LabMedica International October 2020 by Globetech

WORLD’S CLINICAL LABORATORY NEWS LEADER ISSN 1068-1760

Vol. 38 No.6 • 10/2020

Protein Biomarker for Risk of liver Disease

esults obtained during a recent study suggest that neuronal regeneration related protein (NREP) can be used as an early biomarker for the detection of nonalcoholic fatty liver disease (NAFLD). NAFLD is the most common

Cont’d on page 16

n extraction-free, direct sample addition RT-PCR test for the detection of SARS-CoV-2 viral RNA in patients suspected of COVID-19 has the potential to increase testing capacity by millions per week. BioGX Inc. (Birmingham, AL,

Researchers testing alternative ways to measure COVID19 antibody levels have developed a process that is faster, easier and less expensive to use on a large scale, and holds promise for accurately identifying potential donors who have the best chance of helping infected patients through convalescent plasma therapy. LabMedica’s COVID-19 Diagnostics Update section starts on page 4.

lINKXPReSS COM

R E A D E R

S E R V I C E

P O R T A L

Renew /Start your Free Subscription

access Interactive Digital Magazine

Instant Online Product Information:

Identify linkXpress codes of 1 interest as you read magazine ®

on linkXpress.com 2 toClick reach reader service portal

code(s) of interest on 3 Mark linkXpress inquiry matrix ®

If your subscription is not renewed every 12 months your Free Subscription may be automatically discontinued

Simple RT-PCR Test for COVID-19 Could Raise Testing Capacity by Millions per week

USA; www.biogx.com) has applied for Emergency Use Authorization (EUA) with the US Food and Drug Administration (FDA) for its extraction-free, direct sample addition RT-PCR test for the detection of SARS-CoV-2 viral RNA in suspected COVID-19 Cont’d on page 20

New Testing Process Could Revolutionize Measurement of COVID-19 antibody levels

See article on page 23

Test Predicts Kidney Transplant Failure

cells recognize foreign or aberrant antigens presented by major histocompatibility complex (MHC-I) expressing cells through the T cell receptor (TCR) and is the first critical step towards establishment of protective immunity against viruses and tumors. Staining with multivalent MHC class-I reagents (multimers) followed by flow cytometry is

COVID-19 Testing without Reagents

Clinical Studies Confirm FDa Data for abbott's COVID-19 Rapid Test

bbott Diagnostics has shared new interim clinical data results on its ID NOW COVID-19 rapid test that confirm the data submitted to the US Food and Drug Administration (FDA) in March for Emergency Use Authorization (EUA) and the interim results shared in its May 21 press release.

Cont’d on page 25

Serology assay Rapidly Characterizes Immune Response to SaRS-CoV-2 antigens

DaIly ClINICal laB NewS

Cont’d on page 22

Image: New Testing Process Could Simplify Measuring COVID-19 Antibody Levels (Photo courtesy of USAMRIID VIO)

new SARS-CoV-2 multi-antigen assay for Simple Western offers quantitative characterization of patient serum or plasma derived human IgG antibodies reactive against recombinant Nucleocapsid protein (N), S1 receptor binding domain protein (RBD), S1

V I S I T

subunit full length, S2 subunit full length, and Spike (S1+S2) viral antigens within one 3-hour run. Bio-Techne Corporation (Minneapolis, MN, USA; www.bio-tech ne.com) has launched its SARSCoV-2 Multi-Antigen Serology Module for Jess and Wes Simple Cont’d on page 27

newly-developed COVID-19 testing method that does not make use of key chemicals, or reagents, but still delivers accurate results, could pave the way for inexpensive, widely available testing amidst the supply shortage of reagent supplies globally. A team of scientists at the University of Vermont (Burlington, VT, USA; www.uvm.edu), working in partnership with a group Cont’d on page 20

INSIDE

COVID-19 Update . . . . . 4 Clinical News . . . . . . . . . 8 IFCC News . . . . . . . . . . 25 Product News . . . . . 6-24 Events Calendar . . 30-31

PUBLISHED IN COOPERATION WITH

International Federation of Clinical Chemistry and Laboratory Medicine

GlOBeTeCH >>> MeDIa <<<

lINKXPReSS COM

lMI-10-20 102

lINKXPReSS COM

lMI-10-20 103

COVID-19 Diagnostics Update

he report that follows provides a survey of news and advances from August 15 until September 30 of this year. For a recap of earlier developments, the reader is invited to refer to previous issues of LabMedica.

Ground-Breaking One-Step COVID-19 Cartridge

A new one-step testing cartridge for COVID19 antibody testing is being developed by Vivera Pharmaceuticals, Inc. (Newport Beach, CA, USA; www.viverapharmaceuticals.com) that will use a simplified procedure to eliminate operator error and deliver more consistent results. Vivera is currently in discussions with top telemedicine providers in the US to develop effective testing protocols for the one-step cartridge once the FDA provides the appropriate pathways.

New Low-cost COVID-19 Test Detects Coronavirus in 20 Minutes

Scientists at the University of Melbourne (Melbourne, Australia; www.unimelb.edu.au) have developed a low-cost nasal swab test which can diagnose the presence of SARS-CoV2 virus in 20 minutes. The test named N1STOP-LAMP is 100% accurate in diagnosing samples containing SARS-CoV-2 at high loads and could help in fast-tracking COVID testing.

AI Spectral Technology COVID-19 Test Achieves 95% Success Rate

An AI spectral technology rapid COVID-19 detection test developed by Newsight Imaging Ltd. (Ness Ziona, Israel; www.nstimg.com) has shown promise in clinical trials by achieving a 95% success rate. The test developed includes a single cost-effective chip and uses an AI algorithm to separate the profile of a human infected with a specific virus, from a human infected with a different virus or from a healthy human.

PerkinElmer Launches Explorer Series Workstations for High-Throughput SARS-CoV-2 Testing

PerkinElmer, Inc. (Waltham, MA; USA; www. perkinelmer.com) has launched a series of explorer workstations for SARS-CoV-2 testing capable of preparing and running up to 10,000 COVID-19 tests per day. These modular and scalable workstations will enable laboratories to ramp up SARS-CoV-2 testing capacity quickly to generate results. Yale’s SalivaDirect COVID-19 Test Receives FDA EUA

The Yale School of Public Health (New Haven, CT, USA; www.publichealth.yale.edu) has been issued an emergency use authorization (EUA) by the US Food and Drug Administration (FDA) for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19 infection. SalivaDirect does not require any special type of swab or collection device; a saliva sample can be collected in any sterile container. This test is also unique because it does not require a separate nucleic acid extraction step.

ELITech Distributes More than 3.5 Million COVID-19 Tests

ELITech Group Molecular Diagnostics (Puteaux, France; www.elitechgroup.com) has distributed more than 3.5 million SARS-CoV-2 tests and also installed more than 500 ELITe InGenius polymerase chain reaction (PCR) systems, globally, with over a 100 systems placed since the start of the COVID-19 pandemic. ELITechGroup has been at the forefront of fighting the COVID-19 outbreak in Europe and has been supplying tests on its ELITe InGenius system since early March in Italy, and other affected countries, such as France, the UK, the Benelux and more. Beckman Coulter and Thermo Fisher to Expand US Diagnostic Labs’ COVID-19 Testing Capacity

The US Department of Health and Human Services (HHS) will make combined investments of USD 6.5 million in Aegis Sciences Corporation (Nashville, TN, USA; www.aegislabs.com) and Sonic Healthcare USA (Austin, TX, USA; www.sonichealthcareusa.com). These companies will provide critical laboratory equipment supplied by Beckman Coulter Life Sciences (Brea, CA, USA; www.beckmancoulter.com) and Thermo Fisher Scientific Inc. (Waltham, MA, USA; www.thermofisher. com), and increase staffing and infrastructure to allow the US to perform an additional one million tests each week by early October.

New 1-Step COVID-19 PCR Collection Buffer for Viral Detection

A novel PCR collection buffer from RayBiotech Inc. (Peachtree Corners, GA, USA; www.raybiotech.com) allows for immediate use of the saliva and other sample types on authorized tests, cutting out a significant amount of the required processing effort and time. The 1-Step COVID-19 PCR collection buffer can also be used directly in the assay without RNA purification from nasal and throat swabs.

10-Minute POC COVID-19 Test Detects SARS-CoV-2 3C-Protease in Saliva

A new 10-minute rapid point-of-care salivabased test developed by Todos Medical Ltd. (Rehovot, Israel; www.todosmedical.com) for detecting active SARS-CoV-2 infections has provided positive proof-of-concept data by achieving analytical performance for detecting active 3C-protease in a rapid visual format. The proof-of-concept analytical performance data demonstrate that the protease signal was specifically and significantly distinguishable from background protease activity present in normal saliva.

Diagnostic Test for Heart Failure Could Lead to COVID-19 Diagnostics and Treatments

Cardiologists at the University of Alberta (Edmonton, Alberta, Canada; www.ualberta. ca) have found that a new blood test that reliably Cont’d on page 5

labmedica.com T

EDITORIAL BOARD

Graham Beastall United Kingdom Claus Christiansen Denmark Hernán Fares Taie Argentina Bernard Gouget France Maurizio Ferrari Italy Jocelyn M. Hicks United States Anders Kallner Sweden Tahir S. Pillay South Africa Andreas Rothstein Colombia Dmitry B. Saprygin Russia Praveen Sharma India Rosa I. Sierra-Amor Mexico Peter Wilding United States Andrew Wootton United Kingdom

A GLOBETECH PUBLICATION

Published in cooperation with the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). HospiMedica International • HospiMedica en Español • HospiMedica China LabMedica International • LabMedica en Español • LabMedica China Medical Imaging International • Bio Research International • Medimaging.net HospiMedica.com • LabMedica.com • BiotechDaily.com • TradeMed.com

Dan Gueron Publisher

Raymond L Jacobson, PhD News Editor Gerald M Slutzky, PhD News Editor Andreas Rothstein News Editor

Sanjit Dutt New Products Editor

Theresa Herman Regional Director

Dr. Jutta Ciolek Regional Director

Parker Xu Regional Director

David Gueron Reader Service Manager Stan Caines Production Director

HOW TO CONTACT US

Subscriptions: Send Press Releases to: Advertising & Ad Material: Other Contacts:

www.LinkXpress.com LMNews@globetech.net ads@globetech.net info@globetech.net

USA, UK Theresa.Herman@globetech.net

Miami, FL 33280, USA Tel: (1) 954-686-0838

ADVERTISING SALES OFFICES

GERMANY, SWITZ., AUSTRIA Simone.Ciolek@globetech.net

OTHER EUROPE Theresa.Herman@globetech.net

JAPAN Katsuhiro.Ishii@globetech.net CHINA Parker.Xu@globetech.net OTHER COUNTRIES ads@globetech.net

Bad Neustadt, Germany Tel: (49) 9771-1779-007

Miami, FL 33280, USA Tel: (1) 954-686-0838 Tokyo, Japan Tel: (81) 3-5691-3335

Shenzen, Guangdong, China Tel: (86) 755-8375-3877

Contact USA Office Tel: (1) 954-686-0838

SUBSCRIPTION INFORMATION

LabMedica lnternational is published eight times a year and is circuIated worldwide (outside the USA and Canada) without charge and by written request, to clinical laboratory specialists and administrators, and other qualified professionals allied to the field.

To all others: Paid Subscription is available for a two-year subscription charge of US$240. Single copy price is US$20. Mail your paid subscription order accompanied with payment to Globetech Media, P.O.B. 801932, Miami, FL 33280-1932. For change of address or questions on your subscription, write to: LabMedica lnternational, Circulation Services at above address; or visit: www.LinkXpress.com

ISSN 1068-1760

Vol.38 No.6. 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 October/2020

Cont’d from page 4

predicts outcomes for heart failure patients could lead to new diagnostics and treatments for COVID-19 patients as well. The researchers have proposed that the test should be used routinely to determine the risk of adverse outcomes in both heart failure and COVID-19 patients.

Diazyme Secures Second FDA EUA for COVID-19 Antibody Test

Diazyme Laboratories, Inc. (Poway, CA, USA; www.diazyme.com) has received FDA Emergency Use Authorization (EUA) for the company’s DZ-Lite SARS-CoV-2 IgM CLIA test which runs on the fully automated DZ-Lite 3000 Plus chemiluminescence analyzer. The test is for the qualitative detection of IgM antibodies to SARS-CoV-2 in human serum and plasma (potassium EDTA, disodium EDTA and lithium heparin) to aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

COVID-19 Diagnostics Update Test uses the QIAGEN eHub to analyze nasalswab samples from up to eight symptomatic people at once. The easy-to-use eStick uses nanoparticle fluorescent detection technology to flag the SARS-CoV-2 nucleocapsid protein. The device delivers negative results in 15 minutes and in as little as three minutes in the case of a strong positive.

Leica Biosystems Partners with Bio-Techne

Leica Biosystems (Wetzlar, Germany; www. leicabiosystems.com) and Bio-Techne Corporation (Minneapolis, MN, USA; www.bio-tech ne.com) have entered into a partnership for the automation of RNAscope COVID-19 probes on BOND RX, Leica's staining platform, for research use only. The BOND RX is a flexible, open platform with the capability to run Bio-Techne RNAscope (duplex and multiplex) protocols,

allowing for boundless innovation. The RNAscope probes are designed to detect SARS-Cov-2 viral RNA, SARS-Cov-2 viral replication sequences, and cellular receptors targeted by the virus, including ACE2 and TMPRSS2.

Ultra-High-Volume COVID-19 Test Can Screen up to 40,000 Samples per Day

Veracyte Inc. (San Francisco, CA, USA; www. veracyte.com) and MAVIDx, Inc. (Miami, FL, USA; www.mavidx.com) have entered into an agreement for MAVIDx to develop ultra-high throughput genomic testing for SARS-CoV-2 on the nCounter Analysis System, Veracyte’s diagnostics platform. The novel approach using molecular barcodes for viral RNA to perform ultrahigh throughput genomic testing for SARS-CoV2 may enable processing of over 40,000 patient samples per day.

Accelerate Diagnostics’ COVID-19 Antibody Testing System Granted FDA EUA

Accelerate Diagnostics, Inc. (Tucson, AZ, USA; www.acceleratediag nostics.com) and BioCheck, Inc. (San Francisco, CA, USA; www.biocheck inc.com) have been issued an Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for the BioCheck SARS-CoV-2 IgM and IgG Combo Test and fully-automated MS-Fast instrument. The kit contains chemiluminescent immunoassays that qualitatively detect the content of SARS-CoV-2 IgM and IgG antibodies in human serum samples performed on the Sophonix MS-Fast Automated Chemiluminescent Immunoassay Analyzing System. QIAGEN Launches QIAseq SARS-CoV-2 Primer Panel

QIAGEN NV (Venlo, Netherlands; www.qiagen.com) has launched the QIAseq SARS-CoV-2 Primer Panel for next-generation sequencing (NGS) of the novel coronavirus genome, along with integrated analysis and interpretation workflows for insights into the evolution and spread of the virus that causes COVID-19 disease. The panel provides optimized, single-day workflows to prepare libraries for sequencing as researchers use NGS to track viral genome changes in studying the epidemiology of virus outbreaks. Additionally, QIAGEN plans to launch a rapid portable test that can detect SARS-CoV-2 antigens in people with active infections in less than 15 minutes and process on average around 30 swab samples per hour using a small digital detection system. The Access Anti-SARS-CoV-2 Antigen

LabMedica International October/2020

lINKXPReSS COM

lMI-10-20 105

Cont’d on page 6

PRODUCT NEWS

COVID-19 IGG/IGM RAPID TEST

To receive prompt and free information on products, log on to www.LinkXpress.com or fill out reader service form located on last page, or scan the QR code on your mobile device

URINE STRIP READER

PROCESS MANAGEMENT SYSTEM

CTK BIOTECH

ERBA MANNHEIM

SIEMENS HEALTHINEERS

The OnSite COVID-19 IgG/IgM Rapid Test is designed for initial screening by detecting anti-SARSCoV-2 IgG and IgM antibodies in either human serum, plasma or whole blood within just 10 minutes.

