LabMedica International September 2019 by Globetech

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WORLD’S CLINICAL LABORATORY NEWS LEADER ISSN 1068-1760

Vol. 36 No.5 • 8-9/2019

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Biomarker Test for Chronic Fatigue Syndrome yalgic encephalomyelitis, or chronic fatigue syndrome (ME/CFS), is a serious condition that may affect up to 2.5 million people in the USA. Symptoms include extreme tiredness, difficulty sleeping, trouble with thinking and remembering things, muscle

Invasive Pulmonary Aspergillosis Diagnosed by Molecular Test nvasive aspergillosis (IA) is a common opportunistic fungal infection, mainly affecting patients with severe and prolonged neutropenia. Early diagnosis of invasive pulmonary aspergillosis (IPA) is notoriously difficult, but crucial for prompt treatment initi-

ation required to improve patient outcome. The mycological evidence used for the diagnosis of probable IPA includes traditional microbiological microscopy and culture of a respiratory specimen, along with non-culture-based serologi-

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Machine Learning Detects Cancer by Analyzing DNA In Blood Samples

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bola and Marburg viruses can cause severe bleeding and organ failure, with fatality rates reaching 90% in some outbreaks. The diseases spread through direct contact with bodily fluids of an infected person, monkey, gorilla, chimpanzee or bat. Early symptoms of Ebola and Marburg, include fever, headache and diarrhea, and mimic more common diseases, so there’s a

New Urine Test Could Prevent Cervical Cancer

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he strategy of cervical screening depends on reducing the incidence of cervical cancer through the detection and treatment of its precursor lesion, highgrade cervical intraepithelial neoplasia (CIN2+).

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nderstanding the immunological phenotype of transplant recipients on standard immunosuppression, immune-cell therapies and new drug treatments is essential for improving transplantation outcome. Immune monitoring by multicolor flow cytometry is a highly useful tool to assess the immune response in transplantation, and has the potential to shed insight

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Flow Cytometry Predicts Transplant Rejection

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Simple and Inexpensive Ebola Test Developed

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hile cell-free DNA in the blood provides a noninvasive diagnostic avenue for patients with cancer, characteristics of the origins and molecular features of cell-free DNA are poorly understood. As a remedy, researchers have now developed a machine learning approach to identify abnormal patterns of DNA fragments in the blood of patients.

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gilent Technologies Inc., a global leader in the life sciences, diagnostics and applied chemical markets, has signed a definitive agreement to acquire privately-owned BioTek Instruments which designs, manufac-

tures, and distributes innovative life science instrumentation. The acquisition of BioTek makes Agilent well positioned in the large and growing immunooncology and immunotherapy markets and expands the company’s Cont’d on page 25

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Invasive Pulmonary Aspergillosis Diagnosed by Molecular Test cont’d from cover

tests, like that of GM antigen in serum and bronchoalveolar lavage (BAL) fluid, as well as β-d-Glucan in serum. Medical scientists from Rambam Health Care Campus (Haifa, Israel; www.rambam. org.il) and their associates performed bronchoscopies using a fiber-optic bronchoscope with cardiopulmonary monitoring. The procedure was conducted under conscious sedation and local anesthesia. Laboratory analysis of the broncho-alveolar lavage (BAL) fluid included the following: cytological staining for the detection of fungal elements, Pneumocystis jirovecii (PJ) bodies and viral inclusion bodies in alveolar cells; bacterial stains and cultures including specific growth media for Mycobacterial spp., Legionella spp.; fungal cultures; viral cultures for herpes simplex virus (HSV), and cytomegalovirus (CMV); polymerase chain reaction (PCR) for the detection of Aspergillus spp., Legionella spp., Mycobacterial spp., PJ, HSV, CMV and respiratory viruses (influenza, parainfluenza, respiratory syncytial virus, adenovirus, human metapneumovirus) nucleic acid. The GM antigen in serum and BAL fluid was measured using ELISA: (Bio-Rad, Marnesla-Coquette, France; www.bio-rad.com). Total DNA was prepared from 5 mL of a BAL fluid sample using QIAamp DNA mini kit (Qiagen, Hilden. Germany; www.qiagen.com) and was PCR-amplified using a two-step (nested) PCR assay that specifically amplifies a highly conserved Aspergillus species-specific region of the 18S ribosomal RNA gene. A 232bp PCR fragment encoded by the human β-globin gene was amplified in parallel as a control for the presence of host DNA. Total DNA products were amplified in a T3 Thermocycler (Biometra, Gottingen Germany; www.biometra.de). During the 12-year study period, January

critical need for a rapid diagnostic test. Such a test could help in efforts to limit outbreaks by quickly quarantining infected persons. But existing diagnostic tests either are inaccurate or are expensive and require extensive training to administer. Scientists at the Loyola University Health System (Maywood, IL, USA; www.loyolamedicine.org) have generated a panel of mouse single-chain Fv-antibodies (scFvs) to filovirus glycoproteins (GPs) using cell-free ribosome display and determined their cross-reactivity profiles to all known filovirus species. Antibodies could be the key to diagnosing Ebola and Marburg viruses. An antibody is a Y-shaped protein made by the immune system. When a virus or other pathogen

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2005 to December 2016, 1,072 patients underwent 1,248 bronchoscopies with BAL for a suspected opportunistic lung infection. Of the study population, 630/1072 (59%) were males; median age was 55 (1–90) years. Hematological malignancy was found in 77%, of them 40% had AML and 35.6% underwent hematopoietic stem cell transplantation (HSCT). IPA was diagnosed in 531 patients (42.5%), seven-proven, 280-probable and 244-possible. PCR was positive in 266 cases, of them 213 had IPA, indicating a true positive rate of 80% (213/266) and a false positive rate of 20% (53/266). These results establish the diagnostic performance of PCR to have sensitivity of 40%, specificity of 93%, PPV- 80% and NPV-68%. Of 244 patients with possible IPA, 80 had positive PCR. Including PCR in the diagnostic criteria would move 80 cases from the possible group to the probable one. A combination of positive PCR and/or BAL-GM increases sensitivity to 74%, while positivity of both tests elevates PPV to 99.4%. The authors concluded that including PCR test for the detection of Aspergillus DNA in BAL in the mycological criteria of the EORTC/MSG definitions increases the rate and the certainty of IPA diagnosis. The study was published in the June 2019 issue of the International Journal of Infectious Diseases. Image: The PLATELIA ASPERGILLUS Ag Test (Photo courtesy of Bio-Rad Laboratories).

Simple and Inexpensive Ebola Test Developed cont’d from cover

invades the body, antibodies mark it for the immune system to destroy. The team used a technology called cell-free ribosome display, and generated two synthetic antibodies that bind to all six Ebola and Marburg viruses. The study involved the use of non-hazardous proteins that sit on the surface of Ebola and Marburg viruses. Because the actual viruses were not used in the study, there was no risk of infection to the scientists or the public. The antibodies, which are inexpensive to produce, potentially could be used in a simple filter paper test to detect Ebola virus and the related Marburg virus. If the filter paper turns color, the virus is present. The study was published on May 6, 2019, in the American Journal of Tropical Medicine & Hygiene.

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ISSN 1068-1760 Vol.36 No.5. Published, under license, by Globetech Media LLC; Copyright © 2019. 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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Machine Learning Detects Cancer by Analyzing DNA In Blood Samples esearchers have described a proof-of-principle approach for the screening, early detection, and monitoring of human cancer based on a machine learning approach that evaluates fragmentation patterns of cell-free DNA across the genome. While cell-free DNA in the blood provides a non-invasive diagnostic avenue for patients with cancer, characteristics of the origins and molecular features of cell-free DNA are poorly understood. To correct this lack, investigators at Johns Hopkins University (Baltimore, MD, USA; www.jhu.edu) developed a machine learning-based approach to identify abnormal patterns of DNA fragments in the blood of patients with cancer. They used this DELFI (DNA evaluation of fragments for early interception) method to analyze the fragmentation profiles of 236 patients with breast, colorectal, lung, ovarian, pancreatic, gastric, or bile duct cancer and 245 healthy individuals. The machine-learning model incorporated genome-wide fragmentation features with sensitivities of detection ranging from 57% to more than 99% among the seven cancer types at 98% specificity. Fragmentation profiles could be used to identify the tissue of origin of the cancers to a limited number of sites in 75% of cases. Combining this approach with mutationbased cell-free DNA analyses detected 91% of patients with cancer. “For various reasons, a cancer genome is disorganized in the way it is packaged, which means that when cancer cells die they release their DNA in a chaotic manner into the bloodstream,” said first author Dr. Jillian Phallen, a postdoctoral research fellow at Johns Hopkins University. “By examining this cell-free DNA (cfDNA), DELFI helps identify the presence of cancer by detecting abnormalities in the size and amount of DNA in different regions of the genome based on how it is packaged.” “We are encouraged about the potential of DELFI because it looks at a completely independent set of cellfree DNA characteristics from those that have posed difficulties over the years, and we look forward to working with our collaborators worldwide to make this test available to patients,” said senior author Dr. Victor E. Velculescu, professor of oncology at Johns Hopkins University. The DELFI method was described in the May 29, 2019, online edition of the journal Nature.

