M etastatic cancer cancer that has spread to other or gans in the body is not often curable, and chemotherapy and newer targeted therapies may not work for all patients. Biopsies to help determine the best treat ments for this type of cancer are rarely performed due to their invasive nature and the high risk of complications. This is often a major barrier in studying and C urrent clinical studies pose significant challenges in dis tinguishing disease subtypes with accurate molecular signatures and tracking the disease progression in a non-invasive way. Identifying molecular clues in samples from patients, such as specific proteins or genes from vesicular structures called exosomes, could improve the accuracy of diagnoses. Since small extracellular vesi cles (sEVs, exosomes) reveal spe cific functions in various biologi cal processes, including immune regulation, angiogenesis, tumor Diseases Diagnosed by Isolating Biomarkers in Tears
The global point-of-care (POC) testing market is projected to reach USD 70.8 billion by 2030, driven by an increasing num ber of pathology labs and ser vices equipped with advanced diagnostic equipment. Molecular testing technology allows nucleic amplification and screening of sample. As a result, industry players have been focusing their efforts on developing new POC molecular diagnostic technolo gies to deliver faster results with high accuracy and specificity.
For Parkinson’s Disease
Cont’d on page 13Cont’d on page 20
U ntil now, the diagnosis of Parkinson’s disease has been based primarily on typical move ment disorders such as muscle stiffness, slower movements and shaking. However, the disease starts up to 20 years before it becomes noticeable as a result
Maternal Autoantibodies As Autism Biomarkers
® INTERNATIONAL Vol 39 No 5 • 8-9/ 2022ISSN 1068-1760 WORLD’S CLINICAL LABORATORY NEWS LEADER Cont’d on page 17 Cont’d on page 18 Cont’d on page 6 If your subscription is not renewed every 12 months your Free Subscription may be automatically discontinued Digital Magazine Instant ProductOnlineInformation: Identify LinkXpress ® codes of interest as you read magazine Click on LinkXpress.com to reach reader service portal Mark code(s) of interest on LinkXpress ® inquiry matrix321 Cont’d on page 14 VISITDAILYCLINICALLAB NEWS International Meetings Rebound After Long COVID Hiatus International Meetings Rebound After Long COVID Hiatus GLOBETECHMEDIA>>><<< PUBLISHED IN COOPERATION WITH International Federation of Clinical Chemistry and Laboratory Medicine COVID-19INSIDEUpdate..... 4 AACC 2022 Roundup . 7 Clinical News ....... 13 News ......... 21 Product News .... 6-20 Events Calendar .... 26 Blood Test Can Aid Cancer Treatment
A utism is a neurodevelopment condition affecting 1 in 44 children in the U.S. It has a wide range of characteristics with dif ferent intensities and causes. One type of autism is maternal autoan tibody–related autism spectrum disorder (MAR ASD). MAR ASD is marked by the presence of specific maternal im mune proteins known as auto antibodies that react to certain
Growth of Point-of-Care Testing Driven By Molecular Diagnostics Advances
This year’s prestigious “AACC Disruptive Technology Award” went to Nanopath Inc., for the com pany’s point-of-care testing (POCT) platform for women’s health, based on breakthrough molecular diagnos tics technology that can provide re sults in minutes instead of days. Women’s POCT Platform Wins 2022 AACC Award
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The cobas SARS-CoV-2 Duo test from Roche Diag nostics (Basel, Switzerland; www.roche.com) is a first of its kind PCR test that simultaneously detects COVID-19 and quantitatively measures the viral load levels of COVID-19. It is the first automated, real-time RT-PCR assay for the in vitro qualitative and quantitative detection of SARS-CoV-2 RNA in nasal and nasopharyngeal swab specimens. The cobas SARS-CoV-2 Duo test combines the standard qualitative result of a traditional SARS-CoV-2 PCR test with a quantitative result, which measures the viral load of a patient suspected of COVID-19. The test aims to help the healthcare community with contact tracing, patient triage and the approach to medical care Dried Saliva and Blood Samples for Monitoring Immune Responses to COVID-19 Vaccines
The PictArray SARS-CoV-2 IgG enzyme-linked immunosorbent assay (ELISA) antibody test from Pictor Limited (Auckland, New Zealand; www. pictordx.com) is a first-of-its-kind test that enables personalized COVID-19 assessments. The test detects if a patient has antibodies from a previous SARS-CoV-2 infection (from spike protein (SP) and nucleocapsid protein (NP) antibodies) or from COVID-19 vaccination alone (SP antibodies only).
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Last year, a team of pathologists at The Univer sity of Texas Southwestern Medical Center (UTSW, Dallas, TX, USA; www.utsouthwestern.edu) had developed CoVarScan, a rapid COVID-19 test that detects the signatures of eight hotspots on the SARS-CoV-2 virus. Now, after testing CoVarScan on more than 4,000 patient samples, the team has reported that the test is as accurate as other methods used to diagnose COVID-19 and can suc cessfully differentiate between all current variants of SARS-CoV-2. CoVarScan hones in on eight re gions of SARS-CoV-2 that commonly differ between viral variants. It detects small mutations - where the sequence of RNA building blocks varies - and measures the length of repetitive genetic regions that tend to grow and shrink as the virus evolves.
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COVID-19 Diagnostics Update
Carolyn.Moody@globetech.net Tel: (1) 954-686-0838
First-Ever Antibody Test Shows If Patients Require COVID-19 Booster
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ProtonDx Ltd.’s (London, UK; www.protondx. com) innovative molecular testing technology plat form is designed to rapidly and simultaneously detect and differentiate multiple pathogens with high sensitivity and specificity. The technology is poised to help revolutionize rapid infectious disease diagnosis and tracking worldwide. The company’s Dragonfly is a portable, rapid diagnostic system that is able to identify multiple viral pathogens at the point of need. This revolutionary approach allows SARS-CoV-2, influenza A virus (IAV), influenza B virus (IBV), respiratory syncytial virus (RSV) and hu man rhinovirus (HRV) to be detected in a single test. Using proprietary ultra-fast nucleic acid extraction, and isothermal colourimetric detection, the system achieves PCR equivalent sensitivity and specificity in less than 30 minutes from sample to result
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The method relies on polymerase chain reaction (PCR) - a technique common in most pathology Cont’d
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Identifies Specific SARS-CoV-2 Lineages LabCorp Diagnostics (Burlington, NC, USA; www.labcorp.com) has received an emergency use authorization (EUA) from the FDA for its VirSeq SARS-CoV-2 NGS Test on the PacBio Sequel II sequencing system. VirSeq SARS-CoV-2 NGS Test is the first test that is FDA authorized for the identification and differentiation of SARSCoV-2 Phylogenetic Assignment of Named Global Outbreak (PANGO) lineages, which are genetic variations in circulating virus strains. The test could be used by health care providers if they believe, based on a patient medical history and other diagnostic information, that strain-specific information could help determine appropriate patient treatment.
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PCR Test Simultaneously Detects COVID-19 and Quantitatively Measures Viral Load Levels
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Sal6830 Point-ofCare PCR System is a next generation person-por table diagnostic device that aims to move complex molecular biology testing out of highly skilled lab oratories to non-laboratory settings where they can be used quickly at the point of need. The pathogen detection and gene expression system is relevant in both the infectious disease and precision medicine fields, and produces lab-quality results in 27 minutes.
The test also indicates whether at-risk patients have failed to mount a detectable antibody response despite vaccination or infection (SP and NP negative).
T he report that follows provides a selection of news and advances announced from June 15 to July 31, 2022. For a recap of earlier developments, the reader is invited to refer to previous issues of LabMedica or visit our website at www. LabMedica.com
PCR System Moves Ultra-Fast Testing From Lab to Patients at Point of Need MicroGEM International’s (Charlottesville, VA, USA; www.microgembio.com)
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Multiviral Pathogen Detection System to Revolutionize Rapid Infectious Disease Diagnosis
Praveen Sharma India Rosa I. Sierra-Amor Mexico Peter Wilding United States Andrew Wootton United Kingdom
Based on an antibody study by researchers at the University of Helsinki (Helsinki, Finland; www. helsinki.fi), dried samples of easily self-collected saliva and of blood drawn from the fingertip could be useful for monitoring people’s immune responses to vaccination. For the study, researchers analyzed the levels of antibodies associated with the SARSCoV-2 virus in more than 1,200 employees in the social welfare and healthcare sector to determine whether there were differences in different antibody classes according to viral exposure. The study pro vided important information on the use of saliva in the determination of antibody levels. The benefit of dried saliva and fingertip blood samples is that they are easy to collect. Samples can be taken at home outside laboratory conditions. Their collection is inexpensive and, in the case of saliva samples, non-invasive
The Sal6830 SARS-CoV-2 Saliva Test is the first vali dated test for the Sal6830 Point-of-Care PCR System. It is also the first FDA emergency use authorized saliva test for SARS-CoV-2 using PCR directly at the point-of-care where people can wait for fast results after providing a sample. The test is designed to capture and enrich viruses and cells, including bac teria and epithelial cells, from saliva and then detect extracted RNA from the SARS-CoV-2 virus if present in the saliva specimen
Pictor has received confirmation of CE registration for its PictArray SARS-CoV-2 IgG ELISA antibody test as per In Vitro Diagnostic Directive (IVDD) regulations, allowing it to market the COVID-19 antibody test in Europe and gain regulatory approval in Southeast Asia Rapid COVID-19 Test Identifies SARSCoV-2 Variants within Hours
New Assays Differentiate between Multiple Respiratory Viruses with Similar Symptoms
Becton, Dickinson and Company (BD, Frank lin Lakes, NJ, USA; www.bd.com) has launched the BD MAX Respiratory Viral Panel (RVP) molecular diagnostic combination test that can help eliminate the need for multiple tests or doctor visits and aid clinicians in implementing the right treatment plan quickly. The BD MAX Respiratory Viral Panel (RVP) uses a single nasal swab or a single nasopharyngeal swab sample to determine if a patient has COVID-19 or the flu or RSV. The BD MAX RVP assay is an RT- PCR assay that detects and differentiates the mRNA of SARS-CoV-2, flu A, flu B and RSV in approx imately two hours, with the easy-to-use and automated workflow of the BD MAX System. The co-testing approach can also help to increase testing capacity during the busy flu season and speed the time to diagnosis.
A team of diagnosticians from the Mayo Clinic (Rochester, MN, USA; www.mayoclinic.org) have developed and validated using droplet digital PCR (ddPCR) for a qualitative test for detec tion of SARS-CoV-2 in formalin-fixed paraffin-embedded (FFPE) tissues. The scientists reported that SARS-CoV-2 was detected in all 21 known positive samples and none of the 16 negative samples. As few as approximately five viral copies were reliably detected. Of the 195 clinical specimens, the positivity rate was 35% with placenta and fetal tissue showing the highest percentage of positive cases. The scientists concluded that that ddPCR provides both accura cy and sensitivity in detecting patients with low viral load. SARS-CoV-2 ddPCR testing will also aid in understanding atypical presentations of COVID-19, in cluding in patients who present with “unexplained” symptoms or potential long-term sequelae Plug-And-Play Antibody Test Keeps Tracks of Immunity to SARS-CoV-2 Variants
Researchers at the University of To ronto (Toronto, ON, Canada; www. utoronto.ca) have developed an anti body test to measure immunity that could become a valuable tool for de ciding who needs a booster and when, helping to save lives and avoid future lockdowns. The Neu-SATiN (Neutral ization Serological Assay based on split Tri-part Nanoluciferase) test is a newer version of SATiN, which monitors the complete IgG pool they developed last year. Neu-SATiN is a pin prick test pow ered by the fluorescent luciferase protein from a deep-water shrimp. It measures the binding between the viral spike protein and its human ACE2 receptor, each of which is attached to a luciferase fragment. The researchers say the plug-
and-play design of the test means it can be adapted to emerging variants by engineering mutations in the spike protein
labs - to copy and measure the RNA at these eight sites of interest COVID-19, Flu and RSV Combination Test to Increase Testing Capacity and Speed Time to Diagnosis
Researchers at the Institute of Industrial Sci ence at the University of Tokyo (Tokyo, Japan; www.iis.u-tokyo.ac.jp) have developed a new antibody-based method for the rapid and reliable detection of SARS-CoV-2 that does not require a blood sample. The team developed the method after exploring the idea of sampling and testing the interstitial fluid (ISF), which is located in the epidermis and dermis layers of human skin. The novel detection device has great potential for the rapid screening of COVID-19 and many other infectious diseases that is safe and acceptable to patients. It holds promise for use in many countries regardless of their wealth, which is a key aim for the global management of infectious disease
SARS-Cov-2 RNA Detected in FFPE Tissue by Droplet Digital PCR
Hologic, Inc. (Marlborough, MA, USA; www. hologic.com) is offering its Panther Fusion SARSCoV-2/Flu A/B/RSV assay and its Novodiag RESP-4 molecular diagnostic test for sale in the European Union in time for the northern hemisphere’s respi ratory viral season. Both assays detect and differen tiate severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A (Flu A), influenza B (Flu B) and respiratory syncytial virus (RSV) that can present with similar clinical symptoms. The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is a high-performance cartridge-based assay that uses nasopharyngeal swab samples and runs on the fully automated high-throughput Panther Fusion system. The Novodiag RESP-4 assay, which runs on the No vodiag system, uses nasopharyngeal swab samples and includes an embedded cellularity control to ensure that the sample was correctly taken.
COVID-19 Diagnostics Update • Particle enhanced immunoturbidimetric assay • High precision at clinical cut-offs • Outstanding onboard and calibration stability • Reliable alternative for sepsis management DiaSys. Total confidence in patient results. www.diasys-diagnostics.com Procalcitonin FS Precise • Cost-efficient • Time-saving Cont’d on page 6 Cont’d from page 4 5 LabMedica International August-September/2022 105LMI-09-22LINKXPRESS COM
Antibody-Based Method Detects SARS-CoV-2 without Blood Sample
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Among the two other finalists for the award, Biological Dynamics presented its Verita Isolation Platform, which will be come the basis of an annual screening blood test for multiple cancers, according to the company. The platform uses technology for isolating nanoparticles and macromolecules from whole blood, plasma, serum, urine, and saliva. The company recently received an FDA Breakthrough Device Designation for its first liquid biopsy assay that uses the platform for the early detection of pancreatic ductal adenocarcinoma using exosomal proteins.
