WORLD’S CLINICAL LABORATORY NEWS LEADER ISSN 1068-1760
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Blood Based Biomarkers Characterize Parkinson’s
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arkinson’s disease (PD) is characterized by progressive loss of dopaminergic neurons in the substantia nigra, resulting in a clinical syndrome defined by bradykinesia, rigidity, tremor, and postural instability. By the time a clinical diagnosis
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New Tool Developed for Diagnosis of Chronic HBV Infection
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team of Chinese researchers has described the development of a new and powerful tool for the diagnosis and treatment of chronic hepatitis B virus (HBV) infection. Methods currently used to diagnose and monitor chronic hep-
atitis B (CHB) infection are for the most part based on dynamic and real-time HBV DNA, genotype, and reverse transcriptase (RT) mutation analysis. However, the methods used to perform these analyses are limited by poor sensitivity or inability to detect more than one
Global Coronavirus Crisis: Researchers, Industry Mobilize to Offer Solutions Cont’d on page 4
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s part of the effort to create better methods to detect and treat sepsis, researchers developed a technique that enables measurement of the activation and function of white blood cells. Sepsis is caused by an inflammatory immune response triggered by an infection. It is a life-threatening condition that arises when the body's response to infection
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INSIDE
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new blood test in development has shown ability to screen for numerous types of cancer with a high degree of accuracy, a trial of the test shows. In study, test proved able to detect and localize more
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New Blood Test Detects Multiple Cancer Types
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Inexpensive laMP-Based Schistosomiasis Tests Developed
chistosomiasis is one of the most prevalent Neglected Tropical Diseases, affecting approximately 250 million people worldwide. Schistosoma mansoni is the most important species causing human intestinal schistosomiasis.
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Point-of-Care Method for Diagnosis of Sepsis
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remature birth and its complications are the largest contributors to infant death in the USA and globally. Complications of preterm birth are the single largest cause of neonatal deaths and account for 35% of the world’s 3.1 million neonatal deaths each year. A short cervical length and the depletion of Lactobacillus species are known risk factors for preterm
n light of the worsening global Coronavirus health crisis, the In Vitro Diagnostics sector around the world is racing to develop a definitive test for the COVID-19 virus. Several such assays are currently in the pipeline, and some are to become marketable within weeks.
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DaIly ClINICal laB NewS
Vaginal Biomarkers Predict Preterm Birth Risks
A Special Report
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V I S I T
Several polymerase chain reaction (PCR)-based molecular approaches, including conventional PCR (cPCR), real-time quantitative PCR (qPCR), droplet digital PCR (ddPCR), have been proven effective in detection of schistosome-derived DNA with more Cont’d on page 12
Clinical News . . . . . . 4-26 IFCC News . . . . . . . . . . 27 product News . . . . . 6-26 Industry News . . . . . . 33 Events Calendar . . 34-35 PUBLISHED IN COOPERATION WITH
International Federation of Clinical Chemistry and Laboratory Medicine
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Blood Based Biomarkers Characterize Parkinson’s
LabMedica International
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is made, 50% of nigral dopaminergic neurons may already be lost, suggesting a long prodromal phase during which intervention may be possible. Current medical practice for the diagnosis of PD relies almost entirely on clinical examination, with no laboratory-based testing available. Neurologists from the University of Pennsylvania (Philadelphia, PA, USA; USA; www. med.upenn.edu) and their collaborators analyzed 141 plasma samples (96 PD, 45 neurologically normal control [NC] individuals; 45.4% female, mean age 70.0 years) from a longitudinally followed Discovery Cohort based at the University, and they measured levels of 1,129 proteins using an aptamer-based platform. Samples from the Discovery and Replication Cohorts were assayed using the 1.1k and 1.3k Assay versions of the SOMAScan platform (Somalogic, Boulder, CO, USA; https://somalog ic.com) in two separate runs, with operators blinded to disease status. This platform is based on protein-capture slow off-rate modified aptamers (SOMAmers), which are chemically modified oligonucleotides with specific affinity to recombinant protein targets, developed by in vitro selection (SELEX). Candidate proteins were then ranked by Stability Selection. Of the top 10 proteins from the Discovery Cohort ranked by Stability Selection, four associations were replicated in the Replication Cohort. These blood-based biomarkers were bone sialoprotein (BSP), osteomodulin
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(OMD, aminoacylase-1 (ACY1), and growth hormone receptor (GHR). Plasma measures of OMD, ACY1, and GHR differed in PD versus NC but did not differ between 59 individuals with amyotrophic lateral sclerosis (ALS) versus NC. Measures of these proteins were not significantly affected by differences in sample handling, and they did not change comparing plasma samples from 10 PD participants sampled both on versus off dopaminergic medication. The authors concluded that in their unbiased screening of more than 1,000 plasma proteins in multiple PD cohorts, they identified four plasma proteins, BSP, OMD, ACY1, and GHR, with consistent alterations in PD, one of which, growth hormone receptor, also predicted subsequent cognitive decline in multiple cohorts, across multiple cognitive testing instruments. The study was published on October 11, 2019, in the journal PLOS Medicine. Image: A diagram of the SomaScan Assay that relies on the distinctive properties of Slow Off-rate Modified Aptamer (SOMAmer) reagents, which are proprietary protein binding reagents (Photo courtesy of Somalogic).
Second Malignancy Risk Higher for Some leukemia Survivors
hronic lymphocytic leukemia (CLL) is the most common leukemia diagnosis in adults, with favorable outcomes in majority of patients and a 5-year survival of around 85%. A large proportion of CLL patients may never require treatment, requiring only ongoing surveillance. As the population of CLL survivors grows, there is a need to understand their long-term health. It is known that nearly one in five cancers diagnosed currently occurs in an individual with a previous diagnosis of cancer, and these second primary malignancies (SPMs) are a leading cause of morbidity and mortality among cancer survivors. Hematology-Oncology specialists at the Mayo Clinic (Jacksonville, FL, USA; www. mayoclinic.org) and their colleagues used the Surveillance Epidemiology and End Results (SEER) database, and conducted a large, population-based analysis of SPMs occurring in CLL patients to better understand their trends and document the risk of specific SPMs according to patients’ demographic factors. The investigators found that 6,487 new SPMs were diagnosed in about 270,000 person-years of follow-up, for a standardized incidence ratio (SIR) of 1.2. Higher risk was seen for both solid and hematologic malignancies
(SIRs, 1.15 and 1.61, respectively). The highest risk for SPMs was seen between two and five months after CLL diagnosis (SIR, 1.57) and for patients aged 50 to 79 years. Compared with 1973 to 1982, there was a significant increase in SPMs in 2003 to 2015 (SIRs, 1.36 versus 1.19, respectively). CLL patients who had received prior chemotherapy had higher a risk for SPM (SIR, 1.38) compared with those untreated or those with treatment status unknown (SIR, 1.16). The risk for developing SPMs was increased among men, after chemotherapy, for recent years of diagnosis, for advanced age, and for nonwhites in multivariate analysis. The team noted a significantly high rate of SPMs, both solid-organ and hematologic malignancies in patients with CLL as compared to age-matched USA population. The authors concluded that they had demonstrated trends in the incidence of SPMs among patients with CLL with a longer follow-up and a larger patient sample, thus building upon previously known data. This could inform further studies about the etiology of SPMs and help shape improved survivorship for patients with CLL. The study was published on September 30, 2019 in the Blood Cancer Journal.
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ISSN 1068-1760
Vol.37 No.1. Published, under license, by Globetech Media LLC; Copyright © 2020. All rights reserved. Reproduction in any form is forbidden without express permission. Opinions expressed are solely those of the authors, and do not represent an endorsement, or lack thereof, by the Publisher of any products or services. Teknopress Yayıncılık ve Ticaret Ltd. şti. adına İmtiyaz Sahibi: M. Geren • Yazı işleri Müdürü: Ersin Köklü Müşir Derviş İbrahim Sok. 5/4, Esentepe, 34394 şişli, İstanbul P. K. 1, AVPIM, 34001 İstanbul • E-mail: Teknopress@yahoo.com Baskı: Postkom A.ş. • İpkas Sanayi Sitesi 3. Etap C Blok • 34490 Başakşehir • İstanbul Yerel süreli yayındır. Yılda sekiz kere yayınlanır, ücretsiz dağıtılır.
LabMedica International February-March/2020
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Global Coronavirus Crisis: Researchers, Industry Mobilize to Offer Solutions
To view this issue in interactive digital magazine format visit www.LinkXpress.com
LabMedica International
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A Special Report
new Coronavirus, designated COVID-19 and also known as 2019-nCoV, is rapidly spreading from its origin in Wuhan, Hubei Province, China. At the conclusion of February 2020, the number of infected globally was reported at over 90,000 cases, including some 3,200 deaths and around 50,000 recoveries. Outside China, the virus had spread across some 80 countries and caused over 200 fatalities. These numbers are fluid, with increases expected on a daily basis. For confirmed COVID-9 infections, reported illnesses have ranged from mild symptoms to severe illness and death. Signs of infection are highly non-specific and include respiratory symptoms such as shortness of breath, fever, cough, dyspnea, and viral pneumonia. It is believed that symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. As the number of cases of COVID-19 rise rapidly, especially as some of those new numbers are now being based not on molecular assays, but reportedly on radiographs which are open to interpretation, there is an urgent need for a definitive and verifiable assay. Metagenomic RNA sequencing of a bronchoalveolar lavage fluid sample from the first hospitalized patient, identified a novel RNA virus from the family Coronaviridae. Phylogenetic analysis of the complete viral genome (29,903 nucleotides) revealed that the virus was most closely related (89.1% nucleotide similarity) to a group of SARS-like Coronaviruses (genus Betacoronavirus, subgenus Sarbecovirus). The World Health Organization has hosted an emergency meeting to assess the current level of knowledge about the new COVID-19 disease, identify gaps, and work together to accelerate and fund priority research needed to help stop this outbreak and prepare for any future outbreaks. The WHO website provides interim guidelines for the laboratory diagnosis of COVID-19. Both government agencies and scientists in the in-vitro diagnostics sector have been racing to implement a definitive test for COVID-19. Several assays that detect the COVID-19 have been and are currently under development. Some assays may detect only the novel virus and some may detect also other strains (e.g., SARS-CoV) that are genetically similar.
ing upper respiratory (nasopharyngeal and oropharyngeal swabs), and lower respiratory (sputum, if possible) for those patients with productive coughs. The CDC diagnostic test is a reverse transcriptase real-time PCR (rRT-PCR) assay developed for respiratory and blood serum samples. The protocol to make the assay has been made publicly available. The protocol specifies primers and probes, provides guidance on sample preparation, and advises performing rRT-PCR on the AB 7500 Fast DX thermal
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US Centers for Disease Control Assay
In the USA, the Centers for Disease Control and Prevention (CDC, Atlanta GA,USA; www.cdc.gov/coronavirus) have publicly posted its assay for novel Coronavirus 2019-nCoV and is now developing the test into kits. The CDC recommends for initial diagnostic testing for COVID-19 collecting and test-
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PRODUCT NEWS
POC HBA1C ANALYZER
ELISA WASHER
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MICROBIOLOGY READER
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DYNEX
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The DCA Vantage Analyzer is a point-of-care system that helps monitor glycemic control and detect early kidney disease. It provides HbA1c results in six minutes using a sample of 1µl finger stick.
The DYNAWASH Automatic is a fully automated ELISA washer with a small compact design that offers smart assays programming via PC. The processing area is protected with a transparent lid and the working area is illuminated.
The ErbaScan is a benchtop microbiology reader optimized for standardized semi-automated reading of Erba MIKROLATEST identification and AST tests. It features robust and high quality optics and delivers reliable results.
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Global Coronavirus Crisis: Researchers, Industry Mobilize to Offer Solutions cont’d from page 5
cycler (Thermo Fisher Scientific, Waltham, MA, USA; www.thermofisher.com). To date, all USA states have been shipped COVID-19 test kits, as have at least 30 international sites, but the CDC laboratories are the only ones allowed to report positive results. However a recent report suggests that some state laboratories found that the novel Coronavirus test kits sent by the CDC have provided inconclusive results during the quality control process. These were not tests being run on clinical specimens from potential patients, but rather were part of the verification process. Further evaluation has suggested there might be issues with one of the three assays in the test. BGI Test
As early as December 2019, BGI (Copenhagen, Denmark; www.bgi.com) successfully developed a Real-Time Fluorescent Reverse Transcription Polymerase Chain Reaction (RTPCR) kit for detecting COVID-19, which can issue results in a few hours. BGI has since begun a collaboration with Curetis (Holzgerlingen, Germany; https://curetis.com) and its subsidiary Ares Genetics (Vienna, Austria; www.ares-genetics.com) to develop a sequencing-based test and to distribute BGI's PCRbased test in Europe. A sequencing platform from BGI subsidiary MGI, called DNBSEQ-T7, has also passed the emergency approval procedure of the National Medical Products Administration, becoming the first officially approved testing product in China for surveillance, discovery, and identification of unknown infectious diseases. Randox BAT-Based Assay
While there are numerous companies engaged in producing an assay to detect COVID19, Randox Laboratories (Crumlin, UK; www.
randox.com) has announced the imminent release of a rapid diagnostic test for this Coronavirus. The company has adapted its patented Biochip Array Technology (BAT) for diagnosis of Coronavirus. BAT is an innovative multiplexing technology which is utilized within the cartridge aspect of an autoanalyzer platform. The Biochip allows for the simultaneous detection of multiple analytes from a single sample.
IDbyDNA Explify Respiratory Test
Coyote Bioscience (San Jose, CA, USA; www.coyotebio.com), has reportedly submitted its one-hour, sample-to-answer 2019-nCoV Prep-Free QPCR Assay to National Medical Products Administration (NMPA) for emergency authorization. It runs on the firm's CFDA-approved Mini8 Portable Molecular Diagnostic QPCR Station. The test is reportedly being used as an RUO in China in more than 30 hospitals, 16 local CDC offices, and eight airports, and the firm has donated 500 instruments to Hubei province.
