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WORLD’S CLINICAL LABORATORY NEWS LEADER ISSN 1068-1760
Vol. 35 No.1 • 2-3/2018
DAILY CLINICAL LAB NEWS
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Hepatitis C Screening Recommended During Pregnancy
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ew guidelines from the Society for Maternal-Fetal Medicine (SMFM, Washington, DC, USA; www.smfm.org) recommend a thorough testing regime for pregnant women at high risk for the hepatitis C virus (HCV) and a prescriptive set of recommendations on screening workups for the disease. The guidelines were reviewed and endorsed by the American College of Obstetricians and Gynecologists (ACOG, Washington, DC, USA; www.acog.org). The estimated prevalence of antenatal Hepatitis C (HCV) infection is
team of researchers have demonstrated that Dipeptidyl peptidase-4 (DPP-4) can serve as a suitable biomarker to identify people with severe asthma who have greater activation of the interleukin-13 (IL-13) pathway and thereby benefit from IL-13-targeted treatments. Increased IL-13 messenger RNA (mRNA) expression and protein concentration in bronchial biopsies, sputum and bronchoalveolar lavage fluid from patients with asthma, compared with healthy individuals, supports a role for IL-13 in the pathophysiology of some types of asthma.
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Microscope-Based Artificial Intelligence Identifies Bacteria
Simple Blood Test Predicts Aggressive Prostate Cancer
icroscopes enhanced with artificial intelligence (AI) could help clinical microbiologists diagnose potentially deadly blood infections and improve patients’ odds of survival. Scientists have demonstrated that an automated AI-enhanced microscope system is “highly adept” at identifying images of bacteria quickly and accurately. The automated system could help alleviate the current lack of highly trained microbiologists, expected to worsen as 20% of technologists
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newly-developed blood test uses machine learning to identify men with aggressive prostate cancer 40% more accurately than current tests, thereby eliminating a great part of unnecessary biopsies, hospitalizations, and treatments.
Image: Courtesy of University of Alberta
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INSIDE
Next-Generation Hematology Analyzer Introduced irst in a series of advanced hematology instruments to be released, the Alinity hq analyzer addresses the productivity needs of high-volume laboratories. The Alinity hq analyzer (Abbott, Abbott Park, IL, USA; www.corelaboratory.abbott) for hematology is now CE Marked, and available in Europe and other countries
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Automated RNA Extraction from Plasma Analytically Validated novel automated method for extracting circulating RNA from plasma has been demonstrated and the method performed equivalently or better than the established manual method that is currently used. A team of scientists utilized a commercially-available laboratory developed test (LDT) for echinoderm microtubule-associated protein-like 4 (EML4-ALK) messenger ribonucleic acid (mRNA) fusion variants as a reference assay to assess the performance of an automated solution for RNA extraction that was developed and optimized by Norgen Biotek
Clinical News . . . . 5-26 IFCC News . . . . . . . . 27 Product News . . 10-26 Industry News . . . . .33 Events Calendar . . . 34 PUBLISHED IN COOPERATION WITH
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International Federation of Clinical Chemistry and Laboratory Medicine
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Hepatitis C Screening Recommended During Pregnancy cont’d from cover
low in the USA, about 1%-2.5%, although some have suggested that it’s as high as 4% and some have recommended against screening all pregnant women for HCV, citing a lack of data on the cost-effectiveness of universal screening. The guidelines recommend HCV prenatal testing for women with certain high risk factors, such as illegal drug use, unregulated tattoos, those on long-term hemodialysis or a history of incarceration, or who received blood products from a donor who eventually tested positive for HCV. Women who received transfusions or organ transplants prior to July 1992 and clotting factor concentrates produced before 1987 should also get screened. Screening for high risk patients should take place at the first prenatal visit and even if this initial test is negative, a second screening may be warranted at a later stage of the pregnancy if new or persistent HCV factors arise, such as the use of intranasal or injected illicit drugs. Clinicians use anti-HCV antibody tests to screen for this disease. Positive results can mean one of several things: an acute or chronic HCV infection, a past infection that has since resolved, or a false positive result. SMFM and ACOG recommend that a quantitative nucleic acid test for HCV RNA follow any positive result for HCV antibodies. In other screening recommendations, SMFM and IDSA advised that clinicians follow up with HCV RNA testing in patients exposed to HCV within a 6-month period who have tested negative for anti-HCV antibodies. This is necessary because these antibodies might not have become detectable at the time of initial testing. HCV-positive pregnant women also should get tested for sexually transmitted diseases such as HIV, syphilis, gonorrhea, chlamydia, and hepatitis B virus. Patients who request invasive prenatal diagnostic testing should be notified about the limited data available on the risks of vertical transmission, and that amniocentesis is a preferred method over chorionic villus sampling. In other recommendations, the authors advised against relying on cesarean delivery to indicate HCV. Brenna Hughes, MD, MSc, a Maternal-Fetal Medicine Specialist and the guidelines’ lead author, said, “The rationale for the timing of the diagnosis of infants relates to the fact that maternal antibodies can persist for months in infants leading to false positive diagnoses. It is also possible that an infant can clear virus from the mother so the requirement for HCV RNA twice after the age of one month is to avoid false positive diagnoses.” The guidelines were published in the November 2017 issue of the American Journal of Obstetrics and Gynecology.
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Image: A histopathology of active hepatitis C viral infection of the liver (Photo courtesy of California Pacific Medical Center).
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Microscope-Based Artificial Intelligence Identifies Bacteria
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labmedica.com EDITORIAL BOARD Graham Beastall United Kingdom Claus Christiansen Denmark Hernán Fares Taie Argentina Bernard Gouget France Maurizio Ferrari Italy Jocelyn M. Hicks United States Anders Kallner Sweden Tahir S. Pillay South Africa Andreas Rothstein Colombia Dmitry B. Saprygin Russia Praveen Sharma India Rosa I. Sierra-Amor Mexico Peter Wilding United States Andrew Wootton United Kingdom A GLOBETECH PUBLICATION
Published in cooperation with the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). HospiMedica International • HospiMedica en Español • HospiMedica China LabMedica International • LabMedica en Español • LabMedica China Medical Imaging International • Bio Research International • Medimaging.net HospiMedica.com • LabMedica.com • BiotechDaily.com • TradeMed.com
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reach retirement age in the next five years. Scientists working with the Department of Pathology, Beth Israel Deaconess Medical Center, (Boston, MA, USA; www.bidmc.org) used an automated microscope designed to collect high-resolution image data from microscopic slides. In this case, blood samples taken from patients with suspected bloodstream infections were incubated to increase bacterial numbers. Then, slides were prepared by placing a drop of blood on a glass slide and stained with dye to make the bacterial cell structures more visible. The investigators then trained a convolutional neural network (CNN), a class of artificial intelligence modeled on the mammalian visual cortex and used to analyze visual data, to categorize bacteria based on their shape and distribution. These characteristics were selected to represent bacteria that most often cause bloodstream infections; the rod-shaped bacteria including Escherichia coli; the round clusters of Staphylococcus species; and the pairs or chains of Streptococcus species. All slides were imaged without coverslips using a MetaFer Slide Scanning and Imaging platform (MetaSystems Group, Inc., Newton, MA, USA; www.metasystems-international.com) with a 140-slide capacity automated slide
loader equipped with a 40× magnification Plan-Neofluar objective (0.75 Numerical Aperture, Carl Zeiss, Oberkochen, Germany; www.zeiss.com). To train it, the scientists fed their unschooled neural network more than 25,000 images from blood samples prepared during routine clinical workups. By cropping these images, in which the bacteria had already been identified by human clinical microbiologists, the scientists generated more than 100,000 training images. The machine intelligence learned how to sort the images into the three categories of bacteria (rod-shaped, round clusters, and round chains or pairs), ultimately achieving nearly 95% accuracy. The team challenged the algorithm to sort new images from 189 slides without human intervention. Overall, the algorithm achieved more than 93% accuracy in all three categories. Sensitivity/specificity was 98.4/75.0% for Gram-positive cocci in chains/pairs; 93.2/97.2% for Gram-positive cocci in clusters; and 96.3/98.1% for Gramnegative rods. The study was published on November 29, 2017, in the Journal of Clinical Microbiology. Image: The MetaFer Slide Scanning and Imaging platform with a Zeiss microscope (Photo courtesy of MetaSystems Group).
Next-Generation Hematology Analyzer Introduced cont’d from cover
that recognize CE Mark. The Alinity hq was built from the ground up to help solve every day operational challenges and anticipated future needs for high-volume laboratories. Capabilities of the Alinity hq system include: Innovative, advanced optical technology combined with robust algorithms to handle normal and pathological samples. Design features are intended to reduce manual steps and minimize errors, improve confidence in data and allow for uninterrupted operation and scalable. Modular design allows to customize
configurations in order to better serve a broad spectrum of laboratories. As part of the Alinity family of harmonized systems, the Alinity hq analyzer features an intuitive user interface with iconography, color coding and reporting features shared by all Alinity instruments. The Alinity family also uses a common method for sample loading and reagent management, which helps laboratories simplify technician training. The Alinity portfolio includes clinical chemistry, immunoassay, blood and plasma screening, point of care, hematology and molecular diagnostics.
Raymond L Jacobson, PhD News Editor Gerald M Slutzky, PhD News Editor Andreas Rothstein News Editor Marcela Jensen Assistant Editor Brenda Silva New Products Editor Theresa Herman Regional Director Dr. Jutta Ciolek Regional Director Parker Xu Regional Director David Gueron Reader Service Manager Arda Turac Production Director
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ISSN 1068-1760 Vol.35 No.1. Published, under license, by Globetech Media LLC; Copyright © 2018. 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. S¸ti. adına ˙Imtiyaz Sahibi: M. Geren • Yazı is¸leri Müdürü: Ersin Köklü Müs¸ ir Dervis¸ ˙Ibrahim Sok. 5/4, Esentepe, 34394 S¸is¸ li, ˙Istanbul P. K. 1, AVPIM, 34001 ˙Istanbul • E-mail: Teknopress@yahoo.com Baskı: Printkom Ltd. • İpkas Sanayi Sitesi 3. Etap C Blok • 34490 Başakşehir • İstanbul Yerel süreli yayındır. Yılda sekiz kere yayınlanır, ücretsiz dag˘ıtılır.
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Automated RNA Extraction from Plasma Analytically Validated cont’d from cover
Corporation (Thorold, ON, Canada; https://norgenbiotek.com). Results suggest that the automated method performed at least equivalently to the established manual method on all measures in the study, including quality and yield of mRNA from analytic blood samples. The GeneStrat test (Biodesix, Boulder, CO, USA; www.biodesix. com) is a blood-based genomic test for patients with lung cancer that can inform the use of targeted therapies; test results are available within 72 hours. The test delivers results for EGFR sensitizing; EGFR resistance (T790M), KRAS, and BRAF mutations; and EML4-ALK, ROS1 and RETS fusion variants. The liquid biopsy test measures circulating tumor DNA and RNA with a highly-sensitive droplet digital PCR
(ddPCR) platform. Gary Pestano, PhD, Vice President of Development and Operations at Biodesix, said, “As molecular testing becomes the standard in oncology, automation will be increasingly important to help us maintain the high quality of our test results and continue to meet our industry-leading 72-hour turnaround time. The data presented suggest that it is possible to automate testing without sacrificing performance. They represent one of many evaluations we are conducting to assess potential automation methods for the Biodesix Lung Reflex with both our GeneStrat and VeriStrat tests.” The study was presented at the Association for Molecular Pathology Annual Meeting held November 16-18, 2017, in Salt Lake City, UT, USA.