Image: A new liquid biopsy test called DELFI (DNA evaluation of fragments for early interception) uses artificial intelligence to detect patients with cancer by identifying altered DNA fragmentation in the blood (Photo courtesy of Carolyn Hruban, Johns Hopkins University).

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Flow Cytometry Predicts Transplant Rejection cont’d from cover

on the mechanisms responsible for successful treatment. Islet transplantation is a frontier therapy for type 1 diabetes with notable success in hypoglycemic patients, where pancreatic beta cells from a donor are transplanted into a recipient, enabling the body to produce insulin, and regulate blood sugar. Scientists from Westmead Institute for Medical Research (Sydney, Australia; www.westmeadinstitute.org.au) and their associates recruited eight healthy individuals and 13 patients with type 1 diabetes (T1D) including four islet transplant recipients enrolled in islet transplantation and whole-peripheral-blood (WPB) was collected. The team used 46 fluorochrome-conjugated anti-human antibodies for the finalized panels. All antibodies were supplied by BD Biosciences (La Jolla, CA, USA; www.bdbiosciences.com), except CD303 and CCR7 (CD197), which were obtained from other manufacturers. An additional 21 antibodies were tested for certain antigens of multiple clones and/or fluorochrome. The 43 individual antibodies were titrated using anti-coagulatedWPB of healthy-control samples under 5–6 serial dilutions of antibodies. Antibody titrations for CD137 (4-1BB) and CD154 were performed on peripheral-blood-mononuclear-cells (PBMCs) that were stimulated with T-activator CD3/CD28 beads (Thermos Fisher Scientific, Waltham, MA, USA; www.thermofisher.com) overnight at 1:10 dilution. Panel design was based on fluorochrome brightness, antigen density and co-expression, fluorochrome spillover of interested immune-cell subsets and reagent availability in each panel for the BD Biosciences’ five laser 18 parameter BD-LSR Fortessa. The operating procedures, including specimen collection, antibody cocktails, staining protocol, flow-cytometer setup and data analysis, were standardized. The staining index of 43 antibodies and the spillover spreading matrix for each panel was calculated. The final concentrations for the 46 antibodies used were determined for staining of WPB samples. Absolute cell-count and seven leukocyte profiling panels consisting of subsets and/or status of granulocytes, monocytes, dendritic, B, NK, and T cells including regulatory T cells (Tregs) and NKT were designed

and established on a five laser BD-LSRFortessa. The ability to reproducibly measure immune subsets and immune-profiles of islet transplant patients up to 18 months post transplantation has been established as a tool to measure immune cell reconstitution after transplantation. The authors concluded that they have standardized the operating procedures, instrument setup and data analysis for absolute immunecell-count and seven leukocyte multicolor panels using 12 parameters of a five-laser flow cytometer. The settings allow for clear identification of multiple leukocyte subsets even when they are present in low frequency in peripheral blood. They demonstrated the procedures utility in making longitudinal evaluations in islet transplant patients and it has the potential for monitoring transplant patients and other patients on longterm immunosuppression and for determining if any changes in leukocyte subsets are associated with outcomes. The study was published on May 22, 2019, in the journal PLOS ONE. Image: The LSRFortessa cell analyzer offers the ultimate in choice for flow cytometry, providing power, performance, and consistency (Photo courtesy of BD Biosciences).

New Urine Test Could Prevent Cervical Cancer cont’d from cover

Human papilloma virus (HPV) detection in urine has recently been considered as an alternative means to identify women at increased risk of high grade CIN. Of the 100 or so types of HPV, some are linked to cervical cancer, and some are linked to other conditions, like genital warts. Most cervical cancers are caused by high-risk types HPV-16 and HPV-18. Medical scientists collaborating with those at the University of Manchester (Manchester, UK; www.manchester.ac.uk) collected urine, vaginal and cervical samples from consecutive women attending the local colposcopy clinic between June and September 2015. Cervical samples were collected using SurePath Liquid Based Cytology (Becton Dickinson, Franklin Lakes, NJ, USA; www.bd.com) and vaginal cells were suspended in solution by agitating the Evalyn brush in SurePath preservative on receipt in the laboratory. Sample aliquots were added to Abbott and Roche secondary tubes. Batches of samples were tested for high risk HPV using the Abbott V

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RealTime (ART, Abbott Laboratories. Abbott Park, IL, USA; www. molecular.abbott) and Roche Cobas 4800 (RC, Roche Diagnostics, Pleasanton, CA, USA; https://diagnostics.roche.com) assays within 48 hours and one week of sample processing, respectively. Urine sample processing was optimized by comparing HR-HPV detection in samples refrigerated at 4 °C both without preservative (‘neat’) and following transfer to Abbott and Roche preservative tubes (’preservative-fixed’), by dividing samples in half upon receipt by the virology laboratory for the first 50 study participants. The stability of neat and preservative-fixed urine samples was compared by HR-HPV testing using both assays within 48 hours, one week and one month of receipt. The team reported that preservative-fixed, but not neat urine, showed good concordance with vaginal samples for the detection of HR-HPV. The sensitivity for detecting CIN2+ was 15/18 (83%) for urine and 16/18 (89%) for cervical and vaginal samples by ART, and 15/17 (88%) for all samples by RC. Urine-based testing was broadly acceptable to women. The authors concluded that urinary HR-HPV testing has good sensitivity for the detection of CIN2+ in a colposcopy clinic cohort. The study suggests that vaginal HR-HPV testing is slightly more sensitive than urine HR-HPV testing; however urine self-sampling may be more acceptable to cervical screening non-attenders than vaginal self-sampling. Emma J. Crosbie, MB ChB, PhD, a Consultant Gynecological Cancer Surgeon and senior author of the study, said, “These results provide exciting proof of principle that urine HPV testing can pick up cervical pre-cancer cells, but we need to trial it on a greater number of women before it can be used in the NHS. We hope that is going to happen soon. Urine is very simple to collect and most hospitals in the developed and developing world have access to the lab equipment to process and test the samples.” The study was published on April 29, 2019, in the journal BMJ Open. LabMedica International August-September/2019

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Biomarker Test for Chronic Fatigue Syndrome cont’d from cover

pain and aches, a recurring sore throat, and tender lymph nodes. Currently, physicians can only diagnose ME/CFS by examining a person’s symptoms and medical history, and by excluding other possible illnesses. This can make the diagnosis process difficult, lengthy, and inaccurate. A new diagnostic test looks at how a person’s immune cells react to stress. Scientists at the Stanford University School of Medicine (Stanford, CA, USA; www.stanford.edu) have developed a nanoelectronics assay designed as an ultrasensitive assay capable of directly measuring biomolecular interactions in real time, at low cost, and in a multiplex format. The team applied the test to the blood samples of 40 people, 20 of who had ME/CFS and 20 whom did not. The scientists used a nanoelectronic assay, which measures small changes in energy to assess the health of immune cells and blood plasma, to see how the immune cells and blood plasma process stress. To develop the test, the team took advantage of “advancements in micro/nanofabrication, direct electrical detection of cellular and molecular properties, microfluidics, and artificial intelligence techniques.” The test detects “biomolecular interactions in real time” by using thousands of electrodes to create an electrical current, and by using small chambers that contain blood samples with only immune cells and blood plasma. Inside the small chambers, the immune cells and plasma interact with the electrical current, altering its flow. The scientists used salt to stress the blood samples of some people with ME/CFS and some people without the condition. They then assessed the changes in electrical current. Their test accurately identified all of the people with ME/CFS without misidentifying any of the people who did not have the condition. The team concluded that they had observed robust impedance modulation difference of the samples in response to hyperosmotic stress can potentially provide a unique indicator of ME/CFS. Moreover, using supervised machine learning algorithms, they developed a classifier for ME/CFS patients capable of identifying new patients, required for a robust diagnostic tool. Rahim Esfandyarpour, PhD, a Bioengineer and first author of the study, said, “Using the nanoelectronics assay, we can add controlled doses of many different potentially therapeutic drugs to the patient’s blood samples and run the diagnostic test again.” The study was published on April 29, 2019, in the journal Proceedings of the National Academy of Sciences. Image: A nanoelectronics assay: stressed blood cells could be a biomarker for chronic fatigue (Photo courtesy of The Scientist).