WuXi Diagnostics Kits
Coyote Bioscience Prep-Free Assay
Biomeme Go-Strips
Biomeme (Philadelphia, PA, USA; https:// biomeme.com) have tests called 2019-nCoV Go-Strips that run on Biomeme's mobile handheld qPCR devices available on the firm's website. The test contains Coronavirus RNA target multiplexed with Biomeme's RNA extraction and RT-PCR control (MS2), with each order containing 10 individually packaged Go-Strips that are shelf-stable for up to two years. GenScript One-Step Assay
GenScript (Piscataway, NJ, USA; www.gen script.com) has launched a one-step 2019-nCoV quantitative reverse-transcription polymerase chain reaction (qRT-PCR) based on the World Health Organization's (WHO, Geneva, Switzerland; www.who.int) protocol. The firm is also
marketing plasmids encoding the surface glycoprotein and nucleocapsid phosphoprotein of 2019-nCoV that can be used as positive control for the detection of 2019-nCoV by RT-PCR.
IDbyDNA (Salt Lake City, UT, USA; www. idbydna.com) has an Explify Respiratory Test that uses next-generation sequencing-based metagenomics to detect COVID-19 as well as over 900 other viral, bacterial, fungal, and parasitic pathogens. It is a validated Laboratory Developed Test (LDT) currently offered by IDbyDNA's laboratory for respiratory pathogens, including human Coronaviruses, and its COVID19 detection has been computationally validated using in silico generated samples.
WuXi Diagnostics (Shanghai, China; www. wuxidiagnostics.com) has developed a series of COVID-19 detection kits, including the 2019nCoV IgM Detection kit (Enzyme-Linked Immunoassay, ELISA); the 2019-nCoV IgM/IgG Detection Kit (Enzyme-Linked Immunoassay, ELISA); and the 2019-nCoV Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method). As an integrated solution set, these tests are aimed to improve epidemic prevention and control at all levels.
Thermo Fisher Kit
Thermo Fisher Scientific (Waltham, MA, USA; www.thermofisher.com) has developed a real-time PCR kit for the detection of RNA from COVID-19, using Applied Biosystems TaqMan Assay technology, which is available for ordering. The firm is also developing a multiplexing test that offers a faster time-to-result to further expand laboratory capacity, which will be available within the next few weeks, as well as a syndromic panel it expects to be available in late February.
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LabMedica International February-March/2020
Vaginal Biomarkers Predict Preterm Birth Risks
To view this issue in interactive digital magazine format visit www.LinkXpress.com
LabMedica International
Cont’d from cover
birth. In many resource-poor areas of the world, the technology to test for the occurrence of these risk factors is unavailable, and pregnant women with specific risk factors are neither identified nor treated. An international team of scientists working with the University of Idaho (Moscow, ID, USA; www.uidaho.edu) collected and analyzed vaginal fluid samples from 340 mid-trimester pregnant women to determine correlates of a short cervix. They carried out a prospective study of these women who were undergoing a routine vaginal ultrasound to assess cervical length at the obstetrical outpatient clinic at The Federal University of Sao Paulo (Sao Paulo, Brazil; www.unifesp.br). Vaginal levels of the D- and L-lactic acid isomers were quantitated by colorimetric assays using the EnzyChrom D-lactic acid and L-lactic acid kits (BioAssay Systems, Haywood, CA, USA; www.bioassaysys.com). The levels of TIMP-1, TIMP-2, MMP-2, MMP-8, and Hsp70 (all from R&D Systems, Minneapolis, MN, USA; www.rndsystems.com) and total protein (Thermo-Fisher Scientific, Waltham, MA, USA; www.thermofisher.com) were measured in the vaginal fluid supernatant. The p62 (Enzo Life Sciences, Farmingdale, NY, USA; www.enzolifesciences.com), the a2 isoform of vacuolar ATPase (a2V) (MyBioSource, San Diego, CA, USA; www. mybiosource.com), and total protein in the lysed epithelial cell fraction were determined by commercial enzymelinked immunosorbent assay (ELISA) kits. The compositions of vaginal microbiomes were assessed by analysis of the V1-V3 regions of 16S rRNA genes, while cervical length was determined by transvaginal ultrasonography. The scientists reported that the vaginal microbiomes could be clustered into five community state types (CSTs), four of which were dominated by a single Lactobacillus species. The dominance of Lactobacillus crispatus or Lactobacillus jensenii in the vaginal microbiome predicted the level of D-lactic acid present. Several of the biomarkers, especially TIMP-1, in combination with the subject’s age and race, were significantly associated with cervical length. Larry Forney, PhD, a professor and senior author of the study, said, “Measuring levels of TIMP-1 and D-lactic acid in vaginal secretions might be a straightforward way to assess a woman's risk for preterm birth. This is a prime example of the kind of study that can be done when you bring people in from different disciplines. This team of investigators included obstetricians, gynecologists, immunologists, microbial ecologists, and statisticians. The authors concluded that concluded that measuring levels of TIMP1 and D-lactic acid in vaginal secretions might be a straightforward way to assess the risk for preterm birth due to a short cervix and microbiome composition. The study was published on October 22, 2019, in the journal mBio.
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Image: The DuoSet ELISA kit for determining levels of MMP-3 and TIMP-1 (Photo courtesy of R&D Systems).
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PRODUCT NEWS
LIQUID HANDLING SYSTEM
RAPID TEST
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CLINICAL CHEMISTRY ANALYZER
EUROIMMUN AG
MAST GROUP
SIEMENS HEALTHINEERS
The EUROLabLiquidHandler modular system for flexible and efficient liquid handling for IFT, ELISA and immunoblot applications offers flexible loading of 45 racks with patient samples, reagents and labware.
The MASTDISCS Combi antibiotic resistance detection sets are intended for the identification and differentiation of enzyme types using a combination disc technology, incorporating specific inhibitors.
The Atellica CH 930 clinical chemistry analyzer can run up to 1, 800 tests per hour (photometric 1,200 tests per hour and IMT 600 tests per hour) with an onboard capacity of 70 assays (67 reagent positions and three IMTs).
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Singapore Institute for Health Innovation
Teams that are developing assays for detecting COVID-19 include the Singapore Institute for Health Innovation & Technology (Singapore; www.nus.edu.sg) which is working on the development of an assay based on the enVision technology platform. Based on the lab-on-chip detection kit currently in development by Veredus Laboratories (Singapore; www.veredus labs.com) the assay can produce results in about two hours. Cepheid Molecular Diagnostic Test
An automated molecular diagnostic test for the novel Coronavirus in development by Cepheid (Sunnyvale, CA, USA; www. cepheid.com) for use on its GeneXpert Systems, is expected to deliver point-of-care results in around 30 minutes.
BATM Diagnostic Kit
The development of a reverse-transcription PCR (RT-PCR) based diagnostic kit detecting Coronavirus COVID-19 from saliva samples in less than half an hour, was announced by BATM (Hod Hasharon, Israel; www.batm. com). BATM had been offering a diagnostic kit detecting SARS (Severe Acute Respiratory Syndrome) and MERS (Middle East Respiratory Syndrome), and the COVID-19 feature is now being added to it. The company is currently focusing on producing the test at a price range suitable for extensive worldwide distribution.
Mobidiag Point-of-Care Test
Mobidiag (Espoo, Finland; www.mobidiag. com) is developing a rapid point-of-care test that will run on its Novodiag analyzer, which is a sample-to-answer cartridge-based qPCR system with accelerated turnaround time enabled by rapid thermal cycling. A major differentiating factor of the Mobidiag test is that it will detect and distin-
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guish COVID-19, influenza A, and influenza B viruses. The firm expects the test to be ready for clinical evaluation within a month, and the firm will pursue regulatory paths appropriate to different geographies.
Vircell Detection Kit
The new test, developed by Vircell (Granada, Spain; www.vircell.com), is currently available for research use only. Suitable for use in any qPCR thermal cycler with (FAM/HEX) detection, the test applies to COVID-19 as well as other coronaviruses related to SARS, generating reliable results in 90 minutes. The assay kit contains two lyophilized master mixes for virus detection and confirmation, as suggested by international guidelines. The assay does not show cross reactions with other common human respiratory CoVs or MERS, and includes an internal amplification control in each master mix. Other R&D Initiatives
Additional institutions that have available protocols for the diagnosis of COVID-19 include: • Chinese National Institute for Viral Disease Control and Prevention (Beijing, China; https:// ivdc.chinacdc.cn) is focusing on the gene targets ORF1ab and N; • Charité University Hospital (Berlin, Germany; www.charite.de) is focusing on the gene targets RdRP, E, N; • University of Hong Kong (Pok Fu Lam, Hong Kong; www.hku.hk) is focusing on the gene targets ORF1b-nsp14, N. The investigators have developed two rapid tests for the detection of Coronavirus which require only about an hour and a quarter to perform; • Japanese National Institute of Infectious Diseases, Department of Virology III (Tokyo, Japan; www.niid.go.jp) is studying Pancorona and multiple targets, Spike protein; • Thai Ministry of Public Health (Mueang Nonthaburi District, Thailand; www.moph.go. th) is focusing on N as the gene target.
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Vaccine Development
The global vaccine industry is dominated by four major companies, but none have yet shown interest in the developing a vaccine for the new virus. Typically, developing a new vaccine takes a decade or longer. But latest genetic techniques and new methods make scientists optimistic, so that they can shorten that timetable to months and possibly weeks, and deliver a tool by Fall 2020 that can slow the spread of infection. Scientists at the Wistar Institute (Philadelphia, PA, USA; https://wistar.org) are developing what is called a DNA vaccine, while those at the University of Queensland (Brisbane, Australia; www.uq.edu.au) are developing a vaccine that is based on virus genetic sequence. The Queensland team has come up with an approach it calls the Molecular Clamp. It works by improving the body's immune response to certain viral proteins. A team of scientists at MIGAL Galilee Research Institute (Qiryat Shmona, Israel; www.migal.org.il) that after four years of research succeded in developing an effective vaccine against the Avian Coronavirus Infectious Bronchitis Virus (IBV) afflicting poultry, are currently focusing on genetic modifications for adapting it toward the creation of a human vaccine against the COVID-19 strain. The company's goal is to produce the vaccine within 8-10 weeks, and achieve safety approval within 90 days. The vaccine will be oral, making it particularly accessible to the general public. Drug Trials
Gilead Sciences (Foster City, CA, USA; www.gilead.com) that makes anti-HIV drugs, has announced it will trial its drug Remdesivir. Meanwhile Kaletra, a combination of two antiHIV drugs from AbbVie Inc (North Chicago, IL, USA; www.abbvie.com) is being trialed on patients in China. Both trials are based on existing drugs. LabMedica International February-March/2020
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PRODUCT NEWS
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ELECTROLYTE ANALYZER
NEWBORN HEMOGLOBIN PCR INSTRUMENT SCREENING SYSTEM BIO-RAD BIOER
The EC 90 is an electrolyte analyzer with maintenance-free electrodes in an all-in-one sensor cartridge that directly measures Na+, Cl-, K+ and Ca2+ from whole blood, plasma, serum and pre-diluted urine.
The VARIANTnbs automated newborn screening system for sickle cell disease and other hemoglobin disorders features fully automated analysis and advanced result reporting for maximum efficiency.
The new XP gene amplification instrument is a multifunctional, multi-purpose PCR instrument with powerful software. Its large screen display and interface make operation simple and easy to understand.
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ERBA MANNHEIM
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Hematological Ratios associated with Mortality in Pediatric Trauma Patients
rauma-related injury as a potential cause of death affects millions of people worldwide, especially in less developed countries and furthermore, it is the leading cause of mortality in pediatric trauma patients. The hematological parameters, the neutrophil-to-lymphocyte ratio (NLR) and the platelet-to-lymphocyte ratio (PLR) (as a new marker of inflammatory status), have been investigated to examine the prediction ability of systemic inflammatory response in many other disorders, including malignant cancers and pulmonary diseases. An emergency physician at the Sivas Cumhuriyet University Hospital (Sivas, Turkey; www.cumhuriyet.edu.tr) evaluated the prognostic ability of NLR and PLR on mortality in pediatric trauma (PT) patients. This retrospective study included a total of 358 PT patients admitted to the emergency department (ED) of the hospital, between January 2010 and June 2018, due to acute trauma. Data for hemoglobin (Hb), neutrophil, monocyte, white blood cell (WBC), lymphocyte, blood glucose, alanine aminotransferase (ALT), aspartate aminotransferase (AST), activated partial thromboplastin time
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(aPTT), and international normalized ratio (INR) were retrospectively derived from the medical record database of the first electronic application of biochemical results. Both the NLR and PLR were calculated at the time of admission by dividing the blood neutrophil count and the blood platelet count, respectively, by the lymphocyte count. The data regarding absolute neutrophil count and absolute lymphocyte count were obtained from the first routine blood assay at the time of admission. The scientists reported that the NLR and PLR values were significantly higher in survivors than in non-survivors (NLR, 6.2±5.7 versus 2.6±2.5; PLR, 145.3±85.0 versus 46.2±25.2. The NLR (odds ratio [OR], 3.21 ;) PLR (OR, 0.90) blood glucose (OR, 1.02), and Injury Severity Score (ISS) (OR, 1.28)) were independent predictors of the mortality risk in PT patients. The area under the curve in the ROC curve analysis was 0.764 with a cut-off of 2.77 (sensitivity 70%, specificity 77%) for the NLR; and 0.928 with a cut-off of 61.83 (sensitivity 90%, specificity 85%) for the PLR. The study was published in the October 2019 issue of the Rambam Maimonides Medical Journal.