Automated Immunoassay Can Improve Asthma Treatment cont’d from cover
A team of scientists collaborating with those at the Abbott Laboratories (Abbott Park, IL, USA; www.abbott.com) obtained serum samples from healthy volunteers and from subjects with asthma and type 1 diabetes. They used in DPP-4 concentration assessments, samples obtained from a Phase IIb study of tralokinumab in subjects with severe uncontrolled asthma receiving concomitant high-dose fluticasone and salmeterol. Additional samples, collected for a pre-analytical in-house study to confirm specimen-handling procedures, were provided by consenting volunteers with self-reported asthma. The team assessed assay performance, utilizing analyses of precision, linearity and sensitivity; interference from common endogenous assay interferents, and from asthma and antidiabetic medications, were also assessed. The new automated IUO DPP-4 immunoassay was performed on Abbott’s ARCHITECT i System. The immunoassay measurement of DPP-4 has a range from 109 ng/mL to 580 ng/mL. The assay is fully automated with a throughput of 200 tests per hour. The investigators reported that the total precision of DPP-4 concentration measurement, determined using percentage coefficient of variation, was ≤5% over 20 days. Dilution analysis yielded linear results from 30 to 1,305 ng/mL; the limit of quantitation was 19.2 ng/mL. No notable endogenous or drug interferences were observed at the expected therapeutic concentration. Median DPP-4 concentrations in healthy volunteers and subjects with asthma or Type 1 diabetes were assessed, with concentrations remaining similar in subjects with diabetes and asthma across different demographics. The authors concluded that their analyses indicate that the ARCHITECT DPP-4 immunoassay is a reliable and robust method for measuring serum DPP-4 concentration. The assay is currently being applied to assess
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the clinical utility of DPP-4 as a predictive biomarker in Phase III studies of tralokinumab in subjects with uncontrolled asthma. The study was published online on October 20, 2017, in the journal Practical Laboratory Medicine.
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Simple Blood Test Predicts Aggressive Prostate Cancer urrent tests such as the prostate specific antigen (PSA) and digital rectal exam (DRE) often lead to unneeded biopsies and more than 50% of men who undergo biopsy do not have prostate cancer, yet suffer the pain and side effects of the procedure such as infection or sepsis. Less than 20% of men who receive a prostate biopsy are diagnosed with the aggressive form of prostate cancer that could most benefit from treatment. A newly developed diagnostic will allow men to bypass painful biopsies to test for aggressive prostate cancer. The test incorporates a unique nanotechnology platform to make the diagnostic using only a single drop of blood, and is significantly more accurate than current screening methods. Scientists at the University of Alberta (Edmonton, AB, Canada; www.ualberta.ca) developed The Extracellular Vesicle Fingerprint Predictive Score (EV-FPS) test, which uses machine learning to combine information from millions of cancer cell nanoparticles in the blood to recognize the unique fingerprint of aggressive prostate cancer. The developed diagnostic was evaluated in a group of 377 Albertan men who were referred to their urologist with suspected prostate cancer. It was found that EV-FPS correct-
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ly identified men with aggressive prostate cancer 40% more accurately than the more common PSA blood test, which is widely used today. It is estimated that successful implementation of the EV-FPS test could eventually eliminate up to 600,000 unnecessary biopsies, 24,000 hospitalizations and up to 50% of unnecessary treatments for prostate cancer each year in North America alone. Beyond cost savings to the health care system, the scientists say the diagnostic test will have a dramatic impact on the health care experience and quality of life for men and their families. The team plans to bring the test to market through university spin-off company Nanostics Inc. Adrian Fairey, MD, an urological surgeon at the Alberta Urology Institute (Edmonton, AB, Canada; http://aburologyinstitute.com), said, “Compared to elevated total PSA alone, the EV-FPS test can more accurately predict the result of prostate biopsy in previously unscreened men. This information can be used by clinicians to determine which men should be advised to undergo immediate prostate biopsy and which men should be advised to defer biopsy and continue prostate cancer screening.” The study was presented at the International Society for Extracellular Vesicles (ISEV) annual meeting, held May 18-21, 2017, in Toronto, Canada.
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ELISA RAPID TEST
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Sensors Developed to Detect Disease Markers in Breath small, thin square of an organic plastic that can detect disease markers in breath or toxins in a building's air could soon be the basis of portable, disposable sensor devices. A device that monitors ammonia in breath, a sign of kidney failure, has been demonstrated. Different groups of scientists have tried using organic semiconductors for gas sensing, but the materials were not sensitive enough to detect trace levels of disease markers in breath. One group has realized that the reactive sites were not on the surface of the plastic film, but buried inside it. Bioengineers at the University of Illinois Urbana-Champaign (Urbana, IL, USA; www.illinois.edu) focused on ammonia as a marker for kidney failure. Monitoring the change in ammonia concentration could give a patient an early warning sign to call their doctor for a kidney function test. The material they chose is highly reactive to ammonia but not to other compounds in breath, but by changing the composition of the sensor, they could create devices that are tuned to other compounds. For example, the scientists have created an ultrasensitive environmental monitor for formaldehyde, a common indoor pollutant in new or refurbished buildings. By introducing tunable nanopores (50–700 nm) to organic semiconductor thin films enhances their reactivity with volatile organic compounds by up to an order of magnitude, while the surface-area-to-volume ratio is almost unchanged. Mechanistic investigations show that nanopores grant direct access to the highly reactive sites otherwise buried in the conductive channel of the transistor. The high reactivity of nanoporous organic field-effect transistors leads to unprecedented ul-
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trasensitive ultrafast, selective chemical sensing below the 1 ppb level on a hundred millisecond time scale, enabling a wide range of health applications. Ying Diao, PhD, an assistant professor and lead investigator said, “We would like to be able to detect multiple compounds at once, like a chemical fingerprint. It's useful because in disease conditions, multiple markers will usually change concentration at once. By mapping out the chemical fingerprints and how they change, we can more accurately point to signs of potential health issues.” The study was published on May 2, 2017, in the journal Advanced Functional Materials. Image: Sensors made from porous thin films of organic conductive plastics can be used in portable, disposable devices for medical monitoring (Photo courtesy of L. Brian Stauffer, MA).
Antimalarial Compound Improves Forensics of Bloodstains orensic investigators often use a luminol chemiluminescence test to detect latent bloodstains at crime scenes. Now, researchers have found that combining luminol with the antimalarial drug artemisinin, a natural peroxide, reduces the risk of false positives compared to the traditional method that mainly uses hydrogen peroxide or sodium perborate as coreactants. They also obtained test results using a smartphone, which could provide highly accurate on-scene analyses. Luminol is often combined with hydrogen peroxide to react with the heme groups in
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blood, producing the blue chemiluminescent glow. This allows crime scene technicians to detect blood on surfaces. While this test has proven beneficial in numerous criminal investigations, false positives due to interferences from biomolecules and metal ions, as well as from the breakdown products of hydrogen peroxide, can occur. In an effort to minimize erroneous identifications, Prof. Guobao Xu of ChangChun Institute of Applied Chemistry, Chinese Academy of Sciences (Changchun, Jilin, China; http:// english.ciac.cas.cn) and colleagues investigated
the use of artemisinin with luminol as artemisinin is more structurally sound and more resistant to interferences than hydrogen peroxide. The researchers showed that the luminolartemisinin combination is more selective than luminol-hydrogen peroxide, resulting in fewer false positives when challenged with components of bleaches and disinfectants, which criminals often use to cover up a misdeed. The method could distinguish blood from coffee, tea, and brown sugar stains. The study, by Gao W et al, was published May 11, 2017, in the journal Analytical Chemistry. LabMedica International February-March/2018
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LabMedica International
Performance of Immunosuppressant Drug Assay Kits Analyzed yclosporine (CsA) and tacrolimus (TAC) are immunosuppressant drugs that are often used to treat autoimmune diseases and as transplantation therapy and therefore, their concentrations need to be monitored carefully. The main analytical methods for CsA and TAC in whole blood have been liquid chromatography combined with mass spectrometric detection (LC-MS/MS), affinity chrome-mediated immunoassay (ACMIA), and chemiluminescence immunoassays (CLIA). Scientists at the Osaka University Hospital (Osaka, Japan; www.hosp.med.osaka-u.ac.jp) used 200 residual EDTA whole blood samples from patients who had received an organ transplant and were under CsA or TAC therapy. CsA concentrations were measured using an affinity chrome-mediated immunoassay (ACMIA) and an electrochemiluminescence immunoassay (ECLIA). TAC concentrations were measured using a chemiluminescence immunoassay (CLIA) and ECLIA. The investigators used the Elecsys Cyclosporine assay kit and the Elecsys Tacrolimus assay kit where the concentrations were measured on a cobas e411 analyzer (Roche Diagnostics GmbH, Mannheim, Germany; www.roche.com). The ACMIA for measurement of CsA concentration was performed with a Dimension Xpand analyzer (Siemens Healthcare Diagnostics, Inc., Deerfield, IL, USA; www.healthcare. siemens.com) and CLIA for measurement of TAC concentration with an ARCHITECT i2000SR (Abbott Laboratories, Abbott Park, IL, USA; www.abbott.com). It was necessary for accurate measurements of CsA and TAC concentrations to sufficiently mix samples and pretreatment reagent. The hematocrit was assayed using the fully automated hematological analyzer Sysmex XN-1000 (Sysmex Co., Ltd., Kobe, Japan; www.sysmex.com). The scientists investigated assay precision, linearity, lower limit of quantitation (LOQ), stability of calibration, influence of interference substances and the hematocrit, correlation of ACMIA with ECLIA, and correlation of CLIA with ECLIA. They found that the limits of quantitation (LOQ) were defined as the concentration at which the coefficient of variation (CV) was approximately 10%. Each lower LOQ obtained was 16 ng/mL (CsA), and 0.95 ng/mL (TAC). CsA and TAC calibrations were stable for at least 21 days. Neither the presence of conjugated bilirubin, unconjugated bilirubin, chyle, and rheumatoid factor nor the hematocrit affected these assays. The authors concluded that the analytical performances of the Elecsys Cyclosporine and Elecsys Tacrolimus assays were acceptable. Furthermore, CsA and TAC concentrations may be simultaneously measured using a single pretreatment, which is of benefit if patients have to undertake conversion between these two drugs. Additional-
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ly, it benefits the workflow in the clinical laboratory. The study was published in the August 2017 issue of the journal Practical Laboratory Medicine. Image: The cobas e 411immunoassay analyzer (Photo courtesy of Roche Diagnostics).
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The Hb-Vario is designed for HbA1c testing with Beta Thalassemia flagging based on HPLC technology. Features include results in 3.5 minutes with HbA2 &HbF flagging, and small pack size of 200 tests for small- to medium-sized volumes.
