Your guide to laboratory and pathology equipment in Europe € 15.– Automation & Sample Processing Chemistry & Immunochemistry Hematology Pathology DNA Microbiology POCT IT Other Applications 2021 Vol. 8 Shed light on the mysteries of rare microbial infections with Zybio’s 4th generation MALDI-TOF EXS2600 Mass Spectrometry System. Zybio EXS2600 series is tailored for microbiology laboratories by presenting accurate results, elevating efficiency and benefiting clinical research.

Editorial Dear readers, 2021 – the second year of a pandemic is coming to an end and it seems that over the course of the past months we have somehow lost the strength that characterized our initial answer to this challenge. In the beginning, we as societies faced the new challenge with solidarity as laboratory medicine methods and terms such as PCR or quick tests entered our daily vocabulary. But with enthusiasm and solidarity waning, laboratory medicine is once again relegated to the sidelines, at least in Germany. Even more importantly, objective lab results are being interpreted not only by physicians but also by lay- people with a political agenda. Despite this somewhat pessimistic review and preview: welcome to the 2021 LABBook. Unsurprisingly, COVID-19 plays a prominent part in our lab medicine purchasing guide as manufacturers present their SARS-CoV-2 kits and our authors examine the topic from different angles. There is still no reliable patient-side quick test that performs near as well as the gold standard PCR. For 2022, Bernard Banga expects considerable efforts and developments in POCT analytics with improved test procedures and new platforms. “Lab-on-a-chip” technology will most likely provide devices linked to the smartphone and wearables. Mass spectrometry continues to make a major contribution to diagnostics as Uta Ceglarek’s report on newborn screening in Leipzig underlines. Established in 2005, the screening programme now encompasses 19 tests, 9 of which are performed on an MS/MS platform; PCR moreover recognizes further immunodeficiencies and spinal muscular atrophy (SMA). While not all diseases that are detected can be cured, an early diagnosis may significantly slow down their progression. The European lab community is closely watching the political developments since not only mass spectrometry laboratory-developed tests (LDTs) are affected by the EU regulation on in vitro diagnostic medical devices (IVDR, (EU) 2017/746). Thomas Streichert outlines the risks and opportunities for patients, labs and manufacturers as well as the likely effects of Brexit. Raquel Cumeras introduces us to ion mobility spectrometry, a new measurement principle which closes the gap between chromatography and mass spectrometry and thus opens up new application potential, e.g. in breath gas analysis and combining LC and IMS. As usual, the LABBook – in print, as an e-paper or in our database – presents new as well as tried and tested lab instruments, software and supplies for all tasks in the medical laboratory, categorized in chapters ranging from automation and information technology to peripheral devices. All information contained in the LABBook is accessible online at www.labbook.eu and www.healthcare-in-europe.com where you will also find contact details of the manufacturers and authors. Manufacturers, authors and the editorial team – we all look forward to receiving your feedback, be it praise, criticism or suggestions what you would like to find in the next edition. Enjoy reading and browsing, Dr Markus Neumann LABBook 2021 1

78 1 Editorial 106 Companies & Suppliers 113 Imprint 84 82 88 78 Zybio – Shed light on the mysteries of rare microbial infections by MALDI-TOF MS The EXS2600 mass spectrometry system enables rapid microbial identification, including bacteria and fungi. 82 Early detection – New diagnostic possibilities with MS qPCR newborn screening The range of diseases diagnosed through screening has increased significantly by using mass spectro- metry (MS/MS) and lately qPCR. 84 Ion-mobility Spectrometry – Rapid results from breath analysis IMS is flexible, portable and can be used for point- of-care testing or remotely. 88 Trends – Emerging technologies in POCT Lab-on-a-chip platforms, innovations in smart- phone-based technology and wearable technology will drive POCT. Products & Systems 7 Automation & Sample Processing 20 Chemistry & Immunochemistry 39 75 Mass Spectrometry 45 Hematology 57 Pathology 62 DNA 74 Microbiology 86 POCT 95 Information Technology 99 Other Applications LABBook 2021 3

According to a recent study under IVDR, a notifi ed body has to be involved in about 78 percent of the approval procedure for in vitro diagnos- tic medical devices – up from previously eight percent. You are referring to a MedTech Europe study which is quite enlightening in many aspects: it shows the substantial risk that, next year, many tests will no This means a lot of work for hospitals and labs. The most problematic assays, in my opinion, are modifi ed tests – i. e. commercially available assays where the labs deviate from the manufacturer’s protocol, for example by using the test with a different matrix. currently busy making their tests IVDR-compliant by the deadline. If they modifi ed the intended purpose they would also have to go through the conformity assessment procedure again. Putting into service Conformity declaration (publicly accessible) Product monitoring / vigilance IVDR There are also concerns that, in the future, labs will have to pay for tests that they themselves developed, but that are being distributed by an external company. Are these concerns justifi ed? At the University Hospital Cologne we use a number of mass spectrometry assays which we developed ourselves to measure medication levels. Today, a company is offering one of these tests in its product portfolio. If we want to comply with IVDR requirements with regard to the socalled industry privilege, longer be available. Particularly for rare diseases there are tests which are distributed by very small enterprises, often university spin-offs. For them, continuing to offer these tests might fi nancially not be viable due to the high costs. If a manufacturer can no longer sell his tests as a CE-marked product, the test is still available on the market but the lab manager who purchased it has to validate the test and can be held liable. But validating a purchased test is pretty close to impossible. We understand that tests developed by the labs them- selves will also face diffi culties. Can you explain the problems? A university hospital uses on average 700 to 800 laborato- ry-developed tests – so-called LDTs. In the future, all these in-house tests will have to comply with IVDR standards. At the University Hospital Cologne we measure a certain tumour marker in CSF, not in serum or plasma as the manufacturer prescribes. Strictly speaking this is a signifi cant modifi cation, which means we are considered the manufacturer of this product. Consequently, we have to validate this test ourselves. However, to do so we’d need the technical details of the assay, for example where the antibody binds, and we’d need access to the relevant perfor- mance tests. This is not only a time-consum- ing task but also requires the manufacturer to disclose this information. It might well hap- pen that we have to discontinue using this test even though it is useful for the patients. Could manufacturers adapt the intended purpose of their tests? Manufacturers are not keen to do that. They are PROFILE Dr Thomas Streichert is Director of the Institute for Clinical Chemistry, Medical Director of the Centre for Laboratory Diagnostics (Clinical Chemistry, Microbiology, Virology, Pharma- cology, Endocrinology) and Interim Director of the Institute of Pharmacology, Therapeutic Drug Monitoring, at the University Hospital Cologne. Born in South Africa, Streichert studied medicine in Hamburg where he also worked as junior physician and consultant. In 2013, the specialist physician for laboratory medicine joined the University Hospital Cologne. He is chair of the E-Learning Commission at the University Hospital Cologne and member of the German Society for Clinical Chemistry and Laboratory Medicine (Deutsche Vereinte Gesellschaft für Klinische Chemie und Laboratoriumsmedizin e.V.). LABBook 2021 5

Automation & Sample Processing A u t o m a t e d S a m p l e P r o c e s s i n g Sample Processing Automation Sample Logistics LABBook 2021 7

Sample Processing Dimensions: Sample throughput: 490 × 330 × 570 mm (w × h × d) for one instrument configuration 1 – 128 tests per 24 hours Highlights: The Novodiag System offers a simple and fast way to pinpoint patients most at risk with targeted and syndromic on-demand testing. · Offers a wide menu of targeted and multiplex assays in one instrument · Clear displays of results in around an hour · Small, quiet, fully automated easy-to-use platform · Up to four instruments can be stacked and controlled by a single computer (Novodiag PLUS) · Part of Hologic Molecular Scalable Solutions portfolio Sample Processing Hologic – Novodiag System Improve Medical – Automatic Biosafety Decapper Highlights: · Biosafety protection design · Micro-vibration design for specimen safety · Auto run and walk away with supporting sample-in and sample-out buffer zone · Aerosol filtration efficiency > 99.99 % · A pf > 3 × 105 · Able to decap Φ 75 / 100mm tubes, even in one rack at the same time · Decapping throughput: > 1,800 tubes / h MolGen – PurePrep TTR Highlights: The PurePrep TTR offers high throughput automated liquid handling to quickly, accurately and consistently transfer liquid consistently from tubes to Deep Well microtiter plates. · Automated de-capping and capping of tubes · Processes up to 320 samples per hour · Liquid-level sensing · Full Track and trace of your samples The PurePrep TTR reduces contamination risk throughout the complete workflow AD CORP 0011 V1.0 15-NOV-2021 LABBook 2021 9

Sample Processing an additional 210 tests to be run in 24 hours, providing a total throughput of greater than 1,200 patient samples in that time. Laboratories can gain additional effi ciencies by using Panther Link, a software solution that creates a virtual connection allowing multiple Panther instruments to communicate with one another and function within a singular, streamlined workfl ow. Linked instruments can share information such as reagent kits and refl ex test orders, enabling more effi cient reagent utilization and improved turnaround time. A dashboard command feature allows technicians to monitor instrument inventories, maintenance tasks and test results on a single screen from a centralized location. Finally, the upcoming Panther Trax* will offer the ultimate in lab automation by physically and electronically linking multiple Panther instruments together into a single, powerful workcell that allows labs to increase testing volumes without increasing staff. Taken together, these confi gurable options address the needs of today’s laboratories, allowing them to increase operational capacity and testing volumes at their own pace, while building on the fl exibility and streamlined user experience they require. To fi nd out more about how the Hologic’s Molecular Scalable Solutions can meet the growing pressure and demands of today and tomorrow visit Hologic’s website. This is an advertorial by Hologic Inc. *Not CE-IVD, not for sales. LABBook 2021 11 antibiotic resistance management. It is a small, quiet, stackable, fully automated platform that combines easy to use functionality with molecular performance. With just a few simple steps the Novodiag system enables fast, life-saving diagnoses, delivering precise, easy-to-read results in an hour, so improving effi ciency and bringing clinical confi dence closer to the patient. Infectious diseases are detected from a single use cartridge in about one hour and a comprehensive menu of assays for screening of antibiotic resistances, gastrointestinal, respiratory (including COVID-19) and hospital acquired infections is available. Each Novodiag assay can detect multiple targets simultaneously, for example, the Novodiag Bacterial GE+ assay has 14 targets, while the Novodiag Stool Parasites assay detects 26. For settings that need a larger on-demand capacity, Novodiag Plus links up to four instruments. These can be stacked and controlled by a single computer and offer a total of four indepen- dent slots per instrument, adding fl exibility and convenience. For laboratories requiring systems with a higher throughput, Hologic’s Panther® Scalable Solutions offer a range of options with a broad menu of high performing assays, allowing laboratories to expand their testing menu while adding on fl exibility, capacity and walkaway time. The portfolio’s foundation is the Panther system, which was launched in Europe in 2010. This offers random access and full automation for molecular testing with a broad assay menu including tests for women’s health, sexually transmitted infections (STIs), respiratory health, and viral load, as well as Open Access functionality for laboratory developed tests (LDTs). This menu enables laboratories to consolidate molecular testing onto a single platform. The Panther system has additional add-ons including Panther Fusion, which launched in 2016 and provides additional IVD menu and the Open Access™ func- tionality, the Panther Plus, Panther Link and Panther Trax*. The Panther Fusion® module adds the ability to run real-time PCR, TMA and RT-TMA assays on a single, fully auto- mated platform. This enables laboratories to consolidate testing, increase walkaway time and enhance fl exibility. With Panther Plus, laboratories can load more consumables directly on the instrument, allowing even greater walkaway time (up to 13.5 consecutive hours). Both fl uids and waste can be changed while tests are in process, and an option for automatic liquid waste disposal is available. These features allow

Sample Processing Sarstedt – Sample Distribution System PVS 1625 Sample Processing Sarstedt – Sorter DC/RC 900 Flex Sarstedt – Sort Connect Highlights: The PVS 1625 is a tailor made automation system for pre- and post-analytical processing of samples. It is capable to handle most kind of rack and tray types. As an open system, it is complementary to any analytical platform or can be used independently. Full function pre- and post-analytical system · Modular configuration according to laboratory needs with: Loading platform / ID Module / Decapper / Recapper / Aliquoter / Sorter · For all common tube types: 13 – 16 mm diameter, 65 – 100 mm length (without cap) · Aliquoter for secondary tubes or multi-wells available Highlights: Pre- and post-analytics in one system: · Processes any tube diameter from 11 to 16 mm · Sample throughput up to 900 tubes / h · Compatible with most racks or carrier types · Online or offline operation · Opens tubes with push caps, stoppers and screw caps · Can be customised to sort by tube type, material (barcode) or test request · Closes tubes with universal archiving caps · Retrofitting of decapping or recapping module is possible · Recapping with screw caps for Sarstedt tubes with 13 or 15 mm diameter Highlights: · Sort Connect – Bulk feeding of samples with universal connection to laboratory track systems · Process optimization with pre sorting and separation of tubes not destined for testing on the track · Modular design enables a range of configurations · Sample accessioning · Intelligent sample re-routing where test order is missing · Freely configured sorting platforms · Automatic distribution to all common makes of analyser racks or into bins · Can handle a large number of different tube types LABBook 2021 13

