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WORLD’S CLINICAL LABORATORY NEWS LEADER ISSN 1068-1760
Vol. 35 No.3 • 5/2018
DAILY CLINICAL LAB NEWS
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Novel Assay Rapidly Detects Candidemia andidemia is among the four most common bloodstream infections in hospitals in the USA, and Candida are the third most common cause of infections in intensive care units. The mortality rate among patients with candidemia is 40%.
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High-Value Practice Reduces Wasteful Blood Transfusions lthough blood transfusion is a lifesaving therapy for some patients, transfusion has been named one of the top five overused procedures in hospitals in the USA. As unnecessary transfusions only increase risk and cost without providing benefit, improving trans-
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fusion practice is an effective way of promoting high-value care. Most high-quality clinical trials supporting a restrictive transfusion strategy have been published in the past five to 10 years, so the value of a successful patient blood management program has only recently
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Image: Courtesy of The Children’s Lyme Disease Network
Blood Test Detects Multiple Tick-Borne Diseases newly-developed blood test can discriminate antibody responses to eight major tick-borne pathogens, enabling earlier detection and hence rapid and appropriate treatment. The test could replace the cumbersome two-test approach currently used to diagnose Lyme disease, the most common thick-borne disease.
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eckman Coulter (Brea, CA, USA; www.beckmancoulter.com) announced the award of CE Mark to its compact hematology analyzer designed to serve physician office laboratories with increased productivity and ease. Featuring as little as two environmentally-friendly reagents and
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Blood Test Distinguishes Between Bacterial and Viral Infections
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he difficulty in properly distinguishing between viral and bacterial infections results in one of two outcomes. Either there is an overuse of antibiotics, which results in a rise in antibiotic resistance; or antibiotics are under-prescribed, which hurts those pa-
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next-generation mass spectrometry-based solution has been launched to analyze dried blood spots from newborn babies to test for wide range of metabolic disorders. The new in-vitro diagnostic (IVD) kit is intended for the semiquantitative measurement and evaluation of amino acid, succinylacetone, free carnitine, acylcarnitine, nucleoside and lysophospholipid
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n 2013, there were approximately 2.8 million traumatic brain injuries (TBI)-related emergency department visits, hospitalizations and deaths in the USA. Of these cases, TBI contributed to the deaths of nearly 50,000 people. TBI is caused by a bump, blow or jolt to the head or a penetrating head injury that disrupts the brain’s normal functioning. Its severity may range from mild to Cont’d on page 6
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Compact Hematology Analyzer Serves Small-Volume Labs
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Mass Spectrometry Test For Newborn Disorders
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Image: Color enhanced scanning electron micrograph (SEM) showing Borrelia burghdorferi (Lyme disease)
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Brain Trauma Test Reduces CT Scans
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tients who have a legitimate need. A novel assay that integrates measurements of blood-borne host-proteins including tumor necrosis factor-related apoptosisinducing ligand (TRAIL), interferon γ-induced protein-10 (IP-10), and C-reactive protein (CRP) has Cont’d on page 4
Clinical News . . . . 2-28 IFCC News . . . . . . . . 29 Product News . . . 6-28 Industry News . . . . .33 Events Calendar . . . 34 PUBLISHED IN COOPERATION WITH
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High-Value Practice Reduces Wasteful Blood Transfusions cont’d from cover
been recognized. Experts at the Johns Hopkins Medical Institutions (Baltimore, MD, USA; www.hopkinsmedicine.org) and their colleagues analyzed data from randomized clinical trials comparing blood transfusion approaches and endorse recommendations for blood transfusions that reduce blood use to improve patient safety and outcomes. The clinical trials that were examined compared so-called liberal versus restrictive blood transfusions. Liberal transfusions are those given to patients with hemoglobin values of 9 to 10 g/dL, of blood volume, while restrictive transfusions are those given to patients with 7 to 8 g/dL. Many of the clinical trials examined by this team used the number of patients who died within a 30- to 90-day window post-transfusion as a measure of patient outcome. Of the more than 8,000 patients included in eight clinical trials that were reviewed, there was no difference in mortality between liberal or restrictive transfusions. One clinical trial found an increased mortality associated with liberal transfusion, and occurrence of blood clots was increased in the liberal cohort in a study that involved traumatic brain in-
jury patients. The team also found that the largest randomized trials reduced the amount of blood used by 40% to 65%. Earlier this year, the results of a four-year project to implement a blood management program across the Johns Hopkins Health System, reducing blood use by 20% and saving more than USD 2 million on costs over a year. Stable adult patients, including critically ill patients, with hemoglobin levels of 7 g/dL or higher should not be transfused. Patients undergoing orthopedic or cardiac surgery, or VISIT US AT: patients with underlying heart disease with hemoglobin levels of 8 g/dL or higher should not be trans2018 ANNUAL fused. Patients who are stable and MEETING not actively bleeding should be transBooth: 4041 fused with a single unit of blood and then reassessed. Steven M. Frank, MD, professor of anesthesiology and the lead investigator, said, “In summary, there is no benefit in transfusing more blood than necessary and some clinical trials actually show harm to patients. All this does is increase risks and cost without adding benefit.” The study was published on November 20, 2017, in the journal JAMA Internal Medicine. V
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Blood Test Distinguishes Between Bacterial and Viral Infections cont’d from cover
been developed to assist in differentiation between bacterial and viral disease. A large team of scientists led by those at the Faculty of Medicine at the TechnionIsrael Institute of Technology (Haifa, Israel; www. md.technion.ac.il) performed double-blind, multicenter assay evaluation using serum remnants collected at five pediatric emergency departments and two wards from children older than three months to less than 18 years, including 68 without and 529 with suspicion of acute infection. Infectious cohort inclusion criteria were fever equal to or greater than 38°C and symptom duration equal to or less than seven days. The novel blood test, ImmunoXpert (MeMed, Tirat Carmel, Israel; www.me-med. com) accurately distinguishes between bacterial and viral infections in children. Of 529 potentially eligible patients with suspected acute infection, 100 did not fulfill infectious inclusion criteria and 68 had insufficient serum. The resulting cohort included 361 patients, with 239 viral, 68 bacterial, and 54 indeterminate reference standard diagnoses. The assay distinguished between bacterial and viral patients with 93.8% sensitivity and 89.8% specificity. The assay outperformed CRP (cutoff 40
novel blood test for the simultaneous diagnosis of multiple tick-borne diseases has been developed and shown to discriminate antibody responses to eight major tickborne pathogens present in the United States. Investigators at Columbia University (New York, NY, USA; www.columbia.edu) demonstrated the ability of the Tick-Borne Disease Serochip (TBD-Serochip) assay to detect and differentiate Anaplasma phagocytophilum, Babesia microti, Borrelia burgdorferi, Borrelia miyamotoi, Ehrlichia chaffeensis, Rickettsia rickettsii, Heartland virus and Powassan virus. Each assay contained approximately 170,000 12-mer linear peptides that tiled along the protein sequence of the major antigens from each agent with 11 amino acid overlap. This format enabled accurate identification of a wide range of specific immunodominant IgG and IgM epitopes that could then be used to enhance diagnostic accuracy and integrate differential diagnosis into a single assay. The new test should replace the cumbersome two-test approach currently used to diagnose Lyme disease, the most common TBD.
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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).
mg/L; sensitivity 88.2%. specificity 73.2% and procalcitonin testing (cutoff 0.5 ng/mL; sensitivity 63.1%, specificity 82.3%. Kfir Oved, MD, PhD, co-founder and chief technology officer at MeMed, and a co-author of the study, said, “Our solution was to try to bring a very simple solution that, within a few minutes, a few drops of blood, and with a relatively high level of accuracy we would provide this exact information to physicians and enable them to better manage their patients.” The study was published in the October 2017 issue of the journal Pediatrics. Image: The ImmunoXpert is a pioneering invitro diagnostic test that accurately distinguishes between bacterial and viral infections based on the patient’s immune response (Photo courtesy of MeMed).
Blood Test Detects Multiple Tick-Borne Diseases
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This method, which relies on subjective criteria for the interpretation of results, accurately identifies fewer than 40% of patients with early disease and results in false positives 28% of the time. To test the performance of the TBD-Serochip, the investigators examined sera from patients with confirmed Lyme disease, babesiosis, anaplasmosis, and Powassan virus disease. They identified a wide range of specific discriminatory epitopes that facilitated accurate diagnosis of each disease. In addition, they also identified previously undiagnosed infections. “Diagnosing tick-borne illness is a difficult journey for patients, delaying effecting treatment,” said senior author Dr. W. Ian Lipkin, professor of epidemiology at Columbia University. “The TBD-Serochip promises to make diagnosis far easier, offering a single, accurate test for eight different TBDs. Early detection of infection enables rapid and appropriate treatment.” The TBD-Serochip test was described in detail in the February 16, 2018, online edition of the journal Nature: Scientific Reports.
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ISSN 1068-1760 Vol.35 No.3. 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. Şti. adına İmtiyaz Sahibi: M. Geren • Yazı işleri Müdürü: Ersin Köklü Müşir Derviş İbrahim Sok. 5/4, Esentepe, 34394 Şişli, İstanbul P. K. 1, AVPIM, 34001 İstanbul • E-mail: Teknopress@yahoo.com Baskı: Postkom A.Ş. • İpkas Sanayi Sitesi 3. Etap C Blok • 34490 Başakşehir • İstanbul Yerel süreli yayındır. Yılda sekiz kere yayınlanır, ücretsiz dağıtılır.
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Mass Spectrometry Test for Newborn Disorders cont’d from cover
concentrations. The kit analyzes newborn heel prick blood samples dried on filter paper and is used with a tandem mass spectrometer. The NeoBase2 non-derivatized MSMS kit (PerkinElmer, Inc, Waltham, MA, USA; www.perkinelmer.com) can test for up to 57 analytes, including markers for screening of X-linked adrenoleukodystrophy (X-ALD), the most common peroxisomal disorder. It can also screen for adenosine deaminase severe combined immunodeficiency (ADA-SCID), which is caused by a deficiency of the enzyme ADA and is the second most common SCID. The NeoBase2 MSMS kit enables labs to use a simple three-step
Compact Hematology Analyzer Serves Small-Volume Labs cont’d from cover
a compact five-part differential system, the DxH 520 hematology analyzer enhances efficiency and resource management through a comprehensive feature set that automates daily tasks. This reduces the amount of VISIT US AT: time spent on laboratory operations and frees time for patient care. Laboratories with low-volume 2018 ANNUAL workloads are under increased presMEETING sure to deliver high-quality patient Booth: 325 care with greater operational efficiency. The DxH 520 analyzer strengthens clinical decision-making with its proprietary dynamic-gating method that improves sample flagging, and reduces slide reviews and technical interpretation, while maintaining effective clinical sensitivity. As an upgrade from a three-part to a five-part differential instrument, the DxH 520 analyzer gives the clinician more information by which to make decisions when assessing a patient. A robust IT and data-management package helps reduce clerical errors and inefficiencies, and allows for easy retrieval of up to 30,000 patient samples. The system’s small 17-microliter aspiration is ideal for puncture samples from infants, geriatric, oncology, and critical care patients. Closed tube aspiration capability both simplifies analysis and ensures safety for laboratory technologists by eliminating sample exposure. The DxH 520 complements Beckman Coulter's wide-ranging product portfolio, delivering performance and functionality to meet the needs of clinical laboratories of all sizes – from low- to ultra-high volume. The company used its time-proven flagship DxH 800 hematology solution as the predicate method for the DxH 520 system, establishing a strong correlation throughout the entire DxH line of hematology analyzers. This provides a high level of continuity of care for clinical laboratories, regardless of whether they are small- or high-volume facilities.
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assay workflow to screen for more disorders in less time from a single dried blood spot punch. PerkinElmer’s optional MSMS Workstation software, which includes database functionality, helps laboratories effectively store, manage, review and report results. The analysis time per sample for the whole acylcarnitine and amino acid profile is typically less than two minutes. The kit includes internal standards for the following acylcarnitines and amino acids: Acylcarnitines C0 (free Carnitine), C2, C3, C4, C5, C5DC, C6, C8, C10, C12, C14 C16, and C18; Amino acids Glycine, Alanine, Valine, Leucine, Methionine, Phenylalanine, Tyrosine, Ornithine, Citrulline, Arginine and Proline. Linh Hoang MD, PhD, Vice President, Neonatal Screening at PerkinElmer, said, “As the industry leader in mass spectrometry-based newborn screening, we continue to evolve our technologies to meet the needs of laboratories worldwide, especially as more countries mandate certain metabolic tests such as those for SCIDs and peroxisomal disorders. As these labs face pressure to screen for more disorders in less time and with limited resources, they are seeking advanced technology to expand their MSMS testing capabilities.”
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The DS 5 system uses the established reference method of ion exchange chromatography. It features a 15-position auto sampler and delivers HbA1c results in five minutes, making it ideal for main lab, clinic or satellite lab settings.
The i SMART 30 PRO is portable, easy to use and maintenance-free. It measures NA+, K+, Cl- concentrations using 60µL of blood sample and reports patient results in 35 seconds on a large color screen.
The Cera-Stat 2000 provides HBA1C as well as eAG results from whole blood within just seven seconds. Other features include a 3.5inch full color touch screen, built-in thermal printer, voice-guided operation and 300-test results memory.
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Novel Assay Rapidly Detects Candidemia cont’d from cover
Blood cultures fail to detect yeast in approximately 50% of Candida infections, and typically take two to three days for positive results to be apparent. A commercial blood test seems to perform as well as, if not better than, traditional blood cultures at detecting a type of fungal yeast infection that commonly strikes hospital patients. Scientists at the University of Pittsburgh Medical Center (Pittsburgh, PA, USA; www.health.pitt.edu) and their colleagues enrolled from 14 health centers 152 patients who had been diagnosed with candidemia through a blood culture. On average, it took nearly two days for the culture to identify that the patient had candidemia, and another day-and-a-half to specify which strain of Candida. Patients with Candida albicans, Candida glabrata, Candida parapsilosis, Candida tropicalis, or Candida krusei candidemia were identified at the 14 centers using diagnostic blood cultures (dBCs). Follow-up blood samples were collected concurrently for testing by T2Candida panel (T2 Biosystems, Lexington, MA, USA; www.t2biosystems.com) and companion cultures (cBCs).
