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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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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Quality indicator monitors instrument HIL interference detection
, /in Product News /by 3wmediaAlthough your instruments may automatically detect HIL interferences, shouldn’t the lab’s QC program include pre-analytical checks to monitor instruments’ ability to detect them? Studies show that interferences from hemolysed, icteric or lipemic (HIL) specimens are amongst the most common pre-analytical errors. Liquichek Serum Indices is a quality indicator intended for use as part of laboratory interference testing to monitor an instrument’s ability to detect these three types of samples. Replicating relevant concentrations of HIL interferences using human-sourced materials will allow confidence in the instrument’s performance. With Bio-Rad’s Unity Interlaboratory Program, the user is able to compare instrument responses among peer groups to help avoid costly test repeats. https://tinyurl.com/yxpmoe2e
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Device to accelerate cell therapy manufacturing
, /in Product News /by 3wmediaThe Finia Fill and Finish System is a first-of-its-kind device developed to help bring reproducibility and control to cell therapy manufacturing. Finia is a fully automated, modular, functionally closed system that creates the final formulation of cell and gene therapies and divides them into user-defined doses for patients. The technology automates a process that is currently manual and labour-intensive with the added risk of error. The production and delivery of cell-based therapies is a complex and logistically challenging process. Developers and manufacturers appreciate support in determining when to automate, which processes to automate and how to integrate automation into their existing process. Finia combines, mixes and divides the final product into predetermined volumes, all under controlled, refrigerated temperature. It automatically removes air before it seals the final product bags, simplifying the downstream process. Finia also works with Terumo BCT’s Cell Processing Application software in the customers’ network to facilitate compliance to current good manufacturing practices (cGMP), including electronic record-keeping, control of process workflow, user credentialing and permission, and guidance of operators through the process with an intuitive user interface module (UIM).
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Compact inverted microscope
, /in Product News /by 3wmediaioLight, creator of the world’s first high-resolution portable microscope, has now designed a new compact inverted microscope for cell culture observation in the lab. This very compact, lightweight and robust inverted microscope is even tough enough for use inside an incubator. The ioLight inverted microscope is just 170mm in size and sealed to protect the inner workings. This means it is perfectly suited to observing cell culture in a lab incubator without having to open the door. Cell development is monitored by an inverted microscope, with the lens underneath the petri dish looking upwards into the sample with illuminators both above and below the sample. Because the inverted microscope accommodates a petri dish, observation of cells and organisms can be achieved using standard laboratory procedures without having to prepare a slide sample. Through a simple Wi-Fi connection, the inverted microscope enables images to be stored on a tablet, mobile phone or laptop and shared instantly with collaborators anywhere. The ioLight inverted microscope uses both bright field and dark field illumination. Bright field mode illuminates high contrast samples from above, displaying them against a bright background. Dark field mode illuminates lower contrast or even transparent samples with scattered light, highlighting them against a dark background. This allows a wide range of samples to be imaged. The ioLight inverted microscope is a cost-effective and compact laboratory tool that is really simple to use. Users have the ability to view images on a mobile phone and because it is wireless they can leave the microscope inside an incubator so they do not have to disrupt the experimental conditions.
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High throughput 5-part differential hematology analyser
, /in Product News /by 3wmediaThe Diatron Aquila 5Dretics is a new member of the Aquila family designed to deliver quality results and is suitable for use in many environments including centralized and de-centralized laboratories plus near-patient testing. The Diatron Aquila 5Dretics with a maximum throughput of 80 tests/hour will be the smallest and most compact cap piercing 5-part diff analyser with reticulocytes available on the market. The instrument has low reagent consumption (<30ml), requires only a small sample volume (40ul) and has a continuous loading autoloader, making the analyser a walk-away system convenient for all customers. User-defined rerun/reflex rules standardize decision criteria and reduce turn-around time (TAT). Being a fully optical system, the Diatron Aquila 5D uses only two reagents, meaning the instrument has low reagent consumption to position the Aquila 5Dretics as the most cost-efficient hematology instrument on the market. The newly available analyser, while requiring little bench space (32cm W x 30cm D x 37cm H without autoloader), features a large touch screen, an intuitive user interface and a protected reagent pack system with unique connection.
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Random access analyser for medium-sized labs
, /in Product News /by 3wmediaRespons940 is a random access analyser with a true throughput of 400 tests/hour (640 tests/hour with ISE) irrespective of whether mono- or 2-component tests are performed. With an onboard capacity of 36 different methods in mono- or twin containers, 50 barcoded samples plus 30 positions for calibrators, controls or emergency samples, respons940 offers superior flexibility in organizing laboratory workflows. Ready-to-use reagents, one-grip loading of reagent containers, integrated bar code reader for samples and reagents, durable hard glass cuvettes, a maintenance-free photometric unit as well as a modern software interface turn respons940 into an allround system for everyday use. Owing to low reagent consumption and the proven quality of DiaSys reagents with long-term stability and broad measuring ranges which minimizes the need for re-runs, respons940 constitutes an economical analyser for medium-sized laboratories.
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Antibodies for IVD applications
, /in Product News /by 3wmediaMonoclonal antibodies (mAb) are important components of CE-marked IVD reagents used in diagnosis of diseases and follow-up of treatment. DIAsource Immunoassays, a BioVendor group company, recently announced the launch of 13 new antibodies for IVD applications: Adiponectin, FABP4, COMP, NT-ProANP, Uromodulin, Soluble Transferrin Receptor, Placental Protein 13, Cathepsin K and Procalcitonin antibodies are now available and offered to the IVD providers for development of Immunoassays. This follows the launches of novel Vitamin D conjugates, Vitamin D dissociation buffers, and antibodies against ACTH, PTH, IGF-1, Testosterone and Progesterone. All these antibodies were developed with special focus on sensitivity, selectivity and stability to ensure long-term supply. They are produced and fully automatically purified under strict ISO 9001 – ISO 13485 conditions. Products are available in purified unconjugated format. Large scale productions can be guaranteed in state-of-the-art facilities. DIAsource is continuously expanding its product portfolio with niche, high valued parameters and these new launches consolidate its actual position on the market, with an enlarged portfolio of proven and performing antibodies for IVD providers.
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