LabMedica International March 2021 by Globetech

V I S I T

WORLD’S CLINICAL LABORATORY NEWS LEADER ISSN 1068-1760

Vol. 37 No.1 • 2-3/2021

Blood Test Detects Early Colorectal Adenomas

olonoscopies are the gold standard for screening but have low compliance rates due to the invasiveness of the procedure. Stool-based tests have poor compliance and low sensitivity for advanced adenomas (AA), at about 24% to 42%.

DAILY CLINICAL LAB NEWS

New Control Mechanism Discovered in Innate Immune System

roteases are enzymes that cleave other proteins. Most often, proteases occur in cascade networks, where a particular event triggers a chain reaction in which several proteases cleave and thereby activate each other. Most well-known is probably

the coagulation cascade, which causes clotting of our blood when a vessel is punctured. Inter-α-inhibitor heavy chain 4 (ITIH4) is a liver-produced plasma protein belonging to the inter–α-inhibitor/ITIH family of proteins that consists of bikunin

Cont’d on page 6

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Liquid Biopsy Monitors COVID -19 Damage to Cells, Tissues and Organs

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lzheimer’s disease (AD) is the predominant form of dementia and the most common neurodegenerative disorder. Advanced age and the presence of the ε4 allele of the apolipoprotein E gene (APOE) are the most relevant late-onset sporadic ADpromoting factors as they interact with the core mechanisms of this neurologic disorder. ApoE is essential to modulate

pilepsy is a central nervous system disorder in which brain activity becomes abnormal, causing seizures or periods of unusual behavior, sensations, and sometimes loss of awareness. Epilepsy affects both males and females of all races, ethnic backgrounds and ages. Epilepsy affects over 70 million people worldwide. This common brain condition has multiple risk

Automated Urine Microscope Serves Regional Laboratories

P O R T A L

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Early Plasma Biomarkers Discovered for Alzheimer’s

See article on page 4

Blood Test Distinguishes Epileptic Seizures From PNES

hile COVID-19 primarily affects the lungs, the virus can also lead to systemic disease with multi-organ involvement, a failure that can now be diagnosed with a newly-developed blood test. LabMedica’s COVID -19 Diagnostics Update section starts on page 5.

Cont’d on page 10

utomated Urine Microscopy examines a sample of urine under a microscope. It can check cells from the urinary tract, blood cells, crystals, bacteria, parasites, and cells from tumors. This test is often used to confirm the findings of other tests or add Cont’d on page 12

COVID-19 Testing to Boost Global IVD Sector To Nearly USD 120 Billion By 2027

he global in-vitro diagnostics (IVD) market is projected to register a CAGR of 7% from 2020 to 2027 to reach USD 118.5 billion by 2027, driven mainly by the increased demand for diagnostic testing for understanding and managing infectious diseases,

such as COVID-19. These are the latest findings of Meticulous Research (Pune, Maharashtra, India), a market intelligence provider. The epidemiological burden of infectious diseases worldwide has increased in the past few years. Cont’d on page 18

INSIDE

COVID-19 Update. . . . . 5 Clinical News. . . . . . 4-26 IFCC News. . . . . . . . . . 25 Product News . . . . . 6-28 Industry News . . . . . . . 29 Events Calendar . . 30-31

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LabMedica International

Liquid Biopsy Monitors COVID -19 Damage to Cells, Tissues and Organs

recent study presented results that point to the utility of exploiting cellfree DNA as an analyte to monitor the damage caused to cells, tissues, and organs by COVID-19. While COVID-19 primarily affects the lungs, evidence of systemic disease with multi-organ involvement has emerged. In order to better understand this phenomenon, investigators at Cornell University (Ithaca, NY, USA; www.cornell.edu) and colleagues in the United States and Canada developed a blood test to broadly quantify cell, tissue, and organ specific injury due to COVID-19. For this study, the investigators employed a liquid biopsy method to conduct genome-wide methylation profiling of cell-free DNA in the blood plasma. They assessed the utility of this test to identify subjects with severe disease in two independent, longitudinal cohorts of hospitalized patients. Cell-free DNA profiling was performed on 104 plasma samples from 33 COVID-19 patients and compared to samples from patients with other viral infections and healthy controls.

The investigators reported finding evidence of injury to the lung and liver and involvement of red blood cell progenitors associated with severe COVID-19. Furthermore, a high concentration of cell-free DNA in the blood was itself a strong prognostic marker for severe COVID-19 cases. “A lot of what we have learned about the involvement of the virus with different organs is from invasive biopsies, postmortem biopsies,” said senior author Dr. Iwijn De Vlaminck, assistant professor of biomedical engineering at Cornell University. “But a liquid biopsy is potentially very useful as a biological measurement, a way to study what is going on in patients who have different types of symptoms, for example. It could be used to assess disease severity and help stratify patients in the care system. It could also potentially be a surrogate biomarker that you could include in randomized controlled trials of various anti-COVID therapies and anti-virals.” The cell-free DNA study was published in the January 16, 2021, online edition of the journal Cell Med.

New Control Mechanism Discovered in Innate Immune System

cont’d from cover

and six different heavy chain proteins. This protein family is also referred to as inter–α-trypsin inhibitor proteins since bikunin displays a weak inhibitory effect on proteases for which a biological role is yet to be defined. Biomedical Scientists at Aarhus University (Aarhus, Denmark; www.au.dk) and a colleague investigated which other proteins in the blood the so-called mannan-binding lectin–associated serine protease (MASP) proteases interact with the complement cascade. To characterize in detail how ITIH4 inhibits the MASP proteases, they isolated both free ITIH4 and ITIH4 bound to the MASP-1 protease. By the use of X-ray small-angle scattering and electron microscopy, these samples were studied. Liquid chromatography tandem-mass spectrometry was performed using a Q-Exactive plus mass spectrometer (ThermoFisher Scientific, Waltham, MA, USA; www.thermofisher.com). The scientists showed that ITIH4 is cleaved by several human proteases within a protease-susceptible region, enabling ITIH4 to function as a protease inhibitor. This is exemplified by its inhibition of mannan-binding lectin–associated serine protease-1 (MASP-1), MASP-2, and plasma kallikrein, which are key proteases for intravascular host defense. Mechanistically, ITIH4 acts as bait that, upon cleavage, forms a non-covalent, inhibitory complex with the executing protease that depends on the ITIH4 von Willebrand factor A domain. ITIH4 inhibits

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the MASPs by sterically preventing larger protein substrates from accessing their active sites, which remain accessible and fully functional toward small substrates. The authors concluded that the active sites of MASP within the non-covalent ITIH4-MASP complexes are catalytically competent, but downstream cleavage of C2 and C4 are inhibited by physically blocking access of the scissile bonds to the active sites. Such activity was demonstrated in human and murine serum. ITIH4 was found to be cleaved by various proteases within the protease-susceptible region (PSR), suggesting that ITIH4 is a broad-acting inhibitor that targets numerous proteases. The study was published on January 8, 2021 in the journal Science Advances. Image: Pro-inflammatory IL-6 is responsible for stimulating acute phase protein synthesis, as well as the production of neutrophils in the bone marrow. It supports the growth of B-cells and is antagonistic to regulatory T-cells (Photo courtesy of Wikimedia Commons).

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ISSN 1068-1760

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LabMedica International February-March/2021

COVID -19 Diagnostics Update

he report that follows provides a survey of news and advances from the beginning of Nov. 2020 till the end of Jan. 2021. For a recap of earlier developments, the reader is invited to refer to previous issues of LabMedica. Rapid Antigen Tests for Detection of SARS-CoV-2 Can Provide False Positive Results The US Food and Drug Administration (FDA Silver Spring, MD, USA; www.fda.gov) has alerted clinical laboratory staff and health care providers that false positive results can occur with antigen tests, including when users do not follow the instructions for use of antigen tests for the rapid detection of SARS-CoV-2. The FDA has asked laboratories to expect some false positive results to occur even when very accurate tests are used for screening large populations with a low prevalence of infection.

Liquid Chemistries, Corp. (CLC, Greensboro, NC, USA; www.carolinachemistries.com), has been granted FDA Emergency Use Authorization (EUA) for use with fingerstick whole blood specimens at the point-of-care, i.e. in patient care settings operating under CLIA Certificate of Waiver such as doctor’s offices, hospitals, urgent care centers and emergency rooms rather than having to be sent to a central lab. PerkinElmer’s EUROIMMUN Launches Anti-SARS-CoV-2 QuantiVac ELISA (IgG) EUROIMMUN, a PerkinElmer, Inc. (Waltham, MA; USA; www.perkinelmer.com) company, has launched the Anti-SARS-CoV-2 QuantiVacTM ELISA (IgG) to quantify IgG antibodies against the SARS-CoV-2 S1 antigen. The quantitative test kit applies a recombinant S1 subunit of the SARS-CoV-2

spike protein, enabling detection of IgG antibodies. EUROIMMUN has also launched the CE marked EURORealTime SARS-CoV-2/ Influenza A/B for direct detection of SARSCoV-2, influenza virus type A and influenza Cont’d on page 13

Highly Automated Microlab Detects COVID -19 in 30 Minutes By leveraging the so-called “lab on a chip” technology and the cutting-edge genetic editing technique known as CRISPR, scientists at Stanford Medicine (Stanford, CA, USA; www.med.stanford.edu) have created a highly automated device that can identify the presence of the novel coronavirus in just a half-hour. The microlab is a microfluidic chip just half the size of a credit card containing a complex network of channels smaller than the width of a human hair. The team created the device on a shoestring budget of just about USD 5,000. FDA Authorizes First Test that Detects Neutralizing Antibodies from Recent or Prior SARSCoV-2 Infection The US Food and Drug Administration has authorized the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection. The FDA has issued an emergency use authorization (EUA) to GenScript USA Inc. (Piscataway, NJ, USA; www.gen script.com) for its cPass SARS-CoV-2 Neutralization Antibody Detection Kit, which specifically detects antibodies that bind to a specific part of a pathogen and have been observed in a laboratory setting to decrease SARS-CoV-2 viral infection of cells. Carolina Liquid Chemistries COVID-19 Antibody Test Receives FDA EUA The Fastep COVID-19 IgG/IgM Rapid Test Device by Assure Tech., distributed in the USA by Carolina

LabMedica International February-March/2021

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PRODUCT NEWS

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ELISA PROCESSOR

BLOOD ANALYZER

SEDIMENTATION RATE ANALYZER

EUROIMMUN Analyzer I-2P enables a quick, simple and secure routine operation, owing to the automatic recognition and allocation of reagents and the import of QC data via Data Matrix codes.

The i-STAT Alinity System is a handheld blood testing platform that can perform and analyze a large menu of blood tests on a single device, ranging from blood chemistries to cardiac markers.

The iSED automated sedimentation rate analyzer allows testing with micro-volumes of blood and works directly off the primary EDTA tube. It comes with an internal barcode reader, onboard automated mixer and printer.

