CoV-2 and influenza A virus in saliva samples. It is provided in labeled screw-cap tubes designed to preserve and transport the clinical sample.

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Personalized CtDNA Analysis Detects Minimal Residual Disease ultiple myeloma (MM), is a type of bone marrow cancer. It is called multiple myeloma as the cancer often affects several areas of the body, such as the spine, skull, pelvis and ribs. Minimal residual disease (MRD) is the name given to small numbers of leukemic cells that remain in the person during treatment, or after treatment when the patient is in remission. Despite treatment with high-dose chemotherapy followed by autologous stem cell transplantation (AHCT), MM patients invariably relapse. MRD-negativity post-AHCT has emerged as the most important prognostic marker. Currently, MRD in MM is monitored via bone marrow aspirate sampling. Marrow MRD assays are limited by the spatial heterogeneity of marrow MM localization; extramedullary disease and sampling variability of marrow aspiration. Hematologists at the Medical College of Wisconsin (Milwaukee, WI, USA; www.mcw. edu) and their colleagues, analyzed in a retrospective, single-center study, circulating tumor DNA (ctDNA) MRD in blood samples collected from 28 patients with MM after upfront AHCT. A total of 80 plasma time points were available pre and post AHCT with a median follow-up of 92.4 months. Multiparameter

flow cytometry (MFC) at 10-4 level was used to assess the MRD from the BM biopsy. Individual bone marrow aspirates or Formalin-fixed, Paraffin-embedded (FFPE) slides from the time of MM diagnosis and matched normal blood were whole-exome sequenced, and somatic mutations were identified. MRD assessment at three months post-AHCT was performed by ctDNA analysis using a personalized, tumor-informed Signatera bespoke mPCR NGS assay (Natera Inc, San Carlos, CA, USA; www.natera.com). The prognostic value of ctDNA was evaluated by correlating MRD status with clinical outcomes. The scientists reported that ctDNA was detectable in 17/24 (70.8%) of pre-AHCT, 15/28 (53.6%) of three months post-AHCT, and 11/28 (39.2%) of patients during the surveillance phase post-AHCT. Of the 15 ctDNA MRD positive patients, 93.3% experienced relapse on follow-up (hazard ratio: 5.64). Patients negative for ctDNA at three months post-AHCT had significantly superior progression-free survival (PFS) compared to positive (median PFS, 84 months versus 31 months) The positive predictive value (PPV) for relapse among patients positive for ctDNA at three months post-AHCT was 93.3%, and signifi-

cantly higher than marrow multiparametric flow cytometry (MFC) of 68.4%. The authors concluded that their study shows the feasibility that a tumor-informed assay on archival blood samples is predictive of relapse post-AHCT. Future prospective studies with real-time marrow next generation sequencing (NGS) and ctDNA samples are needed to define the role of ctDNA in MM and its prognostic significance. The study was presented at the virtual 2021 ASCO Annual Meeting held June 4-8, 2021. Image: Bone marrow aspirate showing mature plasma cells with eccentric nuclei and abundant basophilic cytoplasm indicative of multiple myeloma (Photo courtesy of Dr. David Israel Garrido, MD et.al.)

Low-Density Lipoprotein Cholesterol Associated with Insulin Secretion Cont’d from page 23

XPT Clinical Chemistry System. Glycated hemoglobin measurements were performed using the Tosoh A1c analyzer HLC-723G8 (Tosoh Bioscience GmbH, Griesheim, Germany; www.tosohbioscience.de). The scientists reported that there was association between LDL cholesterol and fasting glucagon or post–glucose load glucagon levels, but they detected significant

positive associations of LDL cholesterol and C-peptide–based indices of insulin secretion. In contrast, they found a negative association of insulin-based insulin secretion indices with LDL concentrations. LDL cholesterol levels, however, were positively associated with insulin clearance assessed from C-peptide and insulin concentrations, both in the fasting state and post–glucose load.

The authors concluded that as C-peptide based indices reflect insulin secretion independent of hepatic clearance, their results indicate lower insulin secretion in case of lesser LDL cholesterol. This could explain deteriorating glycemic control in response to cholesterol-lowering drugs. The study was published in the June, 2021 issue of The Journal of Clinical Endocrinology & Metabolism. LabMedica International June-July/2021

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LabMedica International

Urinary Sodium / Potassium Ratio Screens for Hyperaldosteronism in Hypertensive Men mong individuals with hypertension, the prevalence of secondary hypertension has been reported to be around 10%. More than half of individuals with secondary hypertension have associated hyperaldosteronism. Hyperaldosteronism is a medical condition wherein too much aldosterone is produced by the adrenal glands, which can lead to lowered levels of potassium in the blood (hypokalemia) and increased hydrogen ion excretion (alkalosis). A team of medical scientists led by those at Kyoto Prefectural University (Kyoto, Japan; www.kpu-m.ac.jp) hypothesized that the urinary sodium/potassium ratio (Na/K) could be used as a simple, low-cost method of screening for hyperaldosteronism among individuals with hypertension in primary care and health examination settings. They recruited hypertensive individuals aged 30-69 years old who were not taking any antihypertensive medications from among participants in health examinations. Overall, 160 participants (108 men and 52 women) with a mean age of 54.3 years were eligible for this study. Urinary Sodium (Na) and potassium (K)

were measured using second morning urine samples, and the plasma aldosterone concentration (PAC) was also measured. The assay kit used for the measurement of the PAC was the SPAC-S Aldosterone Kit (TFB, Inc. Tokyo, Japan; www.otsuka.co.jp). The team evaluated the association of the second morning urine Na/K ratio (SMU Na/K) with a high PAC, defined as ≥90th percentile (24.3 ng/dL), using receiver operating characteristic (ROC) curves. The investigators reported that the area under the ROC curve for the relationship between SMU Na/K and high PAC was 0.77 (95% confidence interval [CI]: 0.590.95) in men and 0.64 (95% CI: 0.36-0.93) in women. In men, SMU Na/K values of less than 1.0 could detect hyperaldosteronism with a sensitivity of 45.5%, a specificity of 97.9%, a positive predictive value of 71.4%, and a negative predictive value of 94.1%. The authors concluded that the use of the urinary Na/K ratio may be appropriate as a method of screening for hyperaldosteronism in hypertensive men. The urinary Na/K ratio in second morning urine was inversely associated with the PAC in hypertensive

men but not in women. A low urinary Na/K ratio could be a surrogate marker for the detection of a high PAC in hypertensive men. The study was published on May 17, 2021 in the journal Hypertension Research. Image: Blood test for plasma aldosterone concentration was used to screen For hyperaldosteronism in hypertensive men (Photo courtesy of VisitHealth Ltd)

