LabMedica International October 2019

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WORLD’S CLINICAL LABORATORY NEWS LEADER ISSN 1068-1760

Vol. 36 No.6 • 10/2019

DAILY CLINICAL LAB NEWS

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Whole-Blood Test for Acute Zika Infections ika virus infections are linked to congenital malformations in neonates from mothers infected during pregnancy and to neurologic disorders in adults. Reverse transcription polymerase chain reaction (RT-PCR) is the most reliable method for confirming Zika

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Identifying Colorectal Cancer Subtypes Improves Treatment Decisions olorectal cancer is the second leading cause of cancer death in the USA, and is expected to cause over 50,000 deaths in 2019, but until now, it was unclear which drugs were most effective for which patients.

Consensus Molecular Subtype

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categorizes colorectal cancer into four distinct biologically characterized subgroups based on how mutations in the tumor behave. The subgroups were created using data from several teams around the world that had previously analyzed tumors of colorectal cancer

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Biomarker Panel Accurately Predicts Risk of Mortality

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Improved Test for Ovarian Cancer varian cancer is often discovered at a late stage and has a high mortality rate. Overall 5-year survival is expected at 30% to 40% after treatment, and there has been no test specific enough to justify screening.

Women with accidental findings of an ovarian cyst or with symptoms instead undergo ultrasound and if abnormalities are seen, surgery is the only way to

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Test Indicates Need For Chemotherapy nvasive lobular carcinoma (ILC) is the most common special type of breast cancer, and is characterized by functional loss of Ecadherin, resulting in cellular adhesion defects. ILC typically present as estrogen receptor positive, grade 2 breast cancers, with a good short-term prognosis.

Many of the clinical challenges associated with diagnosing and managing patients with ILC

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eriatrics researchers used advanced metabolomic techniques to identify a panel of 14 biomarkers that can predict 5-10 year mortality risk with a high degree of accuracy. By segmenting patients at higher risk, the blood-based test panel can improve healthcare and extend lives.

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Study Urges Wider Use of C-Reactive Protein Point-of-Care Testing

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-Reactive Protein (CRP) testing in point-of-care (POC) or other primary settings, can help reduce diagnostic uncertainty by differentiating between bacterial and viral infections, and has been shown to be cost-effective toward reducing inappropriate

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Alzheimer’s Stratified by Apolipoprotein E Genotype

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lzheimer’s disease (AD) is a chronic neurodegenerative disease that usually starts slowly and gradually worsens over time.

It is the cause of 60% to 70% of cases of dementia.

Apolipoprotein E (APOE) is a protein involved in the metabo-

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lism of fats in the body. It is implicated in Alzheimer’s disease and cardiovascular disease. The gene, APOE, is mapped to chromosome 19 in a cluster with apolipoprotein C1 (APOC-I) and the apolipoprotein C2 (APOC-2). An international team of scientists led Cont’d on page 6

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Biomarker Panel Accurately Predicts Risk of Mortality cont’d from cover

To find aging-related biomarkers, Investigators at the Max Planck Institute for Biology (Cologne, Germany; www.age.mpg.de) and the Leiden University Medical Center (The Netherlands; www.lumc.nl) used a well-standardized metabolomics platform to identify metabolic predictors of long-term mortality in blood samples from 44,168 individuals (age at baseline 18–109), of whom 5512 died during follow-up.

Meta-analysis of the results enabled the investigators to identify 14 circulating biomarkers associated independently with all-cause mortality. Overall, these associations were similar in men and women and across different age strata. The set of 14 biomarkers included, among other indicators, various amino acids, levels of LDL and HDL cholesterol, fatty acid balances, and inflammatory factors.

The 14 biomarkers were involved in various metabolic processes, such as lipoprotein

and fatty acid metabolism, glycolysis, fluid balance, and inflammation. Although the majority of these biomarkers have been associated with mortality before, this is the first study to demonstrate their independent effect when combined into one model.

"The blood-based measurement is intended as a first step towards a more personalized treatment of the elderly, said senior author Dr. Eline Slagboom, professor of molecular epidemiology at the Leiden University Medical Center. "As researchers on aging, we are keen to determine the biological age. The calendar age just does not say very much about the general state of health of elderly people: one 70-year-old is healthy, while another may already be suffering from three diseases. We now have a set of biomarkers which may help to identify vulnerable elderly people, who could subsequently be treated."

The study was published in the August 20, 2019, online edition of the journal Nature Communications.

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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

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Study Urges Wider Use of C-Reactive Protein Point-of-Care Testing cont’d from cover

antibiotic prescriptions. However, despite the availability of POC devices, POC CRP testing has not yet been widely adopted in primary care clinics.

C-reactive protein (CRP) is a key mediator of the acute-phase response, with blood levels of CRP increasing rapidly after an inflammatory stimulus. Therefore, changes in serum levels of CRP are a clinically useful marker of infection, inflammation, and tissue injury.

CRP testing in the primary setting as in pointof-care (POC) can help reduce diagnostic uncertainty by differentiating between bacterial and viral infections and has been shown to be costeffective for reducing inappropriate antibiotic prescriptions. However, despite the availability of POC devices, POC CRP testing has not yet been widely adopted in primary care clinics.

Clinical laboratory scientists at the Catharina Hospital and Technical University Eindhoven (Eindhoven, The Netherland) and their colleagues evaluated a POC CPR test at three sites and one reference laboratory. Within-run (repeatability), within-laboratory (intermediate precision), and between-laboratory precision (reproducibility) were assessed. Method comparison and matrix/lot-to-lot comparison studV

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ies were conducted using prospectively collected blood samples from 217 adults (apparently healthy or with clinically relevant conditions).

The investigators compared the analytical performance of the cobas b 101 POC system, which provides glycated hemoglobin (HbA1c) and lipid panel tests (measurement of cholesterol, triglyceride, and high-density lipoprotein; calculation of low-density lipoprotein) for managing diabetes and dyslipidemia at pointof-need. This method was compared with a reference test: CRPNX reagent on a Roche cobas c 501 module.

The scientists reported that clinically relevant CRP concentrations measured with the CRP Test showed good agreement with those measured by CRPNX reagent. Coefficients of variation (CV) for repeatability and intermediate precision ranged from 1.7%–4.0% and 1.9%–4.5%, respectively, for human serum pools containing CRP 4.7–350.7 mg/L; repeatability in clinical samples ranged from 1.6%–5.9% (3.3–360.3 mg/L). CVs for reproducibility ranged from 2.5%–4.0% (4.7– 344.3 mg/L). CRP concentrations were comparable for capillary whole blood, serum, Liheparin whole blood/plasma, K2 and K3 EDTA whole blood/plasma. The overall mean usability score was 4.18/5 and the error rate across 9,378 tests was 1.00%.

The authors concluded that their findings indicate that healthcare professionals can obtain precise and reproducible CRP values with the cobas POC CRP Test that show very good correlation with laboratory measurements. Importantly, operators considered the system convenient for use in the POC environment. The study was published in the September 2019 issue of the journal Clinical Biochemistry.

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ISSN 1068-1760 Vol.36 No.6. 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.

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Whole-Blood Test for Acute Zika Infections cont’d from cover

virus infections. The stakes for an accurate diagnosis are high when congenital Zika syndrome might be involved, such as in diagnosis in pregnant women and their partners, because Zika virus infections can be sexually transmitted. Diagnostics are based on Zika virus RNA detection, detection of Zika virus–specific antibodies, or both.

Scientists at the Erasmus Medical Center (Rotterdam, the Netherlands; www.erasmusmc.nl) compared Zika virus quantitative reverse transcription PCR (qRT-PCR) results for 249 EDTA–whole blood and EDTA–plasma pairs submitted for laboratory testing from 227 patients with suspected Zika virus infection during July 2016 – May 2017.

For testing, they spiked the samples with an internal control and extracted total nucleic acids from a 500- L sample in 100 L of eluate using the MagNAPure 96 DNA and Viral NA large volume kit and Viral NA Universal LV 2.0 protocol (Roche, Basel, Switzerland; www. roche.com). They confirmed all Zika virus RNA−positive samples using a commercial Zika virus qRT-PCR (Altona Diagnostics, Hamburg, Germany; www.altona-diagnostics.com).

The team detected Zika virus RNA in 31 (12.4%) of 249 whole-blood samples and in 23 (74.2%) of the 31 corresponding plasma samples. The 31 positive whole-blood samples were collected from 31 individual patients.

This comparison indicated that eight additional Zika virus–positive patients would have been identified if whole blood had been used routinely instead of plasma. This finding represented a 34% increase in confirmed cases of Zika virus infection.

The scientists tested urine and plasma by qRT-PCR and tested serum

by ELISA (Euroimmun, Luebeck, Germany; www.euroimmun.com) for the presence of Zika virus–specific IgM and IgG. For three of the eight additional patients, Zika virus infection had already been confirmed on the basis of the presence of Zika virus RNA and IgM in an earlier plasma sample. For the remaining five patients, only a status of probable case was achieved without the whole blood testing.

The authors concluded that that individual patient care might benefit from whole-blood testing in a routine diagnostic laboratory setting, thereby possibly reducing the need for more specialized serology (i.e., comparative flavivirus neutralization tests) to confirm cases based on serology. Therefore, they have implemented whole blood RT-PCR testing for Zika virus diagnostic requests in our routine diagnostic setup. The study was published in the July 2019 issue if the journal Emerging Infectious Diseases.

Image: The RealStar Zika Virus reverse transcription polymerase chain reaction (RT-PCR) (Photo courtesy of Altona Diagnostics).

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Identifying Colorectal Cancer Subtypes Improves Treatment Decisions cont’d from cover

patients who were treated with surgery and adjuvant chemotherapy. An international team of oncology specialists led by the University of Southern California (Los Angeles, CA, USA; www.keckmedicine.org) compared the efficacy of two different therapies (chemotherapy and cetuximab versus bevacizumab) on metastatic colorectal cancer patients categorized by CMS. They characterized the CMS classification using a novel NanoString gene expression panel (Seattle, WA, USA; www.nanostring.com) on primary CRCs from 581 patients enrolled in this study to assess the prognostic and predictive value of CMSs in these patients.