AUTOMATED ELISA-IFA-BLOT PROCESSOR SRL AP 22 IF BLOT ELITE is a fully automated system that can run two ELISA micro-plates with eight tests on line, 16 IFA slides or 24 BLOT strips. It is also able to carry out full automation for the Dot/Western Blot.
Nanopath’s platform will require minimal training to operate, making high-complexity molecular diagnostics testing accessible at the point-of-care. Nanopath’s technology has the potential to simultaneously test for multiple viral, bacterial and fungal pathogens, based on presenting symptoms, and reduce delivery of test results from days to just 15 minutes.
The IMMULITE 1000 system is a small bench top immunoassay analyzer with an extensive menu, low cost of operation, reliability, and ease of use, making the system a great choice for labs with low-vol ume immunoassay tests. 201LMI-09-22COM 202LMI-09-22LINKXPRESS COM 203LMI-09-22LINKXPRESS COM
Women’s POCT Platform Wins 2022 AACC Award
A new blood test developed by a research team at Medical University Vienna (Austria; www. meduniwien.ac.at) can indicate a person’s status of cellular immunity to SARS-CoV-2 within just 48 hours. The new test is based on the memory response of T cells to three different SARS-CoV-2 peptide mixtures. T cells are an important part of the specific cellular immune defense: they eliminate cells infected with SARS-CoV-2 and support antibody production by B cells. The test is particularly relevant for vulnerable patient groups, whose own antibody response is not meaningful. It can even indicate whether immunity is the result of vaccination against SARS-CoV-2 or of survived infection. The new test will be particularly useful for those who are unable to produce antibodies against SARS-CoV-2 Non-Invasive Skin Test Accurately Diagnoses COVID-19 Metabolic changes caused by COVID-19 infec tion can be detected in skin and saliva samples as well as in the blood, which suggest that noninvasive diagnostic tests for the disease could be available in the near future, according to findings of a study by investigators at the University of Surrey (Surrey, UK; www.surrey.ac.uk). The investigators analyzed the correlations between serum metabolites, salivary metabolites, and skin sebum lipids in COVID-19 positive and negative individuals. Results revealed widespread alterations to serum-sebum lipid rela tionships in COVID-19 positive participants versus negative controls. There was also a marked correla tion between sebum lipids and the immunostimula tory hormone dehydroepiandrosterone sulfate in the COVID-19 positive group
ELECTROLYTE ANALYZER SNIBE Biossays E6 is a small-size electrolyte analyzer occupying less than 0.23 m2 of space with a high throughput of 300T/hour (60 sam ples per hour) and five electrodes as per request of any combination: iCa2+, Na+, K+, Cl-, pH.
BENCH TOP IMMUNOASSAY ANALYZER SIEMENS HEALTHINEERS
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Nanopath’s technology can simultaneously characterize multiple pathogens with one test, leading to faster, more precise diagnosis and treatment. The company’s proprietary biosens ing technology utilizes ultrasensitive optical detection to identify DNAs and RNAs, with out the need for nucleic acid amplification. This amplification-free approach minimizes re agents, lowers costs and reduces user steps that are ubiquitous across molecular diagnostics.
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The two other finalists for the award were: Biological Dynamics (San Diego, CA, USA; biologicaldynamics.com) for its annual blood screening test for multiple cancers, and Visby Medical (San Jose, CA, USA; www. visbymedical.com) for its point-of-care PCR platform detecting causes of serious infections in under 30 Nanopath’sminutes.(Cambridge, MA, USA; www. nanopathdx.com) novel approach to molecular diagnostic testing harnesses advances in bio engineering and nanotechnology to accurately identify and characterize a variety of pathogens within minutes, compared to existing gold-stan dard diagnostics that take days to return results.
DAS
Rapid Blood Test Indicates Cellular Immunity to SARS-CoV-2 within 48 Hours
Visby Medical PRC Point-of-Care Tests run on an instrument and cartridge-free, single-use PCR platform that fits in the palm of the hand and delivers accurate results about causes of serious infections in under 30 minutes. The test would eliminate the need to send samples to remote central labs for processing and has been shown to detect DNA from chlamydia, gonorrhea, and trichomoniasis. The platform could benefit patients in remote areas without access to high complexity labs. from cover
New COVID-19 Test is Fast, Efficient, Accurate and Unprecedentedly Sensitive A new biosensor that is currently being developed by researchers from the School of Science at IUPUI (Indianapolis, IN, USA; www.iupui.edu) has the po tential to achieve the speed and efficiency required for the future of COVID-19 testing. The COVID-19 test can currently analyze samples from 96 individuals in under three hours and the system requires only 10 microliters of blood. By comparison, a typical blood panel order by a primary-care physician collects 10 milliliters of blood - over 1,000 times more. The sen sor also works with other sample types, such as saliva, although the study was conducted using blood since it is the most complex bodily fluid and therefore, the best indicator of a sensor’s accuracy. Additionally, the sensor was found to be highly accurate at measuring the body’s COVID-19 antibody concentration.
7 LabMedica International August-September/2022 AACCRoundup2022To view this issue in interactive digital magazine format visit www.LabMedica.com AACC 2022 Roundup: On-Site Report from the World’s Foremost Clinical Laboratory Showcase
he 2022 AACC Annual Scientific Meeting & Clinical Lab Expo show cased cutting-edge science and tech nology shaping the future of laboratory medi cine. Hosted by the American Association for Clinical Chemistry (Washington, DC, USA; www.aacc.org), this year the show took place at McCormick Place in Chicago from Sunday, July 24 through Thursday, July 28. The world’s premier event for laboratory medicine offered five days packed with opportunities to learn about exciting science. At the AACC Clinical Lab Expo, more than 700 exhibitors released their latest news and developments to an estimated audience of more than 40,000 visitors, with the aim to return to attendance figures prior to the COVID-19 pandemic. The AACC Clinical Lab Expo had more than 200 new product introductions this year. Exhibitors filled the show floor with displays of the latest diagnostic technology, including but not limited to mobile health, molecular diag nostics, mass spectrometry, point-ofcare, and automation. EKF Diagnostics (Penarth, Cardiff, UK; www.ekfdiagnostics. com) exhibited its range of labo ratory and point-of-care diagnostics products, including the FDA cleared Lucica Glycated Albumin-L test kit, Hemo Control and DiaSpect Tm hemoglobin analyzer ranges, as well as Quo-Lab and Quo-Test HbA1c an alyzers, alongside its newly-launched EKF Link digital connectivity solu tion. Thermo Fisher Scientific (Waltham, MA, USA; www.thermofisher. com) participated at the event with demonstrations of its Phadia 250 laboratory system, Indiko and Indiko Plus clinical and specialty chemistry analyzers, Applied Biosystems QuantStudio 7 Pro Dx and QuantStudio 5 Dx Real-Time PCR Systems, and its latest LC-MS/ MS medical devices for IVD use, including the Quantis MD and Altis MD systems. Siemens Healthineers (Erlangen, Germany; www.healthcare. siemens.com ) showcased its “Continuous Innovation for a Lifetime of Answers” theme at the event where the company demonstrated its Atellica Solution comprising flexible, scalable, automationready immunoassay and chemistry analyzers with integrated automation. Siemens also displayed the Atellica DCA Analyzer for fast quality HbA1c and ACR results, Atellica 1500 Automated Urinalysis System, and the epoc Blood Analysis System that delivers critical testing results securely at patient-side in less than one minute. Beckman Coulter (Brea, CA, USA; www.beckmancoulter.com) highlighted its latest medical advancements in laboratory solutions at the event, including its new DxA 5000 Fit Workflow Automation System and the new DxONE Workflow Manager which is the industry’s first cloud-based middleware solution that enables users to amplify produc tivity and future-proof their lab. Also presented at the event were the company’s DxC and AU T Cont’d on page 8
Sysmex America (Lincolnshire, IL, USA; www.sysmex.com) exhibited virtually as well as live at the event where the company presented the XN-Series of automated hematology analyzers with new complimentary products, such as DI-60 Automated Digital Cell Morphology Analyzer that connects directly to the XN-9100 analyzer or can be configured with the SP-50 Slidemaker/Stainer. On display for the first time was the company’s BT-50 Barcode Terminal and Start yard with “touch-free” quality control (QC) workflow. Sysmex America also exhibited the UN-Series automated urinalysis solution with expanded chemistry functionality that offers the world’s first bi-directional urinaly sis connection for Total Lab Automation (TLA).
Jiangsu Bioperfectus (Shanghai, China; www.bioperfectus.com) demonstrated its range of molecular diagnostic instruments and testing solutions for infectious diseases, including its SAW-96 and SMPE-960 nucleic acid extraction systems, alongside the STC-96A and STC-96A PLUS real-time PCR systems. Bioperfectus also showcased its wide range Cont’d on page 10 AACC 2022 Roundup Cont’d from page 7
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D-DIMER TEST FAPON D-Dimer (DD) for the quantitative determination of DD in plasma samples, a marker for thrombosis, adopts the Latex-enhanced turbidi metric immunoassay methodology to produce turbidity to indicate the concentration level of DD.
8LabMedica International August-September/2022 To receive prompt and free information on products, log on to www. LinkXpress.com or fill out reader service form located on last page, or scan the QR code on your mobile devicePRODUCT NEWS PORTABLE POC READER RANDOX LABORATORIES
Nova Biomedical (Waltham, MA, USA; www.novabiomedical.com) presented its range of whole blood testing products that improve patient safety and care, including point-of-care, whole blood meters and critical care blood gas analyzers. These included the Allegro POC capillary blood chemistry analyzer that features a clinically important menu of 10 measured and individually selectable tests, plus seven calculated tests, as well as the Stat Profile Prime Plus comprehensive whole blood critical care analyzer that offers blood gases, electrolytes, metabolites, hematology, and co-oximetry testing in a simple, compact device.
RSV/ADENOVIRUS TEST SEKISUI DIAGNOSTICS
The OSOM RSV/Adeno test is a rapid chromato graphic immunoassay for the qualitative detection of Respiratory Syncytial Virus (RSV) and/or Adenovirus antigens directly from nasal swabs or nasal suction fluid. LMI-09-22COM 205LMI-09-22LINKXPRESS COM 206LMI-09-22LINKXPRESS COM series of clinical chemistry analyzers, and the DxH range of hematology analyzers. Bio-Rad Laboratories (Hercules, CA, USA; www.bio-rad.com) exhibited its range of quality control solutions that help streamline workflows, reduce errors, maintain compliance, and facilitate accredita tion—improving efficiency and saving money. These solutions included its InteliQ Load-and-Go Controls that can transform QC workflow with load-and-go-efficiency and its Unity QC Data Management Solutions that help achieve greater efficiency while reducing costs. Visitors at Bio-Rad’s booth experienced its D-100 hemoglobin testing system, a fully automated, best-in-class HbA1c analyzer featuring a highly evolved combination of hardware, software and chemistry for high-volume labs.
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The VeraSTAT is a simple, accurate, portable POC device that delivers fast results via use of patented cathodic rapidoffertechnologyelectrochemiluminescence(C-ECL),designedtousersthenextgenerationofdiagnosis.
DiaSys Diagnostic Systems (Holzheim, Germany; www.diasysdiagnostics.com) showcased its expanding product portfolio of analyzers and POCT instruments with a special focus on its reagents, such as HDL-c direct FS, LDL-c direct FS, Cystatin C FS, Procalcitonin FS and CRP FS. Additionally, DiaSys demonstrated the respons 940 fully automatic random access analyzer (RAM) with a sample throughput of 400 (640 incl. ISE) tests/hour. Due to its durable quartz cuvettes, low reaction volume, maintenance free photometer and intuitively operated software, respons 940 offers the economic use and reliability required in small to medium sized labs.
2. Krabbe J et al. Significant interference on specific point-of-care glucose measurements due to high dose of intravenous vitamin C therapy in critically ill patients. Clin Chem Lab Med. 59(5) 2021.
Nova’s StatStrip Glucose Meter Has No Known Clinical Interferences and is the Only Meter FDA Cleared for use on Critically Ill Patients. Ask for Nova’s list of 200 StatStrip peer-reviewed publications.
1. Orija IB et al. Pseudohyperglycemia Secondary to High-Dose Intravenous Vitamin C Managed as Diabetic Ketoacidosis: An Endocrinological Catastrophe. AACE Clin Case Reports 2021.
“High Dose vitamin C treatment in combinations with Accu Chek II and Hemocue BGMs in patients with acute kidney failure may cause misinterpretation with potentially fatal consequences.” 2 Clin Chem Lab Med, 2021
“Yet, vitamin C has been associated with multiple reports of factitious hyperglycemia and harmful iatrogenic hypoglycemia causing death in at least one report.” 4 J Med Care Reports, 2021
3. Katzman B et al. Unintended Consequence of High-Dose Vitamin C Therapy for an Oncology Patient: Evaluation of Ascorbic Acid Interference with Three Hospital-Use Glucose Meters. J Diabet Sci and Tech. 15(4) 2021.
4. Lachance O et al. High-dose vitamin-C induced prolonged factitious hyperglycemia in a peritoneal dialysis patient: a case report. J Med Case Reports 2021.
Papers in 2021 Continue to Show Certain Glucose Meters Cause Serious Adverse Events Due to Interferants
“While the Nova StatStrip glucose meter effectively detected the presence of ascorbic acid interferant and suppressed glucose results, the Roche Inform II and Abbott Precision Xceed Pro demonstrated falsely increased results that could have impacted patient care (delayed PET scan) or possibly led to inappropriate patient treatment.” 3 J Diabetes Sci and Tech, 2021
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“We report a case that probably resulted in the death of a patient from an erroneous interpretation of POC BG readings due to interference from high-dose vitamin C.” 1
AACE Clin Case Reports, 2021
LumiraDx (London, UK; www.lumiradx.com) joined the global labo ratory medicine community at the event with demonstrations of its trans formative tests and technology, including the company’s next-generation diagnostics platform that supports a broad menu of tests on a single, por table diagnostic platform with lab comparable performance at the pointof-care. In addition, LumiraDx demonstrated its Fast Lab Solutions which enable laboratories to improve throughput by using current molecular infrastructure and eliminating the need for extraction and purification.