Meconium Microbiome Can Help Predict Risk of Developing Allergies econium, which is typically passed within the first day of life, is made up of a variety of materials ingested and excreted during development, ranging from skin cells, amniotic fluid and various molecules known as metabolites. Microbiota maturation begins in earnest immediately after birth, when pioneering bacteria are introduced into the neonatal gut and form a niche capable of supporting successive colonizers that will comprise the infant microbiota. Maturation of this microbial community continues through the first few years of life and occurs concomitantly with dramatic shifts in host immune function. A team of scientists from the University of British Columbia (Vancouver, BC, Canada; www. ubc.ca) analyzed meconium samples from 37 healthy control infants and 63 atopy infants enrolled in the CHILD Cohort Study (CHILD), a world-leading birth cohort study in maternal, newborn and child health studies. These samples were analyzed by Metabolon, Inc (Morrisville, NC, USA; www.metabolon.com) for non-targeted metabolic profiling via their mView Global Metabolomics Profiling Platform using Ultrahigh Performance Liquid Chromatography-Tandem Mass Spectroscopy (UPLC-MS/MS). The scientists discovered that the fewer different types of molecules a baby’s meconium contained, the greater the child’s risk of developing allergies by one year. They also found that

LabMedica International June-July/2021

a reduction in certain molecules was associated with changes to key bacterial groups. These bacteria groups play a critical role in the development and maturation of a vast ecosystem of gut microbes, known as the microbiota, which is a powerful player in health and disease. Using a machine-learning algorithm, the scientists combined meconium, microbe and clinical data to predict with a high degree of accuracy (76%), and more reliably than ever before, whether or not an infant would develop allergies by one year of age. Stuart E. Turvey, MBBS, DPhil, FRCPC, a Professor of Pediatrics and the senior author of the study, said, “We know that children with allergies are at the highest risk of also developing asthma. Now we have an opportunity to identify at-risk infants who could benefit from early interventions before they even begin to show signs and symptoms of allergies or asthma later in life.” The study was published on April 29, 2021 in the journal Cell Reports Medicine. LINKXPRESS COM

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NEXT-GENERATION SEQUENCING (NGS) WORKSTATION HAMILTON ROBOTICS

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The CellaVision Remote Review Software gives remote users access to processed slides and makes it possible to review and verify cell differentials from anywhere, anytime.

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Hemostatic Profile Associated with Migraine with Aura early 15% of the population in the USA experiences migraine. One subtype of migraine that is not well understood is migraine with aura (MA). Individuals who experience MA often see flashing lights, blind spots, or jagged lines in their visual field prior to onset of their migraine headaches. Individuals who experience MA also face a heightened risk of stroke and cardiovascular disease, although scientists continue to explore why this correlation exists. Based on prior studies, it is controversial whether enhanced atherosclerosis among individuals with MA is likely to explain the migraine association with stroke, suggesting the existence of alternative mechanisms including endothelial activation or a potential role of hypercoagulability and microemboli. An international team of Medical Scientists led by Brigham and Women’s Hospital (Boston, MA, USA; www.brighamandwomens.org) investigated potential causal relationships between hemostatic profiles and migraine by leveraging largescale genome-wide association study (GWAS) summary statistics for migraine and migraine subtypes (MA and migraine without aura [MO]), and for eight hemostatic factors (including plasma levels or

activities of fibrinogen, D-dimer, coagulation factor VII [FVII], coagulation factor VIII [FVIII], coagulation factor XI [FXI], von Willebrand factor [vWF], tissue plasminogen activator [tPA], and plasminogen activator inhibitor-1 [PAI-1] among up to 120,246 individuals), two hemostasis clinical tests (activated partial thromboplastin time [aPTT] and prothrombin time/international normalized ratio [PT/INR], which are commonly used to screen for coagulation-factor deficiencies), as well as serum concentrations of two forms of fibrinopeptide A (fibrinopeptide A [ADSGEGDFXAEGGGVR*] and phosphorylated fibrinopeptide A [ADpSGEGDFXAEGGGVR*]). The investigators found a strong association between four coagulation factors and migraine susceptibility. They observed that genetically increased levels of three blood clotting factors: coagulation factor VIII, von Willebrand factor, and phosphorylated fibrinopeptide A, and genetically decreased levels of fibrinogen (a protein important in the late stages of the blood clotting process) were all associated, in part, with migraine susceptibility. Interestingly, scientists did not find this association among individuals who experience migraine without aura (MO), indicating a specific relationship between these hemostatic factors and MA. Yanjun Guo, MD, PhD, of the Division of Preventative Medicine at the Brigham and the first author of the study, said, “It is very exciting that by using Mendelian randomization we were able to show that hemostatic factors are associated with MA. And because in the observational studies we saw that MA patients have a higher risk of stroke, these findings may reveal a potential connection between MA and stroke.” The authors concluded that their findings suggest potential causal roles of genetically determined elevated FVIII, vWF, phosphorylated fibrinopeptide A, and decreased fibrinogen in migraine susceptibility, especially for MA, but the effects of FVIII and vWF on migraine are not independent from each other. The study was originally published online on April 1, 2021 in the journal Neurology. Image: Appearance of a common form of typical migraine visual aura (Photo courtesy of Poojitha Mamindla, PharmD)