The LAURA uses reflectance photometry for objective evaluation of color reactions on diagnostic pads. Convenient sample identification and data input via barcode reader and LIS connectivity minimize potential data errors.

The Atellica® Process Manager provides data-driven insights to help labs control and optimize their workflow. With over 10 standard reports available right out of the box it allows labs to better balance system workloads.

lINKXPReSS COM

lMI-10-20 201

COVID -19 Diagnostics Update

Cont’d from page 5

Quidel’s Point-of-Care Sofia SARS Antigen FIA Test for COVID-19 Quidel Corporation’s (San Diego, CA, USA; www.quidel.com) Emergency Use Authorization (EUA) for the Sofia SARS Antigen FIA has been amended to include either nasal or nasopharyngeal swabs. The new kit labeling, with the addition of a nasopharyngeal swab, allows Quidel to offer a second kit configuration to support the nasopharyngeal sample commonly performed in hospitals and helps alleviate some of the supply chain constraints around nasal swab-based kits. LumiraDx SARS-CoV-2 Antigen Test Granted FDA EUA

LumiraDx (London, UK; www.lumiradx. com) has secured Emergency Use Authorization from the US Food and Drug Administration (FDA) for its LumiraDx SARS-CoV-2 antigen test, which detects antigen nucleocapsid protein from a nasal swab with results in under 12 minutes from sample application in symptomatic patients. In clinical studies, the test demonstrated 97.6% positive agreement versus PCR in patients tested within 12 days of the onset of symptoms, making it the fastest, most sensitive antigen point of care test currently commercially available. Tests Detect Common Immune Signature in Blood of COVID-19 Patients

Researchers at the Francis Crick Institute (London, UK; www.crick.ac.uk), King’s College London (London, UK; www.kcl.ac.uk) and Guy's and St Thomas' NHS Foundation Trust (London, UK; www.guysandstthomas.nhs.uk) have found a common immune signature in the blood of patients with COVID-19. The

lINKXPReSS COM

lMI-10-20 202

common immune signature could be used to predict how severely ill a patient will become, thereby aiding patient management. OpGen Launches Molecular Diagnostic SARS-CoV-2 Kit with PULB

OpGen, Inc.’s (Gaithersburg, MD, USA; www.opgen.com) subsidiary Curetis GmbH (Holzgerlingen, Germany; www.curetis.com) has obtained the CE mark certification in the European Union for its own SARS-CoV-2 Kit with PULB for the detection of SARS-CoV-2, the virus that causes COVID-19. Developed and manufactured by Curetis’ team, the SARSCoV-2 Kit with PULB uses real-time reverse transcription polymerase chain reaction (RTPCR) technology for qualitative detection of the SARS-CoV-2 virus isolated from oropharyngeal and nasopharyngeal swab specimens from individuals suspected of COVID-19 by their healthcare provider or for screening of asymptomatic individuals. Beckman Coulter Launches SARS-CoV-2 IgM Antibody Test

Beckman Coulter Diagnostics (Brea, CA, USA; www.beckmancoulter.com) has launched its new Access SARS-CoV-2 Immunoglobulin M (IgM) assay which demonstrated 99.9% specificity against 1,400 negative samples and 98.3% sensitivity at 15-30 days postsymptom onset. Among all the tests developed by the top four in vitro diagnostic manufacturers capable of delivering high-volume testing to the US, Beckman Coulter's test is the only SARS-CoV-2 IgM assay which targets antibodies that recognize the receptor binding domain (RBD) of the spike protein which SARSCoV-2 uses to bind to a human cell receptor.

Zymo Research’s Quick SARS-CoV-2 rRT-PCR Kit Receives CE-IVD Mark Zymo Research (Irvine, CA, USA; www. zymoresearch.com) has received the CE-IVD mark for its Quick SARS-CoV-2 rRT-PCR kit,

lINKXPReSS COM

lMI-10-20 203

enabling its use in the European Union and other countries that accept the designation. The kit targets three different regions of the viral nucleocapsid (N) gene and a host-specific target region (human RNase P gene) to assess sample quality. It can be used on purified RNA samples isolated from upper respiratory and lower respiratory systems.

New COVID-19 Pooling Test Method Identifies Asymptomatic Carriers

Researchers from the Ben-Gurion University of the Negev (BGU Beer-Sheva, Israel; www.bgu.ac.il) have developed P-BEST, an algorithmic method for pooling-based efficient SARSCoV-2 testing. The new COVID-19 pooling test identifies all positive subjects, including asymptomatic carriers, in a single round of testing.

First-Ever Saliva-Based COVID and Influenza Combo Test

Researchers at Rutgers University’s (New Brunswick, NJ, USA; www.rutgers.edu) RUCDR Infinite Biologics are developing a potential coronavirus and influenza combo saliva-based test that would indicate if an individual has been infected by COVID-19, the flu, or neither, according to a report on NJ.com. The researchers hope to receive approval for the coronavirus and influenza combo saliva test by the fall in time for the flu season, marking a crucial development as both the viruses share similar characteristics and symptoms. Novel SERS Assay Could Identify Superspreaders Carrying Coronavirus Mutations

Scientists from Rutgers University (New Brunswick, NJ, USA; www.rutgers.edu) have developed a new technique that can not only identify and quantify viral RNA in living cells, but also detect minor changes in RNA sequences that might give viruses an edge or make some people “superspreaders.” Based on the Cont’d on page 7

LabMedica International October/2020

Cont’d from page 6

new technique, the scientists are now developing COVID-19 diagnostic tests to identify superspreaders, or people carrying unusually high amounts of the SARS-CoV-2 virus and infecting many others. Novel Coronavirus Breathalyzer Test

A team of scientists from Technion – Israel Institute of Technology (Haifa, Israel; www.technion.ac.il) and Russell Berrie Nanotechnology Institute (Haifa, Israel; www.rbni.technion.ac.il), in collaboration with Chinese researchers, has devised a novel breathalyzer that uses that can rapidly detect COVID-19 from specific volatile organic compounds (VOCs) in exhaled breath. The novel breath analyzer test to rapidly detect the disease caused by the novel coronavirus has “the potential to serve as a monitoring and epidemic control tool.” Fluidigm’s Saliva-Based Advanta Dx SARS-CoV-2 RT-PCR Assay Secures FDA EUA

Fluidigm Corporation (South San Francisco, CA, USA; www. fluidigm.com) has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for the Advanta Dx SARS-CoV-2 RT-PCR Assay, an extraction-free salivabased test to detect nucleic acid from the SARS‑CoV‑2 virus. Being saliva-based, the assay does not require collection via invasive nasopharyngeal swab and is designed to be run on the Fluidigm Biomark HD microfluidics platform, providing throughput advantages that reduce the impact of capacityconstrained supply chains.

COVID -19 Diagnostics Update

Mobile Testing Platform Manages and Tracks On-Site COVID-19 Testing

A new first-of-its-kind COVID-19 mobile testing and tracking platform developed jointly by Relay Medical Corp. (Toronto, Canada; www.relaymedical.com) and Fio Corporation (Toronto, Canada; www.fio.com) aims to enable lab-grade diagnostic testing in clinics, pharmacies, workplaces, airports, nursing homes and other community-based locations. The Fionet mobile testing and tracking platform has been specifically developed for controlled, rapid response to pandemics. The platform combines handheld devices linked to online AIpowered cloud, automating frontline testing and capturing test results for tracking. New CE-Marked ELISA Test Detects COVID-19 Antibodies

A new test that can detect COVID-19 antibodies in people with recent exposure and having mild symptoms has been developed by The Binding Site (Birmingham, UK; www.bindingsite.com) and the University of Birmingham’s Clinical Immunology Service (Birmingham, UK; Cont’d on page 8

Coronavirus Screening Platform Detects SARS-CoV-2 Structural Fingerprint

A screening platform being developed by Botanisol Analytics (Phoenix, AZ, USA; www.botanisolanalytics.com) can identify biological threats by shining a laser onto the sample and interpreting the light that scatters is being used to develop a coronavirus screening platform, according to a report by BioSpace. The screening platform can identify biological threats, including contaminants and pathogens (such as the novel coronavirus), by shining a laser onto the sample.

Abbott's USD 5, 15-Minute BinaxNOW COVID-19 Ag Card Receives FDA EUA

Abbott (Lake Forest, IL, USA; www. abbott.com) has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for its BinaxNOW COVID-19 Ag Card rapid test for the detection of COVID-19 infection. BinaxNOW is highly portable (about the size of a credit card), affordable at USD 5 and provides results in 15 minutes. The test uses proven Abbott lateral flow technology, making it a reliable and familiar format for frequent mass testing through their healthcare provider.

LabMedica International October/2020

lINKXPReSS COM

lMI-10-20 107

PRODUCT NEWS

MICROPLATE READER

To receive prompt and free information on products, log on to www.LinkXpress.com or fill out reader service form located on last page, or scan the QR code on your mobile device

SPECIMEN COLLECTION KIT

HEMATOLOGY ANALYZER

ERBA MANNHEIM

PURITAN MEDICAL

HORIBA MEDICAL

The Lisa Scan EM is an automated microplate ELISA & microbiology reader that can perform various ELISA tests with elaborate reports. Its features include 100 test programs and built-in shaker with three-speed variable mixings.

The UniTranz-RT is a sterile kit, with a 3ml vial of Universal Transport Medium and an ultrafine PurFlock Ultra swab. Patented fibers guarantee maximum cell collection and ultrafine tip make it perfect for nasopharyngeal sampling.

The Pentra XLR is a compact and reliable hematology platform, including reticulocytes by fluorescence, with a throughput of up to 80 samples per hour. It enhances productivity, quality, and flexibility.

lINKXPReSS COM

lMI-10-20 204

COVID-19 Diagnostics Update

Cont’d from page 7

www.birmingham.ac.uk) with the initial antigen being provided by the University of Southampton (Southampton, UK; www.southam pton.ac.uk). The SARS-CoV-2 Antibody ELISA assay which focuses on mild non-hospitalized patient blood samples specifically detects antibodies (IgG, IgA, and IgM) to the SARS-CoV-2 trimeric spike protein, which is an important protein for the virus infectivity. AI-Powered COVID-19 Cough Analyzer App

A team of scientists have repurposed an artificial intelligence/machine learning-powered cough analysis mobile app for assessing respiratory health and associated COVID-19 risks. The mobile app called kAs has been developed by Zensark Technologies (Hyderabad, Telangana, India; www.zensark.com), in collaboration with Salcit Technologies (Hyderabad, Telangana, India; www.salcit.in), to assess respiratory health of the patients by leveraging machine learning and disease specific cough signatures.

New COVID-19 Test for Patients with Suppressed Immune Systems

A new test developed by the University Hospital at Ruhr-Universität Bochum (RUB Bochum, Germany; (www.ruhr-uni-bochum.de) that provides information on the immune response to the novel coronavirus in patients who need to take immunosuppressive drugs has shown that these patients can achieve a good immune response to SARS-CoV-2 despite immunosuppression. The test which can be used to adapt immunosuppressive therapy individually during a COVID-19 infection, such as following an organ transplantation, is of great clinical relevance for transplant patients as

lINKXPReSS COM

lMI-10-20 205

it provides information that goes far beyond a pure antibody test. Chinese COVID-19 Test Delivers Accurate Results in 40 Minutes

Researchers from the Xuzhou Medical University (Xuzhou, Jiangsu, China; www.xzmc. edu.cn) have developed a rapid CRISPR-based diagnostic for COVID-19 that delivers accurate results without the need for sophisticated equipment. CRISPR-COVID takes only 40 minutes and requires no sophisticated thermo-cyclers, providing a valuable alternative to the conventional RT–PCR assay to circumvent the bottlenecks in assay turnaround time, equipment and reagent supplies for COVID-19 testing. Researchers Warn Against Targeting Only One Viral Gene for SARS-CoV-2 Detection

Researchers at the Chan Zuckerberg Biohub (San Francisco, CA, USA; www.czbiohub.org) have warned against targeting only one viral gene when carrying out reverse transcriptasepolymerase chain reaction (RT-PCR) testing for the SARS-CoV-2 virus, according to a report by News Medical. The researchers carried out a study to demonstrate that a mutation had occurred in the N gene of the SARS-CoV-2 virus that impaired the annealing of a commonly used RT-PCR primer. Based on their findings, the researchers have suggested the routine use of at least two targets when testing for SARSCoV-2 using RT-PCR, even in areas where transmission rates are high.

Seropositivity Increases with Time after COVID-19 Symptom Onset

A head-to-head evaluation of a dozen SARS-CoV-2 serology assays by researchers from the University of California San Francisco (San Francisco, CA, USA; www.ucsf.edu) has revealed several variables in their test performance, including increasing seropositivity with increasing time from symptom onset and

lINKXPReSS COM

lMI-10-20 206

a range of test specificities. The researchers found that the number of seropositive results typically increased with time from patients' symptom onset, with seropositivity peaking after more than 20 days.

Rapid POC Antigen and Molecular COVID-19 Tests May Not Replace RT-PCR Tests

A new study by researchers from Cochrane (London, UK; www.cochrane.org) has revealed that rapid point-of-care antigen and molecular tests may not be accurate enough to replace RT-PCR for diagnosing COVID-19 infection. Their findings were based on studies that measured the accuracy of rapid point-of-care tests compared with RT-PCR tests to detect current COVID-19 infection.

Erba Mannheim Introduces Validated Automated Protocols

Erba Mannheim (London, England; www.er bamannheim.com) has announced availability of validated automated protocols for its range of ErbaLisa COVID-19 IgG and IgM ELISA kits in order to improve global availability of highquality testing methods for SARS-CoV-2. Optimized protocols for popular instruments manufactured by Dynex, Stratec, Awareness, and Delta Biologicals are now available, as well as for Erba's own analyzers, including the ELAN 30s microstrip processor.

Nasopharyngeal and Oropharyngeal Swabs Detect More COVID-19 Cases than Saliva Testing

A new study by Canadian researchers has found that nasopharyngeal and oropharyngeal swabs can detect more COVID-19 cases than saliva testing among patients who were asymptomatic but at high risk or who were mildly symptomatic. The findings add to those of previous studies, which have focused on salivary tests of symptomatic or hospitalized patients and found that saliva tests may be more sensitive.

