LabMedica International September 2020

WORLD’S CLINICAL LABORATORY NEWS LEADER ISSN 1068-1760

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Vol. 38 No.5 • 8-9/2020

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kidney Transplantation Rejection Risk Assay

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or kidney transplant recipients, prompt and accurate detection of transplant rejection is vital for timely intervention. Unfortunately, the gold standard for diagnosis of rejection is kidney biopsy, an invasive procedure.

To diagnose acute rejection in

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remature atherosclerotic disease commonly occurs in individuals with atherogenic dyslipidemia who share a phenotype characterized by centripetal obesity, insulin resistance, and physical inactivity. Cardiovascular diseases (CVD) are the leading cause of mortality in the Western World

In a new study, an international team of researchers found significant variability in the accuracy of commercially available SARS-CoV-2 serological tests. The peer reviewed study also provides a performance ranking of both lab-based and point-of-care tests. LabMedica’s COVID-19 Diagnostics Update section starts on page 4.

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being subclinical atherosclerosis the triggering factor for most of these events.

The reduction in the incidence of cardiovascular events requires the early detection of cardiovascular risk factors (CVRFs), such as low-density lipoprotein cholesterol (LDL-C) concentration, Cont’d on page 13

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Rapid Test Detects Carbapenemase

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s a potent β-lactamase, carbapenemase can degrade almost all β-lactam antimicrobial drugs, including the carbapenems, regarded as the last line of therapy for many life-threatening infections. If uncontrolled, the spread of these carbapenemases is expected to increase therapeutic failure and leave many patients with noeffective treatment options.

sTNFR2 a Biomarker for Acute ATL

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Colorized scanning electron micrograph of apoptotic cell (green) heavily infected with SARS-COV-2 virus particles (purple).

Courtesy of NIAID-IRF.

n innovative portable COVID-19 test kit, based on miniaturized PCR (polymerase chain reaction) technology, has been granted Emergency Use Authorization (EUA) by the US-FDA. The single-use test, with less than two minutes of hands-on time, is easy to use, and delivers fast and accurate results right at the point of need, in less than 30 minutes. A sample taken via a nasal swab is inserted into Cont’d on page 5

Global COVID-19 Diagnostics and Therapy Market Projected at USD 14 Billion in 2025

he global COVID-19 diagnostics and therapy market is estimated to reach nearly USD 14 billion per year in 2025, driven by the high transmission rate of the novel coronavirus leading to a rapid increase in COVID-19 cases and deaths worldwide.

DAILy CLINICAL LAB NEwS

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Miniaturized PCR Enables Portable COVID-19 Testing with Palm-Sized Device

Access Interactive Digital Magazine

Instant Online Product Information:

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Novel Method Estimates LDL Particle Size

Study Finds Significant Variance in Accuracy of COVID-19 Antibody Tests

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These are the latest findings of Meticulous Research (Pune, India; www.meticulousresearch.com) a global market research company.

Healthcare systems have been struggling to manage the COVID19 patient population globally and hence, medical researchers Cont’d on page 23

dult T-cell leukemia/lymphoma (ATL) is a mature T-cell neoplasm associated with human T-cell leukemia virus type 1 (HTLV-1). Although only about 5% of HTLV-1 carriers progress to ATL, early diagnosis is challenging because of the lack of ATL biomarkers. Soluble tumor necrosis factor 2 (sTNFR2) is a novel and promising diagnostic biomarker for acute ATL. Plasma proteins play key roles Cont’d on page 20

INSIDE

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

PUBLISHED IN COOPERATION WITH

International Federation of Clinical Chemistry and Laboratory Medicine

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COVID-19 Diagnostics Update

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s clinical laboratories and healthcare institutions around the world rush to order large volumes of COVID-19 diagnostic products, the In Vitro Diagnostics (IVD) industry continues its unprecedented expansion to meet exploding global demand. The report that follows provides a survey of news and advances from July 1 till mid-August of this year.

For a recap of earlier developments, the reader is invited to refer to previous issues of LabMedica.

Roche Secures FDA Emergency Use Authorization for Elecsys IL-6 Test

Roche (Basel, Switzerland; www.roche. com) has secured Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its new Elecsys IL-6 test to help in identifying COVID-19 patients at a high risk of severe inflammatory response. The FDA EUA now makes IL-6 testing accessible to patients in the US to assist in identifying severe inflammatory response in patients with confirmed COVID19 and is also available in markets accepting the CE-mark.

T2 Biosystems Launches COVID-19 Molecular Diagnostic Test

T2 Biosystems, Inc. (Lexington, MA, USA; www.t2biosystems.com) has completed validation of its COVID-19 molecular diagnostic test, the T2SARS-CoV-2 Panel. The panel is designed to detect SARS-CoV-2 and provides sample-to-answer results in less than two hours, utilizing a nasopharyngeal swab sample.

Eurofins Launches CE-IVD Marked Rapid POC Testing Devices

Eurofins Technologies (Budapest, Hungary; www.eurofins-technologies.com) has launched CE-IVD marked rapid point-of-care testing devices to identify a person’s past exposure to COVID-19 (SARS-CoV-2) in only 10 minutes. The serology-based, finger-prick tests detect virus antibodies with a sensitivity of 94.5% from 19 days following the onset of symptoms.

Eurofins has also launched its pooled PCR test to detect SARS-CoV-2 and significantly reduced the price per PCR test for clients.

The test will be offered through its network of US laboratories, including Viracor Eurofins beginning mid-August. Pooling can be used to continuously and cost-effectively monitor prescreened, low-risk groups that show a low prevalence of COVID-19 infection. It can also be used as part of surveillance testing for positive individuals in quarantine.

Additionally, Eurofins has launched reagents for automated isolation of high-quality SARS-CoV-2 RNA (ribonucleic acid) from viral particles of human respiratory specimens. Eurofins' launch of the GSD NovaPrime RNA Extraction kits aims to help laboratories to meet this demand with an easy and highly efficient extraction method that works with a large range of existing au-

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tomation equipment.

Fluxergy Evaluates One-Hour COVID-19 Diagnostic Test Fluxergy (Irvine, CA, USA; www.flux ergy.com) will work with Mass General Brigham (MGB Boston, MA, USA; www. massgeneral.org) to further evaluate the company’s innovative Research Use Only (RUO) COVID-19 testing platform, designed to deliver accurate PCR test results in under one hour.

Subject to confirming the performance of the Fluxergy system, and the potential receipt by Fluxergy of the EUA, MGB may utilize the new platform within its healthcare system.

COVID-19-Influenza Combination Test Granted FDA EUA

The US Food and Drug Administration (FDA Silver Spring, MD, USA; www.fda.gov) has issued an emergency use authorization (EUA) for the third diagnostic test for detection and differentiation of the viruses that cause flu and COVID-19 in individuals suspected of COVID-19 by their healthcare provider to the US Centers for Disease Control and Prevention (CDC Atlanta, GA, USA; www.cdc.gov). The move aims to assist health care providers around the US in preparing for the upcoming flu season during the COVID-19 pandemic.

Advanced Biological Releases COVID-19 rRT-PCR Assay Validated for Saliva

Advanced Biological Laboratories (ABL; Luxembourg; www.ablsa.com) has announced the CE-IVD marking of its UltraGene Combo2Screen SARS-CoV-2 qPCR assay. The assay is the first qPCR detection kit now validated with SARS-CoV-2 RNA extracted from nasopharyngeal swabs and saliva.

BD Launches POC Antigen Test to Detect SARS-CoV-2

BD (Becton, Dickinson; and Company Franklin Lakes, NJ, USA; www.bd.com) has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for its rapid, point-of-care, SARSCoV-2 diagnostic test for use with the company’s BD Veritor Plus System. The new immunoassay test joins a portfolio of three molecular solutions for COVID-19 testing that have been registered for use with the BD MAX Molecular System, including two with EUAs and two with CE mark.

Separately, the US Department of Health and Human Services (HHS) has committed to purchase 2,000 BD Veritor Plus Systems and 750,000 SARS-CoV-2 antigen test kits for use on the system from the company. BD has received a commitment from the HHS to purchase its diagnostic solutions in expanding access to rapid point-of-care testing for COVID-19 through a broad, decentralized network of testing instrumentation.

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LabMedica International August-September/2020

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COVID-19 Diagnostics Update

Study Finds Significant Variance in Accuracy of COVID-19 Antibody Tests

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peer-reviewed study by a team of international researchers has found significant variability in the accuracy of commercially available COVID-19 antibody tests, and ranks both lab-based and point-of-care tests in the market in terms of performance.

Serological diagnostic tests are being increasingly used to provide a broader understanding of COVID-19 incidence and to assess immunity status in the population. The urgent need for the development of serological diagnostic tests in response to the COVID-19 outbreak has compelled regulatory bodies to implement emergency use authorization programs to expedite the commercialization process of these tests. In light of this, independent and robust post-market evaluations of COVID-19 serological tests are needed to confirm manufacturers’ performance claims.

However, there are discrepancies between claimed and actual performance data for serological diagnostic tests on the market. In the peer-reviewed study entitled, "COVID-19 Serological Tests: How Well Do They Actually Perform?", a team of international researchers at NSF International (Ann Arbor, MI, USA; www.nsf.org) and Novateur Ventures (Vancouver, BC, Canada; www.novateur.ca) conducted a review of independent studies evaluating the performance of SARS-CoV-2 serological tests.

The researchers included studies that reported sensitivity and specificity, stage of disease (early, intermediate, or late), the test format (CLIA, ELISA, RDT), and antibody target (IgA, IgG, IgM, or IgG + IgM). If available, the SARS-CoV-2 antigens used for antibody detection were recorded. The studies that did not specify the disease stage of test samples were grouped under the “overall” category and assessed separately. In total, the researchers reviewed performance data on five serological CLIA tests, 15 serological ELISA tests, and 42 serological RDTs currently on the market.

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They found significant variability in the accuracy of marketed tests and highlight several labbased and point-of-care rapid serological tests with high levels of performance. The findings of this review highlight the need for ongoing independent evaluations of commercialized COVID19 diagnostic tests.

"No single assay can be used for all diagnostic use cases in the COVID-19 response for a country. What works well in one setting may be inappropriate or not accessible for another. As such, access to information on test performance, that is generated independently, greatly assists countries in informed decision-making," said study co-author Robyn Meurant, Executive Director of Health Sciences for NSF International.

"Antibody testing is important to understand the extent of exposure for COVID-19 so it can be effectively monitored and treated. It is important for regional and national governments to continue their coordinated efforts to independently validate antibody test performance and also partner with industry to scale up manufacturing and production capacity," said co-author Ali Ardakani, Founder & Managing Director at Novateur Ventures.

The study was published in the July 2020 issue of the journal Diagnostics, an international peer-reviewed open-access journal published monthly by MDPI – the Multidisciplinary Publishing Institute (Basel, Switzerland; www. mdpi.com).

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PRODUCT NEWS

CHEMISTRY ANALYZER

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MICROPLATE READER WASHER URINE ANALYZER

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The respons®910 fully automated system makes routine lab operations more efficient and streamlines workflow. Features include a unique container system for liquid-stable reagents and throughput of up to 30 samples in one run.

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COVID-19 Diagnostics Update

cont’d from page 4

Additionally, BD has received additional pandemic orders for needles and syringes totaling 177 million injection devices from the US and Canada as part of their COVID-19 vaccine preparations. The new US order for 140 million injection devices brings total US orders from BD to 190 million devices. The new Canadian order for 37 million brings total Canadian orders from BD to 75 million devices.

Diasorin CE Marks New Simplexa Flu A/B & RSV Direct Gen II Assay

DiaSorin Molecular (Cypress, CA, USA; www.molecular.diasorin.com) has CE marked its Simplexa Flu A/B & RSV Direct Gen II kit to run alongside its Simplexa COVID-19 Direct kit. The kit delivers continued comprehensive strain coverage and accurate detection in an efficient and trusted sample-to-answer format that does not require extraction.

Diazyme Receives FDA Emergency Use Authorization for New COVID-19 Antibody Test

Diazyme Laboratories, Inc. (San Diego, CA, USA; www.diazyme.com) has received FDA Emergency Use Authorization (EUA) for the Diazyme DZ-Lite SARS-CoV-2 IgG CLIA test. The test is an indirect chemiluminescence immunoassay that is run on the fully automated DZ-Lite 3000 Plus chemiluminescence analyzer and specifically detects the presence/absence of COVID-19-specific IgG antibodies in the blood of a patient.

Separately, Diazyme has entered into a partnership with Maccura Biotechnology (Sichuan, China; www.maccura.com) for the launch of a FDA EUA approved SARS-COV-2 RT-PCR diagnostics test. Maccura’s SARS-CoV-2 Fluorescent

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PCR Kit is designed for triple-targets and is better at preventing the missed detection of SARSCoV-2. At the same time, internal standards are added to prevent false negative test results.