10LabMedica International August-September/2022
CYSTATIN C is a CE-Marked immunochromato graphic rapid test for the quantitative detection of cystatin C in whole blood, serum or plasma. It has a measuring range of 0.1-8 mg/L and a reading time of 10 minutes. 207LMI-09-22COM 208LMI-09-22LINKXPRESS COM 209LMI-09-22LINKXPRESS COM of testing solutions for infectious diseases, including respiratory, sexually transmitted, vector-borne, gastrointestinal, and zoonotic.
BioProfile pHOx is a compact, easy-to-use analyzer designed specifically to provide rapid, accurate measurement of acid base and re spiratory parameters in cell culture and fermentation samples.
CYSTATIN C RAPID TEST VEDA LAB
Awareness Technology (Palm City, FL, USA; www.awaretech. com) demonstrated its updated Stat Fax 4500 and 4700 microwell strip readers with a new interface that features a high resolution backlit display with a capacitive touch screen. A new feature of their improved memory capacity is the ability to not only store over 100 programmed tests but also store over 500 results. Awareness also displayed the ChemWell 2 Automated ELISA/Chemiluminescent analyzer that offers a two plate solution for running a variety of applications.
To receive prompt and free information on products, log on to www. LinkXpress.com or fill out reader service form located on last page, or scan the QR code on your mobile devicePRODUCT NEWS PHOX ANALYZER NOVA BIOMEDICAL
QUANTITATIVE IMMUNOASSAY ANALYZER GETEIN BIOTECH
Sebia (Lisses, France; www.sebia.com) showcased its wide portfolio of instruments and tests designed to address clinical needs and improve laboratory efficiency and safety. These included the CAPILLARYS 3 TERA MC high throughput capillary electrophoresis system that allows the combination of one to three CAPILLARYS 3 TERA instruments to a Sebia loader, with a loading capacity of 528 samples in one row. In addition, Sebia showcased its fully automated, random access Alegria 2 ELISA platform with its comprehensive menu of antigen assays & panels utilizing a unique Monotest strip technology that allows serum, plasma, Cont’d from page 8 Cont’d on page 11
Abbott Diagnostics (Lake Bluff, IL, USA; www.abbott.com) offered one-on-one and group demonstrations of its latest diagnostic offerings, including its next generation of Alinity systems designed to simplify diagnostics and help deliver results. In addition, Abbott provided demonstrations of its GLP Systems Track that allows users to easily modify their track for future changes and maximize floor space while transforming the laboratory from 2D to 3D. Abbott also demonstrated how its AlinIQ Always On services can help labs achieve operational efficiency and increase productivity by avoiding unexpected downtime.
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Cepheid (Sunnyvale, CA, USA; www.cepheid.com) demonstrated the advantages of its PCRplus Solution comprising one platform and 22 IVD tests that combine accuracy, speed, flexibility, quality, and simplic ity. PCRplus is an elevated PCR test category reserved for molecular diagnostic testing solutions that deliver uncompromised accuracy, speed, flexibility, simplicity, and exceptional test design expertise. Cepheid offers a growing portfolio of PCRplus respiratory tests that run on its 40,000 GeneXpert systems placed worldwide to deliver rapid, accurate, and actionable respiratory results.
The FIA8000 quantitative immunoassay analyzer is intended for the processing and analysis of Getein test kits, including markers for cardiovascular disease, renal disease, inflammation, fertility, dia betes control and thyroid.
AACC 2022 Roundup
Getein Biotech (Nanjing, China; www.getein.com) presented its range of POCT immunofluorescence quantitative analyzers, including the Getein1160, Getein1180, Getein1200 and Getein1600, which automate the detection and quantification of markers for cardiovascular diseases, renal diseases, inflammation, fertility, diabetes mellitus, bone metabolism, tumor, and thyroid in biological samples. In addition, Getein exhibited the fully automated CM-400 clinical chemistry ana lyzer, alongside the BHA-3000 and BHA-5000 automatic hematology analyzers and the XN06 semi-automated blood coagulation analyzer.
Gold Standard Diagnostics (Davis, CA, USA; www.gsdx.us) highlighted its comprehensive diagnostic solutions, with particular focus on the new version of its AIX1000 Automated RPR Test System with improved software and hardware features. The AIX1000 is an FDA cleared, CE marked, fully automated system for nontreponemal, rapid plasma reagin (RPR) testing.
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EUROIMMUN (Lubeck, Germany; www.euroimmun.com), a PerkinElmer company, featured its latest automation solution in molecu lar diagnostics - the EUROArray Processor - that enables fully automated processing of EUROArray slides. The company also introduced the new UNIQO 160 IIFT system which provides full IIFT automation of the next generation – from the primary sample to the micros copy result with only one instrument.
Werfen (Barcelona, Spain; www.werfen.com) introduced key innovations for the cardiovascular operating room, including the new ROTEM sigma Thromboelastometry System that delivers real-time, rapid and actionable results, now at the point-of-care, to guide bleeding management. Werfen also introduced the new GEM Hemochron 100 whole blood hemostasis system which lever ages leading Hemochron technology to deliver fast, actionable activated clotting time (ACT) results in minutes, inform ing patient-management decisions and helping improve workflow at the POC. In addition, Werfen introduced the new GEMweb Live, a real-time viewer of comprehensive, rapid test results for cardiac surgical procedures, at the POC, all in one screen.
Hologic (Marlborough, MA, USA; www.hologic.com) highlighted its Panther Scalable Solutions that allow laboratories to expand their testing menu while adding on flexibility, capacity and walkaway time. Also featured at the event were Hologic’s ThinPrep processors which are intuitive, versatile, and scalable solutions for laboratories of all volumes. The company’s ThinPrep Pap test is the first FDA-approved, liquid-based cytology option in cervical disease screening and remains the preferred choice in Pap testing in the US.
AACCRoundup2022To view this issue in interactive digital magazine format visit www.LabMedica.com 11 LabMedica International August-September/2022 and fecal sample testing in the same run.
Seegene (Seoul, Korea; www.seegene.com) introduced its InLife PCR campaign, a global initiative that seeks to encourage regular testing of respiratory viruses, including COVID-19, flu, and colds, to stay protected from infectious diseases. Seegene’s EU-Approved Allplex SARS-CoV-2/FluA/FluB/RSV Assay is expected to help small hospitals,
Technopath Clinical Diagnostics (Tipperary, Ireland; www. technopathclinicaldiagnostics.com) showcased the Multichem range of barcoded consolidated Quality Control (QC) materials combined with IAMQC informatics software that offer unique work-flow automation.
Globe Scientific (Mahwah, NJ, USA; www.globescientific.com) exhibited its recently-launched Globe Glass premium quality laboratory glassware with superior GlassGuard packaging. Designed to meet the needs of both laboratory professionals and laboratory supply distributors, Globe Glass combines quality glassware and superior packaging at an affordable price point. The company also showcased its broad range of high-performance, innovative and affordable laboratory balances and accessories for precision and analytical weighing.
Technopath also demonstrated the IAMQC Infinity open QC data man agement solution that can complement and support the Multichem QC product range, and provides laboratory managers and technologists with a range of QC software tools to analyze their QC results in real-time.
Nikon Instruments (Melville, NY, USA; www.microscope.healthcare. nikon.com) displayed its latest clinical pathology products, including the ECLIPSE Ci-E upright microscope with Digital Sight 10 camera alongside the ECLIPSE Ci-L plus upright microscope with DS-Fi3 camera and NIS-Elements L tablet. Nikon also showcased the NISElements D imaging software and NISElements BR imaging software, alongside the D-LEDI Fluorescence LED Illumination System, a long-lasting, multi-color light source for fluorescence observation.
Meridian Bioscience (Cincinnati, OH, USA; www.meridianbioscience. com ) displayed its state-of-the-art BreathID Hp Lab urea breath test system for H. pylori detection that intuitively combines market-leading diagnostic ac curacy with efficient automation and fast batch-test analysis for maximizing large lab testing throughput. Meridian also exhibited the Curian fluorescent immu noassay platform focused on gastrointes tinal testing that is packaged in a small AACC 2022 Roundup Cont’d from page 11 Cont’d on page 25
12LabMedica International August-September/2022 To receive prompt and free information on products, log on to www. LinkXpress.com or fill out reader service form located on last page, or scan the QR code on your mobile devicePRODUCT NEWS
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The Natch CS2 fully automated nucleic acid ex traction system offers an extremely simple workflow with an excellent sample addi tion function. It offers efficient an ti-contamination and super mag netic and effective adsorption. LMI-09-22COM 211LMI-09-22LINKXPRESS COM 212LMI-09-22LINKXPRESS COM local clinics, and public health centers effectively identify COVID-19, influenza A and B and respiratory syncytial virus (RSV). The assay is compatible with the company’s ‘AIOS’ (All-in-One System), the first fully automated high throughput MDx system for syndromic testing, that sup ports “hands-free” PCR workflows – from nucleic acid extraction to PCR setup, gene amplification and results analysis. Seegene has also received CE-IVD marking for the saliva-based testing application for Allplex SARSCoV-2 Assay and Allplex SARS-CoV-2/FluA/FluB/RSV Assay, and both the products with the feature are now available in Europe. Roche Diagnostics (Basel, Switzerland; www.roche.com) provided demonstrations of 18 innovative systems, including the cobas pro and cobas pure serum work area solutions, the cobas 5800 molecular system and the cobas pulse point-of-care professional glu cose management solution. To address current laboratory challenges, Roche also introduced the Roche Idea Lab, where experts in areas critical to laboratory success provided key insights. Roche presented 11 interactive workshops as part of the Idea Lab to share best prac tices and provide answers on topics that matter most in today’s evolving lab environment. CerTest Biotec (Zaragoza, Spain; www.certest.es) presented its VIASURE Complete Solution for molecular diagnostic laboratories, along side its new CLIA diagnostic equipment, new releases for Rapid Test, Turbilatex, bioSCIENCE or BioSynProbes, and its newly-launched Viasure Monkeypox Virus Real Time PCR Detection Kit. Wondfo (Guangzhou, China; www. wondfo.com) exhibited its automatic bench-top chemiluminescence immuno assay (CLIA) analyzers with advanced features for point-of-care testing, includ ing its compact and automatic Accre 8 and Accre 90 CLIA bench-top analyzers which are 70% smaller than ordinary CLIA analyzers. With a single-dose re agent cartridge, these analyzers allow 600 days MTBF, requiring no extra consumables.
ELISA & CLIA ANALYZER MONOBIND
The Autoplex Gen2 ELISA & CLIA analyzer offers an automated platform for managing and running assays. It is completely integrated with Monobind’s immunoassays and programmed with all 55+ Monobind tests.
The BC-7500 CRP is a high speed CBC+CRP inte grated hematology analyzer that simultaneously pro vides results of WBC differentiation and FR-CRP at a throughput of 100 samples/hour.
CBC+CRP INTEGRATED HEMATOLOGY ANALYZER MINDRAY IN-VITRO DIAGNOSTICS
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PerkinElmer (Waltham, MA, USA; www.perkinelmer.com) demonstrated its high-throughput Vanadis NIPT solution that takes all the complexity out of nonin
vasive prenatal testing, making it accessible to more women – and more cost-effective for laboratories. This breakthrough cell-free DNA (cfDNA) technology eliminates PCR amplification and gene sequencing, making it so easy to use that one laboratory technician can handle 2000 to 20 000 samples per year. Vanadis is the only NIPT screening platform to enable targeted cfDNA analysis without PCR, instead directly capturing target fragments and labeling them for counting.
AUTO NUCLEIC ACID EXTRACTION SYSTEM SANSURE BIOTECH
Other methods included in the study were Western Blot analysis, on-device exosome detection, proteomic analysis, and exosomal miRNA sequencing. The investigators successfully distinguished between healthy controls and patients with various types of dry eye disease based on a proteomic assessment of extracted proteins. Similarly, the Incorporated Tear Exosomes Analysis via Rapid-isolation System (iTEARS) enabled the team to observe differences in microRNAs between patients with diabetic retinopathy and those that didn’t have the eye condition, suggesting that the system could help track disease progression. The team says that this work could lead to a more sensitive, faster and less invasive molecular diagnosis of various diseases, using only tears.