Automation Beckman Coulter – DxA 5000 Fit Sample throughput: up to 375 tubes / h Highlights: At a time when up to 75 percent of lab errors take place pre- analytically, laboratories can benefit from comprehen- sive workflow automation. For this reason, Beckman Coulter developed the DxA 5000 Fit, an automation system that offers an improved approach to laboratory workflow by making intelligent automation accessible to labs of virtually any size. The DxA 5000 Fit leverages DxA 5000 technology, providing the benefit of intelligent automation to midsize labs in a compact footprint. Improve Medical – Intelligent Blood Collection Management Solution Promega – Maxprep Liquid Handler Dimension: Weight: Sample throughput: Number of channels: Assays: 1069 × 706 × 833 mm (w × h × d) 98.6 kg 1 – 48 samples / hour; (2) 24 position Maxwell RSC 48 / CSC 48 (RUO) or (2) 16 position Maxwell RSC / CSC (RUO) removable trays 4 Promega Maxwell Kits Highlights: Complete nucleic acid purification system in combination with Maxwell RSC / CSC (RUO) and Maxwell RSC 48 / CSC 48 (RUO) · Automated Maxwell sample preparation · Hands-free nucleic acid extraction on the Maxwell RSC / CSC (RUO) or RSC 48 / CSC 48 (RUO) · Post-extraction sample preparation for quantitation, normalization and amplification setup using the Maxprep Liquid Handler · UV decontamination and barcode scanner Automation Highlights: · Total solution for complete processes of blood collection management and sample processing · Intelligent and standardized blood collection process · Reduced errors during preanalytical phase Component: · Blood collection tube preparation system · Intelligent sorter · Multi-function blood collection table · Queuing system LABBook 2021 15

Automation Beckman Coulter – DxA 5000 Fit Beckman Coulter – DxA 5000 Fit The biggest problem lies in pre-analytical errors, which account for up to 70 percent of all mistakes made in laboratory diagnostics.4 Of these, it has been found that 24 – 30 percent of laboratory errors infl uence patient care, while actual or potential patient harm as a result of errors is registered in 3 – 12 percent of cases.5,6,7 These numbers show the desperate need faced to reduce these errors to improve patient care and avoid mistreatments across the board. In addition to their impact on patient care, however, laboratory errors are also costly. According to research, a laboratory in the US can expect to incur approximately $180,000 per year in costs related to pre- and post-analytical errors, on average, with these errors including labelling mistakes, incorrect samples and insuffi cient sample volumes.8,9 Many of the errors detected in labs can be put down to one simple cause: human error. This means the solution is clear: automation. Automation can play a key role Automation is key to minimising time-consuming errors and is a necessity for any lab striving to meet the ever-evolving demands faced. In streamlining services by helping mitigate bottlenecks in the sample preparation phase, automation cuts down on the time spent on each test, speeding up the service. However, it also reduces person-to-person variation and human error in lab testing, substantially cutting down on mistakes and leading to more accurate results across the board. Implementing ways to automate pre- and post-analytical phases of routine laboratory testing also enables technologists to focus their time on analytics and reporting. In addition, automation helps mitigate bottlenecks faced when preparing samples by processing samples quicker, more effi ciently, and more consistently than ever before. Convinced that automation is the next necessary step for your laboratory? Visit our automation page to view our full suite of automation solutions: www.beckmancoulter.com/en/products/automation. Sources 1. Badrick T. (2013) Evidence-Based Laboratory Medicine. Clin Biochem Rev. 2013 Aug; 34(2): 43–46 2. Bonini P, Plebani M, Ceriotti F, Rubboli F. Errors in laboratory medicine. Clin Chem 2002;48:691-8. 3. Astion ML, Shojana KG, Hamil TR, Kim S, Ng VL. Classifying laboratory incident reports to identify problems that jeopardize patient safety. Am J Clin Pathol. 2003;120(1): 18-26. doi: 10.1309/8EXC-CM6Y-R1TH-UBAF. 4. Lippi G, Chance JJ, Church S, Dazzi P, Fontana R, Giavarina D, et al. Preanalytical quality improvement: from dream to reality. Clin Chem Lab Med. 2011;49:1113–26. doi: 10.1515/CCLM.2011.600. 5. Carraro P, Plebani M. Errors in a stat laboratory: types and frequencies 10 years later. Clin Chem. 2007 Jul; 53(7):1338-42. doi: 10.1373/clinchem.2007.088344. 6. Plebani M. The detection and prevention of errors in laboratory medicine. Ann Clin Biochem. 2010 Mar; 47(Pt 2):101-10. doi: 10.1258/acb.2009.009222. 7. Plebani M, Carraro P. Mistakes in a stat laboratory: types and frequency. Clin Chem. 1997 Aug; 43(8 Pt 1):1348-51. 8. Barak M, Jaschek R. A new and effective way for preventing pre-analytical laboratory errors. Clin Chem Lab Med. 2014 Feb;52(2):e5-8. doi: 10.1515/cclm-2013-0597. PMID: 24096442. 9. Green SF. The cost of poor blood specimen quality and errors in preanalytical processes. Clin Biochem. 2013 Sep;46(13-14):1175-9. doi: 10.1016/j.clinbiochem.2013.06.001. Epub 2013 Jun 14. PMID: 23769816. Reducing the time overworked personnel spends on testing by implementing ways to automate pre- and post-analytical phases of routine laboratory testing also, however, provides labs with an additional benefi t: it enables technologists to focus their time on analytics and reporting, harnessing their expertise and allowing them to apply it where it’s needed most, therefore improving their analysis of results and, again, reducing errors further. CONTACT Beckman Coulter Diagnostics 22, Rue Juste-Olivier 1260, Nyon, Switzerland phone: +41 22 365 38 08 PANEUMarketing@beckman.com www.beckmancoulter.com LABBook 2021 17

Sample Logistics Sarstedt – Tempus600 Vita Sarstedt – Tempus600 Quantit Sarstedt – Tempus600 Connection Module Automation Highlights: The Tempus600 Vita provides dedicated, direct and fast transport of blood samples to the laboratory without batching or manual pack- aging steps. The samples are placed in the insertion point of the Vita, transported via a pipeline ø 25 mm and landed in the laboratory within seconds. Drastically reducing the total turnaround time for blood sample testing results in faster diagnosis and patient treatment. · Handles up to 810 sample tubes / hour · Compatible with all sample tubes: length 80 – 110 mm, diameter 12 – 18 mm · Connectable to all lab automation, sorters and bulk loaders Highlights: The Tempus600 Quantit provides direct and fast transport of blood samples to the laboratory without batching or manual packaging steps. The samples are placed in a drawer, transported via a pipeline ø 25 mm and landed in the laboratory within seconds. Drastically reducing the total turnaround time for blood sample testing results in faster diagnosis and patient treatment. · Sending both high volume and urgent samples · Samples are always oriented the right way by the system · Compatible with all test tubes: length 80 – 110 mm, diameter 12 – 18 mm · Connectable to all lab automation, sorters and bulk loaders Highlights: The Tempus600 Connection Module is part of an automated one-touch handling system for sample tubes. The sample tubes are delivered from the ward to the laboratory through the dedicated point- to-point system. The sample tubes are gently slowed down before landing in the automation module. From here they are automatically transferred e. g. onto a track system. · Compatible with all lab automation systems including sorters and bulk loaders · A brake module can be fitted to increase sample throughput · and failure-free tube loading. · Up to 8 connections LABBook 2021 19

LABBook 2021 21

Chemistry & Immunochemistry Clinical Chemistry Beckman Coulter – DxC 700 AU Beckman Coulter – HbA1c Advanced Dimensions: Weight: Sample throughput: Power consumption: 1300 × 1250 × 890 mm (h × w × d) 460 kg 800 – 1,200 / h 200 – 240 W Highlights: Designed to meet the needs of mid- to high-volume clinical laboratories, the DxC 700 AU reduces the number of test-processing steps by 30 percent due to its intuitive user-interface that allow operators to spend less time on daily tasks and more time producing the quality results that empower better decision-making. · Simple, intuitive design of the DxC analyzer with the robust throughput capabilities of the AU analyzer · Configurable with a total laboratory solution option to connect the DxC 700 AU with pre-analytical automa- tion, immunoassay and clinical IT Highlights: The fully automated HbA1c Advanced assay enables mid- to high-volume laboratories to provide physicians with state-of-the-art precision and accuracy for diagnosing diabetes mellitus, monitoring long-term glucose control in individuals with diabetes mellitus and identifying pa- tients who may be at risk of developing diabetes mellitus. · National Glycohemoglobin Standardization Program (NGSP) certified/DCCT standardized and precise, providing clinically relevant results for diagnosing and monitoring diabetes · Unaffected by common hemoglobin variants, mini- mizing misdiagnosis or missed diagnosis for patients with these blood conditions · Easy to implement and integrate into the laboratory’s existing chemistry testing practices, providing work- flow efficiency · Available in a single all-in-one kit for Beckman Coulter DxC 700 AU analyzers Dirui – CS-T240Plus Auto-Chemistry Analyzer Fujifilm Wako – Hyaluronic Acid LT Assay Dimensions: Weight: Sample throughput: Sample reagent positions: 744 × 703 × 530 mm (d × w × h) 100 kg 240 tests / h, 480 tests / h with ISE unit 40 – 80 Highlights: · Whole blood test for HbA1c item · Water consumption only 3 L / h · Minimum reaction volume only 100 μL Assays: Quantitative determination of Hyaluronic Acid (HA) based on the latex agglutination method Highlights: · Measurement of key marker for fibrotic stage of chronic liver diseases · Method applicable to general analyzers of clinical chemistry · Fast determination of hyaluronic acid in serum or plasma (10 min) · High precision LABBook 2021 23

Chemistry & Immunochemistry Clinical Chemistry Mindray – BS-430 Clinical Chemistry Analyzer Mindray – BS-480 Clinical Chemistry Analyzer Dimensions: Sample throughput: 1050 × 1150 × 720 mm (w × h × d) Constant 420 tests / h, up to 626 tests / h with ISE Highlights: · Large loading capacity: 92 reagent positions, 102 sample positions · HbA1c smart sampling: supports HbA1c onboard hemolysis · Advanced software platform: auto QC, auto reflex, substrate depletion & enzyme linearity extension, etc. · Quick start-up time: 5 minutes system initialization, 1 minute system wake-up · Low reagent consumption: minimal 100μl reaction volume Dimensions: Weight: Sample throughput: No of parallel samples: 1185 × 1150 × 710 mm (w × h × d) 300 kg Constant 400 tests / h, up to 560 tests / h with ISE up to 78 on-board chemistry tests Highlights: · Discrete, random access, fully automated · Constant throughput with 400 photometric tests / h, up to 560 tests / h with ISE · 24-hour on board refrigerated reagent compartment at 2~10 C · Reusable cuvettes with auto-washing station · Two independent mixing stirrers · Clot detection, automatic probe cleaning, liquid level detection & collision protection (V&H) · Reversed grating system with 12 wavelengths (340~800nm) · Pre-dilution and post-dilution for sample · Built-in barcode scanner · Bi-directional LIS interface Mindray – BS-800M Clinical Chemistry Analyzer Mindray – BS-2800M Modular System Dimensions: Weight: Sample throughput: No of parallel samples: 1600 × 1200 × 1015 mm (w × h × d) ≤ 450 kg for analytical unit, 150 kg for SDM Constant 800 tests / h, up to 1,200 tests / h with ISE up to 68 on-board chemistry tests Highlights: · Modular system: flexible connection · HbA1c smart sampling, automatic hemolysis · Accurate: high pipetting precision, coolant circulation reagent refrigeration direct solid-heating system, effective mixing unit and intelligent clot detection · Innovative: reagent bubble detection, dot light source and water quality monitor · Cost-efficient: large capacity with SDM racking system, 100 μl minimum reaction volume, one key STAT, continuous reagent loading and unloading · Original calibrators with traceability Dimensions: Sample throughput: Power Consumption: Reagent position: Sample position: 2450 × 1150 × 1300 mm (d × w × h) (Single module + SD) M1 (2,000 T / H, up to 2,400 T / H with ISEs) M2( 4,000 T / H, up to 4,800 T / H with ISEs) 220±10% V 50 Hz±1Hz M1 ≤ 5,200 VA / M2 ≤ 9,800 VA 144 positions (M1) 300 Highlights: · High efficiency and quick tests for STAT · Modular design & high throughput · 1 min quick response and 8 mins quick report for STAT tests · High reliability and accuracy of results · HIL.L innovation solution · Real-time monitoring atmospheric pressure · Smart design, easy to operate and less manual intervention · Independent PAD for reagent management · Sample probe ultrasonic wash; · IF & Reddot design award winner PDR optical platform 2021 LABBook 2021 25

Chemistry & Immunochemistry LABBook 2021 27

Chemistry & Immunochemistry Immunochemistry DRG Instruments – DRG:Hybrid-XL Sarstedt – ELISA Plates / Micro test plates for immunoanalytics Sample throughput: Assays: Dimensions: Highlights: Turnover of approx. 120 samples / day, fully automated Antibiotic Treatment Control (TDM): Ceftazidim, Linezolid, Ciprofloxacin and other intensive care unit (ICU) parameters 600 × 600 × 630 mm (w × h × d) Antibiotic Treatment Control (TDM) with DRG:Hybrid-XL DRG adds an important step in Antibiotics Stewardship: · Fully automated quantitative analysis of antibiotics for therapeutic drug monitoring (TDM), other ICU parameters and more unique assays · Fast Results: no sample preparation, results in 1-1.5 h · Flexibility: up to 40 different parameters per sample in one run · Ease of Use: the intuitive user interface simplifies daily work · Secure: calibration is provided via master curve. Cali- bration and reagents offer a long stability. Highlights: One of the analyses most commonly used is the Enzyme-Linked Immunosorbent Assay (ELISA). With this method, even the smallest concentrations of a range of substances (proteins, peptides, antibodies, hormones etc.) can be detected and quantified from complex solutions. Immunoassays Beckman Coulter – SARS-CoV-2 Assays Beckman Coulter – Access High Sensitivity Troponin I (hsTnI) Highlights: The Access SARS-CoV-2 IgG (1st IS) assay and the Access SARS-CoV-2 IgM assay detect antibodies to the receptor-binding domain (RBD) of the spike protein which may be important to identify an immune response. Adding SARS-CoV-2 IgG (1st IS) and / or IgM testing to assess COVID-19 patients provides greater clinical clarity for patient assessment. · Access SARS-CoV-2 IgG (1st IS) assay · The overall specificity of the Access SARS-CoV-2 IgG (1st IS) assay is 99.8 percent and the sensitivity ≥14 days post-symptom onset was 100 percent · Access SARS-CoV-2 IgM assay · The overall specificity of the Access SARS-CoV-2 IgM assay is 99.9 percent and the sensitivity >18 days post symptom onset and post positive PCR was 100 percent Highlights: The Access hsTnI assay provides the advanced diagnostic capabilities necessary to aid physicians in diagnosing at risk patients for acute myocardial infarction earlier and discharging non-acute patients faster. In comparison to standard troponin assays, high-sensi- tivity assays demonstrate significantly improved preci- sion at and below the 99th percentile upper reference limit (URL), allowing better discrimination of small differ- ences in troponin values between serial measurements. · Aids in rapid diagnosis of AMI and confidently excludes AMI in as little as one hour after patient presentation · Provides optimal precision at concentrations about 10x lower than previous generation troponin assays. Improved precision at the clinical cutoff reduces chance of misclassifying patients in the Emergency Department LABBook 2021 29

