WORLD’S CLINICAL LABORATORY NEWS LEADER ISSN 1068-1760
I
N
Vol. 38 No.2 • 4/2020
T
E
Blood Test Screens for Multiple Cancers
A
new targeted methylation-based assay has been developed that is able to screen blood samples for more than 20 types of cancer at all stages, including lung cancer, with high accuracy and it also correctly pinpoints the tissue of
Cont’d on page 13
R
N
A
T
I
O
Rapid Method Selects Proper Antibiotic Against Multidrug Resistant Pathogens
A
new diagnostic approach allows physicians to accurately identify bacterial pathogens and identify the most appropriate antibiotic within a period of hours rather than days. Multidrug resistant organisms are a serious threat to human
health. Fast, accurate antibiotic susceptibility testing (AST) is a critical need in addressing escalating antibiotic resistance, since delays in identifying multidrug resistant organisms increase mortality and use of broad-spectrum antibiotics, further selecting for resistant organisms.
COVID-19 Diagnostics: Racing to Fill Demand and Improve Testing Speed
Cont’d on page 15
V
I
S
I
T
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
G
ynecologist visits are often motivated by an inflammation of the vagina called vaginitis. Infectiou vaginitis, due to either bacterial vaginosis (BV), Candida vaginitis (CV), or Trichomonas vaginalis (TV) accounts for a significant proportion of all such gynecologic visits.
T
A
®
L
New Biomarker for Cancer Stem Cells
T
umors often contain a small subset of drug-resisting, self-renewing, and highly metastatic cells called tumor initiating cells or cancer stem cells (CSCs). These cells can self-renew, divide asymmetrically, and form tumors in isolation. CSCs have been linked to drug resistance, metastasis and tumor relapse and it would be important to discover treatments targeting these
Cont’d on page 16
remic-retention solutes are the compounds whose concentration in an organism increases with decreasing kidney function. At uremic concentrations, they play a crucial role in the progression of chronic kidney diseases (CKD) and have negative outcomes. Until now, the role of the compounds in pathogenesis of neurological disorders is not completely understood. However, a link between CKD
Molecular Panel Distinguishes Cause of Vaginatis
Cont’d on page 14
Thermo Fisher to Acquire Qiagen
hermo Fisher Scientific Inc. (Waltham, MA, USA) has announced that it plans to acquire Qiagen N.V. (Venlo, Netherlands), a provider of molecular diagnostics and sample preparation technologies. Thermo Fisher's boards of directors and the
N
U
A
See article on page 4
DAIly ClINICAl lAB NewS
level of Uremic Toxins Detected in Parkinson’s
A Survey of Emerging Tests
mong over 70 known diagnostic initiatives worldwide, all vying for a convenient, reliable and rapid COVID19 test, several were recently granted Emergency Use Approval (EUA) by US-FDA authorities. Others are in the various stages of approval or development. Our special survey reviews dozens of latest entrants.
V I S I T
managing board of Qiagen have both unanimously approved the proposal. Qiagen provides life science and molecular diagnostic solutions and its sample preparation technologies are used to extract, isolate and purify DNA, RNA and proteins from a Cont’d on page 12
Cont’d on page 10
INSIDE
Covid-19 Update . . . . . . 4 Clinical News . . . . . . . . . 8 IFCC News . . . . . . . . . . 27 product News . . . . . 6-26 Events Calendar . . 34-35 PUBLISHED IN COOPERATION WITH
International Federation of Clinical Chemistry and Laboratory Medicine
GlOBeTeCH >>> MeDIA <<<
lINkXPReSS COM
lMI-04-20 102
lINkXPReSS COM
lMI-04-20 103
COVID-19 Diagnostics: A Survey of emerging Tests
LabMedica International
S
ince our last COVID-19 Update appearing in LabMedica's previous issue, the US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to several assays and test kits for the detection of Novel Coronavirus. Clinical laboratories and healthcare institutions around the world have begun using these diagnostic tools to detect SARS-CoV-2, the virus that causes COVID-19. Furthermore, a whole range of additional COVID-19 assays, instruments and test kits based on various technologies, are currently in the different stages of the certification or development process. Altogether a total of over 70 tests are currently known to be in use, certification or development, with a focus on improving the convenience, reliability and speed of COVID-19 diagnosis. The report that follows provides a survey of entries and advances from mid-March to midApril. For a recap of earlier developments the reader should refer to the previous issue of LabMedica. BioMedomics Rapid IgM-IgG Test
BioMedomics, Inc. (Morrisville, NC, USA; www.biomedomics.com) has developed and launched one of the world’s first rapid point-ofcare lateral flow immunoassays for the diagnosis of coronavirus infection. The new rapid IgM-IgG combined antibody test for COVID19 is used to qualitatively detect IgG and IgM antibodies of the novel coronavirus in human serum, plasma or whole blood in vitro. Microbiologics SARS-CoV-2 Synthetic RNA March 13
Microbiologics, Inc. (Saint Cloud, MN, USA; www.microbiologics.com) has prepared synthetic RNA to assist in the development of diagnostic assays and the evaluation of the performance of nucleic acid tests for determination of the presence of SARS-COV-2. The SARS-CoV2 material is a 1044 nucleotide RNA specific for the SARS-CoV-2 N (nucleocapsid) gene. It contains all three markers (N1, N2 and N3) detected by the CDC Real-Time RT PCR Panel for Detection of 2019 Novel Coronavirus. Sentinel STAT-NAT COVID-19 Assay March 13
Sentinel Diagnostics (Milan, Italy; www. sentineldiagnostics.com) is offering STAT-NAT COVID-19 assay, a freeze-dried ready-to-use Real-Time PCR mix that detects novel coronavirus disease in human respiratory tract specimens in about 90 minutes. The company has developed two versions of this kit - STAT-NAT COVID-19 HK kit is based on the Hong Kong protocol, while STAT-NAT COVID-19 B assay follows the Berlin protocol.
I
N
labmedica.com T
E
R
N
A
T
I
O
N
A
L
EDITORIAL BOARD
Seegene Allplex 2019-nCoV Assay
Seegene Inc. (Seoul, South Korea; www. seegene.com) has launched its novel coronavirus (COIVD-19) Real-time PCR assay in Korea and across the world. Seegene’s single-tube assay, Allplex 2019-nCoV Assay identifies the three different target genes (E gene, RdRP gene and Ngene) designed based on the WHO’s international recommended protocols. Seegene's automated system with its auto analysis software provides test results in four hours and can perform thousands of tests a day. The firm is capable of manufacturing 100,000 COVID19 tests a day in order to meet the demand. AMSBIO Recombinant Proteins and Antibodies
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
AMS Biotechnology (AMSBIO; Abingdon, UK; www.amsbio.com) has begun supplying high quality 2019-nCoV full length S protein, S1 protein and human ACE2 protein based on the HEK293 human cell expression platform. The firm is also offering antibodies, including antibody pairs against coronavirus for ELISA, PCR detection kit for SARS-CoV-2 and ACE2 expression vectors, shRNA vectors and CRISPR kits. Bio-Rad SARS CoV-2 Standard
Bio-Rad Laboratories, Inc. (Hercules, CA, USA; www.bio-rad.com) has launched a SARS CoV-2 Standard to support laboratory assay validation of coronavirus testing through its Exact Diagnostics product line. Additionally, Bio-Rad has launched a blood-based immunoassay kit to identify antibodies to the coronavirus SARSCoV-2. Bio-Rad’s immunoassay kit detects total immunoglobulin (IgG, IgM, and IgA) for use manually or on an automated immunoassay platform, such as the firm’s EVOLIS System. John Hopkins University Coronavirus Screening Test
A team of clinical microbiologists from John Hopkins University (Baltimore, MD; www.jhu. edu) have developed an in-house coronavirus screening test that could allow the health system to test about 1,000 people daily. Currently, the test delivers results in about 24 hours, which the doctors hope to shorten to three hours. Cepheid Xpert Xpress SARS-CoV-2 Test
Cepheid (Sunnyvale, CA, USA, www. cepheid.com) has been issued EUA by the US FDA for Xpert Xpress SARS-CoV-2, its rapid molecular diagnostic test for the qualitative detection of SARS-CoV-2. The test has a detection time of approximately 45 minutes and has been designed to operate on any of Cepheid's more than 23,000 automated GeneXpert Systems worldwide. Cont’d on page 5
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.37 No.2. 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 April/2020
4
COVID-19 Diagnostics: A Survey of emerging Tests
To view this issue in interactive digital magazine format visit www.LinkXpress.com
cont’d from page 4
Roche Cobas SARS-CoV-2 Test
Roche Holding AG (Basel, Switzerland, www. roche.com) has been granted EUA by the US FDA for its cobas SARS-CoV-2 Test which runs on the firm’s fully automated cobas 6800 and cobas 8800 systems. The CE-IVD test is also available in markets accepting the CE mark for patients with signs and symptoms of COVID-19 disease and living in affected areas where the SARS-CoV-2 virus is known to be present. Quidel Lyra SARS-CoV-2 Assay
Quidel Corporation (San Diego, CA, USA. www.quidel.com) has obtained EUA from the US FDA to market its Lyra SARS-CoV-2 Assay, a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal or oropharyngeal swab specimens from patients suspected of COVID-19. The assay targets the nonstructural Polyprotein (pp1ab) of the SARS-CoV-2 virus. The authorized testing consists of nucleic acid extraction on the bioMerieux NucliSENS easyMAG system or EMAG system, followed by RT-PCR on the FDAcleared Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument. The rest results are available in less than 75 minutes after extraction.
Israeli Pooling Method
Hologic Panther Fusion SARS-CoV-2 Assay
Hologic, Inc. (Marlborough, MA, USA; www. hologic.com) has secured EUA from the US FDA for its new Panther Fusion SARS-CoV-2 assay. The real-time RT-PCR in vitro diagnostic test is intended for the qualitative detection of RNA from the SARS-CoV-2 isolated and purified from nasopharyngeal and oropharyngeal swab specimens obtained from individuals who meet COVID-19 clinical and/or epidemiological criteria. Hospital, public health and reference laboratories can perform the test on Hologic’s Panther Fusion system, a fully automated, high-throughput molecular diagnostic platform which can provide results in less than three hours and process up to 1,150 coronavirus tests in a 24hour period.
Researchers from Technion – Israel Institute of Technology (Haifa, Israel; Technion) and Rambam Health Care Campus (Haifa, Israel; www. rambam.org.il) have successfully tested a method, known as pooling, that enables simultaneous testing of dozens of samples and can dramatically increase the current COVID-19 testing capacity using existing available resources. Its implementation has the potential to greatly accelerate the rate of testing and detection of COVID-19 infected patients in the population. LexaGene LX Analyzer
LexaGene Holdings, Inc. (Beverly, MA, USA; www.lexagene.com) is accelerating its FDA
EUA submission for its rapid, onsite analyzer for detection of novel infectious diseases such as
BioMérieux BIOFIRE COVID-19 Test
BioMérieux’s (Marcy-l'Étoile, France, www.biomerieux.com) subsidiary, Bio-
Fire Defense, has been issued EUA by the US FDA for its BIOFIRE COVID19 test for use in CLIA moderate and high complexity clinical laboratories to detect SARS-CoV-2. The BIOFIRE COVID-19 test detects SARS-CoV-2 in approximately 45 minutes from a nasopharyngeal swab in transport media and runs on the fully automated FILMARRAY 2.0 and FILMARRAY TORCH platforms. BioMérieux has already launched the SARS-COV-2 RGENE real-time PCR test running on open platforms. The firm is also developing an expanded version of its BIOFIRE FILMARRAY Respiratory Panel 2, called the BIOFIRE Respiratory Panel 2.1 (RP2.1). This new panel will include SARS-CoV-2 in addition to the 21 other common respiratory pathogens and will deliver results in approximately 45 minutes. It will also be available on the FILMARRAY 2.0 and FILMARRAY TORCH platforms. Additionally, bioMérieux has received authorization to sell the BIOFIRE COVID-19 test External Control Kit. The positive control material can be used for quality control and laboratory verification of the test.
5
LabMedica International April/2020
LabMedica International
lINkXPReSS COM
lMI-04-20 105
Cont’d on page 6
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
CLINICAL ANALYZER
WHOLE BLOOD TESTING SYSTEM INSTRUMENTATION LAB
BIOSYSTEMS
The XL-200 random access analyzer offers ease of operation, and automated pipetting for samples and reagents. Other key benefits include auto dilution and rerun, on-board laundry and cooling, a compact size, and wide test menu.
Instrumentation Laboratory’s GEM® Premier™ 5000 analyzer with integrated CO-Oximetry panel is a revolutionary analyzer for point-of-care and centralized laboratory, featuring Enhanced Intelligent Quality Management 2 (iQM®2).
Biosystems offers a line of clinical chemistry and turbidimetry ready-to-use liquid reagents with bottles especially designed to be used directly in the BA400, A25 and A15 analyzers.
ERBA MANNHEIM
lINkXPReSS COM
lMI-04-20 201
cont’d from page 5
lINkXPReSS COM
lMI-04-20 202
REAGENTS
lINkXPReSS COM
lMI-04-20 203
COVID-19 Diagnostics: A Survey of emerging Tests
COVID-19. LexaGene’s scientists have adapted the CDC Coronavirus Diagnostic Panel comprised of three tests for SARS-CoV-2 to the firm’s LX Analyzer platform and successfully detected the presence of the SARS-CoV-2 N-gene RNA in contrived respiratory samples.
Mesa Accula SARS-CoV-2 Test
Mesa Biotech (San Diego, CA, USA; www. mesabiotech.com) has secured the US FDA’s EUA for its Accula SARS-CoV-2 Test, which gives COVID-19 diagnostic results in 30 minutes at the POC use. The visually read test uses PCR technology to detect SARS-CoV-2 via throat and nasal swab samples.
GenMark ePlex SARS-CoV-2 Test
GenMark Diagnostics, Inc. (Carlsbad, CA, USA; www.genmarkdx.com) has obtained the US FDA’s EUA for its ePlex SARS-CoV-2 Test for the qualitative detection of SARS-CoV-2 virus in nasopharyngeal swab samples in patients suspected of COVID-19 infection. The test is exclusively for use on the company’s automated ePlex system which provides results in under two hours with the capacity to process up to 96 tests per eight-hour shift.
BD and and BioGX Sample-Ready Assay On BD MAX System
Becton, Dickinson and Company (BD; Franklin Lakes, NJ, USA; www.bd.com) and BioGX Inc. (Birmingham, AL, USA) have submitted EUA requests to the US FDA for new diagnostic tests that, if authorized, would increase the potential capacity to screen for COVID-19 by thousands of tests per day. The tests will be run on the fully automated BD MAX Molecular Diagnostic Platform which can process 24 samples simultaneously and analyze hundreds of samples per day.
Fulgent NGS COVID-19 Test
Fulgent Genetics, Inc. (Temple City, CA, USA, www.fulgentgenetics.com) has launched one of the market’s first diagnostic tests for the COVID-19 virus that has been developed based on NGS technology. Fulgent has partnered with MedScan Laboratory (Williston, ND, USA; www.medscanlab.com) to launch the COVID-19 test and both have begun accepting specimens for testing from healthcare providers, clinics and reference labs. Iceni Artificial Glycan Receptor Technology
Iceni Diagnostics (Norwich, UK), a biotechnology company, is developing a new approach that identifies the virus not by its genetic code, which can mutate, but by using its reliance on chains of sugars which are constant and unchangeable. The existing prototype product for influenza can detect the virus in less than 20 minutes and could be adapted to identify other pathogens, such as the coronavirus. UC San Diego Partners With Top IVD Manufacturers
The UC San Diego Health and University of California San Diego School of Medicine (La Jolla, CA, USA; www.ucsd.edu ) announced that the UC San Diego Center for Advanced Laboratory Medicine (CALM), in partnership with five leading in vitro diagnostics manufacturers, is ramping up testing for COVID-19, projecting a capacity to complete 1,000 to 1,500 tests per day within two to three weeks. The five in vitro diagnostics manufacturers are Thermo Fisher Scientific (Waltham, MA, USA; www.thermofisher.com), Roche Diagnostics (Basel, Switzerland), GenMark Diagnostics (Carlsbad, CA, USA), Luminex Corporation (Austin, TX, USA) and Ab-
bott Diagnostics (Lake Forest, IL, USA).
Diazyme DZ-Lite SARS-CoV-2 IgG and SARS-CoV-2 IgM CLIA Test Kits
Diazyme Laboratories, Inc. (San Diego, CA, USA; www.diazyme.com) is offering two serological tests for the novel coronavirus (SARSCoV-2), namely the Diazyme DZ-Lite SARSCoV-2 IgG and SARS-CoV-2 IgM CLIA test kits. The Diazyme IgG and IgM tests are run on the fully automated Diazyme DZ-Lite 3000 Plus chemiluminescence analyzer. Abbott ID NOW COVID-19 Test
Abbott (Lake Forest, IL, USA www.abott. com) has been issued EUA by the US FDA for the fastest available molecular point-ofcare test for the detection of novel coronavirus (COVID-19), delivering positive results in as little as five minutes and negative results in 13 minutes. The test runs on the company's ID NOW rapid, instrumentbased, isothermal system for the qualitative detection of infectious disease. The arrival of the Abbott ID NOW COVID-19 test followed the company’s launch of its Abbott m2000 RealTime SARS-CoV-2 EUA test, which runs on the m2000 RealTime System located in hospital and reference labs around the world. Between the two platforms, Abbott expects to produce about five million tests per month. Sensitest Corona Rapid Test
Sensitest International (Delfgauw, The Netherlands; www.sensitest.com) has launched a new coronavirus test that can show whether a patient has the IgM or IgG antibodies of the coronavirus within 15 minutes. Sensitest’s Corona Rapid test for professional use is the only rapid test certified in the EU with a CE certificate issued by a European Notified Body and has been clinically tested.