Medial Scientists at the Wenzhou Medical University (Wenzhou, China; en.wmu.edu.cn) and their colleagues carried out a retrospective case-controlled study that included patients with dry eye and type 2 diabetes. A tear sample was collected by placing a Schirmer paper on each eye, and the moistened length was imme diately recorded after 5 minutes of collection or at completion (length reaching at 30 mm in 5 minutes).Thetear mixture was eluted from the Schirmer strip by shaking at 4 °C for 30 min utes and two-step centrifugation (200g for 10 minutes and 3,000g for 10 minutes) to remove cells and other impurities. Exosomes were sub sequently purified with the rapid-isolation sys tem under the negative pressure of 40 kPa and conversion time of 30 seconds, respectively. Samples were loaded to the equilibrated size exclusion chromatography column (qEV orig inal, IZON Science Ltd., Oxford, UK; www. izon.com), and 16 sequential fractions of 0.5 mL were eluted by adding PBS. The eluted fractions 8–10 were pooled and concentrated to a final volume of 150 μL. Nanoparticle Tracking Analysis (NTA) was performed on a NanoSight NS300 system (Malvern Panalytical, Malvern, UK; www.malvernpanalytical.com).
eurofilament light chain (NfL) is a cytoskeletal protein component ex clusively expressed in neurons that is released into the extracellular fluids, in cluding blood, during neuroaxonal damage. NfL is linked to mortality in neurological dis orders, remaining unexplored in population studies.NfL reflects sub-cortical large-caliber axo nal degeneration. Plasma NfL levels correlate strongly with cerebrospinal fluid (CSF) NfL levels, adding to its clinical utility in differential diagnoses for dementias and other neurode generative diseases. Therefore, plasma NfL measurements are advantageous given the invasiveness of CSF assessments and feasibility for long-term monitoring. Scientists at the National Institute on Aging (Baltimore, MD, USA; www.nia. nih.gov) collected longitudinal data from 694 participants in the Healthy Aging in Neighborhoods of Diversity Across the Life Span study (HANDLS, mean age first visit [v1]: 47.8 years, 42% male, 55.8% African American). Fasting blood samples were col lected between 9:30 am and 11:30 am into EDTA blood collection tubes. Plasma NfL was measured prospectively at three visits. Plasma NfL levels were quan tified using the Simoa NF-light Advantage Kit on a Simoa HD-X analyzer by Quanterix (Billerica, MA, USA; www.quanterix.com). Total cholesterol (mg/dL), HDL cholesterol (mg/dL), high-sensitivity C-reactive protein (hsCRP) (mg/dL), albumin (g/dL), and gly cosylated hemoglobin (HbA1c) (%) were quantified by contract laboratories (Quest Diagnostics, Chantilly, VA, USA; www. questdiagnostics.com). In this study, the δNfL is the annualized rate of change be tween NfLv1, NfLv2, and NfLv3, on aver age, when these measurements were Logetransformed.Theteam reported that most notably, men had significantly higher plasma NfL (Logetransformed) compared to women at both visits 1 and 3. These differences remained Cont’d by Isolating Biomarkers in Tears
on page 14 N Diseases Diagnosed
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The authors concluded that they established the iTEARS for deciphering the biomarkers of diseases from a teardrop, which revealed the promising role of tear exosomes in dis ease classification and course monitoring of ocular disorders and other diseases such as neurodegenerative diseases and cancer. By being applied in extended disease types and validated with abundant clinical cases, they anticipate their teardrop-based iTEARS to be the alternative tool for point-of-care-test. The study was published on July 20, 2022 in the journal ACS Nano.
LabMedicaInternationalTo view this issue in interactive digital magazine format visit www.LabMedica.com 13 LabMedica International August-September/2022 113LMI-09-22LINKXPRESS COM invasion, and cell migration, exosome-based liquid biopsy technology has offered an attrac tive alternative to disease classification and prognostic prediction. Tears are well-suited for sample collection because the fluid can be collected quickly and non-invasively.
Image: The NanoSight NS300 can visualize and measure particles in suspension in terms of size, light scattering intensity, fluorescence and count (Photo courtesy of Mark Wainwright Analytical Centre)
Plasma Neurofilament Light Predicts All-Cause Mortality Risk
While the number of cancer treatment options has expanded in recent years, a common problem is that eventually those treatments stop working. Drug resistance can develop over time as cancer cells accumulate molecular changes that make them less sen sitive to a particular drug or treatment. The study sheds new light on how this resistance develops. By collecting multiple ctDNA sam ples over time, the researchers were able to learn how cancer evolves in response to treatment. The findings revealed new genetic mechanisms of resistance to the most com mon drugs for treating metastatic prostate cancer and more broadly demonstrates how ctDNA profiling can be used to understand treatment resistance across other types of cancers. The researchers say that this min imally-invasive, relatively inexpensive and highly-scalable technology is now being de ployed across large clinical trials. “With only a few drops of blood, we can uncover critical information about a person’s overall disease and how best to manage their cancer,” said senior author Dr. Alexander Wyatt, an assistant professor of urologic sciences at the University of British Columbia (UBC) and senior research scientist at the Vancouver Prostate Centre.
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“This test has the potential to help clinicians choose better tailored treatment options and to more efficiently detect treatment resis tance, allowing clinicians to adjust clinical care as “Metastaticneeded.”cancers are complex and our understanding of them has been limited.
Automated
The new generation of CoL1 V.2 coagulometers for turbodensitometric reading with double wavelength technology are designed for fast and precise coagulometric, chromogenic and turbidimetric tests.
ANALYZER
AUTO URINE MICROSCOPY BECKMAN COULTER
Cont’d from cover Blood Test Can Aid Cancer Treatment
The first-of-its-kind blood test developed by researchers at the Vancouver Prostate Centre (British Columbia, Canada; www. prostatecentre.com) and BC Cancer (British Columbia, Canada; www.bccancer.bc.ca ) analyzes the DNA that metastatic cancers shed into the bloodstream, known as circulating tumor DNA or ctDNA. By sequencing the entire genome of this ctDNA, the test reveals characteristics that are unique to each patient’s cancer, giving physicians new tools to develop more personalized treatment plans. For their study, the researchers examined ctDNA samples collected from patients with metastatic prostate cancer. The researchers discovered that whole genome sequencing of ctDNA provides a host of information about the different metastases spread throughout the body. Using newly developed computer programs, the researchers were able to pin point the unique genetic make-up of various cancer populations in the body to gain a more comprehensive understanding of the disease. The researchers say the information can also be used to help predict which treatments will be effective or ineffective in each patient.
SEMI-AUTOMATIC URINALYSIS URITEST MEDICAL ELECTRONIC
The US-500 is the world’s first semi-automatic AI-Libre urinalysis analyzer featuring a compact twoin-one design that uses CNN and deep learning technology. It enables automation of microscope with raw big pictures.
The DxU Iris Microscopy Series Urine Microscopy Analyzer includes the DxU 840m Iris, with a throughput of 70 samples per hour or the DxU 850m Iris, with a throughput of 101 samples per hour.
COAGULOMETER
Cont’d from page 13 treating this disease. Now, a new blood test provides unprecedented insight into a patient’s cancer make-up, potentially allowing doctors to better select treatment options that will improve patient outcomes.
WIENER LABORATORIOS SAIC
Whereas traditional biopsies only provide a small snapshot of the disease, this new test is able to paint a more complete picture of metastases throughout the body, all from a simple and easy to perform blood test,” added Dr. Wyatt. “Every cancer is unique and every patient responds differently to treatment. This new generation of ctDNA tests can help clini cians choose the treatment option that is most likely to benefit a patient.”
Notably, NfLv1 was shown to be a better prognostic indicator at normal hsCRP values among women, while HbA1c and δNfL inter acted synergistically to determine mortality risk,Theoverall.authors concluded that plasma NfL levels measured both at baseline and over time can predict all-cause mortality in women. The study was published on June 13, 2022 in the journal BMC Medicine.
Plasma Neurofilament Light Predicts All-Cause Mortality Risk comparable after further adjustment for age, race, and poverty status. Moreover, men were more likely than women to be pre-di abetic, with the reverse being observed in the case of diabetes. Self-reported history of cardiovascular disease (CVD) was more prevalent in women (15.9% versus 8.7%). Several continuous components of AL were higher among women, namely hsCRP, total cholesterol, and HDL cholesterol, while the reverse was observed for albumin and dia stolic blood pressure (DBP). Similar patterns were observed for binary AL components.
14LabMedica International August-September/2022 To receive prompt and free information on products, log on to www. LinkXpress.com or fill out reader service form located on last page, or scan the QR code on your mobile devicePRODUCT NEWS
Image: Simoa HD-X Analyzer was used to quantify plasma neurofilament light chain (Photo courtesy of Quanterix)
Bone Turnover Markers Associated With Mortality Risk in Older Men
Serum undercarboxylated osteocalcin, serum total osteocalcin (TOC), procollagen type I N-propeptide (PINP), and collagen type 1 C-terminal cross-linked telopeptide (CTX) were measured from blood samples. Serum TOC, PINP, and CTX were measured by electrochemiluminescence immunoassay using a Modular E170 analyzer (Roche Diagnostics, North Ryde, Australia; www.rocheaustralia.com). The concentration of ucOC in the supernatant was measured using the same method as for TOC.
The investigators reported that during a median follow-up time of 12.3 years, 61% of the study cohort died. The primary cause of death was 27% each for both CVD and cancer. In fully adjusted analyses, each standard deviation increase was statistically signif icant in concentrations of undercarboxylated osteocalcin (hazard ratio [HR] = 1.12), procollagen type 1 N-propeptide (HR = 1.06) and collagen type 1 C-terminal cross-linked telopeptide (HR = 1.13) was associated with an increased risk for all-cause mortality. The associations were similar after 436 men with an incident fracture at follow-up were excluded.
steocalcin in its undercarboxylated form (ucOC) may influence diabetes risk; however, its relationship with all-cause and cause-specific mortality is unclear. Whether other bone turnover markers (BTMs) are associated with mortality risk differently from ucOC also remains uncertain.
Image: Bone Turnover Markers Including Undercarboxylated Osteocal cin Are Associated With Mortality Risk in Older Men (Photo courtesy of Blood Tests in London)
There are inconsistent findings regarding the association between ucOC concentrations and cardiovascular disease (CVD) risk. An increase in bone turnover with age may predispose to reduced bone mineral density and increased risk of fractures, also associated with incident CVD events.
15 LabMedica International August-September/2022 LabMedicaInternationalTo view this issue in interactive digital magazine format visit www.LabMedica.com
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The risk for CVD mortality was increased with each standard deviation increase in undercarboxylated osteocalcin (HR = 1.13) and collagen type 1 C-terminal cross-linked telopeptide (HR = 1.12). No associations were observed between CVD mortality and total osteocalcin or procollagen type 1 N-propeptide. A higher risk for cancer mortality was observed with each standard deviation in crease in collagen type 1 C-terminal cross-linked telopeptide (HR = 1.12). No other bone turnover markers were associated with cancer mortality risk.
Bu Yeap, MBBS, PhD, a Professor of Endocrinology and senior author of the study, said, “Higher mortality was seen in men who had higher concentrations of undercarboxylated osteocalcin, and also those with higher concentrations of two other bone turnover markers, procollagen type 1 N-propeptide and collagen type 1 C-terminal cross-linked telopeptide. Therefore, the underlying pathway appears to involve bone turnover, in general, and not specifically undercarboxylated osteocalcin. The results were similar even after excluding men who experienced bone fractures during follow-up, so there may be a broader effect of higher bone turnover to increase susceptibility to a range of conditions contributing to death.”The authors concluded that higher bone turnover, assessed by different BTMs including ucOC, PINP, and CTX, is a biomarker for all-cause mortality in older men. Higher concentrations of CTX were also associated with cancer deaths. The study was published on June 11, 2022 in the Journal of Bone and Mineral Research.
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Medical Scientist at University of Western Australia (Perth, Australia; www.uwa.edu.au) conducted a prospective cohort study of 3,871 community-dwelling men, aged 77.0 ± 3.6 years at base line, followed for a median of 12.3 years. Approximately 95% of participants were of White ethnic origin. Prevalent diabetes, cardio vascular disease, cancer, Paget’s disease of the bone, osteoporosis, bone fractures within the past 12 months, and current bisphospho nate or glucocorticoid use were collected using questionnaires.
MYCOPLASMA PNEUMONIAE TEST FUJIREBIO
A
Image: A new portable medical device can monitor and enable early detection of CKD (Photo courtesy of Flinders University) iofouling poses a pervasive challenge to the development of electrochemis try-based diagnostics, which could be used to solve important diagnostic problems.
Now, a novel electrochemical sensor plat form will pave the way for the development and commercialization of cost-effective, highly sensitive and specific point-of-care diagnostics for neurological, cardiovascular, and renal dis eases. The foundational discovery that started the development of this multiplexed biosensor technology was a novel antifouling nanocom posite coating that enables electrochemical electrodes to withstand the attack of biofoul ing molecules contained in various biofluids, including blood, and thereby maintains the electrodes’ sensing capabilities and minimizes any electrochemical background signal.
To receive prompt and free information on products, log on to www. LinkXpress.com or fill out reader service form located on last page, or scan the QR code on your mobile devicePRODUCT NEWS SARS-COV-2 ASSAY EUROFINS TECHNOLOGIES
Electrochemical Sensor to Enable New Diagnostic Tests in Near-Patient Settings
ESR
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INgezim COVID 19 SPIKE CROM is a double recognition immunochromatographic assay for the qualitative determination of total antibodies specific to SARS-CoV-2 S protein in vaccinated individuals, in serum and blood samples.
Mobile Kidney Disease Testing Device Measures Urine Albumin at POC new portable medical device for monitoring and early detection of chronic kidney disease (CKD), which affects an estimated 9% of the world’s population, has been shown to have potential to service rural and remote patients and communities with limited medical services. The affordable device can accurately measure levels of albumin in patients’ urine. Elevated albuminuria levels indicate an individual’s kidneys are not filtering blood proteins effectively. The 3D printed medical device was designed, constructed and evaluated by researchers at Flinders University (Adelaide, Australia; www.flinders.edu.au) and accurately measures concentrations of albumin in urine samples via an advanced specified aggregation induced emission (AIE) biosensor. In a proof-ofconcept study, the platform was able to detect urinary albumin with high accuracy and low cost, making it a potential device for detecting and monitoring albuminuria levels for kidney disease.The device is also adaptable for potential monitoring of cancers, amyloid fibrils, and other disease biomarkers. The system requires a digital camera, embedded printed circuit boards, single light source and access to the software and can be operated by anyone without the need for a clinical setting or expert diagnostic laboratory.