New Blood Test Capable of Detecting Multiple Cancer Types
than 20 types of cancer with a high degree of accuracy. The test uses next-generation sequencing technology to probe DNA for tiny chemical tags (methylation) that influence whether genes are active or inactive. The new test looks for DNA, which cancer cells shed into the bloodstream when they die. In contrast to “liquid biopsies,” which detect genetic mutations or other cancer-related alterations in DNA, the technology focuses on modifications to DNA known as methyl groups. Methyl groups are chemical units that can be attached to DNA, in a process called methylation, to control, which genes are “on” and which are “off.” Abnormal patterns of methylation turn out to be, in many cases, more indicative of cancer and cancer type than mutations are. The new test zeroes in on portions of the genome where abnormal methylation patterns are found in cancer cells. The test was developed by GRAIL, Inc (Menlo Park, CA, USA; https://grail.com). Scientists at the Dana-Farber Cancer Institute (Boston, MA, USA; www.dana-farber.org) and their colleagues analyzed cell-free DNA (DNA that had once been confined to cells but had entered the bloodstream upon the cells' death) in 3,583 blood samples, including 1,530 from patients diagnosed with cancer and 2,053 from people without cancer. The patient samples comprised more than 20 types of cancer,
including hormone receptor-negative breast, colorectal, esophageal, gallbladder, gastric, head and neck, lung, lymphoid leukemia, multiple myeloma, ovarian and pancreatic cancer. The overall specificity of the test was 99.4%, meaning only 0.6% of the results incorrectly indicated that cancer was present. The sensitivity of the assay for detecting pre-specified high mortality cancers (the percent of blood samples from these patients that tested positive for cancer) was 76%. Within this group, the sensitivity was 32% for patients with stage I cancer; 76% for those with stage II; 85% for stage III; and 93% for stage IV. Sensitivity across all cancer types was 55%, with similar increases in detection by stage. For the 97% of samples that returned a tissue of origin result, the test correctly identified the organ or tissue of origin in 89% of cases. Geoffrey Oxnard, MD, a medical oncologist and lead author of the study, said, “Our previous work indicated that methylation-based assays outperform traditional DNA-sequencing approaches to detecting multiple forms of cancer in blood samples. The results of the new study demonstrate that such assays are a feasible way of screening people for cancer.” The study was presented at the European Society for Medical Oncology (ESMO) 2019 Congress, held September 27 to October 1, in Barcelona, Spain. LabMedica International February-March/2020
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Gene Fusion Protein Proposed as Prostate Cancer Biomarker
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LabMedica International
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novel gene fusion product has been proposed as a biomarker for the non-invasive diagnosis of prostate cancer. Investigators at the Henry Ford Health System (Detroit, MI, USA; www.henryford.com) recently presented the functional characterization of pseudogene-associated recurrent gene fusion in prostate cancer. The fusion gene KLK4-KLKP1 was formed by the fusion of the protein-coding gene KLK4 (Kallikrein 4) with the noncoding pseudogene KLKP1. Pseudogenes are segments of DNA that are related to real genes. Pseudogenes have lost at least some functionality, relative to the complete gene, in cellular gene expression or protein-coding ability. Pseudogenes often result from the accumulation of multiple mutations within a gene whose product is not required for the survival of the organism, but can also be caused by genomic copy number variation (CNV). Although not fully operational, pseudogenes may be functional, similar to other kinds of noncoding DNA, which can perform regulatory tasks. Currently, diagnostic tests for prostate cancer are not sufficiently specific to be able to differentiate individuals without prostate cancer, those with low risk disease that is unlikely to be of clinical significance, and those with disease that should be treated. To rectify this situation, the investigators carried out a study that began with the screening of a cohort of 659 patients (380 Caucasian American; 250 African American, and 29 patients from other races). Results of the screen revealed that the KLK4-KLKP1 gene fusion product was expressed in about 32% of prostate cancer patients. Furthermore, screening of patient urine samples showed that KLK4-KLKP1 could be detected non-invasively in urine. Development of an antibody specific to the KLK4-KLKP1 fusion protein confirmed the expression of the full-length KLK4-KLKP1 protein in INTeRaCTIVe prostate tissues. In vitro and in vivo DIGITal eDITION functional assays to study the oncogenic properties of KLK4-KLKP1 confirmed its role in cell proliferation, cell invasion, intravasation, and tumor formation. "The unique feature of this fusion gene is the conversion of the noncoding pseudogene KLKP1 into a protein coding gene, and its unique expression in about 30% of high Gleason grade prostate cancer," said senior author Dr. Nallasivam Palanisamy, associate scientist in cancer research at the Henry Ford Health System. "Like other ETS family gene fusions, KLK4-KLKP1 can also be detected in the urine samples of patients with prostate cancer, enabling non-invasive detection of prostate cancer. Given the unique feature of this fusion, prostate cancer specific expression, oncogenic properties, and noninvasive detection, this novel gene fusion has the poten-
tial to be used as a biomarker for early detection of prostate cancer and a therapeutic target." The gene fusion paper was published in the October 2019 issue of the journal Neoplasia. Image: Human Kallikrein 4 (KLK4) protein complexed with nickel and p-aminobenzamidine (Photo courtesy of Wikimedia Commons).
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PRODUCT NEWS
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IMMUNOASSAY SYSTEM
BODITECH
DNA/RNA PURIFICATION SYSTEM BIOVENDOR
The AFIAS-1 automated fluorescent immunoassay system measures the concentration of a targeted analyte in a sample, using quantitative or semi-quantitative methods using blood, urine, and other samples.
The LabTurbo 96 is an ultra–high speed DNA/RNA purification system that can handle 96 sample extractions in one hour, provides high yield and purity of nucleic acid for downstream assay.
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MICROPLATE READER
BMG LABTECH
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Inexpensive laMP-Based Schistosomiasis Tests Developed
sensitivity than parasitological and serological methods, especially in chronic infections and in low transmission areas. Scientists at the University of Salamanca (Salamanca, Spain; www.salamanca-university.org) originally developed a loop-mediated isothermal amplification (LAMP) method for the detection of S. mansoni DNA (SmMIT-LAMP). They have now developed an important improvement for SmMIT-LAMP molecular assay, transforming it into a
cold maintenance dry format suitable for potentially manufacturing as kit for ready-to-use for schistosomiasis diagnosis. DNA from three patients’ tissue samples with microscopy-confirmed infection with S. mansoni was tested by LAMP including cutaneous and hepatic biopsies and an appendix biopsy. DNA was isolated from tissue samples using the QIAamp DNA Mini Kit (QIAGEN, Hilden, Germany; www.qiagen.com). The real-time SmMIT-LAMP reactions were performed in 8-tube Genie Strips on a portable Genie III device (OPTIGENE Ltd., Horsham, UK; www.optigene.co.uk) at 65 °C for 60 minutes followed up by 10 minutes at 80 °C. Amplicons were confirmed on 1.5% agarose gels when required. The team reported that endpoint results at 65–70 minutes (counting 60 minutes for reaction plus 5–10 minutes of inactivation) were clearly observed with naked eye by adding the fluorescent dye SYBR Green I post-amplification. The positive LAMP reactions turned to green; otherwise, they remained orange. Correlation of positive colorimetric results with the typical ladder of multiple bands on agarose gels was clear. Real-time SmMIT-LAMP was carried out on a portable device using the same reaction conditions, but testing including or not betaine in the master mix. Real-time reactions worked properly in both cases and a strong correlation between the signal of the fluorescent EvaGreen dye and electrophoresis was obtained. However, removing betaine from the mixture resulted on a 10 minute reduction in the amplification time while showing identical intensity of electrophoresis bands. Both fresh and desiccated SmMIT-LAMP mixtures yielded amplification signals for S. mansoni-positive control and tissue samples. Nevertheless, a delay in the appearance of positive results and a decrease in the fluorescence signals were observed when using desiccated mixtures. The authors concluded that the one-step dry-up protocol is simpler and faster than those previously reported and allows maintaining the functionality for at least three weeks at RT and up to five months at 4 °C. Their work demonstrated an important improvement for SmMITLAMP molecular assay, transformed into a cold maintenance dry format suitable for manufacturing as kit for ready-to-use for S. mansoni DNA detection. The study was published on October 14, 2019 in the journal Scientific Reports. V
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New Tool Developed for Diagnosis of Chronic HBV Infection
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LabMedica International
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mutation at a time. Other methods are too cumbersome or expensive for clinical use. Investigators at Fujian Medical University (Peoples Republic of China; https://en.fjmu.edu.cn) have improved this situation by establishing a highly sensitive co-amplification at lower denaturation temperature PCR (COLD-PCR) coupled with probe-based fluorescence melting curve analysis (FMCA) for precision diagnosis of CHB patients. COLD-PCR (co-amplification at lower denaturation temperature-PCR) is a modified Polymerase Chain Reaction (PCR) protocol that enriches variant alleles from a mixture of wildtype and mutation-containing DNA. The ability to preferentially amplify and identify minority alleles and low-level somatic DNA mutations in the presence of excess wildtype alleles is useful for the detection of mutations. Melting curve analysis is an assessment of the dissociation characteristics of double-stranded DNA during heating. As the temperature is raised, the double strand begins to dissociate leading to a rise in the absorbance intensity, hyperchromicity. The temperature at which 50% of DNA is denatured is known as the melting temperature. The information gathered can be used to infer the presence and identity of single-nucleotide polymorphism (SNP) mutations. The COLD-PCR/FMCA method was shown to be able to detect HBV DNA, genotypes, and RT mutations, simultaneously. The analytical performance of this method, including imprecision, accuracy, sensitivity, detection limits, linear range, and its ability to detect minor variants was systematically evaluated. Results revealed that the COLD-PCR/FMCA method could detect HBV mutations at much lower concentrations than other techniques such as PCR/FMCA or PCR Sanger sequencing (1% vs. 10% vs. 20%, respectively). The new technique could also distinguish different phases of HBV infection according to the proportion and type of mutations as well as by detecting HBV DNA. "Guidelines have confirmed that dynamic monitoring of HBV DNA, genotypes, and reverse transcriptase (RT) mutant DNA is of great importance to assess infection status, predict disease progression, and judge treatment efficacy in HBV-infected patients," senior author Dr. Qishui Ou, a researcher in laboratory medicine at The First Afilliated Hospital of Fujian Medical University. "We believe COLD-PCR/FMCA provides a powerful laboratory tool for precise diagnosis and treatment of HBV-infected patients." "Our goal was to establish a more practical and inexpensive method with high sensitivity to detect genotype and RT mutations while detecting HBV DNA," said Dr. Ou. "Until now there have not been high-throughput approaches to detect HBV DNA, genotype, and RT mutations simultane-
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ously. Therefore, it is necessary to establish a more practical and inexpensive method with high sensitivity to detect genotype and RT mutations while detecting HBV DNA. COLD-PCR/FMCA has that potential." The study was published in the October 10, 2019, online edition of the Journal of Molecular Diagnostics. Image: Diagram workflow for co-amplification at lower denaturation temperature PCR (COLD-PCR)/fluorescence melting curve analysis (FMCA) (Photo courtesy of The First Affiliated Hospital of Fujian Medical University).
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PRODUCT NEWS
CRP ASSAY
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HBA1C ANALYZER
PIPETTE
BÜHLMANN LABS
DxGen Corp.
CAPP A/S
The Quantum Blue C-Reactive Protein (CRP) lateral flow assay is a sandwich-type immunoassay designed for the quantitative determination of CRP in human serum in combination with the BÜHLMANN Quantum Blue reader.
The Epithod414 AutoDx is a fully-automatic analyzer measuring HbA1c, Glycated Albumin, CRP and Hemoglobin. Featuring a 7-inch full color touch screen, automatic cartridge loader, voice guidance and built-in thermal printer.
The CAPPMaestro is one of the easiest multi-channel electronic pipettes to set up and use, with only a oneside programming manual to familiarize oneself with its functions in minutes.
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Metabolic Classification of Thyroid Nodules Uses MS Imaging
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ine-needle aspiration (FNA) biopsy is a well-established technique for diagnosis of suspicious thyroid lesions. However, histologic discrimination between malignant and benign thyroid nodules from FNA can be challenging. Each year, thanks to inconclusive tests for thyroid cancer, thousands of people undergo unnecessary surgeries to remove part or all of their thyroids. A new test based on the unique chemical fingerprints of thyroid cancer might change that and it is faster and about two-thirds more accurate than the diagnostic tests doctors use today. Biochemists at the University of Texas at Austin (Austin, TX, USA; www.utexas.edu) and their colleagues used a technology called mass spectrometry imaging. The new metabolic thyroid test identifies metabolites produced by cancerous cells that act as a kind of diagnostic fingerprint. The team worked on identifying these diagnostic metabolic fingerprints for over two years using 178 patient tissues before starting a pilot clinical study. During the clinical study, 68 new patients were tested, nearly a third of who had received inconclusive FNA results. The new metabolic thyroid test returned a false positive only about 1 time in 10 and could have prevented 17 patients in the study from undergoing unnecessary surgeries. The scientists employed desorption electrospray ionization mass spectrometry (DESI-MS) imaging to diagnose thyroid lesions based on the molecular profiles obtained from FNA biopsy samples. Based on the molecular profiles obtained from malignant thyroid carcinomas and benign thyroid tissues, classification models were generated and used to predict on DESI-MSI data from FNA material with high performance.
Image: A microscope image of thyroid cancer cells, specifically papillary thyroid carcinoma, or PTC (Photo courtesy of Wendong Yu/Baylor College of Medicine).
icks are the most important vectors for infectious diseases in the northern hemisphere and second only after mosquitos worldwide. As a result, there is an increasing public health interest in tick-borne pathogens. Ticks can transmit diseases such as Lyme disease, human granulocytic anaplasmosis, and spotted fever rickettsioses, among others. Therefore, there is a growing need to develop better and faster diagnostic tools that can detect zoonotic human pathogens in clinical samples. Medical Infectious Disease Scientists from Rutgers University (New Brunswick, NJ, USA; www.rutgers.edu) and their international colleagues collected samples from 212 patients who presented a broad range of clinical signs/symptoms consistent with multisystem disorders that could be suggestive of an infection caused by any of the pathogens included in the panel of the tick-borne bacteria flow chip (TBFC) kit. Human DNA was used to spike positive controls came from cere-
brospinal fluid (CSF) or biopsies from patients who tested negative to the pathogens included in the testing of the TBFC kit. The TBFC is intended for the simultaneous qualitative detection of DNA from seven different genera of tick-borne bacteria, Anaplasma, Ehrlichia, Borrelia, Bartonella, Coxiella, Rickettsia, and Francisella, using a multiplex PCR followed by reverse dot blot automatic hybridization into a macroarray CHIP based on DNA-Flow Technology (hybriSpot). The kit offers the amplification of bacterial DNA by two multiplex polymerase chain reactions (PCRs) containing all primers for the specific amplification of the seven bacteria genera and two sets of primers for the amplification of two internal controls. The authors concluded that the TBFC kit is a rapid and highly sensitive and specific diagnostic tool, capable of simultaneously screening multiple bacterial pathogens. The study was published on October 22, 2019 in the journal Vector-Borne and Zoonotic Diseases.