EUROIMMUN

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ABBOTT DIAGNOSTICS

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ALCOR SCIENTIFIC

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Blood Test Detects Early Colorectal Adenomas Cont’d from cover

Many of the 50,000 annual colorectal cancer (CRC) deaths can be attributed to 1/3 eligible Americans not following screening guidelines or approximately 1/2 of the population not adherent to the follow-up post-polypectomy guidelines. The new understanding of the natural history and shared etiology of adenomas and CRC inform integration of clinically relevant biomarkers. Medical Scientists at the Stanford University Medical Center (Stanford, CA, USA; http://med.stanford.edu) and their colleagues conducted a prospective, blinded study of 458 individuals who had their blood drawn prior to undergoing colonoscopy and who had no prior history of colorectal cancer. Of them, 239 individuals underwent screening colonoscopy and 219 underwent surveillance colonoscopy. Most of the individuals (86%) were asymptomatic, whereas 14% had symptoms or a positive fecal immunochemical test. The team developed the FirstSight blood test (CellMax Life, Sunnyvale, CA, USA; https://cellmaxlife.com) to detect adenoma-carcinoma pathways in blood samples based on the presence of circulating gastrointestinal epithelial cells and somatic mutations of cell-free tumor DNA. The test analyzes two biomarkers: circulating gastrointestinal epithelial cells and somatic mutations of cell-free DNA. The probability of advanced neoplasia was obtained by ordinal/ nominal logistic regression methods together with SEER-incidence rate and prior history of AA on a training set of 346 subjects. A cutpoint was selected to obtain a test specificity (non-neoplastic finding or negative colonoscopy) of 90% resulting in a sensitivity of 100% and

80.0% for detection of CRC and advanced neoplasia (AN = CRC+AA), respectively, on the training subjects. The investigators reported that the area under the ROC curve is 0.91. Validation using the fixed cutpoint and 112 test subjects achieved 91.4% specificity and 100% and 75.0% sensitivity for CRC and AN. Shai Friedland, MD, a Professor of Gastroenterology and his colleagues concluded that “This blood test has high sensitivity for colorectal advanced neoplasia while retaining high specificity. The quantitative nature of the score has the potential to enable prognostic stratification of patients for screening or post-polypectomy surveillance colonoscopy.” The study was presented at the Gastrointestinal Cancers Symposium (virtual meeting); held January 15-17, 2021. Image: Photomicrograph of a moderately differentiated colorectal carcinoma with dirty necrosis (Photo courtesy of Mikael Häggström, MD)

Proinflammatory T Cell Polarization Investigated in Early Knee Osteoarthritis

n osteoarthritis (OA), the cartilage in the knee joint gradually wears away. As the cartilage wears away, it becomes frayed and rough, and the protective space between the bones decreases. This can result in bone rubbing on bone, and produce painful bone spurs. Osteoarthritis develops slowly and the pain it causes worsens over time. Assessment of early OA is indispensable in the search for biomarkers as a diagnostic tool. OA pathology has a temporal pattern, and cartilage, bone, and synovial matrix biomarkers show a positive association with the progression of knee OA. Synovial inflammation has been identified as an independent factor significantly contributing to OA pathology. Orthopedic Specialists at the University Hospital Heidelberg (Heidelberg, Germany; www.heidelberg-university-hospital.com) and their

colleagues enrolled 40 patients (29 women, 11 men) with arthroscopic or MRI findings of early osteoarthritis of the knee. The mean age of the study population was 41.7 ± 14.3 years. Synovial fluid (SF), synovial membrane (SM), and peripheral blood (PB) were collected at the time of surgery. Mononuclear cells were isolated from heparin anti-coagulated whole blood, SF, and SM cell suspensions using Ficoll-Paque PLUS (GE Healthcare, Waukesha, WI, USA; www.gehealthcare.com) density gradient centrifugation. T cells were isolated from PB, SF, and SM mononuclear cells by CD3 MACS bead separation (Miltenyi Biotec, Bergisch Gladbach, Germany; www.miltenyibiotec.com). Samples were analyzed by flow cytometry for surface markers and cytokines, which are preferentially expressed by distinct T cell subsets Cont’d on page 14 LabMedica International February-March/2021

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PRODUCT NEWS CHEMILUMINESCENCE IMMUNOASSAY SYSTEM

SNIBE

The MAGLUMI 2000 Plus Chemiluminescence Immunoassay (CLIA) System has a large test menu and features free quality control and calibrator to reduce the cost per test. It uses key ABEI and nano magnetic microbead technologies. LINKXPRESS COM

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AUTOMATED PHOTOMETER

CARBAPENEMASE TEST

The StarDust MC15 semi-automated photometer simultaneously processes a multi-cuvette strip to allow the reading of 15 endpoint chemistries in one minute or 15 kinetic chemistries in four minutes.

MAST CARBA PAcE is a colorimetric test which rapidly detects carbapenemase producing Pseudomonas spp., Acinetobacter spp. and Enterobacterales.

DIASYS

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MAST

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Early Plasma Biomarkers Discovered for Alzheimer’s Cont’d from cover

cerebral lipid homeostasis and neurogenesis with the ApoE4 isoform promoting less efficiently the transport of essential lipids to neurons. In addition, proteolytic degradation of the amyloid beta (Aβ) peptide is compromised in APOE ε4 carriers, thus increasing amyloidosis and the risk of progression to AD. Medical Scientists from the Institut National de la Recherche Scientifique (Laval, QC, Canada; www.inrs.ca) analyzed blood samples collected as part of the Canadian Study of Health and Aging (CSHA). The population studied consisted of patients with cognitive problems, but not suffering from dementia, and only some of whom developed Alzheimer’s disease. The team determined levels of pathogenic, neurotrophic and inflammatory proteins in peripheral extracellular vesicles (pEVs) and in plasma from cognitively impaired, no dementia (CIND) participants stratified upon the absence (APOE ε4-) or the presence (APOE ε4+ ) of the ε4 allele of APOE. The scientists used the following methods to determine the results: various pEVs suspensions were diluted in ultra-pure filtered water (1:1000) and injected into the NanoSight NS300 system (Malvern Panalytical instruments, Inc., Malvern, UK; www.malvernpanalytical.com); Western blot analysis; Dual immune-labeling of pEVs with image analysis was performed using the Zeiss LSM780 laser scanning confocal microscope (Zeiss, Jena, Germany; www.zeiss.com). The pEVs’ protein content of BDNF, APP, NSE, NPTX-2, α-Syn, DJ-1, MMP-9, S100B, PrGN, LCN-2, and ANGPTL-4 was determined by the multiplex Luminex assay and the accumulation of the protein fragments Aβ1-40, Aβ1-42 and different forms of the protein tau (t-tau and p-tau181) were evaluated by another Luminex assay (Luminex Corporation, Austin, TX, USA; www.luminexcorp.com). The scientists reported that levels of neurotrophic and inflammatory markers were reduced in pEVs from APOE ε4+. The pentraxin-2/α-syLINKXPRESS COM

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nuclein ratio measured in pEVs was able to predict AD five years before the onset among APOE ε4+-CIND individuals. Patients with this gene who developed the disease five years later had markers present that varied with the progression of the disease. The presence of APOE ε4 does not impact on the levels of Aβ1-42, t-tau, and p-tau181, and the ratio Aβ1-42/p-tau181 in pEVs. The profile of inflammatory and trophic factors measured in CIND patients showed that APOE ε4 is associated with lower levels of neurotrophic markers such as DJ-1, PrGN, and α-Syn, with a higher discriminating capacity in pEVs compared to plasma except for α-Syn. The authors concluded that their study provided comprehensive insight and enhanced the knowledge of the emerging role of APOE ε4 in abnormal pEVs cargo proteins processing and the identification of blood-based biomarkers. The measurement of ratio between NPTX-2 and α-Syn in pEVs might be an innovative strategy for monitoring the conversion of CIND patients to AD. The study was published on January 28, 2021 in the journal Alzheimer’s & Dementia: Translational Research & Clinical Interventions. Image: The NanoSight NS300 Instrument provides an easy-to-use, reproducible platform for nanoparticle characterization (Photo courtesy of Malvern Panalytical Instruments) LabMedica International February-March/2021

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PRODUCT NEWS

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MOLECULAR TESTING SYSTEM

CYTOCENTRIFUGE

COVID -19 TEST

The FilmArray EZ is a CLIA-waived system for near patient molecular testing that enables decentralized molecular testing throughout a provider network it offers an intuitive and simplified user interface and results report.

The Cytopro Cytocentrifuge Series 2 is a complete, integrated system for depositing cells onto microscope slides, including an advanced instrument console with touchscreen controls and an eight-station cytocentrifuge rotor.

The new SGTi-flex COVID-19 Ag is a one step, rapid gold nanoparticle-based immunochromatographic test for qualitative detection of specific antigens of COVID-19. It enables simple and reliable handling without requiring a device.

BIOFIRE DIAGNOSTICS

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DIASYS

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Blood Test Distinguishes Epileptic Seizures From PNES Cont’d from cover

factors and a strong genetic predisposition. Psychogenic non-epileptic seizures (PNES) are events resembling an epileptic seizure, but without the characteristic electrical discharges associated with epilepsy. They are of psychological origin, and are one type of non-epileptic seizure mimicked. Neuroscientists from the University of Maryland (Baltimore, MD, USA; https://umd.edu) and their colleagues collected daily blood samples from patients evaluated in the epilepsy monitoring unit (EMU) within 24 hours after electroencephalograms (EEG) confirmed epileptic seizures (ES) or PNES and plasma was isolated. A total of 137 patients were evaluated in the EMU for differential diagnosis or pre-surgical evaluation; 29 healthy volunteers also were prospectively enrolled in the study in 2014-2015. Of the 137 initially enrolled patients, 48 were excluded because no definitive diagnosis could be made. Timing of blood draws excluded another 42 patients, leaving 23 epilepsy patients (65.2% women, mean age 44) and 24 PNES patients (79.2% women, mean age 44). Multiple races and ethnicities were represented. The scientists quantified the levels of 51 candidate plasma proteins using an automated, multiplexed, sandwich enzyme-linked immunosorbent assay (EvoScoreDx, Cognizance Biomarkers, Spring House, PA, USA; http://cog-

nizancebiomarkers.com) and then integrated and analyzed using a diagnostic algorithm. All epileptic seizure patients had confirmed seizure on EEG; average seizure duration was 2.6 minutes. Of note, 79% of PNES patients and all epileptic seizure patients had motor manifestations in their seizures, and 83% of epileptic seizure patients had drug-resistant epilepsy. The team reported that a combination of protein concentrations, TNFrelated apoptosis-inducing ligand (TRAIL), Intercellular Adhesion Molecule 1 (ICAM-1), monocyte chemoattractant protein 2 (MCP-2) and Tumor necrosis factor receptor 1 (TNF-R1) provided a probability that a patient recently experienced a seizure with TRAIL and ICAM-1 higher in PNES than ES, and MCP-2 and TNF-R1 higher in ES than PNES. The diagnostic algorithm yielded an AUC of 0.94 ± 0.07, sensitivity of 82.6% and specificity of 91.6%. Further, expanding the diagnostic algorithm to include previously identified PNES risk factors enhanced diagnostic performance with AUC of 0.97 ±0 .05, sensitivity of 91.3%, and specificity of 95.8%. Peter Crino, MD, PhD, a Professor of Neuroscience and a senior author of the study and his colleagues noted that epileptic seizures can activate both systemic and brain proinflammatory pathways including enhanced interleukin 1β production, activation of toll-like receptor 4, mammalian target of rapamycin, and mitogen-activated protein kinase cascades, attraction of activated lymphocytes, activation of microglia and macrophages, and alteration of astrocyte physiology. The authors concluded that the four plasma proteins, TRAIL, ICAM-1, MCP-2 and TNF-R1, could provide a rapid, cost-effective, and accurate bloodbased diagnostic test to confirm recent ES or PNES. The study was published on January 25, 2021 in the journal Neurology. Image: An association of epileptic and non-epileptic seizures and changes in circulating plasma proteins is linked to neuroinflammation (Photo courtesy of Evogen, Inc)

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PRODUCT NEWS

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BIOCHEMISTRY ANALYZER

HBA1C ANALYZER

C-PEPTIDE ASSAY

The Stat Fax 3300 is a stand-alone Biochemistry analyzer that reads square cuvettes and round tubes, using removable flow cell for reducing reagent consumption. It features an external 37˚ C incubation block with 18 stations.

The HB 715 automated desktop analyzer is intended for measuring glycated hemoglobin (HbA1c, HbA1ab, HbA1c, HbF, HbA0, HbA2/E/D, HbS, HbC). The analyzer has been developed for ease of use and low-cost operation.

The Access C-Peptide Assay aids physicians in diagnosis and treatment of patients suspected of having diabetes mellitus or other insulin-secretion disorders. It helps deliver accurate results and streamline diabetes testing.

AWARENESS TECHNOLOGY

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ERBA MANNHEIM

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BECKMAN COULTER

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Rapid AI-Based Test Screens for Prostate Cancer Biomarkers in Urine

team of Korean investigators developed a highly accurate rapid technique for diagnosing prostate cancer based on AI (artificial intelligence) monitoring of urinary biomarkers. Screening for prostate cancer generally relies on the serum prostate-specific antigen (PSA) test, which unfortunately generates a high rate of false positive results (up to 80%). This generates a large number of unnecessary biopsies with resultant unpleasant side effects, such as bleeding and pain. Considering how often the PSA test is used, there is a critical unmet need for a precision screening method for diagnosis of prostate cancer. Toward this end, investigators at the

Korea Institute of Science and Technology (Seoul; www.kist.re.kr) and their collaborators developed a technique for diagnosing the disease from urine by utilizing an electrical-signal-based ultrasensitive biosensor. The semiconductor sensor system was capable of simultaneously measuring trace amounts of four selected cancer factors in urine. The correlation of clinical state with the sensing signals from urinary biomarkers was analyzed by two common machine learning algorithms. As the number of biomarkers was increased, both algorithms provided a monotonic increase in screening performance. When applied to urine samples from

patients, the 20-minute AI analysis successfully detected 76 urinary samples with greater than 99% accuracy. Senior author Dr. Kwan Hyi Lee, a principal research scientist at the Korea Institute of Science and Technology, said, “This research developed a smart biosensor that can rapidly diagnose prostate cancer with almost 100% accuracy only through a urine test, and it can be further utilized in the precise diagnoses of other cancers using a urine test.” The AI-based assay for diagnosis of prostate cancer was described in the December 9, 2020, online edition of the journal ACS Nano.