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FDA Approves Fourth-Generation Blood Test he US Food and Drug Administration (FDA) has approved a nextgen assay for latent tuberculosis (TB) infection that combines breakthrough CD4/CD8 design for comprehensive immune response detection with flexible blood collection workflow. The FDA approved test QuantiFERON-TB Gold Plus (QFT-Plus) is QIAGEN’s (Germantown, MD, USA and Hilden, Germany; www.qiagen.com) fourth-generation blood test for detecting latent-TB infection. QFT-Plus builds on the foundation of QuantiFERON-TB Gold (QFT), the thirdgeneration version of Qiagen’s leading interferon gamma release assay (IGRA). QFT is well proven, with a vast body of clinical evidence, as a cost-effective and efficient tool for TB infection testing. Availability in the US is planned to begin later this year (2017). “We are pleased by the timely FDA approval for QuantiFERON-TB Gold Plus and that we can now bring a range of very attractive clinical and workflow benefits to customers,” said Thierry Bernard, senior VP and head of QIAGEN’s Molecular Diagnostics Business Area, “Tuberculosis is a global disease that is having an impact in the United States as well, where up to 13 million people are infected and nearly 10,000 people are currently suffering with active disease.” With the addition of proprietary CD8+ technology, QFT-Plus rep-
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resents a key milestone in the development of diagnostic tests for latent-TB infection. For the first time, a test has the potential to offer the ability to capture a much broader picture of an individual’s immune response to TB infection. This technological advancement is critical to improving the understanding of how the immune system reacts to TB infection, and is expected to set a new standard for future disease management. Among the new features of QFT-Plus is workflow flexibility that allows for even more efficient implementation, especially in large-scale TB screening programs. These include a standard single-tube blood collection option that allows blood samples to be processed up to 53 hours after venipuncture without affecting the accuracy of the test. This adds to the existing, unique “assay in collection tube” design allowing for immediate stimulation of the blood sample. Another new feature includes advances to support research into the risk-stratification of latent-TB infections developing into active disease based on the first-time incorporation of CD8+ T cell response data, which provides valuable new information by measuring a broader range of immune response. QFT-Plus is set to be released in the US amid new recommendations that are broadening the use of IGRAs. In December 2016, a task force supported by the American Thoracic Society (ATS), US Centers for Disease Control and Prevention (CDC), and Infectious Diseases Society of America published new evidence-based guidelines recommending the use of IGRA tests in wider groups of people at risk for TB infection. This followed recommendations by the US Preventive Services Task Force (USPSTF) in September 2016 that primary care physicians should screen adult patients in groups at high risk for latent TB infection. Both referred to QFT as an FDA-approved IGRA at the time, preferable in certain patient groups to the century-old tuberculin skin test (TST). Nine independent peer-reviewed publications to date have supported the performance of QFT-Plus, and additional studies underway in 22 countries involve more than 30,000 patients. QFT-Plus is the only IGRA TB test on the pathway to evaluation by the World Health Organization (WHO) as part of its global campaign to eradicate the disease. V
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Panel of Gut Bacteria Serves Colorectal Diagnosis eanalysis and standardization of data from several published studies has enabled a team of molecular microbiologists to identify a panel of gut microflora that is more prevalent in the stools of patients with colorectal cancer than it is in the stools of normal individuals. Colorectal cancer (CRC) is the second leading cause of cancer-associated mortality in the USA, and investigators at Baylor College of Medicine (Houston, TX, USA; www.bcm.edu) and their colleagues at the biotech firm Second Genome Inc. (South San Francisco, CA, USA; www.secondgenome.com) theorized that the fecal microbiome might provide noninvasive biomarkers of CRC. To confirm this theory, the investigators reanalyzed raw bacterial DNA sequence data from several published studies that encompassed a total of 509 samples (79 colorectal adenoma, 195 CRC, and 235 controls). Differential abundance, meta-analysis random effects regression, and machine learning analyses were carried out to determine the consistency and diagnostic capabilities of potential
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microbial biomarkers. Results revealed that definitive taxa, including Parvimonas micra ATCC 33270, Streptococcus anginosus and yet-to-be-cultured members of Proteobacteria, were frequently and significantly increased in stools from patients with CRC compared with controls across studies and had high discriminatory capacity in diagnostic classification. "This is a promising first step to develop a noninvasive test that might be used in the detection of colorectal cancer, supplementing colonoscopy or fecal occult blood tests," said senior author Dr. Emily Hollister, assistant professor of pathology at Baylor College of Medicine. "This was an incredibly large, complex multinational study," said contributing author Todd DeSantis, co-founder and vice president of informatics at Second Genome Inc. "We saw many differences between medical centers in the way each collected and stored stool samples and in the methods used to process the bacterial DNA in stools. These differences can be problematic for identifying the bacterial strains that proliferate in cancer patients,
but our Second Genome KnowlegeBase Team, led by contributing author Dr. Thomas Weinmaier, found ways to enhance our software platform to address these differences along the way. The findings that emerged from this challenging data set helped validate our platform, and in the process we were able to deliver high-quality insights to advance our collaboration with Dr. Hollister." The study was published in the March 24, 2017, online edition of the journal Gut. Image: Researchers reanalyzed raw bacterial DNA sequence data from several studies and confirmed previously reported types of bacteria associated with colorectal cancer and identified other bacteria not previously associated with the disease (Photo courtesy of Baylor College of Medicine).
Biomarker Panel Enables Diagnosis of Mild Concussions panel comprising proteins released into the blood by damaged brain astrocytes was shown to be diagnostic for mild concussions, even those that could not be detected by CAT scan. Concussion, also referred to as mild traumatic brain injury (TBI), is an expanding public health problem with pathophysiology that is difficult to diagnose and thus treat. TBI biomarkers should assess patients across severities and reveal pathophysiology, but currently, their kinetics and specificity are unclear. No single ideal TBI biomarker exists. Following a search for TBI biomarkers, in-
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vestigators at the University of California, Los Angeles (USA; www.ucla.edu) reported that they had identified new candidates by selecting trauma-released, astrocyte-enriched proteins including the enzyme aldolase C (ALDOC), its 38 kiloDalton breakdown product (BDP), brain lipid binding protein (BLBP), astrocytic phosphoprotein (PEA15), glutamine synthetase (GS) and new 18-25 kiloDalton GFAP (Glial fibrillary acidic protein)-BDPs. The investigators reported that levels of these proteins increased over four orders of magnitude in severe TBI cerebrospinal fluid
(CSF). First post-injury week, ALDOC levels were markedly high and stable. Short-lived BLBP and PEA15 related to injury progression. ALDOC, BLBP, and PEA15 appeared soon after the injury and were robust in the blood of severe and mild TBI patients; 25 kiloDalton GFAP-BDP appeared overnight after TBI and was rarely present after mild TBI. Using a human culture trauma model, the investigators analyzed biomarker kinetics. They found that disrupted astrocytes released ALDOC, BLBP, and PEA15 acutely. Delayed cell death corresponded with GFAP release and proteolysis into small GFAP-BDPs. LabMedica International February-March/2018
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PRODUCT NEWS URINE ANALYZER
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NEPHELOMETRIC ANALYZER
POC IMMUNOASSAY TEST
Erba Mannheim
Siemens Healthineers
BIOHIT Healthcare
The LAURA XL provides evaluation of drypad urine chemistry and sediment microscopy with benefits of real images. The system offers highly accurate reproducible results, evaluation of 13 parameters and a throughput of 180 samples/hr.
The Atellica NEPH 630 offers a menu of protein tests for assessment on urine, CSF, plasma and serum. It supports the assessment and monitoring of CV risk, kidney diseases, neurological disorders, nutritional status and other diseases.
The GastroPanel Quick Test reveals Helicobacter pylori infection, atrophic gastritis and high acid output of stomach. It can be performed during a clinical appointment from a fingertip blood sample and delivers results in 15 minutes.
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Test Accurately Detects Latent HIV he ability of the human immunodeficiency virus (HIV) to lie dormant in a "reservoir" of CD4 cells has been the main obstacle to finding a cure; once a patient starts antiretroviral therapy, it becomes very important to measure the level of viremia, and whether the virus can replicate. Most tests available for detecting the virus are not very cost effective and take a lot of time. The most widely available test at the moment is the "quantitative viral outgrowth assay" (Q-VOA), but it requires large amounts of blood, is very labor intensive, and is quite expensive and additionally, the Q-VOA may also underestimate the amount of virus left. Scientists at the University of Pittsburgh (PA, USA; www.pitt.edu) and their colleagues developed a sensitive assay that can accurately and rapidly quantify inducible, replication-competent latent HIV-1 from resting CD4+ T cells, which is essential for HIV-1 eradication studies. The developed test is called TZA and it works by detecting a gene that is turned on only when replicating HIV is present, thereby flagging the virus for technicians to quantify. The TZA test produces results in one week compared to the two weeks needed using the Q-VOA, and at a third of the cost. The TZA test also may be useful for quantification of replication-competent HIV-1 in the pediatric population, because of its low cell requirement, as well as in the lymph nodes and tissues where the virus persists. The assay has several advantages over existing technology in that it is sensitive; requires only a small blood volume; is faster, less labor intensive, and less expensive; and can be readily adapted into a high-throughput format. Using this assay, the authors show that the size of the inducible latent HIV-1 reservoir in aviremic participants on therapy is approximately 70fold larger than previous estimates.
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Phalguni Gupta, PhD, a professor and senior author of the study, said, â&#x20AC;&#x153;Using this test, we demonstrated that asymptomatic patients on antiretroviral therapy carry a much larger HIV reservoir than previous estimates, as much as 70 times what the Q-VOA test was detecting. Because these tests have different ways to measure HIV that is capable of replicating, it is likely beneficial to have both available as scientists strive toward a cure." The study was published on May 29, 2017, in the journal Nature Medicine. Image: Anwesha Sanyal, PhD, indicates HIV-infected cells collecting at the bottom of a test tube being prepared for the TZA test. The yellow color indicates the stimulated (Photo courtesy of the University of Pittsburgh).
Rapid Assay Monitors Influenza Virus Susceptibility arly detection of drug-resistant influenza viruses is needed for timely modification of policies and recommendations on the use of antivirals. In many countries, neuraminidase (NA) inhibitor(s) are the medications of choice for treatment and prophylaxis of influenza infections, with oseltamivir being most commonly prescribed. There have been reports of locally transmitted oseltamivir-resistant A(H1N1)pdm09 viruses harboring the NA amino acid (AA) substitution H275Y, the marker of clinically relevant resistance to oseltamivir. Several genotypic methods including pyrosequencing have been implemented by surveillance laboratories to screen clinical specimens for the
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presence of H275Y. Scientists at the Centers for Disease Control and Prevention (CDC, Atlanta, GA, USA; www.cdc.gov) and their international colleagues used a new rapid assay for detecting oseltamivir resistance in influenza virus, iART, to test 149 clinical specimens. The iART utilizes an advanced enzyme substrate that enables measurement of NA activity in virus isolates and in clinical specimens. Unlike the substrate used in the bioluminescence-based assay, the substrate used in iART is specific to influenza NA, making it more suitable for testing clinical specimens that may contain other pathogens. The study was published on May 4, 2017, in the journal Eurosurveillance. LabMedica International February-March/2018
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PRODUCT NEWS CHEMISTRY ANALYZER
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MICROPLATE READER
RAPID CARD READER
Rayto Life and Analytical Sciences
Erba Mannheim
VedaLab
The Chemray-120 features reagent pre-heating, liquid level detection and real walk-away operation. Other features include simple programming, micro-volume for sample and reagent, as well as user-friendly software.
The LisaScan EM can perform various ELISA tests with elaborate reports. Key features include 100 test programs, built-in shaker with three-speed variable mixings, various wavelength reading options and self-diagnostic capabilities.
The EASY READER+ is designed for the quantitative interpretation of immunochromatographic qualitative rapid test cards. It features a user-friendly touch screen, enhanced memory and Internet upgrading.
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Alzheimer’s Disease Progression Predicted By Gene Mutation lzheimer’s disease is the most common form of dementia in older adults. It is a degenerative condition, characterized by a steady loss of memory and a reduced ability to carry out daily activities. Today, an estimated five million people in the USA are living with the disease. The hallmark of Alzheimer’s disease is a buildup of two types of protein: beta-amyloid plaques outside of nerve cells, and tau tangles within neurons. Although these proteins appear to be involved in the pathology of Alzheimer’s, little is known about why the condition begins and how it progresses. Early detection is still difficult, and treatment options are poor. Scientists at University of Wisconsin School of Medicine (Madison, WI, USA; www.med.wisc.edu) and their colleagues enrolled 1,023 adults, baseline age 54.94 ± 6.41 years, all were healthy but at risk of developing Alzheimer’s. They were followed for a maximum of 13 years. At the start of the study, blood samples were taken to test for genotyping and cognitive assessment at up to five time points. Also, 140 of them underwent neuroimaging to look for beta-amyloid plaques. The team examined the influence of the brain-derived neurotrophic factor (BDNF) Val66Met polymorphism on longitudinal cognitive trajectories in a large, cognitively healthy cohort enriched for Alzheimer disease (AD) risk and to understand whether -amyloid (A ) burden plays a moderating role in this relationship. The Met allele mutation was found to be present in 32% of the individual, and compared to BDNF Val/Val homozygotes,
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Met carriers showed steeper decline in verbal learning and memory and speed and flexibility. In addition, A burden moderated the relationship between BDNF and verbal learning and memory such that Met carriers with greater A burden showed even steeper cognitive decline. Ozioma Okonkwo, PhD, the lead author of the study, said, “The current treatment is most successful if given earlier in the disease’s progression, this could be a vital part of the jigsaw. Because this gene can be detected before the symptoms of Alzheimer’s start, and because this presymptomatic phase is thought to be a critical period for treatments that could delay or prevent the disease, it could be a great target for early treatments.” The study was published on May 3, 2017, in the journal Neurology. Image: According to a new study, a gene mutation may accelerate the loss of memory and thinking skills in people who are at risk for Alzheimer’s disease (Photo courtesy of iStock).