The results of the study showed a strong association between a patient’s CMS subtype and both overall survival and progression-free survival. For example, patients in CMS2 had a median overall survival of 40 months compared to 15 months for patients in CMS1. CMS also was predictive of overall survival among patients on either treatment, with patients in certain subtypes faring better on one therapy over the other.

Survival for CMS1 patients on bevacizumab was twice that of those on cetuximab, whereas survival for CMS2 patients on cetuximab was six months longer than for bevacizumab.

Heinz-Josef Lenz, MD, a Professor of Medicine and lead author of the study said, “We wanted to understand the importance of CMS for patients with metastatic disease who are treated with the two most important first-line therapies. We anticipated that CMS had prognostic value, but we were impressed at how strongly CMS was associated with out-

comes. This study establishes the clinical utility of CMS in treating colorectal cancer.” The study was published on May 8, 2019, in the Journal of Clinical Oncology.

Image: Identifying a metastatic colorectal cancer patient’s Consensus Molecular Subtype (CMS) could help oncologists determine the most effective course of treatment (Photo courtesy of University of Southern California).

Test Indicates Need for Chemotherapy cont’d from cover

are directly related to this behavior, including the difficulty in imaging by mammography and obtaining clear surgical margins. Subsequently, more patients present late, with larger tumors, more frequently involved axillary lymph nodes and requiring higher frequency of mastectomies compared to patients diagnosed with invasive carcinoma of no special type (IC-NST). A large team of medical scientists led by The University of Queensland (Herston, QLD, Australia; www.uq.edu.au) accessed fresh frozen tumors and matching blood samples and used integrative analysis of gene expression and DNA copy number to identify novel drivers and prognostic biomarkers, using 25 in-house, 125 METABRIC and 146 TCGA samples.

DNA and RNA were extracted from frozen tissue sections by either collecting frozen sections directly into extraction tubes or following needle dissection to enrich for tumor cellularity, which was estimated by a pathologist from adjacent-stained frozen sections. QIAgen extraction kits were used (QIAgen, Chadstone, Australia; www.qiagen.com).

Quantification and quality assessment of nucleic acids were performed using the Qubit dsDNA BR and RNA BR assays (Invitrogen, Scoresby,

Australia; www.thermofisher.com.au) and Bioanalyzer RNA 6000 Nano assay (Agilent, Mulgrave, Australia; www.agilent.com). Gene expression profiling of UQCCR samples was performed using the WholeGenome Gene Expression Direct Hybridization Assay (Illumina, Scoresby, Australia; www.illumina.com).

The team used in silico integrative analyses, and derived a 194-gene set that was highly prognostic in ILC, that they named this metagene ‘LobSig’. Assessing a 10-year follow-up period, LobSig outperformed other similar commercial analyses. LobSig status predicted outcome with 94.6% accuracy amongst cases classified as ‘moderate-risk’. Network analysis identified few candidate pathways, though genesets related to proliferation were identified, and a LobSig-high phenotype was associated with the TCGA proliferative subtype. ILC with a poor outcome as predicted by LobSig were enriched with mutations in ERBB2, ERBB3, TP53, AKT1 and ROS1. The authors concluded that the molecular signature, LobSig, which captures the peculiar genomic landscape of ILC tumors, and together with clinico-pathology information, provides a robust mechanism for prognostication in ILC. The study was published on June 27, 2019, in the journal npj Breast Cancer.

Alzheimer’s Stratified by Apolipoprotein E Genotype cont’d from cover

by those at Boston University Schools of Medicine (Boston, MA, USA; www.bmc.org) examined exome sequence data for 5,522 unrelated individuals with AD and more than 4,900 cognitively normal control individuals, all with non-Hispanic white ancestry. After quality controls steps, they were left with data for 2,377 AD cases and 706 yet-unaffected controls that carried the APOE4 allele, along with data representing 3,145 individuals with AD and more than 4,200 control individuals who did not carry the AD-related version of APOE. The team attempted to validate potential AD contributors using data for two more cohorts: exome data for another 1,766 individuals with AD and 2,906 without, as well as 8,728 AD-affected individuals and 9,808 controls assessed by array-based genotyping. The team tracked down as many as 22 variants with potential ties to AD risk. From the discovery group and a meta-analysis done in combination with data from the replication cohorts, for example, they saw a potentially protec-

tive single nucleotide polymorphism (SNP) at the ISYNA1 locus for those carrying the AD-related APOE allele.

In the APOE4-free group, on the other hand, the team’s analysis highlighted potential AD-associated SNPs in AC099552 and in GPAA1, among others, including a variant called rs138412600 that appears to influence the expression of GPAA1 and a related repressive transcription factor called FOXG1 in the brain. In the group of cases and controls lacking the high-risk APOE ε4 allele, the scientists also flagged SNPs with shakier associations in or around genes previously implicated in AD risk, including MAPT and TREM2.

The authors concluded that their study identified multiple possible novel associations for AD with individual and aggregated rare variants in groups of individuals with and without APOE ε4 alleles that reinforce known and suggest additional pathways leading to AD. The study was published on June 10, 2019, in the journal JAMA Neurology.

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Improved Test for Ovarian Cancer cont’d from cover

make sure all cancers are detected. This means that many women are operated on without having cancer, resulting in unnecessary surgery and increased risks for women.

Biomedical scientists from Uppsala University (Uppsala, Sweden; www.uu.se) and their colleagues collected plasma samples of women with benign and malignant ovarian tumors. The discovery cohort consisted of 90 patients diagnosed with benign tumors and 79 patients with ovarian cancer stages I–IV. Samples were collected at time for primary surgery under full anesthesia, but before incision. The first replication cohort consisted of 71 patients diagnosed with benign tumors and 100 patients with ovarian cancer stages I–IV, which were collected under the same conditions as the discovery cohort. The second replication cohort consisted of 77 patients with ovarian cancer stages I–IV and the third replication cohort consisted of 106 patients with benign conditions, 28 with borderline diagnosis and 93 with ovarian cancer stages I–IV. The team compared circulating plasma levels of 593 proteins in three cohorts of patients with ovarian cancer and benign tumors, using the proximity extension assay (PEA). A combinatorial strategy was developed for identification of different multivariate biomarker signatures. A final model consisting of 11 biomarkers plus age was developed into a multiplex PEA test reporting in absolute concentrations. An additional 552 proteins were analyzed using six additional PEA-panels and real-time polymerase chain reaction (PCR) using the Fluidigm BioMark HD real-time PCR platform (South San Francisco, CA, USA; www.fluidigm.com) in the discovery and replication cohorts.

The final model was evaluated in a fourth independent cohort and has an AUC = 0.94, PPV = 0.92, sensitivity = 0.85 and specificity = 0.93 for detection of ovarian cancer stages I–IV. The novel plasma protein signature could be used to improve the diagnosis of women with adnexal ovarian mass or in screening to identify women that should be referred to specialized examination.

Ulf Gyllensten, PhD, Professor of Medical Molecular Genetics and corresponding author of the study, said, “Our results are promising enough to consider screening for early discovery of ovarian cancer. In Sweden, we have long experience of screening for cervical cancer. I see great prospects of developing a strategy for screening for ovarian cancer as well, which could save lives and minimize the need for surgery to rule out cancer.” The study was published on June 20, 2019, in the journal Communications Biology.

Image: The BioMark HD real-time polymerase chain reaction (PCR) platform (Photo courtesy of Fluidigm).

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Immune Signature Drives Leukemia Relapse After Transplantation ransplantation of hematopoietic cells from a healthy individual (allogeneic hematopoietic cell transplantation (allo-HCT)) demonstrates that adoptive immunotherapy can cure blood cancers: still, post-transplantation relapses remain frequent.

A transcriptional signature that is associated with relapse among leukemia patients who have undergone stem cell transplants has been discovered. For many patients, there is an immune pattern that occurs at relapse and could suggest a targeted therapy.

Hematologists and their associates at the IRCCS San Raffaele Scientific Institute (Milan, Italy; www.hsr.it) used samples from 40 adult patients who had undergone transplantation for acute myeloid leukemia (AML) and for whom samples had been collected at diagnosis, relapse after chemotherapy, and relapse after allo-HCT. They isolated leukemic cells from these samples and analyzed the blast cells using single nucleotide polymorphism (SNP) arrays and gene expression arrays.

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The scientists identified a transcriptional signature specific for posttransplantation relapses and highly enriched in immune-related processes, including T cell co-stimulation and antigen presentation. In two independent patient cohorts we confirmed the deregulation of multiple co-stimulatory ligands on AML blasts at post-transplantation relapse (PD-L1, B7-H3, CD80, PVRL2), mirrored by concomitant changes in circulating donor T cells.

After confirming the changes in B7H3 and CD11A levels that were indicated by the gene expression analysis, the team also noted the upregulation of PD-L1, PVRL2, and CD80 after relapse. In particular, they found that the percentage of T cells expressing PD-1 was higher among AML patients before transplantation, as compared to healthy controls, and that it levels were similarly high in patients in remission and became even higher among post-transplant relapse patients.

They also noted also noted that post-transplantation relapse patients exhibited downregulation of almost all HLA class II transcripts. When they tested T cells collected from a patient who experienced relapse after a loss of HLA class II expression, they found that this personâ&#x20AC;&#x2122;s T cells responded to the leukemia they had at diagnosis, but not at relapse. However when exposed to IFN-Îł, the leukemia cells exhibited increased HLA class II expression, allowing the T cells to once again target those cells.

The authors concluded that their results demonstrate that the deregulation of pathways involved in T cellmediated allorecognition is a distinctive feature and driver of AML relapses after allo-HCT, which can be rapidly translated into personalized therapies. The study was published on March 25, 2019, in the journal Nature Medicine.

Image: A photomicrograph of acute myeloblastic leukemia from a bone marrow sample (Photo courtesy of Shutterstock).

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Infant HIV Near Point-of-Care Test Field Evaluated erinatal human immunodeficiency virus (HIV) infection contributes to an increase in morbidity and mortality among children in their first years of life, and lack of antiretroviral treatment (ART) and late ART initiation has seen more than half of the infants infected with HIV die before their second birthday.