6
Cont’d on page 7
LabMedica International April/2020
COVID-19 Diagnostics: A Survey of emerging Tests
To view this issue in interactive digital magazine format visit www.LinkXpress.com
cont’d from page 6
Randox and Bosch Vivalytic Viral Respiratory Tract Infection (VRI) Array Randox Laboratories (Crumlin, UK; www.randox.com) and Bosch Healthcare Solutions GmbH (Waiblingen, Germany; www. bosch-vivalytic.com) will launch a game-chang-
ing point of care coronavirus test in April 2020. The Vivalytic Viral Respiratory Tract Infection (VRI) Array can identify SARS-CoV-2 (COVID-19) and differentiate it from nine other respiratory infections with similar symptoms, including influenza and all known coronaviruses. This provides a more comprehensive respiratory screening which enables precise and informed treatment decisions to be made. Luminex NxTAG CoV Extended Panel
cess 2 and DxI series.
DiaSorin Simplexa COVID-19 Direct Kit
DiaSorin Molecular LLC (Cypress, CA, USA; www.molecular.diasorin.com) has obtained EUA
from the US FDA for its Simplexa COVID-19 Direct kit which provides a sample-to-answer test for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) directly from nasopharyngeal swab specimens. Designed for use on the firm’s LIAISON MDX platform, the Simplexa COVID-19 Direct kit contains an all-in-one reagent mix which is ready to use, and only one instrument and one reagent are required to perform the test. QIAGEN QIAstat-Dx
QIAGEN (Hilden, Germany; www.qiagen. com) has obtained EUA from the US FDA for
its newly-developed QIAstat-Dx Respiratory SARS-CoV-2 Panel test for use in diagnosing patients infected with the novel COVID-19 coronavirus. The QIAstat-Dx test kit can differentiate the SARS-CoV-2 coronavirus from two other serious respiratory infections in patients who may have similar symptoms in a single testing run of about one hour. Carolina AllTest 2019-nCoV IgG/IgM Rapid Screen Antibody Test Cassette
Carolina Liquid Chemistries Corp. (CLC; Greensboro, NC, USA; www.carolinachem istries.com) has begun offering its AllTest 2019nCoV IgG/IgM Rapid Screen Antibody Test Cassette, a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to 2019-nCoV in
Luminex Corporation (Austin, TX, USA; www.luminexcorp.com) has secured EUA from the US FDA for its NxTAG CoV Extended Panel for the detection of the SARS-CoV-2 virus. The NxTAG test runs on Luminex's MAGPIX System which utilizes its unique bead-based chemistry to rapidly detect the virus for up to 96 patients in approximately four hours. Additionally, Luminex has received USD 642,450 in funding from the Biomedical Advanced Research and Development Authority (BARDA) to support the development, testing, and submission or EUA for its ARIES SARS-CoV-2 Assay. This assay will run on the firm’s sample-to-answer ARIES System, an FDA-cleared, automated molecular diagnostics platform for moderate complexity labs. PerkinElmer Coronavirus RT-PCR Test
PerkinElmer, Inc. (Waltham, MA; USA; www.perkinelmer.com ) has been granted EUA by the US FDA for its Coronavirus RT-PCR test. The test is marketed as an in vitro diagnostic (IVD) device by meeting the requirements of the European In Vitro Diagnostic Directive (IVDD) and is available in over 30 countries worldwide. Beckman IgM and IgG Tests
Beckman Coulter (Brea, CA, USA; www.beckmancoulter.com) is develop-
ing assays to identify IgM and IgG antibodies to the coronavirus or SARSCoV-2. The assays will be designed for use on any of the firm’s highthroughput Access family of immunoassay systems, including the Ac-
7
LabMedica International April/2020
lINkXPReSS COM
LabMedica International
lMI-04-20 107
Cont’d on page 8
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
CHEMISTRY ANALYZER
MOLECULAR DIAGNOSTIC BIONEER SYSTEM
CLINICAL CHEMISTRY REAGENTS
The XL 640 is a completely automated, small footprint floor-standing clinical chemistry analyzer. The system can achieve a total throughput of up to 640 tests/hour (400 photometric + 240 ISE [Na/K/Cl/Li]).
The ExiStation 48/48A is an integrated automated molecular diagnostic system consisting of ExiLT for sample dispensing, ExiPrep 48 Dx form nucleic acid extraction, and Exicycler 96 for Real-time quantitative thermal block.
The Glenbio range of multipurpose clinical chemistry reagents provides customers with the choice of high quality, cost effective reagents with improved linearity and stability, in a liquid stable ready-to-use format.
ERBA MANNHEIM
lINkXPReSS COM
cont’d from page 7
lMI-04-20 204
lINkXPReSS COM
lMI-04-20 205
AUDIT DIAGNOSTICS
lINkXPReSS COM
lMI-04-20 206
COVID-19 Diagnostics: A Survey of emerging Tests
human whole blood, serum or plasma specimen.
Siemens Fast Track Diagnostics (FTD) SARS-CoV-2 Assay
Siemens Healthineers (Erlangen, Germany; www.siemens-healthineers.com ) has re-
leased its molecular Fast Track Diagnostics (FTD) SARS-CoV-2 Assay test kit used to aid in the diagnosis of infection by the SARS-CoV-2 virus. It has been optimized on the Biomerieux EasyMag Extraction System and the Applied Biosystems 7500 Real-time PCR Thermocycler and utilizes the same workflow, including PCR profile, as other FTD Respiratory Disease kits from Siemens. Menarini-Credo Distribution Alliance
A. Menarini Diagnostics (Florence, Italy; www.menarinidiagnostics.com) and Credo Diagnostics Biomedical (Singapore; www. credodxbiomed.com ) have entered into an exclusive distribution agreement for the SARS-CoV-2 assay kit and other assays for the diagnosis of respiratory infections (RSV and group Strep A). The tests will be run on the VitaPCR (Credo Diagnostics Biomedical's Point-of-Care molecular testing platform) which allows the diagnosis of COVID-19 in just 20 minutes. NeuMoDx SARS-CoV-2 Assay
NeuMoDx Molecular (Ann Arbor, MI, USA, www.neumodx.com) secured EUA from the US FDA for its NeuMoDx SARS-CoV-2 Assay that is implemented on the NeuMoDx Molecular Systems. The rapid, automated in vitro real-time RT-PCR diagnostic test directly detects SARS-CoV-2 Coronavirus RNA from nasopharyngeal, oropharyngeal and nasal swab specimens in transport medium from individuals with signs and symptoms of infection of COVID-19.
Chembio DPP COVID-19
Chembio Diagnostic Systems, Inc. (Medford, NY, USA; www.chembio.com) has launched its rapid DPP COVID-19 serological point-of-care test for the detection of IgM and IgG antibodies in the US. The results can be obtained within 15 minutes from a simple finger stick utilizing Chembio’s MicroReader 1 and MicroReader 2 analyzers. Chembio has also entered into a worldwide strategic partnership with LumiraDx Limited (London, UK; www.lumiradx.com) to develop point-of-care diagnostic tests for the detection of the COVID-19 virus and IgM and IgG antibodies on both the LumiraDx and Chembio DPP platforms. Vela ViroKey SARS-CoV-2 RT-PCR Test
Vela Diagnostics (Singapore; www.veladx. com) plans to offer its manual ViroKey SARSCoV-2 RT-PCR Test after its validation is completed and is currently working with the US FDA for securing EUA for the test. The test is intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs from individuals meeting CDC SARS-CoV-2 clinical criteria. It is intended to be used on the Sentosa SX101 with the Sentosa SX Virus Total Nucleic Acid Kit v2.0 in conjunction with the Sentosa SA201 instrument for high-throughput RTPCR. The assay also fits into a manual workflow for laboratories with existing Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument. CELLINK qPCR Instrument
CELLINK (Boston, MA, USA; www.cellink. com) has begun reselling its qPCR instrument which can be used for the quantification and genotyping of human viral
pathogens, such as SARS-CoV-2. The instrument includes dual channels and is open source, allowing users to use any kit to run their samples, and runs a sample in 20-40 minutes. Ortho SARS-CoV-2 Antibody Test
Ortho Clinical Diagnostics (Raritan, NJ, USA; www.orthoclinicaldiagnostics.com) has launched its SARS-CoV-2 (COVID-19/coronavirus) antibody test—the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack. The test will run on Ortho’s flagship analyzer, the VITROS XT 7600 Integrated System, the VITROS 3600 Immunodiagnostic System, the VITROS 5600 Integrated System and VITROS ECi/ECiQ Immunodiagnostic Systems and can process approximately 150 tests in an hour.
Novacyt PCR COVID-2019 IVD-CE Test
Novacyt S.A. (Paris, France; www.novacyt. com) has secured EUA from the US FDA for its fast and easily transportable COVID-19 test which was developed by Primerdesign, its molecular diagnostics division. Novacyt’s realtime polymerase chain reaction (PCR) COVID2019 IVD-CE test only detects the SARS-CoV2 virus and produces results in less than two hours. The test is also designed to run on multiple instrument platforms used by clinical laboratories globally, ensuring that it can be used by a large number of clinicians.
Mount Sinai `End-to-End` Diagnostics Solution for COVID-19
Researchers and clinicians in microbiology, virology, pathology, molecular science, and immunology at Mount Sinai are working on designing, validating, and implementing an “end-to-end” clinical pathology laboratory solution that will allow for the COVID-19
8
Cont’d on page 9
LabMedica International April/2020
COVID-19 Diagnostics: A Survey of emerging Tests
To view this issue in interactive digital magazine format visit www.LinkXpress.com
cont’d from page 8
testing of approximately several hundred people per day in order to rapidly diagnose and help guide the selection of treatment and monitor disease course. Fluxergy Analyzer System
Fluxergy LLC (Irvine, CA, USA; www. fluxergy.com) has submitted a EUA request to the US FDA Center for Devices and Radiological Health seeking authorization that would permit medical professionals to begin using the firm’s high-speed Research Use Only Fluxergy Analyzer system as a COVID-19 diagnostic at the point-of-care. The system has been shown to accurately identify the SARS-CoV-2 virus in under one hour in bench lab tests and in follow-up validation tests with patient samples. ThermoGenesis SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit
the Netherlands to transfer and validate the method. Cue Health Monitoring System
Cue Health Inc. (San Diego, CA, USA; www. cuehealth.com) has been awarded a USD 13 million contract to accelerate the development, validation and FDA clearance of a portable, molecular diagnostic test capable of detecting SARS-CoV-2 in less than 25 minutes using a simple nasal swab. Thermo Fisher AcroMetrix Coronavirus 2019 (COVID-19) RNA Control
Thermo Fisher Scientific Inc. (Waltham, MA, USA) has launched the AcroMetrix Coronavirus 2019 (COVID-19) RNA Control to help labs validate and monitor COVID-19 molecular diagnostic tests. The kit contains two
vials of SARS-CoV-2 specific RNA at the concentration that will result low positive and ultra-low positive in most commonly used Polymerase Chain Reaction (PCR) based Coronavirus 2019 (COVID-19) nucleic acid testing methods. Canon COVID-19 RNA Testing Canon Medical Systems Corporation (Ohtawara, Japan; www.global.medical.canon) has commenced the development of a rapid genetic testing system for the novel coronavirus. The test and the reagents developed for COVID-19 RNA testing is based on the LAMP method which allows for detection of the virus to be performed more easily and quickly, making it suitable for testing in local areas where infection is prevalent.
ThermoGenesis Holdings, Inc. (Rancho Cordova, CA, USA; www.thermo genesis.com) has developed SARSCoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit to allow prescreening for COVID-19 infections as well as identification of individuals who have encountered the virus and have developed protective immunity. Requiring just a single drop of blood, the kit is intended for professional use and will deliver results – with no lab equipment necessary – in less than 10 minutes, at the point-of-care. The company is currently completing validations in accordance with the FDA’s policies and will notify the agency upon completion of validation prior to product launch.
BIOTECON foodproof Magnetic Preparation Kit VI
BIOTECON Diagnostics GmbH (Potsdam, Germany; www.bc-diagnos tics.com) has launched its newly-developed foodproof Magnetic Preparation Kit VI for high volume, rapid RNA/DNA extraction from all kinds of viruses. Additionally, BIOTECON has partnered with a Singaporean company to distribute Acu-Corona 2.0/3.0 Kits, which are real-time PCR assays for the detection of SARS-CoV-2 extracted from patient samples. Molecular Biology NEXTGENPCR
Molecular Biology Systems, B.V. (Goes, Netherlands; www.nextgenpcr. com) has developed a method using its NEXTGENPCR endpoint thermocycler and consumables that decreases PCR amplification time for SARS-CoV-2 to eight minutes. The firm is now collaborating with testing laboratories in the US and
9
LabMedica International April/2020
lINkXPReSS COM
LabMedica International
lMI-04-20 109
Cont’d on page 10
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
POC DIAGNOSIS SYSTEM
CLINICAL CHEMISTRY EBOLA TEST ANALYZER CORMAY VEDA LAB
The RapiPlex is a point-of-care diagnosis system based on a set of proprietary technologies capable of producing quantitative and qualitative laboratory quality test results.
The Accent S120 clinical chemistry analyzer with a constant throughput of up to 120 tests per hour and up to 400 tests per hour with ISE is dedicated to small laboratories, requiring only 100 μl minimum reaction volume.
BIOSENSIA
lINkXPReSS COM
cont’d from page 1
lMI-04-20 207
lINkXPReSS COM
lMI-04-20 208
lINkXPReSS COM
lMI-04-20 209
level of Uremic Toxins Detected in Parkinson’s
and neurological disorders has been observed. Uremic toxins increase the risk of cognitive disorders and dementia in patients with kidney disease. Scientists at the Medical University of Warsaw (Warsaw, Poland; www.wum.edu.pl) collected plasma and cerebrospinal fluid (CSF) samples were from 27 volunteers (18 with Parkinson’s Disease (PD) and nine controls). Venous blood samples were collected into a tube with EDTA and without anticoagulants, and centrifuged. CSF samples were collected via lumber puncture and centrifuged to remove blood cells contamination, before freezing. Fresh serum was subjected to routine analyses including the measurement of C-reactive protein (CRP) and creatinine. The team measured the concentrations of uremic toxins: indoxyl sulfate (IS), p-cresol sulfate (pCS), symmetric dimethylarginine (SDMA), asymmetric dimethylarginine (ADMA), and trimethylamine N-oxide (TMAO)) in CSF and plasma, and correlated them with inflammation and oxidative stress biomarkers. The level of toxins was determined using liquid chromatography coupled with tandem mass spectrometry. Hepcidin and prohepcidin levels in plasma were determined using enzyme-linked immunosorbent assay (ELISA) kits (DRG Instruments, Marburg, Germany; www.drg-diagnostics.de). The absorbance for ELISA kits was measured using a SynergyMx microplate reader (BioTek Instruments, Winooski, VT, USA; www.biotek.com). The team reported that there was no statistically significant difference between the study groups regarding the percentage of males, creatinine, CRP, TAC, and marker of oxidative stress: 8-Oxo-2'-deoxyguanosine (8-OHdG). PD patients were slightly older and had lower eGFR (all values were in the reference range regarding the age). They had elevated hepcidin level and lower prohepcidin concentration in plasma than the control group. In PD, for
cont’d from page 9
The Ebola eZYSCREEN® is a rapid test for the detection of Ebola virus (ZAIRE strain) allowing diagnosis of the disease within 15 minutes, using a few drops of serum/plasma or whole blood samples, showing excellent specificity.