Chemistry & Immunochemistry Immunoassays Fujifilm Wako – Autokit CH50 Assay Fujifilm Wako – µTASWako i30 Assays: Quantitative determination of total complement activity (CH50) in human serum Highlights: · In vitro diagnostic homogeneous liposome immunoassay · Applicable to automated analyzers · Precise and accurate · Stable, extended calibration stability · Good correlation with Mayer’s hemolytic method Dimensions: Weight: Sample throughput: Assays: 520 × 550 × 600 mm (w × h × d) 71 kg 25 tests / h AFP / AFP-L3, DCP Highlights: · Electrokinetic Analyte Transport Assay (EATA) · High sensitive fluorescence detection · Assay precision less than 3 % CV for AFP-L3 · Increased sensitivity of liver cancer (HCC) detection by combined use of AFP, AFP-L3 and DCP · Unique system to calculate the GALAD score (Gender, Age, AFP-L3, AFP, DCP) for outstanding p erformance regarding early HCC recognition · Improved chance of detecting HCC early during surveillance of patients at risk Genrui – PA120 Lifotronic – Automated ECL Immunoassay Analyzer eCL 8000 Highlights: Trustable at its accuracy: PA120 is an auto specific protein analyzer with high efficiency and accuracy. Based on proven nephelometry, PA120 has great performance. Also, the large touch screen, one-press operation and multi-item combinations will offer you a fast and conve- nient testing experience. Currently following tests are available: HbA1c, FDP, D-Dimer, NGAL, RBP, ß2-MG, CYS-C, mALB, CRP, hs-CRP, SAA, IgA, IgM, IgG, IgE, C3, C4, ASO, RF, CCP, PG I, PG II More tests are in development Dimensions: Weight: Sample loading capacity: Reagent loading capacity: Reagent loading capacity: 650 × 620 × 650 mm (h × w × d) 92 kg 30 samples 10 reagent kits 86 tests / h Highlights: · Electrochemiluminescence (ECLIA) methodology · High accuracy and sensitivity · Wide application range · Perfect quality control system · Fully automatic operation · LCD color tough screen & concise interface · More than 60 kinds of reagent available · STAT parameters test time only 9 mins LABBook 2021 31

Chemistry & Immunochemistry Immunoassays Mindray – CL-6000i Chemiluminescence Immunoassay System Mindray – CL-8000i Chemiluminescence Immunoassay System Dimensions: Weight: Sample throughput: No of channels: Assays: 2150 × 1166 × 1300 mm (w × h × d) 580 kg up to 480 tests / h 36 68 Highlights: · Industrial highest throughput: up to 480 tests per hour · Measurement principle: enhanced ALP-AMPPD method · Reagent carousel: 36 reagent positions with non-stop refrigerating Dimensions: Weight: Sample throughput: Sample position: Reagent position: Assays: 2305 × 1150 × 1180 mm (w × h × d) (Single module + SD) 789 kg (Single module + SDM) 500 tests / h 300 36 67 · Sample handling: up to 300 samples can be loaded in one Highlights: batch,sample loading and offloading continuously by sample racks, fast prioritizing STAT samples · Continuously loading of reagents, substrate, cuvettes, wash buffer and waste bags · Zero daily maintenance The CL-8000i is an upgraded immunoassay analyzer with high throughput up to 500T/H. CL-8000i helps improve medical quality and operational efficiency using techno- logies such as VU-Mix and FS-sampling. Easy-to-use designs such as one-key calibration quality control and quick reagent replacement greatly improve work efficiency. Siemens Healthineers – Immulite 2000 XPi Immunoassay System Snibe – Maglumi X8 Dimensions: Weight: Sample throughput: 1920 × 1180 × 1500 mm (w × d × h) 670 kg up to 600 tests/h (Single module) up to 2400 tests/hour (Four modules combined) 181 Assays: Highlights: Highlights: Providing multiple tests on a single, easy-to-use analyzer – including allergy, specialty, and routine immunoassay testing – the IMMULITE 2000 XPi Immunoassay System makes it simple to scale your capabilities without disrupting regular day-to-day operations. Product availability varies by country. · Fully compatible with Maglumi 181 parameters · Single-cup design can avoid the stuck of the cuvette and increase the cuvette utilization · Capable to link laboratory automation system (TLA/LAS) · No-pause loading / unloading of reagents, samples and consumables without waiting or interrupting tests · No cross-contamination sampling to ensure accurate results · Highly cost-effective with one pipetting for multiple tests technology LABBook 2021 33

Column LABBook 2021 35

What is PEth analysis needed for? Phosphatidylethanols are formed as abnormal phospholipids within the human body when ethanol is present. PEth itself is not a single molecule, but rather a group of molecules that differ from each other in their fatty acid chain composition. As PEth accumulates in the red blood cells, which prolongs its window of detection, it became popular as a direct alcohol biomarker. Thereby, PEth’s strength lies in recognizing the drinking habits during the past two to four weeks, rather than the detection of a single drinking event with limited quantities of alcohol. PEth 16:0 / 18:1 and PEth 16:0 / 18:2 are the two most abundant PEth homologs in human blood and are often measured together. The concentration of PEth 16:0 / 18:1 is frequently used to classify alcohol consumption behavior based on two threshold concen- trations: a lower threshold is used to distinguish between light or no alcohol consumption and is usually set at 20 ng / mL (~0.03 μmol / L). An upper threshold is used to distinguish between substantial alcohol consumption and heavy alcohol consumption and is set at ~200 ng/mL (~0.3 μmol / L). The analysis of PEth is applied in the follow-up of alcohol-im- paired drivers, diagnosis and treatment of alcohol use disorders, newborn screening for fetal alcohol syndrome, organ transplan- tation and in the security environment. Compared to other direct or indirect alcohol markers (EtG, CDT, or GGT) PEth was found to have better sensitivity and specifi city in various studies. Fully automated PEth analysis The combination of a CAMAG DBS autosampler with a Shimadzu 8050 LC-MS system permits a hyphenated fully automated DBS-LC-MS / MS workfl ow. Thereby, the DBS specimen is eluted onto a short trapping column (Polar RP, 20 mm), separated on a longer analytical column (C5, 50 mm), and subsequently detected using electrospray ionization tandem mass spectrometry. The use of a double-column system has the major advantage that a solid-phase extraction like purifi cation of the target analytes is achieved, which reduces matrix effects, co-elution of disturbances and overall system contamination. In contrast to manual, passive extraction of DBS using a tube and a mixer at ambient pressure, the automated system performs an active extraction by constantly pumping fresh extraction solvent through the DBS. After the extraction of each DBS sample, the extraction cell of the autosampler is washed with a selection of three different wash solutions. By using an additional six-port valve installed on the Shimadzu LC-MS system, seamless switching between the CAMAG DBS autosampler and the standard vial autosampler is possible without reconnecting any capillaries. Why use dried blood spots? PEth showed limited stability in liquid blood unless stored at – 80°C. It was observed that the use of dried blood microsamples increases the sample stability: using DBS, the post-sampling formation and degradation of PEth can be prevented and the stability of the samples is improved, as any enzyme activity is stopped during the DBS’s drying process. Overall, the collection of DBS microsamples is easier, less invasive and cheaper than conventional whole blood sampling, as samples can be handled, shipped and stored more cost Chemistry & Immunochemistry Laboratory equipped with a DBS-MS 500 HCT and a Shimadzu 8060 LC-MS system effi ciently over a prolonged time. In addition, specimen collection can be done by untrained persons, including the study subjects themselves and in remote settings. How does the DBS hematocrit measurement work? “What we developed and implemented for PEth analysis”, Marc explained, “is a way of obtaining the hematocrit from already dried samples in a fully automated fashion, thus making it possible to measure hundreds of DBS samples in a non-destructive way.” The automated hematocrit detection is based on a patented refl ectance measurement setup and is not infl uenced by humidity, temperature or the age of the DBS. During the measurement, a probe illuminates the DBS and measures its refl ectance at a very specifi c wavelength. A built-in laser allows controlling and adjust- ing of the distance between the probe and the DBS. As the signal measured is proportional to the hematocrit of the sample, the red blood cell volume percentage can be calculated based on a pre-recorded calibration curve. Thereby, the HCT scanner allows normalizing for any known HCT related DBS effect such as the HCT area bias, the HCT recovery bias, or HCT related analyte properties. Furthermore, it is possible to normalize the analytical result to a selected HCT value. The system is ideally suited for the reliable, quantitative analysis of non-volumetric DBS samples. PROFILE Dr Marc Luginbühl is the principal scientist of the CAMAG DBS Labora- tory, which develops automated dried blood spot solutions. His specifi c areas of expertise lie in the assessment and measurement of biomarkers using microsampling strategies with a passion for drug of abuse screening and alcohol biomarker analysis. With a PhD in Chemistry and Molecular Sciences, he is a member of The Society of Forensic Toxicol- ogists (TIAFT) and the founder of The Society of Phosphatidylethanol Research (PEth-NET). LABBook 2021 37

Chemistry & Immunochemistry Integrated Systems Mass Spectrometry Siemens Healthineers – Dimension EXL 200 Integrated Chemistry System Biomaneo – NeoSickle solution Highlights: Dimension EXL 200 Integrated Chemistry System inte- grates chemistry and immunoassay testing in a compact system ideal for smaller-sized laboratories. Consolidate testing with a broad menu, including cardiac, thyroid, and automated-pretreatment immunosuppressive drug assays. Transition easily and correlate results between core and satellite labs using the partnership of the Atellica Solution and the Dimension EXL 200 Integrated Chemistry System. Product availability varies by country. Sample throughput: Number of parallel samples: 200 samples / h 96 samples / h Highlights: NeoSickle solution for screening ot haemoglobinopathies including: · Two Kits: NS540 / NS96 Suitable for analysis by MALDI-MS 8020 high-throughput analysis: 1000 samples / day Reliability, usability, fast and quality · Neoplate: traceability, security of transport of DBS punches Neoscreening automated, accurate data interpretation software: · eNeoSickle module: for MALDI-8020 data (Haemoglobinopathies) · NeoAMAC module: for LC-MS / MS data (Metabolic diseases) Shimadzu – LCMS-8060 NX (RUO) Shimadzu – LCMS-8060 CL (IVD) / LCMS-8060 (RUO) Dimensions: Weight: Highlights: 1180 × 540 × 610 mm (w × d × h) 140 kg The LCMS-8060NX delivers high sensitivity and ultra fast analysis speed together with robustness and high flexibility. Developed on the base of the LCMS-8060, it incorporates a newly designed ionsource IonFocus to boost ion transfer to the masss spectrometer and increase even more the robustness of the system for complex biological matrices in daily analysis . The system perfectly suits to high sensitivity applications like steroids, catecholamines, and metabolomics studies in clinical research. Dimensions: Weight: Highlights: 1180 × 540 × 610 mm (w × d × h) 140 kg The LCMS-8060 CL delivers the highest sensitivity and fastest analysis speed of any LCMS on the market today. A newly developed UF-Qarray boosts ion intensity but suppresses noise. By improving the ion sampling device, the ion guide, and vacuum efficiency, Shimadzu has achieved an unprecedented sensitivity in quantitative analysis by LC / MS / MS while keeping high robustness for daily analysis. LABBook 2021 39

Chemistry & Immunochemistry Entering the digital age in MS Introducing the MALDImini-1 digital ion trap mass spectrometer Shimadzu’s first-of-its-kind MALDImini-1 digital ion trap mass spectrometer fits in a space the size of a piece of paper, allowing installation in places where mass spectrometers could not previously fit. It enables ion trapping up to 70,000 Da and the MS/MS and MS3 functionality of the digital ion trap allows researchers to carry out compre- hensive structural analyses with ease. • Fast, simple setup allows for a more convenient workflow • Software allows switching quickly and easily between MS, MS/MS and MS3 modes for seamless analysis • Only device capable of MALDI-MSn in this compact size • Space-saving lightweight design fits anywhere LABBook 2021 41 www.shimadzu.eu / maldi-dit MALDImini-1