T2Candida results were reported qualitatively for C. albicans/C. tropicalis, C. glabrata/C. krusei, and C. parapsilosis. T2Candida and cBCs were positive if they detected a species present in the dBC. Median time between collection of dBC and T2Candida/cBC samples in 152 patients was 55.5 hours (range, 16.4–148.4). T2Candida and cBCs were positive in 45% (69/152) and 24% (36/152) of patients, respectively. T2Candida clinical sensitivity was 89%, as positive results were obtained in 32/36 patients with positive cBCs. Prior antifungal therapy, neutropenia, and C. albicans candidemia were independently associated with T2Candida positivity. The authors concluded that T2Candida was sensitive for diagnosing candidemia at the time of positive blood cultures. In patients receiving antifungal therapy, T2Candida identified bloodstream infections that were missed by cBCs. T2Candida may improve care by shortening times to Candida detection and species identification compared to blood cultures, retaining sensitivity during antifungal therapy and rendering active candidemia unlikely if results are negative. The study was published on February 9, 2018, in the journal Clinical Infectious Diseases.
Brain Trauma Test Reduces CT Scans cont’d from cover
severe, with 75% of TBIs that occur each year being assessed as mild traumatic brain injury (mTBI) or concussions. A majority of patients with concussion symptoms have a negative computed tomography (CT) scan. The availability of a blood test for mTBI will help healthcare professionals determine the need for a CT scan in patients suspected of having mTBI and help prevent unnecessary neuroimaging and associated radiation exposure to patients. The US Food and Drug Administration (FDA, Silver Springs, MD, USA; www.fda.gov) evaluated data from a multicenter, prospective clinical study of 1,947 individual blood samples from adults with suspected mTBI/concussion and reviewed an assay by comparing mTBI/concussion blood tests results with CT scan results. The blood test known as the Brain Trauma Indicator (Banyan Biomarkers, Inc, San Diego, CA, USA; https://banyanbio.com) works by measuring levels of ubiquitin carboxy-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP) within 12 hours of head injury. Levels of these blood proteins after mTBI/concussion can help predict which patients may have intracranial lesions visible by CT scan and which will not. Being able to predict if patients have a low probability of intracranial lesions can help healthcare professionals in their management of patients and the decision to perform a CT scan. Test results can be available within three to four hours.
The Brain Trauma Indicator was able to predict the presence of intracranial lesions on a CT scan 97.5% of the time and those who did not have intracranial lesions on a CT scan 99.6% of the time. These findings indicate that the test can reliably predict the absence of intracranial lesions and that health care professional can incorporate this tool into the standard of care for patients to rule out the need for a CT scan in at least one-third of patients who are suspected of having mTBI. Scott Gottlieb, MD, the Commissioner of the FDA, said, “A bloodtesting option for the evaluation of mTBI/concussion not only provides healthcare professionals with a new tool, but also sets the stage for a more modernized standard of care for testing of suspected cases. In addition, availability of a blood test for mTBI/concussion will likely reduce the CT scans performed on patients with concussion each year, potentially saving our healthcare system the cost of often unnecessary neuroimaging tests.” V
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Pre-Op Test Can Detect Some Pancreatic Cancers newly developed genetic test was highly sensitive at determining which pancreatic cysts are most likely to be associated with one of the most aggressive types of pancreatic cancer. The successful results are a critical step toward a precision medicine approach to detecting and treating pancreatic cancer. Pancreatic cysts – small pockets of fluid in the pancreas – are increasingly detected on medical scans by happenstance. For the most part, the cysts are benign. But because some can progress to pancreatic cancer, doctors must determine whether it is surgically necessary to remove the cysts. The team developed PancreaSeq (http://mgp.upmc.com), which requires a small amount of fluid removed from the cyst to test for 10 different tumor genes associated with pancreatic cancer. It was a first-inthe-field prospective study testing pancreatic cysts before surgery rather than analyzing cysts after surgery as had been done by previous efforts. The study also was the first to evaluate a test that employed the more sensitive next-generation sequencing (NGS) and first to be performed in a certified and accredited clinical laboratory as opposed to a research setting. “This was important to us,” said Dr. Singhi, “If PancreaSeq is going to be used to make clinical decisions, then it needed to be evaluated in a clinical setting in real-time, with all the pressures that go with a clinical diagnosis.” In this analysis phase, the test was not intended to be used as the sole factor in determining whether to remove the cyst or not, so doctors relied on current guidelines when deciding on a course of treatment. A total of 595 patients were tested, and the team followed up with analysis of surgically removed cysts, available for 102 of the patients, to evaluate the accuracy of the test. The study showed that with 100% accuracy PancreaSeq correctly classified every patient in the evaluation group who had intraductal papillary mucinous neoplasm (IPMN) – a common precursor to pancreatic cancer – based on the presence of mutations in 2 genes, KRAS and GNAS. Furthermore, by analyzing mutations in 3 additional genes, the test also identified the cysts that would eventually progress to being cancerous lesions, also with 100% accuracy. The test was less accurate for the less prevalent pancreatic cyst type mucinous cystic neoplasm (MCN) – catching only 30% of the cases. Importantly, PancreaSeq did not any false positives in either cyst type, making it also a highly specific test. The results could be biased by VISIT US AT: choice of which patients had their cysts surgically removed, so the re2018 searchers plan to monitor those who ANNUAL MEETING did not have their cysts removed to Booth: 325 continue evaluation of the test’s reliability. An improved version of PancreaSeq that incorporates additional tumor genes associated with pancreatic cancer currently is undergoing rig-
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orous clinical testing. In the future, clinical guidelines will need to be revisited to explore incorporating tests like PancreaSeq. The PancreaSeq test currently is available to patients and ordered through UPMC. The study, by Singhi AD et al, was published September 28, 2017, in the journal Gut. Image: A new genetic test was highly sensitive at determining which pancreatic cysts are most likely to be associated with one of the most aggressive types of pancreatic cancer (Photo courtesy of Shutterstock).
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The Laura M urine analyzer features an evaluation time of 60 seconds and a capacity of 600 strips per hour. It also offers a memory capacity to save the last 2,000 measurements, making it ideal for use in clinical labs.
The Activin A enzyme-linked CLIA kit provides materials for the quantitative measurement of Activin A in human serum and other biological fluids. It has an assay time of 3.5 hours and a shelf life of 24 months.
The ALT/AST is a qualitative immunochromatographic rapid test for the detection of Alanine Transaminase (ALT) and Aspartate Transaminase (AST). It requires 80IU/L of serum, plasma or whole blood sample.
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Assay Identifies Patients Benefiting From Cancer Immunotherapies rogrammed cell death ligand 1 (PD-L1) has been detected in up to 50% of all human cancers, and has become a major focus of therapeutic and biomarker studies. Patients with cancers expressing the PD-L1 protein are more likely to respond to certain immuno-oncology therapeutics, and several PD-L1-related immuno-oncology therapies have received official approval. A test that delivered PD-L1 results from plasma read out as continuous variables may be of increased utility in the selection of therapeutic options. A team of scientists collaborating with those at Pinehurst Medical Clinic-East (Pinehurst, NC, USA; www.pinehurstmedical.com) focused this test development on mechanisms of blood-based testing for sensitive measurement of circulating RNA using droplet digital polymerase chain reaction (ddPCR). Specifically, they optimized methods for the detection of PD-L1 transcripts recovered from platelet-enriched plasma. Specimens for feasibility and development included tumor derived cell
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lines, activated and resting immune cells, 38 normal donor plasma and 79 non-small-cell lung carcinoma (NSCLC) donor plasma. They collected a total of 43 tissue and blood samples to assess the potential for concordance with tissue testing, The team used an assay developed by Biodesix, Inc (Boulder, CO, USA; www.biodesix.com) with the ddPCR (Bio-Rad, Inc, Hercules, CA, USA; www.bio-rad.com) and found that of the 79 NSCLC donor specimens initially evaluated with the RNA blood test, they observed a frequency of 62% positive samples with highly variable levels of plasma PD-L1 (2 - 774 copies). They then evaluated a subset of a sample cohort with the PharmDX 22c3 immunohistochemistry (IHC) tissue test result (Agilent, Santa Clara, CA, USA; www.agilent.com). Although there was poor concordance with a 50% positive IHC cut-off, when they used a variable threshold based on a logistic regression score for the blood assay and the 1% cut-off, concordance of up to 80% was observed between the two assays.
The authors concluded that they have developed sensitive and specific methods that measure the dynamic range of PD-L1 in circulation. This assay is capable of measuring PDL1 in circulation that arises from activated immune cells and/or tumor cells. The study was presented on October 28, 2017, at the AACRNCI-EORTC conference held in Philadelphia, PA, USA. Image: An immunohistochemistry of PharmDX 22c3 staining of non-small-cell lung carcinoma (Photo courtesy of Agilent).
Droplet Digital PCR Detects Schistosomiasis DNA in Samples chistosoma japonicum is the only human blood fluke that occurs in China and Philippines and also in Sri Lanka. It is the cause of schistosomiasis japonica, a disease that still remains a significant health problem especially in lake and marshland regions. Microscopic identification of eggs in stool or urine is the most practical method for diagnosis. Stool examination should be performed when infection with S. mansoni or S. japonicum is suspected, and urine examination should be performed if S. haematobium is suspected. An international team of scientists led by those at the QIMR Berghofer Medical Research Institute (Brisbane, Australia; www. qimrberghofer.edu.au) have used a previously reported a novel droplet digital-polymerase chain reaction (ddPCR) assay targeting the mitochondrial NADH dehydrogenase subunit I gene (nad1) to diagnose schistosomiasis japonica. The tool identified both pre-patent and patent infections using S. japonicum DNA isolated from serum, urine, salivary glands and feces in a murine model. The assay was validated here using clinical
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samples collected from 412 subjects resident in an area moderately endemic for schistosomiasis in the Philippines. The team reported that S. japonicum DNA present in human stool, serum, urine and saliva was detected quantitatively with high sensitivity. The capability to diagnose cases of human schistosomiasis using noninvasively collected clinical samples, the higher level of sensitivity obtained compared with the microscopy-based Kato-Katz test, and the capacity to quantify infection intensity, have important public health implications for schistosomiasis control and programs targeting other neglected tropical diseases. The authors concluded that the verified ddPCR method represents a valuable new tool for the diagnosis and surveillance of schistosomiasis, particularly in low prevalence and low intensity areas approaching elimination and in monitoring areas where disease emergence or re-emergence is a concern. The study was published on September 27, 2017, in the Journal of Infectious Diseases. LabMedica International May/2018
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The ARCHITECT i4000SR offers a max throughput of up to 400 tests per hour and features a load-up capacity of 285 samples with 35 priority and 250 routine areas. It provides enhanced productivity for labs with high-volume demands.
The NG-Test Reader can detect Ab and Ag on a single test without cross reactions. It offers the possibility to print up to 10 reagents on a single test strip and provides a wide detection range without dilution.
The VIRAPID TULAREMIA is an immunochromatographic test for the qualitative detection of total antibodies against Francisella tularensis in serum/plasma samples. It provides a visual reading in 15 minutes and all reagents are included.
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Blood Test Monitors Nerve Protein in MS Patients ultiple sclerosis is a chronic inflammatory disease of the central nervous system (CNS) in which neuronal damage is present at an early stage. Due to both unpredictable and heterogeneous disease course and treatment response, biomarkers reflecting these processes are highly sought after. A blood test to monitor a nerve protein in the blood of people with multiple sclerosis (MS) may help predict whether disease activity is flaring up. The nerve protein, called neurofilament light chain (NF-L), is a component of nerve cells and can be detected in the blood stream and spinal fluid when nerve cells die. Scientists at the University of Bergen (Bergen, Norway; www.uib.no) and their collaborators enrolled a cohort of 85 patients with relapsing-remitting MS (RRMS) were followed for two years; six months without diseasemodifying treatment and 18 months with interferon-beta 1a (IFNB-1a). Serum samples were collected at baseline and months 3, 6, 12, and 24 and magnetic resonance imaging (MRI) was performed at baseline and monthly for 9 months and then at months 12 and 24. The team analyzed the serum levels of NF-L using a single-molecule array assay and chitinase 3-like 1 (CHI3L1) by enzyme-linked immunosorbent assay (ELISA) and estimated the association with clinical and MRI disease activity using mixed-effects models. The concentration of NF-L was determined using a Simoa assay (UmanDiagnostics, Umeå, Sweden; www.umandiagnostics.com). The concentration of CHI3L1 in serum was measured using an ELISA (R&D systems, Minneapolis, MN, USA; www.rndsystems.com).
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The scientists reported that nerve protein levels in the blood were higher when MRI detected new T1 and T2 lesions, which are areas of damage in the brain due to MS. Those with new T1 lesions had 37.3 pg/mL of the nerve protein in their blood compared with 28 pg/mL for people without new T1 lesions. Those with new T2 lesions had 37.3 pg/mL of nerve protein in the blood compared with 27.7 pg/mL for those without new T2 lesions. Increased nerve protein levels were present for a three-month time period during the development of new lesions. Nerve protein levels also fell when treatment with interferon-beta 1a treatment began. The team found that an increase of 10 pg/mL in a person was associated with a 48% increased risk of developing a new T1 lesion and 62% increased risk of a new T2 lesion. Changes in CHI3L1 were not associated with clinical or MRI disease activity or interferon-beta 1a treatment. Kristin N. Varhaug, MD, the lead author of the study, said, “Since MS varies so much from person to person and is so unpredictable in how the disease will progress and how people will respond to treatment, identifying a biomarker like this that can help us make predictions would be very helpful. These blood tests could provide a low-cost alternative to MRI for monitoring disease activity.” The study was published on November 29, 2017, in the journal Neurology - Neuroimmunology Neuroinflammation. Image: The Neurofilament light (NF-L) ELISA allows fast quantification in less than three hours of NF-L in cerebrospinal fluid (Photo courtesy of UmanDiagnostics). LabMedica International May/2018
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Access Bio
Adaltis Italia
Alifax Diag
The CareStart Malaria diagnoses malaria infection from the whole blood of patients in 20 minutes. A lineup of 11 malaria RDT products is available for different combinations of Plasmodium parasites that cause malaria in humans.