IS and pCS, CSF-plasma ratio was higher. Concentration of pCS in CSF was higher in PD compared to controls. TMAO level was also higher in plasma of that group. Patients with motor fluctuations had higher level of uremic toxins in CSF, but not in plasma. The authors concluded that in PD, higher concentration of pCS in CSF was observed. The CSF-plasma ratio of pCS and IS was four and eight times higher in PD compared to the control group, respectively. It indicates their higher than expected concentration in CSF, compared to their levels in blood. Toxins were higher in CSF, but not in plasma of patients with motor fluctuations. Uremic toxins like pCS, IS, ADMA, SDMA, and TMAO can be associated with pathogenesis and progression of PD. The study was published on November 11, 2019 in the journal Clinica Chimica Acta. Image: The Hepcidin-25 (bioactive) HS ELISA RUO is a highly sensitive enzyme immunoassay for the quantitative measurement of Hepcidin-25 in serum or plasma. Hepcidin is elevated in Parkinson’s disease patients (Photo courtesy of DRG Instruments)
COVID-19 Diagnostics: A Survey of emerging Tests
Co-Diagnostics Logix Smart Coronavirus COVID-19 Test
Co-Diagnostics, Inc. (Salt Lake City, UT, USA, www.codiagnostics.com) has been granted EUA 3by the US FDA for its Logix Smart Coronavirus COVID-19 Test which uses the firm’s patented CoPrimer technology to target the RdRp gene of the SARS-CoV-2 virus. Promega Corporation’s (Madison, WI, USA; www.promega.com) custom manufacturing capabilities have helped Co-Diagnostics in the rapid development and launch of its new test. PHASE Scientific PHASIFY VIRAL RNA Extraction Kit
PHASE Scientific (Hong Kong; www.phasescientific.com) has com-
mercially launched the PHASIFY VIRAL RNA Extraction Kit which purifies and concentrates viral RNA in patient viral transport media samples. This novel technology outperforms conventional solid phase extraction methods in RNA yield and concentration. Eurofins Coronavirus SARS-CoV-2 Serology Testing
Eurofins Scientific’s (Luxembourg) US clinical diagnostics network is offering blood-based antibody testing for Coronavirus SARS-CoV-2 that can identify people who were exposed, may have developed some level of immunity to COVID-19 but potentially had mild to no symptoms. Eurofins also launched active infection testing through laboratories including Viracor Eurofins and Eurofins Diatherix using polymerase chain reaction (PCR) testing. LabMedica International April/2020
10
lINkXPReSS COM
lMI-04-20 111
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., LTD
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
cont’d from page 1
lMI-04-20 210
lINkXPReSS COM
lMI-04-20 211
lINkXPReSS COM
Thermo Fisher to Acquire Qiagen
lMI-04-20 212
wide range of biological samples. The company's assay technologies are then used to amplify and enrich these biomolecules to make them readily accessible for analysis. In addition, Qiagen's instruments can be used to automate these workflows, while its bioinformatics systems provide customers with relevant, actionable insights. Thermo Fisher has built leading specialty diagnostics capabilities, including allergy and autoimmunity, transplant diagnostics and clinical oncology testing. Qiagen has a strong presence in molecular diagnostics with a product portfolio focused on infectious disease and other growth opportunities. The combined company will accelerate the development of higher-specificity, faster and more comprehensive tests that may improve patient outcomes and reduce the cost of care. For life sciences researchers, Qiagen's innovative sample preparation, assay and bioinfor-
matics technologies are complementary to Thermo Fisher's genetic analysis and biosciences capabilities. As an example, with an expanded portfolio, Thermo Fisher will be able to provide research customers with broader capabilities to accelerate discovery and enable scientific breakthroughs. "We are excited to bring together our complementary offerings to advance our customers' important work, from discovery to diagnostics," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "This acquisition provides us with the opportunity to leverage our industry-leading capabilities and R&D expertise to accelerate innovation and address emerging healthcare needs. For shareholders, we expect the transaction to be immediately accretive and to generate significant cost and revenue synergies. We look forward to welcoming Qiagen's employees to
Thermo Fisher and are excited about the new opportunities we'll have to advance precision medicine through new molecular diagnostics and improved life sciences workflows." "Our vision at Qiagen has always been to make improvements in life possible with our differentiated Sample to Insight molecular testing solutions," said Thierry Bernard, interim chief executive officer of Qiagen N.V. and senior vice president, head of the molecular diagnostics business area. "This strategic step with Thermo Fisher will enable us to enter a promising new era and will give our employees the opportunity to have an even greater impact. The combination is designed to deliver significant cash value to our shareholders, while enabling us to accelerate the expansion of our solutions to provide customers worldwide with breakthroughs that advance our knowledge about the science of life and improve health outcomes."
elioidosis, an infectious disease caused by the environmental saprophyte Burkholderia pseudomallei, is endemic across many areas of Southeast Asia, South Asia, Northern Australia and America. B. pseudomallei is a facultative intracellular bacterium, a characteristic that contributes to its pathogenesis and persistence in the host and that may modulate the cytokine response to infection. Patients may present with a wide range of clinical manifestations including pneumonia, bacteremia, abscesses, and sepsis, frequently leading to multiorgan failure and eventually death. The immunological markers and pathways that identify patients at risk of death in melioidosis are not well understood. Several immune cells including macrophages, natural killer (NK) cells, NK T cells, and T cells respond to bacterial infection rapidly by generation of several potent cytokines. Microbiologists and immunologists at the
Mahidol University (Bangkok, Thailand; https://mahidol.ac.th) conducted a prospective longitudinal study in two hospitals in Northeast Thailand to enroll 161 melioidosis patients, 13 uninfected healthy controls, and 11 uninfected diabetic controls. Blood was obtained from all individuals at enrollment (day 0) and at days 5, 12, and 28 from surviving melioidosis patients. IFN- , IL-1, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL13, IL-17A, IL-23, and TNF- were assayed in plasma. These were determined in human plasma samples using bead-based multiplex assays of Luminex technology (MILLIPLEX MAP kit: HSTCMAG-28K-12 plex, Millipore, Billerica, MA, USA; www.emdmillipore.com). The association of each cytokine and its dynamics with 28day mortality was determined. The investigators reported that of melioidosis patients, 131/161 (81%) were bacteremic, and 68/161 (42%) died. On enrollment median levels of IFN-, IL-6, IL-8, IL-10, IL-23, and TNF- were
higher in melioidosis patients compared with uninfected healthy controls and all but IFNwere positively associated with 28-day mortality. IL-8 provided the best discrimination of mortality. Over time, non-survivors had increasing IL6, IL-8, and IL-17A levels, in contrast to survivors. In joint modeling, temporal trajectories of IFN- , IL-6, IL-8, IL-10, and TNF- predicted survival. The authors concluded that in a severely ill cohort of melioidosis patients, specific proand anti-inflammatory and Th17 cytokines were associated with survival from melioidosis, at enrollment and over time. Persistent inflammation preceded death. These findings support further evaluation of these mediators as prognostic biomarkers and to guide targeted immunotherapeutic development for severe melioidosis. The study was published on November 7, 2019 in the journal Clinical Microbiology and Infection.
M
Plasma Cytokine Responses Characterized in Melioidosis
LabMedica International April/2020
12
Blood Test Screens for Multiple Cancers
To view this issue in interactive digital magazine format visit www.LinkXpress.com
cont’d from page 1
origin (TOO). Methylation works to activate or deactivate genes, and altered methylation suggests cancer. Besides lung cancer, the methylation-based assay screens for anal, bladder, colorectal, esophageal, head and neck, liver/bile duct, lymphoma, ovarian, pancreatic, plasma cell neoplasm, and stomach cancers, among others. Methylation works to activate or deactivate genes, and altered methylation suggests cancer. Scientists from the Dana-Farber Cancer Institute (Boston, MA, USA; www.dana-farber.org) and their colleagues in a prospective study colleagues analyzed cell-free DNA (cfDNA), DNA that is released into the bloodstream following cell death, in 3,583 blood samples, of which 1,530 were from patients with cancer and 2,053 were from cancer-free individuals. The assay functions by quantifying abnormal methylation patterns in cfDNA, whereas liquid biopsies isolate genetic mutations or other types of DNA alterations. The team reported that the overall specificity of the assay was 99.4%, and the sensitivity for aggressive cancers was 76%. Specifically, sensitivity was 32% in stage I cancer, 76% in stage II cancer, 85% in stage III cancer, and 93% in stage IV cancer. In all cancer types, sensitivity was 55%. The scientists also noted that 97% of samples yielded TOO results, with correct TOO recorded in 89% of samples. For diagnosing non-small cell lung cancer (NSCLC), biopsy is currently the gold standard, while molecular testing is used to shed light on treatment options in advancedstage or even early-stage NSCLC. The scientists stated that in many types of cancer, methylation is better reflective of cancer diagnosis than are other types of mutations. Indeed, they had previously found that whole-genome bisulfite sequencing (i.e., the methylation assay) outperformed wholegenome and targeted-sequencing strategies in detecting cancer. Ultimately, if this new methylation-based assay was to pick up even a small number of early-stage cancer types, many patients would benefit from earlier treatment. Geoffrey R. Oxnard, MD, a medical oncologist and lead author of the study, said, “Our previous work indicated that methylation-based assays outperform traditional DNA-sequencing approaches to detecting multiple forms of cancer in blood samples. The results of the new study demonstrate that such assays are a feasible way of screening people for cancer.” The study was presented at the European Society for Medical Oncology Congress, (ESMO), held in September 27–October 1, 2019, in Barcelona, Spain. Image: Novel, high-accuracy blood test can screen for multiple cancers (Photo courtesy of European Society for Medical Oncology)
13
LabMedica International April/2020
LabMedica International
NE D ES W IGN
wORlD’S MeDICAl PRODUCT MARkeTPlACe
SIGN UP FOR FREE!
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.
PRODUCT NEWS
TUBERCULOSIS ASSAY
HBA1C ASSAY
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
ESR ANALYZER
DIASORIN
DIAZYME LABORATORIES
DIESSE DIAGNOSTICA SENESE
The LIAISON QuantiFERON-TB Gold Plus is a fully automated CLIA assay, aids in diagnosis of TB infection, detecting active and latent TB infection, designed to work with Qiagen Quantiferon-TB Gold Plus Blood Collection Tubes.
The Direct HbA1c Assay (Enzymatic, On-Board Lysis) test kit is intended for use in the quantitative determination of stable HbA1c in venous whole blood samples with on-board blood lysis application in a clinical laboratory.
The VES-MATIC EASY is an automated system for the direct determination of ESR in 10 samples simultaneously or random access. It is an excellent system for the ESR in lipemic and bilirubinemic samples.
lINkXPReSS COM
contâ&#x20AC;&#x2122;d from page 1
lMI-04-20 213
lINkXPReSS COM
lMI-04-20 214
lMI-04-20 215
Molecular Diagnostic Panel Distinguishes Cause of Vaginatis
A panel of two molecular diagnostic tests launched earlier this year, now aims to detect and distinguish among these three primary causes, and has recently shown high accuracy in a published study. A team of medical microbiologists working with the University of Alabama at Birmingham (Birmingham, AL, USA; www.uab.edu) conducted a prospective multicenter clinical study to validate the performance of two new in vitro diagnostic transcription-mediated amplification nucleic acid amplification tests (NAAT) for diagnosis of BV, VVC, and trichomoniasis. The trial involved more than 1,400 vaginitis patients at 21 trial sites. Six vaginal swabs, including one self-collected by the patient, were used to determine the accuracy of the two molecular tests, with results for each target of the two new tests compared to gold standard diagnostic testing and clinical evaluations. Patient- and clinician-collected vaginal swab samples obtained from women with symptoms of vaginitis were tested with the Aptima BV and Aptima CV/TV assays (Hologic, Marlborough, MA, USA; www.hologic.com). The results of the assays were compared to Nugent score (plus Amsel for intermediate Nugent) for BV, Candida
cultures and DNA sequencing for VVC, and a composite of a NAAT and culture for T. vaginalis. The Aptima BV assay specifically reports positive or negative results for BV based on a mathematical algorithm analysis of ribosomal RNA of Lactobacillus species, Gardnerella vaginalis, and Atopobium vaginae. The Aptima CV/TV detects and differentiates RNA for three targets: a Candida species group that includes C. albicans, C. dubliniensis, C. parapsilosis, C. tropicalis, as well as C. glabrata alone, and T. vaginalis. The scientists reported that the prevalence of infection was similar for clinician- and patientcollected samples: 49% for BV, 29% for VVC due to Candida species group, 4% for VVC due to C. glabrata, and 10% for T. vaginalis. The BV test has a sensitivity of 95% and a specificity of 90% compared to the reference methods. For the CV/TV test, sensitivity and specificity were 92% and 86%, respectively, for Candida species group, 85% and 99% for C. glabrata, and 97% and 99% for T. vaginalis. Sensitivity and specificity were also similar in the clinician-collected and patient-collected samples. The molecular tests detected more co-infections than the refer-
everal types of cancer can form in the liver. The most common type of liver cancer is hepatocellular carcinoma, which begins in the main type of liver cell (hepatocyte). Other types of liver cancer, such as intrahepatic cholangiocarcinoma and hepatoblastoma, are much less common. Tests and procedures used to diagnose liver cancer include blood tests that may reveal liver function abnormalities; Imaging test, such as an ultrasound, computerized tomography (CT) and magnetic resonance imaging (MRI) or a biopsy by removing a sample of liver tis-
sue for testing. Scientists from the Mayo Clinic (Rochester, MN, USA; www.mayo.edu) collaborating with the commercial company Exact Sciences (Madison, WI, USA; www.exactsciences.com) collected blood samples from 137 radiographically diagnosed hepatocellular carcinoma (HCC) and 313 age-matched controls with benign liver disease without structurally apparent HCC. They assessed 10 methylated markers that had previously been reported as having some association with HCC, as well as several protein markers including alpha-fetopro-
S
lINkXPReSS COM
ence methods, 25% of patients versus 20%. The authors concluded that overall, the investigational assays had higher sensitivity and specificity than clinician's diagnoses and in-clinic assessments, indicating the investigational assays were more predictive of infection than traditional diagnostic methods. These results provide clinical efficacy evidence for two IVD NAATs that can detect the main causes of vaginitis. The study was published online on November 20, 2019 in the Journal of Clinical Microbiology. Image: The Aptima BV and Aptima CV/TV assays for the diagnosis of infectious vaginitis (Photo courtesy of Hologic).
Marker Panel Detects early liver Cancer with Increased Sensitivity
tein (AFP). The investigators found that the panel had a specificity of 90%, and they reported that their panel of six markers detected early-stage HCC with a sensitivity of 71% compared to 25% for AFP. The panel also detected Stage A HCC with a sensitivity of 74% compared to 30% for AFP. Overall, the panel's sensitivity was 82.6% compared to 47.1% for AFP. At 90% specificity, AFP's sensitivity was 45%. The team chose to include AFP and an AFP isoform called AFP-L3 as the two protein
Contâ&#x20AC;&#x2122;d on page 16
LabMedica International April/2020
14
Rapid Method Selects Proper Antibiotic Against Multidrug Resistant Pathogens
To view this issue in interactive digital magazine format visit www.LinkXpress.com
contâ&#x20AC;&#x2122;d from page 1
The current gold standard method for "phenotypic" antibiotic susceptibility testing (AST) is growing organisms isolated from the patient in the presence of various antibiotics to see which drug can inhibit growth of the microbe. While such growth-based assays are accurate, they require several days to return results. Newer "genotypic" methods that search bacterial DNA for mutations known to confer drug resistance are quicker but less accurate, since resistance can arise from genetic changes other than those included in the test. A new approach that combines both phenotypic and genotypic analysis has been developed by investigators at the Broad Institute of the Massachusetts Institute of Technology and Harvard University (Cambridge, MA, USA; www.broadinstitute.org). This rapid assay combines genotypic and phenotypic AST through RNA detection. The test, which has been named GoPhAST-R (for Genotypic and Phenotypic AST through RNA), classifies bacterial strains with 94â&#x20AC;&#x201C;99% accuracy by coupling machine learning analysis of early antibiotic-induced transcriptional changes with simultaneous detection of key genetic resistance determinants. The method employs machinelearning algorithms to identify the mRNA transcripts that best distinguish drug-sensitive from drug-resistant organisms and integrates this information with analysis of the sequence of mRNA transcripts to reveal whether the bacteria carry key genes known to cause drug resistance. By performing these analyses on the NanoString (Seattle, WA, USA; www. nanostring.com) prototype Hyb & Seq instrument, the investigators were able to use the GoPhAST-R method to determine antibiotic susceptibility less than four hours after bacteria were positively detected in a blood culture, compared to 28-40 hours using standard clinical laboratory methods. The method was able to detect susceptibility to three major antibiotic classes in clinical use today - carbapenems, fluoroquinolones, and aminoglycosides in five pathogens that often become drugresistant: Escherichia coli, Klebsiella pneumoniae, Acinetobacter baumannii, Staphylococcus aureus, and Pseudomonas aeruginosa. "The ability to quickly and accurately identify the best antibiotic would greatly improve the care of patients with infection, while ensuring that our arsenal of antibiotics is deployed intelligently and efficiently," said senior author Dr. Deborah Hung, associate professor of molecular biology at Harvard
15
LabMedica International April/2020
LabMedica International
Image: Scanning electron micrograph of carbapenem-resistant Enterobacteriaceae bacteria (Photo courtesy of Stephanie Rossow, Centers for Disease Control and Prevention/ Antibiotic Resistance Coordination & Strategy Unit)
lINkXPReSS COM
lMI-04-20 115
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
DIRUI INDUSTRIAL
URINE ANALYZER
IMMUNOFLUORESCENCE ANALYZER EUROIMMUN AG
The FUS-3000Plus is a highly automated urine analyzer with a throughput of 120 samples/hour and an auto loader capacity of 50 samples/270 samples (optional), featuring a compact 3-in-1 design.