Chemistry & Immunochemistry Drug Testing Urine Screening Siemens Healthineers – Viva-ProE System Dirui – FUS-1000 Urinalysis Hybrid Sample throughput: Weight: Highlights: up to 133 EMIT tests per hour with two reagents; up to 65 EMIT tests per hour with three reagents approx. 93 kg / 205 lbs (excl. monitor arm and panel PC) A flexible approach to dedicated drug-testing analysis, the Viva-ProE System provides greater ease of use, workstation efficiency, and a full drug-testing menu, all in one powerful benchtop system that is supported by unrivaled Syva experts. The system offers peltier cooling for efficient reagent use, can run up to 133 Emit tests per hour and 12 Emit assays simultaneously; 120 tests can be programmed with 10 open test channels. Results available within 10 minutes of processing. Dimensions: Principle: Sample throughput: Sample capacity: 520 × 702 × 556 mm (d × w × h) Flow-type micro-imaging technology (formed element detection) 60 tests / h 50 Highlights: · Support cap-piercing function · Reviewable images · A hybrid urinalysis analyzer which can perform chemical, physical and formed element test Sarstedt – Urine V-Monovette, Monovette, tubes & containers Greiner – Vacuette Urine CCM Tube Urine Microbiology Highlights: · The diverse, user-friendly products for urine collection offer pre-analytical and post-analytical solutions thanks to their simple, hygienic use. Our range of conical urine tubes is ideally suited for sediment recovery and subsequent microscopic analysis. · Urine-Monovette: For hygienic and needle-free urine Highlights: collection, transport and analysis. · V-Monovette Urine: For enclosed urine transfer. Optimal hygienic and convenient handling. · For use in microbiology testing · Stabilizes sample for up to 48 hours at room temperature · Easily soluble powder additive · Immediate stabilization of sample after gentle mixing LABBook 2021 43

Hematology Blood Cell Counter Integrated Hematology Microscopy Hemostaseology Hemoglobin / HPLC LABBook 2021 45

Hematology testing (NIT) that uses biomarkers, or imaging, as an alternative diagnostic tool for fi brosis assessment holds the potential for earlier detection – and for dramatically transforming CLD management – but it requires close coordination between physicians and specialties. NITs that use blood-based biomarkers offer the great- est capacity for routinely assessing large numbers of patients for liver fi brosis. Easy-to-use diagnostic pathways that employ these types of NITs have been identifi ed – and data shows that using them leads to a substantial increase in the detection of advanced fi brosis or cirrhosis, while also delivering a marked decrease in inappropriate referrals.4 Prof. Romero-Gómez explains why this is important: “Keep in mind that the average primary care physician is seeing 100 patients to detect two or three at high risk of advanced fi brosis. That is where NITs can transform patient management – by supporting identifi ca- tion of that subset of patients truly in need of referral.” Biomarkers fall into two categories – indirect markers that assess for evidence of damage or infl ammation, such as FIB-4, and direct markers, which detect for evidence of active fi brosis. · The best-studied of the direct biomarkers is the ELF Test – Figure 2. Outcomes Summary4 a fully automated algorithm-based blood test that assesses for three direct markers of active fi brosis. → Table 1. · Notably, it requires only a single routine serum sample and produces a simple-to-interpret numeric score. → Figure 1. · More than 15 years of studies document ELF’s performance. NAFLD diagnostic pathways incorporating ELF have shown a substantial increase in detection as well as a decrease in inappropriate referrals. → Figure 2. Table 1. ELF Test Markers Figure 1. Severity Assessment: The ELF Scoring System CONTACT Siemens Healthineers Laboratory Diagnostics 511 Benedict Avenue · 10591 Tarrytown, NY, USA phone: +1 914 631 8000 · www.siemens-healthineers.com/laboratory-diagnostics Unlike biopsy or imaging, which assess for existing damage, or indirect markers, which refl ect damage or infl ammation, ELF biomarkers are associated with active fi brosis, supporting both diagnostic and prognostic utilities. “NITs are providing valuable tools and associated guidelines for the detection of advanced fi brosis and cirrhosis,” says Prof. Romero-Gómez. “A simple blood test like ELF, or ELF in conjunction with a test like FIB-4, offers the greatest facility for assessing the high volume of at-risk patients presenting in primary care or related settings. As a hepatologist, I can be very confi dent that at-risk patients coming to me with a high ELF score benefi t from the referral, whereas those with lower ELF scores can remain effectively managed in their current clinical setting.” A collaborative approach is imperative All told, the clinical and economic burdens of NAFLD in Europe are particularly high and will likely increase as its incidence continues to rise. Earlier diagnosis and intervention hold the potential for reducing future healthcare – and human – costs. To be effective, routine testing for evidence of disease progression relies heavily on provider awareness and cross-specialty collaboration. “Since most of our referrals come from primary care or special- ties like GI or diabetology, it is essential that we partner in a peer-to-peer fashion to optimize a diagnostic referral pathway,” emphasizes Prof. Romero-Gómez, who advocates for a close, coordinated partnership between hepatologists and those clinicians most likely to initially encounter patients at-risk for CLD. “NITs like ELF will be key to facilitating that partnership.” References 1 Pimpin L, Cortez-Pinto H, Negro F, et al. Burden of liver disease in Europe: Epidemiology and analysis of risk factors to identify prevention policies. Journal of Hepatology. 2018;69(3):718-735. doi:10.1016/j. jhep.2018.05.011 2 Younossi ZM, Golabi P, de Avila L, et al. The Global Epidemiology of NAFLD and Nash in patients with type 2 diabetes: A systematic review and meta-analysis. Journal of Hepatology. 2019;71(4):793-801. doi:10.1016/j.jhep.2019.06.021 3 Wong RJ, Kachru N, Martinez DJ, Moynihan M, Ozbay AB, Gordon SC. Real-world comorbidity burden, health care utilization, and costs of nonalcoholic steatohepatitis patients with advanced liver diseases. Journal of Clinical Gastroenterology. 2020; Publish Ahead of Print. doi:10.1097/ mcg.0000000000001409 4 Srivastava A, Gailer R, Tanwar S, Trembling P, Parkes J, Rodger A, Suri D, Thorburn D, Sennett K, Morgan S, Tsochatzis EA, Rosenberg W. Prospective evaluation of a primary care referral pathway for patients with non-alcoholic fatty liver disease. J Hepatol. 2019 Aug;71(2):371-378. doi: 10.1016/j. jhep.2019.03.033. Epub 2019 Apr 6. PMID: 30965069 LABBook 2021 47

Blood Cell Counter Lifotronic – Auto 3-part Hematology Analyzer AC 310 Lifotronic – Auto 5-part Hematology Analyzer AC 610 & AC 610 Hematology Dimensions: Weight: Sample throughput: Display: 411 × 315 × 416 mm (h × w × d) 26 kg 60 tests / h 10.4 inches touch screen Highlights: · Accurate measurement for low value PLT · Low running cost · One touch to start testing, one click to remove error, friendly operation menus · Large data memory: up to 100,000 results (Including histograms and patient information) · No printer limitation · Compact size · Automatic shutdown and maintenance Dimensions: Weight: Sample throughput: Display: 517 × 375 × 480 mm (h × w × d) 36 kg 60 tests / h 14 inches touch screen Highlights: · Cyanide free reagent for HGB test · Compact design with reagents on board, save the valuable bench space of small labs. · The first innovative analyzer combined the optical method of BASO (BASO-O) and impedance method of BASO (BASO-I) · Premium large touch screen · Smart-flow fluidic patent technology · Accurate measurement for low value PLT · Low running cost · No printer limitation · The only hematology analyzer with auto shut down function LABBook 2021 49

Hematology Taking morphology analysis to the next level Mindray’s new automated digital cell morphology analyzer MC-80 Mindray has launched the new MC-80 Automated Digital Cell Morphology Analyzer, a revolutionary cell morphology system that provides more clarity, more intelligence and more productivity for morphological analysis. Combining MC-80, Mindray’s hematology solution will revolutionize the high-end hematology segment. Morphological review of blood cells is a crucial procedure follow- ing hematology analysis. Most laboratories need to re-examine more than 30 percent of their blood samples, but fi nd traditional microscopic review labor-intensive and time-consuming. Auto- mated digital cell morphology analyzers are now available on the market, but providing clear and accurate cell images comparable to the microscope remains a fundamental challenge. Mindray’s new MC-80 is taking digital morphology analysis to the next level, delivering clearer images which are able to capture abnormalities in more detail. With advanced algorithms, the analyzer enables better identifi cation of different cells with high throughput, resulting in greater productivity. “We have spent eight years developing and optimizing the product by collaborating with over 200 top hospitals worldwide. CONTACT SHENZHEN MINDRAY Bio-Medical Electronics Co., LTD. Mindray Building, Keji 12th Road South High-tech Industrial Park, Nanshan 518057 Shenzhen, China intl-marcom@mindray.com · www.mindray.com Meanwhile, we have applied for over 100 patents and solved many problems, some of which had been considered insurmount- able in automated digital cell morphology analysis,” commented Huan Qi, Director of Clinical Research, Medical Affairs; and Director of Upstream Marketing, IVD, Mindray. The MC-80 provides more in morphology More Clarity: Equipped with advanced multi-layer fusion technology, the MC-80 reproduces the pathological features of cells with clear and authentic images, which helps pathologists to detect abnormal cells more easily and make a quicker diagnosis. More Intelligence: The MC-80 facilitates a smart process and less manual intervention by analyzing the smear in an optimal mode according to the results from hematology analyzers. Its advanced algorithms offer reliable cell pre-classifi cation and pre-characterization, and the high-speed FLY-MODE ensures fast and accurate PLT clump identifi cation. More Productivity: With the remote review function, patholo- gists are able to review results from multiple locations. The high throughput of 60 samples per hour helps shorten the turnaround time, especially for large-sized laboratories. This greatly enhances diagnostic effi ciency and ensures a faster delivery of results to patients. Mindray is committed to providing high quality, reliable IVD solutions to empower trust, delivering accurate results while meeting laboratories’ demands on effi ciency worldwide. LABBook 2021 51

Hematology Integrated Hematology Beckman Coulter – DxH 900 Hematology Analyzer Dimensions: 755.7 × 1740 × 828 mm (w × h × d) Weight: 254 kg Sample throughput: up to 100 samples / h Power consumption: 520 W Highlights: The DxH 900 hematology analyzer is ideal for mid- to high-volume clinical laboratories performing complete blood count and white blood cell differ- ential tests while minimizing repeat testing, allowing you to deliver the right results the first time. · Achieve superb RBC, PLT and WBC differentials through near native-state cellular characterization and precise flagging · Optimized processes help your laboratory maximize staff time through fewer slide reviews, automated QC, and longer walkaway and system uptime · Most reportable results per square meter with industry-leading 93 percent first-pass yield and a > 40 percent smaller footprint than competitive instruments · Exclusive Early Sepsis Indicator: a one-of-a-kind FDA cleared hematologic biomarker designed to help emergency department physicians identify sepsis sooner · The analyzer features a variety of workcell configurations to match laboratory workload, with a mounted user interface, onboard power computer and wireless peripherals, eliminating the need for extra hardware, such as a cart. Mindray – CAL 8000 Dimensions: Weight: Sample throughput: Depending on configuration Depending on configuration CBC+DIFF: up to 800 samples / h SC-120: up to 240 slides / h MC-80: up to 120 slides / h Highlights: · Fully Integrated with the hematology analyzer, slide maker · Streamline laboratory workflow with automatic rerun and & stainer and digital cell morphology analyzer reflex measurement · Flexible configuration with buffer module, start / stock yard · Less maintenance frequency and cost with stable detection and turn module system · Assure accurate results of abnormal cells with advanced detection technology SF Cube · More productivity: up to 60 slides / hour · More clarity: the images look more three-dimensional, · Maximum detection efficiency with the fastest standalone sharper in color and clearer. analyzer · Digital cell morphology system MC-80 · More intelligent: automatically choose the optimal mode for pre-classification of cells with a higher efficiency LABBook 2021 53

Hemosteasology Siemens Healthineers – Atellica COAG 360 System Siemens Healthineers – Sysmex CS-5100 System Hematology Sample throughput: Dimensions: Weight: Highlights: PT and APTT: 350 (simultaneous analysis) 1858 × 1042 × 1415 mm (w × h × d), without LAS connection 2156 × 1042 × 1415 mm (w × h × d), with LAS connection 600 kg (without LAS connection) 617 kg (with LAS connection) The Atellica COAG 360 System* offers high-volume specialty hemostasis labs a transformative array of capabilities to streamline and unify hemostasis testing · Five methodologies–clotting, chromogenic, immu- nologic, platelet aggregation and high-sensitivity immunoassay (LOCI) testing · Primary-tube sample-volume checks, advanced assay-specific sample quality checks for hemolysis, icterus and lipemia (HIL) interference. · Intelligent reagent and consumable management *Not available for sale in the US Dimensions: Sample throughput Weight: approx. 1280 × 1,576 × 1150 mm (h × w × d) approx. 400 simultaneous PT / APTT tests / h approx. 362 kg Highlights: The Sysmex CS-5100 System offers high-volume and multisite labs smartly designed PSI technology and automation connectivity for streamlined workflow and high-quality test results on the first run. Simultaneous, multiwavelength PSI technology helps labs to identify and manage unsuitable test specimens prior to analysis. The Sysmex CS-5100 System offers an expansive test menu of routine and specialty hemostasis assays (including several INNOVANCE assays). Siemens Healthineers – Sysmex CS-2500 System Siemens Healthineers – Sysmex CA-600 Systems Dimensions: Sample throughput Weight: approx. 685 × 1113 × 895 mm (h × w × d) approx. 180 simultaneous PT / APTT tests / h approx. 140 kg Highlights: The Sysmex CS-2500 System offers mid-volume and multisite hemostasis labs smartly designed technolo- gies for improved efficiency, exceptional accuracy, and reliable first-run results. Equipped with next-gen- eration PSI technologies, the system takes hemostasis testing to the next level. The Sysmex CS-2500 System offers an expansive test menu of routine and specialty hemostasis assays (including several INNOVANCE assays), all on a single instrument. Dimensions: Sample throughput: Weight: approx. 490 × 566 × 490 mm (h × w × d) approx. 60 PT tests / h approx. 43 kg Highlights: The Sysmex CA-600 Systems – with the smallest foot- print in their class – are built on a history of proven reliability and provide scalable options for routine and specialty* coagulation testing. · Features clotting, chromogenic*, and immunologic* measurements with true random access · Enables critical tests to be processed at any time via STAT sample processing · Offers the most frequently requested routine and specialty tests, including INNOVANCE D-Dimer* *Sysmex CA-660 System only. LABBook 2021 55

