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Archive for category: Product News

Product News

C300 ELITech crop

STI multiplex assay panel

, 26 August 2020/in Product News /by 3wmedia

ELITechGroup Molecular Diagnostics announces the CE-IVD marking of the STI ELITe MGB Panel: a multiplex assay for the detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Mycoplasma genitalium (MG), three major bacteria involved in sexually transmitted infections. STIs are a global burden with more than 1 million infections acquired every day worldwide.  Accurate and specific detection is important to reduce transmission and complications. In combination with the ELITe InGenius system, the STI ELITe MGB Panel makes it possible to simultaneously detect and differentiate in one single reaction Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium. Patient samples can be directly loaded into the system, which automatically performs all the steps of molecular diagnostics from extraction to result interpretation with minimal hands-on time. The clinical study has demonstrated excellent performance: respectively 96.4%, 100% and 100% diagnostic sensitivity and 100%, 98.4% and 98.4% specificity with C. trachomatis, N. gonorrhoeae and M. genitalium. STI ELITe MGB Panel is the 22nd CE-IVD assay of ELITe InGenius’ menu and the first one intended to diagnose sexually transmitted infections.  Recently identified, M. genitalium is highly prevalent in the general population, and share similar symptoms with C. trachomatis and N. gonorrhoeae, but their specific antibiotic treatments are not fully efficient to cure M. genitalium and generate antibiotics resistance strains. Co-detection of Mycoplasma genitalium, along with Chlamydia trachomatis, Neisseria gonorrhoeae improves the efficiency of STI diagnosis and patient management. ELITe InGenius offers a unique menu with quantitative and qualitative assays for transplant pathogen monitoring, healthcare associated infections, respiratory infections, meningitis, sexually transmitted infections, and the testing of coagulation factors.

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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C300_ELITech_crop.jpg 800 944 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:17:532021-01-08 11:21:30STI multiplex assay panel
C256 Biosystems 01

Ethanol test in serum, plasma and urine

, 26 August 2020/in Product News /by 3wmedia

BioSystems launches a new reagent for measurement of ethanol in serum, plasma and urine. Ethanol is a small molecule found mainly in alcoholic beverages, medical preparation and food. Their consumption is widespread but often abusive. Therefore, ethanol determination is one of the most common diagnostic tests in the toxicology and forensic laboratory and it is used for both medical and legal purposes. Ethanol acts as a central nervous system (CNS) depressant and can cause loss of attention, stupor, coma and possible death. BioSystems introduces this test in dedicated presentation for the A15 and A25 analysers (code 12789: 1 x 10mL + 1 x 7 mL) and for the BA400 analyser (21789: 2 x 20mL + 2 x 7mL). It is calibrated using Ammonia/Ethanol/CO2 Calibrator (BioSystems cod. 18065). The reagent offers an improved detection limit (8 mg/dL) and is optimized to work with the company’s analysers although it can also be adapted to other models. It is recommended to use the Ammonia/Ethanol/CO2 Control level I (cod. 18063) and II (cod. 18064) to verify the accuracy of the measurement procedure.
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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C256_Biosystems_01.jpg 250 680 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:17:532021-01-08 11:27:12Ethanol test in serum, plasma and urine
C318 Diatron

3-part differential hematology analyser

, 26 August 2020/in Product News /by 3wmedia

The Aquila 3-part differential hematology analyser (60 samples /hour throughput) can be used in many testing locations where high-quality complete blood count (CBC) results are desired. The instrument provides an optimal testing solution for both the experienced and inexperienced user, and practices which require a high-quality hematology analyser. Specifically designed for the decentralized laboratory and near-patient testing situations, this small analyser has low reagent consumption (<12ml), requires only a small sample size (20µl) and has a unique on-board reagent pack (sufficient for approximately 200 measurement cycles). With a small footprint, the analyser can be used in many locations, including small laboratories and in point-of-care applications. The low instrument reagent consumption coupled with its on-board reagent pack ensure that the shipping, storage and usage of reagents deliver enhanced ease of use as well as significant cost reductions. The newly available analyser, while requiring little bench space, features a large touch screen, an intuitive user interface, an optional back-up battery pack and extended connectivity options.
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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C318_Diatron.jpg 395 477 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:17:532021-01-08 11:21:253-part differential hematology analyser
C294 Beckman