Automated Urine Microscope Serves Regional Laboratories

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information to a diagnosis. Automation of urine particle counting has become a clinical standard in medium-sized and large laboratories by means of flow cytometry or several types of image analyzers. Reliable implementation of those instruments requires utilization of reference procedures in their verification. Clinical Chemists and Microbiologists from Helsinki University Hospital (Helsinki, Finland; www.hus.fi) carried out the primary verification with 463 urine specimens, and against urine culture on chromogenic agar plates with 396 parallel specimens. Nine secondary instruments were compared pairwise with the primary instrument. Both mid-stream collections (generally 90% of all specimens) and catheterized specimens were taken into the study, based on particle findings. Specimens were chosen from routine analysis by UF-1000i instrument (Sysmex,

Kobe, Japan; www.sysmex.co.jp) for verification of the primary (“Gold”) UriSed 3 PRO instrument (77 Elektronika, Budapest, Hungary; www.e77.hu) against reference visual microscopy during a 6-week period in September - October 2018. Comparisons to urine culture results were available for 396 parallel samples which were cultured by using automated inoculation with 1 µL loop (WASP automated microbiology instrument, COPAN Wasp, Brescia, Italy; www.copangroup.com) on chromogenic agar plates (CHROMagar Orientation medium, CHROMagar, Paris, France; www. chromagar.com) following incubation at 35°C for 18 hours. The scientists reported that relative imprecisions compared to Poisson distribution, R(CV), were estimated to be 1.0 for white blood cell (WBC) and 1.5 for red blood cell (RBC) counts, respectively. Spearman’s correlations against visual microscopy were rS = 0.94 for WBC, rS = 0.87 for RBC, and

rS = 0.82 for squamous epithelial cell (SEC) counts. Agreement with visual microscopy (Cohen’s weighted kappa) was 0.94 for WBC, 0.89 for RBC, 0.88 for SEC, 0.59 for combined casts, and 0.49 for non-squamous epithelial cells (NEC). Bacteria were detected with a sensitivity of 90% and specificity of 39 against culture at 107 colony forming bacteria/L (CFB/L = 104 CFU/mL). Created flagging limits allowed automated reporting for 70-75 % of patient results. The authors were able to install 10 UriSed 3 PRO instruments in a regional laboratory environment at HUSLAB, providing about 160,000 automated particle counts annually at 24/7 basis, thus satisfying both routine testing and emergency analysis of clinical samples. Analytical performance fulfilled the analytical performance specifications and expectations obtained from preliminary testing. The study was published on January 26, 2021 in the journal Clinica Chimica Acta. LabMedica International February-March/2021

COVID-19 Diagnostics Update Cont’d from page 5

virus type B. Additionally, EUROIMMUN has launched the CE marked SARS-CoV-2 Antigen ELISA for specific determination of the SARSCoV-2 protein. PerkinElmer’s SARS-CoV-2 Real-time RTPCR Assay has received CE-IVD marking for the use of saliva as specimen type and the option to pool up to five specimens collected from individuals suspected of COVID-19 or asymptomatic individuals. PerkinElmer has also received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for the PerkinElmer New Coronavirus Nucleic Acid Detection Kit to test individuals without symptoms or other reasons to suspect COVID-19 infection. Stand-Alone COVID -19 Rapid POC Antigen Test Delivers Results without Separate Analyzer A new minimally-invasive, standalone COVID-19 POC antigen test developed and manufactured by AccessBio (Somerset, NJ, USA; www.accessbiodiagnostics.net) delivers rapid results in 10 minutes without the need for a separate analyzer. The CareStart COVID-19 Antigen Rapid Point-of-Care (POC) test kit allows for rapid, effective screening of COVID-19 infection on a large scale with high sensitivity and 100% specificity. Streck Launches Rapid, Modular qPCR Instrument With Market-Leading Speed Streck (La Vista, NE, USA; www. streck.com) has launched the Zulu RT, a rapid, modular qPCR instrument capable of performing four independent experiments simultaneously. It can perform a 40-cycle, 6-channel 3-step real-time PCR in less than 20 minutes, making it the fastest qPCR instrument in the world. The Zulu RT uses unique, proprietary Streck thermal technology combined with powerful optics for market-leading speed. The Zulu RT does not sacrifice test volume for speed; it provides less than 20-minute qPCR for volumes from 10 up to 50 µL. Study Finds New Saliva-Based Antibody Test for SARS-CoV-2 Highly Accurate A new saliva-based test developed by a team at Johns Hopkins Bloomberg School of Public Health (Baltimore, MD, USA; www.jhsph. edu) has been found to accurately detect the presence of antibodies to SARS-CoV-2 from small samples of saliva. In the study, Bloomberg School researchers found that their

LabMedica International February-March/2021

test detected antibodies to several of these antigens in saliva samples from all 24 participants who had confirmed SARS-CoV-2 exposure and whose symptoms had begun more than two weeks prior to the test. ELITechGroup Launches CE-IVD marked SARS-CoV-2 PLUS ELITe MGB Kit ELITech Group (Puteaux, France; www. elitechgroup.com) has launched the CE-IVD marked SARS-CoV-2 PLUS ELITe MGB Kit that detects SARS-CoV-2, Flu A, Flu B, and RSV on the Sample-to Result-Platform ELITe InGenius and is available on major PCR thermocyclers as well. Siemens Offers Quantitative COVID -19 Test for Measuring Neutralizing Antibodies Siemens Healthineers’ (Erlangen, Germany; www.siemens-healthineers.com) SARS-CoV-2

IgG Antibody Test (sCOVG) that has proven to measure neutralizing antibodies has achieved CE Mark. The test is an enhanced version of the assay which became available globally this summer, including in the US. Siemens has also been granted an Emergency Use Authorization by the US Food and Drug Administration for its laboratory-based IL-6 assay to measure the presence of interleukin-6 in human serum or plasma. Bioneer’s Combination Tests for SARS-CoV-2 and Influenza Receive CE-IVD Marking Bioneer (Daejeon, Korea; www.bioneer. com) has received CE-IVD marking for two combination tests for SARS-CoV-2 and influenza - the AccuPower RV1 Real-Time RT-PCR Kit and the AccuPower RV1 Multiplex Kit. Both the tests are designed to detect the E, Cont’d on page 15

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The Allplex SARS-CoV-2 Assay is a multiplex real-time PCR assay to detect four target genes of SARS-CoV-2 causing COVID-19 in a single tube. It can be applied on Seegene’s automated system enabling high throughput testing.

VIROTROL and VIROCLEAR SARS-CoV-2 antibody controls are ready-to-use, liquid controls formulated from human plasma to test on total IgG/IgM and IgG antibody assays, ensuring an unbiased independent assessment of test systems.

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AI-guided Immunoassay Measures Maternal Autoantibodies to Predict Likelihood of Autism Spectrum Disorder

n AI-guided immunoassay that measures maternal autoantibodies accurately predicts the likelihood that a child will develop autism spectrum disorder (ASD). Investigators at the University of California, Davis (USA; www. ucdavis.edu) had previously identified the presence of maternal autoantibodies to fetal brain proteins specific to ASD, now termed maternal autoantibody-related (MAR) ASD. In a recent paper they discussed the creation and validation of a serological assay to identify ASD-specific maternal autoantibody patterns of reactivity against eight previously identified proteins (CRMP1, CRMP2, GDA, NSE, LDHA, LDHB, STIP1, and YBOX) that are highly expressed in developing brain. The investigators analyzed plasma from 450 mothers of children diagnosed with ASD and from 342 mothers of typically developing children to develop an ELISA test for each of the protein antigens. They then used a machine learning algorithm to determine patterns of highly significant association with ASD and discovered several patterns that were ASD-specific. Results revealed that the three main patterns associated with MAR ASD were CRMP1 + GDA, CRMP1 + CRMP2, and NSE + STIP1. Additionally, they found that maternal autoantibody reactivity to CRMP1 significantly increased the odds of a child having a higher Autism Diagnostic Observation Schedule (ADOS) severity score. “The implications from this study are tremendous,” said senior author Dr. Judy Van de Water, professor of rheumatology, allergy, and

clinical immunology at the University of California, Davis. “It is the first time that machine learning has been used to identify with 100% accuracy MAR ASD-specific patterns as potential biomarkers of ASD risk. We can envision that a woman could have a blood test for these antibodies prior to getting pregnant. If she had them, she would know she would be at very high risk of having a child with autism. If not, she has a 43% lower chance of having a child with autism, as MAR autism is ruled out.” The paper was published in the January 22, 2021, online edition of the journal Molecular Psychiatry. Image: Structure of the CRMP1 protein (Photo courtesy of Wikimedia Commons)

Proinflammatory T Cell Polarization Investigated in Early Knee Osteoarthritis

Cont’d from page 6

(Th1, Th2, Th17, regulatory T cells). Furthermore, the team analyzed SF and PB supernatants using the Miltenyi Biotec MACSPlex for multiple cytokine expression profiles. Flow analysis was performed using a Miltenyi Biotec MACSQuant Analyzer, which is a 7-channel flow cytometer. Native SF and PB sera were analyzed by the Miltenyi Biotec MACSPlex 12 Kit. The scientists reported that SF and SM showed a distinct infiltration of CD4+ T lymphocytes, with significantly increased expression of chemokine receptors CXCR3/CCR5, cytokine IFN-γ which is preferentially expressed by Th1 cells, and CD161 which is preferentially expressed by interleukin-17 (IL-17) producing Th17 cells compared to PB. Furthermore, the percentage of CD4+ T cells polarized to regulatory T

cells (Treg) was significantly increased in SM compared to SF and PB. No significant differences were observed for CCR3 and CCR4which are preferentially expressed by Th2 cells, although IL-4 values were significantly higher in SM and SF compared to PB. Cytokine analysis showed comparable results between PB and SF, with only IL-6 being significantly increased in SF. The authors concluded that early OA joints show already significant inflammation through CD4+ T cell infiltration, with predominant Th1 cell polarization. Inflammation seems to be driven by direct proinflammatory cell interaction. Cytokine signaling seems to be negligible at the site of inflammation in early OA, with only IL-6 being significantly increased in SF compared to PB. The study was published on January 22, 2021 in the journal Arthritis Research & Therapy. LabMedica International February-March/2021

COVID -19 Diagnostics Update Cont’d from page 13

RdRp, and N genes of SARS-CoV-2, as well as influenza A and B, in a single nasopharyngeal or oropharyngeal sample.

the front their nostrils, providing organizations with a cost-effective approach to testing individuals swiftly, reliably and securely for COVID-19.

Ortho’s CE-Marked VITROS SARS-CoV-2 Antigen Test Detects Asymptomatic COVID -19 Individuals

Fastest Ever Robotics-Driven COVID-19 Mass Testing Platform Gives 99% Accurate Results

Ortho Clinical Diagnostics (Raritan, NJ, USA; www.orthoclinicaldiagnostics.com) has announced that its CE-marked VITROS SARSCoV-2 antigen test can now detect SARSCoV-2 infection in asymptomatic individuals. Additionally, Ortho’s VITROS SARS-CoV-2 Antigen Test, designed to detect active infection, has become the first high-volume COVID-19 antigen test to receive US Food and Drug Administration (FDA) Emergency Use Authorization (EUA).

A new robotics-driven COVID-19 mass testing platform rolled out by Salient Bio (London, UK; www.salient.bio) is up to three times faster than competitors for mass testing and aims to provide affordable, effective and easy-to-access pre-emptive diagnostic solutions for a range of medical conditions that facilitate early intervention and improve overall health outcomes. The robotics-driven COVID-19 mass testing platform facilitates COVID-secure environments at a quicker and more cost effective rate than the closest approved competitor, with a same day results notification process and a very cost effective per unit price for businesses conducting mass testing.