The EUROLabWorkstation IFA provides fully automated processing of indirect immunofluorescence assays at a capacity of up to 750 reaction fields per run, processing more than 200 tests per hour.
lINkXPReSS COM
lMI-04-20 216
lINkXPReSS COM
lMI-04-20 217
New Biomarker for Cancer Stem Cells
cont’d from page 1
sub-populations to provide improved outcomes. Developing treatment strategies targeting CSCs remains a challenge, due to the paucity of reliable biomarkers identifying such subpopulations. A team of scientists led by the University of Houston (Houston, TX, USA; https://uh.edu) applied an “unbiased” peptoid combinatorial cell screen to identify highly specific ligands that bind a CSC subpopulation of non-small cell lung cancer cells (defined by Aldefluor positivity), but not the remaining aldefluor negative cancer cells from the same preclinical model. The team developed 400,000 potential synthetic chemical compounds (peptoids) and used them to capture the specific biomarker performing a unique, but simple twocolor cell screen. From almost half a million, only three peptoids targeted cancer stem cells and not the remaining cancer cells from the same patient. When those peptoids were used to pull-down their targets, one of them was identified as plectin, proving that it is a unique biomarker for cancer stem cells. The investigators reported that one of the ‘hit’ peptoids bound to plectin, a structural protein, predominantly expressed intracellularly, but whose localization on the cell sur-
face is linked to tumor invasion and metastasis. Because plectin assists in shaping cells, it is pivotal to the spread of cancer, helping cancer stem cells wend their way through the body. The authors concluded that they had used a peptoid on-bead two-color (OBTC) combinatorial cell screen to unbiasedly target a Aldehyde Dehydrogenase 1 positive (ALDH+) subpopulation in a non-small cell lung cancer cells (NSCLC) which led to the identification of peptoid PCS2, which in turn led to identification of its binding target, plectin which was expressed on the surface of NSCLC tumor cells but not normal lung epithelial cells. Gomika Udugamasooriya, PhD, an assistant professor and senior author of the study, said, “We have found a new biomarker, the protein plectin, on cancer stem cells. We believe plectin may be a more common biomarker that could lead to broadly applicable drug development. Plectin is a structural protein, predominantly expressed intracellularly, but whose translocation onto the cell surface is linked to tumor invasion and metastasis. Our studies show both genotypic and phenotypic correlations between plectin and lung cancer stem cells, as well as association of high plectin expression with poor
BLOOD ANALYZER FOR MALARIA
BIOSYNEX
The CellsCheck automaton for rapid diagnosis of malaria, based on unique digital processing technology, is the first platform for detection and identification of the Plasmodium species in human blood by the thick drop method. lINkXPReSS COM
lMI-04-20 218
patient survival in lung adenocarcinoma, potentially identifying plectin as a biomarker for lung cancer stem cells.” The study was published on October 18, 2019 in the journal Scientific Reports. Image: A cancer cell amongst normal cells. A new biomarker, plectin, has been discovered in cancer stem cells that governs cancer survival and spread (Photo courtesy of Laurie Fickman/ University of Houston).
Marker Panel Detects early liver Cancer with Increased Sensitivity
cont’d from page 14
markers in the panel. AFP-L3 is represented as a ratio of a lectin protein to total AFP: the AFP-L3% assay is used to help identify people at risk of developing HCC, and studies have shown that AFP-L3% test results higher than 10% can be indicative of early HCC. They further found that the addition of methylation markers gave the test more diagnostic power than the addition of DNA mutation markers would have. John B. Kisiel, MD, an associate professor of gastroenterology and
hepatology, and a co-author of the study, said, “We think that the data are a very compelling indication that this new panel of markers is substantially better than AFP. The difficulty with ultrasound is that while it's the current standard of care, it is also often insensitive for earlystage cancers, and although it's relatively widely available, it depends on a human operator to take the pictures, and it depends on patients coming in to have it done.” The study was presented at the Annual meeting for the American Association for the Study of Liver Diseases, held November 13-17, 2019 in Boston, MA, USA). LabMedica International April/2020
16
Immune Cells linked to Malaria-Induced Anemia Through Autoantibody Production
To view this issue in interactive digital magazine format visit www.LinkXpress.com
M
alaria is still a major global health threat with over 200 million new infections and around 400,000 deaths per year. Anemia is a common complication associated with malaria that contributes significantly to the great morbidity and mortality associated with the disease. Despite its high clinical relevance, the mechanisms underlying malarial anemia in patients remain largely unknown. The difficulty in studying this syndrome arises at least in part from its multi-factorial etiology, as malaria causes both the clearance (through complement-mediated lysis or phagocytosis) of infected and uninfected erythrocytes and bone marrow dyserythropoiesis. An international team of scientists led by those at New York University School of Medicine (New York City, NY, USA; https://med.nyu.edu) recruited 24 patients who were aged between 18 and 65 years, and a diagnosis of Plasmodium falciparum malaria by microscopy. This cohort suffered from mild anemia with average hemoglobin levels of 12.4 g/dL (males) and 10.2 g/dL (females). Plasma and peripheral blood mononuclear cells (PBMC) were isolated from peripheral venous blood by Ficoll purification and stored at −80 °C until temperature-controlled transportation from Germany to the New York University. Peripheral venous blood from healthy malaria-naïve donors was obtained on the day of the study. The scientists performed flow cytometry on a FACSCalibur (Becton Dickinson, Franklin Lakes, NJ, USA; www.bd.com) and analyzed with FlowJo (Tree Star, Ashland, OR, USA; www.flojo.com). Intracellular T-bet staining was performed using the True-Nuclear Transcription Factor Buffer Set (Biolegend, San Diego, CA, USA; www. biolegend.com). Enzyme-linked immunosorbent assays were performed to estimate malarial antibodies. Assessment of the erythrocyte lysis capacity of plasma was performed following previously described methods with small modifications. Supernatants were read in a spectrophotometer at 414 nm to assess erythrocyte lysis. ELISPOTs were performed as previously reported. The team identified the production of an unusual type of immune B-cell: FcRL5+T-bet+ B-cells, that increases anti-phosphatidylserine (PS) antibody production associated with the development of ane-
17
LabMedica International April/2020
mia in the patients. These immune cells also developed and produced anti-PS antibodies in blood drawn from uninfected people that was then exposed to broken remnants of malaria-infected red blood cells in the laboratory. Ana M. Rodriguez, PhD, a Professor of Microbiology and a senior author of the study, said, "There is a great need for novel targeted treatments for malaria-induced anemia, which is common and can be fatal for many malaria patients. The unique phenotype and specificity of these immune B-cells could allow them to be used as a biomarker for anemia or as a target for new therapies.” The study was published on November 12, 2019 in the journal eLife.
lINkXPReSS COM
LabMedica International
Image: Photomicrograph of a blood smear that revealed the presence of numerous Plasmodium falciparum ring-form parasites. Note that some red blood cells (RBCs) contain multiple parasites. Anemia is a common and sometimes deadly complication of malaria infections (Photo courtesy of Centers of Disease Control and Prevention/Dr. Greene).
lMI-04-20 117
PRODUCT NEWS
HEMATOLOGY 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
NUCLEIC ACID ANALYZER
RAPID ASSAY
DYMIND BIOTECHNOLOGY
GENEREACH BIOTECHNOLOGY
GREINER BIO-ONE
The DX450 is a 5-part auto hematology analyzer with immunoassay that supports flexible detection items. It enables the testing of seven independent specific proteins in parallel with the blood cell detection channel.
The POCKIT Micro Plus nucleic acid analyzer is the newest generation of the insulated isothermal polymerase chain reaction (iiPCR) detection system, light-weighted and hand-held, delivering PCR results in around 30-45 minutes
The CytoInspect assay utilizes DNA microarray technology for detection and species-specific identification of Mycoplasma species in biologics with the results delivered in five hours.
lINkXPReSS COM
lMI-04-20 219
lINkXPReSS COM
lMI-04-20 220
lINkXPReSS COM
lMI-04-20 221
Coagulation Function explored for Gestational Diabetes Hemorrhage
G
estational diabetes mellitus (GDM) is characterized as glucose intolerance of any degree that begins or first diagnosed during pregnancy. It possesses a higher risk of hemorrhage, which may be caused by the coagulation dysfunction. GDM is a common metabolic disease with variable prevalence rates between 0.6% and 15% worldwide, and it aggravates the risk of severe perinatal complications, such as massive hemorrhage, preeclampsia, shoulder dystocia, and macrosomia, for both mothers and offspring. Laboratory scientists at Sun Yat-Sen University (Guangzhou, China; www.sysu.edu.cn) recruited a total of 662 subjects (273 from a population-based study and 389 from a prospective cohort study) who were selected to measure mean platelet volume (MPV), platelet dis-
tribution width (PDW), platelet (PLT), thrombocytocrit (PCT), prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), and fibrinogen (FIB). All pregnant individuals were divided into normal glucose tolerance (NGT) controls and GDM patients diagnosed between the 24th and 28th weeks of gestation. Platelet parameters (MPV, PDW, PLT, and PCT) analysis was performed on an Automatic Blood Cell Analyzer (Abbott Laboratories, Abbott Park, IL, USA; www.abbott.com). Coagulation parameters (PT, APTT, TT, and FIB) analysis was performed on an Automatic Coagulation Analyzer, the STAGO STACompact (STAGO, Asnières sur Seine, France; www.stago.com). The team reported that compared with normal glucose tolerance (NGT) controls, GDM females showed shortened PT, short-
ened APTT, and increased blood FIB levels, while the platelet parameters MPV, PDW, PLT, and PCT remained unchanged in midpregnancy. By late pregnancy, the platelet parameters MPV, PDW, and PCT were increased in the GDM group compared with the NGT group, while PT and APTT were unchanged. The authors concluded that the GDM group was hypercoagulable compared with the NGT group rather than hypocoagulable as predicted, but still within the normal range. Therefore, their findings demonstrated that the variation degree of coagulation function is not responsible for extra risk of hemorrhage in GDM, and prevention of hemorrhage should focus on other causes. The study was published on November 27, 2019 in the Journal of Clinical Laboratory Analysis.
hile the common genetic variants contributing to schizophrenia in East Asian individuals appear to broadly resemble those found in Europeans, polygenic risk scores (PRS) for the condition cannot necessarily be transferred from one population to the next. Although many common variants and loci have been implicated in schizophrenia, most past studies have focused on individuals of European ancestry. That suggests far more variants are left to be identified but also makes it difficult to know how well the known associations between schizophrenia and variants hold up in other populations. A team of scientists collaborating with those at Massachusetts General Hospital (Boston, MA, USA; www.massgeneral.org) performed a genome-wide association study focused on 22,778 East Asian individuals with schizophrenia and 35,362 without, shoring up findings from the first 13,305 cas-
es and 16,244 controls with additional validation and meta-analysis. Their analyses led to 19 loci with 21 genome-wide significant ties to schizophrenia in East Asians, including 14 associations not identified in a prior schizophrenia study in individuals with Chinese ancestry. The investigators noted that the risk loci included many parts of the genome where allele frequencies differ in East Asian and European populations, although analyses that incorporated linkage disequilibrium and common variant clues suggested that the genetic architecture of schizophrenia risk is comparable for parts of the genome outside of the immune-related major histocompatibility complex region. The team also saw similar selection signatures, overrepresented gene sets, and other similarities when they compared the East Asian genetic data with results from prior schizophrenia studies in Europeans. With a meta-analysis on East Asian and
European individuals, including 56,418 cases and more than 78,800 controls, the team highlighted 208 schizophrenia associations at 123 known and 53 new loci, narrowing in on apparent causal variants at 44 loci with additional fine-mapping analyses. Even so, PRSs for schizophrenia that were developed in Europeans performed more poorly in the East Asian individuals and vice versa, reduced predictive abilities that the authors suspected might stem from allele frequency, linkage disequilibrium, and other populationrelated differences. The authors concluded that their study highlights the importance of including all major ancestral groups in genomic studies, both as a strategy to improve the power to find disease associations and to ensure that the findings have maximum relevance for all populations. The study was published on November 18, 2019 in the journal Nature Genetics.
W
Genetic Architectures of Schizophrenia Compared in Different Populations
LabMedica International April/2020
18
Measles Virus Infection Impacts Immune Cells
To view this issue in interactive digital magazine format visit www.LinkXpress.com
LabMedica International
M
easles is a disease caused by the highly infectious measles virus (MeV) that results in both viremia and lymphopenia. Measles virus is a highly infectious lymphotropic virus associated with an extended period of immunosuppression after resolution of acute viremia. Lymphocyte counts recover shortly after the disappearance of measlesassociated rash, but immunosuppression can persist for months to years after infection, resulting in increased incidence of secondary infections. Memory B cell clones present before infection are depleted in post-measles samples even after lymphocyte counts had recovered, a change not seen in controls given an influenza vaccination. An international team of scientists led by the Wellcome Sanger Institute (Cambridge, UK; www.sanger.ac.uk) used targeted sequencing to follow blood samples from more than two-dozen children prior to measles infections and again more than a month after the infections cleared. The sequence data pointed to decline in immune memory cells and B lymphocyte white blood cell diversity following measles infections. In an effort to untangle the specific immune cell changes involved in the process, the team did isotype-resolved B-cell receptor sequencing to barcode and follow immune cells in peripheral blood samples collected at baseline in 26 unvaccinated children from a study in the Netherlands, and again some 40 to 50 days after their measles virus infections. Using B cell receptor (BCR) sequencing of human peripheral blood lymphocytes, the team extrapolated antibody; naïve B cell and memory B lymphocyte profiles; and other immune patterns, comparing them with those in samples from unvaccinated children who dodged measles infections and with samples from adults who received a trivalent inactivated influenza vaccine. The investigators identified two immunological consequences from measles underlying immunosuppression: (i) incomplete reconstitution of the naïve B cell pool leading to immunological immaturity and (ii) compromised immune memory to previously encountered INTeRACTIVe pathogens due to depletion of previously DIGITAl eDITION expanded B memory clones. The team saw decreased antibody levels and poorer B memory immune cell responses to the influenza H1N1 virus in influenza vaccinated ferrets that had been through a measles-like canine distemper virus infection than in the animals that remained canine distemper virus-free. The authors concluded that their results show that MeV infection causes changes in naïve and memory B lymphocyte diversity that persist after the resolution of clinical disease and thus contribute to compromised immunity to previous infections or vaccinations. This work highlights the importance of MeV vaccination not only for the control of measles but also for the maintenance of herd immunity to other pathogens, which can be compromised after MeV infection. The study was published on November 1, 2019 in the journal Science Immunology.
Image: Colored scanning electron micrograph (SEM) of a B lymphocyte white blood cell (Photo courtesy of the US National Institute of Allergy and Infectious Diseases)
pREMIER MULTIMEDIA pLATFORM SERVING THE WORLD’S CLINICAL LABORATORY COMMUNITY Anytime, Anywhere, On the Go...
19
LabMedica International April/2020
PRINT MAGAzINe
weB PORTAl
website editions: english Spanish
labmedica.com
PRODUCT NEWS
REAL-TIME PCR
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
ELISA ANALYZER
COVID-19 REAL-TIME PCR TEST
HANGZHOU BIOER TECHNOLOGY
GRIFOLS DIAGNOSTIC
CTK BIOTECH
The QuantGene 9600 real-time PCR features thermoelectric refrigeration technology, with a brand-new light source and light path design, and a unique constant current power and six-zone independent temperature control method.
The SQII is a compact, automated ELISA analyzer featuring an ultra-compact design, high throughput and full walk-away capability for quick and easy processing of ELISA assays.
The Aridia COVID-19 Real-Time PCR Test has 95.1% sensitivity, 95.9% specificity, utilizing multiplex PCRfluorescent probe technology, combined with fast one-step RT-PCR technology, designed to work with open PCR systems.
lINkXPReSS COM
R
lMI-04-20 222
lINkXPReSS COM
lMI-04-20 223
lINkXPReSS COM
lMI-04-20 224
Genetic locus with Unique Tandem Repeats linked to Development of late-Onset Alzheimer’s Disease
esearchers have discovered evidence of a novel genetic variation linked to the development of late-onset Alzheimer’s disease (AD). Late-onset Alzheimer’s disease (LOAD) is a common complex disorder of old age. Though these types of disorders can be highly heritable, they differ from single-gene (Mendelian) diseases in that their causes are often multi-factorial with both genetic and environmental components. Genetic risk factors that have been firmly implicated are mutations in the amyloid precursor protein (APP), presenilin 1 (PSEN1) and presenilin 2 (PSEN2) genes, which are found in large multi-generational families with an autosomal dominant pattern of disease inheritance, the apolipoprotein E (APOE) epsilon 4 allele and the sortilin-related receptor (SORL1) gene. Environmental factors that have been associated with late-onset Alzheimer’s disease include depressive illness, various vascular risk factors, level of education, head trauma, and estrogen replacement therapy. This complexity may help explain their high prevalence from an evolutionary perspective, but the etiologic complexity makes identification of disease-related genes
much more difficult. The “endophenotype” approach is an alternative method for measuring phenotypic variation that may facilitate the identification of susceptibility genes for complexly inherited traits. To identify genetic variations linked to development of LOAD, investigators at the University of Kentucky (Lexington, USA; www.kyu.edu) analyzed Alzheimer's Disease Sequencing Project (ADSP) whole exome sequencing (WES) data derived from over 10,000 individuals. The locus of interest was a poorly annotated region of the exome (the protein-coding DNA within the genome) with unique tandem repeats, largely unreadable by existing sequencing methods. Therefore, the investigators performed additional studies including PCR-based characterization of the tandem repeat-containing region in a cohort of autopsied individuals. Those results were correlated with LOAD pathological endophenotypes, and augmented by immunohistochemical analyses from LOAD cases and non-AD control brains. The investigators reported finding evidence of LOAD-linked genetic variation within an exon of the Mucin 6 (MUC6) gene, and approximately 4000 base pairs downstream from an-
other gene that encodes Adaptor Related Protein Complex 2 Subunit Alpha 2 (AP2A2). PCR analyses on genomic DNA samples confirmed that the size of the MUC6 variable number tandem repeat (VNTR) region was highly polymorphic, and the size of the polymorphic region was associated with the severity of pTau pathology in the neocortex. AP2A2 expression was lower in a subset analysis of brain samples from persons with longer versus shorter VNTR regions, and AP2A2 was often co-localized with neurofibrillary tangles in LOAD. Senior author Dr. Peter Nelson, professor of neuropathology at the University of Kentucky, said, "Our findings were made in a group of patients that is relatively small for a genetics study - some recent studies included hundreds of thousands of research subjects! That small sample size means two things: first, we should exercise caution and we need to make sure the phenomenon can be replicated in other groups; and second, it implies that there is a very large effect size - the genetic variation is strongly associated with the disease." The study was published in the November 4, 2019, online edition of the Journal of Neuropathology & Experimental Neurology.