Software expands capabilities of flow cytometer in routine labs

, 26 August 2020/in Product News /by 3wmedia

Beckman Coulter has significantly expanded the workflow capabilities of its AQUIOS CL Flow Cytometer with the addition of the AQUIOS Designer Software, developed specifically to handle user-defined tests in the routine lab. The AQUIOS Designer Software allows for the creation of customer-defined applications to be run on an instrument that combines sample preparation and flow cytometry analysis in one platform (AQUIOS Load & Go technology). Until recently, this feature combination was only available for pre-defined applications like CD4 analysis and basic immunophenotyping. With traditional flow cytometry, sample preparation and analysis required a two-step approach carried out on different instruments. Even with semi-automated processes this would slow down the lab’s overall productivity and cause bottlenecks. It also limited the role of flow cytometry technology in today’s lab, which requires 24/7, streamlined workflow and a consistent turnaround time (TAT). Many laboratories now create their own reagent cocktails for routine applications to accommodate the specific marker combinations required by their individual focus. The addition of AQUIOS Designer Software fundamentally changes the way flow cytometry technology performs within the routine lab.  It reduces the routine, repetitive task of having to manually mix reagent combinations.  Far greater workloads can be handled quickly and efficiently, without bottlenecks. The optional AQUIOS Designer Software provides an intuitive and user-friendly interface with powerful features to set up user-defined protocols, acquisition templates, panels, compensation settings, and the parameters needed for statistical and quality control compliance. All features can easily be accessed via pull-down menus or slider bars. On the small footprint, high precision AQUIOS CL Flow Cytometer, sample loading is as easy as on a hematology analyser, with integrated automated sample preparation. It delivers first results within 20 minutes for routine applications such as immunophenotyping, with subsequent sample results at a rate of approx. 25 samples per hour for up to a full 96-well plate for each test of Tetra Combo. The company provides the reagents for user-defined assays either through the Contract Manufacturing (GMP) or Custom Design Services of user-defined reagents. Either option provides barcoded and cap-pierceable vials that can be run on the AQUIOS CL instrument with automated tracking of all QC functionalities, including reagent type, container ID, and lot number.

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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C294_Beckman.jpg 586 800 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:17:532021-01-08 11:21:33Software expands capabilities of flow cytometer in routine labs
C259 Sekisui use 01

POC quantitative immunoassay analyser

, 26 August 2020/in Product News /by 3wmedia

The FastPack IP System is a fully automated quantitative immunoassay analyser designed for use in any size physician office laboratory. Utilizing sophisticated chemiluminescence technology, it provides the capability to produce complex immunoassay results in 12 minutes or less with a push of a button. The FastPack IP System is versatile and requires minimal space while offering a test menu that will make a clinical impact at the point-of-care. Assays include Vitamin D, Testosterone, TSH, Free T4, PSA and hCG. The system is simple to use with no specialized training required and “One Touch” operation providing an easy to use format. The innovative reagent pack contains all assay reagents for no chemical exposure with minimal hands-on time. No system maintenance is required. “On Demand” results increase office efficiencies by decreasing patient call-backs, while patient side answers allow for the adjustment of replacement therapy on the spot. The system requires minimal space, yet provides laboratory accuracy and precision at the simple push of a button. It utilizes monoclonal antibody technology coupled with a patented chemiluminescence substrate for true laboratory performance.

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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C259_Sekisui_use_01.jpg 565 800 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:17:532021-01-08 11:27:15POC quantitative immunoassay analyser
C320 Beckman crop

Immunoassay system offers enhanced features

, 26 August 2020/in Product News /by 3wmedia

Built upon a 20-year legacy of reliable performance, the Access 2 immunoassay system is a compact, random-access benchtop analyser that delivers an extensive diagnostic-testing menu. The new features have been added to improve ease-of-use, workflow efficiencies, system reliability and customer satisfaction. Changes include the addition of an internal reagent barcode reader to minimize operating loading errors, an upgraded ergonomic workstation for operator comfort, improved fluidics tray for operational efficiency, a status light bar for notifying operators of instrument status, remote monitoring capability and a refreshed look. The Access 2 provides remote PROService connectivity, on-the-fly reagent and consumable loading, proven reliability and delivers up to 100 tests per hour. Together these features and benefits save laboratories precious time. Ideal for small- to medium-sized physician office laboratories, community hospitals and independent references labs or as a back-up to other primary immunoassay systems, the Access 2 is a reliable and robust system. It is designed with sample probe obstruction detection and remote monitoring capability for instrument diagnostics, maintains greater than 98 percent system availability and delivers less than 1.1 emergency service calls per year. An extensive diagnostic testing menu is available for use on the Access 2 immunoassay system, with tests that cover a range of disease states to fulfill patient care needs. These tests include, adrenal disorders, anemia, bone metabolism, cardiac-related conditions, diabetes, infectious diseases, reproductive health, endocrinology, thyroid and tumour markers.