Pathology Scanner Printer Histology Equipment Microscopy Information Technology Grossing Station Coverslipper Sample Collection LABBook 2021 57

Printer Histology Equipment DTM Medical – Primera Signature Slide Printer KABE Labortechnik – Consumables for pathology / histology Pathology Highlights: The Signature Slide Printer can significantly increase the efficiency of labs while helping to reduce the risk of misidentification of specimens. · On-demand, full-colour printing – prints only the number of slides needed · Prints directly onto slides – eliminates handwriting that is hard to read and labels that are hard to apply · Cost reduction by inventorying only white-frosted slides · Xylene-, alcohol-, heat- and chemical-resistant ink – ensures reliable identification of slides · PTSlide Software allows connection to LIS systems · Compact design · Two years warranty (After product registration within six months of purchase) Microscopy Olympus – BX53LED Highlights: Tissue embedding cassettes · Five variants: standard, uni versal, biopsy, bionet and laser · Available in different colours · Without, with separate or with pre-attached hinged lid · Available pre-stacked – ready for use in cassette printers · High quality material is resistant to solvents, guarantees dimen- sional stability and offers good writing and printability · Comprehensive range of accessories Test tubes with formalin solution · Prefilled with four percent formalin solution · Available in different sizes · Individual labelling possible Olympus – UC90 4K Microscopy Highlights: · Dedicated LED light source for microscopy (Olympus True Color LED) · Ergonomic design for intensive daily usage · Highly expandable frame to follow evolving application needs Highlights: · Up to 4K UHD image capturing · One Camera for Multiple Applications · 9-megapixel CCD camera The BX53 microscope’s ergonomic design helps you stay comfortable during extended periods of use while the intuitive control layout enables fast, efficient obser- vation and imaging. Optimized for laboratory applica- tions, Olympus exclusive True Color LED illumination has a high luminosity and color rendering index so you can see samples in real-to-life colors avoiding color casts of generic LED light sources. The 9-megapixel UC90 camera captures it all: brightfieldimages of superior quality, and up to 4K UHD imaging. Whatever your imaging needs are, expect no less than exceptional results in image quality, sensitivity, dynamic range, and color fidelity. The UC90 offers fluid sample navigation and focusing, making it effortless and convenient to locate regions of interest right on your screen. Excellent microscope imaging has never been as easy and versatile as with the UC90. LABBook 2021 59

Coverslipper Sample Collection Medite – Film Coverslipping Automat Twister Sarstedt – S-Monovette RNA Exact Pathology Highlights: Fast and easy coverslipping with the Twister Film Cover slipper – Made in Germany! · Excellent results: perfect for digital slide scanners · Fast processing: up 1,200 slides per hour · Non-stop operation: continuous insertion and removal of slide baskets · Intuitive touch screen: easy navigation and adjust- ment of parameters by using icons · Matching coverslipping film CytoTape (made in Germany) available Highlights: For increasingly performed gene expression analyses Sarstedt offers the new S-Mono vette RNA Exact, which conserves the gene expression pattern which is present at the time of blood collection, and makes it accessible to all subsequent analyses. Already during the sampling it comes to stabilization of all RNAs contained, and the induction of irrelevant transcripts (stress genes) is additionally prevented. The S-Monovette RNA Exact standardizes the preanalytics of gene expression ana- lyses and brings a significant simplification for the daily laboratory routine and especially for multicenter studies. LABBook 2021 61

Amplification Amplification / Detection Sarstedt – White Multiply PCR Plates Quidel – Savanna – Real-time PCR technology DNA Highlights: In addition to a generally improved quality, Sarstedt now offers optimized white color variants for better detection sensitivity in qPCR. In addition, we have expanded our PCR plate range with high-purity EtO-treated variants (Biosphere plus quality) as well as DNA & protein low binding variants. With our Biosphere plus variants, we offer the maximum and unsurpassed purity standard for an absolutely reliable absence of DNA or other bio- molecules. The low binding variants are our contribution to the increasing use of PCR consumables for other applications, e.g. for sample storage of smallest volumes or for preparing dilution series so that all biomolecules can be recovered from the wells. Dimensions: 210 × 254 × 254 mm (h × w × d) – small size Power consumption: RVP4 (SARS-CoV-2 Influenza A, Influenza B, RSV), RVP11*, GI Panel*, STI Panel* *New test in development Highlights: · True sample to result platform with no up-front sample or reagent preperation · One sample with multiple results · Delivering customized rapid, molecular results [fast turnaround time (< 25 min RVP4)] with test select feature – select parameters now and recall other results within 48 hours · Efficient nucleic acid isolation via magnet beads · Room temperature storage · Low capital and disposable costs Extraction Lifotronic – Nucleic Acid Extraction Kit MolGen – PurePrep 96 Highlights: · Multiple packs are available: 1 T / 8 T / 64 T / 96 T · Magnetic beads-based technology · Suitable for extraction of DNA & RNA from different viruses · Pre-loaded reagent for easy operation · High efficiency with 32 samples in 10 min · High purification& elution efficiency: > 98 % Highlights: The PurePrep 96 is an automated nucleic acid extraction system and suitable for high throughput workflows. · High-quality processing of up to 96 samples per run · Wide volume range: 50 – 1000 µL · Compact, user-friendly and easy to install This device uses magnetic separation technology to process matrices such as blood, cultured cells, bacteria, tissues, cell-free body fluids, and plant samples, moving each through the various purification phases of mixing, binding, washing and elution, resulting in purified DNA and RNA. AD CORP 0008 V1.0 15-NOV-2021 LABBook 2021 63

DNA At MolGen: Wim van Haeringen, CTO, Maarten de Groot, CEO, and Niels Kruize, CCO (from left to right) this branch, the company is revolutionizing research by providing highly accurate, fast throughput, easy to handle, reliable systems and products for next-generation research genetics, in order to improve the health and well-being of all. “By investing in human and animal diagnostics and the agricultural and biotech industries, we’ve become the comprehensive solution that guarantees quality, fl exibility and adaptability in all areas of life science testing.” Wim van Haeringen, MolGen, CTO Today, MolGen has grown to over 100 employees and continues to invest in new products, lines, new markets and global commu- nications. While the company has established long-term part- nerships with large renown service laboratories, scaling up their SARS-CoV-2 test capacity successfully, MolGen is now expanding internationally, bringing its DNA/RNA extraction product offering to the US market. An offi ce has already been opened in the United States and in the United Kingdom, while a logistics hub in China will be established by the end of 2021. From sample to result, MolGen is challenging the status quo in molecular diagnostics by offering platform-agnostic, stand-alone systems and consum- ables, and combining multiple systems into complete diagnostical fl ows that are high-quality, adaptable and safe. In June 2021, SpeeDx Pty, Ltd. and MolGen announced the signing of an agreement to collaborate on supply and distribution of clinical diagnostics products and instrumentation across Europe and Asia Pacifi c. The partnership links specimen handling, nucleic acid extraction, assay set-up, amplifi cation, and results reporting in a seamless integration of the companies technologies. The tremendous growth by MolGen has only strengthened the company’s resolve to fi nd even more avenues for partnership in order to create greater cost effi ciencies and bring the most advanced equipment to laboratories and emerging markets around the world. Additionally, the company is leading the charge for a concept known as monitoring – a pay-by-sample testing method that enables accurate analysis at scale and a lower cost. As society fi ghts to regain normalcy by re-opening its businesses and schools, MolGen is introducing a solution to keep them open. Though the use of spit cup samples that are collected more frequently, and far less invasively than nasal swab tests, monitoring results in more transparency and more reassurance that every precaution is being taken for the sake of all. Reducing the costs of testing through monitoring not only ensures that people participate, it helps mitigate the risks of unsafe self-testing and antigenic testing that has been prevalent throughout the pandemic. “Beyond the pandemic, our vision is to expand to serve more industries in more ways. Beyond testing and diagnostics, we will pioneer the concept of high- frequency testing, or monitoring, to redefi ne how the world looks at disease and other life science conditions now and in the future.” Niels Kruize, MolGen CCO MolGen PurePrep TTR CONTACT MolGen Traverse 2, 3905 NL, Veenendaal, The Netherlands info@molgen.com · molgen.com 1 2 0 2 - V O N - 5 1 0 1 V . 2 1 0 0 0 P R O C D A LABBook 2021 65

DNA Smart simplicity I N O N - D E M A N D T E S T I N G A simple and fast way to pinpoint patients most at risk with targeted and syndromic on-demand testing. Our high multiplex technology is precision engineered for simplicity and accuracy across a broad and growing assay menu. The Novodiag® System is part of our world leading Molecular Scalable Solutions, designed to effortlessly help you to meet the growing demands of your lab, today and in the future. L E A R N M O R E ADS-03410-EUR-EN Rev 001 © 2021 Hologic, Inc. All rights reserved. Hologic, Novodiag and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries. This information is intended for medical professionals and is not intended as a product solicitation or promotion where such activities are prohibited. Because Hologic materials are distributed through websites, eBroadcasts and tradeshows, it is not always possible to control where such materials appear. For specific information on what products are available for sale in a particular country, please contact your local Hologic representative or write to euinfo@hologic.com. LABBook 2021 67

DNA A D C O R P 0 0 0 6 V 1 0 . From Sample to Result 1 5 - N O V - 2 0 2 1 PROVIDING INNOVATIVE MOLECULAR WORKFLOWS TO EMPOWER FUTURE DIAGNOSTICS MolGen is a total solutions global supplier of innovative extraction DNA / RNA technology, systems, products and kits for human and animal diagnostics, agriculture, aquaculture, pharma and biotech. From sample to result, MolGen is challenging the status quo in molecular diagnostics by offering platform-diagnostic stand-alone systems and consumables. Highly customizable, our portfolio offers the perfect workflow for our customers’ specific needs. Please contact us for more information about our flows, systems, kits and consumables. COMPLETE DIAGNOSTICS WORKFLOW including, assay, consumables and chemistry PUREPREP TL+ PUREPREP TUBE PUREPREP TRANSFER SYSTEMS EXTRACTION SYSTEMS PUREPREP FR 1 2 3 4 REAL TIME ANALYZER 5 PUREPREP ANALYSIS 6 • +31 (0) 85 – 200 7431 • info@molgen.com • www.molgen.com LABBook 2021 69

Infectious Disease Snibe – Molecision SARS-CoV-2 RT-PCR Assay (Lyophilized) Snibe – Molecision SARS-CoV-2 & Flu A/B RT-PCR Assay DNA Highlights: The new version of Molecision SARS-CoV-2 RT-PCR Assay is a lyophilized, easy-transporting and one-step RT-PCR assay for the qualitative detection of nucleic acids from SARS-CoV-2 · One-step, lyophilized and easy-transporting assay · Ambient temperature transportation · Includes Negative and Positive Controls · Results available around 60 minutes after extraction · An endogenous internal standard detection system Highlights: In one tube, meet the needs for the screening of SARS-CoV-2, Influenza A and Influenza B · Efficient (Simultaneous detection of SARS-CoV-2 and influenza A / B virus) · High specificity, high sensitivity and good repeatability · Compatible with various sample types and instruments · Amplification time is 56 min Snibe – Molecision SARS-CoV-2, Flu & RSV RT-PCR Assay Siemens Healthineers – Versant HCV Genotype 2.0 Assay (LiPA) Infectious Disease / Hepatitis Highlights: New assay for SARS-CoV-2, Flu and RSV identification from a single respiratory sample · Efficient (Simultaneous detection of SARS-CoV-2 and influenza A/B and RSV) · Compatible with various sample types and instruments · High specificity, high sensitivity and good repeatability Highlights: Optimize your laboratory’s testing with the widely used Versant HCV Genotype 2.0 Assay (LiPA)*. · LiPA utilizes reverse-hybridization technology to detect HCV genotypes 1–6 and subtypes 1a and 1b. · LiPA provides highly accurate identification of HCV genotypes and subtypes for optimal and personalized patient therapy. * LiPA assay is FDA-approved in the U.S. and CE-marked in the EU for IVD use. LABBook 2021 71

Reagents MolGen – PurePrep TL+ Research Use Only Sarstedt – Low DNA Binding Micro Tubes DNA Highlights: Offering the combination of the safe transfer of viruses and lysis in one tube, the PurePrep TL+ buffer optimizes research. · Compatible with most liquid handling systems · Decreases prep time · Improves workflows as it breaks down viscous samples within the tube The PurePrep TL+ buffer is suitable for diagnostic tests and molecular biology techniques, facili- tating processes like nucleic acid extraction. Its unique composition and features make it ideal to test procedures against SARS-CoV-2. Highlights: As the trend towards decreasing sample volumes continues, it is increasingly important to minimize potential interaction between the analyte and tube. Our low protein and new low DNA binding micro tubes are specifically designed to meet the require- ments in protein and DNA analytics while maximizing recovery rates. AD CORP 0010 V1.0 15-NOV-2021 LABBook 2021 73