Rapid POC Test for Influenza ddressing the perennial threat of a major flu pandemic, researchers have developed fast, easy-to-use point-of-care (POC) diagnostic test for influenza that could head off rapid spread of the virus during an outbreak. Preliminary clinical testing of the prototype device were encouraging. Existing rapid diagnostic tests can help with diagnoses but require multiple processing steps that still need to be performed with lab equipment in specialized facilities. Prof. Paul Yager, University of Washington, (Seattle, WA, USA; www.washington.edu), and colleagues set out to create a simpler, low-cost device that overcomes these difficulties. The researchers incorporated multiple steps of influenza detection – viral lysis, target protein capture, labeling, rinsing, and an enzyme-driven color change – into one device. A user swabs the inside of a patient’s nose, inserts the swab into the device, and twirls it for 10 seconds to release the virus. The device takes care of the
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rest. After about 35 minutes (total test time from device initiation to result), it produces a visual readout that can be seen with the naked eye and recorded with a smartphone camera. The materials and reagents for one of these single-use disposable devices cost less than USD 6. The researchers trained clinical staff at Seattle Children’s Hospital to use the prototype device to detect influenza A and B in those specimens. 25 patients were tested during a flu outbreak. Influenza A was detected, with accuracy of 70% based on in-house qRT-PCR influenza A as a gold-standard comparison. The ratio of valid to total completed device runs yielded a success rate of 92%, and the negative predictive value for both the influenza A and B assay was 81%. The ability to diagnose respiratory infections rapidly and close to the patient was well received by hospital staff, inspiring further optimization of device function.The study, by Huang S et al, was published April 26, 2017, in the journal Analytical Chemistry. LabMedica International February-March/2018
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Ultra-Early Inflammatory Biomarker Identified for TBI raumatic brain injury (TBI) is set to become the leading cause of neurological disability across all age groups. Currently, no reliable biomarkers exist to help diagnose the severity of TBI to identify patients who are at risk of developing secondary injuries. Improvements in emergency response times have increased TBI survivability, the necessity for discovering reliable markers by which to identify patients at risk of the development of secondary injuries and thus requiring more active monitoring and intervention remains a significant challenge. Scientists at the University of Birmingham (Edgbaston, UK; www.birmingham.ac.uk) took blood samples from 30 injured patients within
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the first hour of injury prior to the patient arriving at hospital. Subsequent blood samples were taken at intervals of four hours, 12 hours and 72 hours after injury. These blood samples were then screened for inflammatory biomarkers, which correlated with the severity of the injury using protein detection methods. In the laboratory, the team used a panel of 92 inflammation-associated human proteins when analyzing the blood samples, which were screened simultaneously. The Proseek Multiplex Inflammation I (Olink Bioscience, Uppsala, Sweden; www.olink.com) was used to perform the multiplex proximity assay. Briefly, human serum together with a mix containing antibodies labelled with correspon-
ding DNA oligonucleotides was incubated over night at 8 °C. Following this an extension mix containing proximity extension assay enzymes and polymerase chain reaction (PCR) reagents were added. Incubation plates were then placed on the thermal cycler for 17 cycles of DNA amplification. The 96.96 Dynamic Array IFC (Fluidigm, South San Francisco, CA, USA; www.fluidigm.com) was primed and the protein expression program activated in the Fluidigm Biomark reader. The team identified Cystatin D (CST5), AXIN1 and TNF-related apoptosis-inducing ligand (TRAIL) as novel early biomarkers of TBI. CST5 identified patients with severe TBI from all other cohorts and importantly was able to do so within the first hour of injury. AXIN1 and TRAIL were able to discriminate between TBI and healthy volunteers in less than one hour. They concluded that CST5, AXIN1 and TRAIL are worthy of further study in the context of a pre-hospital or pitch-side test to detect brain injury. Lisa J. Hill, PhD, the leading author of the study said, “”Early and correct diagnosis of traumatic brain injury is one of the most challenging aspects facing clinicians. Being able to detect compounds in the blood, which help to determine how severe a brain injury is, would be of great benefit to patients and aid in their treatment. Currently, no reliable biomarkers exist to help diagnose the severity of TBI to identify patients who are at risk of developing secondary injuries that impair function, damage other brain structures and promote further cell death. Thus, the discovery of reliable biomarkers for the management of TBI would improve clinical interventions.” The study was published on July 10, 2017, in the journal Scientific Reports. Image: The 96.96 Dynamic Array IFC for Gene Expression, which enables 9,216 reactions using 96 samples and assay (Photo courtesy of Fluidigm).
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PRODUCT NEWS ALLERGY TESTING SYSTEM
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AMPLIFICATION KIT
NEWBORN SCREENING TEST
Hycor Biomedical
Mast Group
Astra Biotech
The NOVEOS provides maximum walk away time for lab technicians by allowing up to 75 tests per specific allergen and up to 140 allergens at any time. Its on-board reagents supply offers sufficient capacity for up to 8 hours of continuous testing.
The MAST ISOPLEX DNA Lyo uses LAMP technology and is presented in a lyophilised format. The isothermal reaction conditions allow for the continuous amplification of target genes and larger quantities of NAs in a shorter reaction time.
The CFcheck DE-31 Kit detects the 31 CF mutations that are recommended for German newborn screening. The kit combines high sensitivity with easy handling and velocity.
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Simple Urine Test Helps Patients with COPD n innovative technology could hugely improve the quality of life for people who suffer from the serious lung condition called Chronic Obstructive Pulmonary Disease. The urine test, alerts these people that they are about to suffer a life-limiting lung attack. Chronic Obstructive Pulmonary Disease (COPD) is a condition that makes it hard to breathe because of narrowing airways and damage to the lungs. COPD sufferers are prone to lung attacks, which can mean their symptoms worsen and lead to hospitalization and even death. In the UK, three million people are living with COPD and each year the condition causes 115,000 emergency admissions to hospital and 24,000 deaths. Scientists at the University of Leicester (UK; www.le.ac.uk) in partnership with Mologic (https://mologic.co.uk) have unveiled the simple inhome Headstart test has already passed the first stage of the development process. The Headstart test is based upon the basic science used in a standard pregnancy test. It works by measuring biomarkers in the urine and transforms the test data into straightforward actions and medications. This test enables chronic obstructive pulmonary disease (COPD) patients to monitor their disease status at home for early indications of exacerbation. It will test the levels of key biomarkers in the urine, interpret them and identify imminent acute exacerbation
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and cause in 10 minutes. The most important cause of COPD is smoking, but past exposures to fumes, chemicals and dusts at work can also contribute to causes of the condition. COPD symptoms often do not appear until significant lung damage has occurred, and they usually worsen over time, particularly if smoking exposure continues. Other signs and symptoms of COPD may include shortness of breath, especially during physical activities, wheezing, chest tightness and a chronic cough that may produce mucus. Professor Paul Davis, chief scientific officer and Mologic cofounder, said, “We accepted the challenge of coming up with a new way to help COPD patients understand, monitor and control what’s going on in their vulnerable lungs. Our response to the challenge was to develop a simple, low-cost test, which worked in a similar way to a pregnancy test, only this one can predict impending lung problems. The test is simple enough for patients to use themselves at home, so this puts them at the center of their own care, empowering them to take control. There’s a valuable, clear but encoded message written in the substances, which we call biomarkers, when they are excreted into the urine through the kidneys. You just need to know what to look for and how to interpret the message into plain language.”
Biosensor Technology Enables Rapid Detection of Flu Virus research team has developed a voltage-sensor for early detection of influenza virus A (H1N1) that is almost 100 times more sensitive than conventional tests, and can distinguish between human and avian strains. Researchers at Tokyo Medical and Dental University (TMDU; Tokyo, Japan; www.tmd.ac.jp/english) developed the sensor for early detection of even very low virus concentrations. Such early-stage diagnosis is crucial for averting a potential pandemic outbreak, as antiviral medication must be administered in a timely fashion. Conventional tests for detecting the flu virus are often slow and expensive, and can miss early viral infections. In contrast, the new biosensor measures tiny changes in voltage in an electrically conductive polymer to quickly detect virus concentrations almost 100 times smaller than the limit of currently available kits. Conductive polymers are a class of carbon-based molecules that conduct electricity, but can also be used in biological environments. Biomolecules can be easily attached to the polymers, allowing them to bind with specific targets. In this study, poly(3,4-ethylenedioxythiophene) (PEDOT) was modified with a functional group that binds with the
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H1N1 human influenza virus, but not avian influenza strains. “Conducting polymers have several advantages over inorganic counterparts,” explained corresponding author Yuji Miyahara, “These include the ability to conduct both electrical and ionic carriers, mechanical flexibility, low cytotoxicity, low-cost production by casting or printing, and tunable properties via chemical synthesis or doping.” To construct the biosensor, the polymer film was placed between two electrodes. When a solution containing H1N1, which carries a tiny positive charge on its exterior shell, was added, some of the viruses stuck to the polymer and increased the voltage measured by the electrodes. This electrical method allows the sensor to detect the presence of miniscule amounts of the virus. Viral loads are often measured in hemagglutination units (HAU). The new sensor can detect viral concentrations as small as 0.013 HAU. By comparison, commercially available kits that use immunochromatographic tests only work for concentrations greater than about 1.13 HAU. “The device is a good candidate for wearable monitoring and point-of-care testing,” added study coauthor Shoji Yamaoka. The study, by Hai W et al, was published April 5, 2017, in the journal ACS Applied Materials & Interfaces. LabMedica International February-March/2018
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LabMedica International
Test Discriminates Between Viral and Bacterial Infections ower respiratory tract infection (LRTI) commonly causes hospitalization in adults but because bacterial diagnostic tests are not accurate, antibiotics are frequently prescribed. Antibiotics are lifesaving drugs, but overuse is leading to antibiotic resistance, one of the world’s most pressing health threats. Although sensitive molecular diagnostics such as polymerase chain reaction (PCR) allow clinicians to rapidly and accurately diagnose a wide variety of respiratory viruses, their impact on management and antibiotic prescription has been modest primarily due to concern about bacterial co-infection. Scientists at the University of Rochester School of Medicine (Rochester, NY, USA; www.urmc.rochester.edu) recruited a group of 94 adults hospitalized with lower respiratory tract infections. The team gathered clinical data, took blood from each patient, and conducted a battery of microbiologic tests to determine which of 41 patients had a bacterial infection and which of 53 patients had a non-bacterial or viral infection. Patients were enrolled within 24 hours of admission and demographic, clinical and laboratory information collected. Nose and throat swabs (NTS), sputum, urine, and blood samples obtained at admission for bacterial and viral detection were processed at the hospital’s clinical laboratories. Urine was assayed for Streptococcus pneumoniae antigen using Binax NOW (Binax, Inc, Scarborough, ME, USA; www.alere.com). NTS and sputum were tested using the real time multiplex PCR (FilmArray Respiratory Panel, Idaho Technologies, Inc, Salt Lake City, UT, USA; www.biofiredx.com) for detection of 15 viruses and three atypical bacteria. For RNAseq, cDNA libraries were generated using 200 ng of globin-reduced total RNA from each sample. Libraries were sequenced (single end reads) on the Illumina HiSeq 2500 (Illumina, San Diego, CA, USA; www.illumina.com). The investigators showed that RNAseq and qPCR confirmed significant differences in mean expression for 10 genes previously identified as discriminatory for bacterial LRTI. A novel dimension reduction strategy selected three pathways (lymphocyte, α-linoleic acid metabolism, IGF regulation) including eleven genes as optimal markers for discriminating bacterial infection. Using these genes, they constructed a classifier for bacterial LRTI with 90% (79% CV) sensitivity and 83% (76% CV)
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specificity. This novel, pathway-based gene set displays promise as a method to distinguish bacterial from nonbacterial LRTI. Ann R. Falsey, MD, a professor and the lead study author, said, “It’s extremely difficult to interpret what’s causing a respiratory tract infection, especially in very ill patients who come to the hospital with a high fever, cough, shortness of breath and other concerning symptoms. My goal is to develop a tool that physicians can use to rule out a bacterial infection with enough certainty that they are comfortable, and their patients are comfortable,
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foregoing an antibiotic.” The study was published on July 26, 2017, in the journal Scientific Reports. Image: The FilmArray respiratory panel enables rapid and accurate automated detection of pathogens causing respiratory infections (Photo courtesy of Idaho Technologies).