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SERODIA-MYCO II is an in vitro diagnostic test kit for the detection of antibodies to Mycoplasma pneu moniae in human serum. This test is based on Fujirebio’s particle-agglu tination assay using coated gelatin particles. ANALYZER LINEAR CHEMICALS S.L.U IRIA 5 POS is a compact, easy function, low cost Erythocyte Sedimentation Rate (ESR) analyzer with a working load of 18 samples per hour, 5 test tube positions, de livering results in mm Westergren with test time of 17 minutes. LMI-09-22COM 217LMI-09-22LINKXPRESS COM 218LMI-09-22LINKXPRESS COM LabMedica August-September/2022
The Harvard Wyss Institute (Cambridge, MA, USA; www.wyss.harvard.edu) has li censed its affinity-based, multiplexed, elec trochemical sensing technology, eRapid, to StataDX Inc. (Cambridge, MA, USA; www. statadx.com), granting it exclusive worldwide access to the technology in the fields of neu rological, cardiovascular, and renal diseases. The focus will be on developing diagnostic tests that can address critical unmet diagnostic needs in various near-patient settings, such as physician offices, pharmacies and eventually at home.Theaffinity-based electrochemical sensor technology has been developed as a low-cost multiplexed diagnostics platform that can simultaneously detect and quantify a broad range of biomarkers with high sensitivity and selectivity in a small volume of blood or other complex biological fluids. By convert ing their original gold-based chemistry to a graphene-nanocomposite chemistry, the Wyss team further enhanced eRapid’s biomarker detection efficiency, and by developing a “dip coating method,” they reduced the time needed for coating sensor surfaces with the improved antifouling nanocomposite from 24 hours down to less than a minute. The ad vanced coating process dramatically reduced the fabrication costs for eRapid sensors and, in addition, made them storable for an extended period of time with minimal loss of electric signal. This increased their usefulness for fu ture point-of-care diagnostic assays as testing can be done remotely and read on-site or sent C Cont’d on page 17
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“A reliable, portable device to accurately measure urine albumin could be rolled out to point-of-care testing sites in the community to reduce the need for patients with chronic kidney disease to regularly visit a hospital or clinic,” said co-author Professor Karen Reynolds, Director of Flinders University’s Medical Device Research Institute and Joint Research Centre for Personal Health Technologies at Tonsley Innovation District. “It will also help early detection of kidney disease which is imperative for early intervention to slow its progression.”
LabMedicaInternationalTo view this issue in interactive digital magazine format visit www.LabMedica.com 17 LabMedica International August-September/2022
Cont’d from page 16 Thus, the introduction of new POC molecular diagnostic technologies that deliver faster results with high accuracy and specificity will posi tively impact the market growth. These are the latest findings of Global Market Insights Inc. (Selbyville, DE, USA; www.gminsights.com), a market research and strategy consulting firm. Based on product, the cardiometabolic testing products segment dominated the global POC testing market with revenue of more than USD 3.6 billion in 2021. Greater affordability and convenience over conventional testing along with the availability of several cardiomet abolic testing products is expected to continue driving the segment’s growth. Based on technology, the immunoassay segment accounted for the highest revenue share of 17.7% of the global POC testing market in 2021 and is expected to register a significant CAGR through 2030. Immunoassay is a highly selective bioanalytical technique used to deter mine the presence or quantity of analytes ranging from micro molecules to macro molecules in a solution. This technique provides quick, cost effective and simple methods for detection with high sensitivity and preciseBasedresults.onprescription, the home-care settings segment is set to dominate the global POC testing market with revenues surpassing USD 18.2 billion by 2030. This can be attributed to the introduc tion of several monitoring device and other devices that do not require training for operating. Such devices reduce dependency on professionals and offer owners the liberty to monitor, keep a track of glucose levels and manage diabetes efficiently in their home-care setting. Geographically, the POC testing market in Asia Pacific is projected to register a CAGR of 9.5% over the forecast period, driven by the increasing prevalence of infectious diseases, novel product launches and rising government healthcare expenditure. The European POC testing market is expected to be driven by fa vorable government initiatives and programs, rapidly evolving POCT techniques for diagnosing infectious diseases, and technological improvements & innovations for more appropriate and rapid testing products in the region.
Importantly, the coating can be used to embed probes for a broad range of biomarkers, including proteins, antibodies, metabolites, hor mones, and RNA molecules that can be simultaneously detected in multiplexed electrode arrangements. Most recently, the Wyss team presented a comprehensive framework for developing highly effective diagnostic electrochemical sensors, using a broadened range of surface materials that prevent biofouling and enhance detection of a variety of biomarkers, including the neurofilament-light (NFL) protein, which is gaining interest as a potential diagnostic biomarker for multiple sclerosis.
to a central laboratory for analysis.
“Upon chemically detecting a target biomarker, eRapid sensors pro duce electrical signals within minutes that correlate in strength with the levels of the bound biomarkers, much like a commercial glucometer used by diabetic patients does today, but with multiplexing capability,” said Sanjay Sharma Timilsina, Ph.D., a key member of the Wyss Institute research team that extensively de-risked the technology. “This opens up a vast diagnostic space, given that many multifactorial diseases and dis orders require simultaneous measurement of multiple biomarkers with high sensitivity and specificity in order to accurately diagnose, stratify, and monitor patients.” “We showed in our extensive de-risking process at the Wyss Institute that the eRapid platform can address diverse live-threatening diseases and conditions with multiplexed biomarker measurements for which no accurate diagnosis existed before,” said Pawan Jolly, Ph.D, a Wyss senior staff scientist who led the multidisciplinary eRapid team at the Wyss Institute. “This is one of the most promising forays of an electrochemical sensing technology into commercial stages with the prospect to fill im portant diagnostic gaps in critical areas with unmet needs.”
“While there are many at-home tests for viral diseases such as COVID19 available today, nothing yet exists for patients with complex chronic diseases such as multiple sclerosis, heart failure or chronic kidney disease that need periodic measurements of multiple biomarkers. The approach enabled by eRapid addresses underlying limitations of electrochemical biosensing in an elegant way, which may overcome the challenge faced by so many promising diagnostic technologies – the successful transfer to manufacturing at scale,” said Sidhant Jena, CEO and co-founder of StataDX. “Our decision to pursue neurology first stems from the signifi cant healthcare burden of an aging population and the complete absence of a fingerprick blood test for the brain.”
Electrochemical Sensor to Enable New Diagnostic Tests in Near-Patient Settings
Growth of Point-of-Care Testing Driven by Molecular Diagnostics Advances Cont’d from cover 117LMI-09-22LINKXPRESS COM
Autoantibodies
PERIPHERAL BLOOD APPLICATION CELLAVISION
pe
morphological
Image: Histological features of collagenous colitis (Photo courtesy of Michael Bonert, MD, FRCPC) proteins found in the fetal brain. The maternal autoantibodies (IgG) cross the placenta and access the developing brain. Once there, they may cause changes in the way the brain develops in the offspring, leading to behaviors linked to autism. Clinical Immunologists at the University of California, Davis (Davis, CA, USA; www. ucdavis.edu) collected maternal blood mid pregnancy (15–20 weeks of gestation) in ci trate dextrose. They used prenatal plasma from mothers of autistic children with or without co-occurring intellectual disability (ASD = 540), intellectual disability without autism (ID = 184) and general population controls (GP = 420). Plasma was separated, labeled, and stored at −80 °C. Prior to use, samples were thawed at room temperature (RT), vortexed, and centrifuged at 13,000 RPM for 10 minutes. Maternal antibody cross-reactivity against the eight antigens was determined by Enzyme-Linked Immunosorbent Assay (ELISA) using custom-made and commercially available proteins (CRMP1, CRMP2, GDA, NSE, LDHA, LDHB, STIP1, and YBOX). The absorbance was measured at 490450 nm using an iMark Microplate Absorbance Reader (Bio-Rad Laboratories, Hercules, CA, USA;Thewww.bio-rad.com).scientistsreported that they found reactiv ity to at least one of the nine MAR ASD patterns in 10% of the autistic group. This is compared with 4% of the intellectual disability group for some patterns, and 1% of the general population group. Four patterns were present only in moth ers whose children were later diagnosed with Cont’d from cover Cont’d on page 19
Maternal Autoantibodies As Autism Biomarkers
18LabMedica International August-September/2022 To receive prompt and free information on products, log on to www. LinkXpress.com or fill out reader service form located on last page, or scan the QR code on your mobile devicePRODUCT NEWS HEMOGLOBIN A2 CONTROL BIO-RAD QUALITY SYSTEMS DIVISION Lyphochek
The authors concluded that no increased presence of the investigated antibodies could be found in the present study of CC. Neither could antibodies against ASCA or TPO, or ele vated levels of IgE, be found. Consequently, no association was found between CC and these proteins, even though this may not be general izable to other compounds in the collagen layer. The study was published on June 6, 2022 in the journal BMC Immunology. of Against Related Proteins in Collagenous Colitis Hemoglobin A2 Control is a lyophilized control designed to monitor the precision of auto mated and manual procedures for the measurement of Hemoglobin variants. It has a 2-year shelf life at 2–8°C.
ollagenous colitis (CC) is an inflam matory disorder in the colonic mu cosa that predominantly affects elderly women and causes chronic, non-bloody diar rhea with normal or close to normal endoscopic findings.Thehistological criteria for CC are a thick ened sub-epithelial collagen layer (> 10 μm) in the extracellular matrix (ECM) of the mucosa, epithelial damage and presence of an inflam matory infiltrate in the lamina propria. CC shares many of the characteristics found in autoimmune diseases, but no autoantibodies have been identified. In CC, an imbalance in collagen turnover is Gastroenterologistsevident.atthe Skåne University Hospital (Malmö, Sweden; https://vard.skane. se) included in a study, 66 women with CC. The mean age at inclusion was 60 years (range 31–74 years) and mean age at diagnosis was 55 years (range 28–69 years). The size of the control groups differed, but they were selected from the same cohort consisting of 100 healthy female blood donors. The mean age of the total control group was 41.7 years (range 19–69). In-house enzyme-linked immunosorbent assays (ELISAs) were set up for analysis of antiIgM and IgG antibodies against collagen type III (Col III and IV). Analyses of antibodies against matrix metalloproteinase-9 (MMP-9 and Tenascin-C (TNC) were conducted by in-house ELISAs and another in-house ELISA was set up for analysis of IgM and IgG antibodies against tissue inhibitors of metalloproteinase (TIMP1). Anti-Saccharomyces cerevisiae antibodies (ASCA) IgG were analyzed by a fluorescent enzyme immunoassay method (FEIA) for which the reference value is set > 10 U/mL (Orgentec Diagnostika, Mainz, Germany; www.orgentec. com). Thyroid peroxidase (TPO) antibodies were analyzed by a chemiluminescence enzyme immunological method (Siemens Healthcare GmbH, Erlangen, Germany; www. siemens-healthineers.com).Theinvestigatorsreported that there was no difference in prevalence of these collage-associ ated autoantibodies between CC patients and controls. Sixteen patients expressed one type of autoantibody, whereas two patients expressed two different types. The mean disease duration was significantly lower in the subjects who ex pressed collagen-associated autoantibodies (3.7 years; range 1–14), compared to those who did not (6.4 years; range 1–22). The presence of au toantibodies against TPO and ASCA was slightly increased compared to controls, but not statisti cally significant. Increased levels of total IgE were equally present in the CC patients and the control group, and there was no correlation between total IgE-positivity and presence of any autoantibodies.
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Correlate with Clinical Severity
The study also found that a mother with reactivity to any one of the nine MAR ASD patterns has around eight times the chance of having an autistic child. Several MAR ASD patterns were strongly associated with autism with intellectual disability. Others were linked to autism without intellectual disability. The protein pattern most strongly linked to autism was (CRMP1+CRMP2). It increased the likelihood of an au tism diagnosis by 16 times and was not found in the non-autism groups.
Judy Van de Water, PhD, a professor of immunology and neurodevelop ment and senior author of the study, said, “Previously, we identified nine patterns linked to MAR ASD. In this study, we wanted to check the accu racy of these patterns in predicting MAR ASD. To do that, we tested plasma from pregnant mothers, collected by the Early Markers for Autism (EMA) study. We hope our work can help develop better-tailored services based on the type of autism and the child’s strengths and specific challenges.”
Immunobiomarkers in Chronic Rhinosinusitis
hronic rhinosinusitis comprises a heterogeneous group of inflammatory disorders. It is assumed that the disease process lasts over 12 weeks and is accompanied by two or more symp toms, such as nasal discharge/postnasal drip, nasal congestion, sinus pain/pressure, and anosmia/hyposmia. Chronic rhinosinusitis (CRS) is characterized by epithelial inflamma tion and tissue eosinophilic infiltration. Interleukin-5 (IL-5), periostin (POSTN), and IL-33 are important factors that act as chemoattractants for eosinophils, and a tissue-remodeling protein positively correlated with eosinophils in blood and mediators of eosinophilic infiltration. Clinical Scientists at the Medical University of Lodz (Lodz, Poland; www.umed.pl) carried out carried out a study in a cohort of 93 Caucasian patients, aged between 22 and 65 years: group I eosinophilic CRS without nasal polyps (CRSsNP) included 53 patients, 13 of whom were diagnosed with allergy; group II eosinophilic CRS with nasal polyps (CRSwNP) included 40 patients, 16 of whom were diagnosed with allergy. In each case, allergy was confirmed by skin prick testing. The reference group was composed of 40 patients with nasal septum deviation (NSD). Tissue samples were collected during the planned endoscopic proce dures. These comprised sinonasal mucosal and polyp tissue from CRS patients, or a fragment of the mucosa of the lower nasal concha from NSD patients. Blood samples were used to evaluate serum IL-5, perios tin and IL-33 levels using ELISAs (Thermo Fisher Scientific, Waltham, MA, USA; www.thermofisher.com).
19 LabMedica International August-September/2022 LabMedicaInternationalTo view this issue in interactive digital magazine format visit www.LabMedica.com
Tissue samples, after processing, were examined with an Olympus light microscope (Olympus, Tokyo, Japan; www.olympus-lifescience.com).
The epithelial infiltration with eosinophils were evaluated. Determinations of total IgE levels were performed by an immunoenzymatic method on a UNI-CAP immunoan alyzer (Pharmacia, Uppsala, Sweden; www.pfizer.com). The expression of IL-5, POSTN and IL-33 mRNA was determined in sinonasal mucosal samples and in nasal polyp tissue by real-time PCR. The investigators reported that comparison between non-allergic and allergic patients with and without NP show significant differences for total IgE serum levels. NP tissue demonstrated significantly higher IL-5 and POSTN mRNA expression than the sinonasal tissue in the CRSsNP and CRSwNP groups. CRS groups demonstrated elevated IL-33 mRNA expression in comparison to controls irrespective of the presence of NP. No correlation was found between IL-5, POSTN and IL-33 mRNA expression and disease severity. CRSwNP group demonstrated significantly higher serum IL-5, POSTN and IL-33 protein levels than controls, and this corresponds to disease severity.The authors con cluded that serum IL-5, POSTN and IL-33 levels may be useful for identifying CRSwNP patients and predicting the disease severity. Clinical phenotyping of patients with CRS based on selected inflammatory markers could enhance the early recognition of sinus disease, thus representing a promising new therapeutic ap proach. The study was published on June 25, 2022 in the journal BMC Immunology.