Cepheid Receives CE-IVD Registration for SARS-CoV-2, Flu A, Flu B and RSV Combination Test Cepheid (Sunnyvale, CA, USA; www.cepheid.com) has received the CE-IVD marking for its Xpert Xpress SARS-CoV-2/Flu/RSV, a rapid molecular diagnostic test for qualitative detection of the viruses causing COVID-19, Flu A, Flu B, and RSV infections from a single patient sample. The test, which received Emergency Use Authorization from the US Food & Drug Administration in September 2020, is now available in the European Union and other markets that recognize CE-IVD marking. Beckman Coulter Launches Semi-Quantitative Access SARS-CoV-2 IgG II Antibody Test Beckman Coulter Diagnostics (Brea, CA, USA; www.beckmancoulter.com) has launched its Access SARS-CoV-2 IgG II assay that measures a patient’s relative level of antibodies in response to a previous SARS-CoV-2 infection. The assay’s new capabilities enable clinicians to establish a baseline to evaluate an individual’s immune response to the SARS-CoV-2 virus based on a numerical value and assess relative changes of an individual’s immune response to the virus over time. Mast Group Launches New ESPLINE SARS-CoV-2 Lateral Flow Antigen Test Mast Group Ltd. (Liverpool, UK; www.mastgroup.com) has launched the new ESPLINE SARS-CoV-2 lateral flow antigen test for the detection of COVID-19. The ESPLINE SARSCoV-2 is an immunochromographic assay for the detection of SARS-CoV-2 antigen directly from nasopharyngeal swab. The lateral flow test is to be used as an aid in the diagnosis of SARS-CoV-2 infection. FDA Grants EUA to One of the First Tests That Measures Specific Levels of COVID-19 Neutralizing Antibodies The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to one of the first tests that mea-

LabMedica International February-March/2021

sures specific levels of COVID-19 neutralizing antibodies. COVID-SeroKlir, a semi-quantitative SARS-CoV-2 IgG antibody test kit from Kantaro Biosciences, LLC (New York, NY, USA; www.kantarobio.com). Unlike other antibody tests, COVID-SeroKlir determines the presence and precise level of IgG antibodies and has a broad range of applications in the fight against COVID-19. First-Ever COVID-19 Severity Test to Triage Patients Quickly and Accurately A new test developed by Abionic SA (Lausanne, Switzerland; www.abionic.com) offers medical criteria of COVID-19 severity and likelihood of clinical deterioration within minutes of analyzing a blood sample, allowing healthcare practitioners to decide whether COVID-19 patients should be assigned to general wards, intensive care units (ICUs) or be discharged from the hospital. The cSOFA score (Covid Sequential Organ Failure Assessment) is the first-ever test that measures the likelihood of clinical deterioration in COVID-19 patients, enabling triage and assignment to the general ward or ICU upon admission and during the patients’ hospital stay. RapidRona Self-Collection COVID-19 Kit Secures FDA Emergency Use Authorization RapidRona (Chicago, IL, USA; www. rapidrona.com) has received Emergency Use Authorization (EUA) from the FDA for its SARS-CoV-2 sample self-collection kit. The kit aims to deliver convenience, ease-of-use, and guaranteed turnaround times for in vitro diagnostic testing for COVID-19 as the pandemic runs into flu season, testing shortages continue, and lead times among the largest testing labs increase. Self-Swab Kit for COVID-19 Test Granted Emergency Use Authorization by FDA A kit developed by researchers at Stanford Medicine (Stanford, CA, USA; www.med. stanford.edu) that allows individuals to collect their own nasal swabs and ship the specimens to a lab for COVID-19 testing has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA). With the kit, individuals can self-collect a sample using a safe and gentle nasal swab in

Printable POC SARS-CoV-2 Antibody Test for COVID-19 Could Produce Results in Real Time A low-cost electrochemical technology for multiplexed biomarker detection licensed by the Wyss Institute for Biologically Inspired Engineering at Harvard University (Boston, MA, USA; www.wyss.harvard.edu) to The iQ Group Global (Sydney, Australia; www. theiqgroupglobal.com) could facilitate global serological testing for SARS-CoV-2 infections, and help trace immunity in individuals over time. This could lead to the creation of a chewing-gum-sized diagnostic ‘strip’ that can be used for COVID-19 testing at point of care, with the ability to be printed at scale at a low cost, and produce real-time results. COVID-19 Rapid Breath Test Uses Exhaled VOCs in Human Breath as Biomarkers of SARS-CoV-2 Canary Health Technologies (Cleveland, OH, USA; www.canaryhealthtech.com) and Divoc Laboratories (Delhi, India; www.divoc. health) have entered into a collaboration to develop an ultra-rapid and highly accurate breath test for the detection of COVID19. Using exhaled Volatile Organic Compounds (VOCs) found in human breath as biomarkers of the virus, the screening test named ASU Detect CV19 is designed to detect the virus in people with and without symptoms. The hand-held digital test which requires minimal training can be performed at the point of care without the need of a lab. New High-Throughput RT-PCR Testing System for SARS-CoV-2 Can Process Up To 35,000 Tests per Day LGC Genomics (Middlesex, UK; www. lgcgroup.com) has submitted its HTP RT-PCR testing system for SARS-CoV-2 to the FDA for Cont’d on page 19

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YHLO iFlash-2019-nCoV Antigen Test applies the chemiluminescent immunosassay (CLIA) for the qualitative detection of SARS-COV-2 antigen in nasal swab or nasopharyngeal swab.

The Nova Primary is a rapid, accurate, easy to use, blood glucose laboratory analyzer that utilizes a single, reusable glucose electrochemical sensor based on glucose oxidase and has a measurement range of 10-900 mg/dL.

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Liquid Biopsy Predicts Colon Cancer Relapse Months Earlier

olorectal cancer (CRC), also known as bowel cancer, colon cancer, or rectal cancer, is the development of cancer from the colon or rectum (parts of the large intestine). Signs and symptoms may include blood in the stool, a change in bowel movements, weight loss, and fatigue. Despite improvements in curative-intent treatment for stages I-III CRC, 20%-30% of patients relapse. Better detection of minimal residual disease (MRD) could improve postoperative risk assessment, and earlier detection of recurrence would allow more patients to receive curative-intent therapy after recurrence and lead to better survival. Medical scientists at the Aarhus University (Aarhus, Denmark; www. au.dk) organized a clinical study to test the hypothesis that postoperative circulating tumor DNA (ctDNA) measurement could identify patients with MRD and stratify patients into high- and low-risk groups. They also wanted to assess post-treatment relapse risk in ctDNA-positive patients and determine the lead time from ctDNA detection to radiographic recurrence. Data analysis included 260 patients with stages I-III CRC, 48 of who relapsed after curative-intent treatment. The cohort consisted of four patients with stage I disease, 90 with stage II, and 166 with stage III. There were 165 patients who received adjuvant therapy, and relapse-free patients had a median follow-up of 29.9 months. Assessment of ctDNA was performed in 218 patients with the Signatera assay (Natera, San Carlos, CA, USA; www.natera.com), which identified 20 patients with detectable ctDNA (MRD positive) and 198 with no detectable ctDNA. A positive ctDNA test was associated with a recurrence hazard ratio (HR) of 11.0. Among patients who received adjuvant chemotherapy, a positive ctDNA test at the end of treatment was V

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associated with a recurrence rate of 83.3% as compared with 12.5% for those who had negative ctDNA tests (HR 12). Longitudinal assessment of ctDNA showed that the risk of recurrence increased over time in ctDNA-positive patients and decreased in ctDNA-negative patients (89.3% versus 3.4%, HR 51). The investigators compared the performance of ctDNA with the tumor-associated protein CEA. Measurement of postoperative CEA (n=175) and after adjuvant chemotherapy (n=99) did not have a significant association with the risk of recurrence. Longitudinal assessment of CEA (n=197) did predict an increased risk of recurrence (HR 4.9), but not as well as longitudinal ctDNA (n=197, HR 95.7). In a subgroup of 29 patients with clinical recurrence detected by CT scan, ctDNA detection ensured a median of 8.1 months earlier. Tenna V. Henriksen, PhD, the first author of study, said, “We saw that patients with ctDNA detected immediately after surgery had a very high risk of recurrence. We also saw that longitudinal monitoring increased the predictive power of ctDNA. Molecular recurrence by ctDNA was detected a median of eight months before radiological detection of recurrence. Using longitudinal testing with ctDNA outperforms CEA in recurrence-free survival prediction.” The authors concluded that postoperative ctDNA positive status was associated with markedly reduced relapse-free survival (RFS) compared to CEA. The study also shows that effective therapy can be curative in a portion of MRD-positive patients. In a longitudinal setting, ctDNA analysis predicted the risk of recurrence and is a more reliable biomarker for treatment response monitoring. The study was presented at the Gastrointestinal Cancers Symposium virtual meeting held January 15-17, 2021. Image: The Natera Signatera Assay Can Predict Colon Cancer Relapse Months Earlier (Photo courtesy of Mohammed Haneefa Nizamud) LabMedica International February-March/2021

COVID -19 Diagnostics Update Cont’d from page 15

Emergency Use Authorization (EUA) that can expand the capacity of labs by running up to 35,000 tests per day. With the HTP RT-PCR testing system for SARS-CoV-2, EUA request submitted, testing labs can leverage LGC’s expertise in automated sample preparation and RT-PCR workflows in a ready-to-deploy sample-to-answer solution. Bio-Rad Launches SARS CoV-2 Standard for Coronavirus (COVID -19) Testing Bio-Rad Laboratories, Inc. (Hercules, CA, USA; www.bio-rad.com) has launched a SARS CoV-2 Standard through its Exact Diagnostics product line to support laboratory assay validation of coronavirus (COVID-19) testing. Bio-Rad is providing the SARS CoV-2 Standard to help labs validate their COVID-19 assay results and accelerate access to testing. GENETWORx Labs Launches New Breakthrough Diagnostic Flu A-B/ COVID -19/RSV Combination Test TCA/GENETWORx Labs (Glen Allen, VA, USA; www.genetworx.com) has unveiled a new breakthrough diagnostic Flu A-B/COVID19/RSV combination test that provides patients with early detection of all three separate respiratory viruses with just one test sample. The molecular diagnostic PCR test detects two types of influenza viruses - influenza A and B - and differentiates them from RSV, and SARSCoV-2, the virus that causes COVID-19. New Silicon-Based Lab-On-Chip Test Could Pave the Way for Cheap Handheld COVID -19 Testing A tiny new silicon-based lab-on-chip test developed at the Imperial College London (London, UK; www.imperial.ac.uk) could pave the way for cheap COVID-19 testing. The chip known as TriSilix is a ‘micro laboratory’ which performs a miniature version of the polymerase chain reaction (PCR) on the spot. The system could in future be mounted onto handheld blood sugar test-style devices, allowing people to test themselves and receive results at home for colds, flu, recurrent infections like those of the urinary tract (UTIs), and COVID-19. Using Combination of Several SARSCoV-2 Antibody Tests May Give Best Results for Detecting COVID -19 A new study by the University of Tartu (Tartu, Estonia; www.ut.ee) has found that the sensitivity of tests used to detect SARSCoV-2 antibodies in a blood sample may differ significantly and a combination of several tests may give the best result in detecting COVID-19. The study found that the best diagnostic sensitivity in detecting antibodies was achieved by combining several antibody tests, for instance, a test detecting antibodies to the spike protein with the test detecting antibodies to the nucleocapsid.

LabMedica International February-March/2021

New ELISA-Based COVID -19 Test Detects and Ranks SARS-CoV-2 Neutralizing Antibodies by Their Potency

Rapid, Ultrasensitive Test Uses Paper-Based Electrochemical Sensor to Detect COVID-19 in Five Minutes

A new enzyme-linked immunosorbent assay (ELISA)-based COVID-19 diagnostic test by AXIM Biotechnologies, Inc. (San Diego, CA, USA; www.aximbiotech.com) detects and ranks SARS-CoV-2 neutralizing antibodies by their potency in a simple and relatively short test time. The test developed internally by AXIM aims to fulfill the need to know the levels of neutralizing antibodies in longitudinal studies of vaccine response in the post-vaccine COVID-19 fight.

A new rapid, ultrasensitive test developed by researchers at the University of Illinois Grainger College of Engineering (Urbana, IL, USA; www.grainger.illinois.edu) can detect the presence of the SARS-CoV-2 virus in less than five minutes using a paper-based electrochemical sensor. The team has created a graphene-based electrochemical biosensor with an electrical read-out setup to selectively detect the presence of SARS-CoV-2 genetic material.

CRISPR-Based COVID -19 Test Uses Smartphone Camera to Provide Results in 30 Minutes Scientists at Gladstone Institutes (San Francisco, CA, USA; www.gladstone.org), University of California, Berkeley (Berkeley, CA, USA; www.berkeley.edu), and University of California, San Francisco (UCSF; San Francisco, CA, USA; www.ucsf.edu) have developed a CRISPR-based test for COVID-19 that can detect the presence of SARS-CoV-2 in a nasal swab using a smartphone camera and provide accurate results in less than 30 minutes. Not only can their new diagnostic test generate a positive or negative result, it also measures the viral load (or the concentration of SARS-CoV-2, the virus that causes COVID-19) in a given sample.