Clinical tests have shown that the kit has good performance, high sensitivity and specificity.

The test also takes a relatively short time and can complete 96 tests within two hours.

Quantabio RT-qPCR Kit Given Expanded Role in CDC COVID-19 Testing Protocol

Quantabio’s (Beverly, MA, USA; www. quantabio.com) UltraPlex 1-Step Tough-Mix has been recognized as part of the expanded emergency use authorization (EUA) for the Centers for Disease Control and Prevention (CDC) COVID-19 testing protocol. Public health laboratories facing RNA extraction reagent supply shortages are now advised to use the amended protocol, which includes the one-step, reverse transcription and real-time quantitative PCR (RT-qPCR) kit that provides high assay efficiency, sensitivity and specificity in minimal reaction volumes and accelerated thermal cycling rates.

Rapid 45-Minute COVID-19 Test Ideal for Screening at Points of Risk

Researchers at the Aikens Research Center at Beaumont Research Institute (Southfield, MI, USA; www.beaumont.org) have developed a new test to detect COVID-19 via urine, blood, saliva or a mouth-swab sample in just 30-45 minutes that could be used for screening at the point of risk. The test results were found to be highly accurate as compared to existing technology. Additionally, the rapid test is also relatively inexpensive to develop and operate as the materials for it are inexpensive and it does not require expensive machinery to run.

Triple Antibody Test for COVID-19

A new triple antibody test detects antibodies to three different COVID-19 proteins in sev-

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en minutes at the PoC, giving a more powerful profile of the clinically relevant biomarkers than other currently available COVID-19 tests.

The next-generation test developed by Attomarker Ltd. (Devon, UK; www.attomarker. com) uses a multiplex platform to simultaeously test for three virus proteins (Spike 1, Spike 2 & N) and three classes of antibodies (IgM, IgG and IgA), giving a more powerful profile of the patient’s immune response to COVID-19.

EpiGentek Releases SARS-CoV-2 Research Assays

EpiGentek (Farmingdale, NY, USA; www. epigentek.com) has released a series of SARSCoV-2 research assays that focuses on studies of SARS-CoV-2 targeted furin or proprotein convertase (PC) cleavage activity. These firstof-its-kind tools can be used to rapidly detect SARS-CoV-2 targeted PC and facilitated proteases using biological samples as well as screen for inhibitors of these enzymes that cleave SARS-CoV-2 proteins.

New SARS-CoV-2 Rapid Colorimetric LAMP Assay Kit

A newly-launched SARS-CoV-2 rapid colorimetric LAMP assay kit that can be used for the detection of novel coronavirus, SARS-CoV-2 RNA serves as a simple alternative to RT-qPCR and enables visual detection of amplification of SARS-CoV-2 nucleic acid in just 30 minutes.

The new kit launched by New England Biolabs (Ipswich, MA, USA; www.neb.com) utilizes loop-mediated isothermal amplification (LAMP) to detect specific segments of the viral genome.

Enzo Biochem Secures FDA EUA for Coronavirus Detection Test System

Enzo Biochem (New York, NY, USA; www. enzo.com) has received Emergency Use Authorization (EUA) from the FDA for its proprietary product for the detection of Coronavirus SARS-CoV2, enabling other laboratories to use the company’s Cont’d on page 8

LabMedica International August-September/2020

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kidney Transplantation Rejection Risk Assay

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

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kidney transplant patients, clinicians usually extract several small transplanted kidney samples every few months post-transplant, in addition to measuring the patient's serum creatinine levels. However, kidney biopsies can be invasive and expensive, while serum creatinine levels are often inaccurate and not sensitive enough to detect transplant rejection.

Scientists from the University of California, San Francisco (San Francisco, CA, USA; www.ucsf.edu) and their colleagues collected a total of 601 prospective urine samples from both pediatric and adult renal allograft recipients immediately before a renal allograft biopsy. Each sample was then paired with a renal transplant biopsy and classified into the following diagnoses: stable (170); acute rejection (AR, 103); borderline AR (bAR, 50); and BK virus nephropathy (9). The team also collected additional urine samples from 32 patients with AR before the rejection episode and paired them with biopsies.

The team evaluated a noninvasive, spot urine–based diagnostic assay based on measurements of six urinary DNA, protein, and metabolic biomarkers. The team used the QiSant assay (Nephrosant, San Francisco, CA, USA; https://nephrosant.com) that analyzes six biomarkers from 4 mL of urine sample: the amount of cell-free DNA (cfDNA); the fraction of methylated cfDNA; the proteins clusterin and creatinine; the inflammation marker CXCL10; and total protein amount in the urine. The assay uses a proprietary enzyme-linked immunosorbent (ELISA)based tool, including a 5' biotinylated oligonucleated immunoprobe to target cfDNA fragments, and artificial intelligence to estimate the likelihood of acute kidney rejection. After collecting patient samples, the scientists developed a composite Q score – ranging from 0 to 100 – on all six biomarkers in a training set of 39 AR and 72 stable patients (STA).

In the first validation set, which had 32 AR patients and 71 STA patients, the group found that the score between the patient types had about a 91% clinical sensitivity and a 92% clinical specificity. Meanwhile, in a second validation set of 32 AR patients and 27 STA patients, the team found that the scaled score had 100% sensitivity and 96% specificity. Most patients with samples (159) with scores above the AR threshold had a clinical diagnosis of active AR, early AR, or went on to develop biopsy-confirmed AR up to 200 days after using the QiSant assay.

The authors concluded that they had demonstrated the clinical utility of this assay for predicting AR before a rise in the serum creatinine, enabling earlier detection of rejection than currently possible by standard of care tests. This noninvasive, sensitive, and quantitative approach is a robust and informative method for the rapid and routine monitoring of renal allografts.

The study was published on March 18, 2020 in the journal Science Translational Medicine.

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LabMedica International August-September/2020

LabMedica International

Image: Schematic diagram of a urine score for noninvasive accurate diagnosis and prediction of kidney transplant rejection study (Photo courtesy of the University of California, San Francisco).

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PRODUCT NEWS ELISA PROCESSOR

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COVID-19 Diagnostics Update

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products with three diverse platforms without requiring further validation. The AMPIPROBE SARS-CoV-2 Test System is a complete workflow solution based on the real-time reverse transcription polymerase chain reaction (qRT-PCR) technology and designed for the qualitative detection of nucleic acids from SARS-CoV-2 virus.

EKF Diagnostics Launches Novel Molecular Transport Media

EKF Diagnostics (Cardiff, UK; www.ekf diagnostics.com) has added a new novel viral transport media for the safe sample handling and testing of multiple infectious diseases from a single swab to its product range. EKF’s PrimeStore MTM (Molecular Transport Medium) is an FDA cleared and CE IVD marked sample collection device which deactivates viruses, including COVID-19, flu A, flu B, HIV and TB. The fully patented device ensures transportation and workplace safety for disease testing programs, greatly reducing risk of infection to health workers, couriers, and lab technicians.

3M and MIT Researchers Developing Low-Cost COVID-19 Diagnostic Test

3M (St. Paul, MN, USA; www.3M.com) and researchers at MIT (Cambridge, MA, USA; www.web.mit.edu) are testing a new rapid COVID-19 test that detects the novel coronavirus. Accelerated research is underway to learn if a simple-to-use, diagnostic device can produce highly accurate results within minutes and is feasible to mass manufacture. The test would detect viral antigens and deliver highly accurate results within minutes via a paperbased device. It could be administered at the point-of-care and would not need to be sent to labs for testing.

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BioMérieux’s BIOFIRE Respiratory Panel 2.1 Plus with SARS-CoV-2 Receives CE Mark BioMérieux’s (Marcy-l'Étoile, France; www. biomerieux.com) BIOFIRE Respiratory Panel 2.1 plus (RP2.1plus) is CE marked and will be commercially available in all countries that recognize CE marking. The panel is part of BioMérieux’s suite of products in response to the COVID-19 pandemic and tests for 23 pathogens (19 viruses, including SARS-CoV-2, and four bacteria) which are responsible for the most frequent respiratory tract infections.

Separately, the FDA has granted EUA to BioMérieux’s VIDAS SARS-COV-2 IgM and VIDAS SARS-COV-2 IgG automated qualitative assays which rapidly detect antibodies to help identify individuals with previous exposure to SARSCoV-2. With the same protocols to differentiate IgM and IgG results, the VIDAS SARS-COV-2 IgM detects IgM specific for SARS-CoV-2 while the VIDAS SARS-COV-2 IgG detects IgG specific for SARS-CoV-2.

First-in-Class COVID-19 Rapid Diagnostic Test for Neutralizing Antibodies

A new rapid diagnostic test for measuring levels of functional neutralizing antibodies that are believed to prevent SARS-CoV-2 from entering the host cells could serve as an ‘Immunity Passport’ for vaccine developers around the world as they begin larger Phase II and III clinical trials. NeuCovix, a rapid 10-minute test unveiled by AXIM Biotechnologies, Inc. (San Diego, CA, USA; www.aximbiotech. com), measures a specific subpopulation of antibodies to block binding of the virus to host cell receptors, unlike the currently available serological COVID-19 tests that detect an antibody response to the virus.

Targeted Respiratory Pathogen Panel for SARS-CoV-2 IDbyDNA Laboratories (Salt Lake City, UT, USA; www.idbydna.com) is developing a tar-

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geted respiratory pathogen panel to identify the presence of the SARS-CoV-2 virus and approximately 250 additional pathogens that can be tested in parallel, according to a report by BioSpace. The focused pathogen panels being developed by IDbyDNA will bring a practical, cost-effective element to metagenomics that so far has been lacking, with the benefits extending beyond just diagnosis.

Oxford University’s Rapid COVID-19 Test for Detection of SARS-CoV-2

Scientists have developed a rapid test which detects the presence of the SARS-CoV-2 virus and could be adapted for use in settings ranging from community care, schools, airports or home self-testing. The test for the detection of COVID-19 has been developed by the University of Oxford’s Department of Engineering Science and Oxford Suzhou Centre for Advanced Research (OSCAR Oxford, UK; www.ox.ac. uk). The test produces results within 30-45 minutes and detects SARS-CoV-19 with great sensitivity and specificity using throat/nasal swabs directly to identify individuals carrying the virus.

Quest Diagnostics’ SARS-CoV-2 rRT-PCR Test Receives FDA EUA for Sample Pooling

The US Food and Drug Administration has reissued an emergency use authorization (EUA) to Quest Diagnostics (Secaucus, NJ, USA; www.questdiagnostics.com) to authorize its Quest SARS-CoV-2 rRT-PCR test for use with pooled samples. The Quest test is the first COVID-19 diagnostic test to be authorized for use with pooled samples containing up to four individual swab specimens collected under observation.

Luminex COVID-19 Antibody Test Receives FDA for Emergency Use

Luminex Corporation (Austin, TX, USA; www.luminexcorp.com) has secured an

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PRODUCT NEWS

NUCLEIC ACID ANALYZER

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

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

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

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Emergency Use Authorization (EUA) from the US FDA for the company's xMAP SARS-CoV-2 Multi-Antigen IgG Assay. The xMAP-based serology test is the third COVID-19 Luminex test to receive an EUA, joining the NxTAG CoV Extended Panel and the ARIES SARS-CoV2 Assay, which are rapid, RNA-based SARSCoV-2 diagnostic tests that received EUAs in March and April of this year, respectively.

Quidel’s Sofia SARS Antigen FIA Updates EUA Performance Data

Quidel Corporation (San Diego, CA, USA; www.quidel.com) has updated the performance data for its Sofia SARS Antigen FIA test on its package insert to 96.7% using direct nasal swab specimens versus PCR. The move comes as a result of further studies included in its amended Emergency Use Authorization (EUA) that were submitted to the US FDA. Additionally, the Sofia SARS Antigen FIA has received CE Mark for use with the Sofia and Sofia 2 instruments.

Separately, Quidel has entered into a preliminary letter contract with the National Institutes of Health (NIH) to support the expansion of its manufacturing capacity at San Diego, California in the US for its diagnostic assays that test for SARS-CoV-2 Antigen using its Sofia Fluorescence Immunoassay (FIA) platform. Quidel has received the preliminary contract leading to a definitive agreement for USD 71 million under NIH’s newly launched Rapid Acceleration of Diagnostics – Advanced Technology Platforms (RADx-ATP) initiative.

PerkinElmer Launches New Dried Blood Spot Based COVID-19 Serology Test

PerkinElmer, Inc. (Waltham, MA; USA; www. perkinelmer.com) has launched a dry blood spot (DBS) based test for SARS-CoV-2 IgG using its

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GSP/DELFIA platform, enabling processing of up to 5,000 samples per day. The finger-prick sample collection device allows for both decentralized sample collection and high-throughput testing.

The product is being marketed as a CE-IVD test, and the company plans to apply for Emergency Use Authorization (EUA) with the US Food and Drug Administration (FDA).