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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C320_Beckman_crop.jpg 376 800 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:17:532021-01-08 11:21:28Immunoassay system offers enhanced features
C284 Thermo Fisher crop

Automating blood cell washing applications

, 26 August 2020/in Product News /by 3wmedia

A new automated, high-performance cell washer has been specifically designed to enable precise, thorough, reproducible and rapid blood cell washing of up to 24 tubes in a three-minute run. Fully automated, the Thermo Scientific CW3 Cell Washer has been uniquely engineered to combine the benefits of efficient performance with user-friendly design and safe operation. Users can select one of the pre-set programs that have been designed to run in automatic mode, accelerate blood cell washing cycles and achieve significant time savings, while allowing for maximum ease of use and sample safety. Effective blood cell washing is extremely important in the removal of plasma and unwanted antibodies to ensure that patients will not be affected by adverse health effects and that blood-transfused products will retain all of their beneficial attributes. The CW3 Cell Washer has been designed to achieve optimal corpuscle dryness by allowing users to pre-set the desired decanting speed. At the same time, corpuscle washing is improved via the optional overfl ow method. For washing, tubes swing at a fixed positive angle to sediment cells rapidly at the bottom of the tube, whereas when decanting, the rotor holds tubes at a slightly negative angle and the saline is decanted centrifugally. The result is optimized pelleting performance. Furthermore, the flexibility to use 12- or 24-place rotors and standardized, repeatable procedures enables the instrument to adapt to the processes and protocols already in place within the lab. Built with sample safety in mind, the compact CW3 Cell Washer features an automatic alert mechanism that informs users about low or disrupted saline levels and when a run is complete. A view port on top of the unit facilitates quick calibration, while the saline distributor is mounted directly on top of the rotor to reduce the risk of cross-contamination. The new washer is also equipped with tube racks bearing red and blue number labelling for easy sample balancing. In addition, when closed-monitoring of the washing process is required, the system can be operated manually to allow for cells that need to be washed step-by-step. As a low maintenance instrument, the CW3 Cell Washer includes easy-to-change pump tubing and an easy-toremove catch basin, rotor and rotating bowl.
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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C284_Thermo-Fisher_crop.jpg 800 452 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:17:532021-01-08 11:27:10Automating blood cell washing applications
C249 Biosystems 01

CRP-extended range test kit

, 26 August 2020/in Product News /by 3wmedia

C-Reactive Protein is an extremely useful parameter to evaluate acute phase episodes as it quickly reflects the reaction of the organism but is also a useful parameter to monitor infectious or inflammatory state. The normal level of CRP is very low but it can increase more than one thousand-fold in a very short time to decrease progressively in the next 72 hours. If CRP doesn’t return to its basal level there is a clear indication that some clinical action is required. As the range of values that CRP may show in a patient is very wide, analytical methods need to optimize their performance in terms of sensitivity at low values and measure range to cover the most common pathological ranges. BioSystems SA is now introducing its new latex immunoturbidimetry kit of CRP-extended range (CRP-er), covering a range from 1,3 to 300 mg/L, with no pro-zone up to 1000 mg/L and no interference from hemoglobin, lipemia or rheumatoid factors. The test uses a five-point calibration curve stable up to 2 months and it is suitable for use in automatic analysers. Standards and controls suitable for extended range are also available.
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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C249_Biosystems_01.jpg 224 225 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:17:532021-01-08 11:27:18CRP-extended range test kit
C331 Biosystems

Analyser with integrated cooling system

, 26 August 2020/in Product News /by 3wmedia

A 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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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C331_Biosystems.jpg 635 800 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:17:532021-01-08 11:21:23Analyser with integrated cooling system
C301 Chromsystems

Cortisol and cortisone in saliva by mass spectrometry

, 26 August 2020/in Product News /by 3wmedia

Chromsystems has launched the first CE-IVD assay for the quantitative determination of cortisol and cortisone in saliva by LC-MS/MS. MassChrom Cortisol, Cortisone in Saliva is a complete solution from sample to result, saving laboratories time and resources for in-house development. It represents a reliable, robust and proven CE-IVD assay that encompasses all required components for an efficient determination – from a fast sample preparation by filtration with clean-up tubes through to the analysis. Stable isotope-labelled internal standards for both parameters, 6PLUS1 Multilevel Calibrator Set and MassCheck controls ensure high precision of results. The parameters are determined directly by mass spectrometry, eliminating the risk of cross-reactivity as described for many immunoassays. Saliva sampling is easy, stress-free and non-invasive for patients.  Stress-induced adrenal stress responses are removed, making salivary sampling more reliable, in particular in stress research and pediatric applications.

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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C301_Chromsystems.jpg 800 1101 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:17:532021-01-08 11:21:31Cortisol and cortisone in saliva by mass spectrometry
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