A new and complementary member of the GEM Premier family, the GEM Premier ChemSTAT system is a whole-blood analyser designed for rapid basic metabolic panel (BMP) testing at the point of care, primarily in hospital Emergency Departments (EDs) and clinical laboratories. The system provides laboratory-quality results on-demand, in less than 70 seconds, from venous or arterial whole blood samples, with no preparation required. Ultimately, this aids in diagnosis for timely triage of life-threatening conditions and enables rapid risk stratification, prioritization and treatment of high-risk, acutely ill patients. BMP is one of the most widely ordered tests for diagnosing acute conditions, such as kidney failure, sepsis and septic shock, and diabetic ketoacidosis. Featuring a complete BMP panel, the GEM Premier ChemSTAT system offers Creatinine, Blood Urea Nitrogen (BUN) and measured tCO2 – as well as Lactate, Hematocrit, pH, pCO2, Sodium, Potassium, Ionized Calcium, Chloride and Glucose. To assure laboratory-quality results at the point of care, the GEM Premier ChemSTAT system integrates Intelligent Quality Management (iQM), providing a complete picture of quality for each sample – continuously and in real-time – and automated detection, correction and documentation of any action it performs, to ensure the quality of every test result and supporting immediate patient management decisions. No competitive system offers this assurance of sample quality and compliance. Like all GEM Premier systems, GEM Premier ChemSTAT analysers are also exceptionally easy to use. The all-in-one, multi-use GEM PAK cartridge automates the most labour- and skill-intensive processes. Stored at room temperature, GEM PAKs are simply replaced every three weeks, requiring no maintenance or additional handling. All testing components are self-contained, limiting biohazard and infection risk for operators and patients. Additionally, GEMweb Plus Custom Connectivity enables management of all GEM Premier analysers in a network, including the GEM Premier ChemSTAT system, for complete control of instruments, operators and data oversight from any location. GEM Premier systems, combined with GEMweb Plus 500 connectivity, deliver a complete solution for improved patient care and efficiency.
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Clinical microscope for routine pathology
, /in Product News /by 3wmediaBuilt to meet the demands of repetitive routine microscopy, the BX46 microscope has features that help the user remain comfortable while working. The stage is fixed so it is close to the desk’s surface, keeping it nearer to the user’s hands. Samples are focused on using the movable nosepiece. The low-position handles and low-torque stage make it easy to move the specimen with a simple finger tap so that the arms and hands rest in a comfortable position. The tube moves up and down, tilts, and extends forward and back. With this one component, users of nearly any height can adjust the scope so that they’re comfortable. The BX46 microscope combines excellent ergonomics with energy efficient LED illumination, which makes it ideal for routine brightfield histology imaging.
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One-touch handling rapid sample transport system
, /in Product News /by 3wmediaTempus600 Quantit is the latest addition to the innovative Tempus600 product range – a dedicated point-to-point system securing fast and predictable turnaround time for blood samples. Quantit caters for the need to dispatch several samples at the same time without any packaging. The system is characterized by a minimalistic, user-friendly and intuitive design, facilitating easy dispatching of blood samples. Up to 25 samples can be placed simultaneously in the drawer and the system will send them one-by-one with a speed of up to 10 m/sec. The quick transportation time results in a total turnaround time of 31 minutes for blood samples. Quantit handles up to 1050 sample tubes per hour. An optional urgency module allows staff to access the system at any time and manually place priority samples for immediate processing. The Tempus600 Quantit delivers blood samples to fully automated, semi-automated or manual laboratories. The system is installed in existing hospitals in just 2 weeks.
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Automated molecular diagnostic system
, /in Product News /by 3wmediaThe BD COR System from BD (Beckton, Dickinson and Company) is an automated, high throughput molecular diagnostics system developed for large capacity laboratories. The modular and scalable design addresses lab needs to expand molecular testing offerings and increase test volumes by integrating and automating the complete molecular laboratory workflow. The system allows samples to be processed directly from liquid-based cytology vials and is capable of running the diagnostic workflow from pre-analytical processing to test result, unlike other automated molecular diagnostic platforms. As offerings expand, the system will provide a solution for a menu of clinically differentiated diagnostic assays for infectious diseases. It has on-board capacity for reagents and samples to provide up to 360 results in eight hours of system processing, eliminating multiple technologist interactions per shift. Currently, the BD COR System is CE-IVD marked. It integrates and automates the complete molecular laboratory workflow from pre-analytical processing to diagnostic test result. The system will be initially available with the BD Onclarity HPV Assay for the detection and extended genotyping of human papilloma virus (HPV). The system enables the processing of samples directly from liquid-based cytology vials, the creation of molecular aliquot tubes and assay testing, replacing labour-intensive and error-prone manual processes with automated ones. Over the coming years, the company plans to continue seeking regulatory authorizations to sell the BD COR System around the world while expanding the content menu to include many other assays for infectious diseases. The BD Onclarity HPV assay detects and identifies 14 high-risk human papillomavirus (HPV) types and provides genotyping information from specimens collected for cervical cancer screening purposes in the BD SurePath Vial and in the Hologic PreservCyt Solution (not approved in the United States). Different configurations of the test are CE marked and FDA approved.