Separately, PerkinElmer has launched two online, free-access COVID-19 Data Dashboards to help the global scientific community accelerate the discovery of COVID-19 antivirals and vaccines. The dashboards are powered

by PerkinElmer’s data analytics and data visualization solutions which help researchers more quickly and easily leverage the vast amounts of drug compound and clinical trial data that exist across reliable, yet disparate, sites and sources.

COVID-19 Patients with Lymphocytopenia Likely to Suffer Severe Disease Symptoms

An easily recognizable feature in blood samples may be an indicator of whether a COVID19 patient will be likely to suffer from a severe form of the disease, according to investigators at the University of Texas Health Science Center at Houston (USA; www.uth.edu). A study has revealed that revealed that lymphocyte count was lower and lymphocytopenia - abnormally low levels of white blood cells - more frequent in patients admitted to the ICU, a marker of disease severity, relative to those who were not. The findings support the hypothesis that lymphocytopenia could be an early, useful, and easily obtained, prognostic factor in determining the clinical course and disease severity of a patient admitted to the hospital for COVID-19.

US National COVID-19 Testing Implementation Forum

The US Department of Health & Human Services (HHS Washington, D.C., USA; www.hhs.gov) has announced the National COVID-19 Testing Implementation Forum, a

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new program to capture feedback between federal officials and the private sector. The members of the forum will provide their perspectives on how HHS can best identify and address end-to-end testing supply chain issues across commercial, public health, academic, and other sectors and define optimal testing in various settings (diagnostic, screening, surveillance, others).

US National COVID-19 Diagnostic Supply Registry Launched

A new US national testing registry has been launched to aid in the fight against COVID-19 and has released the first data set that shows more than 65 million tests have been shipped nationwide since the beginning of the pandemic. The comprehensive, national COVID-19 diagnostic supply registry has been created by the Advanced Medical Technology Association (AdvaMed Washington, D.C., USA; www. advamed.org) in partnership with 13 commercial diagnostics manufacturers to help state and federal governments in their pandemic responses.

Data released by the US national COVID-19 diagnostic supply registry shows that over one million SARS-CoV-2 tests are being shipped every day. Across leading COVID diagnostic manufacturers, roughly 80 million molecular COVID-19 tests have been manufactured and shipped since March. Manufacturers have increased molecular test production from about 450,0001 shipments per day at the start of May to over 870,0001 shipments per day by July 18. The past week’s shipping patterns show an all-time weekly high of one million tests shipped per day.

Sputum Testing Has Significantly Higher COVID-19 Detection Rate

Among the three approaches to collecting specimens, including sputum, nasopharyngeal (NP) swabs and oropharyngeal swabs, sputum testing has been found to detect the RNA of

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the virus that causes COVID-19 at significantly higher rates while oropharyngeal swab testing had lower rates. Investigators from the Brigham and Women’s Hospital (Boston, MA, USA; www.brighamandwomens.org) who conducted a systematic review and meta-analysis, analyzing data from more than 3,000 specimens to compare the three approaches found that sputum testing detected the RNA of the virus that causes COVID-19 at significantly higher rates while oropharyngeal swab testing had lower rates.

Bruker Launches Second-Generation FluoroType SARS-CoV-2 plus PCR Test

Bruker Corporation (Billerica, MA, USA; www.bruker.com) has launched the FluoroType SARS-CoV-2 plus next-generation 6-plex PCR assay for the highly specific detection of the SARS-CoV-2 virus. The assay has shown 100% sensitivity and 100% specificity in clinical trials and is CEIVD labeled according to the European IVD Directive (98/79/EC). It can be used with Bruker´s FluoroCycler XT real-time PCR system or alternatively with other commonly available real-time thermocyclers.

COVID-19 Diagnostics Update USA; www.truvianhealth.com) has been issued Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for the company's Easy Check COVID-19 IgM/IgGTM antibody test. The test exceeds the current EUA requirements for current COVID-19 antibody tests by delivering a sensitivity rate of 98.44% and a specificity of 98.9%.

Half of All US Labs Lack Supplies for Running COVID-19 Tests

A new survey of clinical laboratories in the US has found that nearly half of all responding labs still do not have the supplies they need to run COVID-19 tests. The survey was conducted by the American Association for Clinical Chemistry (AACC, Washington, DC, USA; www.aacc.org) which has presented its findings to the White House Coronavirus Task

Force, calling on the federal government to take a more active role in alleviating this problem, so that labs can increase their testing capacity in the midst of the virus’s latest surge.

Sorrento to Market Columbia University’s SARS-CoV-2 Saliva Test

Sorrento Therapeutics, Inc. (San Diego, CA, USA; www.sorrentotherapeutics.com) has entered into a licensing agreement with Columbia University (New York, NY, USA; www. columbia.edu) for the rights to a rapid, onestep diagnostic test that detects the SARS-CoV2 virus in 30 minutes from a sample of saliva.

Unlike other commercially available diagnostic products, the test developed by Columbia University's team, to be marketed by Sorrento under the COVI-TRACE name, holds all of the

COVID-19 Test Detects Neutralizing Antibodies with High Specificity and Sensitivity

A first-of-its-kind rapid COVID-19 test can detect neutralizing antibodies with 99-100% specificity and 95100% sensitivity within an hour and is capable of differentiating antibody responses from other known human coronaviruses. The unique and rapid SARS-CoV-2 surrogate virus neutralization test (sVNT) developed by the Duke-NUS Medical School (Singapore; www.duke-nus.edu.sg) could provide a much-needed boost to current COVID-19 investigations to determine infection rate, herd immunity, predicted humoral protection, and vaccine efficacy during clinical trials.

Ultrasensitive Droplet Biosensing Method Shortens Identification Time for COVID-19

Scientists at Virginia Tech (Blacksburg, VA; www.vt.edu) have developed an ultrasensitive biosensing method that could dramatically shorten the amount of time required to verify the presence of the COVID-19 virus in a sample. In the method, all the contents of a sampling droplet can be detected, and there is no extraction or other tedious procedures.

Truvian Sciences’ Easy Check COVID-19 IgM/IgG Test Receives FDA EUA

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LABORATORY WORKSTATION

NEGATIVE QC FOR SARS-COV-2 CLINICAL CHEMISTRY ANALYZER ANTIBODIES TECHNOPATH HUMAN GMBH

The MICROFLOW I is a ductless, carbon filtered, rust resistant workstation equipped with activated carbon filtration, designed to collect small amounts of non-hazardous fumes and odors.

The Multichem ID-COVID19Neg is a negative thirdparty quality control for IgG and IgM antibodies to SARS-C0V-2 with the QC samples specifically optimized and validated to match assays commonly used for COVID-19 disease testing.

HEMCO

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testing materials in a single tube and requires no specialized laboratory equipment, making it easily deployable for point of care, on-site or potentially at-home testing.

Seegene Allplex 2019-nCoV Assay for SARS-CoV-2 Granted Expanded FDA EUA

Seegene, Inc. (Seoul, South Korea; www. seegene.com) has been granted expanded Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for its Allplex 2019-nCoV Assay, a Real-time RTPCR test for SARS-CoV-2. The assay, which had initially received EUA on April 21, 2020, has a unique feature that identifies three different target genes (E, RdRP and N genes) simultaneously in a single reaction tube/well, which allows for highly accurate results and maximizes the throughput for high volume testing. The current expansion greatly increases the number of nucleic acid extraction/isolation systems and extraction kits as well as PCR instruments.

Carolina Liquid Chemistries Secures FDA EUA for COVID-19 Test Kits

Carolina Liquid Chemistries, Corp. (CLC; Greensboro, NC, USA; www.carolinachemistries. com) has been granted FDA emergency use authorization for its COVID-19 test kits. CLC’s COVID-19 test kits include two real-time reverse transcriptase polymerase chain reaction (RT-PCR) diagnostics, the DiaCarta RT-PCR QuantiVirus SARS-CoV-2 Test Kit and QuantiVirus SARS-CoV-2 Multiplex Test Kit. Both are intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, and sputum from individuals suspected of COVID-19.

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New Rapid Test Determines Amount of Neutralizing Antibodies Against SARS-CoV-2 A Swiss-German team of researchers have developed a test that determines the amount of neutralizing antibodies against SARS-CoV-2 within a short period of time. The test was developed at the Institute of Virology and Immunology (IVI) of the University of Bern (Bern, Switzerland; www.unibe.ch) and the Swiss Federal Office for Food Safety and Animal Health (Köniz, Switzerland; www.blv.admin.ch), and evaluated by the Ruhr-University Bochum (RUB Bochum, Germany; www.ruhr-uni-bochum.de) using serum samples from COVID-19 patients. A traditional neutralization test usually takes two to three days and must be carried out with infectious coronaviruses in a laboratory complying with biosafety level 3. The new test launched by the Swiss-German researchers takes only 18 hours and does not have high biosafety requirements.

Siemens’ Tests That Estimate Antibodies from Past COVID-19 Infections Become First To Receive FDA EUA

The US Food and Drug Administration has authorized the first two COVID-19 serology tests that display an estimated quantity of antibodies present in an individual’s blood. Both tests from Siemens Healthineers (Erlangen, Germany; www.siemens-healthineers.com), the ADVIA Centaur COV2G and Atellica COV2G, are what are known as “semi-quantitative” tests, meaning that they do not display a precise measurement, but estimate the quantity of a patient’s antibodies produced against infection with the virus that causes COVID-19.

Cheaper, Rapid, and Accurate Pooling Strategy for RT-PCR–Based Detection of SARS-CoV-2

Researchers at the Medical College of Georgia at Augusta University (Augusta, GA, USA; www.augusta.edu) and PerkinElmer Genomics

The HumaStar 600 clinical chemistry analyzer with a throughput of 900 to 2250 tests per day is designed to run daily photometric and immunoturbidimetric routine as well as optional direct ISE measurement.

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(Pittsburgh, PA, USA; www.perkinelmerge nomics.com) have proposed a mass population screening approach based on sample pooling strategy for rapid and wide-scale population screening that can be adopted by laboratories currently using RT-PCR–based methods to test for SARS-CoV-2. The researchers estimate that the strategy could lead to an approximately 5to 10-fold reduction in the cost of testing of SARS-CoV-2.

Applied DNA’s COVID-19 Diagnostic Kit Granted FDA EUA Amendment

Applied DNA Sciences Inc. (Stony Brook, NY, USA; www.adnas.com) has been granted Emergency Use Authorization (EUA) amendment by the US Food and Drug Administration (FDA) that expands the installed base of PCR equipment platforms which can process the company’s Linea COVID-19 Assay Kit and introduces automation to significantly increase the throughput of the assay by use of robotic RNA extraction. The EUA amendment extends the RT-PCR platform authorization from the Applied Biosystems (ThermoFisher Scientific) QuantStudio Dx to include Applied Biosystems’ QuantStudio 5 Real-Time PCR system (QS5). The amendment also authorizes the use of the Hamilton STARlet robotic automation in conjunction with the Omega Bio-Tek MagBind viral RNA Express kit to speed the process of extracting viral RNA from specimens and drive greater testing throughput.

Thermo Fisher Launches Real-Time PCR Solution for COVID-19 Testing

Thermo Fisher Scientific Inc. (Waltham, MA, USA; www.thermofisher.com) has introduced a new highly automated, real-time PCR solution designed to analyze up to 6,000 samples in a single day to meet increasing global demand for COVID-19 testing. The new Thermo Fisher Scientific Amplitude Solution is a molecular diagnostic testing system that leverages the company's Applied

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Novel Method Estimates LDL Particle Size

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LabMedica International

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nowadays the most important therapeutic target. However, it has been demonstrated that lowering LDL-C concentration is not enough to prevent all ischemic events even in patients without CVRFs. Medical scientists at the Bellvitge University Hospital (Barcelona, Spain; www.bellvitgehospital.net) and their colleagues included in their study 85 patients who were 19 to 75-year-old male non-smokers. Each patient had their biochemical profiles assessed. A complete lipid profile for each patient was also attained including plasma concentrations of cholesterol, very low-density lipoprotein cholesterol (VLDL-C), intermediate-density lipoprotein cholesterol (IDL-C), triglycerides (Tg), LDL-C, high-density lipoprotein cholesterol (HDL-C), apolipoprotein A (ApoA-I), apolipoprotein B (ApoB), apolipoprotein E (ApoE), apolipoprotein CIII (ApoCIII), and lipoprotein A (LPA). In addition, atherogenic indices were calculated using the following formula: IA = LDL-C/HDL-C. LDL size (LDL-Z) and LDL-particles (LDL-P) and small dense LDL (sdLDL-C) were also measured.