Cont’d on page 10

LabMedica International October/2020

lINKXPReSS COM

lMI-10-20 109

PRODUCT NEWS

To receive prompt and free information on products, log on to www.LinkXpress.com or fill out reader service form located on last page, or scan the QR code on your mobile device

IMMUNOBLOT ANALYZER SHENZHEN YHLO BIOTECH

LABORATORY FUME HOOD HEMCO

QC FOR IGM ANTIBODIES TO SARS-CoV-2 TECHNOPATH

The Tenfly Phoenix is a fully automated immunoblot analyzer oferring fully automatic sample loading, 50 sample positions and 60 reagent positions. It allows for up to three different assays to be tested within one batch.

The UniFlow SE AireStream laboratory fume hoods are designed for high efficiency, energy savings and maximum user protection, featuring an aerodynamic face opening with airfoil to provide uniform airflow into fume chamber.

The Multichem ID-COVID19 G is a third-party quality control (QC) for IgG antibodies to SARS-CoV-2 with the QC samples specifically optimized and validated to match assays commonly used for COVID-19 disease testing.

lINKXPReSS COM

lMI-10-20 207

COVID-19 Diagnostics Update

Cont’d from page 8

New Portable 30-Minute COVID-19 Test Researchers at the University of Illinois at Urbana-Champaign (Champaign, IL, USA; www.illinois.edu) have demonstrated a prototype of a rapid COVID-19 molecular test and a simple-to-use, portable instrument for reading the results with a smartphone in 30 minutes, which could enable POC diagnosis without needing to send samples to a lab. The researchers are now exploring whether the assay would work with saliva samples to eliminate the need for nasopharyngeal swabs, and collecting more patient data as they consider next steps for regulatory approvals. Roche to Launch 15-Minute COVID-19 Rapid Antigen Test in Europe

Roche (Basel, Switzerland; www.roche. com) will launch a SARS-CoV-2 Rapid Antigen Test, in late September, for markets accepting the CE Mark and also file for Emergency Use Authorization (EUA) to the US Food and Drug Administration (FDA). The launch is a partnership with SD Biosensor Inc. (Seoul, Korea; www.sdbiosensor.com), with whom Roche has a global distribution agreement and had also launched a Rapid Antibody Test in July. Additionally, Roche’s Cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas 6800/8800 Systems has received EUA from the FDA. The Cobas SARS-CoV-2 & Influenza A/B Test is a multiplex reverse transcription polymerase chain reaction (RT-PCR) assay intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A virus, and Influenza B virus in nasal or nasopharyngeal swab samples collected from individuals suspected of a respiratory infection, and is not intended for the detection

lINKXPReSS COM

lMI-10-20 208

of Influenza C virus. Roche has also received FDA EUA for a rapid version of its Cobas SARS-CoV-2 & Influenza A/B test. The EUA for the Roche test gives the new option of conducting rapid testing in either point-of-care or clinical laboratory settings to detect and differentiate between the viruses.

ThermoGenesis Launches Suite of COVID-19 Products and Services

ThermoGenesis Holdings, Inc. (Rancho Cordova, CA, USA; www.thermogenesis.com), along with its joint venture ImmuneCyte Life Sciences, Inc.’s (Irvine, CA, USA; www.immu necyte.com), has launched a comprehensive COVID-19 product line that will combine diagnostic, therapeutic and service offerings to better detect, track and fight the novel coronavirus. ThermoGenesis and ImmuneCyte are jointly developing a comprehensive list of RTPCR and antigen test products to complement its SARS-CoV-2 IgM/IgG Antibody Test Kit, which has already been granted Emergency Use Authorization (EUA). Combining PCR and Antibody Tests at POC Increases COVID-19 Detection

The use of combined rapid point-of-care nucleic acid and antibody testing for SARS-CoV-2 infection by researchers at the University of Cambridge (Cambridge, UK; www.cam.ac.uk) has shown that this approach was superior to virus detection alone for diagnosing COVID19 disease. This approach could be particularly beneficial in low resource settings where centralized virology laboratories are scarce and the pandemic is expanding, according to the researchers. New Promega XpressAmp Direct Amplification Reagents

Laboratories testing for COVID-19 can now skip the potentially bottlenecked RNA extraction step of the workflow and move directly to polymerase chain reaction (PCR) amplification

lINKXPReSS COM

lMI-10-20 209

by using Promega Corporation’s (Madison, WI, USA; www.promega.com) new XpressAmp Direct Amplification Reagents which facilitate RNA extraction-free sample preparation that is automation-friendly. Oversensitive COVID-19 Tests Detecting Dead Coronavirus Cells

A study by the Oxford University’s Centre for Evidence-Based Medicine (Oxford, England; www.cebm.net) suggests that the current COVID-19 diagnostic tests could be too sensitive and may be detecting dead coronavirus cells, leading to overestimated infections. According to the researchers, the tests used to diagnose COVID-19 are so sensitive that they may be indicating people are infected with SARS-CoV-2 even when they had the virus 70 days ago COVID-19 Test Kit Uses Portable Technology with Mobile App

The new groundbreaking MobileDetect Bio (MD-Bio) BCC19 COVID-19 test kit from DetectaChem (Sugar Land, TX, USA; www.de tectachem.com) that uses portable technology along with mobile app result reporting has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA). The kit utilizes portable laboratory-grade diagnostic technology that can run up to 96 tests per device in just 30 minutes. It detects nucleic acids from the SARS-CoV-2 virus to determine positive or negative results and then utilizes the free MobileDetect App for Apple and Android platforms to generate result reports with time, date, images, patient info, GPS mapping and more.

Groundbreaking RNA Extraction-Free qSanger-COVID-19 Assay

A groundbreaking SARS-CoV-2 diagnostic test from BillionToOne, Inc. (Palo Alto, CA, USA; www.billiontoone.com) that eliminates

Cont’d on page 11

LabMedica International October/2020

Cont’d from page 10

the costly and time-consuming step of RNA extraction has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA). Unlike most other molecular assays that rely on RNA extraction and qRT-PCR, the qSanger-COVID-19 assay uses a different set of instruments and chemicals from existing tests, enabling labs to unlock a new, unused capacity for the detection of SARS-CoV-2. Stool Test Could Better Detect COVID-19

Researchers from the Faculty of Medicine of The Chinese University of Hong Kong (Sha Tin District, Hong Kong; www.cuhk.edu.hk) have found for the first time that COVID-19 patients have active and prolonged gut viral infection, suggesting that stool tests could be more safe, accurate and non-invasive than traditional nose swabs in detecting coronavirus. The researchers believe that stool screening test can help identify asymptomatic people carrying the COVID-19 virus as early as possible in order to stop its spread in the community.

COVID-19 Diagnostics Update which is designed to detect immunoglobulin G antibodies against SARS-CoV-2 in serum, plasma, and venous whole blood. The SGTi-flex COVID-19 IgG from Sugentech is a gold nanoparticle-based immunochromatographic test kit for the qualitative determination of COVID-19’s IgG antibodies in human whole blood (finger prick or venous), serum or plasma.

Avacta Launches Affimer-Based SARS-CoV-2 ELISA Lab Test

Avacta Group plc (Wetherby, England; www. avacta.com), the developer of Affimer biotherapeutics and reagents, has launched an ELISA laboratory test for the SARS-CoV-2 spike protein to support global research efforts into the coronavirus that causes COVID-19. Avacta has developed the high performance ELISA laboratory test to detect the SARS-CoV-2 virus in-house. The Affi-

mer-based ELISA test is capable of detecting the coronavirus spike protein in laboratory samples down to very low concentrations.

DiaSorin Receives FDA Clearance for Simplexa Test

DiaSorin Molecular LLC (Cypress, CA, USA; www.molecular.diasorin.com) has received FDA Clearance for its Simplexa Flu A/B & RSV Direct Gen II kit that can be run alone or alongside the Simplexa COVID-19 Direct kit, allowing for differential diagnosis of SARSCoV-2, influenza A (Flu A), influenza B (Flu B), and respiratory syncytial virus (RSV). The kit delivers continued comprehensive strain coverage and accurate detection in an efficient and trusted sample-to-answer format that does not require extraction.

First-Ever Available COVID-19 Seroconversion Panel

Access Biologicals (Vista, CA, USA; www.accessbiologicals.com) has completed the first-ever commercially available COVID-19 seroconversion panel to confirm the presence of anti-SARSCoV-2 antibodies. The panel will assist diagnostic manufacturers and researchers during assay development and evaluation, as well as troubleshooting COVID-19-test methods. New Gold and Copper Nanoshell-Enhanced Immunoblotting Technique

A team of researchers from DxGen Corporation (Gunpo-si, Gyeonggi-do, Korea; www.dxgenco.com), ChungAng University, ASAN Medical Center, and Choongnam National University Medical School has developed a straightforward and naked-eye-sensitive nanoshell-enhanced immunoblotting technique to detect Mycobacterium tuberculosis (MTB) antigen 85B (Ag85B). Research has revealed that the economical paper-based colorimetric detection method can easily diagnose active TB with only a small amount of urine sample with high sensitivity.

Korea’s Sugentech Granted FDA EUA for COVID-19 Test

Sugentech, Inc. (Daejeon, Korea; www. sugentech.com) has been granted Emergency Use Authorization by the US Food and Drug Administration for the company’s SGTi-flex COVID-19 IgG

LabMedica International October/2020

lINKXPReSS COM

lMI-10-20 111

Cont’d on page 12

PRODUCT NEWS

URINE ANALYZER

To receive prompt and free information on products, log on to www.LinkXpress.com or fill out reader service form located on last page, or scan the QR code on your mobile device

IMMUNOASSAY ANALYZER

EXTRACTION INSTRUMENT

HUMAN GMBH

IMMUNOSTICS

THERMO FISHER SCIENTIFIC

The Combilyzer13 urine analyzer with a throughput of 60 samples per hour (standard mode) and 120 samples per hour (fast mode) is designed for small to medium volume laboratories.

The ALFIS-3 is an ELISA based POC immunoassay analyzer with a built-in automated fluorescence scanning system using magnetic beads and alkaline phosphatase enzyme system for the quantitative immunoassay.

The KingFisher Flex is the most versatile benchtop automated extraction instrument in the lab for 24 or 96 samples per run for consistent highthroughput extraction and purification of DNA, RNA, protein, and cells.

lINKXPReSS COM

lMI-10-20 210

COVID-19 Diagnostics Update

lINKXPReSS COM

lMI-10-20 211

lINKXPReSS COM

lMI-10-20 212

New Ultra-Sensitive Super Antibody Test for COVID-19 Severity

sier and can inexpensively be used on a larger scale to accurately identify potential donors with the best chance of helping patients infected with the SARS-CoV-2 virus with convalescent plasma therapy.

First-In-Class Rapid COVID-19 Diagnostic Test

against a standardized sample panel provided by the agency gives laboratories, healthcare providers and patients a new resource on the relative performance of available tests to better inform which tests they choose to use.

Researchers at the Harvard Medical School (Boston, MA, USA; www.hms.harvard.edu) and Brigham and Women’s Hospital (Boston, MA, USA; www.brighamandwomens.org) have developed a test that could identify COVID-19 patients who are likely to need intensive care. Known as the Single Molecule Array (Simoa) SARS-CoV-2 antigen test, it is the first test that both detects and measures blood levels of S1- a protein that is part of the SARS-CoV-2 viral envelope.

A new rapid diagnostic test from AXIM Biotechnologies, Inc. (San Diego, CA, USA; www.aximbiotech.com) is expected to be the market’s first COVID-19 rapid diagnostic test for measuring the levels of functional SARS-CoV-2 neutralizing antibodies in a lateral flow assay format. AXIM has filed an Emergency Use Authorization (EUA) application with the Food and Drug Administration (FDA) for measuring COVID-19 neutralizing antibodies in plasma and serum through its first-in-class rapid diagnostic test, Tru-19 Neutralizing Antibody Test (Tru-19).

A new CRISPR-based test developed by researchers at the Broad Institute of MIT and Harvard (Cambridge, MA, USA; www.broa dinstitute.org) has shown improved sensitivity and can detect nearly as many cases as the standard COVID-19 diagnostic. The new test, known as STOPCovid, can produce results in 30 minutes to an hour, with similar accuracy as the standard PCR diagnostics now used. The test is still in the research stage but, in principle, could be made cheaply enough that people could test themselves every day.

Cont’d from page 11

Microbiologics Launches Controls for SARS-CoV-2 Testing

Microbiologics, Inc. (Saint Cloud, MN, USA; www.microbiologics.com) has further expanded its comprehensive portfolio of SARS-CoV-2 molecular QC standards by launching IVD Process Controls and Inactivated Whole Virus Controls to meet the complex research and diagnostic challenges of the COVID-19 pandemic. The Process Controls and Inactivated Whole Virus controls are available in ready-to-use swab and pellet formats that mimic patient samples to challenge every step of molecular testing, including sample collection and handling. Universal COVID-19 Antibody Test Identifies Suitable Plasma Donors

Researchers from Houston Methodist (Houston, TX, USA; www.houstonmetho dist.org) are significantly closer to developing a uniform, universal COVID-19 antibody test that could address the need for quick, easy tests to screen plasma donors. The researchers tested alternative ways to measure COVID-19 antibody levels that is faster and ea-

Self-Swab COVID-19 Collection Kit Receives FDA EUA

The Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to a new COVID-19 self-collection kit from Color (Burlingame, CA, USA; www.co lor.com) that will enable public health and large private labs to increase access to testing. The FDA EUA allows labs at universities, states and public health organizations to use the self-swab kit for at-home or on-site COVID-19 testing and also enables CLIA-certified laboratories designated by Color to use its self-swab COVID-19 collection kit for public health.