High-Speed NanoPCR Technology Diagnoses COVID -19 in 20 Minutes with Zero False Positive and False Negative A new high-speed nanoPCR technology for point-of-care (POC) diagnosis of COVID Cont’d on page 21

FDA Authorizes First COVID-19 and Flu Combination Test for Use with Home-Collected Samples The US Food and Drug Administration (FDA) has authorized Quest Diagnostics’ (Secaucus, NJ, USA; www.questdiagnostics. com) RC COVID-19 +Flu RT-PCR Test for prescription use with the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu by individuals who are suspected of respiratory viral infection consistent with COVID-19 when home collection is determined to be appropriate by an individual’s healthcare provider. This is the first diagnostic test to be authorized by the FDA for at home collection of patient samples to detect both COVID-19 and influenza A and B (flu). New Blood Test for Early Immune Response to SARS-CoV-2 Could Enable Early Detection of Serious COVID -19 Patients Researchers at the QIMR Berghofer Medical Research Institute (Brisbane, Australia; ) have developed a new way of testing whether the immune system of COVID-19 patients is preparing to fight the SARS-CoV-2 virus that could be used for early identification of those patients whose immune systems are not responding appropriately and are therefore, at a higher risk of serious infection. The prototype test detects high levels of two key chemical signals that are produced by T cells when they recognize SARS-CoV-2-infected cells and begin fighting the infection. LINKXPRESS COM

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Biosensing Microneedle Patch Quantifies Biomarkers in Interstitial Fluid

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nterstitial fluid (ISF) compared with other peripheral biofluids such as saliva, sweat and tears is a particularly rich source of soluble bioanalytes including proteins, peptides, metabolites and nucleic acids that exhibit close correlation with blood. ISF is a rich source of biomolecules, densely packed with everything from neurotransmitters to cellular waste. However, to analyze biomarkers in ISF, conventional method generally requires extraction of ISF from skin. This method is difficult and usually the amount of ISF that can be obtained is not sufficient for analysis. That has been a major hurdle for developing microneedle-based biosensing technology. Bioengineers and medical scientists at the Washington University in St Louis (St Louis, MO, USA; https://wustl.edu) have developed a biosensing microneedle patch that can be applied to the skin, capture a biomarker of interest and, due to its unprecedented sensitivity, allow clinicians to detect its presence. In addition to the low cost and ease of use, these microneedle patches have another advantage over blood draws, perhaps the most important feature for some: they are entirely painfree. Finding a biomarker using these microneedle patches is similar to blood testing. But instead of using a solution to find and quantify the biomarker in blood, the mi-

croneedles directly capture it from the liquid that surrounds the cells in skin, which is called dermal interstitial fluid (ISF). Once the biomarkers have been captured, they are detected in the same way, using fluorescence to indicate their presence and quantity. The patches are almost pain-free. They go about 400 microns deep into the dermal tissue and they do not even touch sensory nerves. The team used “plasmonic-fluors,” an ultrabright fluorescence nanolabel. Compared with traditional fluorescent labels, when an assay was done on microneedle patch using plasmonic-fluor, the signal of target protein biomarkers shined about 1,400 times as bright and become detectable even when they are present at low concentrations. For people with chronic conditions that require regular monitoring, microneedle patches could eliminate unnecessary trips to the hospital, saving money, time and discomfort. The authors noted that various protein biomarker levels in the ISF are not well characterized and understood, which is an important bottleneck in the clinical translation of this technology. However the technology demonstrated serves as an efficient tool for biomedical and clinical scientists to fill this knowledge gap and propel the technology towards clinical applications. The study was published on January 22, 2021 in the journal Nature Biomedical Engineering. LabMedica International February-March/2021

COVID -19 Diagnostics Update Cont’d from page 19

19 developed by scientists at the Center for Nanomedicine (CNM) within the Institute for Basic Science (IBS; Seoul, Korea; www.ibs.re.kr) can accurately diagnose the infection in less than 20 minutes, with zero false positive and false negative. The nanoPCR technology can diagnose COVID-19 while retaining the accuracy of conventional reverse transcription polymerase chain reaction (RT-PCR) technology. COVID-19 Test Uses “Lab at Your Fingertip” Technology to Measure SARS-CoV-2 Antibodies in 15 Minutes A new rapid serology, self-contained assay from NOWDiagnostics, Inc. (Springdale, AR, USA; www.nowdx.com) uses “lab at your fingertip” technology to accurately measure the presence of SARS-CoV-2 antibodies in 15 minutes with no buffers, reagents, or additional equipment. The ADEXUSDx COVID-19 antibody test is a rapid serology, self-contained assay that measures the presence of SARS-CoV-2 antibodies and delivers lab-quality results in 15 minutes with no buffers, reagents, or additional equipment. EKF Launches One of the First Tests to Precisely Measure Levels of COVID -19 Neutralizing Antibodies EKF Diagnostics (Cardiff, Wales, UK; www.ekfdiagnostics.com) has introduced the new Kantaro COVID-SeroKlir SARS-CoV-2 IgG antibody test kit which is one of the first tests to precisely measure levels of COVID-19 neutralizing antibodies in individuals. The best-in-class serologic COVID-19 assay is based on technology developed by clinicians at the Icahn School of Medicine at Mount Sinai Health System in New York in partnership with RenalytixAI, a spinout company from EKF Diagnostics. Thermo Fisher’s New Direct from Saliva PCR Test for COVID -19 Enables Fast, Low-Cost Results Thermo Fisher Scientific Inc. (Waltham, MA, USA; www.ther mofisher.com) has launched a new direct from saliva PCR test for COVID-19 to enable widespread, high-frequency surveillance testing. By performing the test directly from raw saliva and eliminating the need for equipment, materials, time and labor associated with nucleic acid extraction, the TaqCheck SARS-CoV-2 Fast PCR Assay helps labs meet the turnaround time of 24-48 hours recommended by the Centers for Disease Control and Prevention (CDC). Rapid Lateral Flow Immunoassay Can Function As “Suitcase Laboratory” For On-Site Detection of COVID -19 Scientists from the Suzhou Institute of Biomedical Engineering and Technology (Suzhou, China; www.sibet.ac.cn) have developed a novel amplification-free rapid SARS-CoV-2 nucleic acid detection platform based on hybrid capture fluorescence immunoassay (HC-FIA) to fulfill the need for rapid and accurate nucleic acid detection at the point of care. The whole test procedure involves two steps, namely hybridization and immunofluorescence analysis, and it can be finished in less than an hour.

quantitative reverse-transcriptase polymerase chain reaction (RT-qPCR) method. Randox Launches Mobile COVID-19 Lab that Processes 1000 Samples per Day and Generates Results in 1-3 Hours Randox Laboratories (Crumlin, UK; www.randox.com) has unveiled a new Mobile Laboratory Service which will offer rapid and reliable COVID-19 workplace testing. The service from Randox uses gold standard PCR technology to generate results in one-three hours. Each Mobile Laboratory will be capable of processing up to 1,000 samples per day, to allow employers to uphold COVID safety within the workplace and maintain maximum output. Randox has also launched its new SARS-CoV-2 IgG test, utilizing patented Randox Biochip Technology to simultaneously detect IgG antibodies that are reactive to both of the leading COVID-19 diagnostic antigens - Spike Receptor Binding Domain (RBD) and Nucleocapsid protein (NP). Roche Launches Laboratory SARS-CoV-2 Antigen Test Roche (Basel, Switzerland; www.roche.com) has launched a high-throughput SARS-CoV-2 antigen test as an aid in the diagnosis of SARS-CoV-2 infections, in markets accepting the CE Mark. Roche’s Elecsys SARS-CoV-2 Antigen test is an immunoassay intended for the qualitative detection of SARS-CoV-2 present in the respiratory tract including nasopharynx and oropharynx. First-Ever AI Software Uses Routine Blood Tests to Help Labs Rule Out COVID-19 A recent study of Biocogniv Inc’s (South Burlington, VT, USA; www. biocogniv.com) new AI-COVID software has found it to be highly accurate in predicting the probability of COVID-19 infection using routine blood tests, which can help hospitals reduce the number of patients referred for scarce PCR testing. The researchers were able to train a model that analyzes changes in these routine tests and assigns a probability of the patient being COVID-19 negative with high accuracy. Eurofins Launches Rapid SARS-CoV-2 Antigen Test and RT-PCR Test in Self-Sampled, Gargling Format Eurofins Technologies (Budapest, Hungary; www.eurofins-technolo gies.com) has launched a CE-IVD labeled rapid test for the detection of SARS-CoV-2 antigens in 15 minutes and a SARS-CoV-2 RT-PCR test that has been successfully validated for pharynx gargling samples, providing a gold standard PCR test in an easy-to-use, self-sampling format. The GSD NovaGen SARS-CoV-2 (COVID-19) antigen rapid test provides results from nasopharyngeal samples within 15 minutes. The GSD Cont’d on page 22

Smartphone-Read Ultrasensitive and Quantitative Saliva Test for COVID -19 Provides Results within 15 Minutes A portable saliva-based smartphone platform offers an ultrasensitive yet accessible approach to COVID-19 testing by providing results within 15 minutes without the resource-intensive laboratory tests the current gold standard requires. In a new study that tested the approach in 12 people infected with COVID-19 and six healthy controls, the researchers demonstrated that this technique, which pairs a fluorescence microscope readout device with a smartphone to determine viral load from a CRISPR/Cas12a assay, works as effectively as the well-established

LabMedica International February-March/2021

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RESPIRATORY SARS-COV-2 PANEL

MOLECULAR SYSTEM

IMMUNOASSAY READER

The QIAstat-Dx Respiratory SARS-CoV-2 Panel is a multiplex syndromic cartridge that detects and differentiates 21 respiratory targets, including SARS-CoV-2 from nasopharyngeal swabs (NPS) eluted in universal transport media (UTM).

The VitaPCR Instrument is a rapid molecular POCT platform utilizing real-time reverse transcription polymerase chain reaction (RT-PCR) amplification technology for the processing and analysis of VitaPCR tests.

The ichroma II is an automatic or semiautomatic in-vitro diagnostic device that measures the concentration of analytes, contained in blood, urine, or other samples, in quantitative or semi-quantitative ways.

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A. MENARINI DIAGNOSTICS

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COVID -19 Diagnostics Update Cont’d from page 21

NovaPrime SARS-CoV-2 (COVID-19) is a highly sensitive Multiplex Real-Time PCR test for the direct qualitative pathogen detection of SARS-CoV-2 and has now been successfully validated for pharynx gargling samples. Eurofins has also launched EmpowerDX SARS CoV 2 RT PCR test with at home sampling option after it received an Emergency Use Authorization (EUA) by the FDA. FDA Grants EUA to First COVID-19 Test for Non-Prescription Home Use in Symptomatic and Asymptomatic Individuals The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Ellume COVID-19 Home Test from Ellume (Brisbane, QLD, Australia; www.ellumehealth.com), making it the first rapid, at-home test to be authorized for non-prescription home use for the detection of active COVID-19 in individuals with or without symptoms, and in adults and children aged two years and above. Instrument-Free, Handheld Diagnostic Test for SARS-CoV-2 to Provide Smartphone-Read Electrochemical Readout An instrument-free, synthetic biology-based molecular diagnostics platform from Sherlock Biosciences (Cambridge, MA, USA; www.she rlock.bio) could be adapted to work on a simple paper strip COVID-19 test or to provide an electrochemical readout that can be read with a mobile phone. Sherlock’s INSPECTR technology (formerly known as DROP) uses synthetic biology to enable the creation of instrument-free diagnostic tests that can be conducted at home, at room temperature. Multi-Matrix COVID -19 Test Could Detect SARS-CoV-2 Days Before Symptoms Appear A new multi-matrix COVID-19 test based on ultra-sensitive technology from Quanterix (Billerica, MA, USA; www.quanterix.com) will be able to detect the SARS-CoV-2 virus in its earliest stages, days before symptoms appear, thus filling the urgent need for asymptomatic screening. Quanterix’s newest COVID-19 assay based on its ultra-sensitive Simoa technology is currently being used as a lab-developed test at CLIA labs pending the FDA’s consideration of the company’s EUA application. Abbott Granted FDA EUA for First Virtually Guided At-Home Use Of BinaxNOW COVID -19 Ag Card Rapid Test Abbott (Lake Forest, IL, USA: www.abbott.com) has been granted Emergency Use Authorization (EUA) by the US Food and

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Drug Administration (FDA) for virtually guided at-home use of its BinaxNOW COVID-19 Ag Card rapid test for detection of COVID-19 infection. Abbott has also received CE Mark for two new uses of its Panbio COVID-19 Ag Rapid Test Device for the detection of the SARSCoV-2 virus: asymptomatic testing and self-swabbing. Vivalytic’s Rapid Coronavirus Test Delivers Results for Positive Samples in Less Than 30 Minutes The Vivalytic SARS-CoV-2 rapid coronavirus test from Bosch Healthcare Solutions (Waiblingen, Germany; www.bosch-healthcare.com) now delivers its results even faster due to improved software for the Vivalytic analysis device. By applying optimized evaluation strategies, the Vivalytic analysis device can detect a positive SARS-CoV-2 sample through its high viral load in less than 30 minutes, right where the sample is collected. Menarini Diagnostics Launches New Molecular Test That Distinguishes Between COVID-19 and Flu in 20 Minutes A. Menarini Diagnostics (Florence, Italy; www.menarinidiagnostics. com) has introduced a new test that, with a single diagnostic test and a single swab, can identify if the patient is positive for COVID-19 or if they have contracted the Influenza A or B viruses. The test is carried out on the VitaPCR platform, the Point of Care instrument mainly used for the molecular diagnosis of COVID-19. Quidel Receives FDA EUA for QuickVue SARS Rapid Antigen Test for COVID-19 Diagnosis Quidel Corporation (San Diego, CA, USA; www.quidel.com) has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) to market its QuickVue SARS Antigen test. Quidel has also received EUA from the US FDA to market its Solana SARS-CoV-2 Assay, an isothermal Reverse TranscriptaseHelicase Dependent Amplification (RT-HDA) assay. AI-Based Breathalyzer Can Electronically “Smell’ Coronavirus and Detect Infection in Under Two Minutes A simple breathalyser test developed by scientists at the Gadjah Mada University (Jogjakarta, Indonesia; www.ugm.ac.id) uses artificial intelligence (AI) to electronically “smell’ the novel coronavirus and detect infection in less than two minutes. The device named GeNose C19, or Gadjah Mada Electronic Nose, rapidly detects COVID-19 using only a person’s breath. The electronic-based diagnostic tool uses the cloud computing system to deliver real-time diagnosis results and can also be run in parallel through a centralized diagnostic process to maintain data validity for all connected devices.