Image: The UNI-CAP immunoanalyzer is intended for allergy testing using ImmunoCAP (Photo courtesy of Thermo Fisher Scientific) autism, making those particular autoantibody patterns highly predictive.
The authors concluded that one of the greatest strengths of their cur rent study was that the samples were collected during mid-pregnancy, demonstrating the predicative value of maternal IgG reactivity against MAR ASD + patterns and child outcomes. The study was published on May 26, 2022 in the journal Molecular Psychiatry.
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First-Ever Blood Test For Parkinson’s Disease of these symptoms. To date, there have been neither blood parameters nor imaging examina tions to produce a definite diagnosis, let alone early recognition. Scientists around the world are looking for reliable clinically applicable biomarkers for this chronic progressive brain disease. Now, researchers have developed a method that reliably detects protein changes in blood that are typical of Parkinson’s disease. A research team at the Faculty of Medicine at Kiel University (Schleswig-Holstein, Germany; www.uni-kiel.de) has developed a biochemical blood-based test for the diagnosis of Parkinson’s disease. In a study, the test was able to distin guish the 30 Parkinson’s patients from the 50 control individuals with a very high degree of sensitivity. However, it is still no known whether early stages of the diseases can also be detected and whether the test will work for diseases that are similar to Parkinson’s.
he quality of healthcare is a grow ing concern worldwide. In clinical laboratories, it is essential to define the quality required by an analytical testing process. Sigma metrics are known to be a useful tool for benchmarking the performance of methods. In the six Sigma methodology, “Defects per Million Opportunities (DPMO)” is used as the unit for calculation. A Sigma value indicates the frequency of defects occur ring in a process. Therefore, a higher Sigma value translates into a lower number of de fects and a lower Sigma value means a higher number of defects. Mindray (Shenzhen, China; www.mindray.com) has used the Sigma method decision chart to plot the performance of 30 biochemistry parameters on its BS-600M chemistry analyzer. Original reagents and validated application protocol lower the inaccuracy and imprecision which contributes to achieving world-class and ex cellent Sigma metric performance. Higher Sigma level system can help laboratories offer high level of quality at reduced cost and en hance clinician confidence and satisfaction. A high Sigma performance means high quality of measurement, which can improve clinicians’ confidence and satisfaction. Besides performance benchmarking, Sigma metrics can also be used by laboratories to design quality control processes. For assays with 6-Sigma per formance, the official recommendation is that laboratories can run QC every 1000 patient samples. For those with 3-Sigma performance, it is recommended to run QC every 45 patient samples.So,what does that mean? How does that impact the laboratory? A high Sigma perfor mance level helps laboratories reduce QC measurements, simplify QC rules, and shorten the TAT. It also contributes to a reduced need for trouble bshooting due to false QC viola tions and less QC and reagent consumption. Therefore, with its high Sigma level, Mindray’s BS-600M system can help laboratories offer high level of quality at reduced costs and boost clinicians’ confidence and laboratories’ reputation.
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The Gentier96E Real-Time PCR system is designed to meet the experimental needs of high-end laborato ries. With 6 fluorescence channels, it can process 96 samples in one run.
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Image: A new method reliably detects pro tein changes in blood that are typical of Parkinson`s disease (Photo courtesy of Pexels)
Cont’d from cover Chemistry Analyzer with High Sigma Level Boosts Lab Performance
“We developed a biochemical blood-based test for the diagnosis of Parkinson’s disease. With our procedure, we were able to distin guish the 30 Parkinson’s patients from the 50 control individuals with a very high degree of sensitivity,” said Dr. Annika Kluge from the Faculty of Medicine at Kiel University. “The results are really sensational. They form the basis on which a blood test for diagnosing Parkinson’s disease can be developed.”
C-REACTIVE PROTEIN (CRP) TEST DIASYS DIAGNOSTIC SYSTEMS
REAL TIME PCR SYSTEM XI’AN TIANLONG SCIENCE & TECHNOLOGY
The new method is based on three steps. The first step was to isolate the vesicles of nerve cells in the blood sample. Vesicles are small blisters that are pinched off cells and con tain the protein of the original cell. The second step was to look specifically for the protein that causes the disease in these isolated nerve cell vesicles. This is a changed form of α-synu clein. This pathogenic form of α-synuclein can be detected through structure-specific antibod ies. The third and most significant step of the detection method involves reproducing these misfolded α-synuclein forms of Parkinson’s pa tients from vesicles taken from patients’ blood.
CRP FS is a liquid-stable immunoturbidimetric test with dedicated ready-to-use calibrators and controls. The test results are fully quantitative which allows true differentiation of borderline cases. 224LMI-09-22LINKXPRESS COM
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20LabMedica International August-September/2022
Improved Patient Pathway for Diagnosis, Follow Up and Monitoring of Multiple Myeloma(MM); A Multi-Disciplinary Collaboration to Improve the Pathway from the Initial Request to Long-Term Monitoring Hampshire Hospitals NHS Foundation Trust
Enhanced Discrimination of Myocardial Injury in a Pediatric Population Using Age-Specific Biomarker Reference Intervals Yantai Yuhuangding Hospital
Guozhen LeiChengmingChenSunChen Yanjie GuangyuDingZhou
NEWS
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.
Enhancing Personalized Care for Heart Failure Patients: A Risk-Scoring EMR Model Prisma Health Greenville Memorial Hospital Jason Guichard Sandi StephanieStoudenmireFlippin Beverly Jameson Beth Wehitz
UNIVANTS OF HEALTHCARE EXCELLENCE RECOGNITION OF DISTINCTION
Sustained 97% Opt-out HIV testing in the Emergency Department: Getting to Zero AIDS Croydon University Hospital Ian LeslieMikeCormackBellPerry Sarah Horne Linda Cheyenne Vaccari Andrew Widdowson
Kate Fenna Noel KirstyRymanGordon Ross FrancisSimonSadlerWhiteheadSmith
Early Detection of Unsuspected Cardiovascular Risk in Asymptomatic Blood Donors
UNIVANTS OF HEALTHCARE EXCELLENCE GLOBAL WINNERS
2021 UNIVANTS Awards: Thirteen Teams from Around the World Recognized for Healthcare Excellence
Preventing Cardiovascular Disease in a Large Client Population Through Proactive, CostEffective and Enhanced Identification of Cardiovascular Risk Using a Novel Laboratory Test Medcan Health Management Inc.
Dimitris Grammatopoulos Harpal Randeva Lisa Berry Asad Ali Neil Anderson
Improving Cancer Patients Safety, Confidence and Clincal Care Through Screening Healthcare Workers for Neutralizing COVID-19 IgG Antibodies and Establishing a COVID-19 Convalescent Plasma Bank at KHCC King Hussein Cancer Foundation and Center Maher Sughayer Hala Al MohammedSalahatOwdeh Lina Souan Alaa Al-Shorman
Early Diagnosis of Acute Kidney Injury in Hospitalized Patients with Comorbidities Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute Barnali Das Urja UmeshPoonamParekhMPalVariyani Nirajan Kulkarni Sharad SantoshShethSShetty
Optimizing the Care, Safety and Wellness of Patients with Known Diabetes Through Laboratory Medicine and a 5-Stage Multi-Disciplinary Clinical Care Pathway Zulekha Hospital Dubai Magdy MohamedMariamAllamYounanAbdelhamid Muhammad Khan Eman Yousef TABLE
Renal Osteodystrophy Monitoring by Monthly PTH Determination in Hemodialysis CKD-MBD Patients University Hospital Centre Zagreb & Polyclinic Avitum Sanda Jelisavac Cosic Drasko Pavlovic Boris Kudumija
The website also includes valuable links, tips and access to an application por tal for all healthcare teams who wish to apply for a UNIVANTS of Healthcare Excellence award in 2022. The dead line for 2022 applications is November 15,The2022.UNIVANTS of Healthcare Ex cellence award program includes the following founding program part ners: International Federation of Clinical Chemistry and Laboratory Med icine (IFCC), AACC, EHMA (Europe an Health Management Association), Modern Healthcare, Healthcare Infor mation and Management Systems So ciety (HIMSS), National Association of Healthcare Quality (NAHQ), and the In stitute of Health Economics (IHE); each in partnership with Abbott.
UOC Medicina Trasfusionale AOOR Villa Sofia-Cervello Patrizia FrancescoFrancescoCartaArcoleoGioia Calogero Falletta Aurelio Maggio
UNIVANTS OF HEALTHCARE EXCELLENCE RECOGNITION OF ACHIEVEMENT
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21 LabMedica International August-September/2022 News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information I FCC, in partnership with Abbott and 6 other global healthcare organiza tions are celebrating the success of 13 teams across the globe who have re ceived global recognition for healthcare excellence. By “UNIFYING” across disciplines for the development and im plementation of “AVANT-GARDE” pro cesses, each of the recognized teams achieved measurably better healthcare, awarding them prestigious honors and association with the UNIVANTS of Healthcare Excellence awards. The winning 2021 care initiatives involved innovative, diverse, and in spiring outcomes that spanned multi ple disease states, clinical pathways, geographical locals and healthcare disciplines. Winners were selected by a blinded and comprehensive scoring rubric led by the healthcare profes sionals responsible for judging. With over a hundred initiated applications across over 50 countries, the final out comes for 2021 revealed 3 top global winners, 3 teams of distinction, and 7 teams of achievement in accordance with Table I (displayed on this page). More details on these best practices and/or the award program itself can be found at www.UnivantsHCE.com.
Addressing Covid Clinical and Translational Challenges Via Mulitdiscipline Integrated Diagnostics Networks UHCW NHS Trust and Warwick Medical School
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Utilizing an Innovative Approach to Process Improvement in the Era of a Global Pandemic and the Great Resignation: Rapidly Improving Timeliness of Laboratory Test Results for Multidiciplinary Rounds in an Acute Care Setting Banner Health and Laboratory Sciences of Arizona Kimm KevinTimothyWuestenbergHersomCruz Connie Moreno Teri Dahn
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Improving Morbidity and Mortality in Patients with Sepsis King Abdulaziz Medical City – Jeddah Abobaker BilqasemAliMohammedYagootAlMohammadiBawazeerAlBarakati Fahad Al Hameed Asim Al Saedi Anwar Borai
Metabolomics: From Research to Clinical Diagnostics & Prognostics
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22LabMedica International August-September/2022 News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more informationNEWS
Comprehensive metabolic profiling, using metabolomics, has become widely accepted as a dynamic and sensitive meas ure of the phenotype at the molecular level, placing the technol ogy at the forefront of biomarker and mechanistic discoveries related to pathophysiological processes.
The recently formed IFCC Metabolomics working group has started to survey existing applications in clinical diagnostics and prognostics with the aim of enhancing awareness and de fining requirements for the translation to clinics. Although me tabolomics is in relatively widespread use in clinical research, the complexity of the approach has so far prevented clinical translation of most of the potential applications.
There are, however, several examples whereby an initially broad metabolite profiling approach has led to the identifica tion of sets of biomarkers which were subsequently quantified by (targeted) multiplexed assays. Derived metabolite concen trations were then combined into simple multimarker scores to facilitate their use for medical decision-making.
One example is the Diabetes Risk Index (DRI) multimarker score (1-100) that combines the levels of two branched-chain amino acids (valine and leucine) that are associated with in sulin resistance and obesity with 6 simultaneously-measured lipoprotein subclass and size parameters that comprise the Lipoprotein Insulin Resistance Index (LP-IR) [a,b]. The DRI test is performed on serum and plasma specimens using the clinically-deployed Vantera® NMR clinical analyzer iswww.labcorp.com/tests/123855/diabetes-risk-index-dri)(https://andusedtohelpcliniciansmaketherapeuticdecisionsbased on a patient’s glucose-independent risk of developing type 2 diabetes.Another good example of this approach is an LC-MS based assay used as risk stratifier for primary and secondary preven tion of atherosclerotic cardiovascular disease. Based on abun dant published data, which included lipidomics approaches [c], risk scores using the concentrations of circulating ceramides have been developed and adapted for routine clinical practice (CERT1 Assay) [d]. Both examples demonstrated the great potential of a me tabolomics biomarker discovery approach and its subsequent translation into a multiplexed assay based on NMR and mass spectrometry. To the best of the working group's knowledge there are, to the present date, no examples of the use of un targeted metabolomics workflow for routine clinical diagnos tics. However, given the fast development of data analytics, further applications of pattern-recognition based untargeted metabolomic profiling might be foreseen, especially in the field of volatolomics, such as breath analysis, for example. Here, pattern recognition and machine learning algorithms are particularly useful to rapidly (e.g., in real-time) correlate metabolic profiles to specific end-point phenotypes or clinical outcomes.