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PRODUCT NEWS GLUCOSE/LACTATE ANALYZER
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CENTRIFUGE
ELECTRONIC PIPETTES
EKF Diagnostics
Drucker Diagnostics
Labnet International
The Biosen C-Line GP+ uses chip sensor technology to deliver fast measurements with a high degree of accuracy at a low cost per test. It features a touch screen along with a large memory and is available as a one- or two-channel system.
The 755VES airflow and rotor design guarantees the highest quality sample separations and maintains the integrity of the most sensitive specimens. It is considered ideal for serotology, STAT, PPP, PRP, coagulation, clinical chemistry and more.
The Excel offer modes for standard and reverse pipetting, multiple and sequential pipetting, mixing of samples and serial dilutions. Features include a fully motorized piston drive, auto-calibration guarantee, excellent accuracy and reproducibility.
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Elevated Levels of Beta-2 Microglobulin Linked to Increased Stroke Risk eta-2 microglobulin, also known as B2M, is a component of the MHC class I molecules, which are present on all nucleated cells. They also occur on platelets, but not on red blood cells. Their function is to display peptide fragments of non-self-proteins from within the cell to cytotoxic T-cells; this will trigger an immediate response from the immune system against a particular non-self-antigen displayed with the help of an MHC class I protein. As recent studies had found associations between beta-2 microglobulin and heart disease, investigators at Harvard Medical School (Boston, MA, USA; www.med.harvard.edu) decided to study the association between beta-2 microglobulin and ischemic stroke. The investigators measured B2M levels in 473 ischemic strokes cases confirmed by medical record review and in 473 controls matched 1:1 to the cases on age, race, date of blood collection, menopausal status, postmenopausal hormone use, and smoking status. The subjects were women with an average age of 61 who provided blood samples between 1989 and 1990 and who had no history of stroke or cancer. Participants completed questionnaires about their lifestyle and medical history every two years. The investigators analyzed the association between B2M and ischemic stroke using multivariable conditional logistic regression to adjust for traditional stroke risk factors. Results revealed that participants who later had an ischemic stroke had higher levels of beta-2 microglobulin than those who did not have a stroke. The average level of the protein was 1.86 milligrams per liter
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in those who had ischemic strokes, compared to 1.80 milligrams per liter in those who did not have a stroke. Those in the highest quarter of beta-2 microglobulin levels were 56% more likely to have a stroke than those in the bottom quarter. In the top quarter, 163 of the 283 women had strokes, compared to 106 of the 227 women in the bottom quarter. “Recent studies have found associations between beta-2 microglobulin and heart disease,” said first author Dr. Pamela Rist, instructor in medicine and epidemiology at Harvard Medical School. The study was published in the May 10, 2017, online issue of the journal Neurology. Image: Results published in a recent paper indicated that elevated levels of the protein beta-2 microglobulin in the blood were linked to an increased risk of ischemic stroke among women (Photo courtesy of the AHA).
Vitamin D Assays Compared and Harmonized here are a variety of assay techniques available to measure of 25hydroxyvitamin D (25(OH)D) concentrations and some have the ability to measure the two forms 25(OH)D2 and 25(OH)D3. However, there are significant discrepancies between procedures used to estimate vitamin D status. Vitamin D is a prohormone and is mostly obtained through skin synthesis from UVB exposure, and as such shows strong seasonal trends. Vitamin D can be obtained in two isoforms, and while UVB exposure-related synthesis will always lead to formation of cholecalciferol (D3), in diet or dietary supplements, vitamin D can also exist as egrocalciferol (D2). Scientists at the University of South Australia (Adelaide, Australia; www.unisa.edu.au) and their international colleagues measured concentrations of 25(OH)D3 and 25(OH)D2 using liquid chromatography–tandem
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mass spectrometry (LC-MS/MS) in 5,915 participants (aged 31 years) of Northern Finland Birth Cohort 1966. Blood samples were assayed in batches over a course of 18 months. As anomalies were present in the measurements, 200 samples were reassayed using a radioimmunoassay. Samples were prepared for analysis by thawing, mixing and re-centrifuging, to remove any fibrin debris. The integrated high performance liquid chromatography (HPLC) system used to separate the peaks of interest was the Acquity Ultra Performance Liquid Chromatography system (Waters, Elstree, UK; www.waters.com). The radioimmunoassay Vitamin D kit was obtained from DiaSorin (Saluggia, Italy; www.diasorin.com). To harmonize LC-MS/MS with Diasorin RIA measurements, formulae were derived from the limits of agreement (LoA). The study was published on May 17, 2017, in the Journal of Clinical Laboratory Analysis. LabMedica International February-March/2018
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LabMedica International
Blood Test Improves Cancer Treatment lthough prognosis and treatment of metastatic breast cancer (MBC) have improved over the last years, there is still an unmet clinical need for more precise prognostic and treatment monitoring tools. Thymidine kinase 1 (TK1) is an enzyme involved in nucleotide metabolism and has a fundamental role in the DNA synthesis. It can be used as a marker of cell proliferation rate and the TK1 activity has demonstrated correlations to prognosis and usefulness for treatment monitoring in different malignancies.
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Routine Blood Tests Could Predict Fitness Changes n an initial study of marathoners (runners-bikers) aged >60 years, researchers have found that results from a combination of routine blood analytes predicted improvement or decrease in their fitness. Beneficial impact of endurance sports on physical and mental performance can be seen in blood test results. In collaboration with the Health and Prevention Center of the Healthcare Institution for City of Vienna employees, a group of researchers from the biobank at Medical University (MedUni) of Vienna (Vienna, Austria; www.meduniwien.ac.at/web/en) has shown, in a study conducted with older marathoners, that specific blood parameters could be used in the opposite way to predict future changes in fitness. This could be used for personalized sports medicine to optimize endurance-training programs for individuals. Within the Austrian research infrastructure BBMRI.at, MedUni Vienna biobank works closely with the biobanks and medical archives of the other Austrian universities. The consortium has set itself the joint goal of improving the quality of biomaterial used in biomedical studies and hence increasing the reliability of research results nationwide. In the APSOEM Marathon Study, which has been running since 2009, MedUni Vienna's biobank has already demonstrated that the cognitive ability and mental state of older marathon runners aged >60 are significantly better than those of comparable age groups who do not engage in any endurance sport. Data gathered in this study were used in the new study. The follow-up study was conducted by a research group headed by Dr. Helmuth Haslacher from MedUni Vienna, in collaboration with Robert Winker's team from the Health and Prevention Center of the Healthcare Institution for City of Vienna employees. They took blood samples from 47 marathoners before an ergometer test, and carried out lab tests to determine levels of analytes, including inflammatory markers, and muscle and liver parameters. They study, by Haslacher H et al, was published May 5, 2017, in the journal PLOS One.
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A team of scientists working with those at Lund University (Lund, Sweden; www. lunduniversity.lu.se) studied 142 women with MBC scheduled for 1st line systemic treatment and included in a prospective monitoring trial who were evaluated for serum thymidine kinase 1 (sTK1) at baseline (BL) and during treatment at 1, 3 and 6 months. There were 132 patients who had at least one follow-up sample. sTK1 activity levels were measured and correlations to important clinic-pathological variables and prognosis. Progression-free survival (PFS) and overall survival (OS) at BL and during treatment were evaluated. The investigators measured serum TK1 activity (sTK1) levels with the DiviTum assay (Biovica, Uppsala, Sweden; http://biovica. com). The median sTK1 level at BL was 391 u/L (range 10-35,520 u/L). When comparing patients with high (above median) versus low (below median) sTK1 levels at BL, high sTK1 levels were found to be associated to worse performance status and high number of metastatic sites. There was also a statistically significant association between high sTK1 levels and high Ki67 expression in biopsies from metastatic lesions. High sTK1 levels correlated to worse PFS and OS at BL. At diagnosis in the study, low DiviTum values correlated significantly and independently with improved progression free- and overall survival. The authors concluded sTK1 activity level is an independent prognostic factor for PFS and OS in patients with MBC scheduled for 1st line systemic therapy. During treatment, sTK1 is prognostic for OS evaluated from all
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time-points up to six months. The sTK1 effects observed for PFS are slightly weaker, but still propose potential usefulness for treatment monitoring. Lisa Rydén, MD, PhD, a professor in the department of surgery, said, “The results demonstrate that already after just one month of treatment, DiviTum is a highly valuable marker for clinical use regarding accurate prognosis. Throughout the course of therapy DiviTum can provide clinical information for patients with metastatic breast cancer scheduled for 1st line systemic therapy.” The study will be presented at the San Antonio Breast Cancer Symposium to be held December 5-9, 2017, in San Antonio, TX, USA. Image: Diagram of DiviTum sTK1 assay: BrdUTP is subsequently incorporated into a solid-phase DNA-strand. Incorporated BrdU is detected using an anti-BrdU monoclonal antibody conjugated to the signal generating enzyme alkaline phosphatase. The level of BrdU incorporated over time is proportional to the level of thymidine kinase activity in the sample (Photo courtesy of Biovica).
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Low Levels of Protein Linked to Cognitive Decline lzheimer’s disease (AD) currently affects more than five million Americans. Amyloid plaques, long seen in the brains of people with AD are often blamed for the mental decline associated with the disease. Autopsies and brain imaging studies reveal that people can have high levels of amyloid without displaying symptoms of AD, calling into question a direct link between amyloid and dementia and memory loss in AD is attributed to pervasive weakening and loss of synapses. A large group of scientists led by those at Johns Hopkins University School of Medicine (Baltimore, MD, USA; www.hopkinsmedicine.org) analyzed a library of 144 archived human brain tissue samples to measure levels of the protein encoded by the Neuronal Pentraxin 2 (NPTX2) gene. NPTX2 protein levels, they discovered, were reduced by as much as 90% in brain samples from people with AD compared with agematched brain samples without AD. By contrast, people with amyloid plaques who had never shown signs of AD had normal levels of NPTX2. This was an initial suggestion of a link between NPTX2 and cognition. The team then examined NPTX2 protein in the cerebrospinal fluid (CSF) of 60 living AD patients and 72 people without AD. Lower scores of memory and cognition on standard AD tests, they found, were associated with lower levels of NPTX2 in the CSF. NPTX2 protein levels in CSF were further quantitated by an enzyme-linked immunosorbent assay (ELISA) assay developed for the study. Quantitative polymerase
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chain reaction (PCR) was performed with a StepOnePlus system (Applied Biosystems, Foster City, CA, USA; www.appliedbiosystems.com). NPTX2 correlated with measures of the size of the hippocampus, a brain region essential for memory that shrinks in AD. In this patient population, NPTX2 levels were more closely correlated with cognitive performance than current best biomarkers, including tau, a biomarker of neurodegenerative diseases, and a biomarker known as A 42, which has long been associated with AD. Overall, NPTX2 levels in the CSF of AD patients were 36% to 70% lower than in people without AD. The study was published on March 23, 2017, in the journal eLife. Image: A new study shows “memory protein” NPTX2 underlies cognitive decline in Alzheimer’s (Photo courtesy of Shutterstock).