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Immune Relationship to Lung Tumor Evolution Characterized on-small-cell lung carcinoma (NSCLC) is any type of epithelial lung cancer other than small cell lung carcinoma (SCLC). NSCLC accounts for about 85% of all lung cancers. As a class, NSCLCs are relatively insensitive to chemotherapy, compared to small cell carcinoma. The interplay between an evolving cancer and a dynamic immune microenvironment remains unclear. Scientists have started to unravel the complex relationships between immunoediting, immune cell infiltration, neoantigen formation, and clonal evolution in non-small cell lung cancer (NSCLC) tumors. A team of scientists at the University College London Cancer Institute (London, UK; www.ucl.ac.uk) used RNA sequencing, tumor infiltrating lymphocyte analyses, reduced-representation bisulfite sequencing, and other approaches to assess hundreds of samples from 88 early-stage, untreated NSCLC cases, selected from a set of lung cancers previously profiled by multi-region exome sequencing for the Tracking Non-Small Cell Lung Cancer Evolution through Therapy (TRACERx) project. Along with promoter methylation shifts for genes with new antigen-

producing mutations, or neoantigens, the team saw differences in immune cell infiltration from one tumor to the next, and within different parts of the same NSCLC tumor. Those immune infiltration differences appeared to influence tumor immunoediting and the extent to which neoantigens turned up in the tumors, highlighting the combined impact that the tumor microenvironment, tumor mutations, and altered gene regulation can have on tumor evolution. The group focused on immune cell infiltration in 258 regions from 88 NSCLCs in the exome-sequenced TRACERx 100 cohort, including 164 regions from 64 tumors that were assessed by RNA-seq. They also considered histopathology-based tumor infiltrating lymphocyte profiles for 234 regions from 83 NSCLC tumors. After looking at how well the RNA-seq-based immune estimates lined up with tumor infiltrating lymphocyte profiles generated by pathology, the team compared expression, mutation, and methylation features in the context of tumor region, immune cell infiltration levels, patient outcomes, and the histology of the NSCLC tumor involved. PRINT MAGAZINE The results indicated that more than 40% of the tumors had consistently low immune infiltration, while 28% apiece had either consistently high infiltration or immune infiltration that varied by region. In the latter tumors, they noted, variability in immune infiltration appeared to coincide with tumor mutation heterogeneity. In the NSCLC tumors with adenocarcinoma histology, the team saw declining sub-clonal diversity as CD8+ T cell infiltration increased, WEB PORTAL and vice versa, though this pattern did not hold in the lung squamous cell carcinoma cases. The authors concluded that their results provide evidence that tumor evolution is shaped through immunoediting mechanisms that affect eiNEW: ther antigen presentation or neoantiRUSSIAN genic mutations themselves, at both EDITION the DNA and RNA level arguing that the beneficial role of successful immune surveillance, and the diversity of immune-evasion mechanisms, should be considered and harnessed Website Editions: in immunotherapeutic interventions. English Spanish Russian The study was published on March 20, 2019, in the journal Nature.

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Image: A scanning electron micrograph (SEM) of lung cancer cells (Photo courtesy of Cancer Research UK). LabMedica International August-September/2019

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Genomic Alterations and Expression Profiles Diagnose Acute Erythroid Leukemia

recent paper pinpointed the genomic alterations that define the subgroups that comprise acute erythroid leukemia. Acute erythroid leukemia (AEL) is a high-risk leukemia of poorly understood genetic basis, with controversy regarding its diagnosis within the disease spectrum encompassed by myelodysplasia and myeloid leukemia. Myelodysplastic syndromes (MDS) are a group of cancers in which immature blood cells in the bone marrow do not mature and therefore do not become healthy blood cells. In contrast, leukemia is a cancer of the myeloid line of blood cells, characterized by the rapid growth of abnormal cells that build up in the bone marrow and blood and interfere with normal blood cells. To unravel the controversy regarding diagnosis of AEL, investigators at St. Jude Childrenâ&#x20AC;&#x2122;s Research Hospital (Memphis, TN, USA; www. stjude.org) compared genomic features of 159 childhood and adult AEL cases with non-AEL myeloid disorders. Their results defined five age-related subgroups with distinct transcriptional profiles: adult, Tumor protein p53 (TP53) mutated; Nucleophosmin (NPM1) mutated; Histone-lysine N-methyltransferase 2A (KMT2A) mutated/rearranged; adult, DEAD-box helicase 41 (DDX41) mutated; and pediatric, Nucleoporin 98 (NUP98) rearranged. The investigators found that genomic features influenced outcome of the disease, with NPM1 mutations and HOXB9 (Homeobox protein Hox-B9) overexpression being associated with a favorable prognosis and TP53, FLT3 (FMS related tyrosine kinase 3), or RB1 (RB transcriptional corepressor 1) alterations being associated with poor survival. The paper was published in the March 29, 2019, online edition of the journal Nature Genetics.

Image: A bone marrow smear from a case of acute erythroid leukemia showing a multinucleated erythroblast with megaloblastoid nuclear chromatin (Photo courtesy of Wikimedia Commons). LabMedica International August-September/2019 LINKXPRESS COM

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New Guidelines Suggest Reduced Screening of Urine Cultures ewly released diagnostic guidelines argue against antibiotic treatment of asymptomatic bacteriuria, which the guidelines consider to be an important opportunity for decreasing inappropriate antimicrobial use that promotes development of resistance by pathogens. Asymptomatic bacteriuria (ASB) is the presence of one or more species of bacteria growing in the urine at specified quantitative counts (more than10^5 colony-forming units [CFU]/ milliliter or more than 10^8 CFU/liter), irrespective of the presence of pyuria, in the absence of signs or symptoms attributable to urinary tract infection (UTI). ASB is a common finding in some healthy female populations and in many women or men with abnormalities of the genitourinary tract that impair voiding. In

2005, the Infectious Diseases Society of America (Arlington, VA, USA; www.idsociety.org) published a guideline with recommendations for the management of ASB in adults. This guideline recommended that ASB should be screened for and treated only in pregnant women or in an individual prior to undergoing invasive urologic procedures. Treatment was not recommended for healthy women; older women or men; or persons with diabetes, indwelling catheters, or spinal cord injury. The current guideline reviewed and updated the 2005 guideline, incorporating new evidence that had become available. The recom-

mendations also considered populations not addressed in the 2005 guidelines, such as children and patients with solid organ transplants or neutropenia. The updated guideline also addressed the clinical presentation of symptomatic UTI in populations where there was a high prevalence of ASB, such as patients with spinal cord injury or older adults (over 65 years of age). “Screening these patients is far too common and leads to the inappropriate prescribing of antibiotics, which some studies suggest may actually increase the risk of a UTI, as well as contribute to other serious infections such as Clostridioides difficile,” said first author Dr. Lindsay E. Nicolle, chair of the committee that developed the guidelines and professor emeritus of health sciences at the University of Manitoba (Winnipeg, Canada; www.umanitoba.ca). “Generally, physicians should not obtain urine cultures unless patients have symptoms consistent with an infection, such as burning during urination, frequent urination or abdominal pain or tenderness on the back near the lower ribs.” The latest guidelines were described in the March 21, 2019, online edition of the journal Clinical Infectious Diseases. Image: New guidelines may help decrease antimicrobial use that promotes development of resistance by pathogens (Photo courtesy of Shutterstock).

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Biosensor Device Uses CRISPR-Cas9 to Detect Target DNA Sequence team of biomedical engineers has developed and tested a graphene-based biosensor device that uses CRISPR/Cas9 technology to enable the digital detection of a target DNA sequence within intact genomic material. CRISPR/Cas9 is regarded as the cutting edge of molecular biology technology. CRISPRs (clustered regularly interspaced short palindromic repeats) are segments of prokaryotic DNA containing short repetitions of base sequences. Each repetition is followed by short segments of “spacer DNA” from previous exposures to a bacterial virus or plasmid. Since 2013, the CRISPR/Cas9 system has been used in research for gene editing (adding, disrupting, or changing the sequence of specific genes) and gene regulation. By delivering the Cas9 enzyme and appropriate guide RNAs (sgRNAs) into a cell, the organism’s genome can be cut at any desired location. The conventional CRISPR/Cas9 system from Streptococcus pyogenes is composed of two parts: the Cas9 enzyme, which cleaves the DNA molecule and specific RNA guides that shepherd the Cas9 protein to the target gene on a DNA strand. In contrast to classical methods for the detection of nucleic acids, which require many reagents and expensive and bulky instrumentation, the “CRISPR-Chip” device developed by investigators at the University of California, Berkeley (USA; www.berkeley.edu) and the Keck Graduate Institute (Claremont, CA, USA; www.cgi.edu) exploited the gene-targeting capacity of catalytically deactivated CRISPR-associated protein 9 (Cas9) complexed with a specific single-guide RNA and immobilized on a graphene-based field-effect transistor. This created a labelfree nucleic-acid-testing device whose output signal could be measured with a simple handheld reader. Mechanistically, the CRISPR complex located the target DNA site on the genome, bound to it, and triggered a change in the electrical conductance of the graphene, which, in turn, changed the electrical characteristics of the transistor. These changes were detected with a handheld device. The investigators used CRISPR– Chip to analyze DNA samples collected from HEK293T cell lines expressing blue fluorescent protein, and clinical samples of DNA with two distinct mutations at exons commonly deleted in individuals with Duchenne muscular dystrophy. In the presence of genomic DNA containing the target gene, CRISPR– Chip generated, within 15 minutes and without the need for amplification, a significant enhancement in output signal relative to samples lacking the target sequence. The CRISP-Chip device was described in

LabMedica International August-September/2019

the March 25, 2019, online edition of the journal Nature Biomedical Engineering. Image: A close-up of the CRISPR-Chip device (Photo courtesy of Keck Graduate Institute).