Mass Spectrometry Shimadzu – Axima iDplus Assurance Shimadzu – Axima iDplus Confidence Microbiology Dimensions: Weight: Highlights: 700 × 1920 × 850 mm (w × h × d) 330 kg, excluding data system Axima Assurance – flexibility and quality: The Axima Assurance is designed with the general analytical and life science laboratory in mind. Incorporating a variable repetition rate 50 Hz N2 laser, the system provides high quality and high sensitivity rapid MALDI mass spectra and is particularly suited to identification in the microbiology field. Positive and negative ion modes are included as standard, allowing greater flexibility and extending the compound categories that may be analysed. Dimensions: Weight: Highlights: 700 × 1920 × 850 mm (w × h × d) 330 kg, excluding data system iDplus Confidence – sensitivity and flexibility: · Rapid microbial identification for research use · Identifies and classifies strains based on phenotype characteristics · SuperSpectra reduce the incidence of false positives and ensure robustness and reproducibility · Open system allows addition of new species / entries to the database or the creation of new databases · Clustering allows molecular profiling and tracking of change or evolution · High performance MS for large molecule analysis · MS / M Shimadzu – Axima iDplus Performance Shimadzu – Maldi-8020 Dimensions: Weight: Highlights: 700 × 1920 × 850 mm (w × h × d) 375 kg, excluding data system iDplus Performance – application-centric solutions: · Rapid microbial identification for research use · Identifies and classifies strains based on phenotype characteristics · SuperSpectra reduce the incidence of false positives and ensure robustness and reproducibility Dimensions: Weight: 450 × 1055 × 745 mm (w × h × d) 86 kg · Open system allows addition of new species / entries Highlights: to the database or the creation of new databases · Clustering allows molecular profiling and tracking of change or evolution · High performance MS for large molecule analysis · MS / MS The Maldi-8020 is a benchtop, linear-only MALDI-TOF mass spectrometer designed to meet the needs of laboratories requiring a cost-effective MALDI-TOF platform. This newly designed MALDI-TOF mass spectrometer is functionally simple but provides out- standing MS performance in a compact footprint. LABBook 2021 75

Microbiology Sample ID: Positive Example POS 1.81 0.40 0.75 1.15 3.50 QC Status Valid - In Range Index 1.81 Sample Category Positive Sample ID: Indeterminate Example QC Status Valid - In Range Index 1.04 Sample Category Indeterminate QC Status Valid - In Range Index 0.53 Sample Category Negative IND 1.04 0.40 0.75 1.15 3.50 Sample ID: Negative Example NEG 0.53 0.40 0.75 1.15 3.50 Figure 2: Illustration of underlying kinetic curves derived from the Fungitell STAT method. Samples on the graph: A. is positive and B. and D. are indeterminate, C. Fungitell STAT Standard; E. negative. All plots are delta OD 405 – 495 nm. The gray zone between 1900 and 2400 seconds is the area of linear regression from which rates are determined. Figure 3: Example output from a Fungitell STAT assay as reported by the new BG Analytics (BGA) software. and materials. A simplifi ed method for execution is outlined below in Table 1. With this approach, an emergency department lab or main lab can quickly run one to seven patient tests at a time, saving days over a send-out approach. The output for the Fungitell STAT method is a comparative index (beta glucan index, BGI, [Figure 3]) computed by dividing the patient sample rate by the Fungitell STAT standard rate. This patient sample BGI value is qualitatively interpreted as a negative, indeterminate, or positive result according to the ranges provided in Table 2. The relationship of the STAT BGI output back calculated Step Action 1 2 3 4 5 6 7 8 9 Add serum sample (50 µL)* to an empty vial /test tube Add alkaline pretreatment to sample (200 µL), mix Reconstitute the Fungitell STAT Standard (STD) with LRW (100 µL)*, mix Add alkaline pretreatment solution (APS) to STD (400 µL)*, mix Incubate samples and STD at 37oC for 10 min Reconstitute Fungitell STAT reagent with LRW (300 µL), mix Transfer 75 µL of STD to a Fungitell STAT reagent reaction vial, mix Transfer 75 µL of sample to another Fungitell STAT reagent reaction vial, mix Place reaction vials into instrument 10 Collect data Table 1: Fungitell STAT simplifi ed method outline * The ratio, 1:4, with pretreatment for sample and standard is fi xed, however, reconstitution volumes of the Fungitell STAT Standard (STD) will vary depending on lot. For example, the reconstitution volumes for the standard lot used in this table are 100 µL LRW:400 µL APS. into the pg / mL values of the more familiar Fungitell microplate kit is described in Table 2 as well. Complementing the traditional Fungitell assay, used with high sample volumes, the Fungitell STAT permits clinical settings of any size to utilize rapid BDG testing in their patient care. Additional information is available at www.fungitell.com/fungitell_stat. A B C Fungitell STAT IFU Fungitell Predicate FSTAT to FTELL (pg / mL) Back calc. (pg / mL) < 60 60 – 79 ≥ 80 < 60 60 – 88 ≥ 96 Cutoff Negative (BGI) ≤ 0.74 Indeterminate 0.75 –1.1 Positive ≥ 1.2 Table 2: Fungitell STAT (BGI) and comparison to Fungitell (pg / mL) Discussion References 1 D’Ordine RL, Garcia KA, Roy J, Zhang Y, Markley B, Finkelman MA. Performance char- acteristics of Fungitell STAT, a rapid (1→3)-β-D-Glucan single patient sample in vitro diagnostic assay. Med Mycol. 2020 May 13. pii: myaa028. doi:10.1093/mmy/myaa028. 2 Iwanaga, S., Miyata, T., Tokunaga, F., and Muta, T. 1992. Molecular mecha-nism of hemolymph clotting system in Limulus. Thrombosis Res. 68: 1-32. 3 Tanaka, S., Aketagawa, J., Takahashi, S., Tsumuraya, Y., and Hashimoto, Y. 1991. Activation of a Limulus coagulation factor G by (1→3)-β-D-Glucans. Carbohydrate Res. 218:167-174. 4 Saito, H., Yoshioka, Y., Uehara, N., Aketagawa, J., Tanaka, S., and Shibata, Y. 1991. Relationship between conformation and biological response for (1→3)-β-D-Glucans in the activation of coagulation factor G from Limulus amebocyte lysate and host-me- diated antitumor activity. Demonstration of single-helix conformation as a stimulant. Carbohydrate Res. 217:181-190. 5 Aketagawa, J., Tanaka, S., Tamura, H., Shibata, Y., and Saito, H. 1993. Activation of Limulus coagulation factor G by several (1→3)-β-D-Glucans: Comparison of the potency of glucans with identical degree of polymerization but different conformations. J. Biochem 113:683-686. LABBook 2021 77

Microbiology tools contribute to substantially reducing the laboratory’s manual work and simplifying Standard Operating Procedures (SOPs). Customized design powers up clinical research Equipped with fl exible cluster analysis software and artifi cial intelligence-powered typing software, the Zybio EXS2600 is excellently suited for clinical research, e.g. antibiotic-resistant bacteria research, serotypes and strain traceability analysis as well as identifi cation of routine microbes and some diffi cult-to-iden- tify bacteria. Moreover, due to the positive and negative ion detector, the Zybio EXS2600 can be applied in phosphate protein detection among antibiotic-resistant bacteria and drug sensitivity analysis. In addition to the wide range of application fi elds of MS in the investigation of drug resistance1, 2 and identifi cation of rare and diffi cult bacteria, such as Mycobacterium, Nocardia species and fi lamentous fungi (or molds), the Zybio EXS2600 has a self-built database which can further improve the detection ability of microbiology labs.3. “Since we introduced the Zybio EXS2600, the entire microbiology laboratory workfl ow has been ultra-elevated and streamlined with How can the EXS2600 support microbiological analysis? Zybio’s 4th generation MALDI-TOF hardware, database and software have been optimized in several aspects, e.g. the signal-to-noise ratio is now 1,000 times better than in the original generation. Accuracy, resolution and sensitivity are better calibrated and synchronized. Compared with traditional bio chemical identifi cation methods, MALDI-TOF MS technology constitutes a quantum leap in terms of effi ciency: the turn- around-time (TAT) was shortened by more than 10 times and identifi cation accuracy is now at 95 %+. MALDI-TOF is becoming increasingly popular due to its ease-of-use, productivity and revolu- tionary automation effi ciency which reduce tedious labor and material consumption. Prompt accurate diagnostic results and proper therapeutic suggestions can save lives. A comprehensive database and intelligent technology improve accuracy The Zybio EXS2600 displays identifi cation results and morphological reference intuitively with a clinical database of 5,000+ species covering 20,000+ strains, which meets modern labs’ demands. Especially, delay extraction technology results in high resolution. In order to improve ion transmission capacity and boost sensitivity, Zybio adopted a patented hyper-effi cient ion propulsion technology that reduces ion jitter. Besides, the fl ight tube temperature compensation technology is integrated to ensure stability of the EXS2600. Reliable and lean workfl ow enhances productivity The effi cient and cost-effective workfl ow of the EXS2600 is parti- cularly popular with the end users. Notably, the oil-free vacuum pump requires no maintenance and the reusable target plate can contain up to 96 samples. This not only reduces measure- ment time at a high throughput of 96 samples per 12 minutes but also drives automation and simplifi es repetitive tasks. With its easy and user-friendly sample handling the EXS2600 also brings enormous benefi ts to microbiology labs in terms of one step to target-in for detection with reusable and traceable plates and pre-fi lled reagents, available in four different solutions. Strain identifi cation in the EXS2600 reduces TAT from about 2 days to 15 minutes. All these Apart from bacteria identifi cation, a standard colony plate picture and a morphological reference picture support clinical decision-making. higher effi ciency, shorter TAT, more trust from patients and clinical departments,” says a chinese microbiology supervisor about his experience with EXS2600. Zybio is dedicated to refi ning routine diagnostics with exquisite products and providing reliable microbiology solutions with an industry-leading microbiology system. References 1 Wang, Y., et al., Higher Prevalence of Multi-Antimicrobial Resistant Bacteroides spp. Strains Isolated at a Tertiary Teaching Hospital in China. Infect Drug Resist, 2020. 13: p. 1537-1546. 2 Liu, R., et al., Clonal Diversity, Low-Level and Heterogeneous Oxacillin Resistance of Oxacillin Sensitive MRSA. Infect Drug Resist, 2021. 14: p. 661-669. 3 Yu, K., et al., Establishment and Application of Matrix-Assisted Laser Desorption/ Ionization Time-of-Flight Mass Spectrometry for Detection of Shewanella Genus. Front Microbiol, 2021. 12: p. 625821. CONTACT Zybio Inc. No. 6 Taikang Road, Block C, Jianqiao Industrial Park, Dadukou District Chongqing, China 400082 phone: +86 23 6869 9779 info@zybio.com · www.zybio.com LABBook 2021 79

F U N G I T E L L STAT ® F U N G I T E L L STAT ® F U N G I T E L L STAT Microbiology Single Sample Format Single Sample Format (13)-ββ-D-Glucan Testing For (13)-ββ-D-Glucan Testing For Better Turnaround Time And Better Turnaround Time And Better Patient Management! Better Patient Management! Fungitell STAT ® is the first and only single sample format FDA-cleared and CE marked rapid in vitro diagnostic screening test for IFI (including Candida, Aspergillus and Pneumocystis) that detects (13)-β-D-Glucan in serum. MKT#20-043 w w w. f u n g i t e l l . c o m • ( 4 4 ) 1 5 1 . 5 4 7 . 7 4 4 4 A s s o c i a t e s o f C a p e C o d I n t ’ l . , I n c . LABBook 2021 81

Mass Spectrometry market, and only if they can prove full CE conformity. “The IVDR is not about economic effi ciency, meaning that the use of a different procedure must always be justifi ed with reasons other than cost effi ciency. This means that in case of comparable analytical characteristics, the commercial method must always be used. This also has devastating effects on molecular diagnostics, which, to a large part, works with self-developed reagents. “In our laboratory we are currently having to evaluate which LDTs we can realistically still offer,” Ceglarek explains, adding: “If adherence to the IVDR had been compulsory at the start of the Corona pandemic, the initial supply of Covid LDTs would have taken a lot longer, because each procedure would have needed extensive validation before being used on patients.” The new regulation could therefore turn into a nail in the coffi n for many laboratory-diagnostic procedures, such as those for diagnosis of rare diseases. “If the validation of these tests is this comprehensive, it will no longer be viable to offer them, so important diagnostic procedures will no longer be commercially available and cannot be offered as LDTs,” Ceglarek says, appealing to those in charge, and calling for the IVDR to be modifi ed before the end of the transition period. affected required lifelong care and, in the most severe cases, had to be looked after in specialist care facilities. However, when PKU is detected early, the disorder can be managed well, with strict dietary measures, and specifi cally through the reduction of protein in the diet. “The fi rst patients who had PKU diagnosed during newborn screening are now aged over 40 and, due to early detection of the disease, lead normal lives,” Ceglarek points out. MS/MS covers the lion’s share The range of diseases diagnosed through screening has increased signifi cantly through the use of mass-spectrometry, and spe- cifi cally through the tandem procedure MS/MS. The so-called enhanced newborn screening (funded by the statutory health insurers in Germany since 2005), currently includes 19 inherited diseases, nine of which are diagnosed via MS/MS [source: https:// www.screening-dgns.de/richtlinien.php]. Additionally, PCR diagnosis, a procedure which has become more widely known to the public during the Corona pandemic, is used to diagnose severe combined immunodefi ciency and spinal muscular atrophy. The prerequisite for screening inclusion is the existence of a reliable diagnostic procedure and the respective disorder being treatable. Although curative care is not possible in all cases, such as in the case of mucoviscidosis, early detection helps to delay the progression of the disease and to increase the quality of life for those affected. In some cases, the therapeutic opportunities improve over the course of time, meaning that screening of newborns still makes sense. Currently, this includes spinal muscular atrophy (SMA), which can be safely diagnosed via PCR, but which cannot be cured. Zolgensma (AVXS-101), a new medication introduced only this year, has brought a cure for muscular atrophy within tangible reach. “Newborn screening for SMA started on 1 October 2021,” Ceglarek reports. “The screening community is now observing with great interest how successful pre-symptomatic gene therapy will be.” New legislation threatens diagnostic options The new version of the EU In Vitro Diagnostic Medical Devices Regulation (IVDR), which will fi nally come into force in 2022, will make the use of new, but also of already established, self-developed procedures much more diffi cult, Ceglarek says. This also affects mass spectrometry. On the one hand, all procedures developed in the laboratory must be newly revalidated before they can be used on patients. “This means large, additional overheads for all para-meters which need to be reviewed,” Ceglarek points out. On the other hand, the regulation prescribes the use of CE marked, commercially available laboratory tests. Even self-developed “in-house” solutions, so-called LDTs, can only be used when there is no equivalent product available in the PROFILE Professor Uta Ceglarek is Deputy Direc tor of the Institute of Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics (ILM) at the University Hos pital Leipzig, where she has been heading the Newborn Screening Laboratory since 2005. After completing her chemistry degree and a doctorate in analytical chemistry, Ceglarek completed further training in toxicology and clinical chemistry. In 2010 she was awarded her professorship, writing her habilitation on clinical metabolome research. Since 2000 she has been working on the use of mass-spectrometry diagnostics in newborn screening, for therapeutic drug monitoring and for metabolic indications. Ceglarek is also president of the German Society for Newborn Screening (DGNS) and speaker of the Section for Clinical Mass Spectrometry at the German Society for Clinical Chemistry and Laboratory Medicine (DGKL). LABBook 2021 83

