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InnovaStar is an automatic compact POCT analyser for the daily practice that delivers result quality comparable to laboratory analysers for HbA1c, CRP, glucose and hemoglobin directly from a single 10 μl whole blood sample. The complete measurement procedure, including a sample individual hematocrit correction, is performed automatically thus reducing any handling errors. The newly integrated 2.8” colour touch-screen further improves the ease of use of the instrument, enabling the operator to enter any information such as patient data, user identification etc. The new graphical user interface allows a more efficient access to all soft ware functions and displays on-screen instructions where required. The up-to-date soft ware uses self-explanatory icons for a nearly languageindependent operation of the instrument.
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Optimized 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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The CLAM-2000 automates the pretreatment of blood or other biological samples before LC-MS analysis. The background for this development is to minimize variabilities caused by sample pretreatment and manual work. In recent years, there has been considerable progress in the use of mass spectrometers (MS) in the clinical research field due to their highly sensitive detection and high specificity as well as the possibility of multiplexing analysis without the risk of cross reactions inherent to immunoassays. Mass spectrometry enables direct detection of disease-related biological compounds in blood, urine or other biological samples, measurement of trace concentration levels of drugs as well as other applications. However, the bottleneck is still sample preparation which is often tedious, involves risk of errors and increases the risk of contamination of people dealing with sample preparation. By simply placing blood collection tubes in the system, the CLAM-2000 performs all processes through LC-MS analysis automatically. Unlike dispensing systems based on batch processing 96-well plates, the CLAM-2000 is completely automatic from pretreatment to analysis and processes individual sample successively in parallel. Consequently, it results in uniform pretreatment times between samples without slowing processing speed, while improving data reproducibility and accuracy. Pretreatment processes available include dispensing samples, dispensing reagents, stirring, suction filtration, incubation and automatic transfer of sample vials to an SIL-30AC autosampler after pretreatment. CLAM-2000 automates the sample pretreatment for LC-MS analysis. All necessary steps are automatically executed according to an existing method or a method to be developed. It also features excellent management functions providing a dramatically improved workflow with better safety for clinical research and higher reproducibility. It is compatible with the LCMS TQ systems LCMS-8045, LCMS-8050 and LCMS-8060, giving a large choice to adapt to sensitivity needs. The instrument is for research use only and not available in the USA, Canada and China.
Different from the previous test versions, the new GastroPanel Quick test is designed for the point-of-care (POC) measurement of four stomach- specific biomarkers in the blood: pepsinogen I (PGI), pepsinogen II (PGII), gastrin-17 (G-17) and Helicobacter pylori IgG antibodies. In the new test version, sample processing is based on a lateral flow (LF) principle, with quantitative marker detection by double Ab (Ag) sandwich technique. The results are immediately read by the LF reader, which increases the test acceptance among clinicians, who are now capable of making the diagnosis onsite. The main indications of use for the GastroPanel remain unchanged. The test is designed for the diagnosis of (1) H. pylori infection (2) atrophic gastritis (AG), and (3) functional disorders among symptomatic (dyspeptic) patients as well as for screening of asymptomatic subjects for gastric cancer risk. Also the recently introduced interpretation algorithm remains valid, based on eight distinct biomarker profiles, five of which reflecting morphological abnormalities while the other three reflect a functional disorder.
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β-lactamase enzymes inactivate β-lactam antibiotics and render them ineffective for the treatment of clinically-important Gram-negative bacterial infections. Now, two new kits from Streck Inc. provide a comprehensive, cost-effective molecular method to detect the most clinically-important β-lactamases that confer resistance to penicillins, cephamycins, and in some cases, carbapenems. The antibiotic resistance monitoring and detection (ARM-D) kits, are multiplex real-time PCR kits that can quickly detect more than 450 β-lactamase gene variants. The ARM-D Kit, β-Lactamase detects 9 different carbapenemases, ESBLs and plasmid-mediated ampC gene families. The ARM-D Kit, ampC kit targets 6 plasmid-mediated ampC resistance gene families and can differentiate plasmid-mediated ampC β-lactamase resistance from chromosomal resistance. These genotypic detection methods identify the most prevalent types of β-lactamase-based antibiotic resistance and complement phenotypic methods for the detection of multidrug resistant organisms. They can be used with standard susceptibility tests to improve surveillance and epidemiologic tracking, for improved infection control and increased effectiveness of antibiotic stewardship programmes. AmpC β-lactamases are chromosomally encoded in many bacterial species. Their overexpression can lead to resistance to most β-lactam antibiotics, causing therapeutic failure. Transmissible plasmids with acquired genes for AmpC β-lactamases often cause increased β-lactamase production and can appear in organisms lacking or having low-level expression of a chromosomal ampC gene. Resistance due to plasmid-mediated AmpC enzymes can be broad in spectrum and often hard to detect. As Gram-negative organisms producing multiple or plasmid-mediated β-lactamases are difficult to identify phenotypically, more specific detection methods are essential for the identification of clinically important β-lactamases and selection of the appropriate antibiotic therapy. Detection and genetic identification of both plasmid-mediated and chromosomally expressed AmpC β-lactamases are crucial for a better understanding of these resistance mechanisms and, consequently, for active surveillance and infection control.