Supernatant HDL-C and total cholesterol were measured using a Cobas 8000 modular analyzer (Roche Diagnostics; Risch-Rotkreuz, Switzerland; www. roche.com). Cholesterol concentration was determined enzymatically using cholesterol esterase and cholesterol oxidase in the Roche diagnostics Cobas 701. Since supernatant only contained HDL and sdLDL particles, the sdLDL-C was calculated by subtracting the HDLC from the total cholesterol concentration. Nuclear magnetic resonance (NMR) analyses were carried out with the Vantera analyzer (LipoScience, Inc; Morrisville, NC, USA; www.liposci ence.com).

The investigators reported that regarding the relation between sdLDL-C concentration variation and LDL-Z, they found that an increase in the diameter of LDL particles implies a decrease in sdLDL-C concentration. Importantly, taking into account the multivariate regression, an increment of 1 nm in LDL size leads to a 126 nmol/L reduction in sdLDL-C concentration. As a consequence, smaller LDL particles contain a higher concentration of cholesterol. Due to its composition, smaller LDL particles would support the formation and progression of the atheroma plaques in higher degree than larger ones.

The authors concluded that the association between sdLDL-C, LDL-Z, and LDL-P was clear. From a large number of variables, especially LDL-Z and apoB influence on sdLDL-C. The results showed that the smaller the LDL size, the higher their cholesterol concentration. Therefore, sdLDL-C determination by using this easy method would be useful to risk stratification and to uncover cardiovascular residual risk. The study was published on March 21, 2020 in the Journal of Clinical Laboratory Analysis.

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Image: The high throughput immunochemistry cobas e 801 module (Photo courtesy of Roche Diagnostics).

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SAMPLE PREPARATION SYSTEM ABBOTT DIAGNOSTICS

SAMPLE COLLECTION & TRANSPORT KIT THERMO FISHER SCIENTIFIC

SARS-COV-2 IGG ANTIBODY TEST BECKMAN COULTER

An automated bench-top system with a small footprint, the m24sp features reliable extraction using mSample Preparation chemistry and variable extraction with re-usable reagents plus flexible batch size.

The MicroTest Universal Kits help maintain organism viability and counts for verification studies, quality control procedures, and repeat testing of viruses, chlamydiae, mycoplasma and ureaplasma with quality media.

The Access SARS-CoV-2 IgG Antibody Test is designed to target antibodies against the coronavirus spike protein that may be more likely to confer immunity and detects antibodies to the RBD of the spike protein.

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Biosystems QuantStudio 7 Flex Real-time PCR instruments along with liquid handling products from Tecan Group. The modular solution delivers test results in a four-step process requiring minimal hands-on time, laboratory space and staffing resources.

Separately, Thermo Fisher's transplant diagnostic business has developed the LABScreen COVID Plus Assay which will be provided under the company's One Lambda brand representing leading in vitro diagnostic products for the transplant community. The assay leverages the Luminex xMAP technology to detect multiple distinct antibodies and fragments, making it more specific than current assays and able to reduce false positives caused by infections with common coronavirus.

Kantaro Quantitative SARS-CoV-2 IgG Antibody RUO Kit Launched

Bio-Techne Corporation (Minneapolis, MN, USA; www.bio-techne.com) and the Mount Sinai Health System (New York, NY, USA; www.mountsinai.org) through its commercial affiliate Kantaro Biosciences LLC, have launched the COVID-SeroIndex, a Kantaro Quantitative SARS-CoV-2 IgG Antibody RUO kit. The COVID-SeroIndex test kit is an enzyme-linked immunosorbent assay, or ELISA, designed to measure the presence or absence of anti-COVID19 antibodies in addition to measuring the titer (level) of antibodies a person has produced. BioTechne and Kantaro will leverage a joint commercialization and distribution team to support rapid distribution of the assay to the vaccine development community.

First FDA EUA COVID-19 Saliva Testing Kits Launched

The first FDA Emergency Use Authorization (EUA) COVID-19 saliva testing kits have been

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launched in the US by Accumen Inc. (Phoenix, AZ, USA; www.accumen.com) in partnership with Spectrum Solutions (Salt Lake City, UT, USA; www.spectrumsolution.com). This authorization mandated saliva collection solely using Spectrum’s SDNA-1000 saliva collection device based on a trial with Rutgers University.

The Spectrum saliva collection kit has been engineered to produce more accurate and sensitive test results, reduce sample collection errors, including for at-home self-collection, reduce labor required for collection and reduce use of valuable PPE. Rapid COVID-19 Test Uses Graphene-Enhanced Sensor

A new COVID-19 rapid test delivers accurate and reliable results in seconds using a graphene-enhanced sensor that produces a signal when exposed to COVID-19 viral antigens.

The graphene-enhanced sensor has been developed by Graphene Leaders Canada (GLC) Inc. (Alberta, Canada; www.grapheneleaderscan ada.com) together with its subsidiary GLC Medical (GLCM) Inc. for use in their Rapid COVID19 Virus Detection Test Kit. The only of its kind saliva test eliminates the nasopharyngeal swab, all certified practitioner oversight requirements, does not require expensive equipment, and there is no cross handling which increases cross contaminations.

Mammoth Biosciences’ CRISPR SARS-CoV-2 Diagnostic Platform to Be Funded By NIH

Mammoth Biosciences (San Francisco, CA, USA; www.mammoth.bio) has received a contract from the National Institutes of Health (NIH) as part of its USD 1.5 billion Rapid Acceleration of Diagnostics (RADx) program, making it the first CRISPR based initiative to be funded by the program. The award will help scale Mammoth’s CRISPR-based DETECTR test onto high-throughput automated platforms in commercial labs for COVID-19 diagnostics at an accelerated rate, increasing access to accurate

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tests with faster turnaround across the US.

Snibe’s Maglumi SARS-CoV-2 S-RBD IgG Test Receives CE Mark Snibe Diagnostic (Shenzhen, China; www. snibe.com) has received the CE mark for its fully automated quantitative serology test for detecting IgG antibodies against SARS-CoV-2SRBD, the receptor-binding domain of S protein.

The test, called Maglumi SARS-CoV-2 S-RBD IgG, is designed for the quantitative detection of antibodies to the receptor-binding domain of the S protein, which are believed to neutralize the coronavirus and are an effective measure of immunity as compared to antibodies that target other SARS-CoV-2 proteins.

Hologic to Ramp Up COVID-19 Tests Capacity

The US Department of Health & Human Services (HHS Washington, D.C., USA; www.hhs.gov) and Department of Defense (DOD Arlington, VA, USA; www.dod.defense. gov) have awarded an undefinitized contract action with a ceiling of USD 7.6 million to Hologic, Inc. (Marlborough, MA, USA; www.hologic.com) to expand production of custom sample collection and processing consumables for COVID-19 testing. The investment will increase Hologic's production from 4.8 million COVID-19 tests per month to 6.8 million tests per month. The company is expected to deliver the increased volume of consumables to market by January 2021.

Separately, Hologic has validated use of its Aptima and Panther Fusion molecular diagnostic COVID-19 assays with pooled patient samples and completed an emergency use notification to the US Food and Drug Administration (FDA) to make this workflow available to laboratory customers in the US. . Hologic’s pooling protocol enables clinical laboratories to combine up to five patient samples into a single tube for processing. Hologic believes it

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is the first test manufacturer in the country to validate and launch a pooling workflow that ensures highly accurate detection of the SARS-CoV-2 virus.

UK Government to Roll Out Millions of 90 Minute COVID-19 Test Kits

The UK government has placed orders for millions of high-speed COVID-19 test kits from DnaNudge (London, UK; www.dna nudge.com) and Oxford Nanopore Technologies (Oxford, UK; www.nanoporetech. com) to be used in NHS hospitals from September. The order will see 5.8 million lab-free, rapid and reliable PCR test from DnaNudge that delivers results in under 90 minutes and can work in about an hour being rolled out across the UK in urgent patient care and elective surgery settings, with further deployments in out-of-hospital settings.

The UK government will also roll out about half a million of the novel “LamPORE COVID-19” assay which provides precise detection of SARSCoV-2 using Oxford Nanopore’s DNA/RNA sequencing technology.

No-Touch, Paper-Based Test Could Detect SARS-CoV-2

Researchers from Iowa State University (Ames, IA, USA; www.iastate. edu) are developing a closed, contactfree diagnostic sensing system that could be used to quickly test for COVID-19 or other outbreaks. The researchers aim to develop a low-cost, mail-safe, fast-scan “diagnostic platform that is well-suited for widespread monitoring of infection during pandemics.

Vela Diagnostics' ViroKey RTPCR Test Granted FDA EUA

Vela Diagnostics (Singapore; www. veladx.com) has obtained Emergency Use Authorization from the US Food and Drug Administration (FDA) for the manual version of its probe-based reverse transcription PCR test that detects SARS-CoV-2. Vela’s ViroKey SARS-CoV-2 RT-PCR Test detects SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs by targeting conserved regions of the viral genome. In addition to being authorized by the FDA for emergency use, the test has also received the CE mark and provisional approval from the Singapore Health Sciences Authority.

New PCR-based COVID-19 Test Uses Switch-Blocker PCR Technology

Biocept, Inc. (San Diego, CA, USA; www.biocept.com) and Aegea Biotechnologies, Inc. (San Diego, CA,

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USA; www.aegeabiotech.com) have entered into an agreement to develop a COVID-19 PCR assay based on the core SwitchBlocker technology used in Biocept's suite of ultra-sensitive oncology-focused assays.

The collaboration focused on the co-development of a highly sensitive PCR-based assay designed by Aegea for detecting the COVID-19 virus will leverage Biocept's experience in developing high-performance assays based on the Switch-Blocker technology.

Helix COVID-19 NGS Test Secures FDA EUA

Helix (San Mateo, CA, USA; www.helix.com) has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for the Helix COVID-19 NGS

Test, making it one of the first sequencingbased COVID-19 tests to be granted FDA EUA. The test is an amplicon-based next-generation sequencing (NGS) test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper respiratory specimens (nasopharyngeal swabs, oropharyngeal (throat) swab, mid-turbinate nasal swabs, and anterior nasal swabs) from individuals suspected of COVID-19 by their healthcare provider.

New COVID-19 Mobile Testing Device Uses AI

Scientists have developed a medical device that has the potential to allow public health professionals to immediately diagnose COVID-19 infection via breath sample and Cont’d on page 19

PREMIER MULTIMEDIA PLATFORM SERVING THE WORLD’S CLINICAL LABORATORY COMMUNITY Anytime, Anywhere, On the Go...

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SARS-COV-2 ASSAY

PCR SYSTEM

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INFLUENZA TEST

SIEMENS HEALTHINEERS

THERMO FISHER SCIENTIFIC

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The SARS-CoV-2 Total (COV2T) Assay detects both IgM and longer-lasting IgG antibodies with high sensitivity of recent and prior infection, allowing for identification of patients who have developed an adaptive immune response.

The QuantStudio 7 Flex Real-Time PCR System advances research further by enabling a broad range of real-time PCR-based applications through its multiplexing capabilities and interchangeable block formats.

The respiraRNA 2.0 Real Time RT-PCR Kit is intended for the in-vitro detection of the RNA of Influenza virus A, Influenza virus B and Respiratory Syncytial Virus in clinical specimens.

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Rapid Test Detects Carbapenemase

Despite the urgency, timely carbapenemase detection remains a challenge for microbiology laboratories. Phenotypic assays are inexpensive and easily performed, but their use requires 24– 48 hours and many lack sensitivity or specificity.

The widespread use of other assays (e.g., molecular tests of carbapenemase genes, mass spectrometry detection of carbapenem hydrolysis) is impeded by the expertise required to perform them and their cost.

Scientists affiliated with the Massachusetts General Hospital (Boston, MA, USA; www.mgh. harvard.edu) demonstrate that by using fluorescence identification of β-lactamase activity (FIBA), carbapenemase production in bacteria can be detected sensitively and specifically in 10 minutes, with only one step. FIBA uses a dark fluorescence probe, β-LEAF (β-lactamase enzyme–

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activated fluorophore), which turns fluorescent when cleaved by β-lactamases, including penicillinases, extended-spectrum β-lactamases (ESBL), AmpC β-lactamases, and carbapenemases.

The team tested FIBA on 76 randomly selected infection isolates. To start the assay, 25 μL of 1 × 1010 CFU/mL bacterial suspension made by colonies grown overnight on BHI agar is added to each well. To monitor the increase rate, fluorescence measurement is then performed at 37 °C at 10-second intervals for 10 minutes with Ex/Em 450/510 nm in the Spectramax M5 plate reader (Molecular Devices, San Jose, CA, USA; www.moleculardevices. com).

Genetic test results for β-lactam resistance were provided with the isolates. Among these, 55 were carbapenemase positive, carrying the major epidemic carbapenemase types including

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Klebsiella pneumoniae carbapenemase, imipenem-hydrolyzing β-lactamase, metallo-β-lactamase, New Delhi metallo-β-lactamase, oxacillinase, Serratia marcescens enzyme, São Paulo metallo-β-lactamase, Verona integron-encoded metallo-β-lactamase, and New Delhi metallo-βlactamase oxacillinase. The other 21 isolates expressed noncarbapenemase β-lactamases.