The first step in the provision of early infant diagnosis (EID) services and linkage to care among HIV exposed infants is early identification; however this still remains a challenge in sub-Saharan Africa (SSA). Access to HIV diagnosis for HIV-exposed infants and children is a challenge in SSA because of the processes involved in HIV detection that require use of nucleic acid amplification tests conducted by trained personnel in centralized laboratories usually based in urban centers.

Scientists at the Kenya Medical Research Institute (Kisumu, Kenya, www.kemri.org) and their colleagues screened and evaluated 3,814 mother-infant pairs who presented to clinics and hospitals in a town in Kenya in 2016. In the six-month timespan of the study, there were 921 infants enrolled who were known to be exposed to HIV based on the mother’s HIV status.

The team performed Rapid HIV testing using serial tests with Determine Rapid HIV-1/2 Antibody test (Abbott Rapid Diagnostics, Abbott Park, IL, USA; www.abbott.com) followed if positive by Unigold Rapid HIV test kits (Trinity Biotech PLC, Bray, Ireland; www.trinitybiotech.com).

The team performed a field evaluation of GeneXpert HIV-1 Qual (Cepheid, Sunnyvale, CA, USA; www.cepheid.com). The GeneXpert HIV-1 Qual Assay was performed on six different GeneXpert instruments by 10 trained laboratory technologists. The test was compared with the gold standard for EID PCR, COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, v2.0 assay (CAP/CTM HIV-1) qualitative PCR (Roche Diagnostics, Branchburg, NJ, USA; www.roche.com).

The scientists performed a total of 969 POC tests on 921 (24.6%) children who were HIV exposed. Approximately 15% of the children were tested as newborns and 49% of them tested at routine EID visit of six weeks.

The authors concluded that their study demonstrated that the GeneXpert POC EID assay has a high sensitivity and specificity and performs well in a field setting with high coverage of ART prophylaxis among mothers and children. The sensitivity and specificity of 94% and 99% respectively, does reflect the true performance of the device even though they had nine discordant results with Roche, seven were what Roche considered as “reference test” errors. The study was originally published on December 27, 2018, in the journal Public Library of Science ONE.

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Liquid Biopsy Identifies Mutations Predicting Ovarian Cancer Treatment Response ffective treatment of metastatic solid cancers is hampered by intrapatient heterogeneity, tumor evolution, and the paucity of representative tissue samples to guide treatment decisions.

Analysis of circulating tumor DNA (ctDNA) is an approach with the potential of overcoming all three obstacles. Circulating tumor DNA sampling is a clinically attractive, minimally invasive technique that is based on the observation that tumor cells leak DNA to the bloodstream, where it can be captured by genomic assays. ctDNA can be used to monitor tumor evolution, detect cancer early, and monitor treatment efficacy.

Scientists at the University of Helsinki (Helsinki, Finland; www.helsinki. fi) and their associates implemented a clinical ctDNA workflow to detect clinically actionable alterations in more than 500 cancer-related genes.

They applied the workflow to a prospective cohort consisting of 78 ctDNA samples from 12 patients with high-grade serous ovarian cancer before, during, and after treatment.

Cell-free DNA (cfDNA) was extracted from plasma samples and subjected to 1000× targeted Illumina Hi-Seq sequencing at BGI (BGI Europe A/S, Copenhagen, Denmark; www.bgi.com) using their Oseq Solid Cancer Panel with more than 500 clinically actionable gene. Potentially clinically actionable alterations were validated through immunohistochemistry (IHC) and in situ hybridization for alterations classified as most prominent, and shown to exist in patients’ tumor tissue. Serum samples were prepared and serum CA125 (IU/mL) levels were analyzed from serum using a chemiluminescent microparticle immunoassay (CMIA, Architect CA 125 II, Abbott Diagnostics, Abbott Park, IL, USA; www.abbott.com ) on an Abbott Architect i2000 system within the hospital routine.

The team reported that the results show good concordance of mutations and copy number alterations in ctDNA and tumor samples, and alterations associated with clinically available drugs were detected in seven patients (58%).

Treatment of one chemoresistant patient was changed on the basis of detection of ERBB2 amplification, and this ctDNAguided decision was followed by significant tumor shrinkage and complete normalization of the cancer antigen 125 tumor marker. The authors concluded that their results demonstrated a proof of concept for using ctDNA to guide clinical decisions. Furthermore, their results show that longitudinal ctDNA samples can be used to identify poor-responding patients after the first cycles of chemotherapy. They provided what they believe to be the first comprehensive, open-source ctDNA workflow for detecting clinically actionable alterations in solid cancers. The study was published on May 3, 2019, in the Journal of Clinical Oncology.

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Image: Circulating tumor DNA provides treatment options for the most common ovarian cancer type (Photo courtesy of the University of Turku).

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The ECL 760 features random access operation with STAT testing for clotting, immunologic and chromogenic assays. It has 27 positions for sample tubes and 23 chilled positions for reagents, diluents and cleaning solutions.

The DxA 5000 helps deliver rapid and consistent turnaround times and provides comprehensive pre-analytical sample quality detection. It also reduces the number of manual processing steps to improve lab efficiency.

The MIX-RATE X20 ESR includes a built-in mixer, scanner and printer, which automatically prints results. It holds up to 20 samples with a capability for performing up to 80 ESR tests per hour and has a reading time of 15 minutes.

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Parallel Assays Developed for Cerebrospinal Fluid Alzheimerâ&#x20AC;&#x2122;s Proteins

etailed knowledge of protein changes in cerebrospinal fluid (CSF) across healthy and diseased individuals would provide a better understanding of the onset and progression of neurodegenerative disorders. The protein concentration in CSF may change as a result of neuronal damage, altered neuronal functions or CSF flow rate. It therefore represents an exquisite source of information about the status of the central nervous system in physiological and pathological conditions.

Scientists from the KTH Royal Institute of Technology (Stockholm, Sweden; www.kth.se) selected 20 brain-enriched proteins previously identified in CSF by antibody suspension bead arrays (SBA) to be potentially biomarkers for Alzheimerâ&#x20AC;&#x2122;s disease (AD) and verified these using an orthogonal approach. They examined the same set of 94 CSF samples from patients affected by AD (including preclinical and prodromal), mild cognitive impairment (MCI), non-AD dementia and healthy individuals, which had previously been analyzed by SBA. Twenty-eight parallel reaction monitoring (PRM) assays were developed and 13 of them could be validated for protein quantification.

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Mass spectrometry analysis was performed on a Q-Exactive HF Hybrid Quadrupole-Orbitrap mass spectrometer coupled to a Dionex Ultimate 3000 RSLC Nano system (Thermo Fisher Scientific, Waltham, MA, USA; www.thermo fisher.com) for reversed phase chromatography. Samples were automatically injected onto a C18 trap column followed by a C18 EASYSpray analytical column.

The authors concluded that their study demonstrated that the application of an orthogonal method such as PRM for the verification of antibody-based experiments is a convenient approach to confirm the most robust protein profiles discovered. The comparison of data obtained by two different platforms is a very powerful approach, but the information gained should be interpreted in the light of the fact that the two methods, based on different analytical principles, present peculiar limits in protein detection and should be regarded as complementary. The study was published online on March 9, 2019, in the journal Clinica Chimica Acta.

Image: Q-Exactive HF Hybrid Quadrupole-Orbitrap mass spectrometer coupled to a Dionex Ultimate 3000 RSLC Nano system (Photo courtesy of Thermo Fisher Scientific).

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Machine-Learning System Diagnoses Genetic Diseases y informing timely targeted treatments, rapid whole-genome sequencing can improve the outcomes of seriously ill children with genetic diseases, particularly infants in neonatal and pediatric intensive care units (ICUs).

A machine-learning process and clinical natural language processing (CNLP) has been utilized to diagnose rare genetic diseases in record time. This new method is speeding answers to physicians caring for infants in intensive care and opening the door to increased use of genome sequencing as a first-line diagnostic test for babies with cryptic conditions.

A large team of scientists collaborating with the Rady Children’s Institute for Genomic Medicine (San Diego, CA, USA; www.radygenomics.org) have described a platform for population-scale, provisional diagnosis of genetic diseases with automated phenotyping and interpretation. Genome sequencing was expedited by bead-based genome library preparation directly from blood samples and sequencing of paired 100-nt reads in 15.5 hours.

The team optimized and integrated several time-saving technologies into a rapid Whole Genome Sequencing (rWGS) process to screen a child’s entire genetic makeup for thousands of genetic anomalies from a blood sample. Key components in the rWGS pipeline come from Illumina, the global leader in DNA sequencing, including Nextera DNA Flex library preparation, whole genome sequencing via the NovaSeq 6000 and the S1 flow cell format.

Speed and accuracy are enhanced by Illumina’s DRAGEN (Dynamic Read Analysis for GENomics) Bio-IT Platform (Illumina, San Diego, CA, USA; www.illumina.com).

Clinical natural language processing (CNLP) automatically extracted children’s deep phenomes from electronic health records with 80% precision and 93% recall. In 101 children with 105 genetic diseases, a mean of 4.3 CNLP-extracted phenotypic features matched the expected phenotypic features of those diseases, compared with a match of 0.9 phenotypic features used in manual interpretation. Automated, retrospective diagnoses concurred well with expert manual interpretation (97% recall and 99% precision in 95 children with 97 genetic diseases). Prospectively, the platform correctly diagnosed three of seven seriously ill ICU infants (100% precision and recall) with a mean time saving of a little over 22 hours.

Michelle Clark, PhD, the first author of the study, said, “Using machine-learning platforms doesn’t replace human experts. Instead it augments their capabilities. By informing timely targeted treatments, rapid genome sequencing can improve the outcomes of seriously ill children with genetic diseases.” The study was published on April 24, 2019, in the journal Science Translational Medicine.

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Image: The NovaSeq 6000 system offers high-throughput sequencing across a broad range of applications (Photo courtesy of Illumina).