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Total bile acids assay for assessment of liver function
, /in Product News /by 3wmediaSerum total bile acid (TBA) levels are a sensitive marker of liver function and may be used for diagnosis and monitoring of various liver diseases. Increased serum TBA levels are associated with diseases such as acute and chronic hepatitis, intrahepatic cholestasis of pregnancy (ICP), liver sclerosis, cirrhosis, and cancer; TBA may as well detect hepatic dysfunction. Conventional liver tests such as ALT and AST cannot provide this because they are indicators for hepatocellular integrity. TBA measurement corresponds to the sum of more than 20 individual bile acids synthetized by the liver, modified by gut bacteria, and involved in complex enterohepatic circulation. Commercially available assays show limitations regarding the detection of individual primary and secondary bile acids. The new DiaSys reagent, Total bile acids 21 FS, is an enzyme cycling assay which enables assessment of all relevant bile acids in a sample and hence offers the possibility to precisely cover all stages of liver diseases. The new liquid-stable, ready-to-use reagent provides a wide measuring range, outstanding precision and shows significantly reduced interferences compared with nitrotetrazolium blue (NBT) methods.
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Mass spectrometer for in vitro diagnostic use
, /in Product News /by 3wmediaHER The TSQ Altis MD Series mass spectrometer offers enhanced sensitivity for demanding quantitative analyses together with speed and robustness. With superb analytical performance, this platform features maximum usability and is powered by Thermo Scientific TraceFinder LDT Software, which provides a workflow-oriented approach to robust, reliable, high-throughput quantitation. The instrument’s ultimate quantitative performance leverages enhanced Thermo Scientific Active Ion Management (AIM+) technology. QR5 segmented hyperbolic-surface quadrupoles deliver best-in-class sensitivity, consistency, and reproducibility, while fast, selected-reaction monitoring enables robust quantitation of more compounds faster. Features include automated compound optimization and intuitive instrument interface as well as optional bi-directional LIS connection available with B-link.
The TSQ Altis MD Series mass spectrometer is intended to identify and quantify inorganic and organic compounds in human specimens for in vitro diagnostic use only by trained, qualified laboratory personnel. It will be used by clinical diagnostic laboratories as a component of a laboratory developed test (LDT) method or workflow.
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Hemoglobin A1c test available on Atellica
, /in Product News /by 3wmediaSiemens Healthineers recently announced the global availability of its new Atellica CH Enzymatic Hemoglobin A1c (A1c_E) Assay to assist clinicians in diagnosing and monitoring diabetes. The International Diabetes Federation projects 642 million people worldwide will have diabetes by 2040 because of leading factors such as higher levels of urbanization, aging populations, and the growing adoption of more sedentary lifestyles which leads to insufficient physical activity, greater rates of obesity and a higher intake of unhealthy foods. When diagnosed, treated and monitored regularly, diabetes is manageable and, in some cases, reversible. Left untreated, however, blood sugar can rise to dangerous levels and lead to kidney damage and other irreversible health consequences. As diabetes awareness increases and screening for the chronic disease rises, testing options for the clinical laboratory are evolving both in sophistication and practicality. The Siemens Healthineers Atellica CH Enzymatic Hemoglobin A1c meets new standards of testing and offers laboratories improved performance – both precision and accuracy – over leading alternative methodologies. Instruments with higher throughput capabilities offer laboratories the ability to run a greater volume of tests and produce patient results more quickly, thus improving patient satisfaction. Laboratories are seeking HbA1c assays that can be integrated onto chemistry testing platforms and that provide the accurate and precise results patients deserve. The new Atellica CH Enzymatic Hemoglobin A1c Assay offers these capabilities.
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Drugs of Abuse Testing in Urine by LC-MS/MS
, /in Product News /by 3wmediaThe LC-MS/MS-based assay MassTox drugs of abuse testing offers the target screening and quantitative confirmation of more than 100 drugs and metabolites with an analysis time of up to 12 minutes. The CE-IVD validated solution includes everything that is required for the analysis, eliminating the need for developing and maintaining several in-house methods or for preparing QC materials for a multitude of analyte compounds. It is designed to work below cut-offs defined by GTFCh and EWDTS. The assay includes a carefully selected hydrolysis enzyme that ensures a complete and selective hydrolysis of all 108 drugs covered in the assay. 99 analytes are safeguarded by isotopically labelled internal standards. The high stability of the 6PLUS1 Multilevel Urine Calibrator Set and three MassCheck urine controls ensure reliable results with highest precision.