Ion-mobility Spectrometry As a rapid separation tool, it can be coupled with several sampling / ionisation methods, other separation techniques such as gas chromatography (GC-IMS), and various detectors, including mass spectrometry. Cumeras, who is a Marie Curie postdoctoral fellow at the Institute of Health Research Pere Virgili (IIPSV), and affi liated to the University Rovira i Virgili (URV) at the Department of Electrical Electronic Engineering and Automation in Tarragona, Spain, explained that the mobility is related to the chemical shape. “What makes it even more attractive is that it works in the millisecond range,” she added, “making IMS perfect for analytical chemistry mass spectrometry instrumen- tation, where chromatography is in the second range, and mass detectors are in the microsecond range. So, IMS can be placed in between second > millisecond > microsecond.” In addition, Cumeras said a whole new branch of applications has emerged with liquid injection now possible (liquid chromatography – LC) with the new mass spectrometry instrumentation. These can include differentiation of isomeric chemical compounds, such as breath or volatiles for GC-IMS and proteins, peptides, lipids, and glycans for the LC-IMS-MS. A complementary tool Over the past two decades, IMS became established for the detection of illicit drugs or chemical warfare agents, but it is becoming attractive for use in clinical laboratories due to the high speed of analysis. The main instrumentation developments have been in research labs, though this is increasingly being performed by specialised analytical chemistry start-ups or vendors. However, data processing and analysis, as well as database generation and curation, remain major fi elds of research. “Ion-mobility spectrometry should be understood as a comple- mentary tool for specifi c molecules,” Cumeras explained. “It will help the clinical laboratory testing units to improve the analysis speed, the specifi city, and maybe the cost.” New applications IMS has opportunities in healthcare because different IMS instru- mentations exist, with each using different ways to generate the electric fi eld, including drift tube IMS (DTIMS), fi eld asymmetric IMS (FAIMS), traveling wave IMS (TWIMS), trapped IMS (TIMS), and differential mobility analysers (DMA). “FAIMS have been shown as a great option for portable in-fi eld instrumentation (GC-IMS) while the others are mainly hyphen- ated to a mass spectrometer,” she said. “These will lead to point- of-care application for FAIMS, like breath analysis or infection determination, while the rest are being applied to other diseases that do not need the patient to be in the offi ce.” GC-IMS: FlavourSpec from GAS A new application of IMS for pathology is also under development in several research labs. “Ion-mobility has an exciting future, as disease specifi c applications are developed and most importantly, validated,” she confi rmed. In some areas, patients are already feeling the benefi ts of IMS. One available instrument, based on IMS, is the Edmon, an exhaled drug monitor of propofol, for patients receiving anaesthesia or sedation. PROFILE Dr Raquel Cumeras is a Marie Curie postdoctoral fellow at the Institute of Health Research Pere Virgili (IIPSV), and affi liated to the University Rovira I Virgili (URV) at the Department of Electrical Electronic Engineering and Automation in Tarragona, Spain. Her research interests are in data learning for metabolomics, understood as the intersection of metabolomics, signal processing, meta-analysis, and machine learning for clinical applications. LABBook 2021 85

Blood Glucose Nova Biomedical – StatStrip Glucose / Ketone* Siemens Healthineers – DCA Vantage Analyzer POCT Highlights: The only glucose meter technology cleared by the US FDA across all professional and healthcare settings, including critical care. · Measures and corrects glucose errors caused by abnormal haematocrit levels · Measures and corrects errors caused by electro- chemical interferences · Measures blood beta-hydroxybutyrate, the preferred ketone for diagnosing ketoacidosis · Available as a fully connected, wi-fi meter, or a smaller Xpress* style meter *StatStrip Glucose only in the US Dimensions: Weight: Highlights: 287 × 254 × 277 mm (w × h × d) 3.88 kg The DCA Vantage Analyzer makes in-office diabetes testing easy, with accurate, clinically trusted results shown to improve decision making, patient compliance, and outcomes. Get precise HbA1c, albumin, creatinine, and A:C ratio results in minutes with good correlation to laboratory methods and simplify management for POC coordinators with advanced operator, data-manage- ment, and security capabilities. Product availability varies by country. Immunoassays Lifotronic – FA-160 Immunofluorescence Analyzer Lifotronic – SARS-CoV-2 Antigen Highlights: · Immnofluorescence-based diagnostic system · Wide diagnosis application: cardiac diseases, lung diseases, infectious diseases, diabetes, etc · Easy operation: no sample pre-treatment required · 6 incubation channels with auto timing reminder · 3-15 min / test · Precision CV ≤ 15 %; repeatability: CV ≤ 15 %, stability: CV ≤ 5 % · Automatically load lot & RFID card and the scanner · High data storage: 10,000 test results · Most popular parameters are available Highlights: · Multiple sample type: Nasopharyngeal swab / Nasal swab / Saliva · Both professional use and self-testing are available, no limitation on scenarios · Specific detection: Nucleocapsid(N) protein for antigen test · Quick result: test can be finished in 15 min · High accuracy: sensitivity ≥ 95 %; specificity ≥ 98 % · Operator-friendly · Room temperature transportation and storage LABBook 2021 87

POCT especially important for patients suffering from critical conditions, as they can monitor their health constantly without the need to go to hospital, or for trained personnel. Artifi cial intelligence and machine learning Artifi cial intelligence (AI), machine learning (ML) and neural networks are now starting to be integrated into POCT. These AI modules have demonstrated their value in diagnostics studies. However, the accuracy of test apps varies greatly and relying on these apps is cautioned against. The future is bright. Since samples can be digitised directly at the point-of-care (POC), advanced digital diagnostic techniques, such as sample analysis using medical AI algorithms, can be deployed outside high-end laboratories. “Hence POC digital microscopy, supported by automated digital image analysis and AI, might be deployed for routine microscopy diagnostics on samples harvested during cancer surgery, or on parasitology samples with an emphasis on potential areas of application in low-resource settings,” added Oscar Holmström from the Faculty of Medicine at the University of Helsinki. r e h p a r g o t p y r C / k c o t s r e t t u h S © POCT and Covid-19 Most promising SARS-CoV-2 POCT methods: immunoas- says for antibody and antigen detection, RT-PCR as the gold standard, isothermal amplifi cation and CRISPR / Cas9 genome editing technology as an emerging technique. Due to growing confi rmed COVID-19 cases globally, rapid and reliable POCT is needed urgently for early detection. A reliable POCT device could reduce transportation, risk of spreading infection, strain on healthcare, and cost of care. Despite outbreaks caused by infectious viral diseases such as MERS, SARS, and Ebola, existing POCT platforms were not suffi ciently ready to address the COVID-19 viral threat. However, in 2020 great efforts were made in POCT to improve COVID-19 detection. LABBook 2021 89 Technology advances change POCT applications Miniaturisation in chip technology, microfl uidics and new biosensors have heralded the design of new systems for POCT. Lab-on-a-chip technology is one of the main drivers of POCT, especially in infectious disease diagnosis. This technology means various bioassays, such as microbiological culture, polymerase chain reaction (PCR) and enzyme-linked immunosorbent assay (ELISA), can now be used at the point of care. Similarly, emerging microfl uidic technologies include a set of miniaturised components allowing chemical or biological samples to be analysed at the microscopic level. Microfl uidic-based POCT devices are widely used in molecular biology as well as in chemi- cal and biochemical analysis. They enable detection and fl uid reg- ulation in a single unit. “Greater sensitivity and specifi city when detecting target analytes in small volumes overcomes several challenges encountered when using traditional POCT techniques,” Saha said. POCT currently centres around two technologies: lateral fl ow assay (LFA) and nucleic acid amplifi cation. The fi rst is used in pregnancy testing; testing for HIV, herpes simplex virus, hepatitis, infectious diseases (Ebola, dengue, malaria, Zika virus) and respiratory infections; and for diagnosis and prognosis in conditions such as cancer, by identifying specifi c biomarkers. The second, much more sensitive and specifi c, is based on polymerase chain reactions (PCR) on a chip and isothermal amplifi cation. Nucleic acid amplifi cation can be used to detect a whole array of infectious diseases, such as Mycoplasma pneumonia, Bordetella pertussis, Legionella pneumonia, Infl uenza A virus, SARS, Legio- nella, Aspergillus, West Nile Virus and, now, SARS-CoV-2. A seventh format joins POCT POC device manufacturers are continually looking for ways to design products that deliver greater user comfort in a cost-effective manner. POCT relies on six main formats: bench-top, monitoring, transportable, portable, handheld and disposable. In recent years, the latest advances have seen the launch of a seventh: smart devices with smartphones and wearable devices. Mobile POCT uses sensors to detect signals from samples in vitro, whereas wearable POCT detects signals directly on the body. Both systems then send quantifi ed results to the clinic via wireless communication. Various body fl uids such as tears, urine, blood, sweat and saliva can be used to analyse metabolites, hormones, proteins, viruses and bacteria. “Smartphones act as minicomputers for sensitive and specifi c data quantifi cation with built-in sensors, high resolution cameras, rapid wireless connectivity and the ability to use various software and apps. This means they can function as standalone sensors and detectors in mobile POCT,” Saha pointed out. Similarly, wearable POCT devices can be physical sensors used to acquire samples from the skin, eye or mouth with minimal invasion. They come in various forms, such as tattoos, patches, bands, watches, spectacles and contact lenses, and can be inte- grated with smartphones for data capture. This type of testing is

Cardiology Blood Gases / Electrolytes / Oximetry Siemens Healthineers – Stratus CS 200 Acute Care Diagnostic System KABE Labortechnik – Consumables for blood gas analysis POCT Assays: Dimensions: Weight: Highlights: Troponin I, D-dimer, NT-proBNP, CKMB, hsCRP, Myoglobin, bhCG 460 × 580 × 710 mm (w × h × d) 68 kg The Stratus CS 200 Acute Care Diagnostic System delivers lab-quality results at the point of care with the speed that is needed for cardiac patients. Its broad menu of tests helps physicians to make more timely assessments, enabling rapid decision making for better patient care. Not available for sale in the U.S. Product availability varies from country to country and is subject to local regulatory requirement. Highlights: The best sampling system in every situation Plastic blood gas capillary: · Unbreakable plastic · Fast drawing · Crystal clear · Numerous drawing volumes and diameters available · Minimum gas permeability for oxygen and carbon dioxide · Comprehensive range of accessories Blood gas tube: · Rapid anticoagulation thanks to liquid preparation · Optimal filling with special piston geometry · Individual sterile packing Both sampling systems are prepared with balanced heparin and are ideal for blood gas and electrolyte analyses on all common blood gas systems. KABE Labortechnik – Pipette-Adapter for Capillaries (PAC) Nova Biomedical – Prime Plus Critical Care Analyser Highlights: Assists in the handling of capillaries and their targeted draining on POCT-analysers and test strips or into vessels · Suitable for different capillaries regarding measure- ments and preparations Assays: PO2, PCO2, pH, Hct, tHb, MCHC, Na, Cl, K, iCa, TCO2, iMg, Glu, Lac, Urea (BUN), Creat, ePV, SO2%, O2Hb, COHb, MetHb, HHb, HbF*, tBil* · Available individually or completed with capillary Highlights: Handling: · Fix capillary in the PAC while using oneway gloves · The capillary is filled as usual – afterwards the thump is put gently on the upper mouth of the PAC · The (dropwise) draining is carried out by generating a slight gauge pressure with the thumb Stat Profile Prime Plus offers a complete test menu panel in about one minute, along with bidirectional connectivity, a robust data management system, and comprehensive cybersecurity protection. This comprehensive critical care menu includes iMg, urea and creatinine and calculated tests for ePV, MCHC and OI. *Not available in the US or Canada LABBook 2021 91