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Lower HbA1c Levels Seen in Diabetic Liver Disease Patients iabetes is a leading cause of liver disease, with cirrhosis responsible for a considerable number of deaths in people with diabetes in the USA. The association is mediated by multiple mechanisms including dyslipidemia and altered hepatic fatty acid processing. Glycated hemoglobin or HbA1c is now widely used for this purpose in primary care, resulting in a doubling of the number of HbA1c assessments requested, and a corresponding decrease in glucose measurement. Since 2014, the use of HbA1c testing has been included in the American Diabetes Association guidelines for the diagnosis of diabetes in hospital.

Scientists at the Queen Elizabeth Hospital (Birmingham, UK; www. uhb.nhs.uk) and their colleagues collected HbA1c and random plasma glucose data for 125 people with diabetes without liver disease and for 29 people awaiting liver transplant with diabetes and cirrhosis. Cirrhosis was caused by non alcoholic fatty liver disease, hepatitis C, alcoholic liver disease, hereditary hemochromatosis, polycystic liver/kidneys, cryptogenic/non cirrhotic portal hypertension and a 1antitrypsin related disease.

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The team measured biochemical variables on the Roche c8000 analyzers (Roche Diagnostics Ltd, Burgess Hill, UK; www.roche.com) and full blood count on Beckman DxH800 analyzers (Beckman Coulter Ltd, High Wycombe, UK; www.beckman.com).

HbA1c was measured in EDTA blood using an International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) aligned TOSOH G8 ion exchange high performance liquid chromatography analyzers (Tosoh, Reading, UK; www.tosoh.com).

The scientists reported that the median (interquartile range) HbA1c was 41 (32–56) mmol/mol [5.9%] (5.1–7.3) versus 61 (52–70) mmol/mol [7.7 (6.9–8.6) %] respectively, in the diabetes with cirrhosis group versus the diabetes without cirrhosis group. The glucose concentrations were 8.4 (7.0–11.2) mmol/L versus 7.3 (5.2–11.5) mmol/L. HbA1c was depressed by 20 mmol/mol (1.8%) in 28 participants with cirrhosis but elevated by 28 mmol/mol (2.6%) in the participant with a 1 antitrypsin disorder.

Those with cirrhosis and depressed HbA1c had fewer larger erythrocytes, and higher red cell distribution width and reticulocyte count. This was reflected in the positive association of glucose with mean cell volume and hemoglobin level and the negative association for HbA1c in the diabetes group with cirrhosis.

The authors concluded that cirrhosis of the liver affects the accuracy of HbA1c results, leading to unreliable estimates of blood glucose over the previous 2 to 3 months. Anemia in people with cirrhosis awaiting liver transplant is associated with altered red blood cell morphology. The study was originally published in the May 2019 issue of the journal Diabetic Medicine.

Image: The TOSOH G8 ion exchange high performance liquid chromatography analyzer (Photo courtesy of Tosoh Bioscience).

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PRODUCT NEWS ELECTROLYTE ANALYZER

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The E-Lyte Plus measures the concentration of K+, Na+, Cl-, Ca++ and pH in whole blood, serum and urine samples. It features a touch screen with intuitive interface, a barcode and LIS connectivity capability and built-in printer.

The ILab Aries can perform photometry, turbidimetry and potentiometry tests with a throughput of up to 280 photometric +160 ISE tests/hour.

The complete system is made up by instrument, reagents and validated applications.

The Hepatitis C Virus kit uses the double antigen sandwich method to detect HCV antibody in serum or plasma samples. The rapid kit is easy to operate without special instruments and results can be interpreted within 20 minutes.

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New Test May Replace ELISA For Detecting Antibodies microwire-based test may replace enzyme-linked immunosorbent assay (ELISA) as the primary method to detect antibodies specific for pathogenic microorganisms in patient’s sera.

Detection of viral infection is commonly performed using serological techniques like ELISA to detect antibody responses. Such assays may also be used to determine the infection phase based on isotype (IgG or IgM) prevalence. However, ELISAs demonstrate limited sensitivity and are difficult to perform at the point of care.

Investigators at Colorado State University (Fort Collins, USA; www.colostate.edu) have described a method for detecting antibodies against pathogenic viruses with sensitivity significantly better than ELISA. Their method reportedly enables label-free, rapid detection of ultralow concentrations of virus specific antibodies.

The simple test comprised a capacitive biosensor that incorporated gold microwires coated with Zika or Chikungunya virus enve-

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lope antigen. An electrical current passed through the wire created a charge on the wire.

Antibodies from the patient’s sample bound to the viral proteins on the wire, which increased the outside mass. In addition, antibody binding increased the ability of the wire to hold the charge. By measuring the change in mass, it was possible to quantify the number of antibodies on the surface of the wire.

The investigators reported that with little discernable nonspecific binding, the sensor could detect as few as 10 antibody molecules in a small volume (30 microliters) of fluid within a few minutes. It could also be used to rapidly, specifically, and accurately determine the isotype of antigen-specific antibodies.

“This type of research project is something that none of us could do on our own,” said senior author Dr. Brian Geiss, associate professor of microbiology, immunology, and pathology at Colorado State University. “We synergized our efforts to come up with new solutions to problems we are hoping will eventual-

ly be used in clinical settings. We hope that it can be used for point-of-care diagnostics, and that it can be developed into a compact handheld system that can be used in the clinic or in resource-limited areas.”

The microwire antibody detection method was described in the April 15, 2019, issue of the journal Biosensors and Bioelectronics.

Image: Dr. Brian Geiss displays a gold microwire that is one-fourth the size of a human hair (Photo courtesy of John Eisele, Colorado State University Photography).

Fecal Microbes Used to Diagnose Liver Cirrhosis onalcoholic fatty liver disease (NAFLD) is the most prevalent cause of chronic liver disease worldwide, and yet remains largely underdiagnosed even in individuals with advanced stage of the disease. NAFLD-cirrhosis represents the most severe stage of the disease, carries a significant risk of hepatocellular carcinoma (HCC), and is consistently identified as the most important predictor of liver-related morbidity-mortality in NAFLD. Medical scientists at the University of California San Diego (La Jolla, CA, USA: https://ucsd.edu) and their associates analyzed the microbial makeup of stool samples from 98 people known to have some form of NAFLD and 105 of their first-degree relatives, including some twins. The study included 26 probands with NAFLD-cirrhosis and 37 of their firstdegree relatives. At the time of each visit, patients provided stool samples. These were collected and immediately stored in a −80 °C freezer.

DNA extraction and 16S rRNA amplicon sequencing were done and DNA was extracted using the Qiagen MagAttract PowerSoil DNA kit

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(Qiagen, Hilden, Germany; www.qiagen.com). Amplicon PCR was performed on the V4 region of the 16S rRNA gene using the primer pair 515 f to 806r with Golay error-correcting barcodes on the reverse primer. Amplicons were barcoded and pooled in equal concentrations for sequencing. The amplicon pool was purified with the MO BIO UltraClean PCR cleanup kit (Carlsbad, CA USA; https://mobio.com) and sequenced on the MiSeq sequencing platform (Illumina, San Diego, CA, USA; www.illumina.com).

The team identified 27 unique bacterial features unique to the gut microbiomes from stools of people with NAFLD-cirrhosis. They were able to use this noninvasive stool test to pick out the people with known NAFLD-cirrhosis with 92% accuracy, but more importantly, the test allowed them to differentiate the first-degree relative with previously undiagnosed NAFLD-cirrhosis with 87% accuracy. The results were confirmed by magnetic resonance imaging (MRI). The study was published on March 29, 2019, in the journal Nature Communications.

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PRODUCT NEWS IMMUNOASSAY ANALYZER

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HEMOGLOBIN TEST SYSTEM

CHEMISTRY ANALYZER

Abbott Diagnostics

Bio-Rad Laboratories

Agappe

The ARCHITECT i2000SR features a load capacity of 135 samples with 35 priority and 100 routine areas.

With 25 refrigerated reagent positions, and throughput of 200 tests /hour, it can integrate with the c8000 or c16000 systems.

The D-10 combines diabetes and ß-thalassemia testing on a single platform and features a startup checklist and touch screen operation. Its one-step cartridge switching and automatic barcode reading increase workflow efficiency.

The TBA120FR Pearl edition offers a high throughput of 800 tests per hour / 1,200 tests per hour (ISE). It features molded hard glass cuvettes with long life and a dual reagent compartment to hold 56 R1 and 56 R2 reagents.

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HDL Cholesterol Measurement Unaffected by Serum Amyloid A

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igh-density lipoprotein cholesterol (HDL) is known as the antiatherogenic lipoprotein. Epidemiological studies have shown that low plasma concentrations of HDL are associated with an increased risk of cardiovascular events. HDL-cholesterol (HDL-C) is the only standardized parameter available to estimate the plasma HDL concentration. Serum amyloid A (SAA) is a highly conserved, acute phase protein that is predominantly synthesized by the liver. During acute inflammation, SAA concentrations in the serum can increase to up to 1000-fold of the basal levels. Under these conditions, SAA displaces apolipoprotein A-I (apoA-I) in HDL and becomes the major apolipoprotein of circulating HDL. Clinical biochemists from the Tokyo Medical and Dental University (Tokyo, Japan; www.tmd.ac.jp) and their colleagues obtained anonymized serum samples with various C-reactive protein (CRP) concentrations from 248 patients without clinically apparent liver disease. The SAA concentration of the serum samples were measured by latex agglutination turbidimetric immunoassay, and the serum samples were stratified into three groups, based on their SAA concentrations: low SAA (SAA ≤ 8 μg/mL, n = 94), middle SAA (8 < SAA ≤ 100 μg/mL, n = 37), and high SAA (SAA > 100 μg/mL, n = 117).

The team performed all assays on an automatic analyzer, JCABM8000 series (JEOL, Tokyo, Japan; www.jeol.co.jp). SAA and CRP were measured by the latex agglutination turbidimetric immunoassay using the LZ test ‘Eiken’ SAA (Eiken Chemical, Tokyo, Japan; www. eiken.co.jp) and CRP-latexX2 (Denka Seiken, Tokyo, Japan; https:// denka-seiken.com), respectively. HDL-C, low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC) and triglyceride (TG) levels were determined using commercial assays. The evaluation of HDL particle size was done with whole lipoproteins isolated by ultracentrifugation from randomly selected serum samples of patients with low or high SAA concentrations and was dialyzed against PBS and subjected to native-gel electrophoresis (native-PAGE) using 8% polyacrylamide gels.