hagas disease, also known as American trypanosomiasis, is a tropical parasitic disease caused by the protist Trypanosoma cruzi. It is spread mostly by insects known as Triatominae, or "kissing bugs". The symptoms change over the course of the infectio. Although Chagas disease is often thought of as a parasitic infection that predominantly affects rural areas of Latin America, it should be noted that a large epidemiological burden of cases in the USA, including an estimated
70,000 in California, 37,000 in Texas, 18,000 in Florida, and 17,000 in New York, none of which included undocumented individuals. Scientists from the Center of Excellence for Chagas Disease, Sylmar, CA, USA; www.cha gasus.org) and their colleagues performed a retrospective chart review of 221 patients from their center, who were a mean age of about 56, and had been in the USA for an average of 37 years. More than half of the patients were women, about half were from El Salvador, with about a quarter from Mexico,
and a little less than half were ages 50-69. A little over 30% of these patients had cardiomyopathy. The most common comorbidity among these patients was hypertension (43%), followed by obesity (39.6%) and hyperlipidemia (30.6%). Only 30% of patients had no comorbidities, while 9% had five or more in this cohort. Men had a significantly higher number of comorbidities compared with women (2.22 versus 1.63, respectively), and the same was
C
Chronic Comorbidities Are Prevalent Among People with Chagas Disease
20
Cont’d on page 22
LabMedica International April/2020
TP53 Gene Promoter Methylation Impacts Chronic lymphocytic leukemia
To view this issue in interactive digital magazine format visit www.LinkXpress.com
C
hronic lymphocytic leukemia (CLL) is a clonal disorder that results in the accumulation of morphologically mature-looking and immunologically incompetent lymphoid cells in the bone marrow, peripheral blood, and lymphatic tissues. CLL is a heterogeneous disease as some patients may progress rapidly, even though they may fail to respond to therapy, and others may remain stable for years without any intervention, and this mirrors the genetic configuration and the epigenetic modification of different genes that lead to disease development, stability, progression, and response to different chemotherapeutic agents. Scientists at the University of Duhok (Duhok, Iraq; https://dpu.edu. krd) carried out a case-control study including 54 newly diagnosed patients presenting with CLL as well as 30 normal individuals as controls from January 1, 2017 to July 30, 2018. Blood was collected from all enrolled individuals for hematological investigations as well as for molecular categorization of TP53 methylation status. Methylation-specific polymerase chain reaction (MS-PCR) technique was used to define the methylation status of the TP53 gene promoter that encompasses
C
Crohn's Disease Associated Bacteria Tolerate Antibiotics
rohn's disease is a chronic disease that causes inflammation and irritation in the digestive tract. The disease is characterized by an imbalance in the intestinal microbiome. In particular, adherent-invasive Escherichia coli (AIEC) strains have been implicated in the disease.. The diversity of virulence factors displayed by multiple AIEC strains suggests that members of this pathovar have evolved different strategies to colonize their hosts. AIEC ability to persist, and in some cases replicate within macrophages is particularly intriguing. A reference strain for this pathovar, AIEC LF82, forms micro-colonies within phagolysosomes, an environment that prevents commensal E. coli multiplication. Microbiologists at the UniversitĂŠ Paris Sciences et Lettres (Paris, France; www.psl.eu) and their associates used single-cell analysis, genetic dissection and mathematical models to monitor the growth status and cell cycle regulation of intracellular AIEC LF82. The investigators infected cells resulting in the observation of three LF82 bacteria per macrophage on average at 1 hour. Imaging was performed on an inverted Zeiss Axio Imager (Jena, Germany; www.zeiss.com) with a spinning disk CSU W1 (Yokogawa, Tokyo, Japan; www.yokogawa.com). The team also performed antibiotic challenge and viable bacterial count using the gentamycin protection assay, fluorescence quantification, live and dead assays using the Live and Dead BacLight Viability kit (Thermo Fisher Scientific, Waltham, MA, USA; www.thermofisher.com), measurement of gene expression by RT-qPCR using a MyiQ real-time qPCR machine (BioRad, Hercules, CA, USA; www.bio-rad.com). The scientists reported that they found that within macrophages, bacteria may replicate or undergo non-growing phenotypic switches. This switch results from stringent response firing immediately after uptake by macrophages or at later stages, following genotoxic damage and SOS induction during intracellular replication. Importantly, non-growers resist treatment with various antibiotics. Thus, intracellular challenges induce AIEC LF82 phenotypic heterogeneity and non-growing bacteria that could provide a reservoir for antibiotic-tolerant bacteria responsible for relapsing infections. Importantly, non-growers resist treatment with various antibiotics. The authors concluded that intracellular challenges induce AIEC LF82 phenotypic heterogeneity and non-growing bacteria that could provide a reservoir for antibiotic-tolerant bacteria responsible for relapsing infections. The study was published on November 14, 2019 in the journal PLOS Pathogens.
21
LabMedica International April/2020
LabMedica International
DNA extraction, bisulfite conversion, conventional PCR amplification, running on agarose gel and documentation. Amplification was performed using a 2729 PCR thermal cycler (Applied Biosystems, Foster City, CA, USA; www.thermofisher.com). The scientists reported that all controls and 42 of 54 patients show unmethylated TP53 gene promoter; on the other hand, the methylated promoter was detected among 12 CLL patients. TP53 gene promoter methylation significantly linked to reduced platelet count and advanced stage at presentation. No significant differences were seen among both methylated and unmethylated TP53 promoters in relation to the age of the affected individuals, total white blood cell counts and hemoglobin level of the affected individuals. The authors concluded that their study revealed that TP53 methylation contributes significantly to CLL development and progression. Further workups are recommended to study their relation with other genetic changes as malignancies are multifactorial and heterogeneous that arises from the interaction of different genetic changes. The study was published on November 25, 2019 in the Journal of Blood Medicine. Image: Peripheral blood smear showing chronic lymphocytic leukemia (CLL). A large lymphocyte (arrow) has a notched nucleus and demonstrates the variable appearance of some of the lymphocytes in CLL (Photo courtesy of Peter Maslak).
lINkXPReSS COM
lMI-04-20 121
PRODUCT NEWS
IMMUNOCHEMICAL FECAL CENTRIFUGE OCCULT BLOOD TEST HELENA HELMER
The ColoScreen Immunochemical Fecal Occult Blood Test (iFOBT) is a one-step lateral flow chromatographic immunoassay for the immunochemical detection of human hemoglobin aimed at screening of gastrointestinal disease. lINkXPReSS COM
S
lMI-04-20 225
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 IGG/IGM DETECTION KIT SINGUWAY BIOTECH
The EBA 200 is a high-performance clinical tabletop centrifuge from Hettich for serology, blood, urine and pediatric applications that offers convenient, simple, and safe operation in a sleek, compact frame. lINkXPReSS COM
lMI-04-20 226
The COVID-19 IgG/IgM Detection Kit (Colloidal Gold) requires one sample drop of blood, serum or plasma to deliver results in 10 minutes. The test card contains novel coronavirus antigen and colloidal gold labeled antibody. lINkXPReSS COM
lMI-04-20 227
Blood Sphingolipidomics Associated with lupus Cardiovascular Comorbidity
ystemic lupus erythematosus (SLE) is a chronic autoimmune disease with heterogeneous organ involvement and severity. The cause of SLE is unknown, and there is at present no cure. The majority of people with lupus are females, and African-American women are three times more likely than White women to have lupus and develop severe symptoms. The risk for cardiovascular disease (CVD) is almost ten times higher in patients with autoimmune diseases than in the general population. Despite the dyslipidemia and accelerated CVD associated with SLE, the significance of the conventional plasma lipid panel (e.g., cholesterol and triglycerides) in the diagnosis/prognosis of CVD in SLE patients has been in question. Scientists from the Medical University of South Carolina (Charleston, SC, USA; www.musc.edu) enrolled 411 new lupus and 141 control participants since April, 2013. Plasma samples have been collected, often across multiple visits, from 358 lupus patients and 179 healthy controls that were negative for autoimmune disease. For this study, 73 female SLE patients and 34 unrelated controls were selected from the cohorts for comparison of their sphingolipid profiles. Mass spectroscopy was used to measure plasma levels of individual species of five classes of sphingolipids: Cers, sphingoid bases: sphingosine and dihydrosphingosine (dhSph) and their phosphates (S1P and dhSph-1P, respectively), SM, and hexosyl- and lactosylceramides (Hex-Cer and LactCer, respectively). The sphingolipids in plasma extracts were separated and their masses quantitated using high performance liquid chromatographytandem mass spectrometry. Lipids eluted during chromatography were detected and quantitated using a Quantum Access triple quadruple mass
spectrometer (Thermo Fisher Scientific, Waltham, MA, USA; www. thermofisher.com) equipped with an electrospray ion source (ESI) operating in multiple reaction monitoring (MRM) positive ion mode. The scientists reported that compared to African-American controls, African-American SLE patients had higher levels of ceramides, hexosylceramides, sphingosine and dihydrosphingosine 1-phosphate. Compared to White controls, White SLE patients exhibited higher levels of sphingoid bases and their phosphates, but lower ratios of C16:0 ceramide/sphingosine 1-phosphate and C24:1 ceramide/sphingosine 1phosphate. White SLE patients with atherosclerosis exhibited lower levels of sphingoid bases compared to White SLE patients without atherosclerosis. In contrast, African-American SLE patients with atherosclerosis had higher levels of sphingoid bases and sphingomyelins compared to African-American SLE patients without atherosclerosis. Compared to White SLE patients with atherosclerosis, African-American SLE patients with atherosclerosis had higher levels of select sphingolipids. Samar M. Hammad, PhD, associate professor in the Department of Regenerative Medicine and Cell Biology and first author said, “We know that the African-American community has higher high-density lipoprotein (HDL) cholesterol, which is a good thing, and lower triglycerides, which is a good thing, but nonetheless, they have more heart disease than the white population. So it is about time to start looking at other molecules and other markers that can explain, at least in part, why African Americans develop more cardiovascular disease, and that's particularly true in autoimmune diseases such as lupus and Type 1 diabetes.” The study was published on Nov. 20, 2019 in the journal PLOS ONE.
Chronic Comorbidities Are Prevalent Among People with Chagas Disease
cont’d from page 20
observed for patients with cardiomyopathy versus patients with no cardiomyopathy (3.06 versus 1.34). The team noted that comorbidities increased with age, with patients ages 70 and older having a mean of almost three comorbidities compared to younger patients ages 1839 with less than one. They also noted that about 63% are living below the federal poverty level, 66% have less than a high school education, and 72% rely on public insurance in California. In a multivariable linear regression, age and presence of Chagas cardiomyopathy were significantly associated with the number of comorbidities. Salvador Hernandez, MD, project manager at the center, said, “That of patients who are infected with Chagas disease, 30%-40% will progress to the chronic phase of the disease, which does not
present until 20-30 years after the initial infection. Of these cases, 60%-70% will have cardiac involvement. This starts as abnormalities on EKG, such as a right bundle branch block or a left anterior fascicular block. These symptoms are followed by slow progressive cardiomyopathy until symptoms of heart failure and sudden death from arrhythmia. At this final stage, the disease becomes irreversible and treatment with anti-parasitic therapy does not alter the disease course. This points to an urgent need for comprehensive care of these patients and for earlier, more proactive screening and treatment of this largely hidden disease.” The study was presented on November 22, 2019 at the American Society of Tropical Medicine and Hygiene Annual meeting held in National Harbor, MD, USA. LabMedica International April/2020
22
Optimized Microscope Developed for Accurate Image Classification
To view this issue in interactive digital magazine format visit www.LinkXpress.com
LabMedica International
D
espite the widespread automation enabled by new post-processing software, the physical layout of the standard microscope has still changed relatively little as it is, for the most part, still optimized for a human viewer to peer through and inspect what is placed beneath. A microscope has been developed that adapts its lighting angles, colors and patterns while teaching itself the optimal settings needed to complete a given diagnostic task. Rather than diffusing white light from below to evenly illuminate the slide, engineers developed a bowlshaped light source with LEDs embedded throughout its surface. This allows samples to be illuminated from different angles up to nearly 90 degrees with different colors, which essentially casts shadows and highlights different features of the sample depending on the pattern of LEDs used. An international team of bioengineers working with Duke University (Durham NC, USA; www.duke.edu) fed the microscope hundreds of samples of malaria-infected red blood cells prepared as thin smears, in which the cell bodies remain whole and are ideally spread out in a single layer on a microscope slide. Using a type of machine learning algorithm called a convolutional neural network; the microscope learned which features of the sample were most important for diagnosing malaria and how best to highlight those features. The algorithm eventually landed on a ring-shaped LED pattern of different colors coming from relatively high angles. While the resulting images are noisier than a regular microscope image, they highlight the malaria parasite in a bright spot and are correctly classified about 90% of the time. Trained physicians and other machine learning algorithms typically perform with about 75% accuracy. The team also showed that the microscope works well with thick blood smear preparations, in which the red blood cells form a highly nonuniform background and may be broken apart. For this preparation, the machine learning algorithm was successful 99% of the time. Roarke Horstmeyer, PhD, an assistant professor of biomedical engineering and senior author of the study, said, â&#x20AC;&#x153;A standard microscope illuminates a sample with the same amount of light coming from all directions, and that lighting has been optimized for human eyes over hundreds of years. But computers can see things humans can't. So not only have we redesigned the hardware to provide a diverse range of lighting options, we've allowed the microscope to optimize the illumination for itself.â&#x20AC;? The study was published in the November, 2019 issue of the journal Biomedical Optics Express.
23
LabMedica International April/2020
Image: A new type of microscope has been developed that uses a bowl studded with LED lights of various colors and lighting schemes produced by machine learning (Photo courtesy of Duke University)
PRODUCT NEWS
SPECIMEN COLLECTION KIT
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
GLUCOSE ANALYZER
COAGULOMETER
PURITAN MEDICAL
HEMOCUE
HOSPITEX DIAGNOSTICS
The UniTranz-RT is a sterile kit, complete with a 3ml vial of Universal Transport Medium and an ultrafine PurFlock Ultra swab, with patented fibers guaranteeing maximum cell collection, perfect for nasopharyngeal sampling.
The HemoCue Glucose 201+ System is designed to measure glucose levels using unique microcuvette technology which gives high accuracy and reduces contamination risks, offering precise monitoring for better glycemic control.
The CLOT S is a four-channel coagulometer for tests such as PT, aPTT, Fibrinogen, TT, Heparin, AT-III, Protein-S, Protein-C, D-Dimer and clotting factors, using advanced scattered light principle and percentage analysis.