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SCREENING SYSTEM

LAB ANALYZER

Randox Laboratories

Abbott Diagnostics

Maccura Biotechology

The Evidence MultiSTAT enables simultaneous detection of up to 21 classical, prescription and synthetic drugs from a single sample. The multi-analyte testing platform provides a complete immunoassay profile within minutes.

The Alinity s system can run up to 600 tests/hour, and allows users to load samples and walk away for three hours. It offers continuous access to samples/supplies, with samples reloaded without pausing or stopping the instrument.

The i 3000 uses the magnetic microparticles-based AE direct chemiluminescence technology to improve stability and anti-interference capability. A single-module runs up to 300 tests per hour with a time to first result of 14 minutes.

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C-Peptide Responsiveness May Explain HbA1c Variation he addition of timing measures of C-peptide responsiveness may partly explain the glycated hemoglobin (HbA1c) level variation at diagnosis of type 1 diabetes (T1D) during the oral glucose tolerance test (OGTT). Previous studies have reported C-peptide responsiveness changes during the progression to T1D, but there are no data regarding the timing of C-peptide responses at diagnosis and the association with glucose levels. The goal of a new trial was to study whether timing of C-peptide responsiveness during test OGTT might explain variance in HbA1c levels at diagnosis of T1D. Scientists at the Indiana University School of Medicine (Indianapolis, IN, USA; https://medicine.iu.edu) and their colleagues enrolled 85 patients age <18 years at diagnosis (mean age, 11.2 years; 51% boys) with complete OGTT data and HbA1c measurement at diagnosis. Peak C-peptide, area under the curve C-peptide, and measures of relative timing were recorded, including early C-peptide response, late C-peptide response, the 120-minute/30-minute C-peptide ratio, and time to peak C-peptide. The team reported that there was an inverse correlation between HbA1c with measures of overall C-peptide responsiveness: area under the curve C-peptide and peak C-peptide. The inverse correlation was consistent with both early and late C-peptide responses and the 120-minute/30minute C-peptide ratio. In 27 patients with a peak C-peptide at â&#x2030;¤60 minutes, HbA1c levels were higher compared with 58 participants with a peak

C-peptide at >60 minutes. Similar to HbA1c, there was also inverse correlation between 2-hour glucose levels after OGTT with early and late C-peptide responses. The authors concluded that their findings show that the addition of timing measures of C peptide responsiveness better explains HbA1c variation at diagnosis than standard measures alone. The study was published on March 20, 2019, in the journal Pediatric Diabetes. Image: Scientists examined whether timing of C-peptide responsiveness during an oral glucose tolerance test might explain variance in HbA1c levels at diagnosis of type 1 diabetes (Photo courtesy of Amit Akirov, MD).

B-Type Natriuretic Peptide Sandwich Immunoassay Evaluated he measurement of circulating natriuretic peptides (NP) is considered to be a useful marker of myocardial function, and international guidelines recommend its use for the diagnosis of patients with heart failure (HF), and in particular ruling out the presence of HF. Point-of-care B-type natriuretic peptide (BNP) testing with adequate analytical performance has the potential to improve patient flow and provide primary care givers with easy-to-use advanced diagnostic tools in the management of heart failure. An international team of scientists working with the Medical University of Innsbruck (Innsbruck, Austria; www.i-med.ac.at) performed a comparison with a lab-testing system using samples from 187 patients. Normal values were determined based on 160 healthy adults, (94 males and 66 females; with 84 aged more than 55 years and 76 aged 55 years or less) with ages ranging from 19 to 70 years. Normal values were determined by testing EDTA whole blood and EDTA plasma samples.

The team compared the Minicare BNP (Minicare BV, Eindhoven, the Netherlands; www.minicare.com) with the Siemens ADVIA Centaur BNP (Siemens Healthcare GmbH, Erlangen Germany; www. siemens-healthineers.com), Alere Triage BNP (Alere, Waltham, MA, USA; www.alere.com) and Abbott I-STAT BNP (Abbott, Princeton, NJ, USA; www.pointofcare.abbott). The team tested and compared EDTA whole blood samples (on Minicare, Triage and I-STAT) and corresponding EDTA plasma samples (on Minicare and Centaur) from respectively 187 to 216 individuals with a BNP concentration range as measured using Minicare from 10 to 2,890 ng/L. The authors concluded that the Minicare BNP assay under development is a fast, robust and sensitive test that can be used in a near-patient setting on capillary or EDTA venous whole blood sample. The Minicare BNP test has the potential for good clinical performance in the diagnosis of HF in various patient settings. The study was published in the May 2019 issue of the journal Practical Laboratory Medicine. LabMedica International August-September/2019

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PRODUCT NEWS CRP TEST

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GRAM STAINING SYSTEM

LAB AUTOMATION SYSTEM

Diasys Diagnostic Systems

BioMérieux

Instrumentation Lab

The CRP IS is intended for the measurement of C-reactive protein to detect acute infection and monitor inflammatory processes. When used on the InnovaStar, the flexibility of a POC analyzer is combined with precise lab quality results.

The PREVI Color Gram provides rapid, standardized results for all types of specimen, while adding efficiency to the microbiology process. It features a touch screen interface, level monitoring and automated cleaning.

The ACL TOP 750 LAS connects to CLSI-compliant LAS to deliver versatility without interfaces. Sample aliquots are drawn from the primary sample tube and stored onboard, and pre-analytical checks minimize the risk of errors.

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Haptoglobin Expression Linked to Newborn Outcomes roteomics has facilitated discovery of biomarkers to better understand the pathophysiology of early-onset neonatal sepsis with the goal of identifying as early as possible the newborns more likely to die or develop significant morbidity. Some preterm babies born without haptoglobin (Hp), a protein in blood cells, have higher odds of brain bleeding, cerebral palsy and death. This finding suggests that the absence of the protein could serve as a potential biomarker indicating a need for increased monitoring or other preventive interventions. A large team of scientists working with the University of Illinois at Chicago (Chicago, IL, USA; https://chicago.medicine.uic.edu) evaluated cord blood samples from 921 newborns of women at imminent risk for preterm delivery randomized to either placebo (n = 471, birth gestational age (GA) median [min-max]: 31 [24–41] weeks) or magnesium sulphate (n = 450, GA 31 [24–42] weeks]). Primary outcome was infant death by 1 year and/or cerebral palsy (CP) ≥ 2 years of corrected age. Adjusted odd ratios (aOR) for neonatal and childhood outcomes were calculated controlling for GA, birth weight, sex, and magnesium

exposure. The team measured cord blood Hp and interleukin-6 (IL-6) concentrations in all samples. IL-6 was measured with commercial ELISA assays of low and high sensitivity (R&D Systems, Minneapolis, MN, USA; www. rndsystems.com). A cut-off in cord blood Hp immunoreactivity of 3,370 ng/mL in an enzyme-linked immunosorbent assay (ELISA) assay had ~100% sensitivity and specificity to segregate samples with switch-off from those with switch-on pattern on Western blots. Because the limit of detection for clinical assays to detect anhaptoglobinemia in adults is 2 mg/dL, Western blots were performed on all cord blood samples measuring Hp ≥ 2,000 ng/mL by ELISA (n = 507). Analysis of the magnesium concentration in cord serum was performed with a minimum detectable magnesium concentration of 0.4 mEq/L. The scientists reported that primary outcome occurred in 2.8% of offspring. Newborns were classified in three pre-defined categorization groups by cord blood Hp switch status and IL-6 levels: inflammation-nonexposed (n = 432, 47%); inflammation-exposed haptoglobinemic

(n = 449, 49%), and inflammation-exposed anhaptoglobinemic or hypohaptoglobinemic (n = 40, 4%). Newborns, found anhaptoglobinemic or hypohaptoglobinemic had increased OR for intraventricular hemorrhage (IVH) and/or death (aOR: 7.0) and for CP and/or death (aOR: 6.27) compared with Category 2. Fetal ability to respond to inflammation by haptoglobinemia resulted in aOR similar to inflammation-nonexposed newborns. Hp1-2 or Hp2-2 phenotypes protected against retinopathy of prematurity (aOR = 0.66). The study was published on March 22, 2019, in the journal EClinicalMedicine. Image: Human IL-6 Luminex Performance ELISA Assay (Photo courtesy of R&D Systems).