Cont’d on page 23

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COVID -19 Diagnostics Update Cont’d from page 22

New Blood-Test Device That Monitors Blood Chemistry Continually Could Be Used To Spot SARS-CoV-2 A new lab-on-a-chip device developed by researchers at Stanford (Stanford, CA, USA; www.stanford.edu) that can continuously sense levels of virtually any protein or molecule in the blood could be transformative for disease detection, such as COVID-19. The device dubbed the “Real-time ELISA” is able to perform many blood tests very quickly and then stitch the individual results together to enable continuous, real-time monitoring of a patient’s blood chemistry. New Nanotechnology-Based Diagnostic System Detects COVID-19 within 10 Seconds A new COVID-19 diagnostic system developed by researchers from the Bilkent University (Ankara, Turkey; https://w3.bilkent.edu.tr) uses nanotechnology to provide results in 10 seconds with 99% accuracy. The new nanotechnology-based diagnostic system, called Diagnovir, can detect the COVID-19 virus within 10 seconds with a swab taken from the mouth. It is an optically based diagnostic and identification system that changes the color of the glow in the presence of the virus, thus detecting viruses with high selectivity. New COVID-19 RNA Test Reduces Testing Time to Less than Five Minutes Researchers from the University of Birmingham (Birmingham, UK; www.birmingham.ac.uk) have developed a new COVID-19 test that reduces testing time from 30 minutes to less than five and delivers accurate results. The team which developed the test believes their method could deliver a test that is not only fast but also sufficiently sensitive. The test does not require samples to be treated at high temperatures, and it can be performed using standard laboratory equipment, making it readily deployable. New COVID-19 Rapid Antigen Test Can Be Run on Mobile Testing Platform for Lab-Quality Test Results in 15 Minutes A new COVID-19 rapid antigen test from Nanōmix, Inc. (Emeryville, CA, USA; www.nano.com) that provides lab-quality test results in 15 minutes could offer a frequent, fast, cheap and easy COVID-19 screening solution to help meet the surging demand for tests and relieve the global supply chain. Nanōmix’s eLab COVID-19 Rapid Antigen test is a low-cost, easy-to-use, point-of-care test that provides results in 15 minutes with lab-quality accuracy. NIH Develops Robust SARS-CoV-2 Serology ELISAs from Serum and Dried Blood Microsamples In order to achieve the high levels of specificity and sensitivity needed for its “serosurvey” to track undetected cases of COVID-19 in the US, researchers at the National Institutes of Health (NIH Bethesda, MA, USA; www.nih.gov) have developed two assays to detect the spike protein and receptor binding protein, achieving sensitivity of 100% (95% CI 76.8%, 100%), and specificity of 100% (95% CI 96.4%, 100%). COVID -19 Test Chip Made By Aerosol Jet Nanoparticle 3D Printing Detects SARS-CoV-2 Antibodies in 10-12 Seconds An advanced nanomaterial-based biosensing platform developed by researchers at the Carnegie Mellon University (Pittsburgh, PA, USA; www.cmu.edu) detects antibodies specific to SARS-CoV-2 within seconds and can also help to quantify patient immunological response to the new vaccines with precision. The new testing platform identifies the presence of two of the virus’ antibodies, spike S1 protein and receptor binding domain (RBD), in a very small drop of blood (about five microliters). FDA Monitoring Impact of SARS-CoV-2 Mutations on Results of Authorized COVID -19 Molecular Tests The US Food and Drug Administration (FDA; Silver Spring, MD, USA: www.fda.gov) has alerted clinical laboratory staff and health care

LabMedica International February-March/2021

providers that it is monitoring the potential impact of viral mutations, including an emerging variant from the UK known as the B.1.1.7 variant, on authorized SARS-CoV-2 molecular tests. The FDA has also warned that false negative results can occur with any molecular test for the detection of SARS-CoV-2 if a mutation occurs in the part of the virus’s genome assessed by that test. Snibe Diagnostic’s Maglumi SARS-CoV-2 Neutralizing Antibody Assay Receives CE Mark Snibe Diagnostic (Shenzhen, China; www.snibe.com) has received CE marking for its Maglumi SARS-CoV-2 Neutralizing Antibody Assay. The fully automated test can detect neutralizing antibodies against SARS-CoV-2 within 20 minutes when used with the company’s Maglumi analyzers. New Simplified Rapid COVID -19 Testing Protocol Requires Less Labor, Expertise and Equipment A simplified COVID-19 testing protocol developed by researchers at the Schmidt College of Medicine at Florida Atlantic University (Boca Raton, FL, USA; www.fau.edu) aims to meet the urgent need for introducing alternative reagents and approaches to provide nucleic-acid testing in the face of heightened demand and potential shortages. The testing protocol offers a distinct advantage over the standard viral or universal transport medium (VTM) as it can detect minimal quantities of the SARS-CoV-2 using samples from both upper respiratory tract swabs (nasal and throat) as well as saliva, and can be used in research laboratories with minimal molecular biology equipment and expertise. Optical Chip on Disposable Card Could Detect COVID -19 Antibodies from Single Drop of Blood in One Minute Researchers, led by the University of Rochester Medical Center (Rochester, NY, USA; www.urmc.rochester.edu), are developing an optical chip on a disposable card that can detect exposure to multiple viruses within a minute - including the coronavirus that causes COVID19 - from a single drop of blood. The USD 1.7 million project funded by the US Department of Defense Manufacturing Technology Program through a contract with AIM Photonics (Albany, NY, USA; www. aimphotonics.com) also involves Ortho Clinical Diagnostics (Raritan, NJ, USA; www.orthoclinicaldiagnostics.com) which develops and manufactures innovative laboratory testing and blood-typing solutions. ‘Lab on a Chip’ Test Could Detect COVID -19 Immune Response Faster Than Current Antibody Testing A new antibody test being developed by researchers at the Southern Methodist University (Dallas, TX, USA; www.smu.edu) has the potential to detect the presence of antibodies generated in response to COVID-19 faster and with more accuracy than current antibody testing. Researchers estimate that the “Lab on a Chip” test could detect immune responses to coronavirus in two to three minutes, with just a drop of blood. New Process Analyzes Predominant SARS-CoV-2 Mutations As Well As Possible New Virus Variants A new and more efficient process has been developed by baseclick GmbH (Munich, Germany; www.baseclick.eu) to determine not Cont’d on page 24

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SARS-COV-2 ANTIBODY TEST

LAB AUTOMATION SOLUTION

COVID-19 TEST

The Lumipulse G SARS-CoV-2 Ag is designed for in vitro diagnostic (IVD) use with the Lumipulse G system for the detection and quantitative measurement of SARS-CoV-2 antigen in human nasopharyngeal swab or saliva.

The SATLAS-TCA total laboratory automation solution, jointly developed by Thermo Fisher Scientific and Snibe, is a combination of Snibe’s fully-automated CLIA system MAGLUMI X8 (600Tests/Hour) and Biochemistry analyzer.

The ID NOW COVID-19 test returns positive results in 13 minutes or less to enable immediate clinical decisions. The ID NOW platform is designed for near-patient, point-ofcare use in a variety of healthcare settings.

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COVID -19 Diagnostics Update Cont’d from page 23

only predominant SARS-CoV-2 mutations but also minor occurring mutations in the virus population which might become eventually new strains. The Click Tech Single Strain Mutation Mapping Kit for SARS-CoV-2 developed by baseclick, together with “long-read” sequence methods, such as those provided by Pacific Biosciences (Menlo Park, CA, USA; www.pacb.com) allow an exact genomic assessment of the frequency of newly-emerging virus variants in the population. Procter & Gamble’s Novel Fully Injection-Molded Polypropylene Nasal Swab Improves Speed of COVID-19 Testing Procter & Gamble (P&G; Cincinnati, OH, USA; www.pg.com) and Rhinostics Inc. (Cambridge, MA, USA; www.rhinostics.com), a Harvard spin-out company, have partnered to develop the nasal swab that improves the speed of testing and adds additional swab capacity for COVID-19 testing. The fully injection-molded polypropylene nasal swab developed for COVID-19 testing that allows for easy collection from the front of the nose and provides sample concentration of up to 30 fold over other swabs in viral transport media is likely to positively impact testing availability. Erba Mannheim Launches Second Generation SARS-CoV-2 RT-PCR Assay with Room Temperature Storage Erba Mannheim (London, UK; www.erbamannheim.com) has launched the ErbaMDx SARS-CoV-2 RT-PCR Kit for the detection of SARS-CoV-2. The ErbaMDx SARS-COV-2 RT-PCR kit is a molecular diagnostic test that aids the detection and diagnosis of COVID-19 infections and is based on latest nucleic acid amplification technologies. It is a real-time reverse transcriptase PCR test that has been developed utilizing universally trusted priming sites with updated primer sequences to maximize long term performance. Innovative Pain-Free Microneedle Patch with Unprecedented Sensitivity Can Test for Level of Antibodies against COVID-19 A nearly pain-free microneedle patch developed by engineers at the McKelvey School of Engineering at Washington University in St. Louis (St. Louis, MO, USA; www.wustl.edu) can be applied to the skin, capture a biomarker of interest and, thanks to its unprecedented sensitivity, allow clinicians to detect the presence of antibodies that signal a viral or bacterial infection, such as SARS-CoV-2. The new technology which is low cost and easy for a clinician or patients themselves to use,

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could eliminate the need for a trip to the hospital just for a blood draw. WHO Changes SARS-CoV-2 Virus Test Criteria to Reduce False Positives In its updated guidance, the World Health Organization (WHO; Geneva, Switzerland; www.who.int) has cautioned experts not to rely solely on the results of a PCR test to detect the SARS-CoV-2 virus and consider the results in combination with other factors such as timing of sampling, specimen type, and assay specifics, among others. Lateral Flow Tests Detect Most Infectious COVID-19 Cases, Reveals New Research Lateral flow devices can detect most infectious COVID-19 cases and could allow a safer relaxation of the current lockdown, according to a new study by researchers from the University of Oxford (Oxford, UK; www.ox.ac.uk). The scientists found that in all groups, the more virus detected in the nose and throat (known as ‘viral load’), the more infectious the individual is. This is the first time this has been confirmed in a large-scale study and explains part of why some people pass COVID-19 on and others do not. Researchers Develop Accurate, High-Speed, Portable Bi-Functional Electrical Detector for COVID-19 Scientists at the Peking University (Beijing, China; www.pku.edu. cn) have developed an unprecedented accurate, rapid, and portable electrical detector based on the use of graphene field-effect transistors (G-FETs) for the detection of RNA from COVID-19 patients. The unique feature of this method is that the extent of hybridization between the ss-DNA probe and viral RNA can be directly converted to the current change of graphene channels without repetition of the PCR process, thus affording an ultra-low limit of detection (LOD) of 0.1 fg/mL for the detection of the RNA-dependent RNA polymerase (RdRp) gene target of SARS-CoV-2. Novel SARS CoV-2 Saliva Collection Devices Improve Lab Efficiency and PCR Test Performance Two new saliva SARS-CoV-2 sample collection products from GenTegra GTR-STMdk saliva sample collection tubes from GenTegra, LLC (Pleasanton, CA, USA; www.gentegra.com) are expected to facilitate the expansion of COVID-19 testing, address testing challenges, and improve lab efficiency and PCR test performance. The company’s GenTegra GTR-STM and direct-into-PCR GenTegra GTR-STMdk saliva sample collection tubes are the only devices that eliminate dilution of virus levels in saliva samples, while providing a safe and convenient means to transport saliva samples at ambient conditions. LabMedica International February-March/2021