FDA Publishes Comparative Performance of COVID-19 Tests

The US Food and Drug Administration (FDA Silver Spring, MD, USA; www.fda.gov) has published comparative performance data for some authorized COVID-19 molecular diagnostic tests. The data showing the Limit of Detection (LoD) of more than 55 authorized molecular diagnostic COVID-19 tests

New CRISPR-Based Rapid COVID-19 Test

Visby’s Portable PCR COVID-19 Test Kit Granted FDA EUA

A new portable PCR COVID-19 test kit from Visby Medical (San Jose, CA, USA; www.visbymedical.com) has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for use in lab environments. Visby, a Silicon Valley startup, has become the first company to be granted FDA EUA for a portable PCR COVID-19 test kit, which it has named Personal PCR. Vivera Launches COVID-19 Tests For Saliva and Nasal Specimens

The Advanced Diagnostics Division of Vivera Pharmaceuticals (Newport Beach, CA, USA; www.viverapharmaceuticals.com) has launched two new diagnostic tests for the detection of SARS-CoV-2 antigens from nasal or saliva specimens, in patients with active infections. Vivera's COVx-RDA Antigen Test Saliva Collection Kit and COVx-RDA Antigen Test Nasal Collection Kit for SARS-CoV-2 are designed for rapid detection in high volume environments requiring highly accurate test results. LabMedica International October/2020

Reactive Pneumocytes Identified by Distinctive Cytology

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

most challenging and exceedingly common diagnostic dilemma in pulmonary pathology is the distinction between reactive and neoplastic epithelial atypia. In particular, reactive pneumocytes in various infectious or inflammatory lung diseases can exhibit marked cytological atypia, which can closely resemble malignancy. Various types of acute and subacute lung injury can cause severe reactive pneumocyte atypia, which may mimic malignant proliferations and present a major diagnostic pitfall. This particularly applies to cytological preparations and frozen sections, where background inflammatory injury may be subtle or not apparent. A pathologist at the Memorial Sloan Kettering Cancer Center (New York, NY, USA; www.mskcc.org) has written that the most severe reactive pneumocyte atypia occurs in florid diffuse alveolar damage, where in the organizing phase, hyaline membranes are associated with markedly atypical pneumocytes. Key morphologic features of reactive pneumocytes in acute/subacute lung injury include marked cytomegaly, prominent nucleoli, and chromatin irregularities (clumping or clearing). Macronucleoli, of the type seen in melanomas or viral cytopathic effects, can be present. Nuclear contours may become focally irregular, but tend to remain smooth. Overdiagnosis of reactive pneumocytes as in adenocarcinoma is well documented in the literature. Some reactive pneumocytes have dense cytoplasm, which may also mimic squamous cell carcinoma. Of particular note was one under recognized but extremely helpful cytomorphological clue to reactive pneumocytes in acute/subacute lung injuries is their highly distinctive shape, characterized by an elongated/pinched outline with a flat surface on one side and a convex surface with protruding nucleus on the opposite side. The flat surface corresponds to the area where the pneumocytes are plastered against the alveolar wall, whereas the convex surface corresponds to the area protruding into the airspaces. Even though the relationship of reactive pneumocytes to alveolar walls is usually not evident in dispersed cytological preparations or may be obscured in frozen sections and some small biopsies, this distinctive shape of reactive pneumocytes tends to be preserved in such specimens. This shape evokes the look of Napoleon Bonaparte's iconic headwear; the bicorne (2-cornered) hat, thus prompting the proposed term of a “Napoleon hat” sign. Unlike reactive proliferations, the Napoleon hat shapes are only rarely encountered in carcinomas. Although lepidic adenocarcinomas

LabMedica International October/2020

do feature rows of neoplastic pneumocytes growing along alveolar walls, those cells characteristically have cuboidal/hobnail rather than elongated/pinched shapes. Notably, Napoleon hat shapes tend to be well preserved in direct smears from fine-needle aspirates and touch preparations of core biopsies, whereas in bronchioloalveolar lavage fluids, cells tend to get rounded off, and this feature appears to be more subtle, but still evident in some cells. In frozen section and small biopsies, Napoleon hat shapes may also provide a useful clue to a reactive nature of epithelial atypia. The study was published in the April 2020 issue of the journal Archives of Pathology & Laboratory Medicine.

lINKXPReSS COM

LabMedica International

Image: Touch preparation smears from cases of various forms of lung injury with reactive pneumocytes, illustrating markedly enlarged and highly atypical epithelial cells retaining distinctive Napoleon hat–like shapes (Photo courtesy of Natasha Rekhtman, MD, PhD).

lMI-10-20 113

PRODUCT NEWS

To receive prompt and free information on products, log on to www.LinkXpress.com or fill out reader service form located on last page, or scan the QR code on your mobile device

MOLECULAR DIAGNOSTICS ANALYZER ABBOTT DIAGNOSTICS

CD4 ASSAY OMEGA DIAGNOSTICS

TUBERCULOSIS (TB) TEST CEPHEID

The ALINITY m is a fully integrated and automated molecular diagnostics analyzer that uses innovative technology to deliver the next level of flexibility and efficiency to the lab.

VISITECT® CD4 Advanced Disease is a rapid, semiquantitative lateral flow assay for the estimation of CD4 protein on the surface of CD4+ T cells in human whole blood indicating whether level is above or below 200 cells/μL.

The Xpert® MTB/XDR* test enables expanded drugresistance tuberculosis (TB) profiling in less than 90 minutes and leverages Cepheid's new 10-colour technology, enabling detection of multiple mutations across several genes.

lINKXPReSS COM

lMI-10-20 213

lINKXPReSS COM

lMI-10-20 214

lINKXPReSS COM

lMI-10-20 215

Susceptibility Gene Identified for Idiopathic Pulmonary arterial Hypertension

diopathic pulmonary arterial hypertension (IPAH) is a lung disorder characterized by high blood pressure in the pulmonary arteries. In this instance, “idiopathic” means that the cause of the pulmonary artery hypertension is unknown. Pulmonary arterial hypertension is rare, with about 1,000 new diagnoses in the USA each year. IPAH is a hard disorder to diagnose because some people do not have symptoms, and when there are symptoms of IPAH, they are similar to those of other heart and lung disorders. Scientists at the Peking Union Medical College Hospital (Beijing, China; www.pumch.cn) and their colleagues enrolled 230 patients with IPAH from two referral pulmonary hypertension centers in China. Eligible patients had no BMPR2 variants and were compared with 968 healthy control participants. Data were collected from January 1, 2000, to July 31, 2015, and analyzed from August 1, 2015, to May 30, 2018. The investigators sequenced the genomes of 42 patients with IPAH, none of whom had BMPR2 variants. The team also performed whole genome sequencing (WGS), Sanger sequencing on an ABI 3730 automated sequencer (Applied

Biosystems, Courtaboeuf, France; www.thermo fisher.com), right heart catheterization, pulmonary vasodilator testing, plasmid construction, cell culture and transfection, measurement of 6-Keto–prostaglandin F1α levels using an enzyme-linked immunosorbent assay (ELISA) kit (Cayman Chemical, Ann Arbor, MI, USA; www.caymanchem.com). After filtering, the scientists uncovered 1,986 rare variants affecting 1,772 candidate genes. Most of these alterations were present only in a single person, but 15 genes were altered in three or more people. Of those, PTGIS, MACF1, GTF3C1, and ABCA3 are expressed in the lung. As PTGIS encodes prostaglandin synthase, which is involved in prostaglandin production, the team suspected it might be the most relevant of those 15 genes. In a replication cohort of 188 patients with IPAH, they uncovered additional patients with PTGIS variants. In all, 14 patients harbored one of three rare PTGIS variants. The three rare PTGIS variants: A447T, R252Q, and c.521 +1G>A, are all located in conserved regions of the gene and are predicted by in silico analysis to be deleterious. Functional studies found that the PTGIS splicing variant affects the gene's transcription, as it led

liquid biopsy assay for multiple biomarkers enables early detection of pancreatic cancer before it metastasizes and while there are still treatment options available. The assay, developed by investigators at the University of Pennsylvania School of Medicine (Philadelphia, USA; www.upenn.edu), was designed to detect pancreatic cancer (pancreatic ductal adenocarcinoma or PDAC) while still in its earliest stages. Initially, the investigators analyzed plasma

samples from 204 subjects (71 healthy, 44 non-PDAC pancreatic disease, and 89 with PDAC) for the following biomarkers: carbohydrate antigen 19-9 (CA19-9), KRAS mutational burden, tumor-associated extra-cellular vesicle (EV) miRNA, and mRNA isolated on a nanomagnetic platform developed by the investigators. Circulating cell-free DNA (ccfDNA) concentration was measured by qPCR, ccfDNA KRASG12D/V/R mutations were detected by droplet digital PCR, and CA19-9 was measured by ECLIA (enhanced chemiluminescence

to exon skipping and an in-frame deletion. The two missense variants, meanwhile, led to impaired enzyme activity, decreased prostaglandin production, and increased cell death of pulmonary microvascular endothelial cells. The authors concluded that they had identified three rare loss-of-function variants in the PTGIS gene from two independent cohorts with IPAH. The genetic variants of PTGIS predispose pulmonary vascular responses to the iloprost stimulation. These findings suggest that PTGIS variants may be involved in the pathogenesis of IPAH. The study was published on April 1, 2020 in the journal JAMA Cardiology. Image: The 96-capillary 3730xl DNA Analyzer is the Gold Standard for high throughput genetic analysis and used for Sanger sequencing (Photo courtesy of Thermo Fisher Scientific)

liquid Biopsy assay for the early Detection of Pancreatic Cancer

immunoassay). Results revealed that in a test group of 47 patients (20 with PDAC, 27 controls), the assay was 92% accurate in its ability to detect PDAC, which was better than measuring the best known PDAC biomarker, CA19-9, alone (89%). In addition, the assay was 84% accurate in determining disease staging in samples from the 25 PDAC patients who imaging showed did not have metastatic disease. This result was significantly better than that obtained by Cont’d on page 24

LabMedica International October/2020

lINKXPReSS COM

lMI-10-20 115

PRODUCT NEWS

NGS SYSTEM

To receive prompt and free information on products, log on to www.LinkXpress.com or fill out reader service form located on last page, or scan the QR code on your mobile device

SARS-CoV-2 RESPIRATORY PANEL VIRAL DNA/RNA KITS

ILLUMINA

BIOFIRE DIAGNOSTICS

PERKIN ELMER

The iSeq 100 System is ideal for small whole-genome sequencing, targeted sequencing of a set of genes or gene regions, gene expression analysis, or 16S metagenomics.

The BioFire® Respiratory 2.1 (RP2.1) Panel with SARS-CoV-2 is intended for the detection of SARSCoV-2 and detects 21 additional respiratory pathogens to help clinicians quickly identify other causes of respiratory illness.

PerkinElmer’s Viral DNA/RNA chemagic™ Viral DNA/ RNA 300 kit delivers fast, high quality RNA extraction from oropharyngeal, nasopharyngeal, and anterior nasal swabs.

lINKXPReSS COM

Cont’d from cover

lMI-10-20 216

lMI-10-20 217

lINKXPReSS COM

Protein Biomarker for Risk of liver Disease

liver disorder worldwide and leading cause of chronic liver disease. The disease affects approximately 25% of the world's population. It is particularly common in developed nations, such as the United States, and affected about 75 to 100 million Americans in 2017. Over 90% of obese, 60% of diabetic, and up to 20% normal-weight people develop NAFLD. Genetic factors are known to play a major role in determining the likelihood of developing NAFLD. Since there are no methods for early detection of the disease, researchers have been searching for early biomarkers that could be used for this purpose. Towards this end, investigators at the Joslin Diabetes Center (Boston, MA, USA; www. joslin.org) studied NAFLD in a mouse model and integrated the results into the human clinical setting.

lINKXPReSS COM

For this study, the investigators used the liver-specific insulin receptor knockout (LIRKO) mouse. This is a unique nondietary model manifesting three hallmarks that confer high risk for the development of NAFLD: hyperglycemia, insulin resistance, and dyslipidemia. The investigators found that parental metabolic syndrome epigenetically reprogrammed members of the TGFbeta family, including neuronal regeneration–related protein (NREP) and growth differentiation factor 15 (GDF15). NREP and GDF15 modulated the expression of several genes involved in the regulation lipid metabolism in the liver. These findings from the mouse model were given clinical significance by the observation of low expression of NREP in the livers of human patients with NAFLD and the negative correlation between serum NREP levels and NAFL activity score in an independent cohort of well-

lMI-10-20 218

characterized obese NAFLD patients. "We detected this protein really clearly and we could show a pattern that tracks the progression of the disease. So, this is really exciting," said senior author Dr. Rohit N. Kulkarni, professor of medicine at Harvard University (Cambridge, MA, USA; www.harvard.edu). "We can really begin to consider, in the clinic, using this protein as a biomarker to identify those individuals in that risk window. We can also track those who already have low NREP but do not have the disease, with the assumption that when it is low, then they are much more susceptible and should be followed up very carefully. That gives an important perspective for extra, personalized care." The NAFLD study was published in the April 6, 2020, online edition of Journal of Clinical Investigation.

HPlC Method Developed for Vitamin B6 Quantitation

ymptoms of vitamin B6 deficiency can include dermatitis, glossitis, depression, confusion, convulsions, and anemia. Inborn errors affecting vitamin B6 metabolism have been associated with vitamin B6-dependent epilepsy. While vitamin B6 status is primarily assessed by measuring the biologically active form of the vitamin, pyridoxal 5-phosphate (PLP), concurrent measurement of the final metabolite 4-pyridoxic acid (PA) can provide additional information regarding supplement intake and hypophosphatasia. Laboratory Scientists at the Cleveland Clinic (Cleveland, OH, USA; https://my.cleve landclinic.org) developed a one-step reverse phase High-Performance Liquid Chromatography (HPLC) method with fluorescence detection by evaluating different derivatization con-

ditions, the use of an internal standard and different calibration strategies. The assay analytical performance was evaluated. A Thermal Vanquish UHPLC system equipped with fluorescence detector (Thermo Fisher Scientific, Waltham, MA, USA; www.thermofisher.com) was used in the analysis. The team reported that pre-column derivatization with semicarbazide showed the best overall performance in terms of signal to noise ratio, retention time and peak shape when compared to pre- or post-column derivatization with chlorite, pre-column or inmobile phase derivatization using sodium bisulfite. The final method provided an analytical measurement range from 7.7300 nmol/L for PLP and 3.7–300 nmol/L for PA, total imprecision <15% and <5% for PLP and PA respectively. Calibration against

the National Institute of Standards and Technology (NIST) standard produced measured values within 3% of NIST assigned PLP values. The use of 4-deoxypyridoxine as internal standard did not improve precision or accuracy when compared to calibration using 5-level external standards. The authors concluded that they had developed a simple one-step HPLC method for evaluation of vitamin B6 status by measuring the bioactive PLP and final metabolite PA simultaneously. The assay procedure was simplified into a one-step approach by combining the protein precipitation and derivatization procedure without compromising analytical performance. The method is fast, precise and sensitive enough to detect vitamin B6 concentrations below 2.5th percentile among the general population in the USA. LabMedica International October/2020

lINKXPReSS COM

lMI-10-20 117

lINKXPReSS COM

lMI-10-20 118

PRODUCT NEWS

SARS-CoV-2 CONTROLS

To receive prompt and free information on products, log on to www.LinkXpress.com or fill out reader service form located on last page, or scan the QR code on your mobile device

INFLUENZA A&B TEST

SARS-CoV-2 ANTIBODY TEST

RANDOX

SEKISUI DIAGNOSTICS

EUROFINS TECHNOLOGIES

Qnostics’ SARS-CoV-2(SCV2) Q Controls are single use positive controls intended to support the validation, verification and performance monitoring of molecular assays used in the testing of SARS-CoV-2 (COVID-19).

The OSOM® Influenza A&B Test is an immunochromatographic assay intended for the qualitative detection of Influenza A and Influenza B viral nucleoprotein antigens from nasal swab specimens.