The authors concluded that FIBA can be performed ≈10 times faster than the most rapid carbapenemase test commercially available while maintaining comparable sensitivity and specificity. Its automated analysis improves turnaround time and reduces operator variability. With a reagent cost/assay of approximately USD 1.00, FIBA is close in price to phenotypic tests but substantially faster and less labor intensive. The study was published in the April, 2020 issue of the journal Emerging Infectious Diseases.

Analyzer Platform for Simultaneous Detection of Multiple Sexually Transmitted Infections

he British health diagnostic company Randox Laboratories (Crumlin, United Kingdom; www.randox.com) announced receipt of CE-marking for its Biochipbased assay, which tests for 10 sexually transmitted infections (STIs) simultaneously.

The Randox patented “BAT” biochip is an innovative multiplexing technology, which is utilized within the cartridge aspect of an autoanalyzer platform. The Biochip allows for the simultaneous detection of multiple analytes from a single sample. Specifically, the Randox STI BAT assay was designed for use with the Vivalytic system, an intuitive point-of-care PCR platform, developed in partnership with the German technology company Bosch (Waiblingen, Germany; www.bosch-vivalytic.com).

Working in concert, from one patient sample, the assay system tests simultaneously for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), Mycoplasma genitalium (MG), Treponema pallidum (syphilis) (TP), Herpes simplex virus 1 (HSV-1), Herpes simplex virus 2 (HSV-2), Haemophilus ducreyl (HD), Mycoplasma hominis (MH), and Ureaplasma urealyticum (UU).

Dr. Peter FitzGerald, managing director of Randox Laboratories, said, “Antibiotic stewardship is a critical issue which we all have a responsibility to embrace and drive forward.

The CE marking of the STI assay, which incorporates Randox Biochip Technology, will be a game-changer for clinicians and patients

across Europe, by facilitating early, accurate and comprehensive diagnoses of STIs that allows for the best possible patient outcome.

Never before has there been this level of accessibility and speed with regards to STI testing.”

Marc Meier, managing director of Bosch Healthcare Solutions, a subsidiary of Bosch Group, said, “We are enthusiastic about partnering with Randox to offer their assay technology on the Vivalytic platform. The core competencies of Bosch in automation, miniaturization, sensor technology and connectivity are complemented by Randox’s expertise in developing excellent biocontent for a wide range of assays and commercializing innovative diagnostic solutions.”

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track through a mobile device without the need for saliva or blood samples. Hoth Therapeutics, Inc. (New York, NY, USA; www.hoththera peutics.com) has licensed the intellectual property rights relating to the development of the medical device from the George Washington University (GW). The device is based on nanotechnology Nanoholes using Plasmonics principles.

Qiagen to Focus on Comprehensive COVID-19 Testing Solutions

Qiagen NV (Venlo, Netherlands; www.qiagen.com) is focusing on building the most comprehensive portfolio of solutions for COVID-19 testing.

These include ramping up production of viral RNA extraction for use on Qiagen’s QIAcube, QIAsymphony and EZ1 platforms as well as third-party instruments; building up a range of PCR tests on the QIAstat-Dx and NeuMoDx systems that enable COVID-19 detection while analyzing samples at the same time for other respiratory infections; and delivering universal next-generation sequencing (NGS) solutions for use with any sequencer, in particular gene panels integrated with bioinformatics for analysis of the SARS-CoV-2 virus.

Korea’s Celltrion Launches Antigen and Antibody Testing Kits in US

Celltrion Group (Incheon, Korea; www.celltrion.com) has launched two rapid COVID-19 testing kits, SAMPINUTE COVID-19 Antigen MIA for detection of SARS-CoV-2 antigen, and DiaTrust COVID-19 IgG/IgM Rapid Test for detection of SARS-CoV-2 IgG/IgM antibody in the US. SAMPINUTE COVID-19 Antigen MIA is an electrochemical immunoassay test for detection of SARS-CoV-2 antigen from nasopharyngeal swab samples, composed of one time use test cartridges and a portable analyzer. DiaTrust COVID-19 IgG/IgM Rapid Test is a one-step in-vitro diagnostic test based on immunochromatographic assay designed for the rapid detection of antibodies of the novel coronavirus in healthcare settings. Both the rapid tests kits have shown a reliable performance and promising clinical trial results.

COVID-19 Diagnostics Update tient contact with highly infectious diseases, such as COVID-19, at the point of testing and making it ideal for large scale testing. The Nasal Swab Robot from Brain Navi Biotechnology Co., Ltd. (Taiwan; www.brainnavi.com) is intended to be used for collecting samples of secretions from the uppermost part of the throat, and behind the nose in suspected cases of whooping cough, diphtheria, influenza, and various types of diseases caused by the coronavirus family of viruses, including SARS, MERS, and COVID-19.

Biomeme SARS-CoV-2 Real-Time RT-PCR Test Granted FDA EUA Biomeme, Inc. (Philadelphia, PA, USA; www.biomeme.com) has been granted Emergency Use Authorization by the US Food and Drug Administration (FDA) for its SARS-CoV-2 Real-Time RT-PCR Test. The test detects the RNA of severe acute respiratory syndrome coronavirus 2 that causes coronavirus disease 2019 (COVID-19). Two RNA targets for the novel coronavirus are multiplexed together with Biomeme's process control assay for RNA extraction and RT-PCR (MS2). The assay targets include SARS-CoV-2-Orf1ab gene, SARS-CoV-2-S gene, and RNA Process Control (RNA extraction and RT-PCR control utilizing MS2 bacteriophage).

LumiraDx's SARS-CoV-2 RNA STAR Assay Secures FDA EUA

LumiraDx (London, UK; www.lumiradx.com) has secured Emergency Use Authorization from the US Food and Drug Administration (FDA) for its SARS-CoV-2 RNA STAR assay. The molecular test kit uses a non-isothermal nucleic acid amplification qSTAR (Selective Temperature Amplification Reaction) method for the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens (such as nasal, midturbinate, nasopharyngeal and oropharyngeal swabs) and bronchoalveolar lavage specimens collected from individuals suspected of COVID-19 by their healthcare provider.

New Nasal Swab Robot to Help Expand Testing for SARS-CoV-2

A new robot can perform nasal swab tests by autonomously navigating and collecting the patient’s samples, thus helping to reduce staff-pa-

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PRODUCT NEWS

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VIRCELL

SAMPLE TRANSPORT

GREINER BIO-ONE

NUCLEOTIDE ISOTHERMAL AMPLIFICATION ANALYZER SINGUWAY BIOTECH

The COVID-19 ELISA is an indirect immunoenzyme assay to test antibodies against SARS-COV-2 in human serum/plasma, available as a complete solution in the form of IgG and IgM+IgA kits, significantly improving sensitivity.

The VACUETTE Transport Line products allow for the secure transport of Biological Substances (UN 3373) Category B - from collection of the specimen right up to analysis in the laboratory.

The Singu2000 is a unique patent technology RSA (recombinant sensitize amplification), which is a brand new nucleotide isothermal amplification analyzer that can provide a wide variety of tests.

COVID-19 ELISA TEST

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in various biological processes, such as signaling, transport, growth, repair, and defense mechanisms, which are often dysregulated in disease states. Analyses of plasma proteins prove valuable for developing disease biomarkers with potential clinical utility, because plasma and other components of blood remain the predominant specimens for routine analysis.

Hematoimmunologists at the University of the Ryukyus (Nishihara, Japan; www.u-ryukyu.ac.jp) and their colleagues analyzed blood plasma profiles of asymptomatic HTLV-1 carriers (ACs); untreated ATL patients, including acute, lymphoma, smoldering, and chronic types; and ATL patients in remission.

The expression levels of 1,305

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sTNFR2 a Biomarker for Acute ATL

proteins from 85 cryopreserved plasma samples were determined using the SOMAscan assay (SomaLogic, Inc, Boulder, CO, USA; https://somalogic.com). This assay utilizes new-generation protein capture slow off-rate modified aptamer (SOMAmer) reagents, which are modified nucleotides with amino acid– or protein-like side chains that have affinities for proteins and, at the same time, are recognizable by DNA hybridization probes and measurable by fluorescence.

Plasma protein concentration levels of selected candidate biomarkers were determined suing the following enzyme-linked immunosorbent assay (ELISA) kits were sourced: sTNFα, sTNFR1, and sTNFR2 (R&D Systems, Minneapolis, MN, USA; www.rndsy stems.com) and sTNFRSF8 (Ray-

Miniaturized PCR Enables Portable COVID-19 Testing with Palm-Sized Device

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the kit, which features LED lights that indicate the test is running and alerts when it is completed.

Visby Medical (San Jose, CA, USA; http://www.visbymedical.com), developer of the kit, has been working for the past seven years on shrinking the traditional PCR analyzer, which is the size of a large microwave device, into a portable size that would fit in a palm. “With our device you get the results you need while you’re still face-to-face with the patient, helping you make better and more timely decisions,” said Dr. Gary Schoolnik, chief medical officer of Visby Medical.

“Visby’s PCR technology is so sensitive that it will pick up a signal that is likely to otherwise be missed,” said Dr. Shlomo Melmed, dean of the medical faculty and professor of medicine at Cedars-Sinai Medical Center. “They have miniaturized the PCR process, validating it in the most rigorous fashion that satisfies both the compliance agencies as well as practicing physicians. This is a very important patient-friendly advance which will lead to a new class of point-of-care diagnostics.”

Biotech, Peachtree Corners, GA, USA; www.raybiotech.com). The team proceeded with flow cytometry to determine if elevations in plasma levels of sTNFR2 were correlated with ATL cell surface expression of TNFR2. They performed flow cytometry with the BD FACSCalibur cell analyzer (BD Biosciences, San Jose, CA, USA; www.bdbiosciences.com). The team also carried out immunostaining and TNFR2 messenger RNA (mRNA) expression determination.

The scientists reported that quantification of sTNFR2 in 102 plasma samples (AC, n = 30; ATL, n = 68; remission, n = 4) using enzyme-linked immunosorbent assay showed remarkable elevations in acute ATL, at least 10 times those of AC samples, and return of sTNFR2 to AC state levels after achieving remission. Flow cytometry and immunostaining validated the expression of TNFR2 in ATL cells. No correlation between sIL-2 and sTNFR2 levels in acute ATL was found, suggesting the possibility of sTN-

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FR2 as an independent biomarker.

The authors concluded that they had demonstrated a novel approach in searching for ATL biomarkers through the use of a SOMAmer-based high-throughput proteomic assay, followed by an extensive proteomic pathway analysis and confirmed using standard laboratory techniques such as ELISA, flow cytometry, and immunostaining. This approach led them to the discovery of candidate biomarkers belonging to the TNF receptor superfamily, namely sTNFR1, sTNFR2, and sTNFRSF8. Among them, sTNFR2 was deemed to be the most prominent in comparing AC versus ATL. The study was published on March 20, 2020 in the journal Blood Advances.

Image: The BD FACSCalibur fluorescent activated cell sorter platform allows users to perform both cell analysis and cell sorting in a single benchtop system (Photo courtesy of BD Biosciences).

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PRODUCT NEWS

NUCLEIC ACID DETECTION KIT FOR COVID-19 SINGUWAY BIOTECH

This kit uses real-time PCR fluorescence technology to detect the nucleic acid of patients with convection like symptoms, patients with severe pneumonia and patients with COVID-19.

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MOLECULAR TRANSPORT MEDIUM

LIQUID HANDLING SYSTEM

EKF DIAGNOSTICS

ANALYTIK JENA

The PrimeStore® MTM (Molecular Transport Medium) is a molecular transport media for infectious diseases that gives the user a “snapshot” in time for that sample by preserving and stabilizing DNA and RNA.

The CyBio FeliX is a fully automatic liquid handling system with interchangeable heads and adapters that save costs by miniaturizing samples and reagents. It features a space-saving and compact design for every laboratory.

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Islet Autoantibody Screening Reveal Pediatric Type 1 Diabetes Risk

ype 1 diabetes (T1D) is a chronic progressive autoimmune disorder with complex polygenic susceptibility, usually associated with certain HLA alleles (IDDM1 locus). Progression to T1D is typically marked by the presence of islet-specific autoantibodies in the serum. In humans, autoantibodies are present months to years before disease onset.

Public health screening for T1D in its presymptomatic stages may reduce disease severity and burden on a population level. Pre-symptomatic T1D increases the risk for developing clinical T1D in children aged two to five years, but can be identified via islet autoantibody screening. The rate of T1D development varies among individuals, possibly due to non-HLA genetic factors and/or environmental factors beyond the initial trigger.