Edited by Katherina Psarra MSc, PhD

IFCC members may send news to: Katherina Psarra, MSc, PhD, Dept of Immunology – Histocompatibility, Evangelismos Hospital, Ipsilantou 45-47, Athens 10676, Greece4; Email: enews@ifcc.org

MESSAGE FROM THE PRESIDENT By Khosrow Adeli

•

President, IFCC

appy New Year to you all in the IFCC family. Moving into 2021, the IFCC is eager to continue its mission of “advancing excellence in laboratory medicine for better healthcare worldwide”. In 2020, we made significant progress towards impacting healthcare delivery and patient outcomes, initiating a number of new programs in the areas of newborn screening, global lab quality, putting together the infrastructure to become the largest provider of free distance learning in the field of laboratory medicine, and aiding clinical laboratories in the fight against the COVID-19 pandemic through development and publication of laboratory practice guidelines. Despite unique challenges presented by the COVID-19 pandemic over the past year, the IFCC has had an immensely successful year, laying the foundation for the 2020-2023 strategic plan. We look forward to continuing this momentum into 2021! In my previous president messages, I had detailed the terms of reference and strategic plans for the new taskforces on Global Newborn Screening, Global Laboratory Quality (iQC and EQA), and Global eLearning/eAcademy. I am happy to inform you that the membership for all these new taskforces is now complete and the taskforces have begun their work. They will be meeting on a monthly meeting via zoom and have already initiated detailed plans to implement the new strategic plans around these key areas of priority for IFCC. We will keep you updated over the coming months. Full membership rosters for TF-NBS, TF-GLQ, and TF-GEL are posted at the IFCC website, www. ifcc.org. As you are all well aware, the COVID-19 pandemic continues to have an enormous impact on our daily life as well as our laboratory practices. The pandemic has engaged the laboratory community in test development, validation, and implementation at unprecedented rates to support patient care and public health initiatives. In March 2020, a new Taskforce known as the IFCC Taskforce on COVID-19 was established by IFCC to summarize, critically review, and disseminate the most up-to-date, evidence-based information about the novel coronavirus as well as provide recommendations regarding test implementation. Beginning in April, the Taskforce published the IFCC Information Guide on COVID-19 to share key information and resources with laboratory professionals worldwide and has since regularly updated this guide on a biweekly basis as new information becomes available. This group also published an evaluation of the latest evidence on clinical testing (Bohn et al. CCLM 2020), as well as guidelines on biosafety (Lippi et al. CCLM 2020). In addition, the Taskforce administered and published the results of surveys to understand how laboratories were managing operational and biosafety challenges during the pandemic (Loh et al. CCLM 2020). Most recently, the Taskforce published interim guidelines based on available evidence for publication, providing practical recommendations to laboratories on molecular testing of SARS-CoV-2 infection, serological testing for antibodies against

LabMedica International February-March/2021

SARS-CoV-2, as well as biochemical and hematological monitoring of COVID-19 patients. Importantly, a kind reminder that IFCC has planned an exciting new IFCC Global Conference on COVID-19, which took place virtually on February 15-17, 2021. The theme of this conference was the Critical Role of Clinical Laboratories in the COVID-19 Pandemic, with the goal of bringing together leading experts on a global virtual platform to present the latest advances in COVID-19 diagnostics and therapeutics. I am pleased to inform you that we received strong sponsorship support for this conference and over 2400 registrations from over 95 countries from around the world (as of January 22nd): an exciting scientific conference with excellent speakers representing regions from around the world, made this a truly international event.

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

NEWS

Editorial By Katherina Psarra MSc, PhD Dear colleagues, wish you a happy, joyful, fruitful, productive, and creative New Year! I admit this is wishing for a lot, but let’s try for the maximum (to get something...). Well, I am looking forward to the time when my editorial won’t begin with a phrase about COVID-19... One step forward..., one or half step back? In this IFCC Corner our president Prof. Khosrow Adeli is presenting the plans of the IFCC for the New Year. He also introduces the members of the new IFCC task forces. We are looking forward to the results of their work.

24 Teams Receive Global Recognition For Healthcare Excellence In 2020

he UNIVANTS of Healthcare Excellence Award Program has recently announced its 2020 winners. Foundational principles across all winning teams include “UNIFYING” across the care continuum for the development and implementation of “AVANT-GARDE” processes with measurable differences to clinical care. The 2020 submissions included hospitals, commercial laboratories, reference laboratories, clinics and rural community care. Applications included best practices across key areas of unmet needs with representation from every region of the world, spanning both emerging and established markets. Following comprehensive judge review, the outcomes revealed 3 top winners, 9 teams of distinction, and 12 teams of achievement. The program is made possible by eight leading healthcare organizations that have partnered together to inspire and recognize integrated clinical care teams who have achieved exceptional outcomes in healthcare. The founding program partners include the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), AACC, EHMA (European Health Management Association), Modern Healthcare, Health Information and Management Systems Society (HIMSS), National Association of Healthcare Quality (NAHQ), and the

Also, we welcome and say farewell to new and old Chairs, and we are trying to learn from valuable IFCC people. There are a lot of interesting activities, virtual of course, from all over the world. They show that IFCC community is really busy, creative, dynamic and tries to face this unprecedented challenge with all forces. Dr. Bernard Gouget discusses the worldwide difficulties. It is important for all of us to realize that vaccines should be a public good, that only solidarity will bring the end of the pandemic. And he finishes: “Stronger than the virus, civilization still prevails, the opposite of a pathogenic virus.” Dear colleagues, working in the labs is a powerful way to fight the virus!

IN MEMORIAM Never Forgotten – In Memory of Ana Leticia Cáceres de Maselli

By Ana Lena, EB Regional Representative and Rosa Sierra-Amor, Member WG eNews CPD. r. Ana Leticia Cáceres de Maselli from Guatemala, Past President (2009-2011) of the Latin American Confederation of Clinical Biochemistry (COLABIOCLI) passed away on January 14th, 2021. Ana Leticia, was Member of the IFCC Education and Management Division Executive Committee (2017-2019), Member of the Nominations Committee (20162017), Advisor of the Public Relations Committee of the Communications and Publications Division, and National Representative of the Association of Chemists and Biologists of Guatemala (Asociación de Químicos Biólogos de Guatemala, AQBG). She graduated as Chemist-Biologist from the Faculty of Chemistry Sciences and Pharmacy at the University of San Carlos in Guatemala. She was elected Vice president and President of the AQBG in the 90s. Ana Leticia was very much involved in quality control and quality assurance, implementing the National External Quality Assessment Program for the clinical laboratories in Guatemala. She was the founder of the Biomedical Reference Laboratory, and the External Quality Assessment Program at the National Society. She formed the Quality Assurance Commission in 1995, and coordinated the Immunology External Quality Assessment Program as well. Ana Leticia was a member of the College of Pharmacists and Chemists of Guatemala. She participated in AACC activities as member of the first Latin American Working Group (2010-2011), activity that has improved the knowledge of quality control for the clinical laboratories in Latin America. She was a pioneer in the standardization of methods for the diagnosis of cysticercosis, a project that began as a research thesis, and she continued making progress in the diagnosis of this parasitic infection, an important contribution to our health until these days. The region and the scientific community of the world will miss a very active and devoted professional in clinical chemistry, and a very caring person. Ana Leticia has left a legacy of humanism and professionalism. Rest in Peace Ana Leticia.

D Institute of Health Economics (IHE); each in partnership with Abbott Laboratories. More details about the UNIVANTS of Healthcare Excellence program or 2020 best practices can be found on the program website at www.UnivantsHCE. com or follow on social media, including #UNIVANTS on LinkedIn. The success stories are especially meaningful in 2020 during unprecedented times for patients, communities and healthcare professionals. They are definitive proof that there is a core of vital partnerships and healthcare providers that work together and accomplish better patient care. It is with great honor that we congratulate all participating teams while celebrating strategic activation and insights from clinical and laboratory medicine to achieve measurably better outcomes for patients, payors, clinicians and health systems.

On demand content for this free IFCC Webinar is available on the IFCC website www.ifcc.org

LabMedica International February-March/2021

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

NEWS

Malawi Society Holds Second National Conference

Conference attendees pause for a group photo. The Guest of Honour, Mr. Kadewere is seated at the center.

he Malawi Association of Medical Laboratory Scientists (MAMLS; www. mamls.mw) held its second scientific conference on 9th December 2020 at the Golden Peacock Hotel in Lilongwe. The meeting was attended by laboratory professionals from across the country, from Central Hospital Laboratories, District Hospital Laboratories, Private laboratories, Christian Hospital Association of Malawi (CHAM) institutions, research institutions and Non-governmental organisations. The meeting was hosted both physically and virtually – 95 professionals participating physically and over 40 participants attending virtually (Malawi government COVID-19 regulations allow meetings of fewer than 100 physical participants). The theme of the Conference was: “Strengthening health services in Malawi through enhancement of the Medical Laboratory Profession”. This theme focussed on the significance of laboratory diagnosis in patient management, thereby strengthening and improving health services in Malawi. The purpose of the conference was to make laboratory professionals understand their role in healthcare provision and to strengthen the association by electing office bearers and endorsing the MAMLS constitution. The Conference was officially opened by Mr. Godfrey Kadewere, the Director of Health Technical Support Services (HTSS) at the Ministry of Health. He stressed the commitment of the government to strengthen clinical laboratory networks in the country. We were honoured to welcome three prominent guest key speakers: Prof. Giuseppi Lippi and Prof. Thomas Zima from the University of Verona, Italy and Charles University of Prague, Czech Republic, respectively presented virtually and Mr Richard Ndovi, Acting Registrar of Medical Council of Malawi (MCM) presented in person. Prof. Giuseppi Lippi presented a lecture on the role of the clinical laboratory in the diagnosis and management of COVID-19. Malawi has not been hit too badly to date by COVID-19, perhaps because it has a young population and a warm climate. MAMLS was keen to ensure that its members were well briefed on what to do should the infection return this winter. Prof. Thomas Zima from Charles University of Prague, Czech Republic delivered an overview of Tumour markers and their clinical applications and limitations. The presentation included the ways in which traditional clinical chemistry tumour makers (AFP, PSA, CA125 etc.) may be used in the diagnosis and management of cancer. Malawi has a high incidence of Hepatitis B and C and one specific example was the diagnosis of hepatocellular cancer in this highrisk population. Mr Richard Ndovi made a presentation on professional conduct during the COVID-19 pandemic and also explained the role of the Medical Council and the challenges it faced. In addition to the keynote speakers, we also had presentations from Bioway, SNIBE and MM African Technology. During the afternoon session, we endorsed our constitution and conducted elections. The following were elected as MAMLS office bearers: NATIONAL EXECUTIVE COMMITTEE President: Confidence Banda; Vice President: Jonathan Majamanda; Secretary General: Titus Chiwindo; Vice Secretary General: Joel Zephaniah Katua; National Treasurer: Elias Chipofya; National Vice Treasurer: Hilary Kapoteza

LabMedica International February-March/2021

THE COUNCIL Chairperson – Editorial, Publicity and Membership Committee: Anthali Munthali; Chairperson – Education, Training and Research Committee: Happy Manda; Chairperson – Finance and Planning Committee: MacDonald Saka; Chairperson – Disciplinary Committee: Brighton Mwenifumbo. The conference was closed by Mr. Joseph Bitilinyu-Bangoh, Assistant Deputy Director of HTSS-Diagnostics. He congratulated the newly elected office bearers and encouraged members to support them for the success of the association. The conference organizers gratefully acknowledge the generous support provided by the following: IFCC, Thofu investment, MM Africa Technology, Southern Skies and Boli Medical.