The EXTRAlab workstation allows realizing a fully automated lab to perform dispensing, dilution and sample preparation. Its modular design also enables easy reconfiguration to meet the customer’s specific requirements.
The Roller 20 PN is for the determination of the ESR with external needle for pediatric samples and uncapped tubes. It delivers results in 20 seconds related to red cells aggregation with the first result available after five minutes.
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Researchers Develop Metabolomics Approach for Diagnosing Multiple Sclerosis team of British researchers has developed a metabolomics approach for diagnosing multiple sclerosis (MS) by testing blood samples. Metabolomics is the analysis of low molecular weight biological molecules that result from metabolic processes. Disease states result in changes in metabolism in cells and systems that affect the profile of metabolites. Analysis of metabolite profiles in disease conditions and comparison with the profiles of non-diseased individuals can be used in diagnosis. Investigators at the University of Huddersfield (United Kingdom; www.hud.ac.uk) sought to identify differences in the metabolomic profiles in the serum of patients with multiple sclerosis (MS), those with neuropathic pain (NP), and those with both MS and NP compared with controls and to identify potential biomarkers of each disease state. For this study, metabolomic profiling was performed using ultra-highperformance liquid chromatography coupled to mass spectrometry. Data analysis involved parametric methods, principal component analysis, and discriminating filter analysis to determine the differences between disease and control serum samples. Results of the metabolomics analysis identified sphingosine and dihydrosphingosine as significant biomarkers.
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These substances were determined to be present in significantly lower concentrations in blood samples from multiple sclerosis patients than from controls. Sphingosine and dihydrosphingosine had been previously found to be at lower concentrations in the brain tissue of patients with multiple sclerosis. The detection of these sphingolipids in blood plasma will allow the non-invasive monitoring of these and related compounds. The multiple sclerosis metabolomics study was published in the September 25, 2017, online edition of the journal Analytical Methods. Image: Researchers have developed a blood sample detection method for MS (Photo courtesy of the University of Huddersfield).
RT-PCR Evaluated for Taenia Detection aenia solium, the pork tapeworm, and the cause of neurocysticercosis (NCC), has significant socioeconomic impacts on communities in developing countries. This disease, along with taeniasis is estimated to infect 2.5 to five million people globally. Control of T. solium NCC necessitates accurate diagnosis and treatment of T. solium taeniasis carriers. In areas where all three species of Taenia tapeworms (T. solium, T. saginata and T. asiatica) occur sympatrically, conventional microscope- and copro-antigen based diagnostic methods are unable to distinguish between these three Taenia species. Scientists at the Tay Nguyen University (Dak Lak, Vietnam; www. ttn.edu.vn) aided by their international colleagues developed and validated a new triplex Taq-Man probe-based a real-time polymerase chain reaction (qPCR) for the detection and discrimination of all three Taenia human tapeworms in human stools. The diagnostic characteristics of the test are compared with conventional Kato Katz (KK) thick smear and copro-antigen enzyme-linked immunosorbent assay (cAgELISA) method utilizing fecal samples from a community based cross-sectional study.
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All fecal samples were microscopically examined for the presence of Taenia eggs using a duplicate KK thick-smear technique. An in-house coproantigen detection ELISA with slight modifications was performed on the stool samples. The qPCR amplification was carried out in a Magnetic Induction Cycler, MIC (Bio Molecular Systems, Upper Coomera, Australia; https://biomolecularsystems.com). The cycling conditions consisted of an initial denaturation step at 95 °C for two minutes, followed by 40 amplification cycles, each comprising a denaturation step at 95 °C for 30 seconds and annealing at 66 °C for 60 seconds. All samples were tested in duplicate with positive and negative control samples were included in each amplification assay. The authors concluded that that microscopic based fecal examination (KK) is neither suitable nor recommended for screening for taeniasis. Therefore, real-time PCR or cAgELISA at a higher OD cut off is recommended for screening T. solium carriers in community-based surveys in South East Asia where sympatric infection of all three human Taenia tapeworms is common. The study was published on July 7, 2017, in the journal Public Library of Science Neglected Tropical Diseases. LabMedica International May/2018
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Analyticon Biotechnologies
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The Biolyzer 100 features pre-installed methods for almost 40 reagents and is optimized for the flow cell mode. With a ready-to-use photometer, memory for 160 tests and a builtin printer, it offers a range of applications.
The PocketChem A1c features an ergonomic design that requires just 4µl blood from fingerprick or venous sample. It comes with a barcode reader to scan calibration data, patient and operator ID.
The IVT Allergy 3 Screen can detect multiple allergens simultaneously with independent results. It contains allergen-coated segments as well as positive and negative controls and Total IgE, offering an alternative to traditional skin testing.
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New Method Helps Rule Out Heart Valve Infection f a blood sample shows the presence of what is known as alphastreptococci, there is a risk that the person suffers from infective endocarditis, a heart valve infection and it is an inflammation of the inner tissues of the heart, the endocardium, usually of the valves. In order to determine whether or not this is the case, the patient must undergo echocardiography, a type of ultrasound examination of the heart, which can be technically difficult to implement and is often unpleasant. Previously, there has been a lack of supporting documentation and evidence to help healthcare professionals determine when such an examination is to be performed on patients. Clinical scientists at Lund University (Lund, Sweden; www.lunduniversity.lu.se) developed a risk assessment system, HANDOC, which distinguishes which patients with alpha-streptococci in the blood who are either at high and low risk respectively of suffering from infective endocarditis (IE). The study was based on medical records from 340 adult patients in Skåne University Hospital (Lund, Sweden; www.skane.se), whose blood samples showed the presence of alpha-streptococci. In 26 of them, infective endocarditis was confirmed. The investigators mapped the factors that distinguished these patients from those who were not diagnosed with infective endocarditis. Based on the result, an assessment system was constructed. The investigators found that several factors differed significantly between the patients with IE and those without. Amongst these variables, the presence of heart murmur or valve disease, etiology with the groups
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of Streptococcus mutans, S. bovis, S. sanguinis or S. anginosus, number of positive blood cultures equal to or greater than two, duration of symptoms of seven days or more, only one species growing in blood cultures, and community acquired infection were chosen to form the HANDOC score. With a cut-off between two and three points, HANDOC had a sensitivity of 100% and specificity of 73% in the first cohort. When tested in the validation cohort, the sensitivity was 100% and the specificity 76%. The study was published on October 10, 2017, in the journal Clinical Infectious Diseases. Image: A scanning electron photomicrograph of Streptococcus mutans; these bacteria are found in cases of infective endocarditis (Photo courtesy of Dr. David Phillips).
Esophageal Cancer in Relative Increases Barrett’s Risk arrett’s esophagus refers to an abnormal change (metaplasia) in the cells of the lower portion of the esophagus. It is characterized by the replacement of the normal stratified squamous epithelium lining of the esophagus by simple columnar epithelium with goblet cells. While it is well known that esophageal adenocarcinoma is a common complication of Barrett’s esophagus, the significance of family history of esophageal adenocarcinoma in disease progression among patients with Barrett’s esophagus is not well-known. Patients with Barrett’s esophagus who have a first-degree relative with esophageal adenocarcinoma are at 5.5-fold increased risk for progression to esophageal adenocarcinoma. Scientists at Thomas Jefferson University Hospital (Philadelphia, PA, USA; www.jefferson.edu) conducted a retrospective cohort study including 301 patients with Barrett’s esophagus undergoing radiofrequency ablation at a tertiary care center. The investigators pooled data from electronic medical records on patient age, sex, age at diagnosis of Barrett’s esoph-
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agus and esophageal adenocarcinoma, pathology and length of Barrett’s esophagus segment. They assessed information on family history in all patients, including those with and without esophageal adenocarcinoma. The team excluded from the study 19 patients with intramucosal adenocarcinoma on index endoscopy. Overall, 6.7% of patients with Barrett’s esophagus had a first-degree relative with a history of esophageal adenocarcinoma. Of these, 21.1% had disease that progressed to esophageal adenocarcinoma compared with 8.7% of patients without a first-degree relative with esophageal adenocarcinoma. After adjusting for sex and the number of radiofrequency ablation treatments, they found that family history of esophageal adenocarcinoma was a significant independent predictor for progression to adenocarcinoma (OR=5.55; 95% CI, 1.47-20). The study was presented at the World Congress of Gastroenterology at American College of Gastroenterology Annual Scientific Meeting, held October 13-18, 2017, in Orlando, FL, USA. LabMedica International May/2018
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LAMP Assay Detects Clonorchiasis in Human Samples lonorchiasis is prevalent in the Far East, and a major health problem in endemic areas. Infected persons may experience, if not treated, serious complications such as bile stone formation, pyogenic cholangitis, and even cholangiocarcinoma. The specific diagnosis of Clonorchis sinensis is important for successful treatment and control of the infection. The Kato-Katz (KK) method and/or formalin-ether concentration technique are commonly used for clonorchiasis diagnosis. However, stool examinations are not highly effective because lightly infected cases can be missed. Scientists at the Seoul National University Medical Research Center (Seoul, Korea; www.useoul.edu) and their colleagues randomly selected from the pool of stool samples of the residents of Sancheong County in Korea, where clonorchiasis is endemic, and risk factors and incidence of cholangiocarcinoma among this resident were investigated since 2006. For each stool sample, two KK smears and one real-time polymerase chain reaction (PCR) were performed. For the KK smear, 41.7 mg of feces was examined by microscopy and multiplied by 24 to convert to eggs per gram of feces (EPG). A loop-mediated isothermal amplification (LAMP) assay was applied for the detection of Clonorchis sinensis DNA. Six primers targeting eight locations on the cytochrome c oxidase subunit 1 gene of C. sinensis were designed for species-specific amplification using the LAMP assay. Amplified LAMP products were detected directly either by the naked eye or by placing the reaction tube under UV light (Gel documentation system, UVItech, Cambridge, UK; www. cleaverscientific.com). In addition, 5.0 L of the LAMP products was examined by electrophoresis on a 2% agarose gel, followed by ethidium bromide staining and visualization under UV light. The LAMP assay was sensitive enough to detect as little as 100 fg of C. sinensis genomic DNA and the detection limit in 100 mg of stool was as low as one egg. The assay was highly specific because no cross-reactivity was observed with the DNA of other helminths, protozoa or Escherichia coli. Then, the LAMP assay was applied to human fecal samples collected from an endemic area of clonorchiasis in Korea. Using samples showing consistent results by both Kato-Katz method and real-time PCR as reference standards, the LAMP assay showed 97.1% of sensitivity and 100% of specificity. In stool samples with more than 100 eggs per gram of feces, the sensitivity achieved 100%. The authors concluded that they had developed a highly sensitive and specific LAMP assay for detection of C. sinensis DNA in human fecal samples. Due to the shorter reaction time and better visual judgment of positivity without requiring sophisticated instruments, the LAMP assay can be more easily applied in field laboratories than PCR as a powerful tool for more specific and reliable diagnosis of clonorchiasis, thereby improving both treatment and control programs. The study was published on October 9, 2017, in the journal Public Library of Science Neglected Tropical Diseases.
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Image: Sensitivity of the loop-mediated isothermal amplification (LAMP) assay for the detection of Clonorchis sinensis eggs in feces experimentally spiked with a known number of eggs in ten-fold serial dilutions from 10,000 eggs (lane 1) to one egg (lane 5) (Photo courtesy of Seoul National University Medical Research Center).
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AUTOMATED RPR ANALYZER
CULTURE INSTRUMENTS
Astra Biotech
Awareness Technology
BD Diagnostic Systems
The Real-time PCR kits for IVD are used to detect gene polymorphisms associated with life-threatening diseases and individual sensitivities to specific drugs. The kits simultaneously detect several SNPs and ensure high reliability and efficacy.
The ChemWell RPR 5800 is capable of performing more than 190 tests per hour in a full walk-away platform. It allows laboratories to automate nontreponemal testing and minimize false-positive results.
The BD BACTEC FX blood culture instruments allow for proper diagnosis and treatment of bloodstream infections. They are designed to streamline workflow and minimize process steps and optimize communication of results to care givers.
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Viral Marker Predicts Flu Severity in Infected Patients nfluenza A viruses are the causative agents of annual epidemics, sporadic zoonotic outbreaks and occasionally pandemics. Worldwide, acute respiratory infections caused by influenza A viruses continue to be one of the main causes of acute illness and death. Influenza is particularly dangerous for infants, the elderly, and people with underlying medical issues, but otherwise-healthy people sometimes experience severe infection, too. Markers of severity have been found for specific strains, but a general marker that applies to multiple strains would be more useful to inform treatment and policy. A team of scientists at the Spanish National Center for Biotechnology (Madrid, Spain; www.cnb.csic.es) included in their study patients in a severe/fatal cohort who were influenza A(H1N1)pdm09 confirmed cases, aged over four and less than 65 years old, admitted to intensive care unit (ICU) and with the information related to risk factors reflected in their clinical history. Those patients who developed highly severe disease did not display any comorbidities associated to severe influenza A virus infection, and deceased patients presented some comorbid conditions. Mild patients were influenza A(H1N1)pdm09 confirmed cases, aged over four and less than 65 years old, who developed mild disease and were monitored by sentinel medical centers. The team focused on defective viral genomes (DVGs), which consist of pieces of viral RNA with missing genetic information, which are found in
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multiple strains of influenza virus. To test whether DVGs could serve as a general marker of influenza severity, they infected both mice and human tissue cell cultures with different strains of influenza A H1N1 virus, the subtype responsible for influenza pandemics. The team also analyzed the genomes of viruses isolated from respiratory samples taken from people who experienced severe infection or death during the 2009 “swine flu” pandemic or later “swine flu-like” seasons. The identity of rescued mutant viruses was ascertained by sequencing of DNAs derived from the polymerase genes PA and PB2 RNA segments by reverse transcription-PCR (RT-PCR) amplification. Quality and quantity of each RNA preparation was monitored using the Agilent 2100 Bioanalyzer (Agilent Technologies, Santa Clara, CA, USA; www.agilent.com). Flow cytometric analysis was performed on a cytometer LSR II (BD Biosciences, San Jose, CA, USA; www.bdbiosciences.com). The team found that the H1N1 strain that caused severe symptoms had significantly less DVG accumulation than influenza A strains sampled from people who experienced only mild symptoms. Together, these results suggest that low levels of DVGs may indicate greater risk of severe disease in patients infected with influenza A virus. With further studies, these findings could help predict influenza severity, guide patient treatment, and inform influenza prevention strategies. The study was published on October 12, 2017, in the journal Public Library of Sciences Pathogens.