The team reported that HDLs obtained from patients with low SAA concentrations were separated into their general particle sizes and classified as HDL2 and HDL3 by native-gel electrophoresis. On the other hand, HDLs obtained from patients with high SAA concentrations occasionally showed distributions different from the typical sizes of HDL2 and HDL3, such as extremely small or large particles. Nevertheless, HDL-C concentrations measured using the homogeneous assay was strongly correlated with those measured using the ultracentrifugation method, regardless of the SAA concentrations. The study was published in the January 2019 issue of the journal Clinical Biochemistry.

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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

15th Asia-Pacific Congress to be Held at Jaipur, India on November 15-19, 2019 An Invitation to Young Scientists for the Extensive Scientific Program

By Prof Pradeep Kumar Dabla, Chair IFCC-TFYS n behalf of Organizing Committee APFCB 2019, it is our immense pleasure to invite you all to join exciting and informative scientific programme encompassing plenary lectures, symposia and workshops related to themes close to heart of Laboratory Medicine and Clinical Chemistry to be delivered by hundreds of world-renowned experts. Congress is being organized at state-of-the-art Jaipur Exhibition & Convention Centre. Jaipur is popular as “Pink City” and situated in the royal deserts of the Rajasthan state. This beautiful city of monuments and forts was founded by Maharaja Sawai Jai Singh II in the year of 1727 AD. IFCC-TFYS is able to continue education programmes with continuous and throughout support of senior members APFCB and IFCC especially Organising Chairperson Prof Praveen Sharma, APFCB 2019. IFCCCCLM and IFCC-TFYS is organiz-

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ing a pre-congress joint workshop titled “Building Tomorrow's Leaders by the Young Generation” delivering informative and encouraging talks

by Prof Praveen Sharma, Prof Edward Randell, Dr Pradeep K Dabla and Prof Sedef Yenice to be held on November 17, 2019. Further, IFCCTFYS is organizing symposium 26, November 19, 2019 titled “Clinical Chemistry to Clinical Laboratory Science – Future Challenges” to be chaired by Prof Maurizio Ferrari, President IFCC and Dr Pradeep K Dabla, Chair IFCC-TFYS. The symposium includes refreshing and distinguished talks by Core Members Dr Guilaine Boursier, Dr Santiago Fares Taie, Dr Giulia Sancesario and Dr Joe El-Khoury.

APFCB 2019 is coming with excellent and numerous Awards and Bursaries for young scientists to join congress from different authorities. IFCC is awarding 5 Roche Scholarships, APFCB is awarding 12 Scholarships, ACBI is supporting 20 Bursaries and Awards. Promoting education and research for young colleagues, IFCC-TFYS is able to provide “IFCC-TFYS Snibe Travel Awards” with generous support by Snibe to join and present research work at APFCB 2019. “3 Young Scientists” will be selected for travel awards and each Award will consist of a certificate and amount value of the sum SGD 1000. TFYS is thankful to all senior members and authorities for grand support to young scientists to join this academic feast.

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Prof. Praveen Sharma, Chairman, Organizing Committee - APFCB 2019; Prof. Pradeep K Dabla, Chair IFCC-TFYS, Convener Scientific Committee APFCB 2019

NEWS

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

Editorial

by Katherina Psarra MSc, PhD eptember is here again and most of us are back to work with full batteries (I hope) and wishes for a S pleasant return. We are all looking forward to new developments at work trying to keep pace with them. They are these developments in our lab work that make our life much more interesting and full of surprises.

In this IFCC Corner we can find out a lot about these

developments. People in IFCC committees and workgroups are studying them and are trying to make them easy and accessible to colleagues all over the world.

Should we adopt them? Under which circumstances?

Go through the articles and discover what is new, what is worth trying and what you should all know for the present and for the future of these new areas. Discover the people and the societies in order to connect with them.

Don’t forget the congresses and meetings lying ahead.

Welcome back to the fascinating lab word!

SIBioc-ELAS 2019: Emerging Visions in LabMed Innovation and Digital Health

by Dr Bernard GOUGET, chair IFCC C-MHBLM, President-Healthcare Division Committee-Comité Français d’accréditation (Cofrac); Prof Damien GRUSON, EC-Member IFCC-ETD; Prof Sergio BERNARDINI, Chair-IFCC-ETD he SIbioC-ELAS (European Ligand Assay Society) conference in 2019, was organized on May 6-8 in Modena (IT). A city declared a “Unesco World Heritage Site” since 1997. It is the second most populated area in the Emilia-Romagna Region, just after the neighbouring capital Bologna. Modena has a famous University dated from 1175 which is the fifth oldest one in the world!

Italian and international “tenors” from SiBioc, IFCC-ETD, IFCC-MHBLM and EFLM-EB members were welcomed the first day of the conference entitled “Expectations of Lab Medicine in the 2020’s” at the “College San Carlo Foundation, prestigious complex, located in the historic center of Modena, in a baroque palace from the 17th century”. This foundation is active in the field of philosophy, the humanities and the social and religious sciences.

All settings successfully met to highlight the challenges and innovation in medical diagnostic and Clinical Lab Medicine!

The morning session was chaired by Tomris Ozben, Tomas Zima and Mario Plebani. Graham Beastall, great well-known lecturer, inspiration to many, faithful friend, lightened us to move forward to the added value of Lab Medicine and its central role in healthcare. He presented the mnemonic added value ‘SCIENCE’ tool which is covering seven domains: standardization and harmonization; clinical effectiveness; innovation; evidence-based practice; novel applications; cost-effectiveness; and education of others.

This assessment includes three dimensions: operational efficiency; patient management; and patient behaviors.” Leadership is required at international, national and local level,” he said, “the time is now right to look outside the laboratory”. Andrew St John, from the Australasian Association of Clinical Biochemists (AACB) defined the concept of a “Value Proposition for Medical Testing” as the provision of information to enable clinicians and other stakeholders to make better decisions about the care of individual patients. This concept relies on better translation of global evidence into local and effective implementation of a test and requires a new skill set for the profession such as understanding economic modelling. Khosrow Adeli, illustrated the critical need for innovative IFCC e-communication strategies as electronic chat rooms, fully Online e-Conferences, WebCasts/Webinars, and expansion of distance education with the e-Academy.

A new generation of technology is changing our lives and profession, from the everyday use of satnavs and smartphones through the profound ability of genomics helping us to develop precision medicine. A large part of the conference was dedicated to discuss the current topics at excellence in Lab Med and in digital health, the e-technologies, AI, m-Health and eHealth as well as to develop the IFCC-ETD strategic vision.

Artificial Intelligence is the hottest topic at the moment in both technology and in medicine at large. Hardly a day goes by without promising research papers and studies being published on how to apply machine and deep learning methods to medical problems. The mention of AI makes companies’ prospects better on any market, hyping and overmarketing what an algorithm can do, is an everyday phenomenon. It is not an easy task to separate the wheat from the chaff. As Jean Christophe Mestres, (GIS Healthcare) said: “Only digital health can bring healthcare into the 21st century and make patients the point-of-care”. AI is likely to transform all areas of health and medicine towards clinical decision-making. Our role is to prepare everyone for the adoption of innovative, disruptive and smart technologies while keeping the human touch. AI in healthcare and medicine could organize patient routes, intelligent disease monitoring or treatment plans better, and also provide health professionals with literally all the information they need to make a good decision. More communication to the general public about the potential advantages and risks of using AI

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in medicine is needed, it is the only way to bring the promise of science fiction into reality and turn AI into “the stethoscope of the 21st century”.

Damien Gruson stressed the fact that digital technologies will impact organization and lab workforce. The convergence of genomics, biosensors, electronic medical records, smartphone apps, and robotics will change the role and functions of the laboratory staff. Technological innovations will increasingly shift the balance of care toward more centralized care and decentralized less specialized care.

The presence of the EFLM President, Michael Neumaier, let us learn about the latest advances in immunology, to understand the existing paradigm of the bipartisan immune system and to get information on immune receptors from myeloid cells and models for functional studies. Then, Maurizio Ferrari, provided an overview of the applications of NGS in diagnostic. The scale and efficiency of high–throughput DNA sequencing technologies that can now be achieved is providing unprecedented progress in areas from the analysis of genomes themselves to how proteins interact with nucleic acids.

He highlighted the breadth of next–generation sequencing applications and the importance of the insights that are being gained through these methods in different biological fields.

As an introduction to the Roundtable, chaired by Bernard Gouget, Tricia Ravalico, IFCC CPD-CM, presented the “Univants of Health care excellence Award” which is recognizing integrated clinical care teams that are driving measurably better healthcare performance. The use of automation, robotics, has become widespread in clinical laboratories. Representatives from the industry reported their latest innovations. Michael Frandsen presented the transport pipeline “Tempus 600” designed for blood and other small clinical samples allowing to save crucial time by transporting biological samples quickly and Andrea Pedrazzini (Impeco) spoke about the leading-edge systems to automate the entire diagnostic cycle for the perfect total testing process. A video, by Health tech Fly Ltd, explained the advantages of the use of drones in healthcare, illustrated by the Naples experience to deliver, blood, vaccines, tubes, organs, and other medical supplies.

The drones allowed to reach rural areas and to have the ability to reach victims who require immediate medical attention within minutes, which in some cases could mean the difference between life and death. They can also be used within hospital walls and courier blood between hospital buildings.

At the end of the day, everyone, according to their affinities, had the opportunity to visit the Duomo, international masterpiece of the Romanesque style, the Plaza Grande, to buy parmesan cheese and the traditional balsamic vinegar at the Albinelli Covered Market or to take a rest listening Luciano Pavarotti, most famous tenor of the 20th century. At dinner, we were delighted with the typical Modenese cuisine (salami, zampone, cotechino sausages) and so famous Lambrusco wine. On the second day, at the Maserati headquarters, we followed the entire production process, subject to numerous automated check that ensured total quality, of very impressive high standards!