lINkXPReSS COM
lMI-04-20 228
lINkXPReSS COM
lMI-04-20 229
lINkXPReSS COM
lMI-04-20 230
Home Urine Collection for More Accurate Prostate Cancer Detection
A
standardized sampling system enables men being tested for prostate cancer to collect a urine sample at home and mail it to a laboratory for analysis. Currently, patient urine samples are collected after a digital rectal examination (DRE) of the prostate, which was thought necessary to boost the levels of prostatic secretions in the urine. The creators of the PUR (Prostate Urine Risk) test now report the development of a sampling system that provides indication of prostate cancer risk in urine samples collected at home, eliminating a visit to the clinic and the uncomfortable rectal examination. The PUR test was established following evaluation of the cell-free expression of 167 genes in urine samples. Investigators at the University of East Anglia (Norwich, United Kingdom; www.uea.ac.uk) identified a mathematical combination of 35 different genes that could be used to generate four prostate urine risk (PUR) signatures for predicting the probability of normal tissue (PUR-1), D'Amico low-risk (PUR-2), intermediate-risk (PUR-3), and high-risk (PUR-4) prostate cancer. Results revealed that application of PUR provided a net benefit over current clinical practice, since each PUR signature was significantly associated with its corresponding clinical category. Furthermore, PUR-4 status predicted the presence of clinically significant intermediate- or high-risk disease. The investigators now describe an At Home Collection Kit that allows urine to be collected by patients at home and then posted to a laboratory for analysis by PUR methodology. The collection tubes contained a commercial preservative, which allowed samples to be maintained at room temperature without loss of RNA quality. A group of 14 participants were provided with an At Home Collection Kit, and instructions. Results of their home urine samples, taken first thing in the morning were compared to samples collected after a digital rectal examination. At the laboratory, harvest of cell-free RNA using a novel high-volume vacuum extraction method increased total RNA yields, improved the detection sensitivity of prostate-cancer-specific transcripts by RT-PCR, and enabled extraction of RNA from historic frozen urine samples. Thus, RNA yields and quality were comparable to those for post digital rectal examination urine. The investigators suggested that this method also has the potential to be adapted for the development of home-collection tests for bladder or kidney cancer. Senior author Dr Jeremy Clark, a senior researcher at the University of East Anglia, said, "Prostate cancer is the most common cancer in men in the United Kingdom. It usually develops slowly and the majority of cancers will not require treatment in a man's lifetime. However, doctors struggle to predict which tumors will become aggressive, making it hard to decide on treatment for many men. The most commonly used tests
for prostate cancer include blood tests, a physical examination known as a digital rectal examination (DRE), an MRI scan or a biopsy. We developed the PUR test, which looks at gene expression in urine samples and provides vital information about whether a cancer is aggressive or â&#x20AC;&#x153;low riskâ&#x20AC;?. Because the prostate is constantly secreting, the collection of urine from men's first urination of the day means that the biomarker levels from the prostate are much higher and more consistent, so this is a great improvement. Being able to simply provide a urine sample at home and post a sample off for analysis could really revolutionize diagnosis. It means that men would not have to undergo a digital rectal examination, so it would be much less stressful and should result in a lot more patients being tested." The At Home Collection Kit for prostate urinalysis was described in the November 29, 2019, online edition of the journal BioTechniques. Image: Micrograph showing a prostate cancer (conventional adenocarcinoma) with perineural invasion (Photo courtesy of Wikimedia Commons) LabMedica International April/2020
24
MicroRNA Panel Distinguishes Benign Moles from Melanoma in the eye
To view this issue in interactive digital magazine format visit www.LinkXpress.com
LabMedica International
A
blood test based on a panel of six microRNAs (miRNAs) is able to distinguish non-cancerous nevi from malignant melanoma in the eye. Uveal melanoma is a cancer of the eye involving the iris, ciliary body, or choroid (collectively referred to as the uvea). Tumors arise from the pigment cells (melanocytes) that reside within the uvea and give color to the eye. These melanocytes are distinct from the retinal pigment epithelium cells underlying the retina that do not form melanomas. When eye melanoma spreads to distant parts of the body, the five-year survival rate is about 15%. Investigators at the University of Queensland (Brisbane, Australia; www.uq.edu.au) previously identified a panel of melanoma-related miRNAs that offered superior sensitivity to currently used serologic markers for cutaneous melanoma progression, recurrence, and survival. MicroRNAs (miRNAs) and short interfering RNAs (siRNA) comprise a class of about 20 nucleotides-long RNA fragments that block gene expression by attaching to molecules of messenger RNA in a fashion that prevents them from transmitting the protein synthesizing instructions they had received from the DNA. With their capacity to fine-tune protein expression via sequence-specific interactions, miRNAs help regulate cell maintenance and differentiation. Furthermore, miRNAs play essential roles in tumor development, are stable under diverse analytical conditions, and can be readily detected in body fluids. The investigators sought to assess their panel of miRNAs in serum from patients with choroidal nevi, localized uveal melanoma, and metastatic uveal melanoma. To this end, they drew blood from subjects presenting with a uveal nevus (n = 10), localized uveal melanoma (n = 50), or metastatic uveal melanoma (n = 5). Levels of 17 miRNAs were measured in blood samples of study participants using a sensitive realtime PCR system. Results revealed that a panel of six miRNAs (miR-16, miR-145, miR-
Image: Photograph of an iris melanoma (Photo courtesy of Wikimedia Commons)
proof-of-concept study demonstrated that protein expression patterns in plasma samples were indicative of many different health issues, and that combining large-scale protein scanning with machine learning was a viable approach for the development of new diagnostic and prognostic tools. Proteins represent an enormous potential resource for personalized, systemic and data-driven diagnosis, prevention, monitoring, and treatment. However, the concept of using plasma proteins for individualized health assessment across many health conditions simultaneously has not been tested. To evaluate the potential of large-scale plasma protein analysis, investigators at the University of Cambridge (United Kingdom; www.cam.ac.uk) and colleagues at institutions in the United States and at the biotechnology company SomaLogic (Boulder, CO, USA; www.somalogic.com) developed and validated protein-phenotype models for 11 different health indicators. These included liver fat, kidney filtration, percentage body fat, visceral fat mass, lean body mass, cardiopulmonary fitness, physical activity, alcohol consumption, cigarette smoking, diabetes risk and primary cardiovascular event risk. The investigators employed a technique that used fragments of nucleic acids known as aptamers to bind to target proteins. Aptamers are nucleic acid species that have been engineered through repeated rounds of in vitro selection to bind to various molecular targets such as small molecules, proteins, nucleic acids, and even cells, tissues, and organisms. Aptamers are useful in biotechnological and therapeutic applications as they offer molecular recognition properties that rival that of antibodies. In addition to their discriminate recognition, aptamers offer advantages over antibodies as they can be engineered completely in a test tube, are readily produced by chemical synthesis, possess desirable storage properties, and elic-
it little or no immunogenicity in therapeutic applications. Relative to monoclonal antibodies, DNA aptamers are small, stable, and non-immunogenic. The investigators used SomoLogicâ&#x20AC;&#x2122;s genetic sequencing technology, to quantify the aptamers and determine which proteins were present and in what concentrations. For the current study, 5,000 proteins in plasma samples contributed by nearly 17,000 participants in five observational cohorts were scanned resulting in about 85 million protein targets being measured. Results of this proof-of-concept study demonstrated that protein expression patterns reliably encoded for many different health issues, and that large-scale protein scanning coupled with machine learning was a viable approach for exploiting this information. "Proteins circulating in our blood are a manifestation of our genetic make-up as well as many other factors, such as behaviors or the presence of disease, even if not yet diagnosed," said contributing author Dr. Claudia Langenberg, a program leader at the University of Cambridge School of Clinical Medicine. "This is one of the reasons why proteins are such good indicators of our current and future health state and have the potential to improve clinical prediction across different and diverse diseases." "It is remarkable that plasma protein patterns alone can faithfully represent such a wide variety of common and important health issues, and we think that this is just the tip of the iceberg," said first author Dr. Stephen Williams, Chief Medical Officer at SomaLogic. "We have more than a hundred tests in our SomaSignal pipeline and believe that largescale protein scanning has the potential to become a sole information source for individualized health assessments." The plasma protein analysis study was published in the December 2, 2019, online edition of the journal Nature Medicine.
A
146a, miR-204, miR-211, and miR-363-3p) showed significant differences between participants with uveal nevi compared with patients with localized and metastatic uveal melanoma. In particular, miR-211 was able to accurately distinguish metastatic disease from localized uveal melanoma. When the six-miRNA panel was evaluated as a group it demonstrated the ability to identify uveal melanoma when four or more miRNAs (93% sensitivity and 100% specificity) reached or exceeded their cut off point. "This blood test was able to detect the difference between a benign mole located at the back of the eye and a melanoma in the eye," said first author Dr. Mitchell Stark, a research fellow at the University of Queensland. "The test also has the potential to show if the melanoma has metastasized and spread to other areas of the body. Moles or nevi in the eye are common, but can be difficult to monitor because changes to their shape or coloring can't always be seen as easily as on the skin. Outcomes are poor for people with melanoma in their eye if their cancer spreads to the liver. Given that having nevi in the eye is fairly common, this test may allow us to better screen these patients for early signs of melanoma formation." The uveal melanoma paper was published in the November 2019 online edition of the journal Translational Vision Science & Technology.
Diagnosing Disease Conditions by Analyzing Plasma Protein expression Patterns
25
LabMedica International April/2020
PRODUCT NEWS
URINE ANALYZER
ERBA MANNHEIM
The LAURA XL is a fully-automated urine analyzer combining trusted urine strip analysis and digital microscopy. It offers automatic evaluation of 10 chemistry parameters and 16 sediment categories. lINkXPReSS COM
lMI-04-20 231
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
POC URINALYSIS SYSTEM
SIEMENS HEALTHINEERS - LABORATORY DIAGNOSTICS
The CLINITEK Status Connect System provides flexible connectivity solutions, data integration, and operational control. It sends routine urinalysis and pregnancy test results to LIS/HIS, EMR or data management systems. lINkXPReSS COM
lMI-04-20 232
MICROPLATE READER
BMG LABTECH
The POLARstar Omega is a versatile, filter-based multi-mode microplate reader with seven detection modes equipped with ultra-fast UV/vis spectrometer and Simultaneous Dual Emission detection. lINkXPReSS COM
lMI-04-20 233
Gene Panel Predicts Failure of Cutaneous leishmaniasis
p
atients infected with the protozoan parasite Leishmania braziliensis develop chronic skin lesions that often fail to respond to treatment with anti-parasitic drugs. Investigators at the University of Pennsylvania (Philadelphia, USA; www.upenn.edu) sought to identify genes, which were differentially expressed among infected patients and which might be associated with the outcome of the disease. These genes could be useful as predictors of treatment failure and as targets for therapeutic drugs. Towards this end, the investigators performed RNA sequencing (RNAseq) of lesion biopsies taken from patients with cutaneous leishmaniasis at the initiation of treatment with pentavalent antimony and identified highly variable genes up-regulated relative to healthy skin. After RNA-seq of biopsies from two distinct patient cohorts and statistical filter strategies, they focused on a set of genes that were up-regulated in lesions from patients who did not respond to treatment, which included genes involved in cytolysis. Given that cytolytic genes are induced early in the formation of the cutaneous leishmaniasis lesion, the investigators hypothesized that variations in the magnitude of expression of such genes might influence disease outcome and provide the potential markers to identify patients who may fail conventional therapy. The results of the RNA-seq study revealed a prognostic signature comprising expression of three cytolytic genes. This gene panel combined with pathogen load predicted treatment response in two different patient cohorts and could potentially be used to triage patients who are unlikely to
M
respond to conventional treatment as candidates for alternate therapies. “The challenge of human studies is that there are so many confounding variables,” said contributing author Dr. Daniel P. Beiting, assistant professor of pathobiology at the University of Pennsylvania. “If you say, “I am going to compare people who have responded to those who did not respond,” it sometimes does not work because in those two groups there are a lot of other variables at play - sex, age, other co-morbidities. So what we did instead was say, “If we believe these patients are variable in the way they respond to treatment, why not look at what genes are variable?” The study was published in the November 20, 2019, online edition of the journal Science Translational Medicine. Image: False color SEM (scanning electron microscope) micrograph of a Leishmania promastigote. The cell body is shown in orange and the flagellum is in red (Photo courtesy of Wikimedia Commons)
Non-Invasive Microscopy Detects Activation and Distinguishes Cell Types
easurement techniques that allow the global analysis of cellular responses while retaining single-cell sensitivity are increasingly needed in order to understand complex and dynamic biological processes. Cells have numerous traits that can be used to identify them: genetic, epigenetic, behavioral, compositional, or morphological features can all be used to define the phenotype of a given cell. As the discrimination capabilities of measurement systems improve, newly defined cell sub-types can emerge. Scientists at the Osaka University (Osaka, Japan; www.osaka-u. ac.jp) developed a label-free multimodal imaging platform that enables the study of cell cultures non-invasively without the need of any contrast agent. The pair showed how the label-free signals can be employed to create models that can detect the activation state of macrophage cells and distinguish between different cell types even in the case of highly heterogeneous populations of primary cells. The tests composed of three cell types and two conditions (Con-
trol and LPS) yield six main sets of controlled conditions where measurements have been approximately evenly distributed between them. To understand how uncontrollable variability might affect the results, the measurements are performed over several days, with cells plated onto different dishes to account for differences in cell culture, where 200–400 cells are measured per dish. The team combined the imaging information from quantitative phase imaging (QPI) recorded with off-axis holography and auto-fluorescence (AF), along with Raman spectroscopy, to retrieve single-cell level indicators enabling the analysis of cellular responses and conditions. The team then developed generalized statistical tools to assess the influence of both controlled (cell sub-populations, immune stimulation) and uncontrolled (culturing conditions, animal variations, etc.) experimental parameters on the label-free biomarkers. The study was published on November 19, 2019 in the journal Scientific Reports. LabMedica International April/2020
26
epigenetic DNA Biomarkers Pinpoint Infertile Men and Predict Potential Success of Treatment
A
To view this issue in interactive digital magazine format visit www.LinkXpress.com
molecular analysis method was developed that identifies infertility in men through evaluation of genome wide alterations in sperm DNA methylation. Male infertility is increasing and has been recognized as playing a key role in reproductive health and disease. The current primary diagnostic approach is to assess sperm quality associated with reduced sperm number and motility, which has been historically of limited success in separating fertile from infertile males. An improved diagnostic approach, based on analysis of genome wide alterations in sperm DNA methylation, was described recently by investigators at Washington State University (Pullman, USA; www.wsu.edu). Results of this study pointed to a signature of differential DNA methylation regions (DMRs), which was associated with male infertility patients. Since a promising therapeutic treatment of male infertility is the use of follicle stimulating hormone (FSH) analogs, which improve sperm numbers and motility in a sub-population of infertility patients, the investigators also sought other biomarkers among the infertile patients that could be used to predict who would be responsive to hormone therapy
S
Image: Human sperm stained for semen quality testing in the clinical laboratory (Photo courtesy of Wikimedia Commons)
New Blood Test Marks Progress in Battle Against Sepsis
epsis is a serious condition in which the immune system launches an overwhelming response to infection. The cause of the infection can be any type of microbe, including fungi, bacteria, and viruses, but usually, it is bacteria. The immune response releases inflammatory proteins into the bloodstream, causing blood clots to form and vessels to leak. This impedes blood flow and leads to organ damage. The progress of sepsis is often unpredictable and rapid. It is a significant cause of hospital deaths and readmission. A team of scientists led by the Cincinnati Childrenâ&#x20AC;&#x2122;s Hospital Medical Center (Cincinnati, OH, USA; www.cincinnatichildrens.org) developed the Pediatric Sepsis Biomarker Risk Model (PERSEVERE) to estimate mortality risk and proposed its use as a prognostic enrichment tool in sepsis clinical trials; prognostic enrichment selects patients based on mortality risk independent of treatment. It assesses five markers in the blood to predict who is at low, medium, and high risk of death. With this knowledge, doctors could start treating the serious condition much earlier and with more precision. In a prospective cohort of 461 children with widely differing risk levels who were receiving intensive care for sepsis, the blood panel reliably predicted who would develop
27
treatment. The investigators reported finding genome-wide DMRs associated with the patients that were responsive to FSH therapy versus those that were non-responsive. This novel use of epigenetic biomarkers to identify responsive versus non-responsive patient populations is anticipated to dramatically improve clinical trials and facilitate therapeutic treatment of male infertility patients. "Male infertility is increasing worldwide and is recognized as playing a key role in reproductive health and disease," said senior author Dr. Michael Skinner, professor of biological sciences at Washington State University. "Having a diagnostic that tells you right away your male patient is infertile and here are the treatment options that will work for him would be immensely useful. We are interested in investigating a similar diagnostic for determining how patients with arthritis and neurodegenerative diseases such as autism will respond to different treatments. In the area of therapeutics where many of the drugs on the market only work for a fraction of patients, this could ultimately save time, money and facilitate much better healthcare management." The infertility study was published in the November 14, 2019, online edition of the journal Scientific Reports.
LabMedica International
LabMedica International April/2020
severe sepsis and accurately distinguished between pediatric survivors and non-survivors of sepsis at 28 days. The cohort was enrolled from a number of pediatric care centers across the country. The overall mortality rate was 12.6%. PERSEVERE includes C-C chemokine ligand 3 (CCL3), interleukin 8 (IL8), heat shock protein 70 kDa 1B (HSPA1B), granzyme B (GZMB), and matrix metallopeptidase 8 (MMP8). Biomarker concentrations were measured in a Luminex 100/200 System (Luminex Corporation, Austin, TX, USA; www.luminexcorp.com). The investigators also found that blood bacterial loads were higher in children who were at greater risk of dying. That finding echoes the group's previous results in mice, which showed that a higher-dose antibiotic rather than a high-dose anti-inflammatory was able to control the infections. Together, the observations indicate that a greater bacterial burden rather than excessive inflammation is the main pathologic impetus of sepsis. Hector R. Wong, MD, a director of critical care medicine and senior investigator of the study, said, â&#x20AC;&#x153;This approach is not about diagnosis, who does or doesn't have sepsis. It's about asking among those with sepsis who's at risk for poor outcome, and we were impressed how well the model performed.â&#x20AC;? The study was published on November 13, 2019 in the journal Science Translational Medicine. lINkXPReSS COM
lMI-04-20 127
Non-Coding Regions of the Genome in Microglia linked to Alzheimer’s Disease Risk
To view this issue in interactive digital magazine format visit www.LinkXpress.com
A
LabMedica International
recently published paper linked risk of developing Alzheimer’s disease (AD) to enhancers - non-coding DNA regions of the genome - that were present in microglia but not in other types of brain cells such as neurons or astrocytes. In genetics, an enhancer is a short (50–1500 base pair) region of DNA that can be bound by proteins (activators) to increase the likelihood that transcription of a particular gene will occur. Enhancers can be located up to one million base pairs away from the target gene, upstream or downstream from the start site. There are hundreds of thousands of enhancers in the human genome. Investigators at the University of California, San Diego (USA; www.ucsd.edu) isolated four different kinds of brain cells: neurons, microglia, oligodendrocytes, and astrocytes from six AD patients. The genes in these cells were examined for genetic variations associated with the disease in non-coding enhancer regions of each cell type. Results revealed that while psychiatric disorders were primarily associated with variants in transcriptional enhancers and promoters in neurons, sporadic AD variants were largely confined to microglia enhancers. Interactome maps (maps of the whole set of molecular interactions in a partic-
ular cell) connected disease-risk variants in cell type-specific enhancers to promoters in an extended microglia gene network in AD. Microglia are a type of neuroglia located throughout the brain and spinal cord. Microglia account for 10 to 15% of all cells found within the brain. As the resident macrophage cells, they act as the first and main form of active immune defence in the central nervous system. Employing pluripotent human stem cells, the investigators were able to target an enhancer region near BIN1, a gene previously been linked to AD. They found that deleting this enhancer region led to a dramatic reduction in expression of BIN1 in microglia, but not in neurons or astrocytes. "Focusing on genetic variation associated with Alzheimer's disease (AD), we show preferential enrichment in disease risk variants in enhancers that are selectively active in microglia, the major immune cell in the brain," said senior author Dr. Christopher Glass, professor of cellular and molecular medicine at the University of California, San Diego. "This finding substantially extends prior studies linking microglia to late-onset Alzheimer's disease." The paper was published in the November 14, 2019, online edition of the journal Science.
ika virus disease is caused by a virus transmitted primarily by Aedes mosquitoes, which bite during the day. Symptoms are generally mild and include fever, rash, conjunctivitis, muscle and joint pain, malaise or headache. Symptoms typically last for 2–7 days. Zika virus infection during pregnancy is a cause of microcephaly and other congenital abnormalities in the developing fetus and newborn. Zika infection in pregnancy also results in pregnancy complications such as fetal loss, stillbirth, and preterm birth. Scientists working with the Florida Department of Health (Tallahassee, FL, USA; www.floridahealth.gov) assessed immunoglobulin M (IgM) detection in Zika patients from the 2016 outbreak in Miami-Dade County, Florida, USA. Demographics and clinical characteristics of the 30/62 participants in an original study who provided an additional follow-up specimen, the median age at symptom onset was 45 (range 22–70) years; all were adults >18 years of age. Fifteen (50%) were female, and 14 (47%) were Hispanic. The team found that 13 (43%) of these participants reported no international travel (outside of the continental United States) during the two years before collection of the last specimen. The scientists tested all serum specimens at the Centers for Disease
Control and Prevention (Fort Collins, CO, USA; www.cdc.gov) by the IgM capture enzyme-linked immunosorbent assay (ELISA) for Zika virus. Diagnosis of Zika virus infection is accomplished by testing for viral RNA or IgM and neutralizing antibodies. Of the 30 participants who provided a follow-up specimen, 19 (63%) were positive for Zika virus IgM, 7 (23%) had an equivocal result, and four (13%) were IgM seronegative. Compared with results from the specimen collection six months earlier, 20 (67%) remained positive for Zika virus IgM, two (7%) remained Zika virus IgM equivocal, four (13%) transitioned from Zika virus IgM positive to equivocal, and four (13%) transitioned from Zika virus IgM equivocal to negative; no participants switched from Zika virus IgM positive to negative. The authors concluded that their findings suggest that approximately three quarters of persons with polymerase chain reaction (PCR)-confirmed symptomatic Zika disease still have detectable IgM at 25 months after initial illness onset. The prolonged detection of IgM after Zika virus infection is consistent with previous findings for related flaviviruses. The study was published on November 18, in the journal Emerging Infectious Diseases.