RSV Plus Human Metapneumovirus Assay Approved iral infections are the most frequent causes of morbidity and mortality due to respiratory dysfunction worldwide, especially in children under five years of age. Several studies have reported the association of Human Metapneumovirus (hMPV) and Respiratory Syncytial Virus (RSV) with acute respiratory infection. The most common clinical symptoms are cough, fever, nasal congestion, and shortness of breath, but may progress to bronchiolitis or pneumonia. RSV and hMPV are also important viral respiratory pathogens in the elderly. In adults greater than 50-years-old, hospitalization rates for RSV and HMPV were similar to those associated with influenza. The US Food and Drug Administration (FDA, Silver Springs, MD, USA; www.fda.gov) have approves for clearance to market the Solana respiratory syncytial virus (“RSV”) + human metapneumovirus (“hMPV”) Assay (Quidel, San Diego, CA, USA; www.quidel.com) for the detection of nucleic acids isolated from nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection to aid in the diagnosis of RSV and/or hMPV infections. The Solana RSV + hMPV Assay is intended for use only with the Solana instrument.
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The Solana molecular platform leverages Quidel’s Helicase-Dependent Amplification (HDA) technology, and in the case of Solana RSV + hMPV Assay, a novel Reverse-Transcriptase HDA that is resident in Quidel’s AmpliVue molecular product line to generate a fast and accurate test result. Solana can process up to 12 patient samples in each 45-minute run, thereby providing time-saving workflow advantages to healthcare professionals in moderately complex settings, which is critical during a busy respiratory season when testing volumes are at their highest. Douglas C. Bryant, BA, president and chief executive officer of Quidel Corporation, said, “We are pleased to introduce an additional innovative, rapid testing solution that addresses the leading cause of viral respiratory infections in both the young and elderly, RSV and hMPV. This economic and focused approach to testing to detect and differentiate these infections replaces expensive syndromic panels or laboratories capable of performing high complexity testing. The Solana RSV + hMPV assay is an easy-to-use, rapid molecular diagnostic test that has superb clinical accuracy. The assay requires no upfront extraction of RNA and generates an accurate result in approximately 45 minutes.” LabMedica International May/2018
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The POCT HbA1c analyzer uses the direct enzyme measuring principle and requires a sample volume of 2.5ul of whole blood. It has a measuring range of 3.5%~16%, an assay time of 4T/10 minutes and can store 1,000 patient results.
The Isletest GAD ELISA is designed for the detection of glutamic acid decarboxylase levels in human serum. It is particularly useful in early diagnosis of IDDM or type 1 diabetes in predisposed individuals several years before its clinical onset.
The Aware Messenger is designed for the collection, stabilization and transport of oral fluid specimens. The device helps with high throughput batch processing, automation, quantitative results and lower costs.
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Glutaraldehyde Test Evaluated for Rapid Tuberculosis Diagnosis uberculosis (TB) remains one of the leading causes of morbidity and mortality worldwide and the primary method for controlling TB is the rapid and accurate identification of infected individuals. Smear examination and culture of Mycobacterium tuberculosis bacilli have remained the gold standard, but the sensitivity of the direct smear examination of sputum, however, is low, while culture is time-consuming, laborious and not always available. Immune response exploitation represents one of the main methods used for early TB diagnosis. Microbiologists at the University Hospital Farhat Hached (Sousse, Tunisia; www.chu-hached.rns.tn) determined the diagnostic value of a glutaraldehyde test (GT) in pulmonary tuberculosis (PTB) and extra-pulmonary tuberculosis (EPTB) and to assess its performance compared with light-emitting diode fluorescence microscopy (LED-FM). This study included 272 specimens, 176 suspected PTB specimens and 96 suspected EPTB specimens. Of the 272 patients, 98 patients had TB infection confirmed by culture (64 PTB cases and 34 EPTB cases), and 174 patients had no TB infection. The gold standard technique (culture) was used as reference to verify the GTâ&#x20AC;&#x2122;s performance. Sputum, extra-respiratory and blood samples for the GT were preferably collected on the same day. All specimens were subjected to smear examination, and each specimen was inoculated into LowensteinJensen (LJ) and Coletsos (Bio-Rad, Hercules, CA, USA; www. bio-rad.com ) culture media for up to eight weeks. Positive growth was
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confirmed by Ziehl-Neelsen staining, and mycobacterial isolates were identified using conventional biochemical techniques. The GT kit, ANDA-TB GA test case finding (ANDA Biological, Strasbourg, France; www.andabiologicals.com) was used and a gelification time less than 10 minutes denotes a possible TB infection. The study was published in the November 2017 issue of the journal MemĂłrias do Instituto Oswaldo Cruz. Image: A digitally colorized scanning electron microscopic (SEM) image depicts a large group of orange-colored, rod-shaped Mycobacterium tuberculosis bacteria, which cause tuberculosis (TB) in human beings (Photo courtesy of US National Institute of Allergy and Infectious Diseases).
Pre-Diagnostic Metabolite Concentrations Related to Cancer Risk rostate cancer is the second most commonly diagnosed cancer in men worldwide, but circulating insulin-like growth factor I is the only established risk factor that is potentially modifiable. The prospective association between plasma metabolite concentrations and risk of prostate cancer overall, and by time to diagnosis and tumor characteristics, and risk of death from prostate cancer has been investigated. Examination of the metabolome may help identify novel risk factors for prostate cancer. A large team of scientists collaborating with those at the Nuffield Department of Population Health (Oxford, UK; www.ndph.ox.ac.uk) recruited 153,400 men from 19 centers in eight European countries. At recruitment, detailed information was collected on dietary intake, lifestyle, anthropometry and previous disease, and 139,600 men also gave a blood sample. Histological grade was known for 83.8% of cases
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and information on tumor stage was available for 61.7% of cases. All plasma samples (citrate anticoagulant) were assayed using the AbsoluteIDQ p180 Kit (Biocrates Life Sciences AG, Innsbruck, Austria; www.biocrates.com). Pre-diagnostic plasma concentrations of 122 metabolites, including acylcarnitines, amino acids, biogenic amines, glycerophospholipids, hexose and sphingolipids, were measured using targeted mass spectrometry and compared between 1,077 prostate cancer cases and 1,077 matched controls. A triple quadrupole mass spectrometer (Triple Quad 4500; AB Sciex, Framingham, MA, USA; https://sciex.com) was used to quantify the metabolites. The concentration of total prostate-specific antigen (PSA) at baseline was measured and was available for 71.1% of men in the current study, including 764 controls, for whom 489 had a concentration below 1 ng/mL, and 768 cases. The study was published on July 5, 2017, in the journal BMC Medicine. LabMedica International May/2018
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The BreathID Gastro is intended to diagnose, monitor and manage gastric infection, gastric emptying and liver function. It can be used to assess patient response to treatment and monitor disease progression.
The AutoLumo A2000 Plus combines sophisticated technology and high performance. It has a high throughput of approximately 200 tests per hour with support for up to four modules online and offers more than 80 kinds of test items.
The DPP Zika IgM/IgG system comprises single-use POC assays with a reader for the discrete, semi-quantitative detection of IgM and IgG antibodies to Zika Virus. It uses ready-touse reagents and delivers rapid results in 15 minutes.
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Apheresis System with Secondary Devices Evaluated herapeutic plasma exchange (TPE) reduces the levels of pathological factors circulating in the patientâ&#x20AC;&#x2122;s plasma and it relieves symptoms or prevents further destruction of the involved organ or system. As an alternative to TPE, specific plasma purification methods such as lipoprotein apheresis or immunoadsorption have been developed for selective removal of the purported pathological substances from the separated plasma. Scientists at the University Hospital Jena (Germany; www. uniklinikum-jena.de) examined the last 300 data log files from November 2015 until October 2016. Of these 300 procedures, 149 secondary plasma treatments were conducted in 13 patients, 76 immunoadsorption (IA) and 73 lipoprotein apheresis (LA). Nine patients had IA due to transplantation and autoimmune diseases. Four patients were treated with LA after heart transplantation. Of the procedures, 62% were performed using peripheral venous access, even in patients with a low inlet blood flow. All patients were treated with the Spectra Optia Apheresis System (Terumo BCT, Lakewood, CO, USA; www.terumobct.com). An adsorption matrix, Immunosorba (Fresenius Medical Care Deutschland GmbH, Bad Homburg, Germany; www.freseniusmedicalcare.com), was used for IA, and the Fresenius Medical Care Monet or Evaflux (Kawasumi Laboratories, Tokyo, Japan; www.kawasumi.jp) was used for LA. The immunoadsorption (IA) columns need an additional device for sec-
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ondary plasma processing. Adasorb devices (Medicap GmbH, Ulrichstein, Germany; www.medicap.de) allow adsorption and desorption (regeneration) of the columns. In one session, the device treats up to 10,000 mL of plasma. The authors concluded that the Spectra Optia had a high plasma extraction efficiency, which allows secondary plasma device procedures with peripheral venous access and moderate inlet flow rates. One of the biggest advantages of the Optia is its high plasma removal efficiency. Ideal plasma flow rates for filter or IA columns could be reached faster. The study was published on May 24, 2017, in the International Journal of Clinical Transfusion Medicine. Image: The Spectra Optia apheresis system (Photo courtesy of Terumo BCT).
Mass Spectrometer Test Developed for Multiple Myeloma he M-proteins are established markers for plasma cell disorders including multiple myeloma and are a key analyte for diagnosis and management of that disease. Electrophoresis-based assays are commonly used to measure levels of these proteins, with higher levels indicating a higher disease burden, but such techniques are fairly time consuming and not highly sensitive. Therapeutic monoclonal antibodies for treating multiple myeloma patients create interferences that can affect the accuracy of electrophoresis-based tests. Therapeutic antibodies can register as M-protein, making expression levels of the protein appear higher than they actually are and causing clinicians to underestimate patient response rates. Scientists at Erasmus MC University Medical Center (Rotterdam, The Netherlands; www.erasmusmc.nl) and their colleagues developed a targeted mass spectrometer-based serum assay for quantifying M protein levels in multiple myeloma patients in the presence of therapeutic monoclonal antibodies. They developed the test using parallel-reaction moni-
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toring (PRM) on an Orbitrap Fusion Lumos Tribrid Mass Spectrometer (Thermo Fisher Scientific, Waltham, MA, USA; www.thermofisher.com). While PRM is not as widespread a targeted proteomic approach as triplequad selected-reaction monitoring mass spectrometry a common clinical technique, adoption of the method is growing. The team addressed the sensitivity in M-protein diagnostics and show that their mass-spectrometry assay is more than two orders of magnitude more sensitive than conventional M-protein diagnostics. The use of stable isotope-labeled peptides allows absolute quantification of the M-protein and increases the potential of assay standardization across multiple laboratories. They discuss the position of mass-spectrometry assays in monitoring minimal residual disease in multiple myeloma, which is currently dominated by molecular techniques based on plasma cell assessment that requires invasive bone marrow aspirations or biopsies was also discussed. The study was published on February 9, 2018, in the Journal of Proteome Research. LabMedica International May/2018
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Accurate HIV Self-Test Receives CE Mark esigned for ease-of-use by untrained lay users, the rapid diagnostic self-test consists of a 3rd-generation HIV test-strip in a handheld device that incorporates a sterile safety lancet and unique blood collection and delivery system. The Atomo HIV Self Test from Atomo Diagnostics (Sidney, Australia; http://atomodiagnostics.com) is the world’s only integrated self-test device, providing wider access to simple, safe, accurate results from a single drop of blood in minutes. This is a 3rd-generation, more sensitive version of its established professional-use rapid diagnostic test Atomo Rapid HIV. The test is a rapid, lateral flow in vitro qualitative immunoassay for detection of antibodies to Human Immunodeficiency Virus Type 1 and Type 2 in human whole blood. It needs only a single drop of blood, obtained from the fingertip using the built-in safety lancet. When used by untrained users in the field, the Atomo HIV Self Test demonstrated 100% concordance to laboratory results in independent studies, making it the best performing self-test approved to date. Additionally, as a 3rd-generation test, it can detect HIV antibodies earlier than established 2nd-generation competitor tests. HIV self-testing is increasingly seen as vital, including toward achieving the global health community’s goals stated in the 90-90-90 initiative of the Joint United Nations Programme on HIV/AIDS (UNAIDS). The initiative aims to, by 2020, reach a point where 90% of those living with HIV will know their status, 90% of those individuals will be on antiretroviral therapy (ART), and 90% of individuals on ART will be virologically
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suppressed. UNAIDS estimated that, as of July 2017, only 70% of people living with HIV knew their status. Atomo HIV Self Test will become available during 2018 via retail, e-commerce, and public health channels. Image: The new Atomo HIV Self Test incorporates a unique blood collection and delivery system to further simplify the test procedure and eliminate user errors common to other test kits (Photo courtesy of Atomo Diagnostics).