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Their results demonstrate the potential for DESI-MSI to reduce the number of unnecessary diagnostic thyroid surgeries. James W. Suliburk, MD, FACS, a co-principal investigator and head of endocrine surgery at Baylor College of Medicine (Houston, TX, USA; www.bcm.edu) said, “With this next generation test, we can provide thyroid cancer diagnoses faster and with more precision than current techniques, this will be the new state-of-the-art. We are able to do this analysis directly on the FNA sample and much more rapidly than the current process, which could take between three and 30 days.” The study was published on October 7, 2019, in the journal Proceedings of the National Academy of Sciences.
Rapid DNa Flow Platform Detects Tick-Borne Bacterial Pathogens
LabMedica International February-March/2020
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Gene Panel Predicts Disease Progession for Patients with B-cell lymphoma
To view this issue in interactive digital magazine format visit www.LinkXpress.com
LabMedica International
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ancer researchers developed a 29 gene–based weighted prognostic score for predicting event-free survival and overall survival of patients suffering from diffuse large B-cell lymphoma (DLBCL). DLBCL is the most common type of non-Hodgkin lymphoma, an aggressive cancer that begins in certain immune system cells and can occur almost anywhere in the body. This cancer occurs primarily in older individuals, with a median age of diagnosis at approximately 70 years of age, although it can also occur in children and young adults in rare cases. An elevated level of circulating cell-free DNA (cfDNA) has been associated with tumor mass and poor prognosis in DLBCL, but the tumorspecific molecular alterations in cfDNA with prognostic significance have remained unclear. To help clarify this issue, investigators at the University of Chicago Medical Center (IL, USA; www.uchicagomedicine.org) studied the association between 5-hydroxymethylcytosines (5hmC), a mark of active demethylation and gene activation, in cfDNA from blood plasma and prognosis in newly diagnosed DLBCL patients. The investigators emplyed the 5hmC-Seal, a highly sensitive chemical labeling–based sequencing technology, to profile genome-wide 5hmC in cfDNA from blood plasma of 48 patients with newly diagnosed DLBCL. This technology used the T4 bacteriophage beta-glucosyltransferase to transfer an engineered glucose moiety containing an azide group onto the hydroxyl group of 5hmC. The azide group could be chemically modified with biotin for detection, affinity enrichment, and sequencing of 5-hmC–containing DNA fragments. The 5hmC-Seal technology was shown to be a robust profiling approach for enriching and quantifying 5hmC-modified DNA fragments with as little as one to two nanograms of cfDNA in less than five milliliters of plasma. The investigators tested the hypothesis that 5hmC profiles in cfDNA at the time of diagnosis reflected the clinical characteristics of DLBCL and were associated with survival. Results obtained during the study enabled the development of a 29 gene– based weighted prognostic score for predicting event-free survival and overall survival. “Our findings, if validated in a larger independent patient population, could impact the cure rate for DLBCL,” said first author Dr. Brian Chiu, associate professor of epidemiology at the University of Chicago Medical Center. “By identifying those patients who are at high-risk of treatment failure, we can see who may benefit from individualized clin-
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ical management or earlier treatment with novel or targeted therapies.” The study was published in the October 8, 2019, online edition of the journal Blood Advances. Image: A micrograph of a diffuse large B cell lymphoma (DLBCL) (Photo courtesy of Wikimedia Commons).
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PRODUCT NEWS
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IMMUNOASSAY ANALYZER
CAROLINA LIQUID CHEMISTRIES
MOLECULAR DIAGNOSTIC SYSTEM CDG BIOTECH
CERTEST BIOTEC
The AIA-900 automated immunoassay analyzer with flexible expansion capabilities has a throughput of 90 tests per hour and can load 10 racks on a board and up to five tests per patient.
The GeneXpert Xpress fully integrated molecular diagnostic system offers standardized molecular testing for any healthcare setting, front-line access and control, with a single system storing 20,000+ test results.
The CerTest Adenovirus Resp. one step card test is a colored chromatographic immunoassay for the qualitative detection of Adenovirus from nasal swab, nasopharyngeal wash or aspirate specimens.
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ADENOVIRUS TEST
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Point-of-Care Method for Diagnosis of Sepsis
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causes injury to its own tissues and organs. Common signs and symptoms include fever, increased heart rate, increased breathing rate, and confusion. There may also be symptoms related to a specific infection, such as a cough with pneumonia, or painful urination with a kidney infection. In the very young, old, and people with a weakened immune system, there may be no symptoms of a specific infection and the body temperature may be low or normal, rather than high. Current testing and diagnostic approaches fail to provide the precise and timely information needed to treat sepsis. To correct this, investigators at Brigham and Women's Hospital (Boston, MA, USA; www.brighamandwomens.org) designed a new method, based on microfluidics, which relies on minute channels to separate 50 microliter samples of peripheral blood into fractions comprising either the larger white blood cells or the smaller red blood cells and other elements of the blood. The size-based microfluidic method was combined with novel isodielectric separation technology - developed by colleagues at the Massachusetts Institute of Technology (Cambridge, MA, www. mit.edu) - which measured cellular electrical activity. This method detected changes that occurred when white blood cells became activated and could distinguish patients with and without inflammation, such as in sepsis. The investigators used the system to assess leukocyte phenotype and function over a period of seven days in serial samples from 18 hospitalized patients with sepsis and 10 healthy subjects. Results revealed that the sepsis samples had significantly higher levels of CD16dim and CD16− neutrophils and CD16+ “intermediate” monocytes, as well as significantly lower levels of neutrophil-elastase release, O2 production, and phagolysosome formation. Repeated sampling of sepsis patients over seven days showed that leukocyte activation (measured by isodielectric separation) and leukocyte phenotype and function were significantly more predictive of the clinical course than complete-blood-count parameters. "Our idea was to develop a point-of-care diagnostic test that, instead of focusing on the white blood cell count, would inform us about white
blood cell activation state and function," said senior author Dr. Bruce Levy, chief of the division of pulmonary and critical care medicine at Brigham and Women's Hospital. "It has been exciting for us, as translational scientists, to work on a solution with outstanding bioengineer colleagues. Together, we are able to address a truly important clinical problem." The potential use of the leukocyte function test to diagnose sepsis was described in the November 11, 2019, online edition of the journal Nature Biomedical Engineering. Image: Three-dimensional rendering of various types of white blood cells (Photo courtesy of Wikimedia Commons) LabMedica International February-March/2020
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Infrared Spectrometry Method Used for Triage of Brain Cancer Patients
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LabMedica International
A
team of British researchers has adapted an advanced spectrophotometric method for use in brain cancer testing as a triage tool to speed up the diagnostic process. Non-specific symptoms, as well as the lack of a cost-effective test to triage patients in primary care, has resulted in increased time-to-diagnosis and a poor prognosis for brain cancer patients. A rapid, cost-effective, triage test could significantly improve this scenario. Towards this end, investigators at the University of Strathclyde (Glasgow, United Kingdom; www.strath.ac.uk), the spinoff biotechnology company ClinSpec Diagnostics Limited (Glasgow, United Kingdom; www.clinspecdx.com), and colleagues at other institutions developed instrumentation based on testing blood samples by attenuated total reflection (ATR)Fourier transform infrared (FTIR) spectroscopy to differentiate cancer and control patients.Fourier-transform infrared spectroscopy (FTIR) is a technique used to obtain an infrared spectrum of absorption or emission of a solid, liquid, or gas. An FTIR spectrometer simultaneously collects high-spectral-resolution data over a wide spectral range. This confers a significant advantage over a dispersive spectrometer, which measures intensity over a narrow range of wavelengths at a time. The term Fourier-transform infrared spectroscopy originates from the fact that a Fourier transform (a mathematical process) is required to convert the raw data into the actual spectrum. Attenuated total reflection (ATR) is a sampling technique used in conjunction with infrared spectroscopy, which enables samples to be examined directly in the solid or liquid state without further preparation. The investigators developed disposable sample slides that allowed the rapid preparation and analysis of multiple samples, enabling high-throughput ATR-FTIR spectroscopy optimized for clinical research. Based upon the design of a microscope slide, these optical sample slides contained four sample areas; one for background measurements and three for repeat measurements of a single patient. This device was developed for the triplicate measurement of patient samples with optimized spectral throughput and performance. The investigators described the transition to this technology for the established application of ATR-FTIR spectroscopy of blood serum for the detection of brain cancer, and the subsequent impact on clinical diagnostics. In the current study, they analyzed samples from a prospective cohort of 104 patients and found that the blood test was able to differentiate cancer and control patients at a sensitivity and specificity of 93.2% and 92.8%, respectively. Senior author Dr. Matthew J. Baker, reader in pure and applied chemistry at Strathclyde University and
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CSO at ClinSpec Diagnostics, said, "This is the first publication of data from our clinical feasibility study and it is the first demonstration that our blood test works in the clinic. Earlier detection of brain tumors in the diagnostic pathway brings the potential to significantly improve patient quality of life and survival, whilst also providing savings to the health services." The clinical feasibility study was published in the October 8, 2019, online edition of the journal Nature Communications. Image: An example of an FTIR spectrometer with an attenuated total reflectance (ATR) attachment (Photo courtesy of Wikimedia Commons).
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PRODUCT NEWS
T. CRUZI. TEST
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CHEMISTRY ANALYZER
POC DIAGNOSIS SYSTEM
CHEMBIO DIAGNOSTIC SYSTEMS
CAROLINA LIQUID CHEMISTRIES
BIOSENSIA
The Chagas STAT-PAK Assay is easy to use, requires no cold chain storage, providing visual detection of antibodies to T. cruzi. It requires a minimal sample size of 10 µL whole blood, 5 µL serum or plasma.
The CLC800 is a quiet, small, fast and economical chemistry analyzer with the ability to process up to 400 photometric chemistry tests per hour, accommodating up to four part reagents.
The RapiPlex is a point-of-care diagnosis system capable of producing quantitative and qualitative laboratory quality test results. It comprises a disposable assay cartridge and a small table top instrument.
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automated Urine analyzer and Components evaluated
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rinalysis is a very common technique used in clinical practice, providing crucial information on the functioning of the kidneys and other organ systems, and aiding clinical decision-making in various diseases, such as diabetes, glomerulonephritis, and suspected urinary tract infections. Automated urine analyzers systems offer practicable and faster urine screening, which may prevent unnecessary culture requests. The increased throughput of these instruments over manual methods enables the reliable and rapid screening of urine samples with reduced labor demands on laboratory staff, thereby improving efficiency and cost-effectiveness. Clinical chemists at the Leiden University Medical Center (Leiden, The Netherlands; www.lumc.nl) and their colleagues conducted a study at three European centers using un-centrifuged surplus routine urine samples; all measurements were performed within 2 hours of sample collection. Precision, sample carry-over and method comparisons were evaluated per Clinical and Laboratory Standards Institute guidelines. The scientists compared the fully automated urine analyzer, the
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cobas u 601 (Roche Diagnostics, Basel, Switzerland; https://diagnostics.roche.com) versus the Roche Urisys 2400 and the Roche cobas u 411 urine test strips; and the Roche cobas u 701 versus KOVA visual microscopy (KOVA International, Garden Grove, CA, USA; www.kovaintl.com) and the iQ200 analyzer (Beckman Coulter Inc, Brea, CA, USA; www.beckmancoulter.com). Operability and functionality were assessed using questionnaires. The team reported that precision of the entire cobas 6500 system was within predefined acceptance limits and no significant carry-over was observed. Erythrocytes, leukocytes, nitrites, and protein were in good agreement (≥93%) with cobas u 411 reflectometry. High correlation was shown between the cobas u 701 analyzer and KOVA visual microscopy for red blood cells (RBC) and white blood cells (WBC), demonstrating equivalence of test results. The 97.5% percentile reference values on the cobas u 701 analyzer were 5.3 cells/μL (RBC) and 6.2 cells/μL (WBC). The cobas 6500 system showed good sensitivity for small bacteria (>1 μm) and pathological casts, and the user interface, maintenance wizards and system design were highly rated by operators. The authors concluded that showed that the fully automated cobas 6500 urine work area meets the analytical quality specifications recommended by European urinalysis guidelines, produces results comparable to those obtained by manual microscopy, and is suitable for routine clinical laboratory use. The study was published on September 19, 2019, in the journal Practical Laboratory Medicine. Image: The cobas 6500 urine analyzer series is a fully automated work area solution designed for laboratories that process 100 – 500 urine samples per day (Photo courtesy of Roche Diagnostics).
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PRODUCT NEWS
ORAL FLUID TEST PLATFORM
PHOTOMETER
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STREP B LATEX TEST
OASIS DIAGNOSTICS
DAS SRL
DENKA SEIKEN
The VerOFy Rapid, oral fluid test platform combines rapid and standardized saliva (oral fluid) collection with high quality immunochromatographic test strips for delivering immediate results in field or point-ofcare locations.
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The Strep B Latex Test is a direct 10-minute slide latex agglutination for the identification of pregnant women at a risk of passing group B streptococcal infections to infants.