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Chromsystems launched MassChrom Metanephrines in Plasma new CE-IVD assays for the efficient quantification of metanephrine, normetanephrine and 3-methoxytyramine by LC-MS/MS. The kits are available in two configurations, either with sample clean up columns or 96 SPE well plates. The assays encompass all required components and enable a simple and fast sample preparation in just a few steps. The analytes are chromatographically separated, avoiding co-elution and minimizing the risk of interferences. Stable isotope-labelled internal standards for every single analyte ensure a reproducible and reliable quantification. The 6PLUS1 Multilevel Calibrator Set and MassCheck controls are based on human plasma to minimize matrix-induced differences. MassChrom Metanephrines in Plasma complement the full range of CE-IVD assays from Chromsystems for the determination of biogenic amines. These include assays for HPLC and LC-MS/MS and in the plasma and urine matrices. Laboratories with higher sample throughput can also rely on the company’s automated systems.
The new CoagL autoanalyser from DIAGON is the lastest addition to its portfolio of specially designed high quality hemostasis testing systems. Coag systems offer advanced, flexible and efficient automation for routine and specialilty testing coagulation labs and is supported by the same test technologies, reagents, cuvettes and consumables with low operation and maintenance costs. CoagL is a compact 4 channel coagulometer designed to include everything that could be improved in its category: it has extremely user friendly software with a high level of customization, offers real-time and post-run curve analysis, random access, reflex testing, and first tube preanalytical optical interference check. The company’s product range also includes a convenient and sensitive photo-optical CoagS POC INR test using recombinant technology, high tech Coag2D and Coag4D multichannel manual coagulometers and the 300 PT test/hour CoagXL fully automated coagulometer. All systems come with a complete reagent system, controls and calibrators both in liquid and lyophilyzed formats. Diagon offers Coag Systems for distribution and for customized OEM cooperation.
POC Connect is the world’s first mobile data management solution designed for a reagent-free hemoglobin testing device. The simple android application enables the user to store, access and transmit hemoglobin results directly from a DiaSpect Tm hemoglobin analyser to a smartphone via Bluetooth. It is now possible to link Hb results with customizable unique IDs, QC information, Cuvette LOT numbers and dates and times, as well as transfer data easily via a file download or through email so it can be added to a central database or lab information system (LIS). The DiaSpect Tm device can be purchased with integrated Bluetooth, meaning there is no need to purchase an additional external Bluetooth dongle. This new solution will prove useful in countries with challenging environmental and geographical conditions where remote hemoglobin testing and access to internet can often be difficult.
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Does your company have an idea for a novel biomarker test, but you’re unsure what the market potential will be?
Have you invented a more sensitive test to diagnose a common autoimmune disorder, but you’re unsure of which regulatory pathway to pursue?
The process of developing a successful in vitro diagnostic (IVD) relies on the expertise of a diverse group of individuals, including the scientists who identify the biomarkers of significance, engineers and assay developers who translate those ideas into a tangible product, and the sales and marketing staff who get the product into the market.
This unique manual will provide an overview of the major components to IVD development, from product conception through commercialization, and important considerations about individual aspects of the process including:
To learn more about this manual, please click here
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November 2024
The leading international magazine for Clinical laboratory Equipment for everyone in the Vitro diagnostics
Beukenlaan 137
5616 VD Eindhoven
The Netherlands
+31 85064 55 82
info@clinlabint.com
PanGlobal Media is not responsible for any error or omission that might occur in the electronic display of product or company data.
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