Metabolic Fingerprinting Diagnoses Fibromyalgia ibromyalgia is the most common cause of chronic widespread pain in the USA, and disproportionately affects women. It is estimated that about 2% of the population, around four million adults, has fibromyalgia; however some organizations estimate even higher numbers. About three in four people with fibromyalgia (FM) have not received an accurate diagnosis, and those who do know they have the disease waited an average of five years between symptom onset and diagnosis. Common symptoms include pain and stiffness all over the body, fatigue, depression, anxiety, sleep problems, headaches and problems with thinking, memory and concentration. Medical scientists at the Ohio State University (Columbus, OH, USA; www.osu.edu) and their colleagues developed a rapid biomarker-based

method for diagnosing FM by using vibrational spectroscopy to differentiate patients with FM from those with rheumatoid arthritis (RA), osteoarthritis (OA), or systemic lupus erythematosus (SLE) and to identify metabolites associated with these differences. Blood samples were collected from 50 patients with a diagnosis of FM, 29 with RA, 19 with OA, and 23 with SLE. Bloodspot samples were prepared, and spectra collected with portable Fourier-transform infrared spectroscopy (FT-IR) and FT-Raman microspectroscopy and subjected to metabolomics analysis by ultra-high performance liquid chromatography (uHPLC), coupled to a photodiode array (PDA) and tandem mass spectrometry (MS/MS). The study was published on February 15, 2019, in the Journal of Biological Chemistry. LabMedica International August-September/2019

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CLIA ANALYZER

ANTI-CHLAMYDIA ELISAS

Beckman Coulter

DiaSorin

Euroimmun

The iQ200ELITE uses APR software to isolate, identify and characterize urine particles, eliminating the need for manual microscopy. It has a throughput up to 70 samples/hour, and produces shortened TAT with standardized results.

The LIAISON combines a flexible operating module with a broad menu, resulting in high efficiency due to a lengthy walk-away time. It can run up to 15 different assays at a time, offering daily tests with a small number of samples.

The Anti-Chlamydia ELISAs employ antigens from both C. trachomatis and C. pneumoniae, ensuring antibodies against both species are detected. The test kit includes IgG/RF absorbent in sample buffer for IgG absorption.

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HbA1c Point-of-Care Test Reliably Diagnoses Diabetes lycated hemoglobin is a form of hemoglobin that is covalently bound to glucose. It is formed in a non-enzymatic glycation pathway by hemoglobin’s exposure to plasma glucose. By measuring glycated hemoglobin (HbA1c), clinicians are able to get an overall picture of what the average blood sugar levels have been over a period of weeks/months. Point-of-care (POC) hemoglobin A1c (HbA1c) testing has advantages over laboratory testing, but some questions have remained regarding the accuracy and precision of these methods. Scientists collaborating with Abbott Rapid Diagnostics (San Diego, CA, USA; www.abbott.com) carried out a prospective and observational study using samples from 120 adults (mean age, 57 years; 56% women) across a range of HbA1c levels (4%-15%) that were taken by finger stick at three clinical sites in the USA. Four groups were formed based on HbA1c levels and categorized as low (4%-5.99%), threshold (6%-6.99%), medium (7%-9.99%) and high (more than 10%). Venous blood samples were also taken from each participant, and three from each HbA1c group were analyzed using a POC test. The POC test assessed in the study was the Afinion HbA1c Dx test (Alere Technologies, Waltham, MA, USA; www.alere.com). The precision of the POC test using venous blood was evaluated from samples run in four replicates on each of three test cartridge lots, twice per day for 10

consecutive days. The SD and CV by study site and overall were calculated. The study was published on March 10, 2019, in the Journal of Diabetes Science and Technology. Image: The AfinionHbA1c assay cartridge is used to test for quantitative determination of glycated hemoglobin (HbA1c) in human whole blood, which is used to monitor metabolic control in patients with diabetes (Photo courtesy of Alere).

Biomarker Predicts Factor VIII Response in Hemophilia A emophilia A is a genetic deficiency in clotting factor VIII (FVIII), which causes increased bleeding and usually affects males. In the majority of cases it is inherited as an X-linked recessive trait, though there are cases, which arise from spontaneous mutations. Trough factor (F) VIII level is a not reliable bleeding risk indicator to predict prophylaxis efficacy in severe hemophilia A (SHA), therefore, accurate biomarkers are in great demand by specialist hematologists. Thrombelastography (TEG) monitors both thrombin and clot formation addressing the global hemostatic status but its usefulness to tailor prophylaxis in hemophilia has been poorly evaluated. Hematologists at the La Paz University Hospital (Madrid, Spain; www.idipaz.es) analyzed a group of 19 adolescents (younger than 18 years) with severe hemophilia A (without signs of inhibitors) on long-term preventive treatment with FVIII. Of the 19 patients, six had at least one spontaneous bleeding event that required treatment in the two years preceding the study and were categorized as “bleeders.” The remaining patients were categorized as non-bleeders. Whole blood was withdrawn before FVIII administration and at five time-points after infusion for the thrombelastography test to assess the

therapy’s pharmacodynamics (what a medicine does to the body) and pharmacokinetics (what the body does to a medicine, referring to the movement of the therapy through the body) profiles. The team hypothesized that the outcomes of the laboratory test may help discern patients who exhibit a bleeding tendency from those who do not. Ten patients completed the five post-infusion time-points, while five patients missed one time-point, and four missed two time-points. The investigators reported that the thrombelastography (TEG) analysis over time showed that the procoagulation activity of patients decreased with time after dosing with FVIII. The therapy’s effectiveness tended to be weaker in the group of bleeders compared to the nonbleeders, although the team saw no significant statistical difference. Moreover, the “half maximal effective concentration” of FVIII (FVIIIEC50), a parameter that describes the concentration at which a therapy induces a response halfway between no response and maximum response, assessed in the TEG test was significantly higher in bleeders, which suggests a poorer response to FVIII. The study was published on February 1, 2019, in the European Journal of Pharmaceutical Sciences. LabMedica International August-September/2019

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LabMedica International

Oral Bacteria Linked to More Aggressive Tumors ancreatic cystic neoplasms (PCN) are increasingly detected in the general population. They comprise a clinically challenging entity with potential to progress to invasive cancer. The disease is often discovered late, which means that in most cases the prognosis is poor. However not all pancreatic tumors are cancerous. For instance there are so-called cystic pancreatic tumors (pancreatic cysts), many of which are benign. A few can, however, become cancerous. It is currently difficult to differentiate between these tumors. To rule out cancer, many patients therefore undergo surgery, which puts a strain both on the patient and on the healthcare services. An international team of scientists working with the Karolinska Institutet (Huddinge, Sweden; https://ki.se) collected cyst fluid and peripheral blood liquid biopsies at the day of surgery from 105 patients undergoing surgical pancreatectomy for suspected pancreatic cystic lesions based on preoperative diagnosis. Fasting venous blood was collected in K2 EDTA tubes and Ficoll Paque PLUS (GE Life Sciences, Marlborough, MA, USA; www.gelifesciences.com) density gradient centrifugation was performed. Microbial DNA was isolated from cyst fluid and plasma using the ZymoBIOMICS DNA Miniprep Kit (Zymo Research, Irvine, CA, USA; www. zymoresearch.com). DNA was isolated from formalin-fixed paraffin embedded (FFPE) pancreas tissue slices using the AllPrep DNA/RNA FFPE Kit (Qiagen, Sollentuna, Sweden; www.qiagen.com). The Human interleukin (IL)-1β/IL-1F2 ELISA DuoSet (R&D Systems, Minneapolis, MN, USA; www.rndsystems.com) was used to quantify plasma and cyst fluid interleukin 1β (IL-1β) levels. The PyroGene Recombinant Factor C Endotoxin Detection Assay (Lonza Bioscience, Falun, Sweden; www.lonza. com) was used to quantify bacterial lipopolysaccharide (LPS) in cyst fluid. The investigators reported that intracystic bacterial 16S DNA copy number and IL-1β protein quantity were significantly higher in intraductal papillary mucinous neoplasms (IPMN) with high-grade dysplasia and IPMN with cancer compared with non-IPMN PCNs. Despite high interpersonal variation of intracystic microbiota composition, bacterial network and linear discriminant analysis effect size analyses demonstrated co-occurrence and enrichment of oral bacterial taxa including Fusobacterium nucleatum and Granulicatella adiacens in cyst fluid from IPMN with highgrade dysplasia. They also found that the presence of bacterial DNA was higher in patients who had undergone invasive pancreas endoscopy, a procedure that involves the insertion of a flexible tube into the mouth to examine and treat pancreatic conditions thus the possible transfer of oral bacteria into the pancreas. Margaret Sällberg Chen, DDS, PhD, a senior lecturer and corresponding author of the study, said,

Image: The ZymoBIOMICS DNA Mini Kit by Zymo Research

“We find most bacteria at the stage where the cysts are starting to show signs of cancer. What we hope is that this can be used as a biomarker for the early identification of the cancerous cysts that need to be surgically removed to cure cancer; this will in turn also reduce the amount of unnecessary surgery of benign tumors.” The study was published on March 14, 2019, in the journal GUT.

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CARDIAC MARKERS

PARASITOLOGY DEVICE

Qiagen

Labnovation Technologies

Apacor

The ipsogen JAK2 RGQ PCR Kit is for the detection of the JAK2 V617F/G1849T allele in genomic DNA extracted from EDTA whole blood. The RT-PCR assay is performed on the Rotor-Gene Q MDx (US) instrument.