Gene Sequencing Reveals Mutations in Endometriosis ndometriosis occurs when tissue lining the uterus forms and grows outside of the organ, most often into the abdomen. The disease occurs in up to 10% of women before menopause and half of those with abdominal pain and infertility problems. Endometriosis is defined as the presence of ectopic endometrial stroma and epithelium and can cause pelvic pain and infertility. Endometriotic lesions are considered to be benign inflammatory lesions but have cancer like features such as local invasion and resistance to apoptosis. Endometriosis most commonly involves the ovaries, fallopian tubes and the tissue lining of the pelvis. Rarely, endometrial tissue may spread beyond pelvic organs. A large group of scientists led by those at Johns Hopkins Medicine (Baltimore, MD, USA; www.hopkinsmedicine.org) analyzed deeply infiltrating endometriotic lesions from 27 patients by means of exomewide sequencing (24 patients) or cancer-driver targeted sequencing (three patients). Mutations were validated with the use of digital genomic methods
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in microdissected epithelium and stroma. Seven of the 24 women were from Japan; the rest were patients at Lenox Hill Hospital-Northwell Health (New York, NY, USA; www.northwell.edu). The team found that of the 24 women, 19 had one or more mutations in their endometriosis tissue that were not present in their normal tissue. The type and number of mutations varied per endometriosis lesion and between each of the women. The most common mutations, occurring in five of the women, occurred in genes including ARID1A, PIK3CA, KRAS and PPP2R1A, all known for controlling cell growth, cell invasion and DNA damage repair. In an additional group of endometriosis samples biopsied from 15 women from British Columbia, the scientists looked specifically for mutations in the KRAS gene, whose expression signals proteins that spur cell growth and replication. They found KRAS mutations in five of the 15 patients. The study was published on May 11, 2017, in the New England Journal of Medicine. LabMedica International February-March/2018
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Edited by Tahir Pillay MBChB, PhD, FRCPath(Lon), FCPath(SA) IFCC members may send news to: Tahir Pillay MBChB, PhD, Head, Dept of Chemical Pathology, Faculty of Health Sciences, University of Pretoria, Private Bag Bag x323, Arcadia, 0007, South Africa Tel: (27) 012-319-2114; Fax: (27) 012-328-3600; Email: enews@ifcc.org
NEWS
MESSAGE FROM THE PRESIDENT by Prof. Howard Morris, President, IFCC t is a great pleasure to present my welcoming message to all our national society and corporate member colleagues. It is your expertise and dedication to improve health outcomes for patients and communities that are the greatest strengths of the IFCC. I very much look forward to working closely with you and together facing the opportunities and challenges for Laboratory Medicine over this next period. It is your expertise which gives me great confidence that we will continue to develop the quality and performance of Laboratory Medicine to meet the future needs of our patients and the healthcare system. Laboratory Medicine currently faces significant challenges some of which confront all the healthcare disciplines. However we face particular issues arising from the perception of Laboratory Medicine as merely a service provider rather than a driver for optimal healthcare. Clinical laboratories are being required to assume increased responsibilities for service provision and patient safety with ever decreasing budgets. Financial constraints also impact our corporate members, moderating their ability to collaborate in professional development and, at the same time, the academic basis of Laboratory Medicine is diminishing. Professional leadership has never been more vital to provide strategies for improving the crucial role of Laboratory Medicine in patient care. Such leadership is provided by the IFCC, our regional federations and our national societies. We work in this field together and each of our organizations plays an essential role at the different levels of engagement. Clearly communication is critical and the interactions between the IFCC and the regional federations will now be markedly enhanced with the inclusion of representatives of each of the regional federations on the IFCC Executive Board. The IFCC General Conference, this year being held in November, provides further opportunity between the national society representatives, regional federations and IFCC Officers to engage in discussions and debate on the key issues currently facing Laboratory Medicine. As President I look forward to extending the work of the IFCC in a range of important areas. Technologies relevant to clinical laboratory practice are rapidly emerging from academic and industry research laboratories and
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being adopted by highly specialized scientists within clinical laboratories. But their full benefits for patient care cannot be realized until they are translated to areas capable of highthroughput processing for medical tests and meeting performance criteria for accreditation purposes. The Emerging Technologies Division (ETD) is a new addition to the IFCC functional units and is responsible for identifying and assessing emerging technologies and translating the emerging and disruptive diagnostic and data analysis procedures from academic laboratories to clinical laboratories and from clinical laboratories to routine practice. Improving clinical laboratory performance through standardization and traceability as it impacts on the rational use of clinical laboratory
resources continues to be a major focus of the Scientific Division. This work will be enhanced by the IFCC hosting the International Consortium for Harmonization of Clinical Laboratory Results (ICHCLR) which will improving the close working relationships between IFCC, ICHCLR and the Joint Committee for Traceability in Laboratory Medicine (JCTLM) during the next triennium. A major challenge is to extend these activities to regions in which the current multi-national In-Vitro Diagnostic industry members are not necessarily the major providers of clinical laboratory instruments and reagents, such as in the Asia Pacific and Central and South American regions. Major achievements have been made in this field only with the close Contâ&#x20AC;&#x2122;d on page 28
News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information
NEWS
Message from the President Cont’d from page 27 collaboration of the IFCC with relevant institutions in Europe (European Commission - Joint Research Centre) and the USA (National Institute of Science and Technology). During 2018 these collaborations will extend to China (National Institute for Food and Drug Control). We look forward to continuing this important work in collaboration with these important institutions. IFCC educational and training activities capable of meeting the needs of both developing and developed communities across general Laboratory Medicine subjects, specialised services and clinical laboratory management have long been a high priority for IFCC. It is most
gratifying that this work will be enhanced through the joint efforts of the Education and Management Division and Communication Publications Division with the promotion of eLearning facilities and opportunities. These electronic resources will be available to clinical laboratory practitioners around the world with internet access. As discussed above Laboratory Medicine faces particular challenges and it is important that as a profession we improve our ability to present a coherent strategy to our clinical colleagues, to healthcare managers and those paying for medical tests such as insurers and governments. Closer interactions between in-
ternational organisations representing the various disciplines of Laboratory Medicine will greatly assist common engagement by our profession with these stakeholders. Of particular interest in these collaborations will be value of medical tests in order to demonstrate to all stakeholders in healthcare that Laboratory Medicine can be a a driver of optimal and financially sustainable healthcare delivery. I look forward to working directly with many of you over the next triennium and particularly hope we can meet at the IFCC General Congress being held in Budapest in November. I welcome any suggestions to improve our organization and activities.
IFCC Standardization of CDT International Standardization of CDT Measurement and Interpretation Improves its Use as Biomarker for Chronic Excessive Alcohol Consumption by Jos Wielders PhD; Chair of the IFCC WG-CDT DT (carbohydrate deficient transferrin) is a biomarker for chronic excessive alcohol consumption. Its diagnostic accuracy exceeds that of traditional markers such as γGT and MCV, while the skills and analysers needed for measuring CDT are available in most mediumsized modern medical laboratories. Because the results obtained and the reference intervals differed significantly between available commercial methods the IFCC decided to start a Working Group for standardisation of CDT (WG-CDT) in 2005. Very recently this standardization task of the WG-CDT was completed by the acceptance in 2016 of the candidate Reference Measurement Procedure by the IFCC-SD (chaired by Prof Ian Young) and the subsequent approval by the national IFCC societies. The present main goal of the WG-CDT, as agreed with Prof Philippe Gillery, is to expand the knowledge about CDT and the worldwide use of the standardized CDT, called CDTIFCC.
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What is CDT and what does it tell us? CDT is the abbreviation for carbohydrate-deficient transferrin which is used as a clinical and forensic alcohol biomarker. The iron transport protein transferrin contains two carbohydrate chains with sialic acid end groups. Chronic excessive alcohol consumption decreases the carbohydrate content of the molecule, increasing the amount of “carbohydrate-deficient” transferrin. Transferrin and CDT, have a halflife of about two weeks, meaning that the CDT level becomes elevated after excessive alcohol intake over a couple of weeks and will not return to baseline until after about 3-4 weeks of alcohol abstinence. CDT has a higher sensitivity and specificity than traditional markers like gGT and MCV. When is CDT measurement relevant? Excessive alcohol consumption is amongst the top-five five risk factors for disease, disability and death throughout the world. Single CDT measurements are used for objective detection of people engaged in chronic excessive alco-
hol use. CDT measurement is also becoming increasingly used in health checks of professions where the client may put others at risk, such as public transport services and aviation. In some countries, CDT is the cornerstone in regranting of a driver’s license in individuals being involved in a traffic accident when driving under the influence of alcohol. CDT is also used in other medical issues with special implications for heavy alcohol consumption, such as pregnancy (first two trimesters), liver transplantation and pre-surgery check-up. How is CDT measured and what are the present reference intervals and decision levels? At present, three different analytical principles are applied for routine CDT testing: high-performance liquid chromatography (HPLC), capillary electrophoresis (CE), and immunonephelometry. Because both the measurand, being the actually measured substance, and the reference intervals differ between available methods the IFCC decided to start a Working Group for Standardization of CDT measurement (WGCDT) in 2005. How was that standardization achieved? The IFCC WG-CDT started with defining the analyte (disialotransferrin) and the way it is measured by an HPLC candidate reference measurement procedure (cRMP). A number of experienced international CDT reference laboratories running the HPLC-cRMP were selected and demonstrated to provide comparable results over time. Multi-level serum calibrators and control materials were then developed and tested for long-term stability, to be used as candidate reference material (cRM). The WG proved that all commercial CDT methods correlated linearly with the cRMP, indicating that standardization was possible. After a validation procedure of the cRMP and the cRM, both were approved by the national societies within the IFCC, making them a formal IFCC RMP and RM.
What is the reference interval and the forensic decision level for the RMP? CDT results obtained with methods that are calibrated against the HPLC-RMP are to be termed CDTIFCC. The clinical reference interval defined using standard procedures has an upper limit of 1.7% CDTIFCC no lower level is defined. For forensic application, the measurement uncertainty, as required by ISO 15189, should be taken into account, leading to a higher decision limit (also called cutoff) of 2.0%. This implies that a single CDTIFCC result of 2.0% could be considered in forensic medicine as the highest expected numerical value without excessive alcohol consumption, considering all sources of imprecision. What changes in reporting results? When is the changeover to the new unit? CDT results expressed in the new standardized CDTIFCC unit will be different from those presently obtained with commercial methods. Especially for some capillary electrophoresis methods (manufacturer claimed upper level of reference interval is 1.3%) and for the immunonephelometry method (manufacturer claimed upper level of reference interval is 2.4%) the change in results will be significant. Manufacturers will adapt their inserts and / or software in the last quarter of 2017. From December 2017, it is advised that results will be provided both as traditional method-specific results (% CDT) and as IFCCstandardized results (% CDTIFCC). From 1 July 2018, only % CDTIFCC results should be used as recommended by the IFCC.