Z
zika Virus IgM Persists 25 Months After Symptom Onset
lINkXPReSS COM
lMI-04-20 128
LabMedica International April/2020
28
Edited by Katherina Psarra MSc, PhD
NEWS
IFCC members may send news to: Prof. Katherina Psarra IFCC Office, Via C. Farini 81 20159 Milano, Italy. E-mail: enews@ifcc.org
winners of the 2020 IFCC Distinguished Awards Announced
Prof. Nader Rifai
Dr Ghassan Shannan
Dr Thomas Annesley
Dr Gary l. Myers
Dr Fred S. Apple
Dr Jean Baptiste woillard
The IFCC is pleased to announce the names of the winners of the ten IFCC Distinguished Awards. The IFCC Distinguished Awards are bestowed to laboratory medicine professionals to recognize their outstanding achievements, publicize their exceptional research and contributions to medicine and healthcare, and encourage the overall advancement of clinical chemistry and laboratory medicine. prof. Nader RIFAI (USA), is the winner of the 2020 IFCC Distinguished Clinical Chemist Award, sponsored by Yashraj Biotechnology Ltd. This award recognizes specifically an individual who has made outstanding contributions to the science of Clinical Chemistry and Laboratory Medicine or the application of Clinical Chemistry to the understanding or the solution of medical problems. Dr Ghassan SHANNAN (Syria), is the winner of the 2020 IFCC Henry Wishinsky Award for Distinguished International Services, sponsored by Siemens. This award, recognizes specifically an individual who has made unique contributions to the promotion and understanding of Clinical Chemistry and Laboratory Medicine throughout the world. Dr Thomas ANNESLEY (USA), is the winner of the 2020 IFCC Award for Distinguished Contributions in Education, sponsored by Abbott Diagnostics. This award recognizes specifically an individual who has made extraordinary contributions in establishing and developing educational materials for the Clinical Chemistry discipline to improve training and educational programs worldwide or in a region.
29
LabMedica International April/2020
Dr Andrea FERREIRA-GONZALEZ (USA), is the winner of the 2020 IFCC Award for Significant Contributions in Molecular Diagnostics, sponsored by Abbott Molecular. This award recognizes specifically an individual who has made unique contributions to the promotion and understanding of molecular biology and its applications in Clinical Chemistry and Laboratory Medicine worldwide. Dr David B. SACKS (USA), is the winner of the 2020 IFCC Distinguished Award for Laboratory Medicine and Patient Care, sponsored by Sekisui Diagnostics. This award recognizes specifically an individual who has made unique contributions in Laboratory Medicine, its application in improving patient care, and having a worldwide impact in clinical medicine. Dr Gary L. MYERS (USA), is the winner of the 2020 IFCC-Robert Schaffer Award for Outstanding Achievements in the Development of Standards for Use in Laboratory Medicine, co-sponsored by NIST and CLSI. This award recognizes specifically an individual who has made outstanding and unique contributions to the advancement of reference methods and/or reference materials for laboratory medicine to facilitate improved quality of clinical diagnostics and therapies, which would in turn lead to reduced costs and improved patient care. Dr Fred S. AppLE (USA), is the winner of the 2020 IFCC Distinguished Award for Contributions to Cardiovascular Diagnostics, sponsored by HyTest. This award honours an individual who has undertaken remarkable
Dr Andrea Ferreira-Gonzalez
Dr Sandra Quijano
scientific work with cardiac markers or immunodiagnostic applications to improve cardiac disease diagnosis. Dr Jean Baptiste WOILLARD (France), is the winner of the 2020 IFCC-Gérard Siest Young Scientist Award for Distinguished Contributions in Pharmacogenetics, sponsored by Biologie Prospective. This award recognizes an outstanding young investigator or young leader (under 40 years of age) for his/her contribution to advancing the scientific discipline of pharmacogenomics and Personalized/Precision Medicine and/or its impact on research, development, standardization, quality management, regulatory evaluation or utilization in therapy. The award will be presented for the first time on occasion of the WorldLab Congress to be held in Seoul in 2021. Dr Sandra QUIJANO (Colombia) is the winner of the 2020 IFCC Distinguished Women Scientist Award For Contribution To In Vitro Diagnostics, sponsored by Yashraj Biotechnology Ltd. This award recognizes a woman who has made significant contributions to the development or utilization of In Vitro Diagnostics with emphasis on applications in primary healthcare. The award will be presented for the first time on occasion of the WorldLab Congress to be held in Seoul in 2021. Dr Livia S. EBERLIN (USA), is the winner of the 2020 IFCC Young Investigator Award, sponsored by IFCC. This award recognizes and encourages the academic and professional development of a young investigator (under 40 years of age) who has demonstrated exceptional scientific
Dr David B. Sacks
Dr livia S. eberlin
achievements in Clinical Chemistry and Laboratory Medicine in his/her career. Prof. Maurizio Ferrari, IFCC President and Chair IFCC Awards Committee, said: "We are delighted in electing these colleagues for the 2020 IFCC Awards. The Awardees are a witness of the contribution that IFCC gives to advancement of excellence in laboratory medicine for better healthcare worldwide. I’m happy that so many National Societies submitted excellent candidates: we had a very hard task selecting the Awardees among them. It has been a privilege considering them and we are sure that the Awardees will inspire a new generation of clinicianscientists worldwide". ABOUT IFCC
IFCC is the leading organization in the field of Clinical Chemistry and Laboratory Medicine worldwide. Through leadership and innovation in science and education, IFCC strives to enhance the scientific level and the quality of diagnosis and therapy for patients throughout the world. IFCC builds on the professionalism of its members to provide quality services to patients. IFCC is a Federation of 93 Full Member and 17 Affiliate member Societies of Clinical Chemistry and Laboratory Medicine representing more than 45.000 individual clinical chemists, laboratory scientists, and laboratory physicians and 48 Corporate Members covering the major areas of clinical laboratory developments. For further details please contact: ifcc@ifcc.org.
NEWS
News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information
editorial
by Katherina Psarra MSc, PhD
IN MeMORIAM
Dear colleagues, I really don’t know what to write that could be exciting enough to tempt you to read this IFCC information in the middle of this unprecedented situation we are facing all over the world. What would be interesting for you? What could make you focus and read the IFCC news? Most of you are working in labs, going back and forth to the hospitals and not staying at home. You definitely play an important role in the patients’
management. Most of you worry about yourselves or your loved ones. Most of you are missing what is important, beautiful, normal in your lives. That is why we are here. To give you a sense of normality. To make you look forward for the next WordLab in Seoul in January 2021. To make you look forward for your local meetings. To make you feel how important, how precious you are for your profession, for the IFCC. Dr Bernard Gouget has written a superb text about the COVID-19 pandemic, the testing, and the future. We will always remember Prof Howard Morris, IFCC past president, a visionary leader and a great man. Stay safe, dear colleagues! We will all meet soon!
Never Forgotten – In memory of Prof. Howard Morris
Prof. Howard Morris, Past President of IFCC, (2018-2019), Professor of Medical Science at the University of South Australia and Clinical Scientist in Chemical Pathology at SA Pathology, Adelaide Australia. The IFCC community takes this opportunity to rememfelt by his friends and colleagues around the world. The ber Prof. Howard Morris who passed away on April 18, medical community lost a talented professional, the IFCC 2019, while still in office as IFCC President. Howard was a lost a dedicated leader, and we all lost a great man. visionary leader, an accomplished clinical biochemist, and Please join us in remembering Prof. Howard Morris. His researcher, an educator and a mentor to many young procontributions to laboratory medicine and to the IFCC comfessionals. He was a gentleman with a hearty, contagious munity were many and his passing was deeply felt by his laugh, and displayed abundant enthusiasm in all that he friends and colleagues around the world. Please join us in did. His contributions to laboratory medicine and to the remembering Prof. Howard Morris. Visit the our website to IFCC community were many and his passing was deeply read the IFCC eNews dedicated to Prof. Morris.
LabMedica International April/2020
30
News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information
NEWS
Myanmar and Andalusian Societies Join the IFCC
Myanmar Medical Technologist Association (MMTA): A Profile
Myanmar Medical Technologist Association is a non-governmental association, founded in 2014 and it is the registered Medical Technologist Association of medical technology professions in the country. Our objective is to assist and support in the Educational, social and health affairs of laboratory technologist and to serve the community and nation by skillful medical technologists. MMTA was formed by eighteen executive committee members and MMTA membership at present stands at 1324. The President of MMTA is Mr Maung Maung and the General Secretary is Ms Kalayar Htun. For medical technology education, MMTA is holding a conference every year in Yangon and Mandalay alternately since 2012. This year in February 2020, MMTA did perform the 6th Conference of Myanmar Medical Technologist Association at the University of Medical Technology in Mandalay. The theme of the conference was “Promoting the Impact of Medical Laboratory Technology on Healthcare System”. Moreover, MMTA has been or-
ganizing the program of “Medical Laboratory Science Knowledge Sharing Talk” every 2 months, since January 2018. The aim of this program is to support and provide advanced medical laboratory science to Myanmar technologists especially for the new generation and to have a habit of sharing the knowledge among them. Furthermore, MMTA had prepared the Myanmar Medical Tech-
nologist Council Law (Draft) and submitted to Ministry of Health and Sports since November 2019. In Myanmar, MMTA collaborates with other organizations; as a member of Licence committee in Myanmar Medical Council, MMTA participates in preparation of the rules and regulations for all medical technologists who are going to hold the licence. MMTA also works together with Myanmar Academy of Medical Sciences
(MAMS) for the Accreditation of medical laboratories and with other associations such as Myanmar Red Cross Society and Myanmar Liver Foundation. MMTA is actively participating in the public health care as per health policy and guidance laid down by the Ministry of Health and Sports, Myanmar. MMTA is a member of Asian Association for Clinical Laboratory Sciences (AACLS) since 2016 and President of MMTA is also the 2nd Vice President of AACLS. Two MMTA executive committee members are also council members of AACLS (2018-2020). As a member of AACLS, MMTA, Myanmar will host the 19th ACCLS Conference and 18thAACLS Biennial General Meeting in 2022. In addition, MMTA is a member of Asia Association of Medical Laboratory Scientists (AAMLS) as well as one of the board of directors of AAMLS. Now MMTA became the member of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) in March 2020.
Scientific Committee of recognized national prestige. This year, more than 60% of the speakers at the National Congress of the Clinical Laboratory were members of SANAC. Our society, with its different commissions and working groups in specific areas, participates with its experts in different forums, issuing scientific reports that may be useful to the Andalusian Autonomous Administration on health issues; as well as whoever request them, be it
companies, private entities, etc. One of our objectives is the representation and defence of the scientific and professional interest of the specialties integrated within the term of Clinical Laboratory and its members before the competent bodies of the Andalusian Government. For more than a year, it has been a constituent part of the SOCILAB group, created together with the Spanish Society for Medical Biopathology (AEBM) and the Spanish Laboratory Society (AEFA), both of which are national in scope and which also include other 6 Regional Societies, among which SANAC has the most members. Our Society has signed several collaboration agreements with the Health Department of the Andalusian Government (Official letter from government authorities) in which it recognizes us as an official collaborating body in its activities, including certain Management activities, including the participation in all the selection processes of laboratory professionals in their public positions as well as in the development of indicators and control panels for public laboratories.
Andalusian Society for Clinical Analysis and laboratory Medicine (SANAC): A Profile
The Andalusian Society for Clinical Analysis and Laboratory Medicine (SANAC) is a professional non-profit scientific association, under the legal regime of the current Associations Law. All professionals in the field of Clinical Laboratory may become members. Its area of operations is the Andalusian Autonomous Community, in southern Spain, with its eight provinces, Almeria, Granada, Malaga, Cadiz, Huelva, Seville, Cordoba and Jaen. The Andalusian community is the most populated in Spain with 8,410,000 inhabitants and an area of 87,300 km2, to which the Autonomous Cities of Ceuta and Melilla, both on the North African coast, are assigned by proximity. Our Scientific Society brings together many professionals who currently work in the laboratories of the Andalusian Public Health System (SSPA), with its 42 Hospitals. Currently, 38 of the SSPA Laboratory Service Heads are members of SANAC, with representation in all Andalusian public laboratories. Its Board of Directors consists of seven members, President,
31
LabMedica International April/2020
Vice President and four members, in addition to having the participation of its three pastpresidents and a scientific committee made up of eight members. Our Society offers many training events, on-line courses, on-site courses, scientific meetings and an annual congress. This year we celebrate our XXVII meeting, with a wide and attractive program that can be found on our website www. sanac.org. For this, we have a
News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information
NEWS
VIewPOINT
Diagnostics, Trust, Solidarity, and Humanism by Dr. Bernard Gouget
Chair, IFCC Committee on Mobile Health and Bioengineering in Laboratory Medicine (C-MHBLM), Past-Chair, IFCC Nominations Committee (NC); Co-Chair, IFCC TF on History, SFBC-International Relations Committee, President Healthcare Division Committee - Comité Français d’Accréditation (Cofrac)
The global spectacle is very strange: in a few days, more than 3.9 billion people, or half of humanity, have now been asked or ordered to stay confined in their homes: a global shutdown to overshadow any stats. As the virus spread from nation to nation, the economies of nearly every country have been brought to their knees, when they are not suffering from a severe embolism. The pandemic seems to have arrived by surprise, like a plague that fell from the sky. In the face of this unforeseen force majeure event, policies are necessarily based on more or
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
WASHING TRAYS MAT
NEW!