The qualitative and quantitative cardiac markers include myocardial troponin I, myoglobin, creatine kinase isoenzyme and heart fatty acid binding protein. The tests help diagnose patients suffering from AMI or myocardial damage.

The ParaSlide system is designed for the rapid analysis of intestinal parasites from fecal samples. The system offers controlled quantity of specimens for each patient and provides labs with a higher throughput and reduced costs.

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Banna Virus Detected by Reverse Transcription-Loop-Mediated Isothermal Amplification anna virus (BAV) has been isolated from a diverse group of vertebrates and invertebrates, including mosquitos, ticks, midges, cattle, and pigs from different regions in China, Vietnam, and Indonesia. BAV is considered to be an emerging pathogen that can result in human infections with possible manifestation of fever and viral encephalitis. Reverse transcription-loop mediated isothermal amplification (RT-LAMP) is a nucleic acid amplification approach that amplifies reverse transcribed DNA from RNA using strand displacement DNA polymerase under isothermal conditions. Due to its rapidness, simplicity, sensitivity and specificity, RT-LAMP has been successfully applied in the detection of various RNA viruses. Scientists at the Wuhan Institute of Virology (Wuhan, China; www. whiov.cas.cn) designed a set of six specific primers to target the segment 12 of BAV, and the reverse transcription-loop mediated isothermal amplification (RT-LAMP) assay was developed and compared with conventional reverse transcription polymerase chain reaction (RT-PCR) method. The team used various cells and spiked samples to test the RTLAMP method. In running the RT-LAMP assay, a DEAOU RNA Amplification Kit (RTLAMP) (DEAOU, Guangzhou, China; www.guangzhou-deaou-bio-ltd. en.drugdu.com) was used. One step RT-PCR amplification for BAV was performed using Prime Script One Step RT-PCR Kit Ver.2 (Takara, Dalian, China; www.takara-bio.com). RNA was extracted from 140 L of BAV-infected C6/36 cell culture supernatant, BAV-spiked human serum or filtered mosquito homogenate samples using the QIAamp Viral RNA Mini Kit (Qiagen, Hilden, Germany; www.qiagen.com). The team reported that the amplification of the RT-LAMP assay can be obtained within 40 minutes at 65 °C. The results from specificity showed that only target BAVs RNA including genotypes A, B and C were amplified and the assay demonstrated a sensitivity of 3.6 × 10−2 PFU/mL, which was higher than conventional RT-PCR measurement. A good reliability for the assay was presented in the further evaluation for BAVs RNA from serial diluted BAV-spiked serum and 47 pools of field mosquito samples. The authors concluded that they had successfully developed a RTLAMP assay for the detection of BAV, which provides a potential new molecular diagnostic test for BAV that could be applied in the field or clinic in the future, and that may contribute to the preparedness for future outbreaks of a BAV endemic, especially for regions with limited resources available. The study was published online on November 2, 2018, in the International Journal of Infectious Diseases.

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LabMedica International August-September/2019

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

NEWS

IFCC Committee on Point-of-Care Testing: Report from Meeting at EuroMedLab 2019 By Prof. Adil I. Khan, IFCC C-PoCT Chair arcelona, the city of Antoni Gaudi, hosted, EuroMedLab 2019, the 23rd IFCC-EFLM European Congress of Clinical Chemistry and Laboratory Medicine. It was also the venue for the meeting of members of the IFCC Committee on Point-of-Care Testing (C-POCT) – which comprises thirty-three members drawn from Canada, the Americas, Europe, Africa, the Middle East, Asia, Australia and New Zealand. Point-of-Care (POC) Testing, the testing of patient specimens at the bedside and outside the confines of the clinical laboratory, and usually performed to improve patient management, is growing exponentially due to its “userfriendliness” and non-reliance on costly hospital infrastructure. But this explosion of POC tests poses a number of challenges. The C-POCT members look at different aspects of point-of-care testing and provides international leadership by developing the clinical practice guidelines or educational materials where none exist or there is lack of clear direction. Its members have devoted ten or more years of their careers to point-ofcare testing and so they are well qualified to give guidance, and furthermore they have been nominated by their country’s professional societies, so they are experts in their own right. As issues are addressed the membership includes representation from companies such as Roche, Siemens, Nova Biomedical and Abbott Diagnostics to ensure opinions are balanced from both academic and industry perspectives. The EuroMedLab 2019 congress hosted a symposium devoted to POC tests whose theme was “Point-of-Care Testing: From quality assurance strategies to clinical utility and patient outcomes.” The speakers, were drawn from the CPOCT committee. Dr. Sverre Sandberg from Norway, gave the opening lecture titled, “Quality control and analytical performance specifications for different clinical POCT settings. Should they be different?” He discussed the importance of performing POC testing based on clinical outcomes, cost and setting and this would in turn determine their performance specifications. Furthermore he went on to explain that since POCT is carried out in a different environment with different users and often with different performance specifications and different types on inbuilt controls, it is important to re-evaluate how and which types of quality control should be used. Dr. Paloma Oliver from Spain discussed her experience in her talk titled: “20 years’ experience on quality assurance strategies of a large and ISO 22870 accredited POCT multipa-

Cont’d on page 22

LabMedica International August-September/2019

Photo: (From left to right) Masaru Yamamoto; Michel Vaubourdolle; Ellis Jacobs; Anne Skurup; Silvia Cardinale; Silvia Colli Lanzi; Paola Bramati; Paloma Oliver; Filiz Akbiyik; Laetitia Crouch; Alessandro Palese; Sean Cunningham; Adil Khan (Chair)

NEWS

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

Prof. Maurizio Ferrari Elected IFCC President

Introducing the IFCC Working Group on Volatolomics

he results of the ballot for the substitution of the IFCC President, following the untimely loss of Prof. Morris, was concluded, June 30th. The voting unanimously confirmed the Executive Board recommendation to appoint Prof. Maurizio Ferrari as President, beginning his term on July 1st. The President-Elect will transition into the role of President during the 2020 year at a date mutually agreed upon between the EB and the President-Elect. In summary 52 societies voted (out of 88 having the right to vote). Full details of the ballot may be found from the independent company that conducted the ballot: https://secure.electionbuddy.com/results/6EFTVWKVRNVV. On behalf of the IFCC Executive Board, we congratulate Prof. Maurizio Ferrari in his role.

by Larry Kricka, Professor of Pathology and Laboratory Medicine, Department of Pathology & Lab. Medicine, University of Pennsylvania Medical Center, Philadelphia, USA

IFCC Committee on Point-of-Care Testing: Report from Meeting at EuroMedLab 2019 Cont’d from page 21

rameter network,” highlighted the issues and complexities of POC testing service. She stressed the importance of creating a homogenous POCT network for all clinical settings, led by Laboratory Medicine and in accordance with the ISO 22870 requirements, that address three key areas: quality assurance, staff training and competency and continuous improvement. All of them are essential to improve the management of POCT and consequently, patient care. Finally, Dr. Rajiv Erasmus from South Africa explained how POC testing for HIV is turning the tide in the fight to end this epidemic in Africa by 2030. In his talk: “How the use of POCT has changed the clinical pathways and outcome for patients with infectious diseases in Africa” he showed how the POC testing was the solution to the lack of infrastructure and highly skilled professionals in rural parts of Africa, that resulted in shorter treatment times and improved outcomes. The symposium ended with the “SensUs Student Competition: Global education and innovation in POCT” given by Marc Vives Enrich (GB), and Eliene Rutten (NL). This is an international student competition on biosensors for health and spurs innovation. The IFCC Working Group on “How should Glucose Meters be Evaluated in Critical Care (WG-GMECC),” chaired by Dr. Cynthia Bowman, updated the C-POCT committee on their progress. This WG has completed a document on “How Should Glucose Meters Be Evaluated for Critical Care” that is available for download from the IFCC –C-POCT website. It addresses the clinical practice of using Blood Glucose Meters (BGM) and what requirements they must fulfill in order to be used in critically ill patients and in Professional Healthcare Settings on patients in various states of health and patients receiving intensive medical intervention and therapy [http://www.ifcc.org/ifcc-education-division/emd-committees/ taskforcepoct/wg-gmecc/]. A second document addressing quality management and training and competency recommendations for BGM is under development. Currently the C-POCT committee is working on a paper addressing the requirements for POC testing outside the hospital setting and includes direct-to-consumer testing. The POCT committee also discussed the upcoming IFCC World Lab Congress in Seoul, 2020, where the C-POCT would hold a POC test mini-symposium, ‘The Current status and Future Roles of Point-of-Care Testing.” Finally, the Africa Federation of Clinical Chemistry (AFCC) Regional Conference will be held in Marrakech, Morocco from 25th to 28th September, 2019. A symposium on Point of Care Testing will be held. Professor Erasmus and Professor Sandberg both affiliated with the IFCC –POCT Committee will take part in this symposium. For all updates, visit the C-PoCT webpage at: www.ifcc.org/ifcc-educationdivision/emd-committees/c-poct/