IFCC OFFICE Via Carlo Farini 81, 20159 Milan, ITALY Tel: (39) 02-6680-9912 • E-mail: ifcc@ifcc.org • Web: www.ifcc.org Office Hours: 8:30-12:30 and 13:00-17:00 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.

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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

Introducing IFCC Working Group on Patient Based Real Time Quality Control

By Tony Badrick (Chair), Andreas Bietenbeck, Mark A Cervinski, Alex Katayev, Tze Ping Loh and Huub H van Rossum (Members of the IFCC WG on Patient Based Real Time Quality Control) he use of patient sample derived Quality Control techniques has been described for more than fifty years. These samples have been widely used routinely in hematology for over forty years, however, because of practical issues they have not been widely utilized in clinical chemistry laboratories1. Recently because of the availability of middleware and a greater appreciation of the benefits of these processes, there has been a willingness to investigate their use as a QC tool.

Patient Based Real Time Quality Control (PBRTQC) techniques use parameters calculated from patient samples in real time as a form of Quality Control. The advantages of a patient-based system are many.

The relatively low frequency of use of conventional QC samples can lead to poor error detection and a risk of release of inaccurate patient results. Non-commutability of conventional QC material leads to higher rates of false rejection and lower rates of true error detection. In addition to this problem, some QC materials may have different measured concentrations on different analyzers because of matrix effects.

PBRTQC processes are also sensitive to pre-analytical errors such as transport or sample preparation. There may be a lack of conventional QC material for some uncommon assays, and the use of PBRTQC techniques can significantly reduce the volume of conventional QC material and hence cost. The fact that PBRTQC methods are real time processes allows earlier detection of a problem.

PBRTQC systems are much like conventional QC in that a parameter such as the population mean, or median is calculated for a given number of patient samples (the block size) and updated with the analysis of each new sample2. The new mean is compared with predetermined control limits (based on the SD of the population mean) and if within these limits, the assay is considered in control. In some assays it is necessary to exclude very high or low results, as they can be encountered clinically, to ensure that the mean is not unduly affected by outlier results. The process of removing these outliers is called truncation of the population. Sometimes it is necessary to have more than one population (eg inpatient and outpatient) for some assays where there is a significant difference between these groups (eg calcium). However, this is usually not the case. In addition to a PBRTQC based on an arithmetic mean, a laboratory can also choose to use a weighted mean where recent samples have a greater impact on the calculation. As well as means and medians, other parameters that are used in PBRTQC include data transformations such as logarithms of the mean or median, square roots of results, and the percentage of abnormal results.

The disadvantages of PBRTQC are primarily the initial complexity of finding the optimal algorithm with associated block size and truncation limits. There is a need to understand the patient populations as well as the underlying characteristics of the analyte and the analytical method being used. Often it is necessary to model the process to find the best combination and this is a challenge when current middleware and instrumentbased software are not available for this purpose3. Middleware and analyser software need to have the capability to offer a range of different calculations and algorithms to allow laboratories to at least extract patient data in order simulations to be undertaken that will allow a laboratory to confidently select and validate the optimal PBRTQC models.

An IFCC Working group has been formed under the auspices of the Committee on Analytical Quality with the following goals: 1) To provide awareness, education and training on PBRTQC systems in the clinical laboratory which include: Guidance on the principles of PBRTQC and its implementation Develop practical recommendations for verification procedures for laboratories adopting PBRTQC, based on sound statistical principles Improve the sensitivity of error detection

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and reduce false rejection rates due to the lack of commutability of commercially available QC materials Reduce the number of repeated testing and correcting results due to the constant real time control of analytical instrument performance Improve cost-efficiency of QC procedures by reducing the use of conventional control materials Use state of the art statistical algorithms based on risk assessment and analyte and method-specific rejection rules Allow laboratory personnel to visually assess multiple instrument performance parameters on a single dashboard and ability to receive visual, audible, or electronic alerts when significant errors are detected 2) To Promote the implementation of PBRTQC by industry engagement and participation: Actively engage with instrument, middleware and laboratory information system providers to discuss IT requirements and algorithms for optimal implementation in routine clinical laboratories 3) Education and training will be provided through multiple channels to ensure widest reach, including: Guidance documents and publications Online presentations Workshops and seminars Consultation and advice to laboratory practitioners and industry 4) To collaborate with other IFCC Committees, Working Groups, professional bodies and industry partners to achieve these aims.

It is inevitable that PBRTQC techniques will be in widespread use in the future. For high volume assays they are superior to conventional QC. For small batch type assays where the QC samples can be used to bracket patient samples, conventional QC has a place. The next areas of work with PBRTQC will be in semi-quantitative assays where some instrument signal such as signal/cutoff value will be used as the moving parameter. The future may also include using Artificial Intelligence to look for patterns of results such as they would occur if a common instrument measuring device is affected (ISE) or there are common reagents on multiple analysers. In the future the Working Group will call for interest expression by members from industry.

References 1. A primer on patient-based quality control techniques. Badrick T, Cervinski M, Loh TP. Clin Biochem 2019; 64: 1-5.

2. Patient-based real-time quality control: review and recommendations. Tony Badrick, Andreas Bietenbeck, Mark A Cervinski, Alex Katayev, Huub H van Rossum, Tze Ping Loh. Clin Chem 65(8); 972-981: 2019.

3. Recommendations for laboratory informatics specifications needed for the application of patient-based real time quality control. Tze Ping Loh, Andreas Bietenbeck, Mark A Cervinski, Alex Katayev, Huub H van Rossum, Tony Badrick. Clin Chim Acta 2019; 495: 625-629.

NEWS

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

Introducing: IFCC Working Group on Guidance for The Implementation of Custom-Made Genomic Panels he new working Group on Guidance for the Implementation of Custom-made Genomic Panels (CGP) is part of the new Emerging Technology Division (ETD). The ETD provides current awareness of emerging technologies likely to have important roles in clinical diagnostics in the near future. The WGCGP will address the difficulties developing countries may have in the implementation and interpretation of genomic findings by providing educational materials, access to industry partners and a practical framework.

Next generation sequencing (NGS) and other genomic tools are increasingly being used as part of the diagnostic work-up in the academic medical oncology hospital setting. Implementation of NGS assays can be costly and complex, which can be pro- Photo: Top row from left to right: Mohan Narasimhamurthy, Martin Carroll, Yehoda Martei, Concetta hibitive in a setting with limited genomic experience, Santonocito, Kurtis Davies, Jennifer Morrissette; bottom row from left to right: Carmela Paolillo, Mark such as a community hospital. Genomic technolo- Ewalt, Melina Marmarelis, Oyetunji Soriyan, Robyn Sussman, Jeremy Segal gies are diverse and can range from relatively simple point-of-care testing for clinically relevant targets to very complex testing will address the basic principles of genomics and genomic assays; our of the whole genome or whole transcriptome. Timely detection of tar- website will serve as a resource for anyone validating a genomic assay getable mutations is beneficial to patients, and therefore clinically validat- regardless of location. The website will also facilitate partnership between industry leaders and laboratories moving into genomics by suged testing of critical molecular targets in-house is desired.

The members of the CGP include an international team of individuals gesting appropriate equipment, reagents and analysis components necwith broad expertise in clinical genomics (ME, JM, JS), laboratory med- essary for genomic assays. The members will write a manuscript that will icine (ME, JS, OS, JM), test development (RS, KD, CP, CS), pathologi- summarize the multiple papers that describe validation and reporting of cal diagnostics (OS, MN, JS, ME) and medical oncology (YM, MM, MC). genomic testing, and provide suggestions for best practices, including The terms of reference for this new working group are First, to develop examples of how to interrogate the different performance characteristics a current awareness website on genomics that will include educational required for clinical validation.

Genomic testing in the community hospital can be difficult due to material for genomic test development, a directory of companies active in the clinical diagnostic applications of oncology driven NGS panels, lack of proficiency needed for validation and analysis, which is comlinks to educational webinars and seminal papers in genomics. Second, pounded in nations that have more limited local expertise. The clinicompose a manuscript describing best practices for validation of cus- cal needs for mutation detection can differ considerably between tom-made genomic panels. Third, to research a manuscript opinion on countries due to different rates of cancers and available treatment opbest practices for moving genomics into emerging economies. Lastly, to tions. The working group will survey clinicians to better understand aid in the identification of an appropriate hospital or clinic to perform ge- the local needs in emerging nations, and write a manuscript detailing our findings. Through this process we hope to identify hospitals or nomic testing associated with targeted therapy in the oncology setting.

The biggest hurdles for implementation of custom-made or off-the- clinics where genomic testing will improve the health care of the local shelf genomic testing are the lack of trained personnel, scalability, cost community, and help validate and implement routine clinical testing in and determining the right fit for the hospital. Our educational component these locations.

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IFCC Working Group on Continuous Glucose Monitoring

by Dr Guido Freckmann, IFCC WG on n July, a new IFCC working group has been established. The â&#x20AC;&#x153;Working Group on Continuous Glucose Monitoring (WG-CGM)â&#x20AC;? was initiated by Dr. Guido Freckmann, Chair and his Co-Chair Dr. Robbert Slingerland. Both have a background in glucose monitoring and recognized the urgent need for quality control of systems for continuous glucose monitoring (CGM) that are increasingly used by patients with diabetes. CGM systems measure the glucose concentration in interstitial fluid (which is usually but not always lagging behind the blood glucose concentration). By using smart algorithms CGM systems try to predict the actual blood glucose concentration.

In contrast to blood glucose monitoring systems, which are well-regulated, there are no standards for CGM systems or established metrics to describe accuracy. In addition, as they measure glucose in the interstitial fluid, CGM values cannot easily be traced to higher order materials or methods.