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Aspergillus antigen ELISA
, /in Product News /by 3wmediaThe Aspergillus Antigen ELISA (EUROIMMUN) provides in vitro determination of Aspergillus spp. to support the diagnosis of invasive aspergillosis (IA), a life-threatening infection in immunocompromised patients. The ELISA is especially suited for screening high-risk patients. The CE-marked assay is based on a monoclonal antibody for the detection of the Aspergillus-specific galactomannoprotein, which is produced during active fungal growth. The analysis is performed on patient serum or bronchoalveolar lavage fluid. Results can be evaluated either quantitatively in pg/ml using a 6-point calibration curve or semiquantitatively by means of a cut-off ratio. Semiautomated processing is available, for example using the EUROIMMUN Analyzer I. In a recently published clinical study with sera from patients with proven IA as well as control sera, the EUROIMMUN Aspergillus Antigen ELISA yielded comparable sensitivity and specificity to another commercially available Aspergillus antigen test (Dichtl et al, J Cli Microbiol 2019). Aspergillus spp. is a ubiquitous sac fungus, which is found in soil or compost or on damp walls. Inhalation of the spores can lead to severe disseminated infections with a high mortality in individuals with a weakened immune system. In particular, infections affecting the nervous system are nearly always fatal. High-risk groups requiring regular monitoring include patients with neutropenia, leukemia or advanced AIDS, as well as bone-marrow or organ transplant recipients. Early diagnosis and prompt treatment of IA are crucial for survival. Since clinical and radiological signs of IA are often non-specific, additional diagnostic tests such as antigen detection and culture are nearly always required to substantiate diagnosis.
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Basic metabolic panel POC analyser
, /in Product News /by 3wmediaA new and complementary member of the GEM Premier family, the GEM Premier ChemSTAT system is a whole-blood analyser designed for rapid basic metabolic panel (BMP) testing at the point of care, primarily in hospital Emergency Departments (EDs) and clinical laboratories. The system provides laboratory-quality results on-demand, in less than 70 seconds, from venous or arterial whole blood samples, with no preparation required. Ultimately, this aids in diagnosis for timely triage of life-threatening conditions and enables rapid risk stratification, prioritization and treatment of high-risk, acutely ill patients. BMP is one of the most widely ordered tests for diagnosing acute conditions, such as kidney failure, sepsis and septic shock, and diabetic ketoacidosis. Featuring a complete BMP panel, the GEM Premier ChemSTAT system offers Creatinine, Blood Urea Nitrogen (BUN) and measured tCO2 – as well as Lactate, Hematocrit, pH, pCO2, Sodium, Potassium, Ionized Calcium, Chloride and Glucose. To assure laboratory-quality results at the point of care, the GEM Premier ChemSTAT system integrates Intelligent Quality Management (iQM), providing a complete picture of quality for each sample – continuously and in real-time – and automated detection, correction and documentation of any action it performs, to ensure the quality of every test result and supporting immediate patient management decisions. No competitive system offers this assurance of sample quality and compliance. Like all GEM Premier systems, GEM Premier ChemSTAT analysers are also exceptionally easy to use. The all-in-one, multi-use GEM PAK cartridge automates the most labour- and skill-intensive processes. Stored at room temperature, GEM PAKs are simply replaced every three weeks, requiring no maintenance or additional handling. All testing components are self-contained, limiting biohazard and infection risk for operators and patients. Additionally, GEMweb Plus Custom Connectivity enables management of all GEM Premier analysers in a network, including the GEM Premier ChemSTAT system, for complete control of instruments, operators and data oversight from any location. GEM Premier systems, combined with GEMweb Plus 500 connectivity, deliver a complete solution for improved patient care and efficiency.
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Serum Amyloid A (SAA), CE-IVD marked, turbidimetric assay
, /in Product News /by 3wmediaTRIMERO has added to its catalogue a new Serum Amyloid A, CE-IVD marked, particle-enhanced turbidimetric immunoassay. Applications are available for the most popular clinical chemistry analysers, and for IMMAGE® nephelometers of Beckman Coulter. In order to ensure lot to lot traceability, the assay has been standardized to the Serum Amyloid A (SAA) 1st International Standard (NIBSC code: 92/680) of the WHO (World Health Organization).
Other available assays for turbidimetry and nephelometry include:
KLoneus® Free Light Chains (FLC), IgD Immunoglobulins, Retinol Binding Protein (RBP) for serum and urine, Soluble Transferrin Receptor (sTfR), Hemopexin, Cystatin-C for serum and urine, A1-Microglobulin, B2-Microglobulin for serum and urine, Kappa and Lambda Light Chains for serum and urine, Complement C1q, Complement C5, Factor B (C3 Proactivator), C1 (Esterase) Inhibitor.
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