Dr. Larry Kricka

Dr Paolo Fortina

Dr Joesph Wiencek

he new Working Group on Volatolomics (WG-Vol) is part of the new Emerging Technology Division (ETD) that was ratified in 2017. It provides current awareness of emerging technologies likely to have important clinical diagnostic applications in the near future – one of those emerging technologies is volatolomics (i.e., breath analysis). Members of the new WG-Vol are Dr Larry Kricka (Chair), Dr Paolo Fortina (Member), and Dr Joesph Wiencek (Member) and the terms of reference for the new working group are to develop a survey of the diagnostic applications of volatolomics (breath analysis) and to develop periodic updates of the volatolomics survey over the next 3 years. Breath analysis is not new and already has a few, but very specific applications (e.g., breath alcohol testing,13carbon/12carbon-based tests). One aspect of current work on volatolomics centers on finding diagnostic utility in the pattern or signature of volatile organic compounds (VOCs) in breath. Breath analysis is an attractive proposition because this type of testing is non-invasive, applicable to the point-of-care and offers the possibility of real-time clinical management. Already, there are more than 10 companies focused on the clinical diagnostic applications of volatolomics employing diverse analytical technologies (breath analysis analyzers are sometimes known as “electronic noses”). The broad scope of diagnostic applications under investigation and development ranges from breath glucose testing to testing for different types of cancer. Volatolomic technologies are diverse and include different types of mass spectrometry [e.g., gas isotope ratio mass spectrometry (GIRMS), selected ion flow tube mass spectrometry (SIFT-MS), field asymmetric ion-mobility spectrometry (FAIMS), secondary electro-spray ionization-MS], sensors and sensor arrays (e.g., copper bromide-based sensor, colorimetric high dimensional sensor array), gas chromatography (e.g., GC SAW). Further notable aspects of breath analysis technologies are the use of artificial intelligence, cloud-based analysis of data and analyzers linked to a smartphone. The survey will be published as a pdf on the WG-Vol website (www. ifcc.org/ifcc-emerging-technologies-division/etd-working-groups/) and will include: News items and opinion pieces from key researchers/opinion leaders about recent developments in the clinical diagnostic applications of volatolomics; A directory of companies active in the clinical diagnostic applications of volatolomics; Links to clinical trials involving volatolomic testing; Details of analyzers and regulatory approvals of clinical diagnostic products based on volatolomic testing; A literature survey updated quarterly designed to provide an educational resource and a snapshot of work since 2010.

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 The views and positions expressed in the IFCC News section are those of the IFCC or the individual authors, and do not necessarily represent the views or positions of LabMedica magazine or its publishers.

LabMedica International August-September/2019

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

NEWS

Call for Nominations: IFCC Distinguished Awards for IFCC WorldLab Congress, Seoul (Korea) 2020 by Maurizio Ferrari, Chair, IFCC Awards Committee s you are aware, the IFCC confers several Distinguished Awards to scientists and clinicians who work in Clinical Chemistry and Laboratory Medicine or related disciplines. These triennial awards are the highest honours that our Federation can bestow to colleagues worldwide in recognition of their outstanding achievements, to publicize their exceptional research and other contributions that have improved medical and healthcare, and to stimulate and encourage other scientists to accelerate their efforts in advancing Clinical Chemistry and Laboratory Medicine. On behalf of IFCC and its Awards Committee, I am pleased to call for nominations for the following ten (10) IFCC Distinguished Awards for presentation at the IFCC Congress in May 2020, Seoul, Korea. These awards for 2020 are listed below and a more detailed description of them, including the former honorees, can be found on www.ifcc.org/ executive-board-and-council/eb-committees/awards-committe/ 2020-ifcc-awards-call-for-nominations/. IFCC Distinguished Clinical Chemist Award - sponsored by Yashraj Biotechnology Ltd; IFCC-Henry Wishinsky Award for Distinguished International Service since 1990 (IFCC Distinguished International Services Award 19811987) - sponsored by Siemens Healthineers; IFCC Award for Distinguished Contributions in Education - sponsored by Abbott Laboratories; IFCC Award for Significant Contributions in Molecular Diagnostics sponsored by Abbott Laboratories; IFCC Distinguished Award for Laboratory Medicine and Patient Care - sponsored by Sekisui Diagnostics; IFCC-Robert Shaffer Award for Outstanding Achievements in the

IFCC Welcomes New Corporate Members Immunodiagnostic Systems - IDS IDS is a leading in-vitro diagnostic solution provider to the clinical laboratory market. We develop, manufacture and market innovative immunoassays and automated immunoanalyser technologies to provide improved diagnostic outcomes for patients. Our immunoassay portfolio is a combination of an endocrinology specialty testing menu and assay panels in complementary fields. The portfolio is available as a combination of tests available for use on our fully-automated systems, or as stand-alone test kits. This complete offering meets the needs of both clinical and research laboratories of all types and sizes, with their diagnostic testing requirements.Our IDS heritage within certain endocrinology fields, including vitamin D testing, offers a solid platform on which to develop a market-leading endocrinology menu for Bone Metabolism, Calcium Metabolism, CKD-MBD (Chronic Kidney Disease & Mineral Bone Disorders), Fertility, Growth Disorders and Hypertension. Through partnership, we develop a broader complementary menu, extending into other clinical areas such as Allergy, Autoimmunity and Infectious Disease. Web: www.idsplc.com

ET Healthcare Inc. ET Healthcare Inc. is an IVD company initially focusing on the China clinical market. We offer a POCT/near patient system, Pylon, for cardiac and inflammation markers. Web: www.ethealthcare.com.cn

LabMedica International August-September/2019

Development of Standards for Use in Laboratory Medicine - sponsored by NIST CLSI; IFCC Distinguished Award for Contributions to the Cardiovascular Diagnostics - sponsored by HyTest; IFCC-GĂŠrard Siest Award Young Scientist Award for Distinguished Contributions in Pharmacogenetics - sponsored by Biologie Prospective; IFCC Distinguished Women Scientist Award for Contribution to In Vitro Diagnostics - sponsored by Yashraj Biotechnology Ltd; IFCC Young Investigator Award - sponsored by IFCC. Nominations are welcome from the President or National Representative of the nomineesâ&#x20AC;&#x2122; national society, which should be a member of the IFCC. Each nomination should contain (1) a statement as to the reasons for nomination, (2) a full CV of the nominees including a bibliography, and (3) other letters of support (optional). They should be sent to Silvia Colli-Lanzi of the IFCC Office (colli-lanzi@ifcc.org). The closing date for receipt of nominations is 30 November 2019. Please do not hesitate to write to Silvia Colli Lanzi or me if you have any queries.

NEWS

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

VIEWPOINT

The Digital Patient Avatar Paradigm by Dr. Bernard Gouget Chair, Committee on Mobile Health and Bioengineering in Laboratory Medicine (C-MHBLM), Past-Chair, IFCC Nominations Committee (NC), SFBC-International Committee; General Secretary of the International Francophone Federation of Clinical Biology and Laboratory Medicine (FIFBCML); President Healthcare Division Committee - Comité Français d’accréditation (Cofrac)

igital simulation, which has been widely used in engineering for decades in the automobile, aeronautic or energy industries, is rapidly evolving in the field of health. A multitude of startups and laboratories have already begun to invest in health and simulating a patient on a computer could be the next medical revolution. Personalized medicine takes on a new dimension. Creating a digital twin of the human body or of a medical equipment in order to measure the impact of various treatments or procedures without relying on physical testing or materials has now become possible. Several clinical applications are in the process of development with, in perspective, countless opportunities for "in silico" research. This is not science fiction but it is the next medical advance that will revolutionize every medical speciality. Programs already exist for the adaptation of stents from patient CT scans, the design of joint prostheses, the development of devices for delivering vaccine intranasally, or modeling synthetic organs to replace transplants. Clinical research will lead to an explosion of the potential of simulation. Before a drug molecule is ingested by a patient, its effects can be tested outside the body. Of course, in silico tests are not close to