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Rapid Immunoassay Shows Potential for lyme Disease Diagnosis
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three-antigen-based immunoassay for diagnosis of Lyme disease has the potential to be developed for point-of-care use. Lyme disease, which is caused by the spiral-shaped bacterium Borrelia burgdorferi, may be difficult to diagnose, as it causes a wide range of symptoms, from fever and rash to neurologic and cardiac symptoms and joint pain. The most widely used method for Lyme diagnosis is testing for antibodies in the blood by ELISA and Western blot. A twotiered protocol is recommended by the [U.S.] Centers for Disease Control and Prevention (CDC): the sensitive ELISA test is performed first, and if it is positive or equivocal, then the more specific Western blot is run. However, the reliability of the CDC two-tiered protocol is controversial. Studies have shown that the Western blot IgM has a specificity of 94â&#x20AC;&#x201C;96% for individuals with clinical symptoms of early Lyme disease. The initial ELISA test has a sensitivity of about 70%, and in two-tiered testing, the overall sensitivity is only 64%, although this rises to 100% in the subset of people with disseminated symptoms, such as arthritis. Erroneous test results have been widely reported in both early and late stages of the disease, and can be caused by several factors, including antibody cross-reactions from other infections, including Epsteinâ&#x20AC;&#x201C;Barr virus and cytomegalovirus, as well as herpes simplex virus. As an alternative to the two-tiered protocol, investigators at NIH/National Institute of Allergy and Infectious Diseases (Bethesda, MD, USA; www.niaid.nih.gov) and collaborators at several institutions including Columbia University (New York, NY, USA; www.columbia.edu) and the University of Tennessee Health Science Center (Memphis, USA; www.uthsc.edu) developed a sensitive immunoassay based on three Borrelia burgdorferi antigens. The investigators used human serum rigorously characterized as acute and convalescent early Lyme disease, Lyme arthritis, and post treatment Lyme disease syndrome, as well as the necessary control samples to select the best of 12 Borrelia burgdorferi proteins to improve their microfluidic assay (mChip-Ld). The operation of mChip is similar to that of ELISA for determining serum antibody concentrations. The mChip contains 10 zones, which detect the passage of a small amount (about one microliter) of blood. The results can be obtained in a colorcoded format in about 15 minutes. The investigators selected three antigens (3Ag) to include in the mChip-Ld: VlsE and a proprietary synthetic 33-mer (repeat units) peptide (PepVF) to capture sensitivity in all disease stages, and OspC for ear-
ly Lyme disease. Results revealed that these biomarkers were more effective than those previously used at identifying signs of Lyme disease infection in early stage samples, possibly as these antigens were able to detect antibodies that peaked in the first two to six weeks following infection. The investigators suggested that their results opened the door for the development of a single, rapid, multiplexed diagnostic test for point-ofcare use that could be designed to identify Lyme disease stage. The study was published in the October 9, 2019, online edition of the Journal of Clinical Microbiology. Image: In this photomicrograph, the spiral-shaped bacteria that cause Lyme disease, Borrelia burgdorferi, have been illuminated using red and green fluorescent antibodies (Photo courtesy of the National Institute of Allergy and Infectious Diseases). LabMedica International February-March/2020
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STREPTOCOCCUS TEST
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The STREPA’LERT is an immunochromatographic rapid test for the qualitative detection of Streptococcus Group A antigen in throat swab specimens. The STREPA’LERT test is now CE marked.
The ComboStik R-700 is a high-speed urine analyzer with a maximum throughput of 720 tests per hour, offering connectivity to LIS system, color LCD display, simple keypad and integrated printer.
The DAW50 stand-alone microplate reader features onboard data reduction that surpasses most computer software packages with its extensive curve-fitting, cutoff calculation, data transformation and validation capabilities.
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Methylation Signature Identified for Brain Metastases of lung Cancer
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hen lung cancer metastasizes to the brain, it means the primary lung cancer has created a secondary cancer in the brain. About 20% to 40% of adults with non-small cell lung cancer go on to develop brain metastases at some point during their illness. DNA methylation is a process by which methyl groups are added to the DNA molecule. Methylation can change the activity of a DNA segment without changing the sequence. When located in a gene promoter, DNA methylation typically acts to repress gene transcription. Scientists at the Zhejiang Cancer Hospital (Hangzhou, China; www.zchospital.com) performed capture-based targeted sequencing to look for somatic mutations in 60 treatment-naïve advanced nonsmall cell lung cancer (NSCLC) patients using a panel of 520 cancerrelated genes, as well as DNA methylation analyses using a methylation panel consisting of 100,000 CpG sites. The patients were split into three groups: one with brain metastases, a second with leptomeningeal metastases, and the third with no metastases. The team identified 370 mutations in the lung primary lesions and 574 mutations in the brain metastases. Among them, 242 mutations were shared, of these, 128 were lung primary-specific and 332 were brain-specific. Among the mutations specific to the brain metastases, 82% of them were copy number variations (CNVs), which was significantly higher than the CNVs found in the primary tumors. Only 16% of the CNVs were found in both the lungs and the brain. The investigators also performed a pathway analysis of the genes that were only mutated in the brain and found an enrichment of genes in the PI3KAKT and focal adhesion pathways. In the leptomeningeal metastasis group, the team found a significant concordance between the driver mutations in primary lung tissue and the metastases in cerebrospinal fluid. These metastases, however, did not have a significantly larger number of CNVs than the primary tumors. They also found that the list of mutated genes was comparable in all three patient cohorts; they next turned to DNA methylation analysis to see if they could find any markers indicating a higher likelihood of developing metastasis. The methylation analysis revealed distinct patterns, with 268 methylation blocks being significantly differentially methylated between primary lung lesions and brain metastases. Among those, 211 blocks were hypermethylated in the brain and the remaining 57 blocks were hypermethylated in lung lesions. When they compared the leptomeningeal metastases to the non-metastatic patients, they
found 323 blocks that were differentially methylated. Of these, the brain and leptomeningeal metastasis groups shared 15 methylation blocks that the scientists believe may be prognostic of central nervous system metastasis. Through a stepwise regression analysis, the team was able to narrow the signature further to six methylation blocks. The study was presented at the Annual meeting of the European Society for Medical Oncology held September 27- October 1, 2019, in Barcelona, Spain. Image: A histopathology of meningeal carcinomatosis with infiltration of the brain gray matter and perivascular malignant cells (Photo courtesy of Zuzana Gdovinova. LabMedica International February-March/2020
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Routine Blood Parameters Predict Invasive aspergillosis Prognosis
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LabMedica International
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spergillosis occurs in chronic or acute forms which are clinically very distinct. Most cases of acute aspergillosis occur in patients with severely compromised immune systems, e.g. those undergoing bone marrow transplantation. Symptoms include fever, chills, shock, delirium, seizures, and blood clots. Acute invasive aspergillosis occurs when the immune system fails to prevent Aspergillus spores from entering the bloodstream via the lungs. Without the body mounting an effective immune response, fungal cells are free to disseminate throughout the body and can infect major organs such as the heart and kidneys. The patient may develop kidney failure, liver failure (causing jaundice), and breathing difficulties and death can occur quickly. A large team of scientists working with the National University of Singapore (Singapore; www.nus.edu.sg) performed a post-hoc secondary analysis of two multicenter randomized trials. The Global Comparative Aspergillosis Study (GCA, N=123) and the Combination Antifungal Study (CAS, N=251) constituted the discovery and validation cohorts respectively. The outcome measures were response to treatment and survival to 12 weeks. Interval platelet, galactomannan index (GMI) and C-reactive protein (CRP) levels prior and during antifungal treatment were analyzed. The investigators reported that the 12-week survival was 70.7% and 63.7% for the GCA and CAS cohorts respectively. In the GCA cohort, every 10×109/L platelet count increase at week 2 and 4 improved 12-week survival odds by 618% (Odds ratio [OR] 1.06-1.18). Survival odds also improved 13% with every 10 mg/dL CRP drop at week 1 and 2 (OR 0.87). In the CAS cohort, week 2 platelet count was also associated with 12-week survival with 10% improved odds for every 10×109/L platelet increase (OR, 1.10). A GMI drop of 0.1 units was additionally found to increase the odds of treatment response by 3% at the baseline of week 0 (OR 0.97). Week 2 platelet and CRP levels performed better than GMI on ROC analyses for survival (area under ROC curve 0.76, 0.87 and 0.67 respectively). A baseline platelet count higher than 30×109/L clearly identified patients with > 75% survival probability. The authors concluded that higher serial platelets were associated with overall survival while GMI trends were linked to invasive aspergillosis treatment response. Routine and simple laboratory indices may aid follow-up of response in invasive aspergillosis patients. The study was published on October 24, 2019 in the journal Clinical Microbiology and Infection.
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LabMedica International February-March/2020
Image: Photomicrograph of a hematoxylin-eosin-stained human lung tissue specimen, harvested from a pulmonary aspergillosis patient. The histopathologic changes indicate the presence of Aspergillus sp. fungal organisms. Note the branching hyphae amongst the lung tissue (Photo courtesy of the Armed Forces Institute of Pathology).
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PRODUCT NEWS
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The Direct HbA1c Assay (Enzymatic, On-Board Lysis) test kit is intended for use in the quantitative determination of stable HbA1c in venous whole blood samples with on-board blood lysis application in a clinical laboratory.
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lynch Syndrome Screening by IHC leads to Mutation Studies
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ynch syndrome or hereditary nonpolyposis colorectal cancer is an autosomal dominant genetic condition that is associated with a high risk of colon cancer, as well as other cancers including endometrial cancer, ovary, stomach, small intestine, hepatobiliary tract, upper urinary tract, brain, and skin. Immunohistochemical expression of mismatch repair (MMR) protein is a well-accepted method for routine screening for Lynch syndrome (LS) with relatively high sensitivity and specificity. Occasionally, however, immunohistochemistry (IHC) can yield an equivocal result with poor reproducibility and the potential for misdiagnosis. A pathologist and a geneticist from the University of Texas Southwestern Medical Center (Dallas, TX, USA; www.utsouthwestern.edu) retrospectively analyzed the data on MMR (MLH1, PMS2, MSH2, and MSH6) IHC results from their database of 479 patients with colorectal cancer (CRC) and endometrial cancer (EC) who were screened for LS between September 2011 and August 2013. Mismatch repair protein IHC was performed prospectively in all patients with a tissue diagnosis of CRC or EC before 70 and 50 years of age, respectively. Semi-quantitative scoring of MMR IHC was performed by image analysis in 479 cases, of which 380 were colorectal and 99 endometrial cancers. Scores of 10% or more, less than 10%, and 0% were used as cutoffs for retained, indeterminate, and loss of expression, respectively. Negative and indeterminate IHC results were confirmed by mutational studies. The automated cell imaging system, (ACIS, Chroma Vision Medical Systems, San Juan Capistrano, CA, USA; www.chroma vision.com) consisted of an automated robotic bright-field microscope module and a Windows NTâ&#x20AC;&#x201C;based software interface that digitizes the IHC-stained slide, and digital images were displayed on a computer screen and analyzed by proprietary software. Confirmatory germline testing was initiated after counseling the patients about the abnormal IHC results and obtaining their permission for further genetic testing. The scientists reported that 418/479 cases (87.2%) were reported as retained expression, 45 (9.3%) as loss of expression, and 16 (3.3%) as indeterminate expression. Fifteen of 45 (33.3%) and eight of 16 (50%) with loss and indeterminate expression, respectively, were found to have Lynch syndrome by germline studies. The overall frequency of Lynch syndrome in the patient population was 4.8% (23/479), and 34.7% of these (8/23) were associated with indeterminate IHC expression. In the indeterminate group, MLH1 germline mu-
tation was the most frequent (6/13; 46.2%), followed by MSH6 (4/13; 30.7%). The authors concluded that their findings provided further evidence that indeterminate IHC should be further investigated for possible MMR germline mutation. Guidelines for interpretation of MMR IHC and the establishment of more objective criteria for defining indeterminate results are important to improve the sensitivity and specificity of the IHC assay. The study was published in the October 2019 issue of the journal Archives of Pathology and Laboratory Medicine. Image: A and B, Mucinous adenocarcinoma of colon and indeterminate PMS2 immunohistochemistry staining. C and D, Poorly differentiated carcinoma of colon and indeterminate MLH1 staining. E and F, Endometrial carcinoma and focal MSH6 staining (Photo courtesy of University of Texas Southwestern Medical Center). LabMedica International February-March/2020
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Immune Processes linked to Multiple Sclerosis Genetics
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LabMedica International
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ultiple sclerosis (MS) is an autoimmune inflammatory degenerative disease of the central nervous system that often starts in young adulthood and affects 2.3 million individuals worldwide. While prior genetic studies have implicated the adaptive immune system in the disease, in particular T cells, much of the genetic architecture of MS has remained unknown. The role of the adaptive arm of the immune system, particularly its CD4+ T cell component, has become clearer, with multiple different T cell subsets being implicated. Although the T cell component plays an important role, functional and epigenomic annotation studies have begun to suggest that other elements of the immune system may be involved as well. Scientists involved with the International Multiple Sclerosis Genetics Consortium (Boston, MA, USA; www.imsgenetics.org) analyzed genotyping data from a total of more than 47,000 MS patients and more than 68,000 unaffected controls. These included both existing datasets and two large-scale new datasets for replication studies. For the autosomal non- major histocompatibility complex (MHC) genome, they applied a partitioning approach to create regions of Âą1 Mbp around the most statistically significant single nucleotide polymorphisms (SNP). The team designed the MS Chip using the Illumina iSelect platform, adding ~90K custom selected SNPs to the Illumina Exome Core content (~200K SNPs) (Illumina, San Diego, CA, USA; www.illumina.com). The team identified 233 associations with MS susceptibility that had genome-wide significance, including 32 loci on the major histocompatibility complex and one on the X chromosome. The latter might help explain why MS affects almost three times more women than men. Using gene expression and epigenomic data for T cells, monocytes, peripheral blood mononuclear cells, and prefrontal cortex tissue, the scientists found that MS risk loci are enriched in many types of immune cells and tissues, as well as in microglia, which are the immune cells of the brain, but not in other types of brain cells. Together with other functional studies into the effects of MS risk variants, they identified a list of 551 putative MS susceptibility genes with involvement in both innate and adaptive immune responses, many of which have roles in the development, maturation, and differentiation of B cells, T cells, natural killer cells, and myeloid cells. The authors concluded that beyond the characterization of the molecular events that trigger MS, this map will also inform the development of primary prevention strategies because they can leverage this information to identify the subset of individuals who are at greatest risk of developing MS. Although insufficient by itself, an MS genetic risk score has a role to play in guiding the management of the population of individuals 'at risk' of MS (such as family members) when deployed in combination with other measures of risk and biomarkers that capture intermediate phenotypes along the trajectory from health to disease. The study was published on September 27, 2019, in the journal Science. V
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Image: A multiple sclerosis chip (MS chip) was designed using the Illumina iSelect platform (Photo courtesy of Illumina).