IFCC OFFICE Via Carlo Farini 81, 20159 Milan, ITALY Tel: (39) 02-6680-9912 • Fax: (39) 02-6078-1846 E-mail: ifcc@ifcc.org • Web: www.ifcc.org Office Hours: 8.30-13.00 and 13.30-17.30 Staff Members: Paola Bramati, Silvia Cardinale, Silvia Colli-Lanzi LabMedica International February-March/2018
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NEWS
Record Number of Travel Scholarships Contributes to Success of WorldLab Durban 2017 by Prof. Howard Morris, IFCC President-Elect record number of travel scholarships strongly contributed to the success of the triennial International Congress of Clinical Chemistry and Laboratory Medicine, (WorldLab) held for the first time on the African continent. The opportunity for the South African Association of Clinical Biochemistry and Laboratory Medicine to host WorldLab 2017 was granted to stimulate the improvement of Laboratory Medicine practice throughout this rapidly developing and populous continent and further assist the IFCC national societies in Africa. Critical to achieving these aims was the attendance of young clinical laboratory practitioners. Members of the Executive Board were very much aware of the impact of attending our own first WorldLab Congresses. It inspired building a rewarding career in Laboratory Medicine and had positive impacts on creating interest in our profession and building national societies. To this end the IFCC Executive Board allocated the historic level of funding for travel scholarships to support 70 young delegates. In addition the IFCC was highly appreciative of the philanthropic support from Prof. Jocelyn Hicks, who supported a further four travel scholarships and our Corporate Member, Roche Diagnostics, for funding to support a further 11 scholarships. We were very pleased to receive applications from some 90 young African scientists who met the criteria for support including aged younger than 40 years, priority for abstract presenters and each applicant had written a personal statement highlighting what they hoped to gain by attending this Congress. The scholarship provided 4 nights’ accommodation, contribution to economy air travel to Durban and coverage of bank charges. The Conference Organizing Committee contributed by providing registration for WorldLab 2017. The IFCC was now faced with the challenge of identifying extra funds to meet the demand from these excellent candidates. We turned to the generosity of our National Societies to allow these young scientists to achieve their dreams and were very pleased to receive an excellence response for this call for action. Support for all 90 eligible applicants was achieved through the contributions received from the following national societies: Australasian Association of Clinical Biochemists (5 scholarships); Association of Clinical Biochemists – UK (1 scholarship); American Association for Clinical Chemistry (2 scholarships); Canadian Society of Clinical Chemistry (2 scholarships); Deutsche Gesellschaft für Klinische Chemie und Laboratoriumsmedizin – DE (2 scholarships); Malaysian Association of Clinical Biochemists (1 scholarship); Société Française de Biologie Clinique – FR (1 scholarship); Saudi Association for Clinical Chem-
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Photo: Group of awardees at the WorldLab Durban 2017
istry (1 scholarship). The IFCC pledged to make up any shortfall. The IFCC is extremely grateful for this extra support from our members and clearly, as indicated by the reports of the scholarship awardees and the photographs from the WorldLab Durban Congress, feel vindicated for this effort. The future of Laboratory Medicine in Africa is immeasurably stronger following the Congress and we are confident that many of these young clinical scientists will play key roles in our profession to improve the outcomes of their patients, a key element in building their young nations.
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NEWS
The Retrospectoscope: A Look Back at WorldLab 2017 FCC Worldlab 2017 Durban was a conference of many firsts: It was the first time that it had been held in Africa. Durban was the chosen city because the original bid had been submitted with the city of Durban in 2010. In South Africa, Cape Town is the popular choice for many conferences but Durban offered a unique African flavor and was still an excellent city to host a conference. In any case, the new MedTech Europe directive1 does not allow the touristic appeal of a city to dictate the choice of venue, therefore, in many respects the choice of Durban had anticipated this philosophy or concept. Durban is a very understated city and can be thought of as South Africa’s best kept secret and delegates soon discovered why this is the case. The conference attracted people from many countries and continents and provided an eclectic mix of topics. It was the first time that many delegates had either visited South Africa or indeed Africa. Owing to the slightly shortened schedule (1 day), the programme was hectic but the numbers of delegates facilitated networking and interaction that often not be possible with conferences that attract many thousands of delegates. There were also a number of satellite conferences attached to the main congress and many delegates took advantage of these. Moreover, the conference was a huge benefit to African delegates who would often not be able to afford to travel to conferences to Europe, USA and elsewhere. African delegates were exposed to eminent speakers. The opening plenary lecture was delivered by Prof Salim Abdool Karim and the audience was enthralled by his overview of the fight against HIV and the recent advances he and his group have been involved in. The closing ceremony saw the final plenary lecture by Dr Bill Bishai from Johns Hopkins and the handing over of the flag to South Korea. It was the first time that an IFCC Conference featured the posters
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Photo: Closing ceremony with the representatives of the Korean Association, Prof Maurizio Ferrari, IFCC President and Prof Howard Morris, IFCC Presidentelect, and Prof Tahir Pillay (congress co-president and chair of the scientific committee).
within an app. This may have had a downside that fewer people visited the posters but this was down to the filled schedule of talks during the lunch times and the lunch symposia taking place. It is hoped that the majority of delegates left with fond memories of South Africa and an appreciation for the beauty and complexity and challenges in this great country in Africa. Reference: 1. Pillay T.S.: The new MedTech Europe directive: implications for educational activities in pathology and laboratory medicine.J Clin Pathol. 2017 Mar;70(3):185-18
23rd COLABIOCLI Congress Held in Punta de Este, Uruguay by Tomris Ozben, IFCC Treasurer would like to express my sincere gratitude to the VLP program and Abbott Company for supporting my attendance at the COLABIOCLI Congress. The joint 23rd COLABIOCLI Congress and 11th Uruguayan Congress Of Clinical Biochemistry was held at the Convention Centre of Punta del Este Uruguay, 17-20 September 2017. On Sunday, 17 September 2017, a full day pre-congress workshop was organized by the AACC. During the main congress, five parallel sessions were organized from 18-20 September 2017. Simultaneous translation from English/Spanish was provided at the main auditorium. The participants of the congress were students of Clinical Chemistry and Pathologists, Medical Laboratory Technicians Licensed in Laboratory Sciences, Clinical Biochemists, Clinical
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Pathologists, Biochemists, Biologists, Chemists, and Physicians. The commercial exhibition and posters’ exhibition were held every congress day between 10:00 and 19:00. Poster defences were received between 13:40 and 17:05. On Monday, September 18, 2017, in the main auditorium, the IFCC sponsored symposium titled “the IFCC eAcademy: Progress and the future” chaired by Janet Smith was held between 08:00-10:50. Following the IFCC symposium, I delivered my lecture titled “Potential Risk Predictors for Cardiovascular Diseases” between 10:55 and 11:45. The Chair was Juana Ortellado. The main auditorium was full and I received a lot of questions regarding cardiovascular disease markers from the audience. The day was ended by the opening plenary conference between 19:00 and 19:50 and opening ceremony between 20:00- 20.25. On Tuesday, 19 September 2017, I took part in the round table held in the main auditorium, “Biomarkers and new therapies in cancer” chaired by Marta Marco between 17:05 and 18.30. The first speaker was Mev Dominguez and the title of her talk was “From genomics to genetic markers”. I was the second speaker and spoke on “Liquid Biopsy: Circulating free tumour DNA (ctDNA) and circulating tumour cells (CTC) as novel diagnostic and prognostic markers”. The last speaker was Monica Vazquez-Levin and the title of her presentation was “From investigation to clinic: identifying new markers of tumour progression and aggression”. After delivering our talks, we answered the questions of the audience. Tuesday night, a dinner was organized for the speakers in a restaurant in front of the Hotel Conrad Punta del Este. On Wednesday, 20 September 2017, I participated in the Workshop “Regulatory Aspects for Clinical Laboratories” which was held in the main auditorium from 08:00 till 09:55. I was the first speaker and the title of my presentation was “In vitro Diagnostics and Evolving Regulatory Changes in Laboratory Medicine”. The second speaker was Sergio Bernardini. He spoke on “Automation and Digital Laboratory”. The last speaker of the workshop was Ingrid Lima and the title of her talk was “Regulatory aspects for reagents and equipment”. After delivering our talks, we answered the questions. The Congress was ended by the closing plenary conference delivered by Jean Claude Forest on “Hypertensive disorders of pregnancy” between 19:00 and 19:50 and closing ceremony between 19:55-20.25. LabMedica International February-March/2018
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THE WORLD OF IFCC
NEWS
Spanish Society of Laboratory Medicine (SEQCML)
Experts Produce a Spanish Consensus on Recommended Values for the Lipid Profile urrently, there is variability in lipid values considered to be advisable by clinical laboratories, which may generate confusion and pose a barrier to the correct treatment of dyslipidemias. The document´s aim is to recommend to all clinical laboratories the adoption of homogeneous recommended values for the variables that make up the lipid profile. This consensus includes wide-reaching and documented information, such as epidemiological data for our country, existing barriers to achieving control of dyslipidemia and strategies to avoid them, and recommendations on which values of lipid constituents should be reported as altered. In Spain, it is estimated that 48% of men and 52% of women over 18 years of age have high total cholesterol levels, while 23% of men and 12% of women have hypertriglyceridemia Alterations in circulating lipid concentrations (total cholesterol and its high ‘HDL’ and low ‘LDL’ density and triglycerides fractions), commonly referred to as dyslipemias, correlate with the development of cardiovascular diseases of ischemic origin. Thus, numerous studies have shown that interventions that "normalize" circulating lipid concentrations protect against these diseases. However, in Spain, there is no unanimous agreement on circulating lipid concentrations that can be considered as "baseline" or "recommended" and, therefore, used to define dyslipidemia when they are altered. In addition, the recommendations in international literature are based on population studies that are not universally applicable. For this reason, the reference or recommended values that accompany analytical laboratory reports may vary between different clinical laboratories. This variability can create confusion among clinicians who receive laboratory results and may be a barrier to the correct treatment of lipid abnormalities (or dyslipidemias) and reduction of ischemic cardiovascular disease. Recently, the European Society of Arteriosclerosis (EAS) and Cardiology (ESC) have developed a recommendation for the control of dyslipidemia, which includes several novel aspects. One of them is the nonneed for fasting to obtain the lipid profile, which requires the varying of concentrations of triglycerides that are considered desirable. Faced with this situation, a group of professionals has developed the consensus document 'Homogenization of lipid profile values', under the auspices of the five scientific societies of which they are part: Spanish Society of Arteriosclerosis, Spanish Society of Primary Care Physicians, Spanish Society of Cardiology, Spanish Society of Family and Community Medicine, and Spanish Society of Laboratory Medicine. "The objective of creating this consensus is to recommend to all laboratories the adoption of homogeneous values, considered as recommended, for the variables that make up the lipid profile," says Dr. Jordi Ordóñez Llanos, one of the authors of the work and member of the Spanish Society of Laboratory Medicine (SEQCML). According to this expert, this consensus not only reflects the recommendations of the EAS-ESC, but also includes epidemiological information for our country, and the details of the pre-analytical, analytical and post-analytic sources of variation that may influence lipid concentrations
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or their evaluation; it also identifies the barriers that exist to achieving control of dyslipidemia, and recommends strategies to avoid them. "In addition," he adds, "it establishes a recommendation for the lipid constituents that the lipid profile should include and, very importantly, what values of the same should be reported as altered in the analytical report provided by clinical laboratories. In addition, it establishes values for blood tests obtained both with and without fasting ". The consensus is directed particularly at clinical laboratory specialists and recommends, in particular, the adoption by the laboratories of limit values to consider the concentrations of circulating lipids as altered. "Although it is also useful for any medical professional who has responsibility in the diagnosis, treatment, and treatment monitoring of dyslipemias," concludes Dr. Ordóñez. High prevalence. Different studies estimate that in our country, 48% of men and 52% of women older than 18 years of age have total cholesterol levels above 200 mg/dL (5.2 mmol/L), while hypertriglyceridemia (triglycerides> 150 mg/dL, 1.67 mmol/L) occurs in 23% of men and 12% of women. The SEQCML: The Spanish Society of Laboratory Medicine (SEQCML) - founded in 1976 - currently comprises more than 2,000 professionals and has as its main objective to bring together all scientists interested in the Clinical Laboratory field, to promote the diffusion of scientific and technical publications, to organize meetings, courses and congresses of national and international character, and to cooperate with other Scientific Societies. Likewise, the Society wants to contribute to the study and recommendation of standardized methods, and to establish guidelines and recommendations for training in the field of Laboratory Medicine. For more information: www.seqc.es by Dr Jordi Ordóñez Llanos; Spanish Society of Laboratory Medicine (SEQCML)
News from eJIFCC eJIFCC indexing reminder We remind all laboratory professionals that the electronic Journal of IFCC (eJIFCC) is officially indexed by MEDLINE/PUBMED. Importantly all issues from 2009 onward are now also indexed, available online, searchable, downloadable, and citable from PubMed.