being able to completely replace in vivo and in vitro tests in the laboratory, but they could give a serious boost to accelerate a process that is very cumbersome today. Digital simulation will reduce both research expense and duration. With a virtual patient, extreme situations can be simulated, and he may be killed hundreds of times without damage. To say nothing of the advantage of a cyber guinea pig in the case of rare disease or pediatric studies, for which it is difficult to recruit patients. Supported by Congress, the FDA clearly encourages in silico testing, and a law was passed to validate the results of research obtained by modelling. Thus, there can be hope that tests, drugs and medical devices will be developed more rapidly in a country where the very high price of treatments is justified by the slowness of their development. To progress toward the design of a complete digital twin, we will have to make sure that it experiences the same things as the patient. Connected objects are a good resource for collecting data in real time. The prediction capacity for a given patient will increase very quickly by coupling digital simulation to artificial intelligence. And what if everyone had their own medical avatar available, a double of themselves in virtual form, which will combine all the personalized data necessary to better manage their health and more effectively care for them in the event of disease? This is what the International Health EU project proposes. – "Human avatars to prevent and cure diseases" managed by a consortium including two polytechnic schools, EPFL (Lausanne) and ETHZ(Zurich), with the participation of more than 25 European research laboratories (FR, IT, BE, NL, DE, UK, CH), (https://www.health-eu.eu/). More than 90 scientists, from 47 leading research groups from universities, institutes, clinics and the private sector of 16 European countries, are directly involved in Health EU. The flagship idea of the project is to marry personalized medicine and digitalization, by using the most recent technological developments, such as connected objects and artificial intelligence to create one's "digital twin". The plan is to set up a veritable technological platform around the patient, capable of generating information of the "big and deep data" type and to consider and relate genomic, biological, environmental and behavioral data. To collect this data, an entire panoply of advanced technologies is considered: portable sensor devices, implants, nanomedicine techniques, medical imaging or even "organ-on-a-chip" technology. These technologies would not interfere in daily life in any way. Invisible, connected biosensors would be found, for example, in a watchband, in a pair of eyeglasses, in clothing or even in tattoos. These tools would provide useful information in multiple areas of translational medicine, particularly targeting cardiovascular, metabolic and neurodegenerative diseases as well as cancer. Adrian M. Ionescu, a professor at the Lausanne Ecole Polytechnique Fédérale and one of the initiators of the project, emphasizes that the virtual avatar system, is not intended only for patients, but rather for everyone. It would serve to introduce better disease prevention, better risk anticipation, earlier diagnosis, personalized advice, more precise medical follow-up, more appropriate prescriptions and treatments, and time saving in data analysis. But there are also many challenges: medical technologies to be developed or refined, and also having the collaboration of experts from many disciplines and of different nationalities, as well as regarding the protection of data that will be collected at the individual level. If everything goes as planned, the Health EU project will be implemented in 2020 and the first results in the cancer and cardiovascular fields are expected for 2030. This project shows that it is necessary to work together to innovate. Integrative medicine supposes a comprehensive human approach. It is by working in synergy, internationally, with all those who contribute to advancing these issues that Laboratory Medicine and health systems can be transformed in a sustainable approach and adapt to future changes, not passively, but rather by being a building force for the world of tomorrow.

LabMedica International August-September/2019

Industry

Agilent Expands Product Range with BioTek Acquisition cont’d from cover

presence in biopharma, academia and research. The combination will support novel workflows that reveal more comprehensive insights for live cell analysis. BioTek is a global leader in the design, manufacture and distribution of innovative life science instrumentation. Its comprehensive product line includes cell imaging systems, microplate readers, washers, dispensers, automated incubators and stackers. These products enable life science research by providing customers with high performance, cost-effective analysis across diverse applications. Agilent Technologies’ (Santa Clara, CA, USA; www.agilent.com) acquisition of BioTek Instruments (Winooski, VT, USA; www.biotek.com) accelerates its multi-year growth strategy to expand its position in cell analysis, a fast-growing multi-billion dollar market. Agilent entered the cell analysis segment in 2015 with the acquisition of Seahorse Bioscience, a provider of specialized instruments and live-cell, kinetic assays. In January 2018, Agilent broadened its portfolio of cell analysis solutions through the acquisition of Luxcel Biosciences, and in September 2018, it went on to acquire ACEA Biosciences, a pioneer in the development and commercialization of high- performance cell analysis platforms for life science research. With Agilent’s latest acquisition of BioTek, their combined portfolio will enable it to provide a more complete and integrated solution for customers in the important and fast-

Global Molecular Diagnostics Market to Approach USD 14 Billion by 2025 he global molecular diagnostics market was valued at USD 8 billion in 2017 and is projected to grow at a CAGR of 7.1% during the period 2018 to 2025 to reach USD 13.87 billion by 2025. The presence of a robust supply chain network and favorable R&D strategies are enabling the players to establish a strong foothold in the global molecular diagnostics market. Additionally, increasing investments in cost management will create growth opportunities in the molecular diagnostics market. These are the latest findings of Fortune Business Insights (Pune, Maharashtra, India; www.fortunebusinessinsights.com), a market research firm. Currently, the increasing incidence of microbial outbreaks is boosting the market for molecular diagnostics. For instance, major outbreaks of bacterial and viral infections in the Middle East and Africa have compelled all government and research institutions worldwide to adopt molecular diagnostics for inhibiting microbial outbreaks. The demand for molecular diagnosis is expected to rise due to the increasing prevalence of infectious diseases in both the developing and developed nations. Awareness programs aimed at spreading awareness on infectious diseases and relevant preventive measures as adopted by the World Bank, World Health Organization (WHO), and other international organizations are also contributing to the growth of the molecular diagnostics market. The huge amount of resource engagement in terms of expertise, technology, and finance along with favorable environment for the simulation of research projects, especially for infectious diseases will fuel the market growth.

LabMedica International August-September/2019

growing area of live cell analysis. “BioTek represents a strong strategic fit with Agilent,” said Mike McMullen, Agilent president and CEO. “The combination of these two companies will accelerate our multi-year growth strategy to expand our position in cell analysis. This is another example of Agilent investing in high-growth segments of the life sciences market to serve new and existing customers. Agilent is committed to continuing operations in Vermont and retaining the great team of nearly 500 employees that have been at the core of BioTek’s 50-year history of excellence and success.” “By combining BioTek’s offerings with Agilent’s, we will deliver a breadth of differentiated workflows, enabling customers to obtain deeper, more reliable insights across a variety of cell analysis applications,” said Jacob Thaysen, president of Agilent’s Life Sciences and Applied Markets Group. “This positions Agilent well in the large and growing immuno-oncology and immunotherapy markets and expands our presence in biopharma, academia and research as customers seek to understand complex cellular environments and interactions.” “BioTek and Agilent have already been in partnership for over a year, successfully unlocking significant value through joint development of customer solutions,” said Briar Alpert, CEO of BioTek. “Both companies share the same focus on customers and employees, as well as a similar purpose, mission and values. I am confident that this is the winning formula for our employees and customers around the world.”

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AUGUST 2019 Vietnam Medi-Pharm Expo 2019. Aug 13; Ho Chi Minh City; Web: www.hcm. medipharmexpo.com 71st AACC Annual Scientific Meeting & Clinical Lab Expo. Aug 3-8; Anaheim, CA, USA; Web: www.aacc.org

SEPTEMBER 2019 ECP 2019 – 31st European Congress of Pathology. Sep 7-11; Nice, France; Web: www.esp-congress.org EUROTOX 2019 – 55th Congress of the European Societies of Toxicology. Sep 8-11; Helsinki, Finland; Web: www. eurotox-congress.com/2019 COLABIOCLI 2019 – 24th Latin American Congress of Clinical Biochemistry. Sep 10-13; Panama City, Panama; Web: colabioclipanama2019.com ASCP 2019 – Annual Meeting of the American Society for Clinical Pathology. Sep 11-13; Phoenix, AZ, USA; Web: www.ascp.org Medical Fair Thailand. Sep 11-13; Bangkok, Thailand; Web: www.medicalfair -thailand.com ESCV – 22nd Annual Meeting of the European Society for Clinical Virology. Sep 11-14; Copenhagen, Denmark; Web: escv2019.com EASD 2019 – 55th Annual Meeting of the European Association for the Study of Diabetes. Sep 16-20; Barcelona,

Spain; Web: www.easd.org ESID 2019 – Focused Meeting of the European Society for Immunodeficiencies. Sep 18-21; Brussels, Belgium; Web: esidmeeting.org ESPE 2019 – 58th Annual Meeting of the European Society of Paediatric Endocrinology. Sep 19-21; Vienna, Austria; Web: www.eurospe.org India Lab Expo & Analytica Anacon India. Sep 19-21; Hyderabad, India; Web: www.indialabexpo.com MSACL 2019 – 6th Annual European Congress on Clinical Mass Spectrometry. Sep 22-26; Salzburg, Austria; Web: wwwmsacl.org ASHI 2019 – 45th Annual Meeting of the American Society for Histocompatibility & Immunogenetics. Sep 23-27; Pittsburgh, PA, USA; Web: www.ashi-hla.org Analitica Latin America 2019. Sep 2426; Sao Paulo, Brazil; Web: www. analiticanet.com.br ExpoMedical 2019. Sep 25-27; Buenos Aires, Argentina; Web: www.expo medical.com.ar 16th Annual Meeting of the German Society for Clinical Chemistry and Laboratory Medicine (DGKL). Sep 25-28; Magdeburg, Germany; Web: www. dgkl2019.de

munological Societies. Oct 19-23; Beijing, China; Web: iuis2019.org EndoBridge2019. Oct 24-27; Antalya, Turkey; endobridge.org BCLF 2019 – 27th Balkan Clinical Laboratory Federation Meeting. Oct 27-31; Antalya, Turkey; Web: www.bclf2019. biyokimyakongresi.org 89th Annual Meeting of the American Thyroid Association. Oct 30-Nov 3; Chicago, IL, USA; Web: www.thyroid.org/ 89th-annual-meeting-ata

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