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The respons 940 is an automated random access clinical chemistry analyzer with a constant throughput of minimum 400 tests/hour, durable quartz cuvettes, low reaction volume and maintenance free photometer.
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aqueous Humor Is Superior to Blood to Diagnose Retinoblastoma
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etinoblastoma is a cancer that forms in the light-detecting cells in the back of the eye. It often appears in children under two years of age and can lead to blindness or eye removal. Most cancers are biopsied and studied so that medical scientists can design targeted treatments. When there is a family history of retinoblastoma, a child is most likely to develop the disease within 28 months of birth. When there is no family history, it is frequently the parents who notice the main symptoms of retinoblastoma: a white pupil reflex instead of a normal black pupil or red reflex, or a crossed eye. Ophthalmologists at the Children's Hospital Los Angeles (Los Angeles, CA, USA; www.chla.org) and their associates performed whole genome sequencing on 20 matched blood and aqueous samples. Tumor-associated chromosomal changes were found in 0/20 blood versus 11/20 aqueous samples along with shorter DNA fragments. The scientists concluded that aqueous humor is superior to blood as a liquid biopsy for retinoblastoma. Jesse L. Berry, MD, Associate Director of Ocular Oncology at Children's Hospital Los Angeles, and senior author of the study, said, “You can't directly biopsy retinoblastoma. The tumor is like liquid and has cells all over the eye. Plus retinoblastoma cells can spread easily. Direct biopsy can cause relapse or spread of the disease outside of the eye. This makes diagnosis tricky. In the absence of molecular tests, trained ophthalmologists must look for anomalies in the eye and use ultrasound imaging to diagnose the disease.” Dr. Berry noted that “Many children actually have retinoblastoma tumors in both eyes. If we were to test the blood and find a positive result, we would not actually know which eye it was from. Instead, aqueous
Image: Retinoblastoma is cancer of the eye and cannot be biopsied. Aqueous humor is superior to blood to diagnose retinoblastoma (Photo courtesy of Aravind Eye Hospital).
umor tissue has traditionally been required for both cancer diagnosis and molecular biomarker testing. All too often, acquired tissue is exhausted during the initial diagnosis, leaving insufficient tissue for subsequent biomarker testing. The use of liquid biopsies for precision medicine for the stratification of patients using biomarkers associated with targeted therapies is an emerging trend in oncology that is gaining adoption for guiding therapeutic decisions in cancer management. A team of scientists working for the commercial company Biocept Inc, (San Diego, CA, USA; https://biocept.com) presented a detailed description of the company's Target Selector approach, including a wildtype suppression method the firm has come to call "switch blocker." They also reported strong reproducibility, and analytical sensitivity and
specificity across five genes, matching closely some of the other highsensitivity polymerase chain reaction (PCR) methods that are also being used in the clinic and/or marketed as kit products. Model cell lines were propagated in culture medium with 10% fetal bovine serum and cells were collected and processed to extract DNA using the QIAamp DNA Mini Kit (QIAGEN, Germantown, MD, USA; www.qiagen.com). Cell-free DNA was extracted from 4 mL of plasma samples using the Qiagen QIAsymphony DSP Circulating DNA Kit on the QIAsymphony SP instrument. Cell-free DNA was eluted into 100- L buffer. DNA samples were then quantitated with the Qubit dsDNA HS Assay Kit (Thermo Fisher Scientific, Waltham, MA, USA; www.ther mofisher.com). Typically, 10 L of DNA sample was used for each Target Selector assay reaction.
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humor biopsies give us specific information for tumors in each eye. Not only can tumor DNA be detected, but the study also showed that genetic factors can predict treatment success for a given tumor. Taken together, the discoveries are set to drastically improve retinoblastoma research and clinical practice.” "Aqueous humor biopsy has potential to becoming the new standard of care for retinoblastoma," said Dr. Berry. "It is our best chance to diagnose and treat these patients on a molecular level.” The study was published on October 30, 2019 in the journal Ophthalmology.
Full analytical Data Validated for Target Selector ctDNa assays
LabMedica International February-March/2020
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Edited by Katherina Psarra MSc, PhD IFCC members may send news to: Professor Katherina Psarra IFCC Office, Via C. Farini 81 20159 Milano, Italy. E-mail: enews@ifcc.org
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15th asia-Pacific Federation Congress Held in Jaipur, India
he 15th Asia-Pacific Federation of Clinical Biochemistry and Laboratory Medicine (APFCB) Congress was held at Jaipur Exhibition and Convention Centre (JECC), Jaipur, Rajasthan, India from 17th to 20th of November 2019. It was organised by the Association of Clinical Biochemists of India (ACBI) along with the support of Association of Medical Biochemist of India (AMBI). The theme of the congress was “Laboratory Medicine – Innovation & Integration” Six pre-congress workshops were held in two sessions on 17 November 2019 at Marriott Hotel, Jaipur. The workshops were: • AACC Global Lab Quality Initiative: Adding value to patient care using quality control (AACC); • Alzheimer's Workshop (IFCC - ETD); • Mass Spectrometry in the clinical laboratory (AACB); • Building Tomorrow's leaders by the young generation (IFCC-CCLM / IFCC-TFYS); • Requirement for High Quality liquid profiling for cancer diagnostics in clinical laboratory practice (IFCC - EB); • Multi-dimensional perspectives of Laboratory (ACBI - Roche). The Congress began on 17 November with the inaugural plenary by Prof Subrat Kumar Acharya. He delivered a talk on ‘Ammonia in Acute Liver Failure: Its influence on pathogenesis, Prognosis and Management’. There were three plenary lectures scheduled on different days of the Congress by Prof Maurizio Ferrari (Expanding space for Next Generation Sequencing diagnostics applications), Prof Sampath Parthasarathy (Alzheimer’s a cerebrovascular disease?) and Prof David Kinniburgh (The Opioid Crisis in North America). ACBI conferred oration awards to the four plenary speakers. Prof Subrat K Acarya was given Awadesh Saran Memorial Oration award, Prof Maurizio Ferrari received Seth G.S. Medical College & K.E.M. Hospital Oration Award, Prof Sampath Parthsarathy received Mrs. And Dr. G. P Talwar Oration Award and Prof David Kinniburgh was given the Prof. T. N. Pattabhiraman Oration Award. The scientific program of the Congress had 40 symposia containing 134 lectures presented on emerging topics of clinical biochemistry and laboratory medicine by various member societies of APFCB, IFCC, AACC, COLABIOCLI, WASPALM etc. Additionally, 40 oral papers and 366 scientific posters were presented in the Congress. During the sessions a survey was also conducted by means of feedback forms for speaker feedback, congress programme, presentation content and services. Participants feedback showed the grand success of the congress. Prof. Leslie Lai was awarded the Lifetime Achievement Award for his outstanding contribution to APFCB and scientific excellence. There were three IFCC – Visiting Lecture Fellows: Prof Sampath Parthasarathy, Prof Sedef Yenice and Prof Ed Randell. The Congress also offered a total of 47 awards and scholarships to support the participation of young fellows and scientists. The awards with the number of awardees were: • APFCB young scientist travel scholarship: 3 • IFCC Roche travel scholarship: 8 • IFCC TFYS Snibe travel grant: 3 • APFCB-RCPAQAP award: 1 • APFCB organising committee travel award: 5. • Best poster award from organising committee: 8. A total number of 662 participants and 308 exhibitors from all over the world participated in this Congress. A total of 28 companies exhibited their products in the Congress. Four academic societies (APFCB Congress, IFCC Worldlab 2020, IFCC and ACBI) also joined the exhibition. Societies meetings were hosted during the Congress. APFCB had its council meeting on November 17, 2019. IFCC ETD and CPD also had their meeting on the same day. IFCC TFYS meeting was on November 19 and IFCC Board meeting was conducted on November 2022, 2019.
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NEWS
LabMedica International February-March/2020
The Congress also hosted a variety of social programmes. The opening ceremony and inaugural dinner were held on November 17, at JECC. The opening ceremony for the Exhibition was held on November 18. On November 19, Cultural programme and Gala dinner was organised. Valedictory ceremony was held on November 20, where successful completion of the congress was celebrated and the flag was handed over to Prof Helen Martin, AACB for the next Congress, the 16th APFCB Congress to be held in Australia in 2022.
NEWS D
News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information
editorial
by Katherina Psarra MSc, PhD
ear colleagues, all the countries worldwide are facing the threat of this new coronavirus. A “crown” in the name of this threat, makes it very bizarre, but we should definitely try not to panic. Some of you may be doing research on it in labs, some may be helping in detecting it. Let’s hope for the better! Due to the Coronavirus concerns and worldwide travel restrictions, the WorldLab Congress in Seoul will be postponed. A new date for the con-
ference will be determined as soon as possible. It is a great pleasure to announce the results of the elections for the IFFC board secretary and treasurer positions. Dr David Kinniburgh (Canada) was re-elected as Secretary and Dr Alexander Haliassos (Greece) was elected as Treasurer. Our sincere and warm congratulations to both of them and our best wishes for a fruitful and successful work. The article in memory of Carl Burtis is really inspiring for us and for the young scientists, who keep always their position in the news and whose reports of their participation in IFCC educational activities are also inspiring and promising. I take the opportunity to remind you of the board decision, that care will be taken in order all the committees to have at least one young member. In this way IFFC future is built. Read about the past, read about the present and build the future!
New IFCC Secretary and Treasurer elected
The IFCC Nominations Committee is pleased to announce that Dr David Kinniburgh (CA) has been elected IFCC Secretary, and Dr Alexander Haliassos (GR) has been elected IFCC Treasurer. We congratulate them both and wish them a fruitful term in the promotion of clinical chemistry and laboratory medicine world-wide. The elections have been conducted via an electronic system in order Dr David kINNIBURGH IFCC to ensure wider participation in this Secretary important moment in the IFCC life. Dr David Kinniburgh has been nominated by the Canadian Society of Clinical Chemists (CSCC) to serve a second term as Secretary of
the IFCC Executive Board (EB). Dr Kinniburgh is the Director of the Alberta Centre for Toxicology at the University of Calgary and a Clinical Professor with the Department of Laboratory Medicine and Pathology at the University of Alberta and an Adjunct Associate Professor in Pharmacology and Therapeutics with the University of Calgary. His professional work experience includes hospital, academic and reference laboratories Dr alexander alexander HalIaSSOS HalIaSSOS Dr and he has served as both a clinical IFCC Treasurer Treasurer IFCC scientist and a senior administrator. He is the current Secretary for the IFCC Executive Board, and previously served as the Representative for the IFCC North American Federation of Clinical Chemistry and Laboratory Medicine (NAFCC) for the 2015-2017 term. Among his other roles, he is a Past President of the Canadian Society of Clinical Chemists and served previously as Treasurer. He is President of the Alberta Association of Clinical Laboratory Doctoral Scientists and have served as President of the Alberta Society for Human Toxicology and the Alberta Society of Clinical Chemists. His past experience and his skills will allow him to make a meaningful contribution to the IFCC Executive Board. The IFCC is glad to welcome Dr David Kinniburgh as IFCC Secretary on the Board. Dr Alexander Haliassos has been nominated by the Greek Society of Clinical Chemistry - Clinical Biochemistry (GSCC-CB) to serve as Treasurer of the IFCC Executive Board (EB). Dr Alexander Haliassos is President and CEO of DIAMEDICA, a Greek reference laboratory specialized in Prenatal Diagnostics based in Athens since 2005. He also acts as Scientific Director of the Greek External Quality Assessment Scheme (ESEAP), a non-profit organization established by the Greek Ministry of Health as a spin-off of the Greek Society of Clinical Chemistry-Clinical biochemistry (GSCC-CB). Dr Alexander Haliassos is registered as European Clinical Chemist (EurSpLM) and he fulfills many responsibilities in teaching medical students at the National Research Foundation, Institute for Biological Research and Biotechnology in Athens, also directing the core medical laboratory, and including the Blood Bank of the Onassis Cardiac Surgery Center, the Athens Euroclinic and the Metropolitan Hospital at Athens, and in participating in genetics research. At national level, Dr Haliassos was GSCC-CB Executive Board member (1996-2003), then as GSCC-CB Scientific Secretary (2005-2011); from 2012 until 2017 General Secretary and from 2017 until today President of the same society. At international level, Dr Alexander Haliassos is member of the American Association of Clinical Chemistry (AACC), and the leading Editor of the website www.labtestsonline.gr. Dr Haliassos’ experience and commitment to IFCC and laboratory medicine will allow him to create effective and sustainable financial strategies for the changing opportunities in the new laboratory medicine and healthcare environment. We congratulate Dr Haliassos on his election as IFCC Treasurer. LabMedica International February-March/2020
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News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information
IFCC-Roche Travel Scholarships awarded
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FCC and Roche are pleased to present the IFCC Travel Scholarship Awardees that attended the XXIV COLABIOCLI Congress 2019, that was held in Panama, from 11 to 13 September 2019. Congratulations to: Alvaro Paul Justiniano Cortez (BO), Harlem Róterdan de León Natareno (GT), Patricia Elizabeth Osorio Pozo (EC), Carmen Maria Castro Ruiz (CO), Jorge Hernández-Bello (MX), Aurora Amarilla (PY). IFCC is pleased to present the IFCC Travel Scholarship Awardees that attended the AFCC Congress that was held in Marrakech, Morocco, from 25 to 28 September 2019. Congratulations to: Eliane Zgheib (LB), Idris Yahaya Mohammed (NG), Lucius Chidiebere Imoh (NG), Dineo Valencia Mabuza (ZA), Mutale Mubanga (ZM). IFCC and Roche are pleased to present the IFCC-Roche Travel Scholarship Awardees that attended the 15th Asia-Pacific Federation
COLABIOCLI Scholarships Reception with Awardees and, L-R: EB COLABIOCLI Representative, Dr R. Sierra Amor, IFCC President, Prof. M. Ferrari, IFCC Treasurer, Prof. T. Ozben
for Clinical Biochemistry and Laboratory Medicine APFCB Congress 2019, that was held in Jaipur, India from 17-20 November 2019.