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LabMedica International

Test Offers Biopsy-Free Colon Cancer Diagnosis cont’d from cover

biopsy sample from the tumor and blood. To eliminate the need for a sample of the tumor, investigators at Massachusetts General Hospital (Boston, USA; www.mgh.harvard.edu) evaluated a plasma-only ctDNA assay, which combined genomic and epigenomic cancer signatures to enable “tumor-uninformed” MRD detection. For this study, the investigators analyzed 252 prospective serial plasma specimens from 103 colorectal cancer (CRC) patients undergoing curative surgery, and the results were correlated with tumor recurrence. From the original group of 103 patients, 84 patients with cancers of various stages had plasma drawn post-completion of definitive therapy, defined as surgery only or completion of adjuvant therapy. Results revealed that in “landmark” plasma drawn approximately one-month post-definitive therapy and followed up a year later, 15 patients had detectable ctDNA, and all 15 recurred. Of 49 patients without detectable ctDNA at the landmark timepoint, 12 recurred. Landmark recurrence sensitivity and specificity were 55.6% and 100%. Integrating epigenomic signatures increased sensitivity by 25-36% versus genomic alterations alone. Notably, the standard measurement of serum carcinoembryonic antigen (CEA) levels did not predict cancer recurrence. For this study, the investigators used the Guardant Health (Redwood City, CA, USA; www.guardanthealth.com) Reveal assay. This test has reportedly achieved industry-leading sensitivity (91%) for detecting ctDNA by simultaneously interrogating both genomic alterations and methylation. Results were obtained from a simple blood draw and returned in as little as seven days without the need for a tissue biopsy. Thus, the test improved the management of early-stage CRC patients by detecting circulating tumor DNA in blood after surgery to identify patients with residual disease who may benefit most from adjuvant therapy, and by detecting recurrence months earlier than current standard-of-care methods like CEA tests or imaging. “The use of ctDNA, which is a type of “liquid biopsy”, is a powerful prognostic tool to detect residual disease, and many prospective trials are under way in the United States, Europe, Asia, and Australia to use ctDNA to guide treatment decision-making,” said first author Dr, Aparna R. Parikh, an oncologist at Massachusetts General Hospital and assistant professor of medicine at Harvard Medical School. “Most studies have used a tumor-informed ctDNA approach that requires testing of the tumor and knowledge of tumor-specific alterations, which cannot be used when a patient has insufficient tumor tissue for analysis. This is one of the first studies to report on a plasma-only approach. There are advantages and disadvantages to each of the approaches.” The tumor-uninformed liquid biopsy was described in the April 29, 2021, online edition of the journal Clinical Cancer Research.

LabMedica International June-July/2021

Image: An assay platform that combines robust, high-efficiency biochemistry at the front-end, with next-generation sequencing, and a machine-learning augmented bioinformatics pipeline provides information that can help advanced cancer patients obtain the right treatment (Photo courtesy of Guardant Health, Inc.)

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FlaskScrubber Vantage Series Glassware Washers have specialized features for contamination-sensitive research. They are designed to wash and dry narrow-neck and general purpose glassware.

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Rapid, Direct-to-Digital Prostate Biopsy Pathology Evaluated ncreasing adoption of digital pathology promises marked improvements in reproducibility, efficiency, and accuracy of tissue-based diagnostics by facilitating routine remote expert consultation and enabling computerized image analysis for clinical use. Clearing histology with multiphoton microscopy (CHiMP) is a new technique for tissue processing and image acquisition that eliminates conventional paraffin embedding by incorporating fluorescent staining during preparation steps and then uses a fast, high-resolution laser-scanning multiphoton microscope to acquire images on intact tissue. Medical Laboratory Scientists at Yale School of Medicine (New Haven, CT, USA; https://medicine.yale.edu) analyzed samples from 40 patients with a high likelihood of prostate cancer based on magnetic resonance imaging consented to investigational core biopsy. A subset of samples was used for direct comparison of physical slide preparation effects and time-tracking determination with multiphoton microscopy. Twenty samples were processed for diagnostic comparison between multilevel digital slides and subsequently produced physical slides. A reference diagnosis based on all data was established using grade groups. Level of diagnostic match and requests for immunohistochemistry were compared between physical and digital diagnoses. Immunohistochemical staining and length measurements were secondary outcomes. Imaging of pathologist study specimens was performed in a prototype specialized ultrafast multiphoton microscope supplied by the startup company Applikate Technologies (Weston, CT, USA) that incorporates a femtosecond pulsed laser and a 0.95 numerical aperture benzyl alcohol/ benzyl benzoate immersion objective. All physical tissue slides were imaged using an Aperio ScanScope (Leica Biosystems, Wetzlar, Germany; www.leicabiosystems.com) at ×40 equivalent resolution for digital storage and preparation of figures. The scientists reported that interpretations based on direct multiphoton imaging yielded diagnoses that were at least as accurate as standard

histology; cancer diagnosis correlation was 89% (51 of 57) by physical slides and 95% (53 of 56) by multiphoton microscopy. Grade-level concordance was 73% (44 of 60) by either method. Immunohistochemistry for routine prostate cancer–associated markers on these alternatively processed tissues was unaffected. Alternatively processed tissues resulted in longer measured core and cancer lengths, suggestive of improved orientation and visualization. The authors concluded that their study demonstrates the viability of using direct digital imaging for definitive microscopic evaluation of tissue without requiring physical slide preparation for gold standard–level diagnosis. Overall, results support practical relevance of the CHiMP technique for prostate biopsy evaluation, with the potential to significantly advance prostate cancer diagnostics, and meriting continuing detailed validation as a process incorporated into clinical diagnostic practice. The study was published in the May, 2021 issue of the journal Archives of Pathology and Laboratory Medicine. Image: Standard hematoxylin-eosin sections are unaffected by processing and imaging by clearing histology with multiphoton microscopy (CHiMP). Portions of the same core biopsy were submitted directly to standard processing (A) or processed by CHiMP and subsequently embedded in paraffin, sectioned, and stained (B), showing equivalent coloration and morphology (Photo courtesy of Yale School of Medicine)