Potential Uses for Smartphone-Based Diagnostic Tool wo recent papers described potential applications for a smartphone-based instrument that can evaluate biological samples with the accuracy of clinical laboratory analyzers but at a fraction of the cost. Investigators at the University of Illinois College of Engineering (Urbana-Champaign, USA; http://engineering.illinois.edu) utilized a smartphone’s internal rear-facing camera as a high-resolution spectrometer for measuring the colorimetric absorption spectrum, fluorescence emission spectrum, and resonant reflection spectrum from a microfluidic cartridge inserted into the measurement light path. Under user selection, the instrument gathered light from either the white “flash” LED of the smartphone or an integrated green laser diode to direct illumination into a liquid test sample or onto a photonic crystal biosensor. Light emerging from each type of assay was gathered via optical fiber and passed through a diffraction grating placed directly over the smartphone camera to generate spectra from the assay when an image was collected. Each sensing modality was associated with a unique configuration of a microfluidic “stick” containing a linear array of liquid chambers that were swiped through the instrument while the smartphone captured video, and the software automatically selected spectra representative of each compartment. Potential uses for the smartphone analyzer were described in a paper in the August 18, 2017, online edition of the journal Analytical Chemistry, where the investigators used the device to detect four horse respiratory diseases, and in a second paper in the August 22, 2017, online edition of the journal Biomedical Microdevices, where the device was used in a point-of-care setting to detect and quantify the presence of Zika, Dengue, and Chikungunya virus in a droplet of whole blood. Contributing author Fu Sun, a research assistant at the University of Illinois College of Engineering, said, “I entered graduate school with the hope to make a better world by developing biomedical devices that can facilitate effective disease prevention, diagnosis, or treatment. This project is in line with my goal since it provides a point-of-care solution for the fast diagnosis of infectious diseases. Connected to a cloud database through a smartphone, it helps healthcare providers in the field embrace the era of big data and the Internet of Things.”
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The BD Veritor system comprises the BD Veritor system reader and test device to provide objective results. The reader eliminates the need for visual interpretation of lab results while the test device allows antigen to interact with antibodies quickly.
The Nuancer VR-II has an analysis time of 69 tests per hour and comes with a built-in 4.2inch touch panel color LCD. Other features include auto calibration for every measurement, tray cleaning reminder and storage capacity of 1,000 tests.
The SIMPLE RSV detects RSV fusion protein antigen in nasal and nasopharyngeal swab samples, as well as in samples of nasopharyngeal washes and aspirates. The one-step test is specially indicated for patients under the age of five.
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Microhole Chip Rapidly Identifies Tumor Cells he higher the concentration of tumor cells in the bloodstream, the greater the risk of metastasis. The number of circulating tumor cells indicates how well a patient is responding to therapy. A new microhole chip has been developed that enables cells to be identified and characterized reliably within minutes. The conventional method of fluorescence-activated cell sorting (FACS analysis) provides only a rough estimate of the number of tumor cells circulating in the blood. Scientists at the Fraunhofer Institute for Biomedical Engineering (IBMT, Sulzbach, Germany; www.ibmt.fraunhofer.de) recently completed a collaborative project concerning the identification of circulating tumor cells; a two-step cell analysis method was applied. In the first step, suspicious-looking cells were selected using a microscope. In the second step, the selected cells underwent detailed analysis using the more timeintensive method of Raman spectroscopy. This involves exposing the cells to light in a defined frequency range. Tumor cells scatter light in a specific way that allows them to be clearly identified. Raman spectroscopy cannot be used on conventional arrays with a glass or polymer substrate, because these materials interfere with the measurement, but this is no problem for the new IBMT chip and its silicon-nitride substrate. Another advantage of the new microhole chip is that it can be populated with 200,000 cells, each one in a separate hole, in a matter of min-
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utes. A micropipette is used to remove individual tumor cells from the chip for further analysis. The level of underpressure chosen to hold them in place is too low to cause any damage. Molecular-biology analysis is a useful means of identifying the factors that determine why a specific drug is able to kill tumor cells or has no effect. Thomas Velten, PhD, whose team developed the microhole chip, said, “Our new microhole chip allows single cells to be picked out of the blood sample, placed on separate holes in the substrate for analysis, and removed individually afterwards. It’s easy to select cells because each one has its own specific position in the array, where they are lined up like ducks in a row. Each cell is placed on a hole but cannot slip through it.” Image: The microhole chip can be populated with 200,000 single cells, each held in place in separate holes (Photo courtesy of Fraunhofer IBMT).
Saliva-Based PCR Assay Detects HIV Antibodies Earlier n oral fluid-based test for human immunodeficiency virus (HIV) shows promise as a population-based screening tool. According to its developers, the test is easier to collect than blood but yields results that are just as reliable. In comparison to blood, which poses an infection risk to healthcare workers, oral fluid is not infectious. However, the problem with human saliva is it contains very few anti-HIV antibodies, the markers of HIV infection, and current oral fluid assays do not detect HIV as quickly or efficiently as blood tests. Scientists at Stanford University (Stanford, CA, USA; www.stanford. edu) have demonstrated how a new oral fluid test, the Antibody Detection by Agglutination – PCR (ADAP) technology, was able to successfully detect HIV at the early stages. The developers of ADAP analyzed how antibodies latch on to the HIV virus to create a more sensitive oral fluid test that was 1,000 to 10,000 times more sensitive than clinical enzyme-linked immunoassays in finding HIV antibodies. ADAP uses polymerase chain reaction (PCR), a technique often used to detect DNA, to find HIV antibodies.
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The team used ADAP technology to accurately diagnose 22 individuals who participated in Alameda County Public Health Laboratory’s HIV screening program and had been diagnosed with HIV through other methods. Overall, it yielded 100% clinical sensitivity and 100% specificity for detecting these antibodies from oral fluids. The test also did not produce any false positive results in 22 additional individuals who were HIV negative. The enhanced analytical sensitivity enables this assay to correctly identify HIV-infected individuals otherwise missed by current oral fluid (OF) assays. Carolyn R. Bertozzi, PhD, a professor of chemistry and the lead investigator of the study, said, “PCR is very sensitive, it can detect very low amounts of the target DNA, whereas techniques people use to detect proteins are far less sensitive. Our test brings the sensitivity of PCR to the testing of proteins, the HIV antibodies in oral fluid, more specifically. We can reset the standards for oral fluid diagnostic sensitivity, bringing it closer to that of blood tests but with convenience of oral fluid. ” The study was published on February 6, 2018, in the journal Proceedings of the National Academy of Sciences. LabMedica International May/2018
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Bacterial Composition Linked to Breast Cancer reast cancer is the second most common cancer in women (after skin cancer) in the USA, where one in eight women will develop the disease in their lifetimes. Bacteria that live in the body is known as the microbiome, and influence many diseases. Most studies have been done on the “gut” microbiome, or bacteria in the digestive tract. Scientists have long suspected that a “microbiome” exists within breast tissue and plays a role in breast cancer, but it has not yet been characterized. Recently they have uncovered differences in the bacterial composition of breast tissue of healthy women versus women with breast cancer. Scientists at the Cleveland Clinic (Cleveland, OH, USA; www.clevelandclinic.org) examined the tissues of 78 patients who underwent mastectomy for invasive carcinoma or elective cosmetic breast surgery. In addition, they examined oral rinse and urine to determine the bacterial composition of these distant sites in the body. Breast cancer patients eligible for inclusion for this study were over 18 years of age, female, had tumors greater than or equal to 2 cm in size, and were undergoing mastectomy. The team extracted total DNA was from the breast tissue, environmental controls, urine,
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and oral rinse pellets using PowerMag Microbiome RNA/DNA Isolation Kit (MO BIO Laboratories Inc., Carlsbad, CA, USA; https://mobio.com). For breast samples, the polymerase chain reaction (PCR) product showed nonspecific bands on a 1% agarose gel. A second round of Ampure XP cleanup was performed and resulting libraries were quantified with Quantiflour dsDNA system (Promega, Madison, WI, USA; www.promega.com). Libraries were validated on a Bioanalyzer DNA 1000 chip (Agilent, Santa Clara, CA, USA; www.agilent.com) to verify size and sequenced. The scientists found that cancer patient breast tissue microbiomes clustered significantly differently from non-cancer patients, largely driven by decreased relative abundance of Methylobacterium in cancer patients (median 0.10 versus 0.24). There were no significant differences in oral rinse samples. Differences in urinary microbiomes were largely explained by menopausal status, with peri/postmenopausal women showing decreased levels of Lactobacillus. Independent of menopausal status, however, cancer patients had increased levels of gram-positive organisms including Corynebacterium, Staphylococcus, Actinomyces, and Propionibacteriaceae. Charis Eng, MD, PhD, the co-senior author
of the study, said, “To my knowledge, this is the first study to examine both breast tissue and distant sites of the body for bacterial differences in breast cancer. Our hope is to find a biomarker that would help us diagnose breast cancer quickly and easily.” The study was published on October 5, 2017, in the journal Oncotarget. Image: The Quantiflour dsDNA system for sensitive quantitation of double-stranded DNA in solution (Photo courtesy of Promega).
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High Thyroid Hormone Levels Linked to Arterial Disease therosclerosis is the process of progressive thickening and hardening of the walls of arteries from fat deposits on their inner lining. Atherosclerosis progresses insidiously from a subclinical condition to the clinical onset of vascular events to death. High and high-normal levels of a thyroid hormone called free thyroxine 4 (FT4), are associated with artery disease and death in elderly and middle-aged people. FT4 is a hormone produced by the thyroid gland that helps control the rate at which the body uses energy. Medical scientists at the Erasmus Medical Center (Rotterdam, The Netherlands; www. erasmusmc.nl) carried out a prospective population-based cohort study that investigated the determinants, occurrence and progression of chronic diseases in the middle-aged and elderly. Baseline measurements for the study were performed during the third visit of the first cohort of 4,797 and the first visit of the second of group of 3,011 and third cohort of 3,932 in the Rotterdam Study. Thyroid function was assessed at baseline in three study cohorts using the same method and assay. Measurements of thyroid-stimulating hormone (TSH), free thyroxine (FT4), and thyroid peroxidase antibodies (TPOAb) were performed in baseline serum samples stored at -80 °C using the electrochemiluminescence immunoassay ECLIA (Roche Diagnostics, Basel, Switzerland; www.roche.com). The reference ranges of serum TSH (0.40–4.0 mIU/L) and
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serum FT4 (0.86–1.94 ng/dL; equivalent to 11–25 pmol/L) were determined. The team found that after a median follow-up of 8.8 years, there were 612 atherosclerosis-related cardiovascular deaths and 934 first-time atherosclerosis-related cardiovascular events. Increasing FT4 levels were associated with twice the odds of having high levels of coronary artery calcification scores, which may be an indicator of subclinical atherosclerosis; 87% greater risk of suffering an atherosclerosis-related cardiovascular event; and double the risk of atherosclerosis-related cardiovascular death. The authors conclude that FT4 levels in middle-aged and elderly subjects were positively associated with atherosclerosis throughout the whole disease spectrum, independently of cardiovascular risk factors. Arjola Bano, MD, MSc, DSc, the lead study author, said, “We expected that thyroid function would influence the risk of developing atherosclerosis by affecting cardiovascular risk factors such as blood pressure. However, our results remained very similar after accounting for several cardiovascular risk factors. This suggests that mechanisms other than traditional cardiovascular risk factors may play a role. Our findings suggest that thyroid hormone FT4 measurement can help identify individuals at increased risk of atherosclerosis.” The study was published on October 31, 2017, in the journal Circulation Research.
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The Encompass Optimum is an automated system for in vitro diagnostic testing. Key features include direct tube sampling, highly multiplexed syndromic and workflow-enabling test panels.
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The Fast Track cycler allows up to 10 thermocyclers to be connected to one computer and permits labs to utilize a range of 1 to 480 wells. It uses magnetic induction technology to deliver results, and does not require calibration.
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Blood Sample Storage Evaluated for PEA Analysis team of Swedish researchers evaluated and optimized conditions for storing samples of dried blood for current and future proximity extension assay (PEA) analysis. Dried blood samples are attractive for sample preservation due to the ease and low cost of collection and storage. In a recent study, investigators at Uppsala University (Sweden; www.uu.se) evaluated their suitability for protein measurements. The investigators analyzed 92 proteins with relevance for oncology using multiplex proximity extension assays (PEA) in dried blood spots collected on paper and stored for up to 30 years at either plus four degrees Celsius or minus 24 degrees Celsius. According to the PEA method, a pair of oligonucleotide-labeled antibodies is allowed to pair-wise bind to the target protein present in the dried-blood sample in a homogeneous assay, with no need for washing. When the two probes are in close proximity, a new PCR target sequence is formed by a proximity-dependent DNA polymerization event. The resulting sequence is subsequently detected and quantified using standard real-time PCR. This method, which has been commercialized under the name Proseek Multiplex by Olink (Uppsala, Sweden; www.olink.com), allows detection of levels of 96 proteins (including four controls) from a disc 1.2 millimeters in diameter punched out of a dried blood spot (DBS) on filter paper. The main findings of the study were that (1) the act of drying only slightly influenced detection of blood proteins in a reproducible manner, (2) detection of some proteins was not significantly affected by storage
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over the full range of three decades (34% and 76% of the analyzed proteins at plus four degrees Celsius and minus 24 degrees Celsius, respectively), while levels of others decreased slowly during storage with halflives in the range of 10 to 50 years, and (3) detectability of proteins was less affected in dried samples stored at minus 24 degrees Celsius compared to at four degrees Celsius. The study was published in the May 13, 2017, online edition of the journal Molecular & Cellular Proteomics. Image: Drops of blood on filter paper, easy to store for future diagnostics (Photo courtesy of Jan Björkeste, Uppsala University).