Recently, Time in Range (TiR), i.e. the absolute time or percentage of time a person with diabetes spends in certain predefined glucose concentration ranges, has been established as a new "biomarker" of glycemic control, complementing HbA1c as a marker that better reflects short-term therapy effects and, in addition, delivers information on high and low values while HbA1c is an average. For the successful application of TiR it is essential that glucose concentrations measured by CGM are traceable and that different CGM systems provide comparable values for the respective TiR. The aim of this working group is to establish the traceability of glucose values obtained by CGM to materials and methods of higher metrological order, and to establish suitable metrics for the evaluation of the analytical performance of CGM. To obtain traceability it is necessary to define the measurand, i.e. the substance, the matrix (and the unit). It needs, e.g., to

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Continuous Glucose Monitoring Chair be specified whether a CGM systems aims to predict capillary blood or venous blood glucose values. Suitable means sufficient for establishing the traceability, appropriate for calibration of CGM systems or for use as reference in analytical performance studies.

In the last decade, a large number of publications about analytical performance results from clinical trials were published. In combination with publications focusing on factors influencing apparent analytical performance, a standardized set of study procedures may be derived from the literature through literature review and subsequent modelling/simulation of these factorsâ&#x20AC;&#x2122; effect on analytical performance. Additional experimental work may be required if certain influencing factors are not sufficiently defined.

Metrics and corresponding acceptance criteria that are suitable to assess the analytical performance of CGM systems need to be identified from the vast array of parameters used in the literature. Metrics should not only focus on analytical performance, but also reflect clinical relevance of glucose values obtained by CGM. Experimental work will likely be helpful in establishing metrics and acceptance criteria, because study procedures are known to impact the apparent analytical performance. After standardized study procedures are established, suitable metrics and acceptance criteria may be derived from experimental results or model simulations.

The working group intends to cooperate with ISO to define acceptable procedures and acceptance criteria to assess analytical performance criteria of CGM systems, with similar scope as that of ISO 15197, which defines procedures and acceptance criteria for systems for self-monitoring of blood glucose. In addition criteria for professional use (e.g. in hospitals) need to be defined.

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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

Measurable Impact of the Clinical Laboratory to Patients, Clinicians and Health Systems tatistics that link test results from the Clinical Laboratory to their usefulness in medical decisions have been widely shared by experts and cited in publications for years. Those figures, while impressively connecting 70-90% of all medical decisions to clinical diagnostics, are also limiting in scope in that does not fully comprehend the emerging value of the Clinical Laboratory as a strategic collaborative asset in transforming healthcare. Stating it differently, the value of Clinical Laboratory extends beyond the impact of their test results to medical decisions and can be directly associated with measurable impact to key performance indicators (KPIs) across the entire care continuum.

Representative examples of such best practices have been highlighted as part of the UNIVANTS of Healthcare Excellence Program.

The UNIVANTS of Healthcare Excellence Program is a prestigious, global award offered annually to integrated clinical care teams who have partnered together across disciplines to leverage data and insights from the Clinical Laboratory to transform the delivery of care. Led by Abbott and offered in partnership with IFCC, AACC, EHMA, Modern Healthcare, HIMSS, NAHQ and IHE, this award has inspired hundreds of care teams to share their successful best practices or begin new ones.

Last month, twelve care teams with leading examples of measurable success to patients, payors, clinicians and health systems were recognized for their innovation and collaboration. It is not surprising that 81% of the submitted care projects for the 2019 awards involved increased clinician confidence. It may be surprising, however, to appreciate that 75% of the submitted care projects were directly associated decreasing overall healthcare costs for payors. Similarly, over 50% were directly associated with improving patient safety with many were also associated with improvements to resource optimization, patient length of stay, and improved patient experience.

While only 4 KPIs (one for each stakeholder of patients, payors, clinicians and health systems) are required for each application, the average KPI per application was 7 with a median of 9. A standout care project among those honored this year for DISTINCTION was Hamilton Health Sciences and Population Health Research Institute. This brilliant and cross-disciplinary team in Ontario, Canada was able to quantify the value of their VISION initiative which touched over 40,000 patients across 28 centers in 14 countries and 5 continents with over 33 unique KPIs including improved patient diagnosis, patient wellness and decreased mortality.

Thus, partnerships and innovation across care teams can have substantial and quantifiable value.

There are no better experts in laboratory medicine than those who work within the Clinical Laboratory.

When utilized to their maximum value, not just for the transaction exchange of high quality test results, but for their critical role in driving insights and transformation to care

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Photo (From left to right) PJ Devereaux, MD, PhD, Director, Division of Perioperative Care, McMaster University; Peter Kavsak, PhD, Clinical Biochemist, Juravinski Hospital and Cancer Centre, Hamilton Regional Laboratory Medicine Program, and Professor, Department of Pathology and Molecular Medicine, McMaster University; Matthew McQueen, MB ChB, PhD, Professor Emeritus, Pathology and Molecular Medicine, McMaster University

processes, the impact is not only significant but often extraordinary.

Learn more about the 12 teams that were recognized in 2019 by visiting the program website at www.UnivantsHCE.com. In addition, applications for the 2020 awards are now being accepted for the UNIVANTS of Healthcare Excellence Program.

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NEWS

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

VIEWPOINT

How AI will Change Work and Careers in Lab Medicine?

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)

rtificial Intelligence (AI) is a quickly-expanding research field that is at the heart of Laboratory Medicine of the future. Beyond the concrete applications that have already been integrated into everyday life, AI makes it possible to process data, provides a great deal of heterogeneous knowledge and helps in understanding complex and abstract rules in the same way as human intelligence but without the involvement of thereof. AI combines two properties, self-learning through the successive and repetitive processing of data, and adaptability, i.e., the possibility for a coded program to process multiple situations that can vary over time.

AI is already applied to various types of data: textual data, such as medical reports, laboratory testing with biomarkers, genetics or even in radiology, thanks to big data, with task shifting in interventional imaging.

It opens up promising prospects: improving the earliness, speed and relevance of diagnosis, detecting side effects, personalizing therapies, predicting the progress of a disease, optimizing biological and pharmaceutical research or improving patient monitoring and quality of life via connected objects, smart prostheses and assisted surgery. AI coupled with robotics will lead to the emergence of partially autonomous tools endowed with high precision.

The spectacular acceleration of developments and successes of AI has been initiated to a great extent by the availability and ease of ac-

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cess to large quantities of data of all types, and by large storage and computing capacities, internally or in the cloud. There is clearly a mirror effect between the development of AI solutions and setting up a robust and sustainable information architecture.

One does not happen without the other. AI enriches the information system with new data and allows hierarchizing the importance of information. Moreover, ethical and transparent AI reveals possible biases and corrects for them by suggesting new data to integrate into the information system.

AI is a key technological building block in digital transformation. The key question is knowing whether AI represents a technological breakthrough such that work will be transformed abruptly, with major repercussions on employment, or if it is part of the continuity of the digital transformations that have been going on for several decades. While AI raises fears because of the increased automation of work, it is also a technology that provides productivity gains and is therefore a source of wealth that promises to put an end to the most tedious tasks. It can improve coordination processes between the various healthcare actors, optimize production flow and allow better a better quality of care. It will also change the boundaries between the health professions. While some people fear a devaluation of skills and loss of independence, on the contrary, new professions will emerge with improved working conditions. This is an opportunity to free time and add value to relational activities between providers and patients, and to further benefit from the advantages of scientific search engines. AI is a formidable opportunity to innovate and create the healthcare of tomorrow, based on the search for excellence. The degree to which AI will spread in professional practices obviously depends on its costs and the profitability of its impact on provider teams and will also rely on the extent of the demographic and regulatory context, social acceptability, education level, available skills and economic context.

The impacts of artificial intelligence may be exerted on both the volume of jobs and the contents of the work since it is no longer a question of increasing physical strength, agility or speed, as in prior industrial revolutions, but rather performing cognitive tasks. The effects of AI on qualifications are complex and will depend on organizational choices: advanced automation or human-machine complementarity. This will influence the skills that are indispensable to the development of laboratory medicine. If we do not commit major and concerted efforts now, in terms of training, we risk seeing the appearance or widening of a massive disconnect between demand and supply tomorrow. In the digital era, human capital is the key to competitiveness. Educational and training systems must evolve to adjust to new skills. Artificial Intelligence will be able to make the education more efficient and engaging, facilitating more customizable approaches to learning both for professors and students. The online education systems will learn as the students learn, understanding their needs and supporting them with a tailor-made itinerary. Also, learning analytics will accelerate the development of new tools for personalized education and with the use of technologies powered by Artificial Intelligence, the problem of a “one-size-fits-all” approach to teaching will be finally solved. So, we have to start considering AI in education as a lifelong learning companion.

Cross-sectional skills appear to be increasingly important to ensure the human-machine interface. The use of AI will continually increase the level of technical skill of the specialist in Laboratory Medicine specialist insofar as they can fully exploit the most current clinical knowledge and medical practices. This increase in skills will be even more necessary as specialists in Laboratory Medicine also need to be able to challenge the software and take full responsibility for explaining the diagnosis and therapeutic management.

As part of its work, the IFCC Committee on Mobile Health and Bioengineering in Lab Med (C-MHBLM), in coordination with the Emerging Technologies Division executive committee ( EC-ETD), wished, in its prospective work program, to integrate and to anticipate the effects of AI on employment and qualifications in laboratory medicine and support the laboratory medicine community in anticipating the needs for new skills. There is a need for the emergence of new talent to produce AI with advanced skills and to communicate on the technical, legal, economic and ethical challenges of using AI-based tools while paying attention to securing the career paths that greatly are impacted by automation and AI and is likely to fundamentally renew the way medicine is practiced and care systems are organized.

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Industry News

With Rapid Growth in Oncology, Global Immunoassay Market Projected To Approach USD 20 Billion by 2025 he global immunoassay market is projected to grow at a CAGR of 5.9% from 2019 to reach USD 19.76 billion by 2025, driven by increasing incidences of chronic and infectious diseases, growing use of immunoassay in oncology, rise in drug and alcohol testing, and technological advancements in immunoassay. The emerging markets and increasing epidemic potentials offer significant growth opportunities for players operating in the market. However, the limitations of immunoassay and development of alternative technologies are expected to hinder the adoption of immunoassay products. These are the latest findings of Research and Markets, (Dublin, Ireland; www. researchandmarkets.com), a global market research company.