Serum Biomarkers Differentiate COVID-19 From Classic Cytokine Storm Syndromes cytokine storm, also called hypercytokinemia, is a physiological reaction in humans and other animals in which the innate immune system causes an uncontrolled and excessive release of pro-inflammatory signaling molecules called cytokines. Infection with the novel coronavirus SARSCoV-2 triggers severe illness with high mortality in a subgroup of patients. Such critical

course of coronavirus disease (COVID)-19 is thought to associate with cytokine storm as in macrophage activation syndrome or secondary hemophagocytic lymphohistiocytosis. An international team of Pediatric Rheumatologist and Immunologists led by the University Children’s Hospital Muenster team (Muenster, Germany; www.medizin.uni-muen ster.de) examined whether immune activation

in COVID-19 mimics conditions seen in secondary hemophagocytic lymphohistiocytosis (sHLH) or macrophage activation syndrome (MAS), both classic cytokine storm syndromes, and analyzed 83 serum samples from 30 patients with COVID-19. The team also included 20 sHLH serum samples, as well as 17 samples of MAS linked to adult-onset Still’s disease. Cont’d on page 32 LabMedica International June-July/2021

Edited by Katherina Psarra, MSc, PhD

IFCC members may sen d ne ws to: Katherina Psarra, MSc, Ph D, D ept of Immunology – Histocompatibility, Evan gelismos H ospital, Ipsilantou 45-47, Athens 10676, Greece4; Email: ene ws@ifcc.org

NEWS

IFCC Webinar Series Posted on IFCC Website

series of latest IFCC webinars providing timely presentations and insights on selected topics in clinical diagnostics, is now made available at the eAcademy on the IFCC website. The IFCC eAcademy is an open educational resource freely available to laboratory professionals and trainees around the world. eAcademy webinars have been developed by international subject matter experts for the continuous professional development of members of IFCC member societies and federations. This new educational tool is managed by the IFCC Committee on Internet and eLearning (C-IeL) and financially supported by Siemens Healthineers and the Boston Children Hospital. Suggestions for topics, content or contributions may be made using the Contact Us form on the IFCC website. As part of this strategy, in 2020 IFCC piloted a LIVE WEBINAR Series via the WorkCast platform to gain experience with these types of virtual global events. The four webinars presented in September, October, and November had between 2500–3500 attendees each from up to 123 countries around the world listening live to the webinar presentations. Truly international in nature! All registered attendees were also issued a certificate of attendance. IFCC webinars currently posted at the IFCC website take about 20 minutes each. 2021 series include the following topics:

n Analytical Performance Specification for EQAS, by Anna Carobene; n EQAS for COVID and Brazil experience, by André Valpassos P. Guimarães; n How to Calculate the Costs of Non-Quality in a Clinical Laboratory, by Elias Miranda Gonzalez; n Direct Oral Anticoagulants: Pharmacodynamic Evaluation for Ensuring Safety and Efficacy, by Qian Xiang; n The Structure and Function Studies for Clinical Diagnosis of Thrombotic and Hemostatic Disorders, by Wenman Wu; n Clinical Manifestation and Mechanism of Thrombocytopenia in COVID-19 Patients, by Jiancheng Xu; n Overview of Risk Management, by Merve Sibel Gungoren; n Process of Risk Management, by Praveen Sharma; n Risk Management and Continuous Improvement, by Edward Randell; n Digital Nucleic Acids Amplification Testing of Infectious Diseases Based on Droplet Array Production Via Cross-Interface Oscillation, by Wenbin Du; n Metagenomic Next-Generation Sequencing in Clinical Microbiology: Utility and Challenges, by Hui Wang; n How to Improve the Impact of Up-to-Date Microbiological Tests on Patient Management: A Clinician’s Perspective, by Jing Zhang. To view above webinars visit the eAcademy Channel at the Resources and Downloads section on the IFCC website www.ifcc.com, or click on the following link: https://eacademy.ifcc.org/events/ ifcc-live-webinar-series-2021/

LabMedica International June-July/2021

NEWS

N e w s fro m th e W orld of th e Intern atio n al F e d eratio n of Clinical C h e mistry a n d La b oratory Me dicin e Visit w w w .ifcc.org for m ore inform atio n

Editorial By Katherina Psarra, MSc, PhD Dear Colleagues, he blue sea is waiting for us, it can cure most of our worries, it offers relaxation and hope. Well, I know, I am writing to you from a blue country, where the sea is at its best, but I wish you a beautiful summer, I hope you will have some rest, you will feel much better. I am sure you appreciated a lot the really interesting webinar about risk management in clinical laboratories. So much information by very good teachers. Let’s try to apply it in our labs. We are looking forward to the next one on Clinical Applications of Thrombosis and Hemostasis, to be held on June 6th. In our president Prof Khosrow Adeli’s message very

important matters are announced like the establishment of two new Task Forces, the IFCC Taskforce on Outcome Studies in Laboratory Medicine (TF-OSLM) and the IFCC Taskforce on Global Reference Interval Database (TF-GRID). Take some time and go through their goals. You may be your society’s best candidate for a position in them. This June issue of the eNews is not very big. It gives you the opportunity to read about a new teamwork, awarded by Univants, about thyroid dysfunction during pregnancy. Go through the issue, dear colleagues. I am sure that you will find a lot of interesting information and get prepared for wonderful holidays. We want you back refreshed and ready for our meetings (hopefully in person) to come. And, Dr Gouget, please, don’t forget us next time.

