A new addition to the Stat Profile line of blood gas critical care analysers, Stat Profile Prime Plus, has gained CE mark certification and is now available in all CE-regulated countries. Prime Plus features maintenance-free sensor technology to provide 22 essential critical care tests including blood gases, electrolytes, metabolites, hematology, and co-oximetry. Prime Plus also features new and patented, non-lysing whole blood co-oximetry technology, along with automated quality control (QC), powerful data management, bidirectional connectivity, and extensive cybersecurity protection. Prime Plus incorporates Nova’s innovative, maintenance-free sensor technology with individual MicroSensor cards, calibrator cartridges, and quality control cartridges. This design eliminates sensor and co-oximeter maintenance, improves analyser uptime, and reduces testing costs. The MicroSensor Card provides 22 whole blood assays including co-oximetry and new critical care assays for urea, creatinine, and ionized magnesium. Prime Plus provides a complete co-oximetry panel without chemically or mechanically lysing the blood, which eliminates corrosive lysing reagents and mechanical complexity and improves instrument reliability and reduces costs. Prime Plus delivers a comprehensive critical care panel in about one minute from 135 microliters of whole blood. Tests include pH, PCO2, PO2, SO2%, Na, K, Cl, iCa, iMg, TCO2, glucose, lactate, urea, creatinine, Hct, Hb, O2Hb, COHb, MetHb, HHb, HbF, and tBil. A special safety sample port allows for easy docking and hands-free sampling, and the Clot Bloc sample flow path protects sensors from blood clot blockages and related downtime. Prime Plus provides total quality monitoring with automated QC that verifies analyser accuracy and precision on assayed liquid controls, and supplemental quality monitoring that electronically monitors and verifies correct performance of all analytical components for each analysis and calibration. It also features a powerful data management system and bidirectional connectivity, remote analyser review and control of connected Prime Plus analysers, and the most comprehensive cybersecurity features to protect patient health information and prevent viruses.
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Comprehensive offering of disease state sera
, /in Product News /by 3wmediaBinding Site’s Immunologicals Group features a comprehensive offering of disease state sera in its broad portfolio of products available to in-vitro diagnostic (IVD) manufacturers and clinical/life science research facilities. The availability of these essential, but frequently overlooked constituent products, will benefit the needs of many allied health professionals, as both their sourcing and availability have been historically problematic.
Following all current regulatory and quality standards guidelines, the company is able to provide materials from a wide variety of disease state conditions – including ANA’s; ANCA’s; aPL’s; ENA’s; infectious/contagious diseases; inflammation markers; and auto-antibodies focused on a variety of human organs and tissues. All of these materials are available in bulk formats with volumes ranging in excess of litres for use in the manufacturing of calibration and/or quality control materials. Smaller volumes may be available upon request. In addition, as the primary source supplier of these products, the company can offer comprehensive data on analyte-positive as well as negative data, along with a comprehensive Certificate of Analysis.
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Microscope camera
, /in Product News /by 3wmediaOptimized for sharing, documenting and publishing, the fast 18-megapixel SC180 camera uses the full optical resolution of the microscope and produces clear, crisp images at all magnifications. The 4K UHD live image helps to engage audiences in large-screen presentations and to increase throughput in tissue documentation and creating detailed images for publication. The SC180 camera provides the benefits of 4K microscopy which enables users to get the same level of detail on the screen as through the oculars and shows true-to-life structures and colours for enhanced sample observation. To guarantee the highest quality of images, the SC180 camera offers fully automated, real-time image processing features. Olympus Smart Image Averaging (OSIA) reduces noise for crisp, clean images; real-time colour profiling with automated white point calibration ensures natural-looking colours for reliable images. Speeding up routine imaging, the SC180 also has Focus Peaking technology as well as a Fast Live function to improve throughput and productivity. Focus Peaking enables users to see which areas of a specimen are exactly in focus and get the desired image with the first click. Fast Live maintains a high frame rate when the specimen is being moved to ensure comfortable, fluid navigation regardless of the illumination conditions.
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Improved PT reagent
, /in Product News /by 3wmediaThe Prothrombin Time test is the cornerstone of the coagulation discipline, representing over 50% of tests performed worldwide. Using a LEAN-based approach to cost reduction and improved patient safety, STA-NeoPTimal is a high performing PT reagent which is adapted to all types of laboratory workflows. For an optimal management, the new reagent offers a flexible solution with a range of 3 packaging sizes (5, 10 and 20 mL). It is the only tissue-extract PT and precalibrated reagent with an ISI = 1, with instrument-specific ISI values assayed against international standards and optimal sensitivity to changes in factor concentrations. The ease-of-use STA-NeoPTimal reagent offers user confidence and safety thanks to a fully validated system: fully automated barcoded reagent management with QC ranges for all Stago analysers and validated for evaluation of exogenous factors (II, V, VII and X); automatic Mean Normal Prothrombin Time (MNPT) calculation with STA Coag Expert module and a unique Viscosity-based Detection System (VBDS) insensitive to analytical interferences, such as hemolysis, icterus and lipelmia (HIL samples).