REFERENCES
By A. Bendt, D. Di Natale, D. Friedecky, E. Fux, J. Ivanisevic, J. Otvos
[a] Flores-Guerrero JL, Gruppen EG, Connelly MA, et al. A newly devel oped diabetes risk index, based on lipoprotein subfractions and branched chain amino acids, is associated with incident type 2 diabetes mellitus in the PREVEND cohort. J Clin Med. 2020,9,2781;doi:10.3390/jcm9092781
[b] Dugani SB, Vinayaga Moorthy M, Li C, et al. Association of lipid, inflammatory, and metabolic biomarkers with age at onset for incident cor onary heart disease in women. JAMA Cardiol. 2021;6:437-47. Doi:10.1001/ jamacardio.2020.7073[c]Publishedonline 2013 Nov 15. Kirill Tarasov, Kim Ekroos, Mat ti Suoniemi, Dimple Kauhanen, Tuulia Sylvänne, Reini Hurme, Ioanna Gouni-Berthold, Heiner K. Berthold, Marcus E. Kleber, Reijo Laaksonen, and Winfried März, J Clin Endocrinol Metab. 2014 Jan; 99(1): E45–E52 doi: 0.1210/jc.2013-2559 PMCID: PMC3928964 PMID: 24243630
IFCC Working Group on
[d] Hilvo M, Vasile VC, Donato LJ, Hurme R and Laaksonen R (2020) Ceramides and Ceramide Scores: Clinical Applications for Cardiometa bolic Risk Stratification. Front. Endocrinol. 11:570628. doi: 10.3389/fen do.2020.570628
etabolomics is a discipline where one or several ana lytical techniques, such as mass spectrometry (MS) or nuclear magnetic resonance (NMR), are used to measure a large set of metabolites present in a biological sample. Primary metabolites involved in cellular function, mainte nance, differentiation, growth and death are of particular interest for biologists and clinicians. The high chemical di versity of metabolites, in addition to the wide concentra tion range in which they are present in biological samples (spanning at least 11 orders of magnitude), has led to the division of the discipline into several subcategories includ ing, for example, lipidomics, volatomics, steroidomics, and eicosanomics.Twomethodological approaches have been taken: 1) untargeted metabolomics, a data-driven and hypothe sis-generating approach involving comprehensive profiling of as many metabolites as possible to enable disease-as sociated patterns to be deduced for potential clinical use, and2) targeted metabolomics, involving analysis of a select ed set of chemically characterized and biochemically annotated metabolites from a single or multiple pathways that are associ ated with a particular pathology or clinical condition of interest.
The second subcommittee will lead the effort to develop a funded research pro gram for investigators in hospitals located around the world to conduct new retro spective and prospective research with outcomes that assess the value of labo ratory medicine in healthcare overall. The taskforce could help centres in setting up studies to properly collect such data (com mon study protocols and formats) and publish their findings. This subcommittee members include M A. Serdar (Member, TR), C. I. Suárez Sánchez (Member, CL), V. Gounden (Member, SA), E. M. Simb aqueba Sánchez (Corp. Rep./IL-Werfen, US), M. Banerjee (Corr. Member, ACBI) and Z. Zhao (Chair, US). Together, the task force will develop pub lications, presentations, webinars and other
For five incredible days, a global body of thinkers, trailblazers, dreamers and disruptors will converge in Anaheim, CA. This is where genius is shared, theories are proven, correlations are discovered and ideas are challenged. Share your expertise as we come together as one global laboratory medicine community. Submit your proposals for AACC University, Roundtables, and Scientific Sessions. Visit aacc.org/proposals for a list of complete submission guidelines and session categories. Deadline for submissions is Friday, November 4, 2022. 2023
By Dr. Zhen Zhao Chair IFCC Task Force on Outcome Studies in Laboratory Medicine (TF-OSLM), Associate Professor of Clinical Pathology and Laboratory Medicine Director, Central Lab and Clinical Chemistry Services New York-Presbyterian/Weill Cornell Medical Center New York, US T he IFCC Task Force on Outcome Stud ies in Laboratory Medicine (TF-OSLM) was formed in October, 2021. The impor tant mission of the task force is to enhance the visibility of Laboratory Medicine through outcome studies. On January 24, 2022, the newly created task force, chaired by Dr. Zhen Zhao from the United States, got together for their first meeting in a virtual conference call. Dr. Khosrow Adeli, the IFCC president, gave a kick-off speech to share the vision of the task force and provide history of pre vious efforts led by IFCC and international partners to promote Laboratory Medicine. The taskforce members discussed roadmap and timelines, as well as major milestones to help move things forward. Specifically, the TF-OSLM will take a two-pronged approach led by two subcommittees, which had two subsequent virtual meetings on February 10 and 11, 2022. The first subcommittee will lead the ef fort to identify existing peer reviewed, high quality publications that demonstrate the value of laboratory medicine in healthcare overall and create a repository/database of publications that is accessible by members of IFCC. This subcommittee members in clude C. I. Suárez Sánchez (Member, CL), J. A. Snyder (Corp. Rep./Siemens, US), C. Strain (Corp. Rep./Abbott, CA), K. Rodri guez-Capote (Corr. Member, CSCC), M.M. Suchitra (Corr. Member, AMBI), E. Koldberg Amundsen (Corr. Member, NSMB) and Z. Zhao (Chair, US).
The Kick-Off Meeting
MEETINGSCIENTIFICANNUALAACC + LABCLINICALEXPO JULY 23-27 I ANAHEIM, CA GLOBAL LAB MEDICINE COMMUNITY Cont’d on page 24
IFCC Task Force on Outcome Studies in Laboratory Medicine (TF-OSLM):
23 LabMedica International August-September/2022 News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information NEWS
CALL FOR PROPOSALS IS OPEN
Exemption of IC in some situations was considered such as the use for methods validation, Quality Control, secondary employment by investigators not involved in diagnostic sample processing, generation of databases with personal information and collection of samples for COVID-19 Biobanks. Reformulation and caveats of the current IC process were also discussed.
Finally other strategies and dilemmas about autonomy were presented.
G, Pezzati P. Ricerca sul materiale biologico: Ritorno al future. [Research on biological material: Back to the future] Biochimica Clinica. 2021;45(3):299-304. theinresearch-on-biological-material-back-to-the-futurehttps://moh-it.pure.elsevier.com/en/publications/Anotherrelevantaspectwaspointedoutanopinionpaperwhichreferredtohowuseofbiologicalspecimensandhealth
Inhttps://bc.sibioc.it/bc/numero/bcnum/197comparisontoAnnexCofthe previous version of ISO 15189 (2007) some progress had been made but ongoing review has stalled. ISO attempts to review each Standard at five yearly intervals but its website reports, in 2022, ten years on from 2012, that ISO/DIS 15189 remains “Under development”. (ISO – ISO/DIS 15189 –Medical laboratories — Requirements for quality and competence). Clearly, more efforts are needed by the community of Laboratory Medicine professionals to definitively install ethical principles in a more sustained communicationsway.
By Nilda E. Fink and Richard Davey
Ethical Concerns in the Use of Residual Biological Material in the Clinical Laboratory
In Laboratory Medicine, residual biological material is often employed for evaluation of new diagnostic methods and procedures. Materials obtained from clinical practice –patients’ samples of blood, urine and other fluids and tissues – are commonly used for this purpose. International Organizations, National Societies and Governmental en tities, among others, have been receptive to this situation and have taken various actions. We describe here some of these actions.
Remes Lenicov, F. Ethical concerns and requirements regarding the use of COVID-19 diagnostic samples for research'. Webinar; 2021; https://search.coe.int/cm/Pages/result_details.researchofCouncilandstored,materialsThisorigintheversiontheplesconcerneddilemmas-in-laboratory-medicine-during-pandemito-the-ifcc-live-webinar-20th-october-2021-ethical-https://www.ifcc.org/ifcc-news/2021-10-08-register-IFCC.cSomeyearsago,agovernmentalentityabouttheuseofresidualsamwastheCommitteeofMinistersofEuropeanCouncil.ItproducedanewofaRecommendationregardinguseofbiologicalmaterialsofhumaninclinicalandbiomedicalresearch.Recommendationstatedthatbiologicalforstudyshouldonlybecollected,andusedinanorganizedmannerinconformitywiththeprinciplesoutlined.ofEurope.RecommendationCM/Rec(2016)6theCommitteeofMinisterstoMemberStatesononbiologicalmaterialsofhumanorigin.
IFCC Task Force on Outcome Studies in Laboratory Medicine (TF-OSLM)
materials to help IFCC members use this data to effectively pro mote the critical value of laboratory med icine in healthcare to key stakeholders. The Taskforce will also closely coordinate with other IFCC groups involved in related activities, including CPD, C-VPLM, TFCM and others, as required. For further information about the TF activities, please visit: laboratory-medicine-tf-oslmeb-task-forces/task-force-on-outcome-studies-in-https://www.ifcc.org/executive-board-and-council/
eJIFCC. 2020;31(4):274-281.
To this end recently IFCC’s Webinar series included a TF-E organized webinar in which one of the speakers treated this aspect focusing on ethical concerns and requirements regarding the use of COVID-19 diagnostic samples for research. Federico Remes Lenicov began by describing different types of samples that enter consideration. Later he pointed out ethical issues in the use of leftover samples and their associated personal data such as autonomy, the process of informed consent (IC), risks and benefits.
This Recommendation acquires more value and relevance considering the need of employment of COVID19 patient samples. In line with this concern the Italian Society of Clinical Biochemistry (SIBioC) made available this Recommendation and other relevant articles in Italian as part of the ethical issues in laboratory medicine that Biochimica Clinica, its official publication, published last year in 2021. Confidentiality and the right to defend the fundamental rights of people whose biological material is gathered and maintained for future research purposes are given special attention from an ethical point of view. The protection of vulnerable subjects, the implementation of control and safety measures, methods to facilitate public access to general information on the nature and purpose of collections of materials for research purposes, and the implementation of policies on the management of results relevant to people's health resulting from the use of their biological materials are all new Sancesarioaspects.
The IFCC’s Task Force on Ethics (IFCC TF-E) contributed to the publication of papers for teaching purposes in a theme eJIFFC number in 2020; 31(4). In one of the arti cles titled “Ethics in Laboratory Medicine: Perspectives and Challenges in Resource Limited Settings”, Sudip K. Datta commented that handling of leftover samples becomes a challenge in resource-constrained envi ronments. To reduce turnaround time labo ratories frequently allow add-on tests using these leftover samples and clearly the given patient must remain identified to facilitate result reporting. Here the informed consent process must also incorporate accommoda tions for this process as well as adhering to ethical code-guiding principles. When using remaining samples for study however, risk can be reduced by eliminating patient iden tification. If essential identifiable information is collected, such as age and sex of the sampled person, other personal identifiers may be removed and replaced with a code, de-identified or anonymized. Identifying in formation is thus not retained and cannot be accessed. The author added that “However, the process of informed consent should abide by the general principles of ethics. In normal circumstances mostly two options are explored for such initiatives regarding consent: (i) recontacting patients and getting consent for each new research study, which is logistically difficult, time-consuming, and expensive, and hence often practically not feasible in resource constrained settings; or (ii) allow patients to give a broad consent that allows for future use of the samples."
Section 4.1.1.3 of the document summarizes the ethical conduct expected of laboratories, including requirements for the pre-, intra- and post-analytical phases of the testing cycle.
https://bc.sibioc.it/bc/numero/bcnum/lastFinally,MarioPlebaniinanother excellent article highlighted the main aspects of Ethics in Laboratory Medicine. A relevant and particularly treated point was that the International Organization for Standardization (ISO) in the accreditation standard ISO 15189:2012 "Medical Laboratories: Requirements for quality and competence" has dedicated a specific section to this issue.
Cont’d from page 23
information in research can speed up the un derstanding of numerous diseases as well as the efficacy of preventive, diagnostic, prog nostic and therapeutic actions. Biological material however must be initially utilized for the diagnostic and analytical procedures mandated by the medical test request, and any subsequent usage requires external approval by an Ethics Committee and patient Banfiagreement.G.Utilizzo del materiale biologico residuo nel laboratorio clinico. [Use of residual biological material in the clinical laboratory] Biochimica Clinica 2021; 45(4):408-11.
24LabMedica International August-September/2022 News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more informationNEWS
Plebani M. L’etica in medicina di laboratorio nella terza era della medicina. [Ethics in laboratory medicine in the third era for medicine] Biochimica Clinica 2021; 45(2) 176-9.
aspx?ObjectId=090000168064e8ff
https://pubmed.ncbi.nlm.nih.gov/33376467
25 LabMedica International August-September/2022 AACCRoundup2022
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Tianlong Science and Technology (Shaanxi, China; www.tlgenetech.cn) showcased its GeneMix Pro automatic sample processing system that is designed to automate laboratory workflow and maintain sample integrity. Tianlong also displayed its PANA9600S automatic nucleic acid workstation which is designed according to the principles of magnetic beads method and rotary nucleic acid extraction technology. In addition, Tianlong showcased its Gentier 96R real-time PCR system which is designed to meet the experimental needs of high-end laboratories.
Scientists from the University of Washington (Seattle, WA, USA; www.washington.edu) presented their research demonstrating a cheap, convenient smartphone test for monitoring patients at risk for dangerous blood clots. The test quickly and inexpensively determines PT/INR using a smartphone’s built-in vibration motor and camera to track movement of a copper particle in a drop of blood.
Cont’d from page 12 AACC 2022 Roundup
To view this issue in footprint to improve hospital operational efficiencies. Also on display at Meridian’s booth was the company’s Revogene flexible molecular platform capable of single analyte and multiplex testing that is packaged in a small footprint, and can help standardize testing throughout the health system. Rhinostics (Boston, MA, USA; rhinostics.com) introduced the patent-pending VERIstic Collection Device which is ideal for use in athome and clinician-assisted collection methods. The device is a highly efficient, high-throughput replacement for antibody, hormone and pro tein detection, sexually transmitted infections (STIs) testing, dried blood spot (DBS) cards, genetic testing, clinical trials, and other applications enabled by a simple finger prick collection. This first of its kind collec tion device combines tried-and-true capillary blood collection with an integrated, automation-ready cap to save time, money, and hassles in a hands-free workflow when the sample reaches the laboratory.
In addition, researchers at Sabin Medicina Diagnostica (Brasilia, Brazil; www.sabin.com.br) presented their findings on a first-of-its-kind NGS panel that detects a mutation in that small spot on the SMN1 gene that causes spinal muscular atrophy, a common genetic disease that is life-threatening but treatable if caught in time.
A team of researchers at the Nationwide Children’s Hospital (Columbus, OH, USA; www.nationwidechildrens.org) became the first to show that a faster method for diagnosing UTIs in adults could also work in children. Known as UTOPIA, this method uses urinalysis results and other variables to predict UTIs, and delivers answers well before the 2-3 days needed for culture results.