Cardiac Troponin Test Uses Single Molecule Counting Technology oronary artery disease (CAD) is the leading cause of death worldwide and a significant proportion of ambulatory health care visits are for evaluation of patients with suspected CAD, with an estimated 1.5% of the population presenting with chest pain every year. Up to 1,000 times more sensitive than existing technologies, Single Molecule Counting-based diagnostics are the first ultra-sensitive tests to routinely and effectively identify minute quantities of protein biomarkers, giving clinicians greater insight, confidence, and certainty in disease detection, rule-out and patient management. Singulex (Alameda, CA, USA; www.singulex.com), a global immunodiagnostics company pioneering ultra-sensitivity in the precision measurement of protein biomarkers, announced it has applied the CE Mark to its ultra-sensitive troponin I assay (cTnl), the first offered on the Sgx Clarity system, a fully-automated, in vitro diagnostics platform powered by Single Molecule Counting technology.
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The Singulex Sgx Clarity cTnl Assay quantitatively measures the biomarker troponin at levels far lower than existing technologies. The Sgx Clarity cTnl Efficient rule-out helps avoid the costs and adverse effects of additional expensive and potential unnecessary testing, such as stress tests, and allows clinicians to focus resources on the sickest patients. The Singulex proprietary Single Molecule Counting technology has been validated in clinical studies involving more than 130,000 subjects, resulting in over 130 peer-reviewed publications. Alessandro Sionis, MD, the director of the Intensive Cardiac Care Unit, Hospital de la Santa Creu i Sant Pau (Barcelona, Spain; www.santpau.es), said, “This is a tremendously attractive concept, especially, from an urgent care perspective. The increased sensitivity and analytical precision of this troponin I assay has the potential to greatly improve the safety and efficiency of myocardial ischemia rule-out in patients especially those presenting to the Emergency Department with chest pain.” LabMedica International May/2018
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Simple Test Helps Cystic Fibrosis Patients Find Best Treatment ndividuals with cystic fibrosis (CF) suffer from abnormal secretions in multiple tissues, including the lungs, pancreas, liver, and intestine, leading to mucus stasis and obstruction. Several cutting-edge treatments have become available in recent years to correct the debilitating chronic lung congestion associated with CF. People develop CF because they do not have a functioning version of the cystic fibrosis transmembrane conductance regulator (CFTR) gene, but the condition, which involves the buildup of thick, sticky mucus in the lungs, is tied to more than 2,000 genetic mutations. A person’s specific combination of mutations affects both the severity of the disease and how well the patient responds to treatment. A collaborating team of scientists led by those at the University of North Carolina at Chapel Hill (NC, USA; www.unc.edu) collected nasal epithelial cell from nine control subjects and three CF subjects with known genotypes. Cells from curettage or brushing were processed and propagated. Nasospheroids were fixed in freshly prepared 4% paraformaldehyde in PBS for 10 minutes at room temperature, centrifuged at 25 g, embedded in Richard-Allan Scientific HistoGel (Thermo Fisher Scientific, Waltham, MA, USA; www.thermofisher.com), and embedded in paraffin. Histological sections were viewed on a phase contrast inverted microscope. Immunofluorescent labeling of CFTR was performed and confocal microscopy imaging completed on a FV1000 confocal microscope system with environmental chamber (Olympus, Center Valley, PA, USA; www. olympusamerica.com). The results VISIT US AT: suggest growing nasospheroids from nasal samples could provide a quick 2018 screening method to determine how ANNUAL MEETING a patient’s cells react to different Booth: 3200 CFTR drugs. This testing approach could offer patients a welcome alternative to rectal biopsy. It might even be more reliable from a screening INTERACTIVE standpoint because the drugs are DIGITAL EDITION able to interact directly with the right parts on the outside of the nasospheroids, rather than having to enter the spheroids as required with the rectal biopsy method. Martina Gentzsch, PhD, an assistant professor and senior study author, said, “It is a relatively simple procedure that doesn’t require any anesthesia and uses a brush that costs a few dollars. The spheroids form quickly in just a few days without much manipulation. It has many advantages, not only because patients should be able to get results really quickly, but also because our model is much more accessible to drugs for testing than the other existing models.” The study was published on November 16, 2017, in the Journal of Clinical Investigation Insight.
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Image: A confocal fluorescent microscopy of living nasospheroids developed from a cystic fibrosis patient’s nasal tissue (Photo courtesy of the University of North Carolina).
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The Instant-view Hepatitis B surface antigen serum test is designed to detect HBsAg in human serum. Its one-step test delivers results in 2-20 minutes and offers ease of use with less potential for procedural errors.
The Roller 20 LC is capable of providing results in 20 seconds by measuring red blood cells aggregation. It delivers the first result expressed in mm/h after five minutes from analysis start and does not required any reagents.
The Sofia Lyme FIA provides rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi. The test provides automated and objective results in 10 minutes, allowing testing to be performed in near-patient environments.
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Enzyme Boosts Power of Liquid Biopsies to Detect Cancers new tool has been developed for liquid biopsy that can detect RNA biomarkers from cancer cells in a patient’s blood much more accurately and completely than other existing methods. This could soon provide doctors with a more complete picture of an individual’s disease. Many current liquid biopsies can detect DNA in blood; others can detect RNA, although they tend to miss many key RNA biomarkers and misinterpret others. An ancient enzyme detects the full range of RNAs with much higher accuracy, which is helpful for understanding both the general profile of a disease such as cancer and specific information about its activity in a particular patient. Scientists at the University of Texas at Austin (TX, USA; www. austin.utexas.edu) uncovered for the first time the molecular structure of this RNA-detecting enzyme in action, offering clues about how it works and how it can be improved for use in medical tests. Both DNA and RNA bear genetic information useful for understanding a disease state such as cancer. Bacterial group II intron reverse transcriptases (RTs) function in both intron mobility and RNA splicing and are evolutionary predecessors of retrotransposon, telomerase, and retroviral RTs as well as the spliceosomal protein Prp8 in eukaryotes. The team determined a crystal structure of a full-length thermostable group II intron RT in complex with an RNA template-DNA primer duplex and incoming deoxynucleotide triphosphate (dNTP). Thermostable Group II Intron Reverse Transcriptases (TGIRTs) are ancient enzymes that date to a time when genetic information was stored mainly in RNA, but life was transitioning to DNA. Another major finding of the study was that TGIRT enzymes are remarkably similar to enzymes from RNA viruses, which copy RNA. This highlights
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the potential evolutionary role of TGIRTs and other closely related enzymes in the evolution of present-day organisms, which use DNA for genetic material. Alan M. Lambowitz, PhD. a professor of Cellular and Molecular Biology and lead investigator, said, “DNA biomarkers are static. They provide information about mutations that cause a disease, but they don’t provide information about the effect of these mutations on cellular processes, which can differ in different individuals. Monitoring cellular RNAs provides a snapshot of exactly what is happening in diseased tissue, such as a tumor, at a particular time. The method can be used to monitor day-to-day progression of the disease and response to treatment and to predict how different individuals with the same cancer will respond to different treatments.” The study was published on November 16, 2017, in the journal Molecular Cell. Image: An ancient bacterial enzyme (grey) crawls along a tangled strand of RNA (orange), creating a complimentary strand of DNA (blue). This enzyme, called GsI-IIC RT, and part of a group of enzymes known as TGIRTs, have novel properties that make it easier to detect RNA biomarkers from cancer and other disorders (Photo courtesy of the University of Texas at Austin). LabMedica International May/2018
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Typhoid Fever Victims Present Unique Metabolomic Profile panel of metabolic markers distinguishes patients with typhoid fever from others suffering from non-typhoid tropical fevers such as malaria. Typhoid fever (or just typhoid) is caused by the bacterium Salmonella Typhi (Salmonella enterica serotype Typhi). The disease is usually diagnosed by blood culture, a method that lacks sensitivity, portability, and speed. Investigators at the University of Oxford (United Kingdom; www.ox.ac. uk) had previously shown that specific metabolomic profiles could be detected in the blood of typhoid patients from Nepal. Metabolomics is the study of chemical processes involving metabolites, while the metabolome represents the collection of all metabolites in a biological cell, tissue, organ, or organism that are the end products of cellular processes. In the current study, the investigators performed mass spectrometry on plasma from Bangladeshi and Senegalese patients with culture confirmed typhoid fever, clinically suspected typhoid, and other febrile diseases including malaria. After applying supervised pattern recognition modeling, the investigators found that they could significantly distinguish metabolite profiles in plasma from the culture confirmed typhoid patients. After comparing the direction of change and degree of multivariate significance, they identified 24 metabolites that were consistently up- or down regulated in a further Bangladeshi/Senegalese validation cohort, and the Nepali cohort from their previous work. The model had excellent predictive power for distinguishing between culture-positive typhoid patients and patients with other types of tropical disease. In addition, the metabolite panel identified five of nine blood-test-negative samples that were actually typhoid positive and three of five patients who were suspected of typhoid from their symptoms. “We wanted to assess if metabolomics could accurately diagnose ty-
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phoid in patients from different regions with a wider range of tropical diseases,” said senior author Dr. Stephen Baker, professor of molecular microbiology at Oxford University’s clinical research unit, Vietnam. “We thought that this approach would more closely reflect the real situation where patients with fever-inducing diseases present with non-specific symptoms. Our results demonstrated a metabolite panel that can distinguish typhoid from other fever-inducing diseases, providing a new approach for typhoid diagnostics. The next challenges are to corroborate these metabolites in larger patient numbers and try and incorporate them into simple diagnostic test formats. This approach could be potentially expanded into other tropical diseases, eventually allowing for more accurate diagnosis and more effective treatment, and hopefully reducing the use of unnecessary antimicrobials.” The study was published in the May 9, 2017, online edition of the journal eLife. Image: Salmonella Typhi, the bacterium responsible for Typhoid fever (Photo courtesy of Animated Healthcare).
POC Test Advances Hepatitis C Diagnosis
Microscopy Innovation Developed to Diagnose Cancer
new test that enables diagnosis of hepatitis C infection in a single visit could improve access to early diagnosis, monitoring, and treatment service for some of the most vulnerable people in Australia and the world. Point-of-care hepatitis C virus (HCV) RNA testing offers an advantage over antibody testing, which only indicates previous exposure, enabling diagnosis of active infection in a single visit. The performance of a HCV Viral Load assay with venipuncture and finger-stick capillary whole-blood samples has been evaluated. Scientists at the Kirby Institute (Sydney, Australia; https://kirby.unsw. edu.au) collected plasma and finger-stick capillary whole-blood samples from participants in an observational cohort enrolled at five sites in Australia, three drug and alcohol clinics, one homelessness service, and one needle and syringe program. Of 210 participants enrolled between February 8, 2016, and July 27, 2016, 150 participants had viral load testing results for the three assays tested. The scientists compared the sensitivity and specificity of the Xpert HCV Viral Load test for HCV RNA detection (Cepheid, Sunnyvale, CA, USA; www.cepheid.com) by venipuncture and finger-stick collection with their gold standard, the Abbott RealTime HCV Viral Load assay (Abbott Laboratories, Abbott Park, IL, U.S.A www.molecular.abbott). The Xpert HCV Viral Load test is a quantitative test for rapid measurement of Hepatitis C virus Viral Load and confirmation of HCV infection delivers on-demand results in less than two hours. HCV RNA was detected in 45 (30%) of 150 participants based on the Abbott RealTime assay. Sensitivity of the Xpert HCV Viral Load assay for HCV RNA detection in plasma collected by venipuncture was 100% and specificity was 99.1%. Sensitivity of the Xpert HCV Viral Load assay for HCV RNA detection in samples collected by finger-stick was 95.5% and specificity was 98.1%. No adverse events caused by the index test or the reference standard was observed. The study was published on April 21, 2017, in the journal The Lancet Gastroenterology & Hepatology.
esearchers have developed a spectrophotometric technique for microscopic analysis of variations in single cancer cells, enabling more efficient diagnosis of melanomas, including metastasize forms. For years, melanoma researchers have studied samples that were considered uniform in size and color. But melanomas don’t always come in the same shape and hue; often, melanomas are irregular and dark, making them difficult to investigate. “Researchers often seek out the types of cancerous cells that are homogenous in nature and are easier to observe with traditional microscopic devices,” said study first author Luis Polo-Parada, associate professor at University of Missouri (Columbia, MO, USA; http://missouri.edu), “Yet, because the vast amount of research is conducted on one type of cell, it often can lead to misdiagnosis in a clinical setting.” In their new study, including researchers in Mexico as part of UM’s “Mizzou Advantage” program to foster interdisciplinary collaboration, the team devised a tool to detect and analyze single melanoma cells that are more representative of the skin cancers developed by most patients. They decided to supplement the emerging technique photoacoustic (PA) spectroscopy, a specialized optical technique used to probe tissues and cells non-invasively. Current systems use the formation of sound waves followed by the absorption of light, so the tissues must adequately absorb the laser light. This is why most researchers have focused only on consistently hued and shaped melanoma cells. The team modified a microscope that was able to merge light sources at a range conducive to observing the details of single melanoma cells. Using the modified system, they could identify irregularities in human melanoma and breast cancers as well as mouse melanoma cells, enabling them to reach a diagnosis with greater ease and efficiency. The team also noted that as the cancer cells divided, they grew paler in color yet the system was able to detect the newer, smaller cells as well. The study, by Polo-Parada L et al, was published March 13, 2017, in the journal Analyst.
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The Speed-oligo workstation carries out the entire post-amplification process on a Speedoligo cassette. It processes 16 samples in 1520 minutes and allows for the introduction of data and automatic checking for correct sample placement.
The MGC 240 has a throughput of 240 tests per hour and can handle 24 two-reagent immunoassays per run. The open, flexible system can be used for drugs of abuse screens and therapeutic drug monitoring.
The AESKULISA product line includes tests for all major autoimmune disease groups, from routine to research application. More than 140 kits are available in different configurations to provide clinicians with maximum flexibility for their needs.