The UNIVANTS of Healthcare Excellence Award Program Initiates Third Award Cycle: Are You Ready To Apply? he UNIVANTS of Healthcare Excellence awards recognize clinical care teams that have integrated across disciplines to lead best practices in care delivery and demonstrated measurably better outcomes across key stakeholder; patient, payor, clinician and health system administration. On August 1, 2021 the next award cycle officially opens and all applicants who meet the award criteria are welcome and encouraged to apply.

Why should I apply? This award is intended to highlight best practices, to inspire unity, and to encourage novel, avant-garde ways of thinking. It is a vehicle for healthcare leaders who are driven by not just the opportunity to be recognized but by the larger goal to disseminate their best practice across the globe and inspire measurable change in care. If this sounds like you and your integrated clinical care team please visit https://www.univantshce.com/int/en/home to learn more about the award, past winners and how to apply.

What does the ideal application look like? Best practices come in many shapes and sizes but what they have in common are that they’re comprised of integrated clinical teams working together towards a shared goal while utilizing clinical and laboratory data in unique ways. Additionally, each team has measured the impact of their project across key stakeholders. Minimum award criteria in order to be considered for recognition include: • The clinical care initiative must be implemented into clinical practice. • The clinical care initiative must include at least three disciplines (including Laboratory Medicine/ Pathology). • There must be at least one measurable impact or Key Performance Indicator (KPI) associated with each of the four stakeholders: patients, clinicians, health systems/ administration, and payors. • Impact can be assessed quantitatively (preferred) or qualitatively, but there must be at least

two quantitative metrics that supports the measurably better healthcare performance within the application. • There cannot be more than four qualitative metrics. What can I do right now? Although you cannot officially apply for the award until August 1, there is a great deal that can be done now to prepare for August 1st. A good first step is to review key documents on the UNIVANTS website (www.UnivantsHCE.come) including the updated applicant guide. We invite teams to convene (if even virtually) to confirm interest,, begin collecting and/or analyzing the necessary data to support your key performance indicators (KPIs), and if needed, to reach out to the UNIVANTS award administration team early for helpful tips and for questions you may have about the award. Direct inquiries to univantsofhealthcareexcellence@abbott.com and let’s have a great year for healthcare excellence.

Survey of Commercial AI-driven Software Platforms for Genomic Analysis and Interpretation of Clinical Sequencing Data

he IFCC Working Group on Artificial Intelligence and Genomic Diagnostics (WGAIGD) presents its new Survey of commercial AI-driven software platforms for genomic analysis and interpretation of clinical sequencing data. An important clinical diagnostic application

of AI is in analysis and interpretation of clinical sequencing data. This is one of the most active commercial areas at the intersection of AI, genomics and clinical diagnostics. Our survey of >20 commercial AI-driven software platforms for genomic analysis and interpretation of clinical

sequencing data can be found HERE. For more information on the IFCC Working Group on Artificial Intelligence and Genomic Diagnostics (WG-AIGD), visit its webpage at: www.ifcc.org/ifcc-emerging-technologiesdivision/etd-working-groups/wg-aigd/

THE WORLD OF IFCC

IFCC Welcomes New Full Member: Peruvian Medical Association of Clinical Pathology (AMPPC) he Asociación Médica Peruana de Patología Clínica (AMPPC) is a scientific association of private law, which by its nature and definition does not pursue profit, and it is representative of registered doctors of Peru, who legally practice in the republic in the field of Clinical Pathology. It is a Scientific Medical Institution recognized by the highest medical authority of Peru, which is the Medical College of Peru. Our medical society was originally called the Peruvian Pathology Society and was founded in the city of Lima, on Thursday, Oc-

tober 25, 1945, being recognized by Supreme Resolution No. 121, dated July 16, 1952. Its first president was Dr. Jorge Ángel Avendaño Hübner, who led it between 1946 and 1949. For almost three decades it was made up of specialists in Pathology and Clinical Pathology, until July 19, 1973, the Medical College of Peru recognized it as the exclusive representative of Clinical Pathologists. In this way, the entity was renamed the Peruvian Society of Clinical Pathology and since then, all its presidents were doctors of this specialty. On July 21, 2016, the association was

re-founded and recognized as a Medical Scientific Society, through Resolution No. 14655-CNCMP-2016 and registered in the Registry of Medical Scientific Societies with code No. 140916-SM-29. To date, we continue to strengthen the leadership of clinical pathologists, within the complex process of the test, seeking to strengthen improvements in professional and labor competencies, better infrastructure, improvements in quality requirements in medical laboratories and making visible the importance of accreditation through ISO 15189. LabMedica International June-July/2021

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NEWS

MESSAGE FROM THE PRESIDENT By Khosrow Adeli

•

President, IFCC

y cordial greetings and compliments of the Summer season to you all in the IFCC family. So far, 2021 has been an extremely productive year for IFCC and we hope to continue this progress into the Summer with the establishment of new taskforces and continuation of the global Live Webinar Series. First, I am delighted to share that we have initiated the establishment of the IFCC Taskforce on Outcome Studies in Laboratory Medicine (TF-OSLM). This taskforce will promote the value of laboratory medicine by gathering evidence to demonstrate the critical role of laboratory medicine in clinical decision making and healthcare delivery as well as communicating these findings to key stakeholders and the public. Developing the evidence to support the value of laboratory medicine in patient care is a key component of our longterm strategy to promote the importance of diagnostic medicine in both patient care as well as public health. The TF-OSLM will aid in the development of a funded research program to assist scientists in institutions around the world with conducting both retrospective and prospective studies to assess outcomes related to the value of laboratory medicine in healthcare. Future plans also include the creation of a database for IFCC members that contains publications that demonstrate this value. A call for nominations was sent out on May 19 to IFCC National Societies and corporate members. Alongside the TF-OSLM, formation of the IFCC Taskforce on Global Reference Interval Database (TF-GRID) is underway. A call for nomination has just been sent out. The primary aim of this taskforce will be the creation of a global reference interval database, which will act as a key resource on pediatric, adult, and geriatric reference intervals for both IFCC members and non-members. An IFCC Reference Interval Website is under development that will highlight major reference interval studies from around the world and should be available online by the end of June. Thereafter, it will evolve into a searchable database that will aid healthcare and labo-