Front
Back
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-04-20 132
less rational reactions and more or less validated methods, but in all cases, a feeling of improvisation and trial and error prevails, while the death toll is relentlessly rising. The countries that have acted quickly to stop the spread of the coronavirus have drawn on their finest technological capabilities to track the movement of their citizens. The West underestimated the necessary industrial mobilization, in particular in advanced sectors while China, Hong Kong, Taiwan and South Korea tested everything from AI to robots, including drones, apps, blockchains, CCTV cameras, GPS digital tracking and facial recognition to prevent the virus from causing a massacre. Confronting the coronavirus crisis forces to take extreme measures on massive scale, but any infringement on civil liberties must be temporary and proportional. The virus is not an army, and evoking war can transform a health crisis into a security one, justifying repressive measures. We are once more experiencing mass recruitment for battle. Some political leaders are using war-talk: “Our war against the Chinese virus”; “We are at war”, “War against an invisible enemy”, to recruit volunteers for the "front line" and urging everybody to "do their part". The “front line” is the hospital. Healthcare professionals are the "heroes" defending our lives and the nation. We thank them very much! Intuitively there is no armed conflict in the sense of the Geneva Convention, but equally we know that this war-talk is not simply idle talk. The dangers are clear. The pandemic may well lead to a serious decline in democracy around the world. Crucially, emergency measures need to have a clearly defined time frame to avoid leading into a permanent state of emergency. Part of the success of countries in confronting the coronavirus is due to their clear and open communication. It is crucial to show self-restraint and vigilance in ensuring that a critical, vibrant and constant debate remains alive. We need international solidarity to fight such a health scourge and to call out war talk for what it really is. The COVID19 pandemic is also forcing our society to make choices of a magnitude and intensity whose consequences we cannot yet measure. While decisions should certainly be backed up by scientific expertise, crucial decisions are a matter of political responsibility. In the matter of public health, they are an indelible marker of the hierarchy of our social values and priorities. Triage, prioritization and therapeutic arbitrations usually stay behind closed doors, within the medical panel, in consultation with families. But today, this question has become visible, sensitive, even disturbing. It challenges the pact that binds us to our hospitals, the trust that ties us to physicians. To measure a pandemic, it is necessary to know how to detect it. The genetic sequence of coronavirus SARS-CoV-2 was quickly shared by Chinese researchers, which enabled teams around the world to develop specific diagnostic tests to establish with certainty whether or not a patient was affected by this novel virus. In Asia, China, Hong Kong, Thailand, Japan, etc. researchers developed their own methods. The Institute of Virology of the Charité Berlin Hospital (Germany), which had already prepared tests for other coronavirus-family viruses, led the way in Europe in mid-January. Other countries around the worked tirelessly on the genetic sequence of coronavirus SARS-CoV-2 isolated by China to develop a molecular technology. Today, we realize how essential laboratory diagnosis is. Lab tests are becoming a major health, industrial and economic issue. The subject is debated in the field as well as in the public. In the current context of a public health emergency, laboratories and research institutes are developing diagnostic solutions. The value of a test comes from its so-called specificity and sensitivity. Large IVD companies rapidly deploy production of coronavirus tests. The PCR Test: the devices currently used for the diagnosis of SARS-CoV-2 are reagents for detecting the virus genome by RT-PCR. In France, the French National Authority for Health (HAS) recommends that these reagents have at least two targets for detecting the genome of coronavirus SARS-CoV-2 by the technique of reverse transcription followed by amplification. While WHO encourages to massively test the populations, the screening strategies are evolving rapidly. The countries are increasing their capacities for screening tests as much is possible, not only with the nasal tests and detection of the virus by PCR in case of symptoms but Cont’d on page 33 LabMedica International April/2020
32
News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information
Diagnostics, Trust, Solidarity, and Humanism
cont’d from page 32 also with blood tests, for qualitative detection of IgM and IgG antibodies, from venous blood or from a drop of blood fingertip, to find out who is immune or not. For the latter serologic tests, the government authorities are not giving details on their dissemination: who will be tested and How? We just know that the goal is to be able measure the collective immunity of the population in order to be ready for the period of release from confinement. There is still room for innovation. Groups led by two of the biggest names in CRISPR (Univ. of Washington School of Medicine and Univ. of California, Berkeley) are each working on tests that take advantage of the popular gene-editing technique to improve testing. The techniques use the CRISPR machinery’s ability to recognize specific genetic sequences and cut them. In the process, it also cuts a ‘reporter’ molecule added to the reaction, which reveals the presence of viral genetic material relatively quickly. Routine testing has shown that a large proportion of invisibly-contaminated asymptomatic subjects or subjects with mild symptoms massively contribute to the spread of the virus. Many minor infections remain unchecked. Lacking the means, large-scale screening is impossible, countries are only able to test people considered to be a priority. Private and public laboratories have opened their doors widely. It is becoming urgent to find quick, simple and widely disseminated screening solutions as locally as possible to the target populations, and to be attentive to the institutionalized elderly and to low-to-middle income countries (LMIC) where barrier efforts and social distancing are more difficult to enforce. The economy is operating minimally and will not turn around for a long time if employees do not regain a minimum of trust; other sectors will not start up again if staff do not have minimal security with masks, gowns and tests to show who is sick, who has been sick and who can infect others. On March 16, Tedros A. Ghebreyesus, WHO Director General, said “once again, our key message is: test, test, test” and recommended conducting a test for every suspected case. This is a worldwide pursuit. Stocks of materials were captured or diverted. Under fire from critics, Governments are racing to buy medical equipment including protective gear as a debate intensifies over providing adequate testing, when it is advisable to wear masks, and whether stricter lockdowns should be imposed. Therefore, countries have gradually increased the number of daily screenings. There are enormous tensions due to shortages of swabs and reagents. Supply lines are complex. The IVD and health industries work by just-in-time production. Some companies are contractually constrained to manage priorities, others must serve the countries in which the factories are located first. We are witnessing a struggle in hospitals to inventory test materials and reagents The shortage of masks and protective clothing has had a delaying effect. Likewise, lab closed systems have limited testing capacity relative to open platforms. Human resources are as important as reagents. The situation has been exacerbated by technical and medical staff becoming infected themselves. There are also logistical and transport issues, with priority being given to the most impacted areas. For the clinical diagnosis, CT scanning is widely used as a triage tool and the diagnosis is confirmed by a coronavirus test. We can hope that testing will actually be ramped up. But it is necessary to determine the strategy: what proportion of the population to test and for which countries and how many weeks until the economy should be started again? Before a disaster happens, nobody believes it will, even though there is every reason to know that it will happen. When it happens, it brazenly invades our reality. This is exactly what is happening with this pandemic. It was announced. Many voices warned the world of the imminence of a pandemic. All the details were there. They were not heard. A lot of progress remains to be made internationally to quickly identify the health threat, coordinate a response and develop the tools and technologies that can combat an emerging lethal disease. Today, everything is amplified by social media, with too much false information creating anxiety. Communication should be better coordinated globally to be as reliable as possible. The solidarity that is already present among researchers and caregivers should be reinforced and what they do under these conditions should be admired. The urgent need is to stop the epidemic and enforce strict compliance with confinement and hygiene measures. There may be short-
33
LabMedica International April/2020
NEWS
IFCC launches Online Resource to Serve COVID-19 Diagnostics
The IFCC is pleased to publish an online resource providing key information on laboratory guidelines, biosafety, and other important resources to assist member societies around the world and their clinical laboratories as they
face the challenges posed by the COVID-19 outbreak. The page is constantly updated with the most recent information. https://www.ifcc.org/ifcc-news/ 2020-03-26-ifcc-informationguide-on-covid-19
ages of medicines and respirators for intensive care units. Assessing new drug molecules takes time and multicenter international trials, like Solidarity and Discovery, have been initiated. Research is also urgent and procedures are accelerated for clinical trials and basic research. Understanding the mechanisms for the entry and replication of SARS CoV-2 in cells will enable future therapeutic strategies to be developed. If physicians and researchers are not always in agreement, they debate publicly via studies published in journals. Politicians must be inspired by this and avoid hiding behind science when it is lacking and stop believing that research is a narcissistic exercise for health professionals outside of health crises. In these dramatic circumstances of both medical and socio-economic importance, let's try to value what can bring us together. Science and trust go hand in hand. Many governments acknowledged that the real number of infections could be much higher due to limited testing. Testing the most people possible allows to understand the characteristics of the disease, grasp the gravity of the epidemic, and contain its spread by immediately isolating the infected and exposed. Nothing could do more to establish trust in countries than massive routine laboratory diagnostic testing. Humanity has survived many pandemics throughout history. In many cases, we learned lessons that helped to spur subsequent progress. Some pointed to culture as a driver of the dichotomy of successful responses in East Asia compared to failed responses in some countries of the Americas and elsewhere in the West. All countries must take a comprehensive approach. Covid 19 is a ticking time bomb. We must all be worried about coronavirus spread in African countries with weak health systems. It is also a biggest concern in India. The current crisis is equally a crisis of globalization, which has also undermined the foundations of sustainability. A better globalization will require nothing less than extending the ethic of human solidarity beyond the contours of our immediate response to the COVID-19 outbreak. Real success will lie not in taming a pathogen, but in rediscovering and institutionalizing the true value of compassion, respect, and generosity in the weeks and months ahead.
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.
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
MAY 2020
ASCO 2020 – Annual Meeting of the American Society of Clinical Oncology. May 29-May 31; Virtual Venue; Web: am.asco.org
JUNE 2020
ESGH 2020 – European Human Genetics Conference. Jun 6-9; Virtual Venue; Web: www.eshg.org BIO International Convention 2020. Jun 8-11; Virtual Venue; Web: convention.bio.org ExpoMED Eurasia 2020. Jun 11-13; Istanbul, Turkey; Web: expomedistanbul.com 25th Annual Congress of the European Hematology Association (EHA). Jun 11-14; Virtual Venue; Web: ehaweb.org/congress American Diabetes Association (ADA) 80th Scientific Sessions. Jun 12-16; Virtual Venue; Web: professional.diabetes.org/scientific-sessions
JULY 2020
ESHRE 2020 – 36th Annual Meeting of the European Society of Human Reproduction and Embryology. Jul 5-8; Virtual Venue; Web: www.eshre.eu AIDS 2020 - 23rd International AIDS Conference. Jul 6-10; Virtual Venue; Web: www.aids2020.org KoreaLab 2020. Jul 27-30; Seoul, Korea; Web: www.korealab.org AUGUST 2020
Vietnam Medi-Pharm Expo 2020. Aug 6-8; Ho Chi Minh City; Web: hcm.medipharmexpo.com
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
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-04-20
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
32nd Congress of the European Society of Pathology (ESP). Aug 29-Sep 2; Glasgow, UK; Web: www.esp-congress.org
SEpTEMBER 2020
IFBLS 2020 - International Federation of Biomedical Laboratory Science. Sep 1-5; Copenhagen Denmark; Web: ifbls2020.org SIOP ASIA 2020 – 8th Asia Conference of the International Society of Paediatric Oncology. Sep 46; Mumbai, India; Web: www.siopasia2020.com EUROTOX 2020 – 56th Congress of the European Societies of Toxicology. Sep 6-9; Copenhagen, Denmark; Web: eurotox-congress.com/2020 ARABLAB 2020. Sep 7-9; Dubai, UAE; Web: www.arablab.com ASCP 2020 -Annual Meeting of the American Society for Clinical Pathology. Sep 9-11; Austin, TX, USA; Web: www.ascp.org ESCV – 23d Annual Meeting of the European Society for Clinical Virology. Sep 9-12; Manchester, UK; Web: www.escv.eu Thailand LAB International 2020. Sep 16-18; Bangkok, Thailand; Web: www.thailandlab.com India Lab Expo & analytica Anacon India. Sep 1719; Hyderabad, India; Web: www.analyticaindia.com EASD 2020 – 56th Annual Meeting of the European Association for the Study of Diabetes. Sep 21-25; Vienna, Austria; Web: www.easd.org ExpoMedical 2020. Sep 23-25; Buenos Aires, Argentina; Web: www.expomedical.com.ar BSACI 2020 – Annual Conference of the British Society for Allergy and Clinical Immunology. Sep 30 - Oct 1; Harrogate, UK; Web: bsacimeeting.org BCLF 2020 - 28th Balkan Clinical Laboratory Federation Meeting. Sep 30 - Oct 3; Sofia, Bulgaria; Web: www.bclf.info 90th Annual Meeting of the American Thyroid
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
3
lMI-04-20 999
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
34
For EXpRESS service: visit www.LinkXpress.com or Scan and Email this form to: subs@globetech.net
LabMedica International April/2020
ATTENTION: Due to the CORONAVIRUS pANDEMIC, many events are being rescheduled for a later date, converted into virtual venues, or altogether cancelled. please check with the event organizer or website prior to planning for any forthcoming event Association (ATA). Sept 29 – Oct 3; Scottsdale, Arizona; Web: www.thyroid.org
OCTOBER 2020
ECC 2020 – 43rd European Congress of Cytology. Oct 4-7; Wroclaw, Poland; Web: cytology2020.eu ICE 2020 – 19th International Congress of Endocrinology. Oct 4-7; Buenos Aires, Argentina; Web: ice-2020.com ISOBM 2020 – 46th Congress of the International Society of Oncology and Biomarkers. Oct 8-11; Bled, Slovenia; Web: www.isobm2020.net EAHP-SH 2020 – 20th Meeting of the European Association for Haematopathology. Sep 11-16; Dubrovnik, Croatia; Web: www.eahp-sh2020.com SIOP 2020 – 52nd Annual Congress of the International Society of Paediatric Oncology (SIOP). Oct 14-17; Ottawa, Canada; Web: siop-congress.org 17th Annual Meeting of the German Society for Clinical Chemistry and Laboratory Medicine (DGKL). Oct 15-16; Mannheim, Germany; Web: www.dgkl.de Analytica 2020. Oct 19-22; Munich, Germany; Web: www.analytica.de EAACI Congress 2020 – European Academy of Allergy & Clinical Immunology. Oct 19-22; Virtual Venue; Web: www.eaaci.org 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; Anaheim, CA, USA; Web: www.ashi-hla.org
V
MEDLAB Asia Pacific 2020. October 28-30; Bangkok, Thailand; Web: www.medlabasia.com AOCE-SICEM 2020 – 17th Asia-Oceania Congress of Endocrinology. Oct 28-31; Seoul, Korea; Web: sicem.kr
15th Baltic Congress of Laboratory Medicine. Nov 5-7; Riga, Latvia; Web: www.balmriga.com 41st Annual Meeting of the American College of Toxicology (ACT). Nov 15-18; Austin, TX, USA; Web: www.actox.org Analytica China 2020. Nov 16-18; Shanghai, China; Web: www.analyticachina.com MEDICA 2020. Nov 16-19; Dusseldorf, Germany; Web: www.medica-tradefair.com
®
p O R T A L
BY WEBSITE
LabMedica International
Inq.No.
–
Advertiser
Advertising Index
Vol. 38 No.2 4/ 2020 page
AACC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
127 Alcor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27 121 Biosynex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
109 Diasys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 105 Erba . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Visit LinkXpress.com to enter your subscription data and reader inquiries.
107 Erba . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
• Fill-out all required data on Reader
103 Nova Biomedical . . . . . . . . . . . . . . . . . . . . . . . . .3
BY EMAIL
• •
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
35
JULY 2021
73rd AACC Annual Scientific Meeting & Clinical Lab Expo - American Association for Clinical Chemistry. Jul 25-29; Anaheim, CA, USA; Web: www.aacc.org
Zdravookhraneniye 2020. Dec 7-11; Moscow, Russia; Web: www.zdravo-expo.ru/en
FREE Subscription
2
EUROMEDLAB 2021- 24th IFCC-EFLM European Congress of Clinical Chemistry and Laboratory Medicine. May 16-20; Munich, Germany; Web: www.euromedlab2021munich.org
DECEMBER 2020
To Continue / Start Your
1
Medical Fair India 2021. Feb 25-27; New Delhi,
MAY 2021
Immunology 2021 - Annual Meeting of the American Association of Immunologists (AAI). May 12-16; Philadelphia, PA, USA; Web: www.aai.org
62nd Annual Meeting & Exposition of the American Society of Hematology (ASH). Dec 5-8; San Diego, CA, USA; Web: www.hematology.org/Annual-Meeting
2 E ASY WAYS S E R V I C E
FEBRUARY 2021
MEDLAB Middle East 2021. Feb 8-11; Dubai, UAE; Web: www.medlabme.com
KIMES 2021. Mar 18-21; Seoul, Korea; Web: www.kimes.kr
11th African Congress of Immunology – Federation of African Immunological Societies (FAIS). Nov 29 – Dec 3; Lilongwe, Malawi; Web: www.faisafrica.com
lINkXPReSS COM
R E A D E R
SLAS 2021– Society of Laboratory Automation and Screening. Jan 23-27; San Diego, CA, USA; Web: www.slas.org
MARCH 2021
AMP 2020 –Annual Meeting & Expo of the Association for Molecular Pathology. Nov 17-21; Vancouver, Canada; Web: amp20.amp.org
72nd AACC Annual Scientific Meeting & Clinical Lab Expo - American Association for Clinical Chemistry. Dec 13-17; Chicago, IL, USA; Web:
T
JANUARY 2021
JIB 2020 - Journées de l’innovation en biologie. Nov 4-5; Paris, France; Web: jib-innovation.com
ASHG 2020 – American Society of Human Genetics. Oct 27-31; San Diego, CA, USA; Web: www.ashg.org
I
Pittcon 2021. Mar 6-10; New Orleans, LA, USA; Web: pittcon.org
IFCC WorldLab Seoul 2021 – 24th International Congress of Clinical Chemistry and Laboratory Medicine. Jan 6-10; Seoul, Korea; Web: www.seoul2020.org
36th International Congress of the International Society of Blood Transfusion (ISBT). Dec 12-16; Barcelona, Spain; Web: isbtweb.org
S
India; Web: www.medicalfair-india.com
LABWorld China 2020 (CPhI & P-MEC China). Dec 16-18; Shanghai, China; Web: www.pmecchina.com/labworld Fertility 2021– Joint Conference of the UK Fertility Societies. Jan 7-9; Liverpool, UK; Web: fertilityconference.org
EndoBridge2020. Oct 22-25; Antalya, Turkey; endobridge.org
I
www.aacc.org
FOCIS 2020 – Annual Meeting of the Federation of Clinical Immunology Societies. Oct 23-28; San Francisco, CA, USA; Web: www.focisnet.org
NOVEMBER 2020
Events Calendar
LabMedica International April/2020
– Ice 2020 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
115 Greiner bio-one . . . . . . . . . . . . . . . . . . . . . . . . .15
136 Instrument Laboratory . . . . . . . . . . . . . . . . . . . .36
111 Instrument Laboratory . . . . . . . . . . . . . . . . . . . .11
128 Karl Hecht . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
– LabMedica.com . . . . . . . . . . . . . . . . . . . . . . . . .19
102 Mayo Clinic Laboratories . . . . . . . . . . . . . . . . . . .2 117 NG-Biotech . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
132 Vicotex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32 Provided as a service to advertisers. Publisher cannot accept responsibility for any errors or omissions.
lINkXPReSS COM
lMI-04-20 136