Based on product, the immunoassay kits and reagents segment is expected to account for the largest share of the global immunoassay market in 2019 due to the increasing number of immunoassay tests being performed across the world driving the recurrent purchase of kits and reagents. Within the immunoassay kits and reagents segment, ELISpot kits and reagents are projected to grow at the highest CAGR during the forecast period, led by the rising incidences of chronic diseases across the world, growing vaccine development to address the challenge of antimicrobial resistance, and technological advancements in ELISpot assay kits and analyzers.

On the basis of application, the infectious diseases segment is expected to hold the largest share of the global immunoassay market in 2019, mainly due to rising incidences of infectious diseases and growing adoption of immunoassay diagnostics in infectious diseases. However, the oncology segment is expected to record the highest CAGR during the forecast period on the back of the rising prevalence of cancer, increasing focus on tumor market development, technological advancements, and growing awareness about cancer.

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Global Hematology Diagnostics Market to Reach USD 5.6 Billion by 2026 he global hematology diagnostics market is projected to grow at a CAGR of 5.0% from USD 3.50 billion in 2017 to USD 5.59 billion by 2026, driven by the growing occurrence of blood disorders and increased adoption of automated testing processes. These are the latest findings of Transparency Market Research, (Albany, NY, USA; www.transparencymarketresearch.com), a global market intelligence company providing business information reports and services.

The WHO has declared that hemoglobin disorders are now substantially common among 89% of the births in 71% of countries. Nearly 1.1% of couples across the globe are at risk of giving birth to children with a hemoglobin disorder and around 2.7 of every 1,000 conceptions are affected by hemoglobin. Additionally, the WHO states that least 20% of the global population is a carrier of Îą+ thalassaemia. This high prevalence of hemoglobin disorders is fueling the growth of the global hematology diagnostics market.

Additionally, the growth of global hematology diagnostics market is being further driven by automation, which is the main focal point for hematology labs. The automation of hematology diagnostics processes has resulted in reduced turnaround time, which has sped up the treatment regimen for blood disorders in general. Several laboratories across the world are adopting automation for pre-analytical, analytical, and post analytical processes to standardize and improve the process.

Geographically, the global hematology diagnostics market is expected to be dominated by North America due to the growing prevalence of various types of blood diseases and presence of prominent market players in the region. Europe is the worldâ&#x20AC;&#x2122;s second-largest hematology diagnostics market due to the growing importance of hematology research in the region. Additionally, Asia-Pacific is estimated to be one of the fastest growing regions in the global hematology diagnostics market due to the growing prevalence of genetic diseases and blood disorders in the region.

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LabMedica International October/2019

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OCTOBER 2019 SLAP 2019 – 32nd Latin American Congress of Pathology. Oct 8-12; Lima, Peru; Web: www.congresoslaplima2019.org ASHG 2019 – American Society of Human Genetics. Oct 15-19; Houston, TX, USA; Web: www.ashg.org CMEF Autumn 2019 – China International Medical Equipment Fair. Oct 1922; Qingdao, China; Web: www.cmef. com.cn 17th International Congress of Immunology – International Union of Immunological 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

www.amp.org 30th Regional Congress of the International Society of Blood Transfusion (ISBT). Nov 16-19; Bangkok, Thailand; Web: isbtweb.org 40th Annual Meeting of the American College of Toxicology. Nov 17-20; Phoenix, AZ, USA; Web: www.actox.org APFCB 2019 – 15th Congress of the Asian-Pacific Federation for Clinical Biochemistry and Laboratory Medicine.

Nov 17-20; Jaipur, India; Web: www.apfcb congress2019.org MEDICA 2019. Nov 18-21; Dusseldorf, Germany; Web: www.medica-tradefair.com JIB 2019 Journées de l’innovation en biologie médicale. Nov 21-22; Paris, France; Web: jib-innovation.com

Web: pittcon.org Medical Fair India 2020. Mar 5-7; Mumbai, India; Web: www.medicalfair-india. com CHINALAB 2020. Mar 11-13; Guangzhou, China; Web: www.chinalabexpo.com ARABLAB 2020. Mar 16-18. Dubai, UAE; Web: www.arablab.com ExpoMED Eurasia 2020. Mar 19-21; Istanbul, Turkey; Web: expomedistanbul.com KIMES 2020. Mar 19-22; Seoul, Korea; Web: www.kimes.kr MEDLAB Asia Pacific 2020. Mar 24-26; Singapore; Web: www.medlabasia.com ENDO 2020 – Annual Meeting of the Endocrine Society. Mar 28-31; San Francisco, CA, USA; Web: www.endocrine.org/ endo2020 Analytica 2020. Mar 31-Apr 3; Munich, Germany; Web: www.analytica.de

DECEMBER 2019 Zdravookhraneniye 2019. Dec 2-6; Moscow, Russia; Web: www.zdravo-expo. ru/en 61st Annual Meeting & Exposition of the American Society of Hematology (ASH). Dec 7-10; Orlando, FL, USA; Web: www.hematology.org/Annual-Meeting

APRIL 2020 World Vaccine Congress 2020. Apr 7-9; Washington, DC, USA; Web: www.terrapinn. com/conference CMEF Spring 2020 – China International Medical Equipment Fair. Apr 9-12; Shanghai, China; Web: www.cmef.com.cn KoreaLab 2020. Apr 14-17; Seoul, Korea; Web: www.korealab.org India Lab Expo & analytica Anacon India. Apr 16-17; Mumbai, India; Web: www.indialabexpo.com ECCMID 2020 – 30th European Congress of Clinical Microbiology and Infectious Diseases. Apr 18-21; Paris, France; Web: www.eccmid.org AACR Annual Meeting 2020 – American Association for Cancer Research. Apr 24-29; San Diego, CA, USA; Web: www. aacr.org

JANUARY 2020 Fertility 2020 – 13th Joint Conference of the UK Fertility Societies. Jan 9-11; Edinburgh, UK; Web: fertilityconference.org SLAS 2020 – Society of Laboratory Automation and Screening. Jan 25-29; San Diego, CA, USA; Web: www.slas.org

FEBRUARY 2020

NOVEMBER 2019 11th World Congress of the World Society for Pediatric Infectious Diseases.

Nov 5-8; Manila, Philippines; Web: www. wspid2019.kenes.com AMP 2019 – Annual Meeting & Expo of the Association for Molecular Pathology. Nov 7-9; Baltimore, MD, USA; Web:

MEDLAB Middle East 2020. Feb 3-6; Dubai, UAE; Web: www.medlabme.com CHINALAB 2020. Mar 11-13; Guangzhou, China; Web: www.chinalabexpo.com

MARCH 2020

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Events Calendar eaaci.org BIO International Convention 2020. Jun 8-11; San Diego, CA, USA; Web: www. convention.bio.org 37th Nordic Congress in Medical Biochemistry. Jun 9-12; Trondheim, Norway; Web: www.nfkk2020.no 25th Annual Congress of the European Hematology Association (EHA). Jun 11-14; Frankfurt, Germany; Web: www. ehaweb.org/congress American Diabetes Association (ADA) 80th Scientific Sessions. Jun 12-16; Chicago, IL, USA; Web: www.professional. diabetes.org/scientific-sessions ASM Microbe 2020 – American Society for Microbiology. Jun 18-22; Chicago, IL, USA; Web: www.asm.org LABWorld China 2020 (CPhI & P-MEC China). Jun 22-24; Shanghai, China; Web: www.cphi.com/china/visit/labworld FOCIS 2020 – Annual Meeting of the Federation of Clinical Immunology Societies. Jun 22-26; San Francisco, CA, USA; Web: www.focisnet.org

JULY 2020 ESHRE 2020 – 36th Annual Meeting of the European Society of Human Reproduction and Embryology. Jul 5-8; Copenhagen, Denmark; Web: www.eshre.eu AIDS 2020 – 23rd International AIDS Conference. Jul 6-10; San Francisco, CA, USA; Web: www.aids2020.org ISTH 2020 – 28th Congress of International Society on Thrombosis and Haemostasis. Jul 11-15; Milan, Italy; Web: www.isth.org 72nd AACC Annual Scientific Meeting & Clinical Lab Expo – American Association for Clinical Chemistry. Jul 26-30; Chicago, IL, USA; Web: www.aacc.org

Glasgow, UK; Web: www.esp-congress. org

SEPTEMBER 2020 EUROTOX 2020 – 56th Congress of the European Societies of Toxicology. Sep 6-9; Copenhagen, Denmark; Web: eurotox-congress.com/2020 16th International Thyroid Congress.

Sep 8-13; Xi’an, China; Web: itc2020.medmeeting.org ASCP 2020 – Annual Meeting of the American Society for Clinical Pathology. Sep 9-11; Austin, TX, USA; Web: www.ascp.org ESPE 2020 – 59th Annual Meeting of the European Society of Paediatric Endocrinology. Sep 10-12; Liverpool, UK; Web: www.eurospe.org ISH 2020 – 38th World Congress of the International Society of Hematology.

Sep 13-16; Bangkok, Thailand; Web: www.ishworld.org EASD 2020 – 56th Annual Meeting of the European Association for the Study of Diabetes. Sep 22-25; Vienna, Austria; Web: www.easd.org

OCTOBER 2020 ECC 2020 – 43rd European Congress of Cytology. Oct 4-7; Wroclaw, Poland; Web: cytology2020.eu ICE 2020 – 19th International Congress of Endocrinology. Oct 4-7; Buenos Aires, Argentina; Web: ice-2020.com ASHI 2020 – 46th Annual Meeting of the American Society for Histocompatibility & Immunogenetics. Oct 19-23; Anaheim, CA, USA; Web: www.ashi-hla.org ASHG 2020 – American Society of Human Genetics. Oct 27-31; San Diego, CA, USA; Web: www.ashg.org

NOVEMBER 2020

AUGUST 2020 32nd Congress of the European Society of Pathology (ESP). Aug 29-Sep 2;

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I

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MEDICA 2020. Nov 16-19; Dusseldorf, Germany; Web: www.medica-tradefair.com

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LabMedica International October/2019

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Vol. 36 No.6 10 / 2019

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