ratory professionals both within and outside of the IFCC organization and facilitate accurate test result interpretation. Once established, this database will facilitate harmonization of reference intervals and comparison of data between regions around the world. In addition to the creation of these new taskforces, the IFCC Live Webinar Series will continue to provide monthly global webinars on all topics relevant to the field of laboratory medicine. In May, several experts from around the world presented on Risk Management in Clinical Laboratories, providing an overview of risk management and frameworks for implementation. The webinar attracted over 4000 registrants from over 100 countries globally. The next webinar, entitled Clinical Applications of Thrombosis and Hemostasis, will be held on June 6. Importantly, I am also pleased to announce that Siemens Healthineers and Boston Children’s Hospital have kindly offered to co-sponsor our IFCC Live Webinar Series over the next three years. Their generous contributions to this global educational program are greatly appreciated by us all in the IFCC family. With these exciting opportunities and advancements, I hope we can look forward to the coming summer months, hopefully free of COVID for many parts of the world. Should you have any feedback, questions, or concerns, please feel free to email me at president@ ifcc.org. Till next time, Khosrow

Prestigious Canadian Site with Top Healthcare Excellence Award Unveils the UNIVANTS “GREAT” Trophy

he UNIVANTS of Healthcare Excellence award program honors and celebrates integrated clinical care teams who have made measurable differences in health outcomes. Among the many honors associated with the program, top-performing teams are now eligible to feature the “Globally Renowned Atlas Trophy” (aka “GREAT” Trophy) at their health system. Reserved only for the most elite healthcare teams, this prominent trophy travels the world, recognizing health systems with patient-centric integrated clinical care teams who have achieved transformational health outcomes. First to receive this elite honor is the 2020 UNIVANTS of Healthcare Excellence award winning team at Seven Oaks General Hospital, Shared Health in Manitoba, Canada. The Kidney Check program, led by Dr. Paul Komenda, Academic Nephrologist, Chronic Disease Innovation Center and

IFCC OFFICE Via Carlo Farini 81, 20159 Milan, ITALY

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

LabMedica International June-July/2021

Professor of Medicine at University of Manitoba is a strategic and comprehensive initiative that involves screening, triage, and treatment for preventive kidney care in rural and remote First Nations communities across Canada. This team drives enhanced wellness for patients and communities through point-of-care testing (POCT) for earlier identification of chronic kidney disease, diabetes, and hypertension in individuals ages 10 and up, regardless of pre-existing risk factors. Using the Kidney Failure Risk Equation (age, sex, eGFR and proteinuria), high risk individuals are identified and linked to appropriate care. Thus far, the Kidney Check program has reached over 11 First Nations communities in Manitoba, Canada. With substantial outcomes and impressive success, the program continues to expand with activation in 4 additional provinces across Canada. The GREAT trophy arrived at Seven Oaks General Hospital in early June 2021. Featured prominently within their main lobby and residing among other honors and affiliations associated with this site, the trophy welcomes patients, employees and executives with its impressive stature and inscription that reinforces the site’s commitment and success in achieving healthcare excellence. “Having the GREAT trophy in the lobby of Seven Oaks General Hospital is a daily reminder of all of our fantastic partnerships and our site’s commitment to patients, communities and healthcare

excellence. We look forward to continued collaboration with our First Nations patients, scientists and clinicians in improving access to early preventative care.” – Dr Paul Komenda, Research Director SOGH CDIC and Professor of Medicine U Manitoba “It is fantastic that our important work with the Kidney Check team has been recognized with this prestigious honor. We love that we are the first site to feature this trophy and are excited to know where it might travel next.” – Heather Martin, Research Coordinator, Chronic Disease Innovation Centre, Seven Oaks General Hospital, Kidney Check Program Learn more about this elite site online at www. cansolveckd.ca/research/kidney-check/ and more about the UNIVANTS program or the GREAT Trophy at https://www.univantshce.com

LabMedica International

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Platelet Indices Analyzed for Tuberculosis and Diabetes Mellitus Co-Morbidity tudies have demonstrated that some diseases accelerate Tuberculosis (TB) occurrence and development. Type 2 diabetes mellitus (DM) has been verified as one of the threatening risk factors for TB, and patients have three times the risk of developing TB compared to non-diabetic patients due to pathogenic mechanisms and metabolic factors. Platelets are enucleate cells and have critical roles in thrombosis, homeostasis and the inflammatory response. When the internal environment is changed, platelet morphology may be altered and play a role in certain platelet-associated parameters, mainly including platelet count (PC), plateletcrit (PCT), platelet distribution width (PDW) and mean platelet volume (MPV). Clinical Laboratorians at Nantong University College of Medicine (Nantong, China; https://ntu.edu.cn) enrolled in a study 246 patients admitted to the hospital and were distributed into three groups (113 TB, 59 DM and 74 TB + DM). A total of 133 individuals were also recruited as healthy controls (HC). Platelet indices, namely, platelet count (PC), mean platelet volume (MPV), plateletcrit (PCT) and platelet distribution width (PDW), were compared among the four groups, and the relationship with inflammatory markers was explored by using statistical software. TB diagnose was based on positive results of Xpert MTB/RIF (Cepheid Inc., Sunnyvale,