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Blood gas testing system
, /in Product News /by 3wmediaThe GEM Premier 5000 whole blood testing system measures blood gases, pH, electrolytes, metabolites, CO-Oximetry and more. iQM2 (/en/intelligent-quality-management-2-iqm2) provides real-time assurance, the all-in-one, multi-use GEM PAK offers advanced simplicity and GEMweb Plus Custom Connectivity allows complete control of point-of-care testing.
iQM2 with IntraSpect technology provides intelligent analysing – automated quality assurance, continuously and in real-time, unlike traditional (auto or manual) QC offerings. With real-time detection, iQM2 performs continuous checks – before, during and after every sample. Error detection time is reduced from hours to minutes and errors automatically corrected and documented for a complete picture of quality with each and every sample. This ensures accuracy of results, regardless of point-of-care operator, time or place.
All-in-one, multi-use, GEM PAK offers advanced simplicity at every point-of-care. Fully self-contained, the GEM PAK automates the most labour-and skill-intensive processes and is available in multiple menu and test volume configurations, GEM PAKs have a use-life of 31-days and require no refrigeration. They allow ultimate flexibility for point-of-care testing needs throughout the hospital.
GEMweb Plus 500 Custom Connectivity is designed to simplify operator supervision and quality management with full traceability. All from a single interface, whether accessed in the lab, at the point-of-care or remotely from an analyser, PC or tablet device, GEMweb Plus 500 provides customizable and automated functionality for complete control of analysers and operators.
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Analyser with integrated cooling system
, /in Product News /by 3wmediaA new version of the A15, a benchtop analyser with a throughput of 150 tests per hour featuring simplicity, high flexibility and analytical robustness, is available now with a new integrated cooling system to increase on-board reagent stability. This new optional configuration guarantees high reagent stability even for those laboratories working in continuous mode, as well as simplifying reagent handling for those that prefer to keep reagents on board. The new cooling system, with a capacity of up to 20 reagents on board in any combination of 20 and 50 mL vials, is able to maintain them at 10ºC below room temperature. It provides increasing stability for those reagents known to be affected by variations or high room temperatures, reducing time required to reagent preparation while facilitating reagent configuration steps. The company also provides a wide range of dedicated and validated reagents, designed to achieve optimal analytical performance when used with its analysers.
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High sensitivity troponin assay
, /in Product News /by 3wmediaBeckman Coulter Diagnostics announced recently that it has received CE-Mark clearance for a new high-sensitivity troponin (hsTnI) assay that aids in diagnosing myocardial infarction for patients presenting with chest pain or other ischemic symptoms. The high-sensitivity assay provides much greater precision at very low levels of troponin. This gives clinicians greater confidence in interpreting test results from patients seeking emergency care due to chest pain. The new hsTnI assay enables hospitals to develop fast-track protocols, resulting in early discharge for patients with suspected myocardial infarction. In the emergency department, assays with improved sensitivity for the detection of troponin allow safe, streamlined assessment of patients with possible heart attacks. There is significant potential for improved efficiency in management of emergency patients using such assays. Because the Access hsTnI assay has excellent low-end sensitivity, it not only reliably measures very low levels of cardiac troponin I (cTnI), but also detects small differences in the cTnI level over time. In comparison to standard troponin assays, high-sensitivity assays demonstrate significantly improved precision at and below the 99th percentile upper reference limit (URL), allowing better discrimination of small differences in troponin values between serial measurements. More precise determination of the 99th percentile URL has also led to an ability to report distinct reference ranges for men and women. Multiple studies confirm that high-sensitivity assays detect cTnl release earlier, increasing sensitivity for myocardial infarction diagnosis at presentation. This may help physicians to either rule in or rule out myocardial infarction earlier in the course of care. The Access hsTnI assay is available for use on the Access 2, DxI and the entire Beckman Coulter family of Access immunoassay systems.