The dual recognition enzyme-linked immunosorbent assay (ELISA) can detect semi-quantitatively total SARS-CoV-2 virus N-protein-specific antibodies in a single human serum or plasma sample.

lINKXPReSS COM

lMI-10-20 219

lINKXPReSS COM

lMI-10-20 220

Simple RT-PCR Test for COVID-19 Could Raise Testing Capacity by Millions per week

Cont’d from cover

lINKXPReSS COM

lMI-10-20 221

patients. The Xfree COVID-19 Direct RT-PCR test is a complete test in a single vial, lyophilized in the trusted BioGX Sample-Ready format. The user would simply Just Add Water, the patient sample, and run the test on a validated real-time PCR instrument. A single 96-well plate instrument can generate up to 1,500 test results every 24 hours, while a 384-well plate instrument can generate up to 6,000 test results. The Xfree COVID-19 test is validated for use on QuantStudio 5 and CFX Touch real-time PCR instruments with the most common specimen types, nasopharyngeal and oropharyngeal (throat) swabs with collections in UTM, UVT, VTM and saline. In addition to extraction-free direct testing, Xfree is also the world’s first COVID-19 test that does not require refrigeration. In a study of its clinical performance by direct, extraction-free testing of 77 patient samples, the Xfree COVID-19 test demonstrated

98% Positive Percent Agreement (PPA) and 100% Negative Percent Agreement (NPA) when compared to the highly sensitive extraction-based BD-BioGX SARS-CoV-2 BD MAX test (FDA-EUA). A comparison with extracted viral RNA using QIAamp DSP Viral RNA extraction kit (CDC EUA method) demonstrated 100% PPA and 100% NPA for Xfree COVID-19. “Xfree is a breakthrough in COVID-19 RTPCR testing. Direct addition of patient samples without any pre-processing or extraction not only overcomes critical reagents supply issues, but also significantly shortens the results turnaround time. The fast and simple workflow is designed to help laboratories increase their testing capacity without adding expert personnel or new automation”, said Shazi Iqbal, Ph.D., CEO of BioGX. “We believe Xfree is a game-changer. Xfree converts the most ubiquitous real-time PCR instruments into high throughput Sample-to-Answer machines – potentially augmenting the

COVID-19 PCR testing capacity by millions”, said Michael Vickery, Ph.D., EVP & CSO of BioGX. “Our current production capacity for the Xfree COVID-19 is nearly 2 million tests per week and can readily scale to 4 million per week. With efficient and early planning, we were able to secure long-term supply of critical raw materials to avoid any potential supply disruptions”, said Shahin Iqbal, Ph.D., SVP of Global Operations.

engue virus (DENV) is a member of the clinically-relevant Flavivirus genus together with Zika virus, yellow fever virus and others. With four distinct serotypes, DENV is thought to infect between 280 and 550 million people worldwide every year. While the majority of individuals suffering from dengue fever recover without showing severe symptoms or requiring extensive medical intervention, approximately 500,000 individuals per year develop severe dengue which has a mortality rate of up to 20%. Subclinical exposure is a significantly complicating factor, as those individuals previously exposed to one DENV serotype are at greater risk for severe symptoms than those with no

previous exposure. Scientists at the Walter Reed Army Institute of Research (Silver Springs, MD, USA; www.wrair.army.mil) and their colleagues used single cell RNA sequencing technology to measure the products of B cell plasmablasts, the antibody-producing cells found in greatest numbers immediately after DENV exposure. They also used a range of analyses to describe the ability of these antibodies to neutralize DENV and characterize their structure. Cell viability was assessed using a CTL-Immunospot S6 Ultimate V Analyzer (Cellular Technology Limited, Cleveland, OH, USA; www.immunospot.com) and cell sorting was performed on a the BD FACSAria Fusion flow cytometer (BD Biosciences, Franklin Lakes,

NJ, USA; www.bdbiosciences.com). The team discovered that that IgA represented a significant fraction of antibodies expressed by B cell plasmablasts circulating after DENV infection, most dramatically in individuals experiencing their first DENV infection. Though these data were generated from a small group of children, this is the first study to measure and characterize the entire output of plasmablasts without limitations to specific types of antibodies. These insights set the stage for future work to fully characterize the body's immune response to DENV, understand risk factors to severe dengue and ultimately could be critical to the development of new diagnostic tools as well as a safe, efficacious dengue vaccine.

Initial Immune Response after Dengue Virus Infection Identified

LabMedica International October/2020

lINKXPReSS COM

lMI-10-20 121

PRODUCT NEWS

PCR ANALYZER

RANDOX

Vivalytic is the easiest-to-use and most-comprehensive multiplex PCR platform on the market and provides the broadest range of test options ever seen for its size. lINKXPReSS COM

lMI-10-20 222

Contâ&#x20AC;&#x2122;d from cover

To receive prompt and free information on products, log on to www.LinkXpress.com or fill out reader service form located on last page, or scan the QR code on your mobile device

SALIVA COLLECTOR FOR COVID-19 TEST LINEAR CHEMICALS

COVID-19 RAPID ANTIGEN TEST SINGUWAY BIOTECH

Saliva collectors for COVID-19 saliva tests enable collection of oral saliva samples through the collection tube and ensure uniform mixing of collected saliva with saliva preservation solutions ensuring integrity of DNA/RNA.

The COVID-19 Ag Test (Colloidal Gold) kit is based on the principle of highly specific antibody-antigen reaction and colloidal gold labeling immunochromatographic analysis technology.

lINKXPReSS COM

lMI-10-20 223

lINKXPReSS COM

Test Predicts Kidney Transplant Failure

lMI-10-20 224

routinely used to interrogate T cell responses, to characterize antigenspecific TCR repertoires and to identify immunodominant clones. Fluorescently tagged multimers displaying individual peptides of interest have revolutionized detection of antigen specific T cells. A team of scientists working with those at the University of California, Santa Cruz (Santa Cruz, CA, USA; www.ucsc.edu) have has developed an approach for high-throughput T cell profiling. The key advance

is the ability to load peptides of interest on the MHC proteins that the body uses to present foreign antigens to the immune system. These MHC proteins display these antigens on the surface of cells, activating the body's T cell response, through which the immune system kills malfunctioning or infected cells. The ability to express antigens in high-throughput fashion would be a boon for immunologists as it could, for instance, allow them to more rapidly and comprehensively profile patient responses to antigens linked to cancer or different infectious diseases. In the case of SARS-CoV-2, for example, the scientist could load MHC proteins with peptides comprising the full complement of the virus' proteins and look at which peptides were most important in prompting the T cell response or how T cell repertoires varied depending on the severity of infection or patient outcome. To address unbound MHC, the team developed an approach using the protein TAPasin Binding Protein Related (TAPBPR), a chaperone protein that binds to MHCs to maintain their stability and also facilitates the exchange of peptides bound to the MHC. The process was streamlined somewhat by use of a workflow that produced MHCs bound to standard placeholder peptides instead of the particular peptide of interest, which allowed the team to produce MHC-antigen peptide complexes in bulk. The placeholder peptides were bound to the MHC via a photosensitive bond that could be disrupted by applying UV light, allowing the investigators to remove the placeholders and replace them with the actual peptides of interest when it was time to perform T cell profiling. The study was published on April 20, 2020 in the journal Nature Communications.

lINKXPReSS COM

lMI-10-20 122

Image: Linking peptide specificities with T cell transcriptomes (Photo courtesy of University of California, Santa Cruz). LabMedica International October/2020

lINKXPReSS COM

lMI-10-20 123

PRODUCT NEWS

NUCLEIC ACID EXTRACTOR

To receive prompt and free information on products, log on to www.LinkXpress.com or fill out reader service form located on last page, or scan the QR code on your mobile device

COVID-19 ANTIGEN TEST

SARS-CoV-2 ANTIBODY TEST

SINGUWAY BIOTECH

BIOSYNEX

DXGEN

The Singu46 is a nucleic acid extractor that uses the magnetic bead method and unique extraction mode for easy and high efficiency of batch operation with a short extraction time of 9-18 minutes.

By way of a simple nasopharyngeal swab, the Ag BSS rapid in vitro immunochromatographic test kit detects SARS-CoV-2 antigens in only 15 minutes, as per 96% sensitivity and 100% specificity.

The Epithod SARS-CoV-2 qAb is a vitro diagnostic (IVD) test that can detect IgM and IgG antibodies produced after virus infection in human whole blood and serum/plasma, with sensitivity and specificity of 97% and 100%.

lINKXPReSS COM

lMI-10-20 225

lINKXPReSS COM

COVID-19 Testing without Reagents

Cont’d from cover

at the University of Washington (Seattle, Wash., USA) has developed the method for the test which omits the step in the widely used reverse transcription polymerase chain reaction (RT-PCR) test where the scarce reagents are needed. The scientists evaluated the accuracy of the new test by using 215 COVID-19 samples that RT-PCR tests had shown were positive, with a range of viral loads, and 30 that

PREMIER MULTIMEDIA PLATFORM SERVING THE WORLD’S CLINICAL LABORATORY COMMUNITY

anytime, anywhere, On the Go... PRINT MaGazINe

INTeRaCTIVe DIGITal eDITION

weB PORTal

MOBIle VeRSION

labmedica.com

lINKXPReSS COM

lMI-10-20 226

lMI-10-20 227

were negative. The new test correctly identified 92% of the positive samples and 100% of the negatives. The positive samples the new test failed to catch had very low levels of the virus. Public health experts increasingly believe that ultra-sensitive tests that identify individuals with even the smallest viral loads are not needed to slow spread of the disease. The standard PCR test has three steps, while this simpler version of the standard test has only two, as the new test skips the second step. The test is ideally suited to screening programs, in both developed and developing countries, since it is inexpensive, takes much less processing time and reliably identifies those who are likely to spread the disease. Its low cost and efficiency could extend testing capacity to groups not currently being tested, including the asymptomatic, nursing home residents, essential workers and school children. The standard RT-PCR test could be reserved for groups, like health care workers, where close to 100% accuracy is essential, according to the scientists. “You can go for the perfect test, or you can use the one that's going to pick up the great majority of people and stop transmission,” said Jason Botten, an expert on pathogenic RNA viruses at the University of Vermont’s Larner College of Medicine and senior author on the paper. “If the game now is focused on trying to find people who are infectious, there's no reason why this test shouldn't be front and center, especially in developing countries where there are often limited testing programs because of reagent and other supply shortages.”

liquid Biopsy assay for the early Detection of Pancreatic Cancer

Cont’d from page 14

imaging alone (64% accurate). "Right now, the majority of patients who are diagnosed already have metastatic disease, so there is a critical need for a test that can not only detect the disease earlier but also accurately tell us who might be at a point where we can direct them to a potentially curative treatment," said co-senior author Dr. Erica L. Carpenter, assistant professor of medicine at the University of Pennsylvania School of Medicine. "If validated, this test could not only provide a key tool for at-risk patients, but also a monitoring tool for patients with certain known risk factors like BRCA mutations." The liquid biopsy assay for detection of pancreatic cancer was described in the April 16, 2020, online edition of the journal Clinical Cancer Research. LabMedica International October/2020

Clinical Studies Confirm FDa Data for abbott's COVID-19 Rapid Test To view this issue in interactive digital magazine format visit www.LinkXpress.com

Cont’d from cover

Abbott (Lake Forest, IL, USA; www.abbott.com) has completed an interim analysis of its ID NOW post-authorization study. A total of 1,003 people were evaluated across two care environments: urgent care clinics (acute care) and hospitals and nursing homes (in-patient care). In these two care environments, the ID NOW delivered the following agreement to lab-based molecular PCR tests: Overall performance of 93.3% positive agreement (sensitivity) and 98.4% negative agreement (specificity). Further, in the 161 patients with high viral titers (Ct <33), and therefore most likely to transmit virus, ID NOW showed performance of 97.0% positive agreement (sensitivity). Performance of 95.0% positive agreement (sensitivity) and 97.9% negative agreement (specificity) in subjects within seven days post symptom onset. Further, in the 129 patients with high viral titers (Ct <33), and therefore most likely to transmit virus, ID NOW showed performance of 98.4% positive agreement (sensitivity). Performance of 94.6% positive agreement (sensitivity) and 97.6% negative agreement (specificity) in symptomatic subjects. Further, in the 136 patients with high viral titers (Ct <33), and therefore most likely to transmit virus, ID NOW showed performance of 97.8% positive agreement (sensitivity). In addition to the post-authorization data, Abbott also provided an update to three studies that were covered in its May 21 interim study press release: • Multi-Site Urgent Care: In a completed analysis from a multi-site urgent care clinical setting of 430 symptomatic patients with two or more symptoms, including 53 PCR positive subjects, ID NOW demonstrated performance of 96.2% in positive agreement (sensitivity) and 99.5% negative agreement (specificity) compared to lab-based molecular PCR tests. • Everett Clinic: In a completed study at The Everett Clinic in Washington of 974 people, including 23 PCR positive subjects, in partnership with Yuan-Po Tu, M.D., ID NOW demonstrated 91.3% positive agreement (sensitivity) and 100% negative agreement (specificity) compared to lab-based molecular PCR tests. • In-Patient: In an in-patient care study (hospitals and nursing homes), a total of 518 symptomatic patients were evaluated, including 94 PCR positive subjects. ID NOW demonstrated 79.8% positive agreement (sensitivity) and 94.3% negative agreement (specificity) compared to labbased molecular PCR tests. These results point to the important role played by reliable point-ofcare testing that is available in convenient and accessible locations where people can get immediate results. "We recognize there is a lot of discussion about testing and ID NOW, and we want to make sure the public

LabMedica International October/2020

LabMedica International

has the facts and real-world data," said Robert B. Ford, president and chief executive officer, Abbott. "The facts we're seeing from one of the largest clinical studies of any COVID-19 test, conducted at some of the nation's leading academic centers, show that ID NOW delivers effective, consistent and reliable performance." "In the beginning of the pandemic, the scientific community had to rely on samples and modeling to predict test performance," said John Hackett, Ph.D., divisional vice president of Applied Research and Technology for Abbott's diagnostics business. "But now we have a significant body of real-world, clinical data that support the critical role ID NOW is playing in identifying infection rapidly in places where people show up for care." "Tests are taken at a moment in time and they detect the virus once there's enough viral material in a person to be able to detect it," continued Dr. Hackett. "While there's no perfect test, to fight a pandemic, we need a combination of gold standard lab-based PCR and accurate, reliable rapid tests like ID NOW to help reduce risk in society and slow the spread of the virus."

PRODUCT NEWS

NUCLEIC ACID ANALYZER

To receive prompt and free information on products, log on to www.LinkXpress.com or fill out reader service form located on last page, or scan the QR code on your mobile device

CELL WASHING SYSTEM

ESR ANALYZER

GENEREACH BIOTECHNOLOGY

HELMER

SHENZHEN YHLO BIOTECH

The POCKIT Micro nucleic acid analyzer is the newest generation of the insulated isothermal polymerase chain reaction (iiPCR) detection system that delivers PCR results in around 30-45 minutes.

The UltraCW II automatic cell washing system offers exceptional performance and consistent reproducible results with intuitive programming for high-performance automated cell washing.