A team of scientists specializing in diabetes and led by the Helmholtz Zentrum München (Munich-Neuherberg, Germany; www.helmholtz-muenchen.de) conducted islet autoantibody screening using the blood samples from 90,632 children aged 1.75 to 5.99 years residing in Bavaria, Germany (median age, 3.1 years; 48.5% girls). Participants

O

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with at least two islet autoantibodies were diagnosed with pre-symptomatic T1D. The team established three stages of pre-symptomatic T1D, culminating in clinical T1D (stage 3).

The investigators identified presymptomatic T1D in 280 participants. Stage 1 occurred in 196 participants, stage 2 in 17 participants and stage 3 in 26 participants. During follow-up, those with pre-symptomatic T1D had a 24.9% cumulative risk and 9% annualized risk for reaching stage 3 T1D. There was a 28.7% cumulative risk and a 10.6% annualized risk for stage 2 and/or stage 3 T1D for those with stage 1 pre-symptomatic T1D at baseline. There were two cases of diabetic ketoacidosis in the cohort with pre-symptomatic T1D, according to the scientists, who noted that four children who did not have pre-symptomatic T1D at baseline went on to have clinical T1D. Anette-Gabriele Ziegler, MD, a Professor and lead author of the study, said, “This sort of screening would reduce the number of acute and dangerous cases of type 1 diabetes that we

would see. Care would start at a much earlier stage when the child is still feeling well. It gives time to learn about the disease, adjust to the likelihood of clinical disease whenever it occurs.” The study was published on January 28, 2020 in the journal JAMA. Image: The composition of patients' microbiomes can predict their clinical outcomes when undergoing stem cell transplants (Photo courtesy of European Leukemia Net).

New Chemistry Analyzer Completes Ortho’s Range of VITROS XT Solutions

rtho Clinical Diagnostics (Raritan, NJ, USA; www.orthoclinicaldiagnostics. com) has announced the launch and availability of the VITROS XT 3400 Chemistry System, which completes the company’s catalogue of VITROS XT Solutions.

The new CE-marked VITROS XT 3400 Chemistry System, like the VITROS XT 7600 Integrated System, simultaneously performs two tests frequently ordered together on one VITROS XT MicroSlide, a multi-layered, postage-stamp sized slide which filters out lipids and proteins that can impinge the quality of re-

sults, and offers an up-to-40% higher throughput than current slides.

Double assay processing offers a 25% faster turnaround time on a common panel of assays, with an average processing time of 7.5 minutes compared to about 10 minutes for other industry options. Furthermore, the XT MicroSlide allows for the lowest sample volume at 2.7 microliters.

Reduction in external factors that could effect results ensures the accuracy of tests performed on VITROS XT Solutions. Thus, Ortho’s proprietary “dry” chemistry technology does

not require water, which eliminates the risk that poor water quality could impact results. In addition, single-use tips and cuvettes eliminate the risk for both sample and reagent carryover.

“Because Every Test is a Life, we make patient care our passion at Ortho Clinical Diagnostics,” said Chris Smith, CEO of Ortho Clinical Diagnostics. “Driven by this, we work diligently to ensure the world’s labs are best equipped to partner with clinicians and medical teams to provide consistently fast, accurate results that help them confidently diagnose, monitor and treat their patients.”

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Industry News

Global COVID-19 Diagnostics and Therapy Market Projected at USD 14 Billion in 2025 To view this issue in interactive digital magazine format visit www.LinkXpress.com

cont’d from cover

are racing to find a solution to the pandemic. Hospitals, medical and drug researchers, and healthcare continue to focus on increasing the production of diagnosis kits and experimenting with different therapies for a possible solution to the pandemic. Based on healthcare options, the COVID-19 impact assessment is segmented into diagnostics and treatments areas. The diagnostics segment is further divided into PCR-based testing and antibody testing. The treatment area is segmented into vaccines, immunotherapies, anti-virals, cell-based therapies, and other therapies.

To deal with the pandemic, governments across the globe have been supporting health and life sciences industries in rapid treatment development. Many governments have set up committees that aid in rapid review of therapies being investigated by medical researchers and firms.

Q

Qiagen to Focus on Molecular Diagnostics Expansion After Takeover Offer by Thermo Fisher Falls Short

iagen NV (Venlo, Netherlands; www.qiagen.com) plans to continue executing its growth strategy aimed at creating significant value for shareholders and other stakeholders after the voluntary public takeover offer by Thermo Fisher Scientific Inc. (Waltham, MA, USA; www.thermofisher.com) failed to achieve the minimum 66.67% acceptance threshold from QIAGEN shareholders.

A total of 47% of the outstanding Qiagen shares were tendered into the offer of EUR 43 per share at the expiry of the Acceptance Period on August 10, 2020. The amended business combination agreement has been terminated due to the acceptance threshold not having been met.

In line with its long-term growth strategy, Qiagen intends to continue implementing initiatives to accelerate the growth of its Sample to Insight portfolio, delivering efficiency and effectiveness, increasing the value of Qiagen as an employer of choice and enhancing customer experience.

Qiagen’s initiatives focus on building the most comprehensive portfolio of solutions for COVID-19 testing. These include ramping up production of viral RNA extraction for use on Qiagen’s QIAcube, QIAsymphony and EZ1 platforms as well as third-party instruments; building up a range of PCR tests on the QIAstat-Dx and NeuMoDx systems that enable COVID-19 detection while analyzing samples at the same time for other respiratory infections; and delivering universal next-generation sequencing (NGS) solutions for use with any sequencer, in particular gene panels integrated with bioinformatics for analysis of the SARS-CoV-2 virus. Qiagen is also scaling up production capacity for reagents sold to other companies for use in their own COVID-19 tests. New Qiagen products in accelerated development include a serology test (assessing the body’s immune response to the coronavirus via antibodies) and a rapid antigen test (detection of an active coronavirus infection), planned for launch in the second half of 2020.

Additionally, Qiagen plans to build on its market and technology leadership in sample technologies, a wide range of solutions to extract nucleic acids from biological samples. Qiagen continues to roll out innovative sample technologies for liquid biopsies, sample and library preparation for NGS and metagenomics applications. Development initiatives include new products in response to the coronavirus pandemic, as well as innovations for customers in areas such as research, clinical healthcare and forensics that include new applications based on 96-well plates.

Qiagen is also implementing a strategy to accelerate the adoption of QuantiFERON-TB in the fight against the tuberculosis (TB) pandemic disease. Qiagen’s highly flexible laboratory automation solutions for QuantiFERON-TB Gold Plus – anchored by partnerships with DiaSorin, Hamilton and Tecan – are supporting the conversion from tuberculin skin tests to modern blood-based technology. Additionally, Qiagen is advancing plans for the launch of QuantiFERON-TB Access (QFT Access), a new version of the gold-standard TB detection test dedicated and tailored to the needs of low-resource settings with a high disease burden of TB. Moreover, Qiagen intends to move forward with the acquisition of

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For instance, FDA announced an accelerated Emergency Use Authorization (EUA) pathway for accelerating emergency use of therapies which could be possible treatment for COVID-19. Several pharmaceutical, biopharmaceutical and biotechnology firms have been granted EUA approval which support further clinical studies on the therapy / candidate being investigated.

The leading areas of research include antibodies, protein-based vaccines, antiviral, drug repurposes, RNA-based vaccines, non-replicating viral vectors, and cell-based therapies. While more than 50% of the therapies being developed are in the preclinical stage, government initiatives, such as EUA by the FDA, is expected to accelerate the research and development (R&D) process. The US, Canada, the UK, Germany, China, and India are some of the key nations that are leading the research and production efforts geared towards developing COVID-19 medication.

LabMedica International August-September/2020

the remaining 80.1% stake in NeuMoDx Molecular, Inc. that it currently does not own. Qiagen expects NeuMoDx to provide significant sales contributions in the future based on its differentiation as a rapid, integrated PCR-based platform that offers a dedicated COVID-19 test as well as an expanding menu of tests for other infectious diseases, such as a new multiplex test combining analysis for influenza, RSV (respiratory syncytial virus) and the SARS-CoV-2 virus, expected to be launched in the second half of 2020.

“We respect the decision of our shareholders and will now continue to execute our strategy to deliver growth and create greater value with our Sample to Insight portfolio that addresses growing molecular testing needs in the life sciences and molecular diagnostics,” said Dr. Håkan, Björklund, Chairman of the Supervisory Board of Qiagen.

“The magnitude and duration of the global coronavirus pandemic have proven the increasingly critical importance of molecular testing to society. Qiagen’s business prospects have improved significantly, as shown in our performance for the first half of 2020 and the strong outlook for the rest of this year and for 2021,” said Thierry Bernard, Chief Executive Officer of Qiagen. “In light of the outcome, we will also move forward with our plans to fully acquire NeuMoDx, Inc., which is growing fast thanks to its unique offering of molecular diagnostic testing platforms along with a solution for coronavirus testing and an expanding range of assays in Europe, the US and rest of the world. Our employees have demonstrated resilience and deep expertise in meeting the challenges of the pandemic, and will continue to play an essential role in building Qiagen as a unique and differentiated leader in molecular testing through a commitment to execution on our goals.”

“Qiagen is moving forward from a position of strength with robust growth prospects, anchored by a differentiated portfolio and multiple new product launches in the pipeline. As we focus on greater value creation, Qiagen builds on a disciplined capital allocation policy anchored by a healthy balance sheet to support investments into our business along with a commitment to increasing returns to shareholders,” added Roland Sackers, Chief Financial Officer of Qiagen.

PRODUCT NEWS

BLOOD GAS ANALYZER

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HEMATOLOGY ANALYZER

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The ABL90 FLEX blood gas analyzer can deliver 17 parameters from a sample as small as 65µL in35 seconds and ensures standardized mixing of blood samples in only 7 seconds using safePICO syringes and a built-in sample mixer.

The BC-2800 is a compact, fully automatic hematology analyzer with 19 parameters for CBC test and micro sampling technology, featuring a user-friendly interface that facilitates an easy and efficient workflow.

The Atellica IM 1600 immunoassay analyzer can run up to 440 tests per hour using the proven acridinium ester (AE) technology. It offers 42 primary assay positions and 35 ancillary reagent positions.

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Two Chikungunya Virus IgM Enzyme-Linked Immunoassays Evaluated

С

hikungunya virus (CHIKV) is an alphavirus transmitted by Aedes (Stegomyia) spp. mosquitoes. Transmission was initially restricted to small outbreaks and sporadic cases in Africa and Asia, but since early 2000s the virus has caused large outbreaks in India and Southeast Asia.

Acute clinical manifestations associated with CHIKV infections are non-specific, usually including fever, rash, and arthralgia, the latter being the most prominent symptom that may last for months or years, causing chronic disabilities. In areas where other arboviruses with similar clinical manifestations co-circulate laboratory diagnostic tools that distinguish CHIKV infections from them are urgently needed.

Scientists from the Fundação Oswaldo Cruz (Salvador, Brazil; https: //portal.fiocruz.br) enrolled 372 patients attending a public emergency health unit in an acute febrile illness (AFI) enhanced surveillance study and blood samples were drawn for arboviral diagnosis. All acute-phase sera, which had not been previously thawed, were submitted to RNA extraction and tested by reverse-transcription polymerase chain reaction (RTPCR) for Dengue (DENV), Zika (ZIKV), and CHIKV. The team tested the acute- and paired convalescent-phase sera available from all the CHIKV, DENV, and ZIKV RT-PCR-positive patients enrolled during surveillance with both the CHIKjj Detect IgM-capture ELISA kit (Inbios International, Inc., Seattle, WA, USA; www.inbios.com) and the Anti-Chikungunya virus ELISA (IgM) Test (Euroimmun, Luebeck, Germany; www.euroimmun.com). They also applied the Inbios and the Euroimmun CHIKV IgM ELISA tests to the acute- and paired convalescent-phase sera from 175 patients randomly selected from those with negative RT-PCR results (for all three arboviruses) and with paired sera available. The ELISA reading was performed by automated microplate reader at 450 nm (TECAN, Männedorf, Switzerland; www.tecan.com).

The scientists reported that the Inbios and Euroimmun tests’ sensitivities for acute samples were 4.0% and 10.3%, while for convalescent samples they were 92.4% and 96.9%, respectively. Overall, Inbios IgM ELISA specificities for acute and convalescent samples were 97.7% and 90.5%, respectively, and Euroimmun specificities were 88.5% and 83.9%, respectively.

The authors concluded that both tests presented high sensitivity for convalescent samples. However, the Euroimmun test returned more equivocal results and presented a slightly lower specificity, which might result in a higher rate of false positives if the test is used in scenarios of low CHIKV transmission, when the chance of CHIKV infection is lower.

The study was published in the February, 2020 issue of International Journal of Infectious Diseases.