Cytovale (San Francisco, CA, USA; cytovale.com) launched its 510(k) pending Cytovale system and 10-minute IntelliSep sepsis risk stratification test, and also shared new data featuring the test. The Cytovale system directly analyzes white blood cells using rapid tech niques that look at cell structure, which may make it faster and less expensive than other approaches. The IntelliSep test aims to simply and clearly determine the risk of a patient having sepsis using a biome chanical evaluation of white blood cells from a standard blood draw at presentation, generating results in under 10 minutes. Advanced Instruments (Norwood, MA, USA; www.aicompanies. com) introduced a new osmometer that delivers the automation and data management capabilities modern clinical labs require to free up tech time, improve result turnaround times, reduce errors, and ensure effortless compliance. The company’s newest addition to its clinical line of freezing point osmometers, the OsmoPRO MAX automated osmometer, has been designed for clinical laboratories of all sizes seeking higher productivity through automation. The instrument’s innovative flow-through technology eliminates manual pipetting and consumables, allowing testing to begin with the push of a button.
RBC Bioscience (New Taipei City, Taiwan; www.rbcbioscience. com) released its new MagCore EDA instrument, which combines DNA/RNA extraction and Smart PCR Setup, providing a complete solution for lab workflow optimization. The new MagCore EDA has three modes of operation: NA extraction, PCR setup and NA extraction with PCR setup. MagCore EDA presents a set of unique features such as HEPA filters, cooling plate for idling eluates, spectrophotometer for automatic OD measurements at the end of extraction, safety locks that ensure the ease of use and safety of the system.
Next year’s AACC Annual Meeting & Clinical Lab Expo is sched uled to take place in Anaheim Convention Center, Los Angeles, CA, on July 23-27, 2023.
CellaVision (Lund, Sweden; www.cellavision.com) announced the launch of DIFF-Line by CellaVision, a new workflow solution for low-volume hematology laboratories. DIFF-Line by CellaVision consists of three instruments for smearing, staining, and analyzing peripheral blood smears: CellaVision DC-1, RAL SmearBox, and RAL StainBox. DIFF-Line by CellaVision is available on the European market and will be rolled out in more markets in 2022.
Researchers at Mayo Clinic (Rochester, MN, USA; www.mayoclinic. org) presented their study on a group of AI-trained algorithms that analyze FTIR kidney stone composition results, in an effort to improve diagnosis and better guide treatment. In a 12-month investigation, these AI-trained algorithms reviewed manual analyses of 81,517 kidney stones, and the researchers found the technologist’s and AI’s interpretations agreed 90% of the time.
ASHI 2022 – 48th Annual Meeting of the American Society for Histocompatibility and Immunogenetics. Oct 24-28; Las Vegas, NV, USA; ashi-hla.org Arab Lab 2022. Oct 25-27; Dubai, UAE; arablab.com
44th National Congress of Clinical Chemistry and Expo – National Federation of Clinical Chemistry (CONAQUIC). Sep 12-17; Guadalajara, Mexico; conaquic.com Thailand LAB International 2022. Sep 14-16; Bangkok, Thailand; thailandlab.com
OCTOBER
ASHG 2022 – Annual Meeting of the American Society of Human Genetics. Oct 25-29; Los Angeles, CA, USA; ashg.org ACPID 2022 – 10th Asian Congress of Pediatric Infectious Diseases. Oct 26-28; Seoul, Korea; acpid2022.org 33rd National Congress of the Turkish Biochemical Society. Oct 26-30; Çeşme, Turkey; turkbiyokimyadernegi.org.tr
FIDSSA Congress 2022 – Federation of Infectious Diseases Societies of Southern Africa. Nov 3-5; For a free listing of your event or a paid advertisement in this section contact: International Calendar LabMedica International E-mail: info@globetech.net August-September/2022
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35th IFBLS World Congress 2022 – International Federation of Biomedical Laboratory Science. Oct 5-9; Suwon, Korea; ifbls2022.org CAP22 – Annual Meeting of the College of American Pathologists. Oct 8-11; New Orleans, LA, USA; cap.org ESID 2022 – 20th Biennial Meeting of The European Society for Immunodeficiencies. Oct 12-15; Gothenburg, Sweden; esidmeeting.org
ATTENTION: Due to the CORONAVIRUS venues, or altogether cancelled. Please check with the event organizer or website prior to planning for any forthcoming event
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European Society of Pathology (ESP). Sep 3-7; Basel, Switzerland; espcongress.org ASCP 2022 – Annual Meeting of the American Society for Clinical Pathology. Sep 7-9; Chicago, IL, USA; ascp.org ESCV – 24th Annual Meeting of the European Society for Clinical Virology. Sep 7-10; Manchester, UK; escv2022.org AFCB Congress 2022 – 16th Conference of the Arab Federation of Clinical Biochemistry. Sep 8-10; Brummana, Lebanon; ifcc.org ISLH 2022– International Society of Laboratory Hematology. Sep 8-10; Bologna, Italy; islh.org 44th Annual Meeting of the European Thyroid Association (ETA). Sep 10-13; Brussels, Belgium; eurothyroid.com 16 Belgrade Symposium for Balkan Region –Serbian Congress of Medical Biochemistry and Laboratory Medicine. Sep 12-14; Belgrade, Serbia; dmbj.org.rs
54th National Congress of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC). Oct 5-7; Genoa, Italy; sibioc.it JFBM 2022 - Journées Francophones de Biologie Médicale. Oct 5-7; Saint-Etienne, France; jfmb.fr
62nd Annual Academic Assembly of the Japan Society of Clinical Chemistry (JSCC). Sep 30 - Oct 2 Toyama, Japan; jscc-jp.gr.jp
ESPE 2022 – 60th Annual Meeting of the European Society for Paediatric Endocrinology. Sep 15-17; Rome, Italy; eurospe.org India Lab Expo & Analytica Anacon India. Sep 1517; Hyderabad, India; analyticaindia.com
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AMP 2022 –Annual Meeting & Expo of the Association for Molecular Pathology. Nov 3-5; Phoenix, AZ, USA; amp.org KAI International Meeting 2022 – Korean Association of Immunologists. Nov 3-5; Incheon, Korea; kai2022.kr
WASPaLM 2022 – 31st World Congress of the World Association of Societies of Pathology and Laboratory Medicine. Sep 29 - Oct 2; Punta del Este, Uruguay; waspalm.com
EASD 2022 – 58th Annual Meeting of the European Association for the Study of Diabetes. Sep 19-23; Stockholm, Sweden; easd.org Cytokines 2022 – 10th Annual Meeting of the International Cytokine & Interferon Society. Sep 20-23; Big Island, Hawaii; cytokinesociety.org ExpoMedical 2022. Sep 21-23; Buenos Aires, Argentina; expomedical.com.ar
EAHP-SH 2022 – 21st Meeting of the European Association for Haematopathology. Sep 17-22; Florence, Italy; eahp-sh2022.com ICT 2022 – 16th International Congress of Toxicology. Sept 18-22; Maastricht, Netherlands; ict2022.com
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DKLM 2022 – Annual Congress of the German Society for Clinical Medicine and Laboratory Medicine (DGKL). Oct 13-14; Mannheim, Germany; dgkl.de 46th ISOBM Congress – International Society of Oncology and Biomarkers. Oct 14-17; Bled, Slovenia; isobm2022.net
22nd Journées Marocaines de Biologie Clinique –Moroccan Society of Clinical Chemistry. Sep 22-24; Casablanca, Morocco; smccbm.org.ma 16th Baltic Congress in Laboratory Medicine. Sep 22-24; Tallinn, Estonia; balm2022.ee
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59th Annual Scientific Conference of the Australasian Association of Clinical Biochemistry and Laboratory Medicine (AACB). Oct 18-20; Perth, Australia; aacb.asn.au 20th Congress of the Polish Society for Laboratory Diagnostics. Oct 19-22; Kielce, Poland; ptdl.pl
91st Annual Meeting of the American Thyroid Association (ATA). Oct 19-23; Montreal, Canada; thyroid.org LABCLIN 2022 – 16th National Congress of the Spanish Societies for Clinical Laboratory (AEBMML, AEFA & SEQCML). Oct 19-21; Malaga, Spain; labclin2022.es MEDLAB Asia 2022. Oct 19-22; Bangkok, Thailand; medlabasia.com EndoBridge 2022. Oct 20-23; Antalya, Turkey; endobridge.org
ENDO 2023 – Annual Meeting of the Endocrine Society. Jun 15-18; Chicago, IL, USA; endocrine.org 48th CBAC – Congress of the Brazilian Society of Clinical Analysis. Jun 18-21; Florianopolis, Brazil; sbac.org.br
JULY Analytica Lab Africa 2023. Jul 5-7; Johannesburg, South Africa; analytica-africa.com FEMS 2023 - 10th Congress of European Microbiologists. Jul 9-13; Hamburg, Germany; fems2023.org 2023 AACC Annual Scientific Meeting & Clinical Lab Expo – American Association for Clinical Chemistry. July 23-27; Anaheim, CA, USA; meeting.aacc.org
FEBRUARY
JUNE 106th Annual Meeting of the German Society for Pathology. Jun 1-3; Leipzig, Germany; pathologiedgp.de
ASCO 2023 – Annual Meeting of the American Society of Clinical Oncology. Jun 2-6; Chicago, IL, USA; asco.org 66th Congress of the German Society for Endocrinology. Jun 5-7; Baden-Baden, Germany; endokrinologie.net
DECEMBER
Medlab Middle East 2023. Feb 6-9; Dubai, UAE; medlabme.com Labquality Days 2023 – International Congress on Quality in Laboratory Medicine. Feb 9-10; Helsinki, Finland; labqualitydays.fi SLAS 2023 – International Conference & Exhibition of the Society of Laboratory Automation and Screening. Feb 25 - Mar 1; San Diego, CA, USA; slas.org MARCH
ECV 2023 – 8th European Congress of Virology. May 4-7; Gdansk, Poland; eusv.eu ESPID 2023 – 41st Annual Meeting of the European Society for Paediatric Infectious Disease. May 8-12; Lisbon, Portugal; espidmeeting.org Immunology 2023 – Annual Meeting of the American Association of Immunologists (AAI). May 11-15; Washington, DC, USA; aai.org ECE 2023 – 25th European Congress of Endocrinology. May 13-16; Istanbul, Turkey; esehormones.org
JMSACL 2023 – Congress of the Association for Mass Spectrometry & Advances in Clinical Lab. Apr 3-6; Monterey, CA, USA; msacl.org ECCMID 2023 – 33rd European Congress of Clinical Microbiology and Infectious Diseases. Apr 15-18; Copenhagen, Denmark; eccmid.org Korea Lab 2023. Apr 18-21; Seoul, Korea; korealab. org Analytica Vietnam 2023. Apr 19-21; Ho Chi Minh City, Vietnam; analyticavietnam.com
IFCC-EFLM WorldLab & EuroMedLab 2023 - 25th International Congress of Clinical Chemistry and Laboratory Medicine. May 21-25; Rome, Italy; ifcc.org Hospitalar 2023. May 23-26; Sao Paulo, Brazil; hospitalar.com
ESHRE 2023 – 39th Meeting of the European Society of Human Reproduction and Embryology. Jun 25-28; Copenhagen, Denmark; eshre.eu
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USCAP 112th Annual Meeting - United States & Canadian Academy of Pathology. Mar 11-16; New Orleans, LA, USA; uscap.org ExpoMED Eurasia 2023. Mar 16-18; Istanbul, Turkey; expomedistanbul.com Pittcon 2023. Mar 18-22; Philadelphia, PA, USA; pittcon.org KIMES 2023. Mar 23-26; Seoul, Korea; kimes.kr
ESHG 2023 – European Human Genetics Conference. Jun 10-13; Glasgow, UK; eshg.org ASM Microbe 2023 – American Society for Microbiology. Jun 15-19; Houston, TX, USA; asm.org
JIB 2022 - Journees de l`Innovation en Biologie. Dec 1-2; Paris, France; jib-innovation.com 64th Annual Meeting & Exposition of the American Society of Hematology (ASH). Dec 10-13; New Orleans, LA, USA; hematology.org 2023JANUARY
FOCIS 2023 – Annual Meeting of the Federation of Clinical Immunology Societies. Jun 20-23; Boston, MA, USA; focisnet.org FIME 2023 – Florida International Medical Expo. Jun 21-23; Miami, FL, USA; fimeshow.com
August-September/2022
ASI 2022 – 50th Annual Scientific Meeting of the Australian and New Zealand Society for Immunology. Nov 29 – Dec 2; Melbourne, Australia; asi2022.org
EHA 2023 - Annual Congress of the European Hematology Association. Jun 8-11; Frankfurt, Germany; ehaweb.org EAACI 2023 – Annual Congress of the European Academy of Allergy & Clinical Immunology. Jun 9-11; Hamburg, Germany; eaaci.org
APRIL
Fertility 2023– Joint Conference of the UK Fertility Societies. Jan 10-13; Belfast, UK; fertilityconference. org
43rd Annual Meeting of the American College of Toxicology (ACT). Nov 13-16; Denver, CO, USA; actox.org Analytica China. Nov 14-16; Shanghai, China; analyticachina.com MEDICA 2022. Nov 14-17; Dusseldorf, Germany; medica-tradefair.com ICC 2022 – 21st International Congress of Cytology. Nov 15-20; Baltimore, MD, USA; cytology-iac.org
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128LMI-09-22LINKXPRESS COM
128LMI-09-22LINKXPRESS COM
GEM Premier 5000 blood gas testing system provides automated quality assurance with every whole-blood* sample. Now with next-generation Intelligent Quality Management (iQM2), featuring IntraSpect™ technology, potential errors are detected not only before and after, but also during sample analysis, along with real-time correction and documentation. Plus, it’s simple—just change the all-in-one GEM PAK once a month. So regardless of testing location or point-of-care operator, quality results and compliance are assured with every sample.
Acute Care Diagnostics
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The Intelligent Analyzer