The VISION automatic ESR analyzer makes use of primary EDTA tubes and delivers results in 20 minutes, providing assigned value and L-J chart of Bio-Rad controls.

lINKXPReSS COM

lMI-10-20 228

lMI-10-20 229

lINKXPReSS COM

lMI-10-20 230

Real-Time assay evaluated for Two Sexually Transmitted Diseases

hlamydia trachomatis and Neisseria gonorrhoeae are the two most commonly reported sexually transmitted infections (STIs) in the USA and the numbers of cases are increasing. C. trachomatis and N. gonorrhoeae infections in the rectum and pharynx are important extragenital reservoirs of infection. Due to their high sensitivity and specificity, nucleic acid amplification tests (NAATs) have become the recommended method for detecting N. gonorrhoeae and C. trachomatis infections of the urogenital tract. The Centers

lINKXPReSS COM

lMI-10-20 126

for Disease Control and Prevention (CDC, Atlanta, GA, USA; www.cdc.gov) recommends screening of all sexually-active men who have sex with men (MSM) for rectal C. trachomatis and N. gonorrhoeae infections and pharyngeal N. gonorrhoeae, at least annually. Scientists from the David Geffen School of Medicine (Los Angeles, CA, USA; https://medschool.ucla.edu) examined the analytical performance of the Abbott RealTime CT/NG assay (Abbott Laboratories, Abbott Park, IL, USA; www.molecular.abbott), including the limit of detection, inclusivity, and analytical specificity for C. trachomatis and N. gonorrhoeae in rectal and pharyngeal specimens. All tests were performed on the Abbott m2000 RealTime system. Elementary Bodies (EB)/mL for C. trachomatis and colony-forming units (CFU)/mL for N. gonorrhoeae, in clinical rectal and pharyngeal swab matrices were measured. Inclusivity was performed against 12 serovars of C. trachomatis and seven strains of N. gonorrhoeae. The analytical specificity was performed using 28 different bacteria and viruses. The limit of detection for C. trachomatis was 2.56 EB/mL in pharyngeal specimens and 12.8 EB/mL in rectal specimens. The limit of detection for N. gonorrhoeae was 0.0256 CFU/mL for both pharyngeal and rectal specimens. The inclusivity and analytical specificity were 100% for both rectal and pharyngeal specimens. In total, there were 80 specimens tested by the second laboratory. All 40 rectal and pharyngeal specimens spiked with C. trachomatis and all 40 rectal and pharyngeal specimens spiked with N. gonorrhoeae tested positive. C. trachomatis was detected in 0/20 of the N. gonorrhoeae-spiked samples from each anatomic site and N. gonorrhoeae was detected in 0/20 C. trachomatis-spiked samples from each anatomic site. The authors concluded that their analytical performance data demonstrate that the Abbott CT/NG RealTime assay is an accurate, sensitive, and specific assay in rectal and pharyngeal specimens, supporting the potential of the assay for detection of rectal and pharyngeal C. trachomatis and N. gonorrhoeae infections. The study was published on April 2, 2020 in The Journal of Molecular Diagnostics. LabMedica International October/2020

New Testing Process Could Revolutionize Measurement of COVID-19 antibody levels

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

team of US Army researchers collaborated with scientists at Houston Methodist (Houston, TX, USA), Pennsylvania State University (University Park, PA, USA) and the University of Texas (Austin, TX, USA) to find alternatives to measuring virus neutralization, or VN, titers. These titers are the gold standard of COVID-19 antibody testing, as VN antibodies in the blood have been shown to correlate with levels of protective immunity. According to the researchers, this kind of antibody testing is not widely available as it is technically complex and requires days to set up, run and interpret. Thus, the team looked to another type of test, called enzyme-linked immunosorbent assays, or ELISAs. ELISAs are standard quantitative tests used to measure the amount of antibody to a particular antigen in a given sample and can also be used for serological monitoring of the disease. Specifically, scientists looked at the relationship of anti-spike ectodomain, or ECD, and anti-receptor binding domain, or RBD, antibody titers in the bloodstream. The spike ECD and RBD proteins are components of the much-talked-about spike protein made by SARS-CoV-2 and are critical to how the virus enters the body, spreads and causes COVID-19 disease. The scientists found that the relative amount of antibody in the bloodstream of COVID-19 patients is linked to their ability to control viral infection; essentially, the more severe the disease, the higher the levels of neutralizing antibody present. This information provides potential benchmarks for a clinical product for convalescent plasma treatment studies; it could also be used to assess how well a vaccine recipient may respond to a subsequent infection. The researchers found that the ELISA tests had an 80% or greater probability of predicting VN titers at or above the Food and

LabMedica International

Drug Administration-recommended levels for COVID-19 convalescent plasma. In addition, the researchers found that convalescent donors maintain high levels of immunity over the course of many weeks, and that frequent plasma donations did not cause a significant decrease in antibody or virus neutralization levels. Perhaps most surprising, the researchers said, is that they identified 27 individuals from the surveillance cohort with high enough antibody titers to indicate that some asymptomatic individuals may have plasma suitable for therapeutic use and may have a degree of relative immunity against SARS-CoV-2. "In all, we discovered that high titer ELISAs correlate well to virus neutralization and can be used as a surrogate for screening convalescent plasma," said Dr. Jimmy Gollihar, biochemist and biotechnologist for the US Army Combat Capabilities Development Command's Army Research Laboratory at CCDC ARL.

Serology assay Rapidly Characterizes Immune Response to SaRS-CoV-2 antigens

Contâ&#x20AC;&#x2122;d from cover

Western automated western blotting systems. ProteinSimple's Simple Western systems are automated, hands-free western blotting platforms that can be used for antigen-down serology assays for SARSCoV-2. The Simple Western serology assay moves beyond 1- or 2-antigen serology assays to measure serum or plasma antibodies reactive against five SARS-CoV-2 antigens simultaneously, providing information-rich views into antibody binding profiles across patients and over the time course of the infection. The SARS-CoV-2 multi-antigen serology assay runs on Jess and Wes systems, enabling the processing of 23 patient samples in three hours. This approach has promise as a tool to rapidly characterize patient immune response and as an orthogonal confirmatory test to validate results derived from lateral flow, ELISA (enzyme-linked immunosorbent assay) or other immunoassay serology techniques. "We are excited about the multi-antigen views this serology assay provides COVID-19 researchers and vaccine developers, while promising to speed up time to data," said Bob Gavin, Sr. Vice President of Bio-Techne's, Analytical Solutions Division. "It leverages Simple Western strengths of minimal set-up time, hands-free operation, and fully analyzed results in three hours." "The new SARS-CoV-2 Multi-Antigen Serology Module is a powerful advancement in the fight against COVID-19," said Dave Eansor, President of Bio-Techne's Protein Sciences Segment. "At Bio-Techne, we are committed to arming COVID-19 vaccine developers and scientists researching the SARS-CoV-2 immune response with cutting edge technology including the new Simple Western serology assay and Kantaro SeroIndex RUO ELISA kit."

LabMedica International October/2020

lINKXPReSS COM

lMI-10-20 127

PRODUCT NEWS

URINE ANALYZER

To receive prompt and free information on products, log on to www.LinkXpress.com or fill out reader service form located on last page, or scan the QR code on your mobile device

MICROPLATE READER

IFA & BLOT ANALYZER

DFI CO.

DIALAB

DAS SRL

The ComboStik R-700 is a high-speed urine analyzer with maximum throughput of 720 tests per hour, offering advanced and reliable test results. It offers convenient connectivity to LIS system and features a color LCD display.

The DIAWasher ELX5O/8 absorbance microplate reader offers buffer selection with automatic switching for up to three wash buffers (depending upon the model), with a soak time of 0-24 hours, volume range of 10-3000 µL/well.

The AP 16 IF BLOT ELITE is an automated system for IFA and BLOT methods, equipped with a sliding sample barcode reader and a camera for the slide and blot – strip barcode reading. It can run 16 IFA slides with 12 wells.

lINKXPReSS COM

lMI-10-20 231

lINKXPReSS COM

lMI-10-20 232

S TOR Y IBU APPL R T DIS ED TO IT INV

yOUR GlOBal SOURCe FOR STeRIlIzaTION aCCeSSORIeS THERMO RESISTANT GLOVES Up to 37 cm in length

STERILIZABLE INSTRUMENT & WORK-SURFACE MATS TURBO WASHING Thermo-Resistant (-60 °C to 300 °C) MACHINES TRAYS Fully washable & Flexible Suitable for central sterilization services Sterilizable Heavy Silicone Cover & Transport Tablet SILICON INSTRUMENT MAT

MICRO INSTRUMENT MAT Front

WASHING TRAYS MAT

NEW!

Back

Front

Back

NEW!

SILICONE TABLET AND STEEL COVER NETS

Front

Back

SILICONE WASHING MACHINE TRAY & TABLET exchangable Net

exchangable Nets

STERILIZABLE WORK-SURFACE MATS

100% Silicone

Size: 2400 x 1200 mm (3 mm thick)

VICOTEX

S.A.

Place de la Gare 1 • 1009 Pully • Switzerland Tel: (41) 21-728-4286 • Fax: (41) 21-729-6741 E-Mail: contact@vicotex.com

www.vicolab.com

lINKXPReSS COM

lMI-10-20 128

lINKXPReSS COM

lMI-10-20 233

Scabies Detected by Molecular Methods in Skin Scrapings

cabies caused by Sarcoptes scabiei mites, is a highly contagious parasitic disease characterized by intense itching which is aggravated at night. Infections by scabies mites result in various skin eruptions consisting of papules, nodules, vesicles, and excoriated eczematous lesions due to scratching. Scabies is associated with long-term residence in nursing homes, the homeless and refugees, and it is a public health burden worldwide Microscopic examination of skin scrapings is widely used for the diagnosis of scabies, but it has a suboptimal sensitivity of only 50%. Dermoscopy has been widely used, but it has a disadvantage in that it has low specificity and is affected by the dermatologist’s experience. Infectious disease specialists at the University of Ulsan College of Medicine (Seoul, Republic of Korea; http://eng.amc.seoul.kr) evaluated the diagnostic value of polymerase chain reaction (PCR) from skin scraping in patients with suspected scabies. Adult patients with suspected scabies, unrelated diseases or healthy volunteers were enrolled at a tertiary hospital, from December 2017 through October 2018. A total of 47 participants, 33 with suspected scabies, 10 with unrelated diseases, and four healthy volunteers were enrolled. Of the 33 patients, 22 were classified as confirmed scabies, two as clinical scabies, six as suspected scabies, and three as no scabies. PCR was performed on the skin scrapings to target the cytochrome c oxidase subunit 1 (cox1) gene of Sarcoptes scabiei. Real-time PCR amplification was performed with the LightCycler 96 system (Roche Molecular Systems, Pleasanton, CA, USA; www.diagnostics.roche.com). The team reported that the sensitivities of the microscopic examination were 100%, 92%, and 73% in confirmed scabies; confirmed and clinical scabies; and confirmed, clinical, and suspected scabies, respectively. The sensitivities of PCR were 86%, 83%, and 80% in confirmed scabies; confirmed and clinical scabies; and confirmed, clinical, and suspected scabies, respectively. The specificity of the scabies PCR in the no scabies control was 100%. Of the 30 patients with scabies, five (17%) revealed negative results for microscopic examination, but positive results for scabies PCR. The authors concluded that scabies PCR was shown to offer an improvement in assay sensitivity compared to that of microscopy examination for the diagnosis of scabies by clinical criteria. This technique can, therefore, be considered as an adjunct method for the diagnosis of scabies, particularly in microscopy-negative suspected cases. The study was published on April 7, 2020 in the journal PLOS Neglected Tropical Diseases. LabMedica International October/2020

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

y cordial greetings and compliments of the Fall season to you all in the IFCC family. 2020 continues to be a tough year for all of us around the world as the infection rates and COVID-19 cases remain high and increasing in many regions globally. But on a positive note, clinical laboratory professionals have become directly and intimately involved in the fight against this growing pandemic and are Prof. Khosrow Adeli, PhD, playing a vital role in diagnosis and FCACB, DABCC, FAACC monitoring of viral infection and exposure, as well as laboratory monitoring of hospitalized patients with COVID-19. Due to the ongoing pandemic and travel restrictions, many of our international and regional conferences are being postponed and, in some cases, replaced with virtual events. The 2021 WorldLab Congress has now been postponed to June 2022 and a new virtual conference is being planned on COVID-19 in February 2021. Despite our inability to hold physical conferences and events at this time, IFCC has been very busy planning and delivering many new programs to enhance communication links among the IFCC membership as well as to initiate new and novel programs in support of the membership and the field of clinical laboratory medicine. Below is a summary of our most recent activities and future plans: New IFCC Testing Guidelines on Covid-19: In response to the current pandemic, IFCC established a COVID-19 Task Force, with the primary objective of providing recommendations for harmonizing use and evaluation of laboratory tests worldwide during the COVID-19 pandemic. The taskforce has recently developed a series of interim guidelines to support clinical laboratories around the world as they support the ongoing fight against the COVID-19 pandemic, with particular focus on the needs of clinical laboratories in developing countries. Three guideline documents have been developed and will be published in peer-reviewed literature as well as on the IFCC website over the next few weeks: • IFCC Guidelines on Molecular Testing of SARS-CoV-2 Infection (in press in CCLM) • IFCC Guidelines on Serological Testing of Antibodies against SARS-CoV-2 Infection (in press in CCLM) • IFCC Guidelines on Biochemical & Hematological Monitoring of COVID-19 patients (in press in CCLM) These guidelines provide practical recommendations on the intended use, selection, evaluation and implementation of laboratory tests used in the diagnosis of SARS-CoV-2 infection and management of COVID-19. They also discuss the various analytical and clinical considerations required prior to test implementation, along with test result interpretation. These guidelines have been developed by critically reviewing published peer-reviewed evidence available to date and establishing a consensus of experts from the IFCC COVID-19 Task Force and other experts in the field. The international authorship of this guideline document represents medical/clinical biochemists, clinical microbiologists/virologists, together with scientists representing the in vitro diagnostics industry. The guideline group took into consideration the global applicability of recommendations in various resource settings, providing practical recommendations that can be of immediate impact worldwide. New IFCC Live Webinar Series: As part of our new communication and eLearning strategy, IFCC has started a new live webinar program. Our first IFCC live webinar on COVID-19 had over 3000 registrations from over 100 countries around the world which clearly indicates the wide interest in such educational programs across the IFCC world. The second Live Webinar was focused on “Advancing Internal and External Quality Assurance on a Global Scale” with presentations by three eminent speakers, Professor Sverre Sandberg, Professor Mario Plebani, and Professor Graham Jones. At this international webinar the speakers presented on current challenges advances in Internal and external quality assurance in clinical laboratories around the world, the critical need for a new international strategy to support internal quality assurance and EQA in developing countries, and the IFCC’s strategic plans to develop a global program

LabMedica International October/2020

NEWS

MeSSaGe FROM THe PReSIDeNT By Khosrow adeli

•

President, IFCC

to support both iQC and EQA around the world. I encourage you all to view on demand this webinar and be part of the discussion on how the IFCC can contribute to improved laboratory quality assurance globally over the coming years. Upcoming live webinars in November will be focused on “Global Newborn Screening” on November 4th and “Value and Impact of Laboratory Medicine in Patient Care: Developing the Evidence” on November 26th. IFCC Virtual Conference on COVID-19 Diagnostic Testing in February 2021: A new fully virtual conference (over 2-3 days) has been planned for early next year to bring together scientific and industry leaders from around the world to present on the latest advances in COVID-19 diagnostics as well as public health authorities and medical experts to present on rapidly growing list of therapeutics and vaccines being developed to control and hopefully eliminate the current pandemic. The theme of the conference will be: Critical Role of Clinical laboratories in Covid-19 Pandemic. The program will include:

◙ Scientific Symposia: At least 4 scientific symposia including presentations by: • Scientific and industry members of the IFCC Taskforce on Covid-19 • Expert representatives from each of six regional federations to present on Covid-19 management in all regions around the world, • Public health and regulatory authorities including WHO, CDC, FDA, and others • Eminent global experts to present on laboratory management and pathophysiology of Covid-19. ◙ A virtual poster session for IFCC members and young scientists from around the world ◙ Virtual Industry Workshops ◙ Virtual Industry Exhibits The conference registrations details will be available soon and I encourage all of you to try to participate. I look forward to seeing many of you (virtually!!) at our upcoming webinars and the IFCC Virtual Conference. Feel free to email me at: president@ifcc.org with your feedback, questions, or concerns.