IN MeMORIaM: CaRl a. BURTIS, PhD
By Prof. David E BRUNS Dept. of Pathology, University of Virginia Medical School; Charlottesville, VA, USA
C
arl A Burtis, a former vice president of IFCC and a leader in clinical and analytical chemistry, died on November 15, 2019, after a battle with glioblastoma. He was 82. Carl was a pioneering chemist, a legendary author and editor, an insightful association leader, and a trusted and admired mentor, colleague and friend. Carl grew up in Montrose, Colorado. According to his family1, “his favorite stories were of his small-town exploits ... Fireworks played heavily in his tales.” Having a birthday on July 3, he felt that the July 4 U.S. Independence Day holiday, which features fireworks, really was for him. Montrose High School, he said2, was “where I really learned to love chemistry, especially sodium and potassium and things that blow up.” Carl earned his bachelor’s degree (nutrition) at Colorado State University where he met his future wife, Marvel, whom many clinical chemists have had the pleasure of meeting over the next 60 years. Carl then excelled at Purdue University, earning Masters and Ph.D. degrees in Biochemistry. Excellent accounts2,3 of Carl’s career path after Purdue have been published. In summary, with the exception of 3 years at the CDC and a year in industry, Carl had a 40-year career at the Oak Ridge National Laboratory, rising from postdoc to leadership. Carl earned an international reputation as a chemist, editor, association leader and, finally, a mentor, colleague and friend.
Analytical and Clinical Chemistry
In the 1970s, Carl published more than 20 key papers on centrifugal analyzers. One described a multipurpose optical system and another described a miniature version of “one cubic foot” (28 L)! Other publications and patents described multiple applications of the analyzer for clinical laboratories, Carl made important contributions in other areas, including reference methods, especially for enzymes, and liquid chromatography. Purdue University conferred a prestigious Honorary Doctorate Degree, recognizing his contributions in to chemistry.
Tietz Textbook and Tietz Essentials of Clinical Chemistry
In the early 1990s, Norbert Tietz selected Carl as an editor of the Textbook of Clinical Chemistry. Carl brought to the task broad and deep knowledge of clinical and analytical chemistry, along with superb organizational skills. He played a leading role in recruiting teams of authors, which ultimately numbered over 100, for each edition of each book. Many a tardy author received an
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LabMedica International February-March/2020
AFCC Scholarship Awardees with IFCC authorities
Congratulations to: Yati Sumiyati (ID), Joseph Dian Bondu (IN Full), Ray Lopamudra (IN Aff), David Enoch Kawalya (KE), Nada Yousfi (TN), Itua Akhabue Igene (NG), Sangita Gimire (NP Full).
email featuring a sketch of a kneeling human skeleton, partially covered with cobwebs, pleading with the author to send the overdue manuscript. The 2014 IFCC Education Award recognized his contribution to clinical chemistry through his editing of the Tietz books, a task he viewed as a service to the profession that had given him opportunities.
Association Leadership
Carl had numerous leadership roles in IFCC (Vice President, 19902005) and AACC (President, 1989). He chaired the Oak Ridge Conference from 1981-1986. He was Co-Chair of the Organizing Committee for the 1990 International Congress in Clinical Chemistry in San Francisco. As chair of the Editorial Board of Clinical Chemistry, Carl led annual meetings of the Board, a task he described as herding “a room full of full professors”. In 1986 and 1991 he received AACC’S highest honors, the National Lectureship Award, and the Award for Outstanding Contributions to Clinical Chemistry. The latter award recognized his contributions in research, education and service. He was truly an academic triple treat.
Colleague and Mentor
When word spread of Carl’s final illness, messages poured in. colleagues and friends around the world expressed their immense regard for him. Others said he was a mentor and a role model. They wrote of his generosity and kindness. Of his sense of humor. His honesty and humility. One said simply, “The world is a better place for his having been here.” In a phone call near the end of his life, Carl reminisced about the editing of the Tietz books — the challenges of getting chapters from authors on time, etc. At some point he stopped and said, “It’s really all about people.” And that is what Carl Burtis was all about: a humble chemist, editor, and leader, who was all about people. When next I see fireworks, I will remember and be thankful that fireworks sparked Carl’s interest in chemistry and that we had the good fortune to know him.
References
1. Carl Alfred Burtis, Jr. [Obituary] https://www.weatherfordmortuary.com/obituaries/Carl-AlfredBurtis-Jr?obId=9033659. Accessed 23 January 2020. 2. Landau M. Carl Burtis. Clinical Chemistry, Volume 55, pages 585–586 (2009). Available at file:///C:/Users/David/Desktop/Burti%20obituary/Landau.full.pd Accessed 23 January 2020. 3. Anon. Carl A Burtis, PhD. https://www.aacc.org/community/awards/hall-of-fame/bios/a-tok/carl-burtis, Accessed 23 January 2020.
News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information
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Uplifting Medical lab Cybersecurity by Dr. Bernard Gouget
Chair, IFCC Committee on Mobile Health and Bioengineering in Laboratory Medicine (C-MHBLM), Past-Chair, IFCC Nominations Committee (NC); Co-Chair, IFCC TF on History, SFBC-International Relations Committee, President Healthcare Division Committee - Comité Français d’Accréditation (Cofrac)
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igital transformation in Lab Medicine and healthcare is the new reality and Internet of Things (IoT) is at the forefront of that transformation. We are more and more familiar with the daily digitalized operations and the interconnected world from personal devices to more complex systems in healthcare and other industry business. A huge amount of devices and machines generate and exchange massive amounts of data. Using these data to make intelligent medical decisions is crucial. With the increased use of data, the vulnerability increases.
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Medical diagnostics is one of the fields in which Internet and AI-based technologies are into widespread use. Biomedical devices are increasingly connected to the Internet, laboratory/hospital networks, and other medical devices to provide features that improve health care efficiency. These same features also increase the risk of potential cybersecurity threats. Cybersecurity can be defined as the protection of internetconnected systems, including hardware, software and data, from cyberattacks. In a computing context, security in Information Technology (IT) is the defense of digital information and IT assets against internal and external malicious and accidental threats. Information security, which is designed to maintain the confidentiality, integrity and availability of data, is a subset of cybersecurity. Threats to IT security can come in different forms. A common threat is malware, or malicious software, which may come in different variations to infect network devices, including: ransomware, spyware, viruses. Ransomware, coupled with an expanded attack surface are among the top security concerns. According Nathan Eddy, technology freelancer from Berlin, a troubling new trend is to attack automatic software and firmware update systems. A good example was, last March 2019, the Operation “ShadowHammer”. The hackers exploited weaknesses in the software pipeline and used software updates to push malware onto victims’ computers. These trending risks are particularly important due to the proliferation of new medical technologies and because often with these technologies the stakes. are higher Cyberattacks will become more frequent and indiscriminate. The "zero trust" approach would emerge as a key strategic approach. An IT security model requires strict identity verification for every person and device trying to access resources on a private network, regardless of whether they are sitting within or outside of the network perimeter. The interoperability coupled with increasing consolidation activity in healthcare are larger driving factors that attackers will exploit. The healthcare sector is especially vulnerable due to the need for timely access to biological and medical data for diagnosis and treatment as well as because of the amount of sensitive data being collected. Shortly, cellular 5G technology will allow a much larger proliferation of IoT medical devices and the security implications of this are enormous. With the introduction of many centralized or decentralized instruments introduced to hospital networks, the ability to monitor, patch and secure devices becomes exponentially more difficult. The increasing complexity of connected equipment significantly raises the stakes with respect to failures in different medical and laboratory areas (robotics, monitoring, etc...) Cybersecurity is continually challenged by hackers, data loss, privacy, risk management and changing cybersecurity strategies. Nothing currently indicates that cyberattacks will decrease. Moreover, with an increased number of entry points for attacks, more strategies for securing digital assets are needed to protect networks and devices. One of the most problematic elements of cybersecurity is the continuously evolving nature of security risks. As new technologies emerge and existing technology is used in new or different ways, new avenues of attack are developed as well. Keeping up with these continuous changes and advances in attacks and updating practices to protect against them is always challenging. This also includes ensuring that all the elements of cybersecurity are continuously changed and updated to protect against potential vulnerabilities. Artificial intelligence (AI) applications in healthcare are all the range Cont’d on page 31
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News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information
worldlab 2020 Takes On Healthcare excellence
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he IFCC is a proud sponsor and founding partner of the UNIVANTS of Healthcare Excellence award program. In partnership with other leading healthcare organizations, the IFCC inspires and recognizes integrated clinical care teams who have worked together to leverage laboratory data in unique ways in order to Tim James achieve measurable better outcomes. Twelve teams across the globe with impressive best practices were recognized with honours last year, including three teams that received the program’s highest honour of “UNIVANTS of Healthcare Excellence” WINNER. One of the winning benefits of the 2019 awards was a prestigious invitation to share their leading best practice with others in a scientific forum at the 24th International Congress of Clinical Chemistry and Laboratory Medicine (IFCC WorldLab Seoul 2020). The highly anticipated symposia will be chaired by IFCC President, Prof. Maurizio Ferrari, and will feature an expert leader from each of the three winning care teams. Presenters include: (1) Prof. Ellie Dow from the University of Dundee who will present on Intelligent Liver Function Testing (iLFT): A Cost-Effective Way to Increase Early Diagnosis of Liver Disease, (2) Prof. Tim James from Oxford University Hospitals NHS Foundation Trust Prof. ellie Dow who will present on the developing role of angiogenic markers in the laboratory assessment of pre-eclampsia and (3) Dr. Saban Elitok, who will present on behalf of Diaverum Kidney Care Centre Potsdam affiliated with Otto-von-Guericke University Magdeburg; Dialysis Centre Potsdam & Ernst-von-Bergmann Hospital Potsdam, who will present on an Improved Diagnostic Pathway and
Uplifting Medical lab Cybersecurity
Cont’d from page 30 now, and so are cybersecurity threats. Cybersecurity seeks to protect data, ideas, innovations, research and processes. It is challenging to understand how AI is being applied and how AI, machine learning and deep learning techniques can augment cybersecurity. Some of the cyberattacks have become more sophisticated through the use of AI to get past cyber defenses. AI applied to cybersecurity can provide security professionals with an augmented ability to protect endpoints, data, and networks and to quickly and cost effectively stop intrusions or even prevent them before they happen. Cybersecurity is multifaceted. Protecting a health structure, a medical laboratory or a hospital or a business company is very complex. The problem with networks, clouds, computers, and connected devices is that people use them. First, the best cybersecurity includes automatically well trained users and an integrated cybersecurity into the phase of software development to avoid malicious attacks because of the vulnerabilities. Obviously, both Artificial intelligence and Cybersecurity are broad fields and the cybersecurity is one of the greatest challenges of our generation over the next decades. Threats and vulnerabilities cannot be eliminated, therefore, reducing cybersecurity risks is especially challenging and requires awareness, continuous vigilance, and a consolidated response from everyone involved. V
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Treatment for Hospitalized Patients with Acute Kidney Injury. Each of the above best practices involved teamwork and included stakeholders from within and outside the core laboratory who worked together for the common purpose of improving healthcare for their patients. The fruits of their labor enabled improved paitent outcomes but also facilitated improved outcomes through other key performance indicators (KPIs) with measurable benefit to clinicians, payors and their entire health systems. The ability to leverage laboratory data to achieve improved, favorable outcomes has been widely recognized by the laboratory medicine community. However, measurement of care continuum is difficult and often underap- Prof. Maurizio Ferrari preciated by stakeholders outside the core laboratory. These best practices, and other examples of leading success stories through the power of clinical data are essential for transformational care. Other key partners of the UNIVANTS of Healthcare Excellence Program include Abbott Diagnostics, AACC, EHMA (European Health Management Association), Modern Healthcare, HIMSS (Health Information and Management Systems Society), NAHQ (National Association of Healthcare Quality) and IHE (Institute of Health Economics). Dr. Saban elitok To learn more about 2020 WorldLab and to keep up-to-date about the evolving situation and rescheduled dates, please visit www.seoul2020.org/2020 To learn more about the UNIVANTS of Healthcare Excellence program, please visit www.UnivantsHCE.com.
Serum levels of Neurofilament light Chain Distinguish FTlD
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hile searching for biomarkers to diagnose frontotemporal lobar degeneration (FTLD), researchers employed the ultrasensitive single molecule array (Simoa) DNA analysis technique to detect neurofilament light chain (NfL) in cerebrospinal fluid (CSF) and, less invasively, from blood samples. Neurofilament light chain is a neurofilament protein that in humans is encoded by the NEFL gene. Neurofilament light chain is a biomarker that can be measured with immunoassays in cerebrospinal fluid and plasma and reflects axonal damage in a wide variety of neurological disorders. It is a useful marker for disease monitoring in amyotrophic lateral sclerosis, multiple
sclerosis, Alzheimer's disease, and more recently Huntington's disease. The frontotemporal dementias (FTD) encompass six types of dementia involving the frontal or temporal lobes. They are: behavioral variant of FTD, semantic variant primary progressive aphasia, nonfluent agrammatic variant primary progressive aphasia, corticobasal syndrome, progressive supranuclear palsy, and FTD associated with motor neuron disease. Second only to Alzheimer's disease (AD) in prevalence, FTD accounts for 20% of young-onset dementia cases. Signs and symptoms typically manifest in late adulthood, more commonly between the ages of 45 and 65, approximately equally affecting men and women. Common signs and symptoms include significant changes in social and personal behavior, apathy, blunting of emotions, and deficits in both expressive and receptive language. Currently, there is no cure for FTD, but there are treatments that help alleviate symptoms. Due to the significant clinical overlap between FTLD spectrum disorders and late-onset primary psychiatric disorders (PPD), diagnostic biomarkers reflecting the different underlying pathophysiologies are urgently needed. Since elevated CSF levels of NfL have been reported in various neurological conditions, investigators at the University of Eastern Finland (Kuopio, Finland; www.uef.fi) and the University of Oulu
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(Oulu, Findland; www.oulu.fi) evaluated the potential of serum NfL (sNfL) as a diagnostic tool able to distinguish between FTLD and PPD. The investigators analyzed sNfL levels using the Simoa technique from 125 participants including 91 patients with FTLD and 34 with PPD spectra. Results showed that sNfL levels were higher in the FTLD group compared to the PPD group as well as in separate clinical subtypes of FTLD compared to different psychiatric manifestations such as mood or psychotic disorders. These findings highlighted the potential of sNfL as a discriminating biomarker for FTLD over PPD in patients with wide-ranging behavioral, psychiatric, and cognitive symptoms. The study was published in the October 8, 2019, online edition of the Journal of Neurology. Image: Gene expression values from microarray experiments can be represented as heat maps to visualize the result of data analysis (Photo courtesy of Wikimedia Commons).