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

M

NEWS

MESSAGE FROM THE PRESIDENT By khosrow Adeli

â&#x20AC;˘

President, IFCC

IFCC webinars will be starting in September and will continue throughout the y sincere greetings to you all during fall and over the coming years. The first live webinar on September 23, 2020 these challenging times around the will be focused on New IFCC Guidelines on Molecular, and Serological Testworld. I hope everyone has had an ening of SARS-Cov-2 as well as Biochemical and Hematological Monitoring of joyable summer and has had a great COVID-19 patients. Each of these live webinars will be presented by a panel time with family and friends. I am of 2-3 speakers and will include a discussion session. I invite you all to parpleased to inform you that the new IFCC ticipate in these live webinars which will be broadcast around the world, inistrategic plans (discussed in June and tially live and then recorded and rebroadcast again at different time zones.

July issues of the eNews) have now I look forward to interacting with many of you over the coming months been formally approved by the IFCC Exboth virtually but hopefully soon in person once the COVID-19 crisis is behind ecutive Board. I have also received a lot us. Feel free to email me at: president@ifcc.org with your feedback, quesof excellent feedback from the memberProf. Khosrow Adeli, PhD, tions, or concerns. ship which have helped improve some of FCACB, DABCC, FAACC Till next time â&#x2DC;ş our initial proposals. We are now in a position to initiate the first steps in executKhosrow ing these plans over the coming months and years.

New Calls for Nominations will be issued in September to invite scientific and industry leaders and experts from around the world to serve on these new taskforces: a) IFCC Taskforce on Global Newborn Screening: To provide scientific oversight of a new IFCC program to advocate and initiate newborn screening programs in developing countries in collaboration with WHO, Gates Foundation, and industry partners. Lack of newborn screening programs in many member societies/developing countries is leading to major health consequences and a burden on healthcare delivery and costs. Development of new programs in developing countries will significantly enhance child health and reduce infant mortality. b) IFCC Taskforce on Global Lab Quality: To provide scientific oversight of the new IFCC program on global lab quality which includes: I) an IFCC External Quality Assurance Program in developing countries, II) an IFCC Internal Quality Assurance on-site training program in developing countries and III) Global Reference Interval Consortium: An IFCC global database of adult and pediatric reference intervals as a key resource for laboratories around the world. c) IFCC Taskforce on Global eLearning/eAcademy: To develop and execute a new strategy to develop and deliver webinars via a new platform (WorkCast) with LIVE global webinars (monthly) starting in September 2020; biweekly live webinars in 2021 and future years; as well as recorded webinars for the eAcademy.

Distance learning/eLearning is a major mandate of the IFCC organization to provide both live and recorded webinars given by experts around the world. This is an important way by which IFCC can give back to the naCLICK TO: www.ifcc.org tional societies around the world and their members especially young scientists and trainees.

As a pilot, the first series of LIVE

NOW AVAILABLE ONLINE

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LabMedica International August-September/2020

NEWS I

IN MEMORIAM

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

Editorial

By Katherina Psarra, MSc, PhD

Dear Colleagues, t is one of the most difficult times of the year. We are back from the holidays, summer is leaving us, the cities seem full of COVID related problems, and it is not all that funny these days. I hope you are managing to find pleasure in our really contributing to better health job even in these strange times.

In this issue our president Prof. Khosrow Adeli is discussing with all of you the IFCC strategic plans, new taskforces are announced, the first series of LIVE IFCC webinars will be starting in September.

Most of you have met late Prof Donald S. Young who

passed away recently. The entire IFCC community mourns his passing. His life is a perfect example of somebody dedicated to our job but at the same time to LIFE itself. He will be missed as Prof Peter Wilding writes in his excellent article.

Take notice and respond, please, to the call for manuscript submission for a thematic eJIFCC issue on “Measurably better Healthcare”. If you wish to understand better the meaning of this title, go through the conversation with this issue editors, Dr Ellie Dow and Dr Tim James, about leading healthcare excellence.

“A dose of AI in developing vaccines at pandemic speed “. What a title! Dr Bernard Gouget is offering a lot of interesting information on the AI use in vaccines development.

Keep healthy dear colleagues! And do try to entertain yourselves!

Never Forgotten – In Memory of Prof. Donald S. young

T

By Peter wilding Prof. Emeritus, University of Pennsylvania School of Medicine; Chair, Education and Management Division (1998-99); IFCC Historian (2013-15)

he entire community of IFCC mourns the passing of Prof.

Donald Young who served as the 7th President of IFCC from 1985 – 1990. IFCC has been blessed with the service of sixteen presidents and I have been fortunate to know nearly all of them including Prof. Earl J. King, the first president who served from 1952-1960. However, of all the presidents Donald was the only one that I worked with closely for 17 years and knew for over 50 years.

Dr. Young was born in Belfast, Northern Ireland, and completed his Bachelor of Medicine at the University of Aberdeen in Scotland in 1957. In 1962 he was granted a PhD in Chemical Pathology from the University of London. Donald’s service to clinical chemistry and IFCC is testament to his devotion to our profession and explains the wide spread of involvement that he played in so many spheres of the discipline. His baptism in clinical chemistry started early due to his father’s role as a professor of pathology at the universities of Edinburgh and Aberdeen in Scotland, but which was expanded into full blown artistry by his training with Prof. Earl J. King at the Royal Post Graduate Medical School, Hammersmith in London from 1951-1965. It was during this latter period that I first met Donald, as he actively participated in meetings of the Association of Clinical Biochemists (UK). His early promise was recognized in 1965 by the National Institute of Health in Bethesda, MD, USA and resulted in his recruitment and subsequent promotion to Chief of the Clinical Chemistry Service at NIH where he worked until 1977. By this time his flair for committee activities related to clinical chemistry and publications were evident. Most notable were his interests and involvement in editorial functions for AACC, an activity which engaged him for over 20 years. For many close colleagues of Donald, one of the most distinguishing talents he displayed was his genuine enjoyment in ‘proof reading’ and editing.

From 1977 to 1984, Donald served as Head of the Section of Clinical Chemistry in the Department of Laboratory Medicine at the Mayo Clinic, Rochester, Minnesota. It was during this period that his role in AACC grew and which resulted in his election as

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President of AACC in 1980.

However in 1984 Donald made his final move to become Chairman of the Division of Laboratory Medicine at the University of Pennsylvania School of medicine, a role he would hold until his retirement and appointment as a Professor Emeritus in 2009.

Throughout this exceptional career, Donald’s continuously involved himself in multiple roles in IFCC, AACC, the World health Organization and others, while at the same time spearheading the developments in automation, clinical laboratory data handling and point-of-care testing at the University of Pennsylvania. One outstanding facet of the activities was his profound interest in the ‘effect of drugs on clinical laboratory tests’, which resulted in the publication of numerous volumes that document these phenomena. The book series on this topic were translated into several languages and were employed as key reference points for clinical chemists around the world Donald’s reputation world-wide was most impressive as he knew almost every clinical chemist of note in the world, and he had visited scores of countries as a lecturer and teacher. I observed Donald at international meetings on many continents, where his stature as a leader in the profession was always obvious. His quiet disposition, his avoidance of conflict and his willingness to discuss issues were qualities he demonstrated during his tenure at the University of Pennsylvania and around the world. These accomplishments resulted in numerous prestigious national and international awards.

For the hundreds, or thousands, of colleagues and friends that Donald made during his visits to numerous countries, he was a sympathetic listener, a wise counselor and a mentor to innumerable young clinical chemists. He will be missed.

IFCC Annual Report 2019 Now Available Online

he IFCC Annual Report 2019, compiled by Dr. David Kinniburgh, IFCC Secretary, is now available online at the IFCC Website, www.ifcc.org.

In the IFCC Annual Report you will find reports from IFCC Officers on key projects covering a wide range of clinical, scientific, educational, and communication-related topics.

National or Area Societies and Regional Federation reports are also

included, allowing the opportunity to communicate their activities to other members.

Download your copy of the 160-page fact-filled publication and read how the IFCC mission "Advancing excellence in laboratory medicine for better healthcare worldwide" has been the guiding principle for our work in 2019.

Link: https://www.ifcc.org/media/478502/ifcc-2019-annual-report.pdf LabMedica International August-September/2020

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

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NEWS

Call for Manuscript Submissions: Thematic eJIFCC Issue on “Measurably Better Healthcare”

Guest Editors for the Special Issue: Ellie Dow and Tim James he clinical laboratory has always played an essential role in high qual- they become “patients”? ity healthcare. Appreciating the link between clinical data and medical • What biomarker-guided processes have enabled new strategic decision making has been widely communicated for decades. Less fre- approaches to diagnostic optimization, disease management, theraquently recognized, however, is the power of the clinical laboratory to peutic intervention, care optimization or improved population health?

Submit a paper on “Measurably Better Healthcare” to be published drive measurable benefits for patients, payers and entire health systems. in this thematic issue of the eJIFCC that is a PubMed listed, platinum Best practices of measurably better healthcare exist across the globe, open access journal with a CiteScore of 0.8 and tend to involve coordinated, cross-disciplinary, and evidence-based Important deadlines and Next Steps collaborations for the implementation and activation of new clinical care • Deadline for all submissions (original articles, critical reviews and pathways. case studies): November 15, 2020 • Have you partnered with clinical colleagues to achieved measura• Manuscripts to be submitted by e-mail to ejifcc@ifcc.org with a bly improved outcomes? copy to ejifccspecialissue@gmail.com • What key performance indicators (KPIs) were improved and how?

Guest Editors: • Who received the benefit and how was it measured?

• Ellie Dow, LRCP, MRCS, Ph.D., FRCPath, Consultant in Biochemical Medicine, This is your chance to publish your best practice Blood Sciences, NHS Tayside, Dundee, Scotland • How did laboratory data improve patient outcomes?

• Tim James, Ph.D., Head Biomedical Scientist, Clinical Biochemistry Depart• What clinical algorithms helped identify at-risk individuals before

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Leading Healthcare Excellence: A Conversation with Dr. Ellie Dow and Dr. Tim James

ment, John Radcliffe Hospital, Oxford, England.

wo experts with globally recognized best practices for Measurably Better Healthcare are Dr. Ellie Dow, Consultant in Biomedical Medicine, Blood Sciences at Ninewells Hospital and Medical School Tayside (Dundee, Scotland) and Dr. Tim James, head biomedical scientist in the Clinical Biochemistry Department at the John Radcliffe Hospital (Oxford, England). Among many commonalities, both leaders earned UNIVANTS of Healthcare Excellence Awards last year and more recently, joined as guest editors for a special issue for eJIFCC. How important is the clinical laboratory in healthcare today? Tim: There is no better evidence of the importance of laboratories in healthcare today than our integral role in responding to the COVID-19 pandemic. Initial diagnosis, management of patients through the escalation of treatment, and population assessments are all dependent upon clinical laboratories. Equally, as we emerge from the COVID-19 peak, re-establishing the ‘new’ normal will require re-engagement of laboratory services including re-engineered patient pathways. This is a great opportunity for all of us. what advice do you have for clinical laboratories aiming to be more strategically involved in their health systems?

Ellie: It’s about getting out of the office and out of the lab, making and expanding those cross-discipline connections, and building networks. In addition, in-person contact cannot be under-estimated for establishing rapport and trust. If in-person meetings are not possible or restricted during the pandemic, face to face contact over video calls is still more ideal than emails. what is the first step to getting started?

Tim: Be realistic. Do not take on too much too soon and don’t be disappointed if it doesn’t always work…but rather learn from all you do through reflection.

Ellie: Be approachable and have a “can-do” attitude. Speaking at local grand rounds is also excellent for expanding networks and participating (or even driving) new team discussion. what types of manuscripts would you like to see submitted to the eJIFCC special issue?

Ellie: Manuscripts that show the strength of clinical and laboratory teams working together to improve healthcare with measurable KPIs appropriate to the project and setting. Demonstrably better healthcare together!

If interested in learning more about the special issue or submitting a manuscript on Measurably Better Healthcare, please email ejifccspecialis sue@gmail.com.

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LabMedica International August-September/2020

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VIEwPOINT

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

A Dose of AI in Developing Vaccines at Pandemic Speed

by Dr. Bernard Gouget

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

t has become the quest for a new Grail. Faced with the extent of the pandemic and at risk for a second wave of COVID-19, the search for a coronavirus vaccine is billed as a major objective for responsible politicians and researchers around the world. While coronavirus continues to spread, concern is rising due to the increase in positive cases. Mandatory mask wearing is imposed more frequently, and lab tests may be required at borders. Lifting restrictions has led to the virus spreading more easily in all the countries that experienced the first wave, but it seems that the upsurge is faster than expected. Countries that did not shut down enough have lost control, like Brazil or the US. The most alarming thing is that the infection now affects countries with health systems that are incapable of resisting for a long time, such as South Africa or India. We believed in the miracle of a virus that did not like the sun; that's over. In other bad news, the antibodies that are developed disperse quickly. Protection is temporary. Knowledge of the virus is a "work in progress" and shows us that science is made up of rationality, complexity, and uncertainty. It is necessary to make the best of a bad situation and to think quickly about the consequences of the virus in all forms of organization, on work, consumption, globalization, politics and health in order to make the best of things in the future.