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Immune Tolerance Level Predicts Leukemia Outcome easurement of messenger RNA (mRNA) encoding an enzyme that augments tumor-induced immune tolerance was shown to be predicative of the outcome for patients with leukemia. Indoleamine 2,3 dioxygenase-1 (IDO-1) is an enzyme in the kynurenine pathway that augments tumor-induced immune tolerance. Previous studies in childhood acute myeloid leukemia (AML) have shown a negative correlation of IDO-1 mRNA expression with outcomes. In other words, increased IDO expression in bone marrow biopsies correlated with lower overall survival rates and early mortality. Investigators at the Medical College of Georgia at Augusta University, USA; www.augusta.edu/mcg) set out to develop a practical and objective immunohistochemical technique to quantify IDO-1 expression on diagnostic bone marrow biopsies of AML patients in order to facilitate its use in routine clinical practice. In establishing the procedure, the investigators extracted IDO-1 mRNA from diagnostic bone marrow specimens from 29 AML patients. IDO-1 protein expression was assessed in 40 cases via immunohistochemistry and quantified by a novel “composite IDO-1 score.” Results revealed that a higher composite IDO-1 score could accurately predict poor outcomes. Further, patients who failed induction therapy (chemotherapy for AML) had higher composite IDO-1 scores. Therefore, the “composite IDO-1 score” was demonstrated to be a prognostic tool that could help identify a certain subset of AML patients with “early mortality.” This unique subset of patients could potentially benefit from specific IDO-1 inhibitor therapy, currently in clinical trials.
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“We want to help people who are not responding to treatment and are dying very soon after their diagnosis,” said senior author Dr. Ravindra Kolhe, associate professor of pathology at the Medical College of Georgia at Augusta University. “Most of the time, we do not know why patients are not responding to chemotherapy. Right now we know it is high in patients who die at six months and we show that it is an independent indicator if you adjust for other known variables.” The study was published in the October 16, 2017, online edition of the journal Scientific Reports. Image: A representation of the molecular structure of the Indoleamine 2,3 dioxygenase-1 (IDO-1) protein (Photo courtesy of Wikimedia Commons).
Second Test Helps Prevent Incorrect HIV Diagnosis he specificity of nucleic acid amplification tests (NAATs) used for early infant diagnosis (EID) of human immunodeficiency virus (HIV) infection is less than 100%, leading some HIV-uninfected infants to be incorrectly identified as HIV-infected. Without confirmatory testing, 128 of every 1000 infants initiating antiretroviral therapy (ART) were actually HIV-uninfected, due to falsepositive diagnoses; with confirmatory testing, only 1 out of 1,000 infants initiating ART was truly uninfected. A team of scientists working under the auspices of the University of Cape Town (Cape Town, South Africa; www.uct.ac.za) examined the impact of a second NAAT in infants to confirm a first positive result. They assumed a NAAT cost of USD 25, specificity of 99.6%, and sensitivity of 100%. The team used the Cost-effectiveness of Preventing AIDS Complications (CEPAC) – Pediatric model, and simulated EID testing at
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age six weeks for HIV-exposed infants without and with confirmatory testing. After diagnosis, infants were linked to and retained in care for 10 years (false-positive) or lifelong (true-positive). Both without and with confirmatory testing, life-expectantly (LE) was 26.2 years for HIV-infected infants and 61.4 years for all HIV-exposed infants; clinical outcomes for truly infected infants did not differ by strategy. Because confirmatory testing averted costly HIV care and ART in truly HIV-uninfected infants, it was cost-effective: total cost USD 1,790/infant tested, compared to USD 1,830/infant tested without confirmatory testing. Confirmatory testing remained cost-effective unless NAAT cost exceeded USD 400 or the HIV-uninfected status of infants incorrectly identified as infected was ascertained and ART stopped within three months of starting. mThe study was published on November 21, 2017, in the journal Public Library of Science Medicine. LabMedica International May/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
IFCC in Alliance to Advance Laboratory Medicine Across Africa Memorandum of Understanding Signed with AFCC and ASLM he African Federation of Clinical Chemistry (AFCC) and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) have formalized a new partnership with the African Society for Laboratory Medicine (ASLM). On 17 March 2018, Dr Ali Elbireer, Chief Executive Officer of ASLM, met with Prof Howard Morris, President of IFCC, and Prof Rajiv Erasmus, President of AFCC, at the ASLM headquarters office in Addis Ababa, Ethiopia, and subsequently signed a Memorandum of Understanding (MOU) to work together on specific collaborative projects aimed at strengthening and improving the quality of Laboratory Medicine in Africa. “The ASLM has developed and lead an excellent programme to assist clinical laboratories across Africa work towards accreditation in an innovative step-wise manner. At each step these laboratories improve the quality of their procedures to improve health outcomes for their communities. The IFCC is proud to work in collaboration with ASLM to extend this improvement in quality clinical laboratory practice” Professor Howard Morris, President of IFCC stated on the importance of this MOU. AFCC President Professor Rajiv Erasmus stated “This is a unique opportunity for the 3 organizations to come together and use their strengths to further advance the practice of Laboratory Medicine and strengthen the laboratory–clinical interface on the African continent”. He emphasized the need for collaboration between these organizations. “Over the course of its history, the IFCC has made outstanding contributions to the fields of clinical chemistry and Laboratory Medicine in Africa,” said Dr Elbireer after the meeting. “ASLM is delighted to work with IFCC and AFCC to continue advancing the field of Laboratory Medicine in Africa and worldwide.” The organizations plan to initiate specific collaborative projects within the next year. Projects will encompass support for continuing education and training programmes for medical technologists and laboratory scientists and management training for laboratory directors, as well as training and preparation of laboratories for accreditation. This will be done, in part, through support of distance learning programmes and clinical and scientific conferences in Africa, and the development and promotion of national reference laboratories. In addition, the organisations will work together to promote the value of Laboratory Medicine in Africa as a means to improve the recognition of clinical laboratories improving clinical outcomes across the continent. One major focus will be on proficiency testing. ASLM, IFCC and AFCC will further collaborate with the diagnostics industry to establish proficiency testing programmes and ensure the availability of quality Laboratory Medicine diagnostics in Africa. “A first priority will be continuing and expanding the external quality assessment programmes for clinical chemistry in Zambia, with the hope that success there provides a format to be expanded
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Photo: (From left to right) Prof Howard Morris, President of IFCC; Prof Rajiv Erasmus, President of AFCC; Dr Ali Elbireer, Chief Executive Officer of ASLM.
across other African nations,” said Prof Morris. “Over the longer term, the focus will be on ensuring the sustainability of proficiency testing and external quality assurance programmes.”
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News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information
Tunisian Society Goes All Out! by Dr Fethy Ben Hassine, STBC General Secretary; Prof Abderrazek Hedhili, IFCC-AFCB Representative; Dr Bernard Gouget, FIFBCML General Secretary he 31st Journées Nationales de Biologie Clinique (JNBC) 2017 of the Tunisian Society of Clinical Biology (Societe Tunisienne de Biologie Clinique-STBC) was the opportunity to set up the Maghrebine Federation of Clinical Biology that brings together Tunisia, Algeria and Morocco to exchange experiences and news on Lab Medicine. Almost 800 attendees with the mission of collecting science convened at the Royal Hammamet Convention centre including high ranking government officials, health and Laboratory Medicine experts, social partners and industry representatives. The congress organizers were passionate about creating an innovative and sustainable congress with lively discussions and exchange of knowledge, practices and experiences between the attendees. Symposia and technical sessions for the 303 accepted e-posters were held in rooms with special multimedia tools to enhance the interactions between presenters and participants as well as to create more dynamic collaborative talks. The main sessions focused on haemoglobinopathies, myelodysplastic syndromes, imported parasites, antibiotic alternatives, hepatitis C, diabetes management, tuberculosis. The Molecular Biology Course for Young Researchers has become a tradition, the theme of New Generation Sequencing (NGS) and Broadband Sequencing Platforms attracted a high attendance and the learning and knowledge exchange continued with IVD booths visits. The new STBC Executive Board (2018-2020) was also elected during the congress: Prof Taieb Ben Messaoud, Président; Prof Brahim Nsiri, 1st VicePresident; Prof Farouk Barguellil 2nd Vice-President; Prof Manel Chaabane, General Secretary; Prof Asma Gheriani, 1st assistant General Secretary, Prof Kalthoum Kallel, 2nd assistant General Secretary; Dr Khelil Ben Abdallah, Treasurer; Dr Leila Kallel, assistant Treasurer, Prof Amina Bibi, archivist. Professor Slama HMIDA, STBC President 2014-2017, has chosen to honour former members of the Tunisian Society of Clinical Biology Society retiring after recognition of outstanding services, contributing to the promotion of medical biology in Tunisia. This tribute is the beginning of a tradition that can be provided in the future as well, in a sustainable way as a pledge of solidarity and strengthening links between medical biologists of different generations. Three of the most valuable former mem-
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CHEMCON 2018: 9th Annual Course of Pakistan Society of Chemical Pathologists Held in Bahawalpur by Sara Reza, Assistant Prof. (Pathology), Quaid-e-Azam Medical College, Bahawalpur he 9th Annual course of Pakistan Society of Chemical Pathologists, CHEMCON 2018, was held on 23-24 February 2018, at Quaid-e-Azam Medical College, Bahawalpur, Pakistan. The conference was well attended by consultants and trainees of Chemical Pathology from all over Pakistan. The conference started with the pre-conference workshop on “Blood gas analysis” conducted by Brig (R) Aamir Ijaz. The opening ceremony had a special welcome from president PSCP, Prof. Asim Mumtaz. With a focus on patient’s health, the theme of conference was “From diagnosis to Patient’s care” and was presented by the Head of Pathology Department, Prof. Asma Shaukat in her state of the art lecture. After the inaugural session the honorable guests were entertained with a variety of recreational activities including the local Cholistani cultural
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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
Photo: (From Left to right) Dr Naoufel Nabli, Prof Farouk Barguelil, Dr Najoua Gharbi, Dr Fethy Ben Hassine, Prof Taieb Messaoud, Prof Neziha Kaabachi, Prof Slama Hmida, Prof Abdelhédi Miled, Dr Khelil Ben Abdallah, Prof Manel Chaabane.
bers of the STBC were honoured (see photo): Prof Abdelhedi Miled, one of the founders and ex STBC Vice President; Prof Neziha Kaabachi, STBC President during two terms; Dr Najoua Gharbi, ex-Treasurer and ex STBC President. A further novelty during the congress was the creation of the “Prof Abderraouf Mbaza Award”, who was the pioneer of the Tunisian Clinical Biology field and the founder of the STBC. This award is dedicated to a young researcher and is additionally endowed with 5000 DT and will be presented for the first time in 2018. A comprehensive survey of attendees conducted during the conference found that the expectations of the participants were not only met, but also exceeded. They were not merely satisfied, but also impressed and they were motivated to implement their newly acquired knowledge in their work. During the closing ceremony Prof. Slama Hmida warmly encouraged and congratulated Prof. A Hedhili, who currently sits on IFCC-EB (2018-2020) as AFCB Regional Representative. It is a tremendous honour for our country to represent the Arabic region. The STBC has a long and proud tradition of providing leading edge expertise, outstanding biomedical research, and comprehensive education in Lab medicine. Prof Slama Hmida, expressed appreciation for the warm collaboration with his EB members and is convinced that the new team will bring innovation and enhance attractiveness. The XXXII JNBC 2018 will take place at the Royal Hotel Hammamet from 10-12 May 2018 with topics such as antibiotic resistance, biosensors, fungal infections, genetics and omics, monitoring of the growth of the child, infectious diseases amongst others. show and visit to the majestic Palaces of Nawab of Bahawalpur, which is why it is often known as the “Princely State”. Shields were distributed at the Gala dinner. These activities promoted social interaction and networking among participants, making Chemcon 2018 a communal event beyond the conference venue. The conference addressed a variety of topics relevant to the main theme: diabetes mellitus, diagnosis & monitoring update, enjoy your breakfast, evaluation of short stature-the right way, role of supervisors: FCPS training, professionalism and emotional intelligence. The sessions also provided a reflection on the role of supervisory skills in this specialty. After the plenary session there was oral and poster presentations by the trainees. The sixth issue of “The Spectrum”, official newsletter of PSCP was distributed among the participants and celebrated the landmark of “The Centurion”- number of FCPS consultants exceeded one hundred. The schedule of Chemcon 2018 was quite busy, with an extensive programme. The Pakistan Society of Chemical Pathologists has always provided a good platform for discussion of new ideas and exchange of information.
IFCC Welcomes New Corporate Member: Timedico AS imedico A/S is a leading global developer of safe and reliable transportation systems for small clinical samples. Timedico is committed to the development, manufacturing and marketing of the patented invention TEMPUS600® - the internal transportation system designed for transferring small clinical samples in hospitals and related businesses. The system is fast, safe and dedicated. By enabling one-touch handling and point-to-point delivery it provides a crucial reduction of the total turn-around time and improves the treatment of the patients and the efficiency of the hospitals.