CA, USA; www.cepheid.com), The team used BACTEC MGIT 960 rapid liquid isolate culture (Becton Dickinson, Sparks, MD, USA; www.bd.com), and the GenoType check system (Hain Lifescience, Nehren, Germany; www.hain-lifescience.de), and MTB smear confirmation by Ziehl-Neelsen acid-fast stain. Full blood counts were carried out using Mindray BC-6800 hematology analyzer (Shenzhen Mindray Bio-Medical Electronics Co. Ltd., Shenzhen, China; www.mindray. com). The Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) were also measured. The scientists reported that MPV and PCT were significantly downregulated in TB + DM patients (9.95 ± 1.25 fL, 0.20 ± 0.05%, separately) compared with DM individuals (10.92 ± 1.17 fL, 0.22 ± 0.04%). Moreover, the changes in MPV were significantly higher in TB + DM patients (9.95 ± 1.25 fL) than in TB patients (9.42 ± 1.01 fL). MPV improved the diagnosis sensitivity when it was combined with clinical parameters, such as fasting blood glucose in DM and Mycobacterium tuberculosis culture result in TB (76.3% versus 64.9%, 72.6% versus 60.8%), respectively. In addition, the sensitivity and specificity of PCT in the differential diagnosis of DM patients versus TB + DM patients were 69.5 and 59.4%, respectively. PCT improved the diagnosis sensitivity when combined with fasting blood

glucose in DM (72.9% versus 64.9%). In addition, MPV was linked to CRP and ESR in the TB + DM patients. The authors concluded that MPV is a valuable candidate marker to screen for TB-DM coinfection risk, as the occurrence of TB developing into TB-DM coinfection will increase MPV levels, and DM developing into a DM-TB coinfection will decrease MPV levels. MPV has significant specificity and sensitivity for predicting and diagnosing DM-TB coinfection. The study was published on May 20, 2021 in the journal BMC Infectious Diseases. Image: The Mindray BC-6800 hematology analyzer (Photo courtesy of Shenzhen Mindray Bio-Medical Electronics)

Serum Biomarkers Differentiate COVID-19 From Classic Cytokine Storm Syndromes Cont’d from page 28

These serum samples were collected from adults in previous studies. Meanwhile, four samples of juvenile sHLH and nine of juvenile MAS, as well as nine from health controls, were collected. The scientists used bead array assay, as well as single-marker ELISA, to quantify levels of 22 biomarkers in the included serum samples. These included IL-1, IL-1 receptor antagonist (Ra), IL-4, IL-6, IL-8, IL-10, IL-18, TNF, interferon (IFN), IFN, IFN-, MCP2

(CCL8), MCP3 (CCL7), CXCL9, CXCL10, MCSF, LRG1, soluble Fas ligand (sFasL), intracellular adhesion molecule 1 (ICAM-1), VCAM-1 and Galectin-3 (R&D Systems, Minneapolis, MN, USA; www.rndsystems.com). Data acquisition and analysis was performed on a MAGPIX instrument (Merck Millipore, Darmstadt, Germany; www.merckmillipore.com). The scientists observed dramatic activation in sHLH/MAS of the interleukin(IL)-18-interferon (IFN)-γ axis, while increased serum levels of IL-1 receptor antagonist (IL-1Ra), intracellular adhesion molecule 1 (ICAM-1) and IL-8, as well as strongly reduced levels of soluble Fas ligand (sFasL) in course of SARS-CoV-2 infection discriminating immune dysregulation in critical COVID-19 from the investigated well-recognized cytokine storm conditions. Christoph Kessel, PhD, the lead author of the study, said, “Our analyses may further raise doubt regarding the efficacy of clinical trials targeting key molecules and pathways associated with sHLH and/or MAS in the treatment of COVID-19. Therapeutic blockade of IFN-, which appears as promising therapeutic option in treating HLH and potentially also MAS, may be less effective in COVID19, as the overall activation of the IL-18-IFN- axis seems far less pronounced in context of SARS-CoV-2 infection. In contrast to IL-18 and IFN-, IL-1Ra levels in COVID-19 are substantially elevated.” The authors concluded that serum biomarker profiles clearly separate COVID-19 from MAS or sHLH, which questions the significance of systemic hyperinflammation following SARS-CoV-2 infection as well as the efficacy of drugs targeting key molecules and pathways specifically associated with systemic cytokine storm conditions in the treatment of COVID-19. The study was published originally April 20, 2021 in the journal Arthritis & Rheumatology. LabMedica International June-July/2021

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Industry News

PerkinElmer to Acquire IDS, Expanding Immunodiagnostics Range cont’d from cover

munoassay portfolio is a combination of an endocrinology specialty testing menu and assay panels in complementary fields. PerkinElmer’s comprehensive global diagnostics portfolio includes solutions focused on: reproductive health; autoimmune, infectious disease and allergy testing; gene analyses; and genomics offerings for oncology and other molecular tests through its wide range of instruments, reagents, assay platforms and software offerings. Through this acquisition, PerkinElmer will be able to grow its overall Diagnostics business and specifically its immunodiagnos-

tics segment. Moreover, the deal will enable PerkinElmer to combine its channel expertise and testing capabilities with IDS’s best-in-class chemiluminescence products in endocrinology, autoimmunity and infectious diseases to better serve customers around the world. IDS’s portfolio and expertise will seamlessly integrate within EUROIMMUN, a PerkinElmer company since 2017. EUROIMMUN is a global leader in autoimmune testing and an emerging force in infectious disease, allergy and molecular genetic testing. “This proposed transaction is highly valuable for both parties as the respective prod-