Trial Finds High analytical Performance in whole-Genome Sequencing
enetic diseases are a leading cause of infant mortality particularly among infants admitted to neonatal, pediatric, and cardiovascular intensive care units (ICUs). Disease progression can be extremely rapid in infants, necessitating early etiologic diagnosis in order to inform interventions that can lessen suffering, morbidity, and mortality. Timely diagnosis requires genome-scale testing since more than 14,000 simple genetic diseases have been described and their presentations often overlap in seriously ill infants. Examples include seizures, respiratory and cardiac failure, hypotonia, hypoglycemia, and jaundice. Whole-genome sequencing can be a viable first-line diagnostic testing option, according to a recent trial. Scientists at the Rady Children's Institute for Genomic Medicine (San Diego, CA, USA; www.radygenomics.org) sought to enroll a greater range of infants, as compared to previous efforts. In the past, clinical sequencing studies focused on infants in intensive care units with unknown, but suspected genetic diseases. Here, the team used broader inclusion criteria, but did, for instance, exclude infants for whom it was thought unlikely that a genetic diagnosis would change their clinical management or who had sepsis but were responding to therapy normally. In all, 213 inlINkXPReSS COM
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fants were enrolled in the study. Eleven percent of these infants were too ill to undergo randomization and instead received ultra-rapid whole-genome sequencing, as that approach would provide the fastest possible route to diagnosis. Of the remaining 189 infants, 95 were randomized to receive whole-exome sequencing and 94 to wholegenome sequencing. They underwent sequencing within 96 hours of their admission to the neonatal ICU (NICU). Trio EDTA-blood samples were obtained where possible and all samples were sequenced upon receipt. Genomic DNA was isolated with an EZ1 Advanced XL robot and the EZ1 DSP DNA Blood kit (QIAGEN, Hilden, Germany; www.qiagen.com). DNA quality was assessed with an assay kit using the Gemini EM Microplate Reader (Molecular Devices, San Jose, CA, USA; www.moleculardevices. com). Genomic DNA was fragmented by sonication, and bar-coded, paired-end, PCR-free libraries were prepared for rWGS with TruSeq DNA LT kits (Illumina, San Diego, CA, USA; www.illumina.com) or Hyper kits (KAPA Biosystems, Wilmington, MA, USA; www.ka pabiosystems.com). The study was published on October 3, 2019, in the American Journal of Human Genetics. LabMedica International February-March/2020
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Questâ&#x20AC;&#x2122;s acquisition in Finland expands Specialty Genetics Offerings
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uest Diagnostics (Secaucus, NJ, USA; www.QuestDiagnostics.com), a leading global diagnostics concern, has acquired Blueprint Genetics (Helsinki, Finland; www.Blue printGenetics.com a specialty genetic testing company with expertise in gene variant interpretation based on next generation sequencing (NGS) and proprietary bioinformatics. Together, Quest and Blueprint Genetics are expected to broaden access to actionable insights in genetic and rare diseases, improving patient care and drug development. Founded in 2012, Blueprint Geneticsâ&#x20AC;&#x2122; growth is based largely on proprietary guideline-supported methods of gene variant interpretation of data generated from NGS, backed by high-touch consultative service. The company provides some 3,900 targeted single gene and over 200 panel tests spanning 14 medical specialties. Gene variant interpretation involves identifying associations between gene variants and disease or treatment response. Through its Advanced Diagnostics offerings, Quest specializes in combining state-of-the-art technologies, such as NGS, with higher-order interpretative expertise and digital customer enablement. Blueprint Genetics brings to Quest high-touch service in variant interpre-
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vices. Class I hemostasis devices are exempt from premarket notification requirements and are used only for general control. Regulations for class II devices are exempt from premarket notification requirements and they can be used for special controls. Class III is the most stringent category as it requires premarket approval (PMA). Companies in the hematology diagnostic devices market are increasingly investing in automation technology. The advancements in automation technology are driving the demand for hematology analyzers and will continue to reduce the errors caused by manual practices in diagnostic centers. However, product recall is one of the major problems being faced by companies in the hematology diagnostic devices market and can negatively affect market growth.
Global lFIa-based Rapid Test Market to Reach USD 8.5 Billion by 2026
he global lateral flow immunoassay (LFIA) based rapid test market was estimated to be worth USD 4.72 billion in 2018 and is expected to grow at a CAGR of 7.6% from 2019 to 2026 to reach nearly USD 8.5 billion by 2026. The market growth will be driven by the benefits of LFIA-based rapid tests over laboratory testing, increasing initiatives by government and non-profit organizations for improving health awareness, and rising healthcare expenditure globally. On the other hand, the market growth will be hampered to some extent by inadequate reimbursement policies for LFIA-based rapid test diagnostics. Nevertheless, the growth prospects in the emerging markets and a surge in various chronic and infectious diseases across the world are expected to create significant opportunities for the key players in the industry. These are the latest findings of Allied Market Research (Portland, OR, USA), a full-service market research and business-consulting firm. Based on application, the infectious disease segment held more than four-fifths share of the global LFIA-based rapid test market in 2018 and is expected to maintain its dominance by recording the fastest CAGR of 7.8% during the forecast period. Increasing initiatives by the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services, Food and Drug Administra-
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tation and reporting as well as associated sequencing and bioinformatics, which complement and extend its existing genetics leadership. Blueprint Genetics recently expanded its presence in the US through a established hub in Seattle, Washington. Over time, the acquisition is expected to yield new capabilities to serve providers specializing in rare disease and neurology, particularly pediatric and academic hospitals. The two organizations also envision that members of the Quest Diagnostics Global Diagnostic Network and its pharmaceutical and in vitro diagnostic collaborators will benefit from Blueprint Genetics' capabilities. "The great challenge with genetic testing is generating quality, actionable, and broadly accessible insights from vast quantities of sequenced genetic data," said Steve Rusckowski, CEO of Quest Diagnostics. "Blueprint Genetics has developed a proven model for delivering highly specialized genetic insights that we believe we can scale to serve new patient populations with unmet clinical needs. The addition of Blueprint Genetics strengthens and extends the Quest value proposition in genetics, delivering on our Accelerate growth strategy and vision of a healthier world."
Global Hematology Diagnostic Devices Market Projected at USD 2.35 Billion for 2022
he global hematology diagnostic devices and equipment market was valued at about USD 1.9 billion in 2018 and is projected to grow to at a CAGR of 5.5% to USD 2.35 billion in 2022. The market growth is driven mainly by an increase in the use of hematology diagnostic devices due to the rising prevalence of blood disorders which affect millions of people each year across the world, irrespective of age, race, and sex. These are the latest findings of the Business Research Company (London, UK), a market research and intelligence company. Despite its potential for rapid growth, the hematology diagnostic devices market is constrained by stringent regulation policies. Currently, the FDA regulates class I, class II, and class III hematology de-
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Industry News
LabMedica International February-March/2020
tion, and National Institutes of Health (NIH) for the diagnosis of infectious diseases will also contribute to the overall market growth. Based on technique type, the competitive assay segment held nearly three-fifths share of the global LFIA-based rapid test market in 2018. Competitive immunoassays are widely used in the market, as they require only a small amount of antibody, higher flexibility, and sensitivity. The multiplex detection assay segment, on the other hand, is projected to grow at the fastest CAGR of 9.0% during the forecast period, driven by their ability to save both time and precious samples by combining the detection of multiple analytes into a single reaction that reduces workflow and sample volume problems. Geographically, North America held more than two-fifths share of the LFIA-based rapid test market in 2018 and is expected to maintain its dominance until 2026. The growth of the North American LFIAbased rapid test market will be driven by a rise in the prevalence of various diseases such as influenza, HIV, and cancer; increase in number of drug screening procedures; and presence of leading players in the region. On the other hand, the Asia-Pacific LFIA-based rapid test market is projected to register the fastest CAGR of 9.2% during the forecast period, led mainly by the high population base, increase in disposable income, and growing awareness about LFIA-based rapid tests in the region.
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ASM Microbe 2020 – American Society for Microbiology. Jun 18-22; Chicago, IL, USA; Web: www.asm.org LABWorld China 2020 (CPhI & P-MEC China). Jun 22-24; Shanghai, China; Web: www.cphi.com/china/visit/labworld FOCIS 2020 – Annual Meeting of the Federation of Clinical Immunology Societies. Jun 23-26; San Francisco, CA, USA; Web: www.focisnet.org
JULY 2020
ESHRE 2020 – 36th Annual Meeting of the European Society of Human Reproduction and Embryology. Jul 5-8; Copenhagen, Denmark ; Web: www.eshre.eu AIDS 2020 - 23rd International AIDS Conference. Jul 6-10; San Francisco, CA, USA; Web: www.aids2020.org
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LabMedica International February-March/2020
ATTENTION: Due to the CORONAVIRUS EpIDEMIC, certain events are being rescheduled for a later date or altogether cancelled. please check with the event organizer or website prior to planning for any forthcoming event ISTH 2020 – 28th Congress of International Society on Thrombosis and Haemostasis. Jul 11-15; Milan, Italy; Web: www.isth2020.org
72nd AACC Annual Scientific Meeting & Clinical Lab Expo - American Association for Clinical Chemistry. Jul 26-30; Chicago, IL, USA; Web: www.aacc.org
AUGUST 2020
Vietnam Medi-Pharm Expo 2020. Aug 6-8; Ho Chi Minh City; Web: hcm.medipharmexpo.com
32nd Congress of the European Society of Pathology (ESP). Aug 29-Sep 2; Glasgow, UK; Web: www.esp-congress.org
SEpTEMBER 2020
IFBLS 2020 - International Federation of Biomedical Laboratory Science. Sep 1-5; Copenhagen Denmark; Web: ifbls2020.org
EUROTOX 2020 – 56th Congress of the European Societies of Toxicology. Sep 6-9; Copenhagen, Denmark; Web: eurotox-congress.com/2020
ARABLAB 2020. Sep 7-9; Dubai, UAE; Web: www.arablab.com
BCLF 2020 - 28th Balkan Clinical Laboratory Federation Meeting. Sep 30-Oct 3; Sofia, Bulgaria; Web: www.bclf.info
OCTOBER 2020
ECC 2020 – 43rd European Congress of Cytology. Oct 4-7; Wroclaw, Poland; Web: cytology2020.eu
ICE 2020 – 19th International Congress of Endocrinology. Oct 4-7; Buenos Aires, Argentina; Web: ice-2020.com
17th Annual Meeting of the German Society for Clinical Chemistry and Laboratory Medicine (DGKL). Oct 15-16; Mannheim, Germany; Web: www.dgkl.de
Analytica 2020. Oct 19-22; Munich, Germany; Web: www.analytica.de
ASHI 2020 – 46th Annual Meeting of the American Society for Histocompatibility & Immunogenetics. Oct 19-23; Anaheim, CA, USA; Web: www.ashi-hla.org
EndoBridge2020. Oct 22-25; Antalya, Turkey; endobridge.org
ASHG 2020 – American Society of Human Genetics. Oct 27-31; San Diego, CA, USA; Web: www.ashg.org
16th International Thyroid Congress. Sep 8-13; Xi’an, China; Web: itc2020.medmeeting.org
ASCP 2020 -Annual Meeting of the American Society for Clinical Pathology. Sep 9-11; Austin, TX, USA; Web: www.ascp.org
ESCV – 23d Annual Meeting of the European Society for Clinical Virology. Sep 9-12; Manchester, UK; Web: www.escv.eu
ESPE 2020 – 59th Annual Meeting of the European Society of Paediatric Endocrinology. Sep 10-12; Liverpool, UK; Web: www.eurospe.org
ISH 2020 – 38th World Congress of the International Society of Hematology. Sep 13-16; Bangkok, Thailand; Web: www.ishworld.org
EASD 2020 – 56th Annual Meeting of the European Association for the Study of Diabetes. Sep 21-25; Vienna, Austria; Web: www.easd.org
ExpoMedical 2020. Sep 23-25; Buenos Aires, Argentina; Web: www.expomedical.com.ar
World Vaccine Congress 2020. Sep 27-29; Washington, DC, USA; Web: www.terrapinn.com/conference/ world-vaccine-congress-washington
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MEDLAB Asia Pacific 2020. October 28-30; Bangkok, Thailand; Web: www.medlabasia.com
NOVEMBER 2020
JIB 2019 Journées de l’innovation en biologie. Nov 4-5; Paris, France; Web: jib-innovation.com
41st Annual Meeting of the American College of Toxicology (ACT). Nov 15-18; Austin, TX, USA; Web: www.actox.org
Medica 2020. Nov 16-19; Dusseldorf, Germany; Web: www.medica-tradefair.com
AMP 2020 –Annual Meeting & Expo of the Association for Molecular Pathology. Nov 19-21; Vancouver, BC, Canada; Web: amp20.amp.org
DECEMBER 2020
62nd Annual Meeting & Exposition of the American Society of Hematology (ASH). Dec 5-8; San Diego, CA, USA; Web: www.hematology.org/Annual-Meeting
Zdravookhraneniye 2020. Dec 7-11; Moscow, Russia; Web: www.zdravo-expo.ru/en
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LabMedica International February-March/2020
Events Calendar
LabMedica International
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132 113 136 115 – – 123 112 105 107 125 – – – – 118 119 117 103 102 109 130
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Vol. 37 No.1 2-3 / 2020 page
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