Urinalysis Siemens Healthineers – Clinitek Status Connect System Siemens Healthineers – Atellica 1500 Automated Urinalysis System POCT Assays: Dimensions: Weight: Highlights: Albumin, Bilirubin, Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Specific gravity, Urobilinogen, Albumin- to-creatinine, hCG 171 × 185 × 272 mm (w × h × d) 2.3 kg The CLINITEK Status Connect System with Auto-Checks Technology simplifies and streamlines your daily opera- tions. This automated point-of-care urinalysis and hCG pregnancy testing solution eliminates the subjectivity of a visual read, helps improve accuracy, saves time, and allows for increased productivity. This system provides flexible data management and connectivity through bi-directional connectivity and on-board Wi-Fi with expanded network compatibility.* * Feature not available in all countries. Sample Throughput: Assays: Dimensions: Weight: Highlights: 106 – 240 samples /h Bilirubin, Clarity, Color, Glucose, Ketone, Leukocyte esterase, Nitrite, Occult blood, pH, Protein, Specific gravity, Urobilinogen, Albumin, Albumin-to-creatinine ratio, Creatinine, Protein-to-creatinine ratio 1260 × 625 × 680 mm (w × h × d) 114 kg Combining the CLINITEK Novus Analyzer and the Atellica UAS 800 Analyzer* into one completely automated unit, the Atellica 1500 Automated Urinalysis System sets the new standard for accuracy and efficiency. It is a truly digital automated urinalysis system, and lets you manage more samples with less staff in shorter time, while never compromising on high-quality results. Not available for sale in the U.S. Product availability varies by country. Information Technology Endochrine Siemens Healthineers – POCcelerator Data Management System Nova Biomedical – Allegro* – a fast simple capillary blood analyser Highlights: Connect securely with an open, reliable POC informatics platform. Gain vendor independence and free choice in selecting the appropriate POCT device to meet your clinical requirements. Confirm that your POC devices are online, operational, and properly maintained with immediate oversight and control. Includes data analytics, operator management, quality assurance, and eLearning integration. Create a long-term solution that saves time and money by simplifying the complexity and cost of maintaining multiple IT systems. Product availability varies by country. Assays: HbA1c, Lipids panel, PT/INR, CRP, blood glucose and creatinine, urine albumin and creatinine Highlights: Allegro* offers a clinically important menu of 10 mea- sured and individually selectable tests, plus 7 calculated tests. All tests are measured with disposable, ready-to- use cartridges or test strips, and are easily performed by non-technical personnel. · Capillary fingerstick samples for all blood tests · Immediate test results during the patient visit · Reduces patient follow-up visits and costs *Not available in the US or Canada LABBook 2021 93

Information Technology LIS / Middleware / POCT Inventory Management LABBook 2021 95

LIS / Middleware / POCT CliniSys | MIPS – GLIMS Genetics CliniSys | MIPS – CyberLab Information Technology Highlights: GLIMS Genetics – digital workflows for the entire genetic spectrum GLIMS Genetics covers the entire genetic spectrum including the latest methods such as next-generation sequencing. It can be used as a standalone solution with a gene panel and variant results management, interconnected with other LIS systems and essential interfaces to all common expert systems. It can also be configured as part of a complete iagnostics LIS or be connected to order entry and result reporting systems such as CyberLab. Highlights: CyberLab – streamline communications between healthcare providers and laboratories CyberLab is a customisable, intelligent order entry and result consultation solution, helping you provide high quality patient care. Clear, fast and correct commu- nication between care providers and laboratories is key in enabling high-quality patient care. From order entry, through sample collection, to result consultation, CyberLab keeps you connected – anytime, anywhere. i-Solutions Health – LabCentre Medat – Laboratory Information System Highlights: LabCentre is a laboratory and pathology information management system. It helps doctors, scientists, technologists and management staff to track samples and testing processes, communicate results to other health professionals, and monitor costs and reporting. LabCentre supports the following disciplines: · Blood sciences · Microbiology · Hygiene · Transfusion medicine · Pathology · Billing Highlights: · Complete solution from order entry to billing. · Highly customisable modules for microbiology, virology, environmental hygiene, cytopathology, histo- pathology, clinical chemistry, serology / toxicology, blood bank and human genetics. · Single, integrated system for all divisions and sites. · Reliable operation in some of Europe’s biggest laboratories. LABBook 2021 97

Other Applications Blood Collection Pipette Tips Saliva Collection Centrifuges Nitrogen Generators Compressors Incubators Freezers Clean Benches Specialties LABBook 2021 99

Blood Collection Pipette Tips Sarstedt – Multi-Safe Disposal Boxes Sarstedt – Low Retention Pipette Tips Other Applications Highlights: · Our wide, tailor-made range of Multi-Safe disposal boxes corresponds to the current ISO 23907-1:2019 on the prevention of needle stick injuries. · With our extensive product range of Multi-Safe boxes Highlights: we are able to meet any disposal need in the field of medicine and laboratory. · With the various options, from the convenient 200 ml format to the autoclavable 60 l disposal box for clinical waste, we offer an optimal solution for every need. · Minimising sample loss · Optimised surface for enhanced dispensing behavior · Improved sample recovery · Minimal sample loss of highly viscous liquids or samples containing detergents · Cost savings in valuable reagents Saliva Collection Centrifuges Sarstedt – COVID-19 virus diagnostics products Hettich – Mikro 220 | 220 R Dimensions: 330 × 420 × 313 mm (w × h × d) Weight: 21 kg / 42 kg Rotational frequency: 18,000 min-1 Relative centrifugal force: 31,514 Highlights: · Validated containers for saliva collection for virus diagnostics: Monovette VD, V-Monovette VD and Salivette VD. · Saliva testing has become particularly important and is ideal for screening for SARS-CoV-2. Saliva collection using gargling and / or the Salivette offers the key advantage that the user can collect the saliva them- selves under supervision. · Both the gargling and the Salivette saliva collection methods are a more pleasant experience for the patient than the commonly used nose and throat swab method. · The sample collected can be transported to the labora- tory securely sealed in a secondary container. · Acute infections can be directly detected using the molecular biological PCR method. There are also rapid tests that use saliva as the sample material. Highlights: · Compact, high-performance microlitre centrifuge · Choice of seven rotors · IvD-conform according to directive 98 / 79 / EC · Impulse key for short cycle mode · Nine program memories for more individuality · Nine individual acceleration and deceleration stages · Model 220 R coolable from –20 to +40 °C with pre-cooling function · Max. number of tubes: 60 × 2.0 ml LABBook 2021 101

Centrifuges Thermo Fisher – Thermo Scientific Small Bench Centrifuges Thermo Fisher – Thermo Scientific Medifuge Clinical Centrifuges Other Applications Highlights: Compact centrifuges designed for effective and efficient processing of clinical samples. · Accommodate up to 24 × 5 / 7 ml blood tubes · Store up to 99 pre-saved protocols · ClickSeal biocontainment lids provide added safety · Flexibility to spin a variety of vessels such as micro- plates, shell vials and urine tubes Highlights: Optimize your workflow with the unique “2-in-1” hybrid design of the Thermo Scientific DualSpin rotor. · 8-place interchangeable fixed angle and swinging buckets · Program up to 4 routine protocols · Fits into doctor’s labs · Can spin blood collection, urine or conical tubes as well as shell vials Thermo Fisher – Thermo Scientific 17 and 21 Microcentrifuges Chromalytic – Nitrogen generators for LC-MS Nitrogen Generators Highlights: Small footprint with outstanding features, suited for molecular diagnostic and pediatric tests. · Spin up to 24 micro or pediatric tubes in a single run · ClickSeal biocontainment lids with transparent design for added safety · Available in ventilated and refrigerated models · Accommodates microtubes, capillaries and 600 μl blood collection tubes Nitrogen flow: Nitrogen purity: up to 64 l / min at 0 bar up to 99.5 % Highlights: · Nitrogen generator with integrated compressor HF30A and without compressor HF30N / HF60N available · Lowest life cycle costs on the market · Oil-free Dürr Technik compressor integrated (HF30A) · Easy usability / plug & play · Developed for continuous operation LABBook 2021 103

Freezers Clean Benches Thermo Fisher – TSX2330LV TSX Series Plasma Freezers Thermo Fisher – Thermo Scientific Biological Safety Cabinets Other Applications Highlights: Our pre-set, high-performance –30° C plasma freezers with automatic defrost are designed to meet strict requirements established by the AABB and are approved products under their Standards-Compliant Product Evaluation (SCoPE) program for the storage of plasma. · Forced-air circulation for temperature uniformity and fast temperature recovery · Convenient, stainless steel, fully extendable and adjustable drawers · GMP Clean Room Class A / ISO 6 (ISO EN 14644-1) compatible with appropriate pre-install preparation · FDA listed Medical Device, 510 K exempt Highlights: Certified performance and protection that stays with you every day. Not true with ordinary cabinets. The difference is our design. · Thermo Scientific SmartFlow technology features dual-DC motors to automatically balance the cabinet inflow and downflow air velocities in real time · Digital Airflow Verification (DAVe) alarm signals any out-of-spec conditions for added assurance · Energy efficient motors and sustainable design provide globally aware world class performance Specialities ibidi – Solutions for microcopy and cell-based assays Sarstedt – Cell Culture Products Highlights: · Cultivate your cells and perform high-resolution microscopy · Benefit from excellent cell culture conditions on the unique ibidi Polymer Coverslip · Investigate angiogenesis, chemotaxis, wound healing, and cells under flow · Available in various open formats or channel slides · Test with a free sample Highlights: For over 25 years Sarstedt has produced a wide range of high quality cell culture products which are distributed worldwide. These many years of experience and know- ledge of the needs of users have allowed us to optimise and continually expand the product range. LABBook 2021 105

Companies & Suppliers y r t s i m e h c o n u m m I & y r t s i m e h C ■ g n i s s e c o r P e l p m a S ■ n o i t a m o t u A ■ y r t e m o r t c e p S s s a M ■ ■ l y g o o t a m e H ■ A N D ■ l y g o o h t a P ■ 58 59 l i y g o o b o r c i M ■ 23 24 31 31 24 43 44 48 54 58 l y g o o n h c e T n o i t a m r o f n ■ I T C O P ■ s n o i t a c i l p p A r e h t O ■ 104 100 101 102 104 9 70 80 LABBook 2021 107 DTM Medical Mainzer Straße 131 65187 Wiesbaden, Germany phone: +49 611 92777-0 info@dtm-medical.eu dtm-medical.eu Dürr Technik GmbH & Co. KG Pleidelsheimer Straße 30 74321 Bietigheim-Bissingen, Germany phone: +49 7142 9022-0 office@duerr-technik.de www.duerr-technik.com FUJIFILM Wako Chemicals Europe GmbH Fuggerstraße 12 41468 Neuss, Germany phone: +49 2131 311-272 diagnostics_wkeu@fujifilm.com www.wako-chemicals.de Genrui Biotech Inc. 4-10F, Building 3, Geya Technology Park Guangming District 518106 Shenzhen, China phone: +86 755 26 83 55 60-1 (-2) international@genrui-bio.com www.genrui-bio.com Greiner Bio-One GmbH Bad Haller Straße 32 4550 Kremsmünster, Austria phone: +43 7583 6791-0 office@at.gbo.com www.gbo.com Hamamatsu Photonics Deutschland GmbH Arzbergerstraße 10 82211 Herrsching, Germany phone: +49 8152 375-203 info@hamamatsu.de www.nanozoomer.com Andreas Hettich GmbH & Co. KG Föhrenstraße 12 78532 Tuttlingen, Germany phone: +49 7461 705-0 info@hettichlab.com www.hettichlab.com Hologic, Inc Heron House, Crewe Road Wythenshawe, Manchester M23 9HZ, Great Britain phone: +44 161 946 2200 euinfo@hologic.com www.hologic.com Helmut HUND GmbH Artur-Herzog-Straße 2 35580 Wetzlar, Germany phone: +49 6441 2004-0 info@hund.de www.hund.de

y r t s i m e h c o n u m m I & y r t s i m e h C ■ n o i t a m o t u A ■ g n i s s e c o r P e l p m a S ■ 9 12 Companies & Suppliers y r t e m o r t c e p S s s a M ■ ■ l y g o o t a m e H ■ l y g o o h t a P ■ A N D ■ 63 66 73 l i y g o o b o r c i M ■ l y g o o n h c e T n o i t a m r o f n ■ I s n o i t a c i l p p A r e h t O ■ T C O P ■ 87 91 93 94 54 59 80 15 66 63 90 12 13 19 26 29 43 44 50 61 63 73 94 101 102 105 39 40 42 44 39 40 42 75 75 87 90 91 92 93 98 18 33 38 39 42 43 28 33 34 52 54 55 70 71 66 68 70 71 LABBook 2021 109 MolGen Traverse 2, 3905 NL, Veenendaal, The Netherlands info@molgen.com molgen.com Nova Biomedical 200 Prospect Street Waltham, MA 02454-9141, USA phone: +1 781 894-0800 info@novabio.com www.novabiomedical.com Olympus Europa SE & Co. KG Amsinckstraße 63 20097 Hamburg, Germany phone: +49 40 23773-0 ScientificSolutions@olympus-europa.com www.olympus-lifescience.com Promega GmbH Gutenbergring 10 69190 Walldorf, Germany phone: +49 6227 6906-129 martin.rossmanith@promega.com www.promega.com Quidel Germany GmbH Leibnizstraße 11 70806 Kornwestheim, Germany MarketingEurope@quidel.com www.quidel.com SARSTEDT AG & Co. KG Sarstedtstraße 1 51588 Nümbrecht, Germany phone: +49 2293 305-0 info@sarstedt.com www.sarstedt.com www.tempus600.com SHIMADZU Europa GmbH Albert-Hahn-Straße 6-10 47269 Duisburg, Germany phone: +49 203 7687-0 shimadzu@shimadzu.eu www.shimadzu.eu Siemens Healthineers Laboratory Diagnostics 511 Benedict Avenue 10591 Tarrytown, NY, USA phone: +1 914 631 8000 www.siemens-healthineers.com/laboratory-diagnostics Shenzhen New Industries Biomedical Engineering Co., Ltd. No.23, Jinxiu East Road, Pingshan District 518122 Shenzhen, China phone: +86 755 26501514 sales@snibe.com www.snibe.com

Notes LABBook 2021 111

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