NEWS

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

VIEWPOINT

The Year Ahead In The Vaccine Purgatory

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

hile Europe struggles against a second wave of the epidemic and Americans are on their third, the forecasters are working overtime. For most of 2020, the coronavirus jumped from human to human, we were all in a race to curb the novel virus spread and flatten the curve with varying degrees of success. This year ahead, we are in another race to vaccine the world and in less than a year since the WHO declared the state of pandemic, we have more than one vaccine. But we need billions of doses to achieve herd immunity and stop the virus spread definitively. The generalization of vaccines is bringing a wave of optimism to major international public and private institutions with the hope of a better future. The slowdown in consumption due to the end of government aid and a health situation that has deteriorated sharply around the globe will penalize service activities at the start of 2021. There are many countries that must continue to be affected by lockdown measures until at least the summer. More than ever, it is crucial to support emerging countries. Reducing inequality has become a more urgent subject in emerging countries, where solidarity measures against the coronavirus that can be applied almost immediately are essential to control the health crisis. The possibility of providing a vaccine at the lowest cost is a particular challenge and restarting the global economy relies heavily on the implementation of vaccine policies. The success of vaccination programs depends on the ability of each government to provide a sufficient number of doses, their ability to administer them under the right conditions as quickly as possible and the willingness of the population to be vaccinated. In other words, all countries do not start from the same line. The new coronavirus variants: UK, South Africa, Brazil, etc. have been in the news since scientists sounded the alarm about B.1.1.7, a SARS CoV-2 variant that first caught the attention of researchers in England in December and which is more transmissible than the viruses circulating previously. The variants have emerged one after another at a sustained pace for several weeks, creating great unrest in the scientific community and public health authorities around the world. Now, researchers are also concentrating on a potential new threat: variants that could escape the human immune response. Some more contagious mutations have even become predominant in some countries, challenging the certainties about acquired immunity and the efficacy of current vaccines. In the face of this danger, researchers appear to be fully mobilized internationally. The WHO also convened its Emergency Committee on January 14 to discuss the impact of the new variants and the travel restrictions many countries are imposing to contain them. The committee has called for a global effort to further sequence and share SARS-CoV-2 genomes in order to monitor mutations. It has also asked countries to support global research efforts to better understand critical unknowns concerning mutations and variants specific to SARSCoV-2. Today, there are 51 countries in which the more transmissible UK variant B.1.1.7 has been detected. Scientists are also concerned regarding 501Y.V2, a variant detected in South Africa. Some mutations that it carries, including those called E484K and K417N, modify its surface spike protein and have been shown in the laboratory to reduce the ability of monoclonal antibodies to fight the virus. The variant identified in Manaus is also already in circulation. It is not yet clear how these new variants will affect the course of the pandemic. However, it is always necessary to remember that changes in human behavior are the still principal driver of this epidemic resurgence. Interactions among the new mutations could make it more difficult to identify

IFCC OFFICE Via Carlo Farini 81, 20159 Milan, ITALY Tel: (39) 02-6680-9912 • E-mail: ifcc@ifcc.org • Web: www.ifcc.org Office Hours: 8.30-13.00 and 13.30-17.30 Staff Members: Paola Bramati, Silvia Cardinale, Silvia Colli-Lanzi The views and positions expressed in the IFCC News section are those of the IFCC or the individual authors, and do not necessarily represent the views or positions of LabMedica magazine or its publishers.

their effects. The UK, South Africa and Manaus variants share a mutation called N501Y, or Nelly. But the mutation, which affects the spike protein, also occurs in some variants that do not spread more rapidly, which suggests that N501Y is not operating alone, explains Kristian Andersen of the Scripps Research Institute. Up until now, the virus does not appear to have become resistant to the COVID-19 vaccines. The bad news is that the rapid evolution of these variants suggests that the virus could evolve into a vaccine-resistant phenotype according to vaccine specialist Philip Krause, who presides over a WHO working group on vaccines. This possibility adds to the urgency of setting up effective monitoring to quickly detect such mutations and quickly vaccinate as many people as possible, even if this means running the risk of only targeting certain variants. If vaccine-resistant SARS-CoV-2 strains arise, vaccines may need to be updated. Several of them could be easily modified to reflect these changes. However, it is important that the public does not think that this is imminent. No doubt new vaccines will be needed. To this end, it is necessary that the biotech and pharmaceutical industries think about producing vaccines designed to generate immunity to mutated versions of the spike protein in order to shutdown one of the viral transmission routes. Social distancing measures and accelerating vaccination campaigns to deal with the threat of the variant are more relevant than ever. As in numerous areas in biology, to obtain a comprehensive understanding of virus operations, multidisciplinary approaches are required and there is a need for major investment in this field to enable rapid response to the dangers of this disease. This may be a major factor in saving lives worldwide. We are far from finished with COVID-19 and yet it must be kept in mind that other pandemics may occur. The transmission of viruses from animals to humans could accelerate since more than two-thirds of emerging diseases and nearly all known pandemics are caused by pathogenic agents of animal origin that scientists call “zoonoses”. The emergence of SARS-CoV-2 has demonstrated the limits of the current approach to the health crisis and highlighted global alert system reaction times that are too long. Control measures (limiting international movements, physical distancing, routine testing, lockdown, etc.) were delayed too long given the extent of the spread in China and then to the rest of the world. Many lessons can be drawn from the epidemic, such as the importance of having emergency plans, with the establishment of monitoring and alert systems coupled with pandemic prevention plans. The crisis has shown the need to have more flexible administrations and bureaucracies. Health systems must be more robust and agile. Political speech must be transparent and sincere to establish trust and help technological innovations to be better understood. The stakes are high, according to recent scientific studies, preventing emergences would cost 100 times less than trying to control them. Several Asian countries: China, Japan, Taiwan and South Korea have proven their efficiency once again while Europe and America have revealed weaknesses. Pandemic preparation plans are only as effective as they are operational, by consistently maintaining resources and equipment stores and conducting full-scale simulations. This epidemic is also a demonstration of the interaction between the environment and health. It is essential to establish a dialog of trust among science, politics and society to be ready to act quickly. Another striking fact is that the health emergency has transformed the vaccine into a in common good which partly escapes the laws of the market. Without killing the competition that stimulates research, the general mobilization has paid off. The example of COVID has precedents. For example, during the second world war, large drug companies successfully pooled their advances in penicillin for the US Army, after which business as usual resumed. Major problems like antimicrobial resistance, which is on the WHO list of the 10 greatest health threats and which carries the risk of tens of millions of deaths by 2050, would lend themselves well to such collaborations. Sooner or later a new pandemic will strike; it should be anticipated now. The challenge is to create good strategies and incentive schemes for more and faster innovation. One of the questions to ask is how far we can go with sanitary and safety requirements in the name of health. Where do we want to go after the pandemic? It is not a question of inventing new values but of remaining faithful to the values that we have been given to provide real meaning to life, freedom, justice and love, which we are responsible for sharing. Stronger than the virus, civilization still prevails, the opposite of a pathogenic virus. Nietzsche wrote that it is by transmitting it that we protect ourselves from nihilism and barbarism, by protecting others! LabMedica International February-March/2021

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Cont’d from cover

COVID-19 Testing to Boost Global IVD Sector To Nearly USD 120 Billion By 2027

During the past few decades, various infections such as severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), Ebola, chikungunya, avian flu, swine flu, and Zika have emerged as major threats to public health. The outbreak of the coronavirus (COVID-19) disease is a recent example. Although healthcare professionals are working tirelessly on the frontlines to fight the pandemic, it is equally important to minimize the spread of the disease by preparing kits for early diagnosis. Testing is an important tool for understanding and managing the coronavirus pandemic. Multiple diagnostic test manufacturers have developed and started offering various assays & kits for diagnosis to mitigate shortages of laboratory-based molecular testing capacity and reagents. These simple test kits detect proteins from the COVID-19 virus in respiratory samples (e.g., sputum, throat swab), blood, or serum of human antibodies generated in response to an infection. Thus, the increasing prevalence of infectious diseases across the globe has significantly boosted the need for diagnosing diseases, which is expected to drive the growth of the IVD market during the forecast period. The outbreak of the COVID-19 pandemic has created immense opportunities for the IVD market as testing has emerged as one of the greatest solutions in managing the pandemic. Though several trials for candidate vaccines and potential therapies are underway, there is currently no cure, and in the absence of effective therapies or vaccines, diagnostic testing has become a valuable tool amidst the pandemic. Different tests serve different purposes in the management of the pandemic: while viral RNA testing enables the point-of-care, acute detection of those infected with SARS-CoV-2, in time, the potential of immunological tests for contact tracing will be increasingly valued, with efforts to produce them on a large scale already being ramped up. Thus, the pandemic has led to the development of new kits and assays by the key manufacturers. This increase in newer diagnostic kits will boost the adoption of IVD, thereby providing

gitis and gastroenteritis. Diagenode previously collaborated with Hologic to develop Panther Fusion assays for group B Streptococcus and Bordetella. Diagenode is also playing a leading role in epigenetics with a robust portfolio of devices, kits, reagents, antibodies and services

to aid in the analysis of DNA and RNA. “Acquiring Diagenode further strengthens our molecular diagnostics business by expanding our international capabilities, improving our regional time-to-market, and allowing us to offer a broader, more differentiated test menu,” said Jan Verstreken, Hologic’s group president, international. “Diagenode has been a great partner since 2016, helping us develop and manufacture PCR-based assays for Panther Fusion. Now we look forward to accelerating and broadening those efforts to benefit our customers and patients.”

HORIBA Acquires MedTest Group of IVD Companies in the US

ORIBA, Ltd. has acquired MedTest Holdings, Inc., composed of MedTest Dx, Inc., Pointe Scientific, Inc., Clinitox Diagnostix, Inc., and Medical Laboratory Solutions, Inc. HORIBA Medical (www.horiba.com; Kyoto, Japan) provides a complete line of hematology and clinical chemistry analyzers and reagents for use in In-Vitro Diagnostics (IVD). MedTest (www.medtestdx.com; Canton, MI, USA) offers a wide portfolio of clinical testing

lucrative opportunities for the growth of the IVD market over the coming years. Based on technology, the immunoassay segment is expected to dominate the global IVD market due to advantages offered by immunoassays such as specificity, high-throughput, high sensitivity, and low costs. The increasing use of immunoassays in POC & infectious disease testing owing to the coronavirus pandemic, development of novel tests, increasing usage of miniaturized devices, and rising demand for immunoassay-based tests are the other factors driving the growth of the immunoassay segment. Based on product and solution, the consumables segment is expected to register the fastest growth during the forecast period, led by the rising need to identify diseases, the growing use of kits and reagents to identify organisms causing various diseases, and low costs. The frequent use of assays & kits for the detection of various chronic diseases, commercial availability of a diverse range of reagents, and increased demand for COVID-19 testing products are expected to further propel the growth of the consumables segment during the forecast period. Based on application, the infectious diseases segment is estimated to account for the largest share of the global IVD market owing to the increasing global prevalence of infectious diseases, growing awareness about the importance of early diagnosis using specific diagnostic tests, and growth in funding for research on infectious disease diagnostics. Based on end user, the diagnostic laboratories segment is estimated to account for the largest share of the global IVD market. The rising number of accredited clinical laboratories, collaborations, partnerships, and other strategies adopted by the key players, and an increase in the volume of testing carried out in diagnostic laboratories owing to the COVID-19 outbreak are some of the key factors supporting the growth of the diagnostic laboratories segment.

Hologic Inks Molecular Diagnostics Acquisition in Belgium

ologic, Inc. (www.hologic.com; Marlborough, MA, USA) has acquired Diagenode (www.diagenode.com; Liège, Belgium), a developer and manufacturer of molecular diagnostic assays and epigenetics products, which is expected to diversify its diagnostic business across test menu, customer segments and geography. Diagenode offers more than 30 real-time PCR (polymerase chain reaction) tests that are CE-marked for the detection of bacteria, parasites and viruses involved in sexually transmitted infections, respiratory diseases, menin-

Industry News

LabMedica International February-March/2021

instruments and reagents for IVD laboratories. The acquisition is seen to combine the complementary technologies of HORIBA Medical with MedTest Dx, Clinitox, and Pointe Scientific’s R&D and manufacturing capabilities, with particular expertise in FDA 510K and CLIA clearances.

“This acquisition provides HORIBA Medical with the opportunity to address the IVD market’s multidisciplinary requirements along with the innovative technologies of Pointe Scientific and MedTest. HORIBA Medical will continue to offer advanced IVD solutions through its Yumizen2 brand and current distribution channels,” said HORIBA Medical segment leader Dr. Jai Hakhu, CEO of HORIBA Instruments, Inc. and President of HORIBA ABX SAS in France.

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AACC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

119 Alcor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 108 Bioperfectus. . . . . . . . . . . . . . . . . . . . . . . . . . . 8 105 DiaSys. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 –

Euromedlab 2021. . . . . . . . . . . . . . . . . . . . . . 27

132 Instrumentation Laboratory . . . . . . . . . . . . . . 32 110 Mast. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 107 Mayo Clinic . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 111 Nova Biomedical . . . . . . . . . . . . . . . . . . . . . . 11 103 Randox. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 116 Seegene. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 121 Singuway. . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 102 Snibe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 109 Snibe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 120 Vicotex. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Provided as a service to advertisers. Publisher cannot accept responsibility for any errors or omissions.

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