Till next time ☺ Khosrow

NEWS I

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

editorial

By Katherina Psarra, MSc, PhD

Dear colleagues, hope you are all well and at least enjoying the autumn colours in the countryside when you are not working in the labs all over the world, trying to cope with the unprecedented new situation. Nature can relieve the burden posed on our shoulders by COVID-19 and its consequences at work and at home.

And when you cannot be near nature what could be an antidote to these difficult times? Education can play this role. IFCC is offering education to all of you through the well-known tools like eAcademy or professional exchange programs. Nowadays, when face to face meetings and conferences seem distant in the future, live webinars seem to take a central position in education. You have already attended, and you can revisit on demand the really successful webinars on: COVID-19 testing in the labs and on lab quality. Don’t miss the opportunity of more education. A lot of information about IFCC educational plans can be found in our President’s inspiring article.

UNIVANTS of Healthcare Excellence Award: Countdown to Nov. 16

are teams around the world endeavor to improve healthcare delivery every single day. Last year, the UNIVANTS of Healthcare Excellence Award Program recognized twelve teams who have achieved measurably better

healthcare with innovative best practices. Details about those winners and the Award program can be found on www.univantshce.com. The prestigious and global UNIVANTS of Healthcare Excellence award program pro-

NOW AVAILABLE ONLINE

CLICK TO: www.ifcc.org

motes and recognizes integrated care teams who have achieved remarkable outcomes in healthcare by developing targeted solutions to meet gaps in care. By maximizing laboratory insights to solve unmet needs, the award-winning teams unify across disciplines to make a significant, positive impact on key stakeholders including patients, clinicians, health systems, and payors. Some of the benefits achieved include reduced clinical uncertainty, improved patient care wellness, increased clinical confidence, enhanced reputation, and decreased costs.

The award program has been made possible through strategic collaborations among eight global healthcare industry leaders, including Abbott, International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), AACC, European Health Management Systems Society (EHMA), Modern Healthcare, Health Information and Management Society (HIMSS), the National Association for Healthcare Quality (NAHQ), and the Institute of Health Economics (IHE). With a shared mission to celebrate healthcare excellence and share best practices, the program is intended to inspire healthcare professionals globally. All partners, excluding Abbott, are currently evaluating qualified applications to select global and area winners. In the meantime, you can explore success stories, best practices, and valued articles of each of the previous winning teams on the program website, or follow the program on social media, including #UNIVANTS on LinkedIn. The 2020 outcomes will be revealed globally this November. The next award cycle will begin in the summer of 2021 and is open to all healthcare professionals and professional teams, regardless of their affiliation with program partners. As more healthcare teams unite and an “all-hands-on-deck approach” is taken, more best practices will materialize, enabling the highest quality care delivery. LabMedica International October/2020

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

THe wORlD OF IFCC

NEWS

IFCC welcomes New Corporate Member: MeGalaB (Tbilisi, Georgia)

Megalab (Tbilisi, Georgia) was founded in 2017 by “Georgian Healthcare Group”. It is the first multidisciplinary laboratory in the region, combining clinical and pathological departments. The laboratory is designed according to the JCI (Joint Commission International) standard, which is the highest accreditation body for medical institutions in the United States. 20 million GEL was invested in the creation of Megalab. Foregin partners took part in the creation of “Megalab”, which will continue to actively participate in the process of quality development and maintenance. Among them, there are such international brands as Labpon

(Netherlands), BioLab (Jordan). In Megalab you can find equipment from well-known manufacturers such as Siemens, Leika, Carl Zeiss, Thermofisher, BioMérieux and more. It is a laboratory hypermarket where it is possible to perform any test necessary for humans, including newly introduced high-tech areas: digital and molecular diagnostics and also analysis of any type of biological material. The laboratory has about 150 highly qualified staff. Among them are leading Georgian specialists working in Europe. Megalab constantly strives to improve the qualifications of its staff with the

IFCC live webinar Series: Fall 2020

The IFCC is pleased to present the IFCC Live Webinar Series that started in the fall 2020: a series of scientific webinars offered freely by the IFCC on a number of important topics delivered by subject matter experts from around the world. ◙ After the two live webinars, that were successfully held on: • New IFCC Guidelines on Molecular and Serological Testing of SARS-Cov-2 as well as Biochemical and Hematological Monitoring of COVID-19 patients • Advancing Internal and External Quality Assurance on a Global Scale ◙ Next webinars will be: • November 4, 2020: Expanding Newborn Screening Globally: Reducing Infant Mortality Through Early Diagnosis

WORLDLAB Seoul Rescheduled to 2022

help of various international or local trainings. In addition, Megalab promotes the upbringing of the next generations, the education and employment of students and residents, as part of the development of corporate social responsibility. Since January 2019, the laboratory has been cooperating with about 100 medical institutions, including leading hospitals. Today Megalab already serves more than 3.000 patients a day, although the capacity of the laboratory exceeds 6 million different profile tests per year.

Website: www.megalab.ge

- Worldwide Gaps and Challenges in NBS - A New IFCC Strategy on Global NBS - Proposed model for NBS Implementation in Developing Countries

• November 25, 2020: Value and Impact of Laboratory Medicine in Patient Care: Developing the Evidence - Critical role of the clinical laboratory in healthcare delivery: What is the Evidence? - The Essential Need for New Retrospective and Prospective Outcome Studies - A New IFCC Strategy to Develop the Evidence in Key Areas of Clinical Medicine Details for these three webinars will be available in due time.

The IFCC Executive Board, in consultation with the Korean Society of Clinical Chemistry and MZ Organising Secretariat, has arrived at the difficult and undesired decision to reschedule the upcoming WORLDLAB Congress to 2022 because of the uncertainties and the revolving scenarios with regards to COVID-19 in the coming months, including major international travel restrictions. The 24th International Congress of Clinical Chemistry and Laboratory Medicine will now be held on 26-30 June 2022. The venue remains the same: the Coex Convention and Exhibition Center in Seoul, South Korea.

eJIFCC Vol. 31, Issue 3 Published

eJIFCC Vol. 31, Issue 3 is now available! The issue starts with the call for submission for a thematic eJIFCC an issue on “Measurably Better Healthcare”, followed by an imaginary conversation between SARS-CoV and SARS-CoV-2 and another one considering scholarly pressure in COVID-19 times, and by a reflection on the vogue for naming reactions and methods. We find then an article on Leptin levels and Q223R leptin receptor gene polymorphism in obese Mexican young adults; a systematic review on Extra-analytical clinical laboratory errors in Africa; an analysis on Vitamin D deficiency impact on PSA reference ranges in a general university hospital; and an article on trends in laboratory testing practice for diabetes mellitus. The issue is completed by two case reports on an Anti-tuberculosis treatment, and on pediatric septic arthritis of the hip.

LabMedica International October/2020

lINKXPReSS COM

lMI-10-20 131

NEWS

VIewPOINT

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

life with the Virus: a New Norm

by Dr. Bernard Gouget

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

t the end of the summer in the northern hemisphere and of the winter in the southern hemisphere, COVID 19 has completed its first lap. In the early days of the pandemic, some Presidents exhorted their citizens to wage war against the coronavirus. Having abandoned hopes of eradicating the virus or developing a vaccine within weeks, today, their message is to learn how to live with the virus. Many countries have opted for coexistence as infections keep rising. Summer recedes into a risk-filled autumn and the possibility of a second wave haunts the continents. The WHO predicts a higher mortality this fall. New infections have soared in recent weeks, the jump is not surprising since the overall number of tests being performed. Those infected now tend to be younger, the virus is still circulating freely, we are controlling poorly the chain of infections, and inevitably high-risk people will end up being affected. It is not possible to stop the virus. It is about maintaining equilibrium and we only have a few tools available to do that. Uncertainty is everywhere and it leaves us with a profoundly unsettled feeling. It is a return to the world in « protective » mode. The workplace is shaken up: tele-meetings, teleworking, relocations, e-commerce, etc. The health crisis is accelerating business reorganization, overturning care structures and threatening the cohesion of social groups. The difficulty in access to testing, the wait for vaccines, the crucial question of patient treatment and triage faced with whether or not to go to intensive care, reinforces concerns. COVID suspends our initiatives and requires caution everywhere. The pandemic requires us to move forward in an uncertain system. Many digital projects have been initiated during this crisis. A strong increase in the recreational and occupational use of streaming films, video games, news sharing on social networks, videoconference meetings, and so on, can be observed. By accentuating the dependence on online approaches, lockdown has also reinforced inequalities in digital access. Furthermore, the health crisis has hindered the necessary discussions that conferences allow. However, the health challenges faced require cohesion and communication: ensuring the continuity of care, rethinking education, maintaining the links between community members, ensuring the sustainability of research projects, etc. Adapting to this situation is a major challenge! E-conferences, e-workshops, e-congresses, webinars, the virtual offerings are vast, technical and complex. Everything has the feeling of a video game: the camera overlooks the conference center towards the lobby entrance, where participants crowd into the conference room via their avatars. We are virtually side by side while thousands of miles apart. Our travel volume and our methods of communication will never be the same. Our procedures, travel, meetings and celebrations are suspended for a higher purpose: protecting life. So adjusting to vital priorities requires navigating without knowing all the facts. COVID 19 carries its share of stigma, including segregation of those infected, shifting between responsibility and guilt for having spread the virus. In the absence of a vaccine or effective treatments, contact tracing combined with isolation of positive cases is an effective prevention tool, but it must be accompanied by education and considered as a tool for understanding and protection. Despite everything, it is possible to hope that the excess mortality observed in the spring will not reoccur in such proportions. The progress made in management of patients with severe forms by oxygen therapy or corticosteroid therapy has reduced mortality rates by 21%. While we wanted to

IFCC OFFICE

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

The views and positions expressed in the IFCC News section are those of the IFCC or the individual authors, and do not necessarily represent the views or positions of LabMedica magazine or its publishers.

eliminate all hazards, even moral ones, here we need to learn to navigate without guideposts. The protection of life is now our guiding principle. Biospheric limits are our collective challenge. The challenge of this return to normal life is to accept these limits, not by losing freedom but by renewing possibilities. Everything must be done to live with the virus. Politicians and medical scientists are undertaking a balancing act, given the great uncertainty about the trajectory that the epidemic could follow in the weeks to come. Just because cases are increasing does not mean that we have to return to complete lockdown. However, it can be noted that Israel is reimposing a national lockdown which should be finished by the end of Sukkot. Facing an alarming spread of cases, Jakarta has installed partial lockdown. According to the WHO, the numbers should be analyzed and strategies compared to see what measures are the best suited to maintain an acceptable transmission level. We must therefore be prepared to wear a mask and adhere to the preventive measures for a while. In the second half of the nineteenth century, in 1846, Ignaz Semmelweis released the hygiene theory of handwashing. Louis Pasteur who hated to shake hands, was a big fan of handwashing, even if it meant being “pretentious”! Hand hygiene still has the same goals. These goals remain the prevention of cross contamination, prevention of infection or colonization of patients or caregivers, and prevention of environmental contamination. Many authors have demonstrated the value of hand hygiene in reducing HAIs or the risk of spreading MDRB, whether by descriptions of epidemics, before-after studies or time series analyses. The SARS CoV-2 epidemic has proven that hygiene freaks are right, these handwashing and hydro-alcoholic sanitizer obsessives, who have sworn by handwashing for years, are finally recognized as pioneers. Of course, some of us have already been converted by the H1N1 epidemic in 2009 to prevent flu and gastroenteritis. But today, the use of hand sanitizer is widespread. It has become obligatory to enter a business or public place. Any surface or object touched must be suspect and lead to hydro-alcoholic gel use. While rubbing yourself with a hand sanitizer gel or solution is as effective as with soap, you still have to do it correctly: at least 20 seconds between your fingers and with the right product capable of eliminating viruses and bacteria. The hydro-alcoholic formula validated by the WHO is unpatented in order to prevent its distribution from being limited. Thank you to Didier Pittet, Swiss epidemiologist and infectious disease specialist, who promoted its usage since 1995 to fight nosocomial infections. Since then, an incalculable number of people have been saved by means of this very simple process. But today still, the WHO estimates that every year, 5 to 8 million lives could be saved with better hygiene. Hand sanitizer is one of the indispensable preventative measures to slow SARS CoV-2 contamination and protect the most vulnerable, in the same way as hand washing, mask wearing and physical distancing. The precious virucidal fluid has taken a leading and sometimes excessive role in daily rituals, bordering on obsessive compulsive disorder (OCD). In the anxiety-inducing context of the pandemic, faced with the desire to protect yourself and others, it is normal to feel more vulnerable and to latch onto the first bottle that comes along, like a protective amulet. People with true OCD are rare, but intensive use can reveal the existence of background anxiety that was already present, anchored somewhere in our unconscious and amplified by the collective fear of contamination. With SARS CoV-2, every object and every individual becomes a potential contaminator and threat. Recent sociological studies have shown that when you enter a shop or administrative building, anointing your hands is reminiscent of the purification rites practiced in places of worship. Like holy water, sanitizer purifies us and keeps us away from the impure, where there is a risk of contamination and therefore of death, as if the sanitizer, an invisible film, was preventively protecting others. Sanitizer also demonstrates good behavior and bad, so many questions formerly decided by religion, once again at the heart of social interactions. Obviously, the civilization of social distancing, the advent of “untact” culture and the digital technological revolution are destabilizing everyone. Sanitizer generates ambivalence and uncertainty in interactions: masks prevent us from reading other people’s smiles, and we sometimes shake hands by reflex before quickly dousing ourselves with sanitizer. How do we rediscover predictability in our social relations that keep our exchanges amicable and avoid underlying aggression that we can see in public spaces or on public transportation? We try to wear masks from the base of the eyelashes to the glottis, we greet our neighbor wisely with joined hands with Thai compunction, but we often allow our noses to escape and forget preventative measures in Cont’d on page 33 LabMedica International October/2020

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

COVID-19 Fueling Growth of In-Vitro Diagnostics Market

The global in-vitro diagnostics market is projected to register a compound annual growth rate of 5.60% from USD 55 billion in 2016 to nearly USD 90 billion by 2025, fueled by the massive rise in COVID -19 infections which is driving an increase in research and development activities in the diagnosis of infectious diseases. These are the latest findings of Transparency Market Research (Albany, NY, USA; www.transparencymarketresearch.com), a market intelligence provider. 2020 AACC Annual Scientific Meeting & Clinical Lab Expo to Be All Virtual

The American Association for Clinical Chemistry (AACC Washington, DC, USA; www.aacc.org) has decided to hold the 2020 AACC Annual Scientific Meeting & Clinical Lab Expo as a virtual event, rather than as a live meeting, due to the ongoing coronavirus pandemic. AACC’s flagship scientific conference and expo will now be offered on an innovative digital platform built for learning, collaboration, networking, and technology exploration. The virtual event will be held on December 13-17, 2020. Thermo Fisher Opens New Plant