One of the solutions for actively fighting this virus is found in Artificial Intelligence. AI provides very effective means to manage, inform, treat and detect areas where patients are at risk, with a precise map of the epidemic, tracing its geographical and temporal progress, and eventually offering an effective treatment or a vaccine, or to stop the spread outright. According to experts around the world, AI could be able to solve the most complex challenges of our century. It is necessary to be able to rely on analytical techniques that can identify rare but significant events. Several sources of information are thus mixed into analytical data sets (official incidence reports, data from emergency departments, medical records, social media, absenteeism at work or school, drug sales, targeting of the scientific literature, etc.). AI can therefore define the characteristics of a potential new viral epidemic such as coronavirus COVID-19. This technology is establishing itself in a large number of other fields, such as digital or augmented clinical trials, which make it possible to retrieve data collected by connected objects or patients' medical devices and to learn more, for example, about the effect of a vaccine or therapy under study. Thus, AI allows carrying out simulations and understanding biological data as never before, as well as understanding how a drug or vaccine works.

Currently, there is a real competition around vaccines. The demand for vaccine risks being colossal and businesses are seeking to optimize their production. Advanced clinical trials have started all over the world. Faced with the economic damage of the pandemic, the cost of the vaccine becomes almost a secondary point. Large drug companies have launched communication operations, admittedly with an impact on stock prices, but communication does not mean lying and it is necessary to communicate well to obtain financing with intensifying competition. Research, clinical trials, and production are very costly and if it doesn't work, the inventory will have to be destroyed. But keep in mind that the world economy will lose USD 12.5 trillion in 2020 and 2021 according to the IMF. Faced with this, it is urgent to find and distribute a vaccine, regardless of the cost.

IFCC OFFICE

Via Carlo Farini 81, 20159 Milan, ITALY Tel: (39) 02-6680-9912 â&#x20AC;˘ E-mail: ifcc@ifcc.org â&#x20AC;˘ 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.

AI is currently used at every step of development, manufacture, and marketing of vaccines, all in a strictly controlled regulatory context. The activity is tested during and after the manufacture of vaccines using an AI and batch quality is supervised via a plethora of techniques (analysis of images or even shelf life).

AI facilitates the work conducted in the context of clinical trials because it ensures that the antiviral vaccines designed are safe and effective. Moreover, once the vaccine is administered to the population, its potential adverse effects are collected, analyzed, and recorded to verify safety. Some analytical approaches used to detect rare side effects are like epidemiological surveillance.

This crisis is a real challenge for research. All deadlines have been shortened and the diversity of strategies (from inactivated virus to messenger RNA genetic technologies) increases the chance of having several vaccines on arrival. There is a fierce and stimulating technological competition, coupled with a battle that crosses geopolitical borders. By entering into agreements with various pharmaceutical companies, governments seek to secure their supplies as quickly as possible and diversify their risks in the event of failure.

While Latin America is still failing to contain the virus, the Chinese CoronaVac vaccine from Sinovac Biotech has already been tested on 9,000 Brazilians. The Anglo-Swedish group AstraZeneca, which relies on research at Oxford, has already vaccinated more than 10,000 people in the UK, 5000 in Brazil and 2000 in South Africa with a study in progress in India and eventually aiming for a phase 3 program of 360,000 people vaccinated by the fall.

According to P. Soriot, CEO of AstraZeneca, the first results give hope for protection of at least a year. The US biotech company Moderna has launched the last Phase 3 clinical in late July in the US on 30,000 participants. Novavax received USD 1 billion from Washington to develop a vaccine. Johnson & Johnson announced that they are in negotiation with the European Union.

Germany is also well advanced with its US partner and BioNtech and Pfizer (US) have conducted conclusive first trials. GSK (UK), Sanofi (FR), Institut Pasteur and other organizations in China have made progress, for their part.

In Russia, a promising vaccine project is on track. The financial stakes are enormous; billions of USD have been invested in the 140 vaccine projects counted by the WHO in research and production.

The extent of the need has made this an extremely coveted market. It may reach USD 100 billion and generate USD 40 billion in profit according to the predictions of Josh Slimmer, an American analyst. The cards could be further reshuffled depending on the phase 3 results of the main players. The rapid development of a vaccine is a global imperative with a real competition around vaccines to offer them by late 2020 to mid 2021. However, the urgency must not overshadow safety and it is up to national regulatory authorities or agencies responsible for vaccine strategies to validate vaccine candidates.

Then, who should be vaccinated and according to what protocols? To prevent the vaccine race from turning into international fist fight, WHO has once again pleaded against vaccine nationalism, pleading for pooling of tools to allow the planet to fight COVID-19 and ensure equitable distribution. More than 170 countries have already indicated their interest or joined a future scheme for global access to COVID-19, known as COVAX. The WHO recommends first targeting healthcare workers or those with jobs with high exposure risk, or 3% of the global population, then those above age 65 and vulnerable individuals (20%). The question of access will remain. Beyond the logistical and regulatory challenges, North/South inequalities will reappear. International initiatives are already reserving doses for disadvantaged countries.

The challenge is to transform the sprint into a collective long-distance event with clear rules and stated objectives. Some drug companies are guaranteeing sale at cost during the emergency phase, others refuse to do so. This vaccine should be a global public good, but national ego is at work and the world is quickly returning to a place of bidding for profit!

While the course of vaccine development intensifies, the pandemic has reached nearly 809,108 deaths as of August 24 worldwide since late December. A COVID-19 vaccine offers real hope, but willingness to become vaccinated must be built up. Communication will especially be one of the conditions for success of the vaccine campaign. It must be transparent regarding the procedures that allowed marketing to be accelerated without being detrimental to safety and regarding the uncertainties and scientific foundations of the recommendations. Communication should be differentiated according to the target audiences and evoke a form of social contract calling everyone to take responsibility. It can only benefit from a participatory approach, open and transparent, of the citizen forum type, especially involving patient associations.

LabMedica International August-September/2020

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

THE wORLD OF IFCC

NEWS

Uruguay to Hold Virtual Congress in October 2020

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By Q.F. B.C. Laura Yametti; Q.F. Fernando Antúnez; Organizing Committee President, ABU President

he Uruguayan Biochemistry Association (ABU) is organizing it’s 13th Uruguayan Congress of Clinical Biochemistry to be held from the 15th to the 17th of October this year.

Due to the worldwide health emergency, this event will be held virtually. It is both a challenge and an honor for us to organize this event, allowing us to engage with other colleagues from different regions of the world, in order to exchange our opinions and experiences. We considered the possibility of not moving forward with the event, but as health care professionals we understand that this is the most important time to contribute by divulging scientific knowledge.

We propose not only to offer academic activities with first-rate speakers, in the form of conferences, symposia and courses; but also, to provide a virtual space to interact with representatives of the industry and with representatives of entities related to vocational training.

We understand that today more than ever we must stay connected in order to mitigate the impossibility of face-to-face relationships and to allow the dissemination of knowledge.

We created the Virtual Expo, a robust platform that gives exhibitors enhanced opportunities to share information and engage with attendees, we really believe that this space can be very useful for the National Organization to promote their activities and to drive the educa-

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transferring knowledge for the application of molecular diagnosis and for the development of serological tests, among others, which have allowed Uruguay to carry out the necessary studies on its population in a timely manner.

We look forward to seeing you in our first virtual congress, hoping that it will be an innovative and positive experience for all of you and that it will allow us to strengthen our ties as a scientific community.

We greet you cordially. http://congresoabu2020.org

Ethiopian Society Holds 25th Annual Conference

By Gizachew Taddesse AKALU, EB Member of EMLA and AFCC, IFCC National Representative

espite all odds of COVID-19 pandemic, the Ethiopian Medical Laboratory Association (EMLA) convened its 25th annual conference and continuing professional development from 26-28 February 2020. The main theme of the conference was “Laboratory Medicine for Better Biomedical Research and Human Health”. During this annual conference, four subthemes have also been managed including: (1) Why the evolution and carrier of laboratory professionals remains uncertain in Ethiopia? (2) Improving the research capacity of medical laboratory scientists in Ethiopia; (3) Laboratory Stewardship: Ordering, performing and reporting laboratory test results and mitigating the risk of over diagnosis; and (4) Emerging molecular diagnostic platforms having the power to revolutionize modern medicine and continue to improve health system.

Justification for the Main Theme of the Conference

Why Laboratory Medicine for Better Biomedical Research and Human Health?

Laboratory generated data are used in support of several types of global health research.

Routinely obtained clinical diagnostic data are used for disease surveillance, epidemiologic analysis of trends and health outcomes research. Laboratory medicine is a critical component of disease prevention and management within this paradigm. Traditional disease classi-

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tion process in the scientific community.

The theme of our event is “Talent, Technology and Time: The Key to Transformation”. In this phrase, we refer to what the world is currently going through. Talent is essential in order to reach our personal and collective goals; technology is our greatest ally in the face of adversity and time…gives us the opportunity to change and improve.

In the clinical laboratory, it is clear that the talent of people and professionals is what contributes to the high-quality standard needed for our clients, but we must not forget that it is technology which allows that to be possible, in less time.

On the proposed agenda we offer two intracongress courses: Interference in immunoassay and platelet-rich plasma. We also have conferences and symposia related to quality assurance, molecular biology, autoimmunity, hematology, microbiology, endocrinology, among others.

We cannot hold an event of this magnitude, without addressing the most important topic of the moment: The SARS- CoV-2 pandemic. In this regard, we hope to be able to successfully carry out activities that summarize the measures implemented by our country and scientific community to minimize the spread of this virus in our environment and to carry out an early diagnosis. We have had the possibility of rapidly

LabMedica International August-September/2020

Newly Elected EMLA EB Members Dr. Berhanu Seyoum, President; Prof. Baye Gelaw, Member; Gizachew Taddesse, Member; Dr. Eyob Abera, Member; Dr. Gertachew Kabew, Member; Hulemenaw Delelegn, Member; Zerihun Woldesenbet, Member.

fication and approaches symptom based and organ centered are no longer valid. The presentation of disease is changing and shared mechanisms such as inflammation and abnormal immune responses are recognized. Growing knowledge demonstrates the need for a new approach to health and disease based on causative pathways that include genes, environment and lifestyle, generating big data even for individuals and health interventions that will soon become increasingly personal.

Biomedical research drives better health and patient care through innovation and implementation into practice of novel findings. In a changing society new challenges demand a new research and innovation framework and strategy.

Improved health and wellbeing of the people is the ultimate goal of research. It is part of a vision of science and knowledge in a participative society.

Today, developed nations understood that research brings health and benefits to society.

Achievements in health have been driven by research and innovation and by the high value

placed on science in a free and open spirit of critical thinking. Research in the humanities, natural sciences and technology are one with health but, biomedical research is a holistic view of humankind. Most importantly, biomedical and health research bring economic value too. Research and innovation have advanced medical diagnostics, therapeutics and technology in many fields, with major impact on both life expectancy and healthy life years. Society gains economic benefits from these additional years of good health and productivity. Innovation in biomedical and health research can create new companies and jobs while boosting the economy. On the other hand, health and disease are global. Changes in lifestyle, demographics and environment are leading to changing patterns of infectious and non-infectious disease globally.

Human health and disease are intricately linked with health in animals, plants and agriculture requiring a new approach like ‘One Health’.

Most importantly, preventing disease, prolonging life and promoting health is best achieved through the integrated and organized efforts of research and this requires not only national action, but intensified cooperation at continental and global levels. National research, cross border research, cross border consultation and comprehensive policies are required as all need scientific leadership at a scale that takes full advantage of the Ethiopian health research arena.

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

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Sep 9-11; Virtual Venue; Web: www. ascp.org

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NOVEMBER 2020

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

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

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DECEMBER 2020

MEDLAB Asia Pacific 2020. October 2830; Virtual Venue; Web: www. medlabasia.com

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

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

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

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

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

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

EuroMedLab 2021 – 24th IFCC-EFLM European Congress of Clinical Chem-

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istry and Laboratory Medicine. May 16-20; Munich, Germany; Web: www.euromedlab2021munich.org

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

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

37th International Congress of the International Society of Blood Transfusion (ISBT). Jun 6-9; Milan, Italy; Web: isbtweb.org FOCIS 2021 – Annual Meeting of the Federation of Clinical Immunology Societies. Jun 8-11; Boston, MA, USA; Web: www.focisnet.org

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

AUGUST 2021

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

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

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JULY 2021

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

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

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

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

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ESHRE 2021 - 37th Annual Meeting of the European Society of Human Reproduction and Embryology. Jun 2730; Paris, France; Web: www.eshre.eu

IAS 2021 – 11th International AIDS Society (IAS) Conference on HIV Science.

Jul 18-21; Berlin, Germany; Web: ias2021.org

26th Annual Congress of the European Hematology Association (EHA). Jun 1013; Vienna, Austria; Web: ehaweb.org

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