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Fully automated random access multiplex analyser
, /in Product News /by 3wmediaThe BioPlex 2200 System is the industry’s first fully automated, random access multiplex testing platform. It combines innovative, reliable automation with the diagnostic power of proprietary multiplex chemistry and state-of-the-art eFlex software to bring a new level of flexibility and operational benefits to the laboratory. It improves workflow with random access sampling and priority processing. Performing multiplex analysis on the BioPlex 2200 is easy: simply load a tray of primary tubes and walk away. The system can automatically process up to 100 samples per hour – for a maximum of 2200 reportable results (assay-dependent) – with eight hours of walk-away capability. First results are available in approximately 40–60 minutes (assay-dependent), with subsequent patient samples completed approximately every 30 seconds. BioPlex 2200 immunoassays use magnetic 8 µm beads, infused with varying ratios of fluorescent dyes to create unique bead sets. Beads within each set are coated with a ligand (i.e. antigen, antibody, analyte, etc.) specific to a particular assay. Bead sets are then mixed in a single reagent pack, allowing for simultaneous detection of multiple analytes from a single sample. The dual-laser, multiplex flow detection method processes a minimum of 150 individual bead results for each assay. Intuitive, touch-screen eFlex software allows precise system control and powerful information management. eFlex interfaces with the laboratory information system (LIS) and direct connectivity solutions for troubleshooting, reportable billing and Internet-based QC programmes (i.e. Unity). Add-on tests can be ordered from previously processed samples without a patient redraw. Users can also create custom test groups, fine-tune quality control rules to accommodate facility needs and analyse results using interpretive software algorithms (available with certain panels). The expanded menu covers autoimmune, infectious diseases and vitamin D testing.
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Liquid urinalysis quality control
, /in Product News /by 3wmediaQuantimetrix introduces Dipper POCT, an innovative single-use urinalysis dipstick control with extended room temperature stability of 3 months and 3 years refrigerated from date of manufacture, exceeding that of all other urinalysis controls formulated with native ketones currently on the market. The special slim pouch design allows users to visually verify full immersion of the dipstick that simulates the dipping method used on patient samples, minimizes the risk of contamination and reduces the volume required for testing. Dipper POCT urinalysis dipstick control is particularly suitable for UA testing at the point-of-care and for use in traditional testing environments including central labs, reference labs, nursing stations and doctor’s offices.
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Critical care analyser
, /in Product News /by 3wmediaA new addition to the Stat Profile line of blood gas critical care analysers, Stat Profile Prime Plus, has gained CE mark certification and is now available in all CE-regulated countries. Prime Plus features maintenance-free sensor technology to provide 22 essential critical care tests including blood gases, electrolytes, metabolites, hematology, and co-oximetry. Prime Plus also features new and patented, non-lysing whole blood co-oximetry technology, along with automated quality control (QC), powerful data management, bidirectional connectivity, and extensive cybersecurity protection. Prime Plus incorporates Nova’s innovative, maintenance-free sensor technology with individual MicroSensor cards, calibrator cartridges, and quality control cartridges. This design eliminates sensor and co-oximeter maintenance, improves analyser uptime, and reduces testing costs. The MicroSensor Card provides 22 whole blood assays including co-oximetry and new critical care assays for urea, creatinine, and ionized magnesium. Prime Plus provides a complete co-oximetry panel without chemically or mechanically lysing the blood, which eliminates corrosive lysing reagents and mechanical complexity and improves instrument reliability and reduces costs. Prime Plus delivers a comprehensive critical care panel in about one minute from 135 microliters of whole blood. Tests include pH, PCO2, PO2, SO2%, Na, K, Cl, iCa, iMg, TCO2, glucose, lactate, urea, creatinine, Hct, Hb, O2Hb, COHb, MetHb, HHb, HbF, and tBil. A special safety sample port allows for easy docking and hands-free sampling, and the Clot Bloc sample flow path protects sensors from blood clot blockages and related downtime. Prime Plus provides total quality monitoring with automated QC that verifies analyser accuracy and precision on assayed liquid controls, and supplemental quality monitoring that electronically monitors and verifies correct performance of all analytical components for each analysis and calibration. It also features a powerful data management system and bidirectional connectivity, remote analyser review and control of connected Prime Plus analysers, and the most comprehensive cybersecurity features to protect patient health information and prevent viruses.
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QC management software
, /in Product News /by 3wmediaAcusera 24•7 is an Interlaboratory data management and peer group reporting package complementing the Acusera range of true third party controls. Designed to help laboratories efficiently and effectively manage their daily QC activities, Acusera 24•7 has many benefits to laboratories. Providing access to instantly updated peer group data, the software will automatically calculate advanced QC statistics, such as measurement uncertainty, total error and sigma metrics. The dashboard functionality will instantly flag any rejected or alerted results from the last 7 days, therefore helping to reduce the time spent analysing QC data. Quick and easy performance monitoring can also be achieved thanks to the on-demand nature of the interactive Levey-Jennings, histogram and performance summary charts. Coupled with comprehensive reports, including data review, exception report and statistical metrics report, Acusera 24•7 speeds up troubleshooting in even the most demanding of labs and therefore gives greater confidence in QC test results. Now available in three separate packages, Acusera 24•7 is suitable for every lab regardless of size of budget.
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