Thermo Fisher Scientific Inc. (Waltham, MA,

USA; www.thermofisher.com) has officially opened its new USD 40 million plant in Lenexa, Kansas, USA for the production of viral transport media (VTM) that will continue to be expanded to meet the expected sustained demand for COVID-19 testing. . In addition to supporting the US government’s response to the COVID-19 pandemic, the products from the new facility will also be used for collection and sampling for flu and other viruses. MicroGEM Awarded Over USD 40 Million by NIH

MicroGEM (Southampton, Hampshire, UK; www.microgembio.com) has been awarded up to USD 40.9 million by the National Institutes of Health (NIH), Rapid Acceleration of Diagnostics (RADxSM) initiative to expedite the launch of the company's molecular diagnostic test that provides rapid, sensitive and specific identification of SARS-CoV-2 and influenza types A and B at the point-of-need. MicroGEM's COVID-19 saliva test provides laboratory-quality results in 15 minutes, allowing non-medical personnel to obtain rapid, on-site detection of COVID-19 without a laboratory. NIH Offers USD 129 Million to Support New COVID-19 Testing Technologies

The National Institutes of Health (NIH Bethesda, MA, USA; www.nih.gov) has announced

Industry News

USD 129.3 million in scale-up and manufacturing support for a new set of COVID-19 testing technologies as part of its Rapid Acceleration of Diagnostics (RADx) initiative. Under the RADx initiative to speed innovation in the development, commercialization and implementation of technologies for COVID-19 testing, NIH is awarding contracts to nine companies for technologies that include portable point-of-care tests for immediate results and high-throughput laboratories that can return results within 24 hours. Swab and Viral Transport Medium Market Growing Due To COVID-19

The global swab and viral transport medium market (VTM) was valued at USD 0.9 billion in 2019 and is projected to expand at a CAGR of ~3% from 2020 to 2030 to reach USD 2.2 billion by 2030, driven by increased demand during the COVID-19 (coronavirus) pandemic. Rapid antigen testing and molecular assay experiments have fueled the demand for swab and VTM during the ongoing coronavirus crisis. Long-term freezers and direct fluorescent antibody (DVA) applications are creating incremental opportunities for companies in the swab and VTM market. These are the findings of Transparency Market Research (Albany NY, USA; www.transparencymarketresearch.com), a nextgeneration market intelligence provider.

life with the Virus: a New Norm

Cont’d from page 32 the spirit of conviviality. Paradoxically, contemporary society, so quick to expose the body as an object, finds itself confronted with physical separation and the pain of not touching. Regardless of the utility of screens in our lives and the virtual realities to which they give access, nothing is better than embodied reality. The depth of human relationships is felt in experience and contact, which cannot be completely replaced by hitting “like”. Touch, the most important of the senses, is also a victim of the epidemic since, by definition, touch does not allow any intermediary, nothing can touch without being touched. Likewise, masks upset our relationships with others. We struggle to avoid misunderstandings, we seek out the emotional cues that once guided us, and we watch for narrowing of the eyes or the shadow of a glance. No further sign comes to soften a clumsy gesture or seal a fleeting complicity. Often, we would like to drop our masks to again experience the lost spontaneity. Nothing is worse than the man with no expression, a masked man whose intentions and emotions cannot be divined. We need the smiles of others to smile our-

LabMedica International October/2020

selves. Smiles show our way of reacting to the world, of inhabiting it, in short, of existing. Despite everything that it deprives us of, a mask makes us realize what we need from the other and, at the same time, makes visible to us the absolute and mysterious distance that separates us from them. Social interaction is essential in humans; the presence of one person conveys something of the truth of our world to another. This is why, despite legitimate health injections, outbursts of affection drive people to those they love. The countries are putting to use the hard-won lessons from the pandemic’s initial phase: the need to wear masks, handwashing and practice social distancing, the importance of testing and tracing, the critical advantages of reacting nimbly and locally. All of those measures, tightened or loosened as needed, are tools for success against the pandemic. But will we sustainably ingrain these measures in our habits? Will contactless society become the norm? Hopefully if the epidemic recedes, we will return to our previous behaviors with a little more caution. This is no reason to wash your hands of them!

NE DE W SIG N

wORlD’S MeDICal PRODUCT MaRKeTPlaCe

Connecting Buyers with Suppliers worldwide

Reach new sources of supply Identify latest products and technologies Send inquiries directly to suppliers Receive latest product alerts Chat live with suppliers

TradeMed provides a sophisticated yet easy-to-use global B2B platform for sourcing medical equipment. TradeMed connects buyers and sellers worldwide through a safe, secure and dynamic network. Solely dedicated to medical products, TradeMed is the premier choice for medical suppliers, hospital decisionmakers and buyers worldwide, regardless of size or budget.

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

OCTOBER 2020

BSACI 2020 – Annual Conference of the British Society for Allergy and Clinical Immunology. Oct 1-2; Virtual Venue; Web: bsacimeeting.org

SIOP 2020 – 52nd Annual Congress of the International Society of Paediatric Oncology (SIOP). Oct 14-17; Virtual Venue; Web: siop-congress.org

ESID 2020 – 19th Biennial Meeting of the European Society for Immunodeficiencies. Oct 14-17; Virtual Venue; Web: esidmeeting.org

Analytica 2020. Oct 19-22; Virtual Venue; Web: www.analytica.de

CMEF 2020 – China International Medical Equipment Fair. Oct 19-22; Shanghai, China; Web: www.cmef.com.cn

ASHI 2020 – 46th Annual Meeting of the American Society for Histocompatibility & Immunogenetics. Oct 19-23; Virtual Venue; Web: www.ashi-hla.org

EndoBridge2020. Oct 22-25; Virtual Venue; endobridge.org

ASHG 2020 – American Society of Human Genetics. Oct 27-31; Virtual Venue;

American Society of Hematology (ASH). Dec 5-8; Virtual Venue; Web: www.hematology.org

USA; Web: www.ashg.org

MEDLAB Asia Pacific 2020. October 28-30; Virtual Venue; Web: www. medlabasia.com

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

AOCE-SICEM 2020 – 17th Asia-Oceania Congress of Endocrinology. Oct 28-31; Virtual Venue; Web: sicem.kr

Zdravookhraneniye 2020. Dec 7-11; Moscow; Web: www.zdravo-expo.ru/en

FOCIS 2020 – Annual Meeting of the Federation of Clinical Immunology Societies. Oct 28-31; Virtual Venue; Web: www.focisnet.org

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

NOVEMBER 2020

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

JIB 2020 – Journées de l’innovation en biologie. Nov 4-5; Paris, France; Web: jib-innovation.com

15th Baltic Congress of Laboratory Medicine. Nov 5-7; Riga, Latvia; Web: www.balmriga.com

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

ExpoMED Eurasia 2020. Nov 5-7; Istanbul, Turkey; Web: expomedistanbul.com

JANUARY 2021

IFCC WorldLab Seoul 2021 – 24th International Congress of Clinical Chemistry and Laboratory Medicine. Jan 6-10; Seoul, Korea; Web: www.seoul2020.org

41st Annual Meeting of the American College of Toxicology (ACT). Nov 15-18; Virtual Venue; Web: www.actox.org

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

Fertility 2021 – Joint Conference of the UK Fertility Societies. Jan 7-9; Virtual Venue; Web: fertilityconference.org

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

SLAS 2021 – Society of Laboratory Automation and Screening. Jan 23-27; Virtual Venue; Web: www.slas.org

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

FEBRUARY 2021

Medical Fair India 2021. Feb 25-27; New Delhi, India; Web: www.medical fair-india.com

DECEMBER 2020

62nd Annual Meeting & Exposition of the

LAB MEDICA INTERNATIONAL

Reader Service Form

PLEASE COMPLETE THE FOLLOWING

WRITE CLEARLY IN BLOCK LETTERS or AFFIX YOUR SUBSCRIBER LABEL APPEARING ON COVER

I. TYPE OF LABORATORY

Subscriber Code on Your Label (Needed for All Renewals)

Name of Individual

Position and Department

Name of Institution

Mailing Address

City, Province

Postal Code

(a) (i) (c) (d) (f) (g) (l) (h) (t)

o o o o o o o o o

(1) (2) (3) (4) (5) (6) (7)

o o o o o o o

Hospital Laboratory Independent/Reference Laboratory Blood Bank Laboratory Public Health Laboratory Industrial/Biomedical Laboratory Government Authority/Health Agency Research/Educational Laboratory Distributor/Dealer/Manufacturer Other

Please Specify . . . . . . . . . . . . . . . . . . . . . . . . . . .

II. YOUR TITLE OR FUNCTION Director of Laboratory(ies) Dept. Chief/Supervisor Chief Technologist Technologist Administrator/Manager Medical Practitioner Other

Please Specify . . . . . . . . . . . . . . . . . . . . . . . . . . .

III. Are you a Ph.D. or M.D.?

YES

IV. YOUR DEPARTMENT OR SPECIALTY

Country

(h) o (b) o (c) o (d) o (e) o (p) o (a) o (o) o (q) o (r) o (g) o (k) o (l) o (m) o (j) o (t) o

General Lab Diagnostics Clinical Chemistry/Biochemistry Microbiology Hematology Blood Bank Immunology Anat. Pathology Serology Histology Cytology Toxicology Virology Oncology Endocrinology Administration/Purchasing Other

Please Specify . . . . . . . . . . . . . . . . . . . . . . . . . . .

V. With how many readers do you share this copy of Lab Medica Intl ? . . . . . . . . .

Tel: (..........)(..........)......................

E-MAIL (REQUIRED):

....................................................

@................................................

VI. CIRCLE LINKXPRESS NUMBERS OF INTEREST TO RECEIVE FREE INFORMATION

101 111 121 131 141 151 161 171 181 191 201 211 221 231 241 251 261 271 281 291

102 112 122 132 142 152 162 172 182 192 202 212 222 232 242 252 262 272 282 292

103 113 123 133 143 153 163 173 183 193 203 213 223 233 243 253 263 273 283 293

104 114 124 134 144 154 164 174 184 194 204 214 224 234 244 254 264 274 284 294

105 115 125 135 145 155 165 175 185 195 205 215 225 235 245 255 265 275 285 295

106 116 126 136 146 156 166 176 186 196 206 216 226 236 246 256 266 276 286 296

107 117 127 137 147 157 167 177 187 197 207 217 227 237 247 257 267 277 287 297

108 118 128 138 148 158 168 178 188 198 208 218 228 238 248 258 268 278 288 298

LMI-10-20

109 119 129 139 149 159 169 179 189 199 209 219 229 239 249 259 269 279 289 299

110 120 130 140 150 160 170 180 190 200 210 220 230 240 250 260 270 280 290 300

Yes, I wish to receive free copies of lab Medica International SIGNATURE (REQUIRED)

DATE: DAY

MARCH 2021

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

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

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

SIOP ASIA 2021 – 8th Asia Conference of the International Society of Paediatric Oncology. Mar 19-21; Mumbai, India; Web: www.siopasia2020.com APRIL 2021

Analytica Vietnam 2021. Apr 14-16; Ho Chi Minh City, Vietnam; Web: www. analyticavietnam.com

Analytica Anacon India & India Lab Expo Mumbai. Apr 15-16; Mumbai, India; Web: www.analyticaindia.com

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

ISLH 2021 – International Society of Laboratory Hematology. May 6-9; New Orleans, LA, USA; Web: www.islh.org

ESPE 2021– 59th Annual Meeting of the European Society of Paediatric Endocrinology. May 7-9; Liverpool, UK; Web: www.eurospe.org

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

Renew /Start your Free Subscription FREE PRODUCT Instant Online INFORMATION Product Information Every advertisement or product item in this issue contains a LinkXpress ® number as shown below:

lINKXPReSS COM

1 2

lMI-10-20 999

Identify linkXpress ® codes of interest as you read magazine Click on linkXpress.com to reach reader service portal Mark code(s) of interest on linkXpress ® inquiry matrix

Or, Circle LinkXpress Numbers of Interest on Reader Service Card and Scan and Email this form to: subs@globetech.net

................. MONTH ........................ YEAR ....................

The publisher reserves the right to qualify requests

For EXPRESS service: visit www.LinkXpress.com or Scan and Email this form to: subs@globetech.net

LabMedica International October/2020

EuroMedLab 2021 – 24th IFCC-EFLM European Congress of Clinical Chemistry and Laboratory Medicine. May 16-20; Munich, Germany; Web: www.euromedlab2021munich.org

Hospitalar 2021. May 18-21; Sao Paulo, Brazil; Web: www.hospitalar.com

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

37th International Congress of the International Society of Blood Transfusion (ISBT). Jun 6-9; Milan, Italy; Web: isbtweb.org

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

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

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

BIO International Convention 2021 Jun 1417; Boston, MA, USA; Web: convention.bio.org

CMEF Indonesia. Jun 17-19; Jakarta, Indonesia; Web: www.cmefindonesia.com

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

ESHRE 2021 - 37th Annual Meeting of the

European Society of Human Reproduction and Embryology. Jun 27-30; Paris, France; Web: www.eshre.eu

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

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

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

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

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

S E R V I C E

EUROTOX 2021 – 56th Congress of the European Societies of Toxicology. Sep 26-29;

P O R T A L

Visit LinkXpress.com to enter your subscription data and reader inquiries.

BY EMAIL

• Fill-out all required data on Reader

•

Service Card including signature and date (incomplete or unsigned cards cannot be processed). Circle inquiry numbers of interest to receive free information Scan card and Email to: subs@globetech.net

ATTENTION: IF YOUR APPLICATION IS NOT RECEIVED AT LEAST ONCE EVERY 12 MONTHS YOUR FREE SUBSCRIPTION MAY BE AUTOMATICALLY DISCONTINUED

LabMedica International October/2020

October 2021

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

DECEMBER 2021

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

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

BY WEBSITE

•

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

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

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

FREE Subscription

EASD 2021 – 57th Annual Meeting of the European Association for the Study of Diabetes. Sep 28 - Oct Stockholm, Sweden; Web: www.easd.org

ALACI 21 – 13th Latin American and Caribbean Congress of Immunology. Nov 15; Varadero, Cuba; Web: iuis.org/events/alaci-2021

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

To Continue / Start Your

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

NOVEMBER 2021

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

2 E ASY WAYS

R E A D E R

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

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

SEPTEMBER 2021

lINKXPReSS COM I

Copenhagen, Denmark; Web: eurotox-congress.com

Events Calendar

LabMedica International

Inq.No.

– 131 123 115 113 126 105 107 127 – – – 136 – 121 102 117 118 122 103 109 – 128 111

Advertiser

Advertising Index

Vol. 38 No.6 10/ 2020 Page

AACC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Alcor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Bio-Rad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Dynex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Diasys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 ELI Tech Group . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Erba Mannheim . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Erba Mannheim . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Euroimmun . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 EuroMedLab 2021 . . . . . . . . . . . . . . . . . . . . . . . . 29 ICE 2020 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 IFCC 2019 Annual Report . . . . . . . . . . . . . . . . . . 30 Instrument Laboratory . . . . . . . . . . . . . . . . . . . . . 36 LabMedica . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24 Nova . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Quantimetrix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Randox . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Seegene . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18-19 Serosep . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Snibe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Snibe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Trademed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Vicotex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Vircell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Provided as a service to advertisers. Publisher cannot accept responsibility for any errors or omissions.

lINKXPReSS COM

lMI-10-20 136