Global Clinical Chemistry Analyzer Market to Grow to USD 16 Billion by 2028 he global clinical chemistry analyzers market is projected to grow at a CAGR of 4.25% from USD 11.45 billion in 2020 to USD 15.97 billion by 2028, driven by growth in technology, rising global population, technological improvements in point of care testing devices, and development of laboratory automation. These are the latest findings of Verified Market Research (Lewes, Delaware, USA; www.verified marketresearch.com), a global research and consulting firm. The increasing incidences of chronic diseases triggered largely due to lifestyle changes have been a key growth driver of the clinical chemistry analyzers market. A number of tests are carried out for the diagnosis of such diseases that gives a physician important insights into renal, cardiac and liver functions, among others. Thus, the growing prevalence of chronic diseases, especially diabetes, is expected to significantly contribute to the growth of the clinical chemistry analyzers market. Another key growth driver of the clinical chemistry analyzers market is the rise in geriatric population around the world. The high geriatric population makes it vulnerable to contracting numerous age-associated chronic diseases that require efficient diagnosis, thus leading to the growth of the global clinical chemistry analyzers market. However, COVID-19 has had a negative impact on the clinical chemistry analyzers market. Due to the ongoing lockdowns, people have been forced to stay indoors, and this restricted movement has slowed down the pace of testing, hence hampering market growth. Additionally, high initial setup costs and shortage of skilled laboratory technicians create further expenses for maintenance of equipment, which further hinders market growth. Nevertheless, increasing government support in the area of diagnostics, coupled with technological advancements, will provide further growth opportunities in the global clinical chemistry analyzers market. Geographically, North America holds the highest share of the global clinical chemistry analyzers market and is expected to maintain its dominant position throughout the forecast period due to the presence of globally leading market players, technological leadership and an established healthcare infrastructure in the region. The Asia Pacific region is expected to register the highest CAGR in the forecast period, with countries such as China and Japan increasing their expenditure on healthcare facilities. This, coupled with a growing geriatric population and rapid technological growth, will be the key growth drivers of the clinical chemistry analyzers market in Asia Pacific.

LabMedica International June-July/2021

uct lines are to a large extent complementary,” said Wolfgang Schlumberger, CEO of EUROIMMUN. “The cooperation of our global distribution channels, the expansion of the immunoassay portfolio in closely related indication fields and IDS’s fully automated random access chemiluminescence platform strengthens our presence in immunodiagnostics. Our customers will benefit from a broader range of assays and laboratory diagnostic workflows. We are excited about these new opportunities and we look forward to welcoming Immunodiagnostic Systems into the PerkinElmer family following the completion of the transaction.”

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 JULY ECCMID 2021 – 31st European Congress of Clinical Microbiology & Infectious Diseases. Jul 9-12; Virtual Venue; 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 IAS 2021 – 11th International AIDS Society (IAS) Conference on HIV Science. Jul 18-21; Virtual Venue; Web: ias2021.org ASV 2021 – 40th Annual Meeting of the American Society of Virology. Jul 19-23; Virtual Venue; Web: asv.org/asv2021 AUGUST 11th African Congress of Immunology – Federation of African Immunological Societies. Aug 1-5; Virtual Venue; Web: www.faisafrica.com IFBLS 2021 – International Federation of Biomedical Laboratory Science. Aug 24-28; Copenhagen Denmark; Web: ifbls2021.org 33rd Congress of the European Society of Pathology (ESP). Aug 29-31; Virtual Venue; Web: www.esp-congress.org

26 - Oct 1; Virtual Venue; Web: eurotox-congress.com

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

ASHI 2021 – 47th Annual Meeting of the American Society for Histocompatibility & Immunogenetics. Sep 27 – Oct 1; Orlando, FL, USA; Web: www.ashi-hla. org

Thailand LAB International 2021. Sep 1-3; Bangkok, Thailand; Web: www. thailandlab.com

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

ECI 2021 – 6th European Congress of Immunology. Sep 1-4; Virtual Venue; Web: eci2021.org 43rd Annual Meeting of the European Thyroid Association (ETA). Sep 4-7; Virtual Venue; Web: www.eta2021.com

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

ESCV – 23rd Annual Meeting of the European Society for Clinical Virology. Sep 15-17; Virtual Venue; Web: www. escv2021.org ExpoMedical 2021. Sep 22-24; Buenos Aires, Argentina; Web: www.expo medical.com.ar

90th Annual Meeting of the American Thyroid Association (ATA). Sep 29 - Oct 3; Virtual Venue; Web: www.thyroid.org

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

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

India Lab Expo & Analytica Anacon India. Sep 23-25; Hyderabad, India; Web: www.analyticaindia.com

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

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

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

73rd AACC Annual Scientific Meeting & Clinical Lab Expo – American Association for Clinical Chemistry. Sep 26-30; Atlanta, GA, USA; Web: www.aacc.org EUROTOX 2021 – 56th Congress of the European Societies of Toxicology. Sep

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Events Calendar

– 123 – 125 – 107 – 109 – 115 – 103 111 126 118 121 102 136 120 105

AACC 2021 . . . . . . . . . . . . . . . . . Alcor . . . . . . . . . . . . . . . . . . . . . . . AMP 2021 . . . . . . . . . . . . . . . . . . Bioperfectus . . . . . . . . . . . . . . . . . COLABIOCLI 2022 . . . . . . . . . . . . . . . . DiaSys . . . . . . . . . . . . . . . . . . . . . EuroMedLab 2021 . . . . . . . . . . . . Euroimmun . . . . . . . . . . . . . . . . . ICPLM 2021 . . . . . . . . . . . . . . . . . Instrumentation Laboratory . . . . . LabMedica International . . . . . . . . Nova Biomedical . . . . . . . . . . . . . Randox . . . . . . . . . . . . . . . . . . . . . Rayto . . . . . . . . . . . . . . . . . . . . . . Seegene . . . . . . . . . . . . . . . . . . . . Singuway . . . . . . . . . . . . . . . . . . . Snibe . . . . . . . . . . . . . . . . . . . . . . Snibe . . . . . . . . . . . . . . . . . . . . . . Vicotex . . . . . . . . . . . . . . . . . . . . . Vircell . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . 27 . . . . . . . . 23 . . . . . . . . 17 . . . . . . . . 25 . . . . . . . . . . 32 ......... 7 . . . . . . . . 29 . . . . . . . . 09 . . . . . . . . 33 . . . . . . . . 15 . . . . . . . . 13 ......... 3 . . . . . . . . 11 . . . . . . . . 26 . . . . . . . . 18 . . . . . . . . 21 ......... 2 . . . . . . . . 36 . . . . . . . . 20 ......... 5

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