eJIFCC Vol 28, n°4 is now available The issue is the last under the Chairmanship of Prof. Gábor Kovács (HU). The IFCC thanks Prof. Kovacs for the many accomplishments and for having brought the eJIFCC to a higher level. Congratulations and thank you, Prof Kovács! eJIFCC Vol 28, n°4 is guest edited by Dr. Flavio F. Alcantara (BR), Chair of the IFCC Task Force on Chronic Kidney Disease (TF-CKD), and by Dr. Vanja Radišić Biljak (CR), member of the TF. The issue focuses on the laboratory diagnosis of chronic kidney diseases. The IFCC TF-CKD sheds light on several aspects of the field, from basic research to daily clinical practices, uniting many IFCC member countries working in different aspects of the laboratory in chronic kidney care.
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Artificial Intelligence and Big Data: The Next Digital Disruption by Dr. Bernard Gouget Counselor for Public Health FHF; Chair-Human Health Care Committee-COFRAC; IFCC Chair-Nominations Committee; General Secretary of the International Francophone Federation Of Clinical Biology and Laboratory Medicine (FIFBCML) he constantly increasing volume of data and the increase in calculation speeds have brought Artificial Intelligence (AI) and Big Data mining to the forefront. These two booming and promising technologies are irreversible. The truly revolutionary potential of the two technologies resides in the possibilities offered by their convergence. In healthcare, as in many other fields, technological progress has caused an exponential explosion in the volume of information collected at any time. This is a boon for health research, for which big data is an almost inexhaustible source of new knowledge that is indispensable to innovation and medical progress.
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The enormous volume of data now available raises technical challenges concerning data storage and mining capabilities. Increasingly complex computer and statistical programs and algorithms are essential. Data mining platforms with servers and supercomputers are pooled for more operationality internationally. Examples include the European immuno-monitoring platform managed by several biotechnology companies, including the Cancer Center and INSERM, that aim to assist physicians with treatment decisions in oncology and infectious diseases and allow analysis of initial patient immunological status. Mining Big Data, which combines all socio-demographic and healthcare information, has many benefits: identification of disease risk factors, diagnostic assistance, choosing treatments and monitoring their efficacy, pharmacovigilance, epidemiology, etc. Unfortunately, this information is fragmented and heterogeneous. In order to make processing and mining this complex information possible, it must be acquired in a structured manner and encoded before being integrated into databases or data warehouses. Standards, such as I2B2 (Informatics for Integrating Biology and the Bedside), origininating in Boston are being developed.,. Thanks to these standards, hospitals and health centres will be better armed to compile all the data collected (pharmacy, laboratory medicine, imaging, genomics, health economics, clinical practice, etc.) in biomedical data warehouses that can be queried by researchers via web interfaces. Many research teams work on integrated platforms, to match databases and aggregate their data with those of cohorts. If we want to set in motion the development of medical care that works as early as possible, population studies are necessary. We can hope that researchers will soon be able to access gigantic biological databases to tap them, initiate research, and create hypotheses to construct new a medical paradigm based on early screening and targeted therapies. A futurist fantasy? Finland has already embarked on this path. Big Data mining and Artificial Intelligence are two inextricably linked technologies, to the point that we talk about Big Data Intelligence since nearly every field of AI is concerned with applications in the healthcare field: from the representation of knowledge and the modeling of reasoning to robotics, and including statistical learning and the automatic processing of natural language. The expected benefits include: diagnostic assistance, in particular in difficult cases, assistance with writing medical reports, assistance with medical procedure coding, or even assistance with publishing research results by helping to write them. 5P medicine (preventative, personalized, precise, participatory, and predictive) is one of the fields to exploit the basis of “omics.” This field promises a paradigm shift and significant advances where symptoms will no longer be the main guide for diagnosis, but rather patients will be treated according to their own genome, epigenome or metabolome. Extracting information from textual medical reports for the secondary use of healthcare data and assistance with mining knowledge published in the scientific literature will be part of the possibilities offered by AI. These data offer phenomenal raw material that complement the algorithms for AI in healthcare for a better approach to databases. One of the lines for development of AI relies on acceptability, especially by clinicians, researchers and biologists, as well as patients, institutions and businesses. One of the major lines concerns the deployment of models and algorithms built to preserve privacy and confidentiality. Ethics and use must also be taken into consideration to facilitate acceptability. In addition, the clinical benefit of AI systems must be proven, and cybersecurity questions must be addressed. It is also essential to train the medical biologists right now in function of the digital world in which they will practise. The technologies have an increasingly important place alongside medical diagnosis and the clinic. Digital teaching must be integrated by medical universities using transversality of expertise. Simulation using interactive digital means must also be deployed more widely in both initial and continuing training. A reflection has to be undertaken quickly on the foreseeable evolution of the professional exercise in Lab Medicine because of the tasks that could be accomplished by intelligent systems. Machines will not routinely replace healthcare providers; rather they will provide support to them. This is indispensable for communicating results and diagnosis. AI will considerably evolve and transform professions, refocusing them on intervention and leaving diagnosis to machines. All these challenges are intimidating. They can lead to suspicion around this convergence of AI and Big Data mining. It is important to remember that technologies are only disruptive when we are poorly prepared. LabMedica International February-March/2018
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Industry News
Steady Growth Projected for Global Laboratory Centrifuge Market he global laboratory centrifuge market is expected to grow steadily at a CAGR of more than 5% during the forecast period 20172022, driven mainly by the increasing number of biotechnology and pharmaceutical research studies, growing use of molecular diagnostics in hospitals, and technological advancements. These are the latest findings of Technavio Research, (London, UK; www.technavio.com), a global technology research and advisory company: Increasing number of biotechnology and pharmaceutical research studies: The biotechnology and pharmaceutical sector is being driven by a large unmet demand for the medical needs of the people. These industries are recording consistent growth owing to the advent of new diseases and continuous drug discovery. Since innovations require better treatments and product delivery, research in these sectors acts as a backbone for these industries. Increasing use of molecular diagnostics in hospitals: There has been an increase in the treatment of diseases at the molecular level in hospitals in order to determine diseases elaborately and provide the complete profiling of diseases. Microcentrifuges and mini centrifuges are
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QIAGEN to Acquire Barcelona-Based Multiplex Diagnostics Developer IAGEN N.V. (The Netherlands; www.qiagen.com) has entered into an agreement to acquire STAT-Dx (Barcelona, Spain; www. stat-dx.com), a privately-held company which develops next generation multiplex diagnostics for one-step, fully integrated molecular analysis of common syndromes using a novel system based on real-time PCR technology and proven QIAGEN chemistries. The system, which will be branded as QIAstat-Dx, enables scalable Sample to Insight processing of up to 48 molecular targets simultaneously for diagnosing syndromes, such as serious respiratory or gastrointestinal infections, as well as for use in oncology. With cost-efficient, easy-touse assays suitable for any clinical sample type, the system can provide qualitative as well as quantitative insights into the precise cause of various syndromes in about one hour. Based on the proprietary DiagCORE technology, the system received a first CE-IVD marking in January 2018. The system utilizes cost-efficient, single-use cartridges with built-in sample processing and all reagents on board. The cartridges are loaded with QIAGEN sample and assay technologies and a lab technician only needs to load a clinical sample into a cartridge and place it in the analyzer, requiring less than one minute of hands-on time. The flexible modular system, which has bi-directional LIS (laboratory information system) interface capabilities, is designed to operate in a range of near-patient clinical settings, eliminating the delay of sending samples to a centralized laboratory. The cartridges are processed in a scalable, proprietary and fully integrated platform, which can be configured from one to eight modules, independently running cartridges with predefined assay protocols and managed via a touchscreen that offers simple step-by-step directions. QIAstat-Dx is planned to be further developed with the aim of becoming the first analyzer that combines capabilities to run the highest multiplexing molecular diagnostic assays with the ability to quantitate and also process immunoassays. The first two tests, which are extensive respiratory and gastrointestinal (GI) panels, are to be launched in Europe in the second half of 2018, in the US in 2019 following regulatory clearance, and in other markets worldwide. Additional tests are under development for infectious diseases, immune response monitoring, oncology and companion diagnostics. “We are excited about accelerating the commercialization of our technology to bring fast, cost-effective syndromic testing closer to care for patients and healthcare providers. At the closing of the transaction, we will build on the achievements of our fantastic team in developing a best-in-class system and leverage QIAGEN’s resources with extensive R&D and commercial reach around the world,” said Jordi Carrera, cofounder and Chief Executive Officer of STAT-Dx.
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used in large-sized hospitals and diagnostics centers to separate body fluids. The high throughput and easy maintenance of laboratory centrifuges have propelled their demand among hospitals. Technological advances: Laboratory centrifuges are undergoing rapid technological transformations, including changes in design and material in their interiors and rotors. Centrifuges have also witnessed changes in their structure and function. Various types of benchtop and floor standing centrifuges are available, based on their speed and functions. For instance, microcentrifuges and ultra-centrifuges provide high speed and better resolution. Over the next few years, next-generation centrifuge systems will gain traction in the laboratory centrifuge market. The emergence of Internet of Things (IoT) has led to the introduction of smart centrifuges known as next-generation centrifuge systems, which overcome the speed, space and volume limitations of conventional centrifuge systems. Nextgeneration centrifuge systems also provide indications and assistance to users, and come with automatic electric brakes, speed control mechanisms, and safety features. In 2017, the benchtop centrifuges segment held the largest share of the medical centrifuge market, as their smaller footprint and cost-effectiveness makes them an ideal solution for laboratories and diagnostics centers with space and budget constraints. The Americas is expected to be the major revenue contributor to the global laboratory centrifuge market over the forecast period. The US and Canada dominate the region’s medical centrifuge market due to the presence of several laboratories and academic institutions, and a well-established healthcare industry in these countries. Additionally, growing research activities in the Latin American countries will also fuel the growth of the laboratory centrifuge market in this region. The laboratory centrifuge market is fragmented due to the presence of several players. A majority of the market share is held by the key players who compete with each other on the basis of price, quality, and new innovations. These players are investing heavily in R&D in order to remain competitive in the medical centrifuge market.
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Events Calendar European Congress of Cytology. Jun 10-13; Madrid, Spain; Web: www. cytology2018.com 14th Annual Biomarkers & ImmunoOncology World Congress. Jun 1113; Boston, MA, USA; Web: www.biomarkerworldcongress.com ESHG 2018 – European Human Genetics Conference. Jun 16-19; Milan, Italy; Web: www.eshg.org International Congress of African Society for Blood Transfusion (AfSBT). Jun 19-22; Arusha, Tanzania; Web: www.afsbt.org FOCIS 2018 – Federation of Clinical Immunology Societies. Jun 20-23; San Francisco, CA, USA; Web: www. focisnet.org
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