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News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information
NEWS
New IFCC Committee on Clinical Applications of Cardiac Bio-Markers (CB) Plans its Activities for 2018 By Fred Apple PhD, Chair C-CB, Hennepin County Medical Center; Prof., Laboratory Medicine and Pathology University of Minnesota School of Medicine fter one year as Chair of the Task Force (TF) on Clinical Applications of Cardiac Bio-Markers (CB), effective January 1, 2018, the TF was newly designated as the Committee on Clinical Applications of Cardiac BioMarkers (C-CB) under the supervision of the new Education and Management Division. Along with the diverse and talented committee members, consultants and corporate partners, the C-CB has been very busy. Please visit our website: www.ifcc.org/ifcc-education-division/emd-committees/ Photo: C-CB group, at meeting on April 7, 2018 in Boston. task-force-on-clinical-applications-of-cardiac-bio-markers-tf-cb/ Our primary activity has been, from the start, to develop educational materials for a) high-sensitivity, contemporary and point of care cardiac held at the Chicago AACC meeting on August 1, 2018. On behave of the C-CB, I thank the IFCC office for their ongoing suptroponin assays and b) natriuretic peptide assays used in clinical practice. We have been successful in distributing over 5000 posters and port as well as the generous financial support of our corporate partners. mouse pads based the initial TFCB educational documents. Our goals for 2018 are as follows: NE DES W Firstly, to develop publishable IGN Laboratory Medicine, interdisciplinary, expert opinion materials and papers, as well as present global workshops in collaboration with industry, clinical societies and other IFCC committees. Our recent collabWORLD’S MEDICAL PRODUCT MARKETPLACE orative ‘Special Report’ paper with the AACC Academy: Wu AHB, Christenson RH, Greene DN, Jaffe AS, Kavsak PA, Ordonez-Llanos J, Apple SIGN UP FS. Clinical Laboratory Practice RecFOR FREE! ommendations for the Use of Cardiac Troponin in Acute Coronary Syndrome: Expert Opinion from the Academy of the American AssociaVISIT US AT: tion for Clinical Chemistry and the Task Force on Clinical Applications of 2018 Cardiac Bio-Markers of the InternaANNUAL MEETING tional Federation of Clinical Chemistry and Laboratory Medicine. Clin Booth: 3200 Chem 2018; 64:, 645-655, was an excellent start to the new year. Secondly, we will continue to update and post educational tables on the IFCC website addressing cardiac troponin assay and natriuretic peptide assays based on manufacturer claims and peer-reviewed literature. Our most recent posting addresses interference tables for biotin and haemoglobin on cardiac troponin and natriuretic peptide assays. Thirdly, we have started organizing materials for developing an Connecting Buyers with ‘APP’ for cardiac troponin and natriuretic peptide assays and their Suppliers Worldwide role in clinical decision making for Reach new sources of supply both laboratorians and clinicians. Identify latest products and technologies Finally, we have designed a ‘ClinSend inquiries directly to suppliers ical Scorecard Study’ pertaining to Receive latest product alerts hs-cTn assays based on optimizing Chat live with suppliers ruling out myocardial infarction and we hope to have preliminary data completed this summer. TradeMed provides a sophisticated yet easy-to-use global B2B platform for sourcing medical Fifth, and finally, in partnership equipment. TradeMed connects buyers and sellers worldwide through a safe, secure and dywith our corporate colleagues, a namic network. Solely dedicated to medical products, TradeMed is the premier choice for medfirst, joint-industry sponsored ‘carical suppliers, hospital decisionmakers and buyers worldwide, regardless of size or budget. diac biomarkers’ workshop will be
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News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information
NEWS VIEWPOINT
The Next “Big Leap” Forward for Lab Medicine: Artificial Intelligence 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) or several months, the numbers of official reports on Artificial Intelligence (AI) strategies, such as the one by Cédric Villani (FR), have been multiplying. In a report submitted in late March to the French President, this renowned mathematician states that AI is one of the niches of excellence for state economies. The countries that will be leaders in this field will be able to capture a large part of the value of the systems that they transform, as well as control these same systems, threatening the independence of other countries. Global competition is fierce. AI requires a collective and coordinated approach, concentrated in strategic sectors such as health, environment, transport-mobility and defence-security.
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Health is one of the sectors where the stakes of AI are the highest. To what extent will a machine be able to analyze, diagnosis and continuously learn? What forms will the human-machine collaboration or partnership take? Will it replace the professional, and if so, to what extent? How are skills delegated? What is the division of labour? And what activities or medical specialities will be concerned as a priority? With increasingly greater computing power available at increasingly lower costs, massive data processing technologies becoming more mature, an increase in storage capacities and continuous development of new algorithmic methods, such as deep learning, AI has shown unprecedented acceleration for 5 years. The most measurable sign of this dynamic is the multiplication of the number of startups in the sector worldwide and the explosion of investment. In 2016, more than 1600 startups specialized in artificial intelligence were counted globally. Since 2012, investments in startups specialized in AI have been increasing, going in 5 years from 415 million dollars to 5 billion dollars. The large digital/IT companies are obviously not to be outdone and are acquiring many young companies in order to capture the latest innovations. For them, it is a question of guaranteeing control of technological advances, new uses and new, unprecedented economic models. These actors clearly understand the growth opportunities represented by AI. The artificial intelligence market for business applications is estimated at more than 36 billion dollars by 2025. But beyond the potential for economic growth that it represents, AI is a source of innovation in all of its forms. While the technological innovation of AI is no doubt the most spectacular effect, it goes hand in hand with innovation in uses, services and products, economic models, marketing and commercial models, organization models and, of course, with social innovation. Artificial intelligence is truly transformative in these various dimensions. In a world marked by inequality, artificial intelligence must not lead to increasing social and economic inequalities or to increasing phenomena of exclusion and concentration of value. On the contrary, it should reduce them. An algorithmic society cannot be a society of black boxes. The risk of reproducing existing discriminations or producing new ones is substantial. It must be possible to open these black boxes and think beforehand about the ethical issues that artificial intelligence algorithms may raise. There is therefore a necessity to see the emergence of a data ecosystem going further toward opening up data for purposes of research or public interest by the creation of research networks of excellence in AI. The impact of AI on healthcare work and occupations will cover all medical specialities, regardless of the field. It has many applications, in simple or complex tasks: from assistance with diagnosis and prescription to robotization of certain medical procedures and monitoring of connected remote patients. Both in the hospital and private practice, sharing of relevant information increases cooperation among healthcare professionals and coordination of the decision and task planning processes. The use of decision support software will help keep knowledge about best practices and clinical protocols up to date. AI is an advance for patients: providing improved and more secure diagnosis, saving time and allowing for more appropriate referrals, improved disease prevention, better epidemiological monitoring, improved and continuous and remote care, and greater patient autonomy and empowerment. Training professionals in the issues of AI is a guarantee of success. They must equip themselves against the risk of disempowerment and loss of autonomy. The entire relationship between human and machine must be changed through the design of algorithmic systems, in the sense of empowerment of humans and increase of their ability to make informed decisions. It must foster the emergence of talents to produce AI and encourage the development of skills in mathematics and IT to deploy AIbased systems. Simultaneously with this development of advanced skills, young people must be trained very early and widely to be aware of the technical, legal, economic or ethical issues posed by using artificial-intelligence based tools. At all levels, explanations should be provided to demystify it through collective reflection on the issues both in terms of research and the transformation of work. Acceptability will also be learned via the trust that the users themselves, i.e., healthcare professionals, will place in applications and tools. This confidence involves developing a framework of ethics regulations for the development of AI and robotization in healthcare. But confidence will also be increased by the proof of efficacy of AI: new tools will be adopted if they reduce the risk of error, speed up the treatment process, improve practices and are easy to use. Social acceptability will also depend on the ability of industry to understand and meet these demands. The universality of AI and its infinite variety of its forms is a revolution full of challenges and rebound effects.AI only makes sense; it is part of the human, social and environmental progress. LabMedica International May/2018
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Industry News
POC Glucose Monitoring Devices Market to Exceed USD 2 Billion in 2022 he global POC blood glucose monitoring devices market is expected to reach USD 2.03 billion in 2022, driven mainly by public and private initiatives to reduce diabetic cases. However, the high cost associated with diabetes management is one of the major factors hindering the market growth. These are the latest findings of Research and Markets, (Dublin, Ireland; www.researchandmarkets. com), a global market research company. Most POC blood glucose monitoring devices manufactured by global and local players are cost-efficient. However, the cost associated with diabetes management in high, resulting in out-of-pocket expenditure for consumables used in POC blood glucose monitoring devices. These consumables, including blood glucose test strips, reagents, and cassettes are expensive and are required on a daily basis. Moreover, an invasive device such as lancet needs to be purchased separately along with the POC blood monitoring devices, resulting in additional cost being incurred. Of late, there has been a paradigm shift to non-invasive products in the POC blood glucose monitoring devices market. Non-invasive POC blood glucose monitoring devices are hand-held units that offer a number of benefits over finger prick glucose test, such as helping to avoid finger prick and providing a convenient, easy to read large number display. Non-invasive POC blood glucose monitoring devices can also track patient compliance and allow multiple tests to be run in order to allow healthcare providers to provide adequate therapeutic decisions.
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Blood-Screening Market to Reach USD 3.9 Billion in 2024 he global blood screening market size was valued at USD 1.6 billion in 2015 and is expected to grow at a CAGR of 10.2% during the forecast period 2016-2024 to reach USD 3.9 billion by 2024, driven by increasing screening of donors and continued technological advancements by the market players. The demand for blood screening tests continues to increase due to growing donations, increasing awareness about transfusion-transmitted diseases, and technological developments in the industry. These are the latest findings of Grand View Research, Inc. (San Francisco, CA, USA; www.grandviewresearch. com), a market research and consulting company. Based on technology, nucleic acid amplification test or Nucleic Acid Test (NAT) is expected to be the fastest growing segment during the forecast period, led by its increasing preference over ELISA tests due to the high sensitivity and specificity for viral nucleic acid. Moreover, the contract in 2014 between the Red Cross in Japan and Grifols for NAT for a blood donation camp in Japan is further expected to boost the market for NAT during the forecast period. However, ELISA held the second-largest share of the blood screening market in 2015 due to the continuous development for increasing its specificity, lower cost in comparison to NAT, and rising incidence of infectious diseases in Asia Pacific. Based on products and services, reagent dominated the blood screening market in 2015 and is expected to maintain its leading position during the forecast period owing to the introduction of new assays for the detection of various diseases. Higher accuracy and specificity in detecting the presence and type of various elements in small sample, cost-effectiveness for customers and high return on investment to vendors is also expected to aid the growth of this market segment. On the other hand, the growth of the instrument segment is expected to be restrained during the forecast period by the high cost and reusable nature of instruments. The market players are adopting the strategies of new products development and partnerships & collaborations for the development and commercialization of products to increase their share. Collaborations for commercialization and development are expected to propel the growth of the blood screening market during the forecast period.
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LabMedica International May/2018
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JUNE 2018 ISBT 2018 – 35th International Society Blood Transfusion Congress. Jun 2-6; Toronto, Canada; Web: www. isbtweb.org 2018 BIO International Convention. Jun 4-7; Boston, MA, USA; Web: http://convention.bio.org European Congress of Cytology. Jun 10-13; Madrid, Spain; Web: www. cytology2018.com
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Events Calendar slas.org
OCTOBER 2018 ASHI 2018 – 44th Annual Meeting of the American Society for Histocompatibility and Immunogenetics. Oct 15; Baltimore, MD, USA; Web: www. ashi-hla.org ASCP 2018 – American Society for Clinical Pathology. Oct 3-5; Baltimore, MD, USA; Web: www.ascp.org BCLF 2018 – Meeting of Balkan Clinical Laboratory Federation. Oct 3-5; Skoplje, Macedonia; Web: www.bclf. info 5th Joint EFLM-UEMS Congress Laboratory Medicine at the Clinical Interface. Oct 10-13; Antalya, Turkey; Web: www.ifcc.org ASHG 2018 – The American Society of Human Genetics. Oct 16-20; San Diego, CA, USA; Web: www.ashg.org ANALYTICA CHINA 2018. Oct 31-Nov 2; Shanghai, China; Web: www.analytica china.com
NOVEMBER 2018 Association for Molecular Pathology (AMP) Annual Meeting. Nov 1-3; San Antonio, TX, USA; Web: www.amp.org Medica 2018. Nov 12-15; Dusseldorf, Germany; Web: www.medica.de
14th Annual Biomarkers Congress. February; Manchester, UK; Web: www. biomarkers-congress.com
MARCH 2019 PITTCON 2019. March 17-21; Philadelphia, PA, USA; Web: pittcon.org ENDO 2019 – Endocrine Society. March 23-26; New Orleans, LA, USA; Web: www.endocrine.org MEDLAB Asia Pacific. March 27-29; Singapore; Web: www.medlabasia.com
APRIL 2019 ECCMID 2019 – 29th European Congress of Clinical Microbiology and Infectious Diseases. April 13-16; Amsterdam, Netherlands; Web: www. eccmid.org
MAY 2019 ISLH 2019 – International Society of Laboratory Hematology. May 9-11; Vancouver, Canada; Web: www.islh.org
MEDLAB 2019. Feb 4-7; Dubai, UAE; Web: www.medlabme.com
AAI Immunology 2019 – American Association of Immunologists. May 9-13; San Diego, CA, USA; Web: www. aai.org
SLAS 2019 – Society of Laboratory Automation and Screening. Feb 2-6; Washington, DC, USA; Web: www.
ECE 2019 – 21st European Congress of Endocrinology. May 18-21; Lyon, France; Web: www.ese-hormones.org
FEBRUARY 2019
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Labqaulity Days 2019: International Congress on Quality in Laboratory Medicine. Feb 7-8; Helsinki, Finland; Web: www.labquality.fi
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LabMedica International May/2018
Inq.No.
Advertising Index
Vol. 35 No.3 5/ 2018
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P O R T A L
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LabMedica International
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30th European Congress of Pathology . . . . .33 AACC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29 Beckman Coulter . . . . . . . . . . . . . . . . . . . . . . .9 Biohit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23 Diagnostica Stago . . . . . . . . . . . . . . . . . . . . .15 DiaSys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 Erba . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 Erba . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7 Euroimmun . . . . . . . . . . . . . . . . . . . . . . . . . . .21 ExpoMedical 2018 . . . . . . . . . . . . . . . . . . . . .34 Instrumentation Laboratory . . . . . . . . . . . . . . .13 LabMedica.com . . . . . . . . . . . . . . . . . . . . . . .25 Medicall 2018 . . . . . . . . . . . . . . . . . . . . . . . . .35 Mindray . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 Nova Biomedicals . . . . . . . . . . . . . . . . . . . . . .17 Randox . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3 SNIBE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19 SNIBE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36 TradeMed.com . . . . . . . . . . . . . . . . . . . . . . . .31 Vicotex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32 Provided as a service to advertisers. Publisher cannot accept responsibility for any errors or omissions.
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