Beckman Coulter recently announced the release of the DxH 900 hematology analyser, giving mid- to high-volume clinical laboratories the ability to perform complete blood count (CBC) and white blood cell differential tests with minimal repeats. The DxH 900 is now available for sale in Europe, the United States, Canada, Australia and New Zealand. The DxH 900 analyser offers advanced technologies to support patient care, by delivering the right results the first time. Foundational to the system are its core technologies, including the enhanced Coulter Principle, VCS 360 and DataFusion. These features offer high-resolution analysis of cells in their near-native states, providing a precise cellular assessment for excellent red blood cell, platelet and white blood cell test results on the first pass. The suite of technologies is intended to help laboratories deliver quality results for fast, accurate clinical decision-making. At the same time, the system includes automated solutions that streamline the number of procedural steps needed to produce those results, offering predictable performance and greater laboratory efficiency. The DxH 900 analyser demonstrates 93% first-pass throughput, providing accurate flagging and reducing the number of slide reviews. This helps to generate reportable results as quickly as possible, reducing the time, supplies and costs that may be required for systems with higher repeat rates. Adding to this is the analyser’s lean reagent portfolio, which includes four reagents compared to eleven reagents required by other analysers. Further, the DxH 900 features one of the smallest footprints in its class, making it highly efficient in utilization of laboratory space. Many of the parameters available with the DxH 900 analyser are designed to directly impact patient care by addressing critical conditions, such as thrombocytopenia, anemia and leukopenia. Beckman Coulter is evaluating a hematology sepsis parameter that is part of a routinely ordered test in the emergency department, where earlier recognition and treatment of sepsis can begin. This test can be performed on the DxH 900 analyser (see below). The DxH 900 hematology analyser complements the recently announced DxH 520 system, and further expands Beckman Coulter’s hematology portfolio.
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Hemoglobin and hematocrit meter system
, /in Product News /by 3wmediaThe latest addition to the StatStrip line of handheld, hospital meters, the StatStrip Hemoglobin and Hematocrit Meter System (StatStrip Hb/ Hct), has gained CE mark certification and is now available in all CE regulated countries. StatStrip Hb/Hct is the only point-of-care (POC) meter to measure hemoglobin and hematocrit for accurate anemia screening and blood loss monitoring. StatStrip Hb/Hct provides measured hemoglobin and hematocrit results, which are more accurate than calculated results, with excellent correlation to laboratory reference methods. With a fingerstick capillary sample and results in 40 seconds, StatStrip Hb/Hct provides the real-time accuracy that helps improve clinical decision making in a variety of healthcare settings. These include blood banks and temporary blood collection locations, dialysis centres, primary care clinics, hospitals, and oncology clinics. For example, in blood banks, StatStrip Hb/Hct provides safe and effective blood donor screening and avoids false deferrals. For patients receiving dialysis, StatStrip Hb/Hct helps maintain Hb target levels and also monitor erythropoiesis stimulating agents (ESAs) to the lowest effective dose. In emergency care settings and in hospitals, StatStrip Hb/Hct can aid in rapidly evaluating blood loss, initiating treatments more quickly, and monitoring critically ill patients who are at risk for low hemoglobin and hematocrit. In oncology clinics, StatStrip Hb/Hct can help proactively identify patents at high risk for chemotherapy-induced anemia and direct treatment accordingly. StatStrip Hb/Hct’s single-use biosensors do not require calibration or coding, and testing is as easy as glucose self-testing. StatStrip Hb/Hct helps reduce costs by eliminating the need for blood drawing supplies, venous phlebotomy, and laboratory testing. Wired and wireless connectivity for data integration with patient records are available. Compact and lightweight, StatStrip Hb/Hct is less than half the size and weight of other POC systems that measure only hemoglobin.
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nSMOL for fast and precise mAb Bioanalysis
, /in Product News /by 3wmediaShimadzu’s new nSMOL Antibody BA reagent kit offers a unique and standardized workflow for the quantitation of monoclonal antibody drugs by LC-MS/MS in blood or other biological samples. The technique, called nano- Surface and Molecular-Orientation Limited (nSMOL) proteolysis, has been designed to minimize sample complexity while maintaining the specificity of the protein substrate for LC–MS/MS quantitation in therapeutic drug monitoring of mAbs. nSMOL proteolysis is an entirely novel solid-solid proteolysis method engineered to deliver highly efficient and quantitative detection of CDR (Complementarity-Determining Region) peptides while decreasing the peptide numbers of the analytical target without antibody denaturation.
For more information on Shimadzu’s total solution for biopharmaceutical lab please visit: www.shimadzu.eu/nsmol-antibody-ba-kit and https://www.youtube.com/watch?v=KoOarzAQg68
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Free 25OH Vitamin D ELISA kit
, /in Product News /by 3wmediaFree 25OH Vitamin D kit is a CE marked ELISA kit available worldwide from Diasource ImmunoAssays SA (Belgium). Recent posters and publications clearly show that Free 25OH Vitamin D is a better marker than Total 25OH Vitamin D in healthy pregnant women, in women taking hormonal contraceptives and in diabetic patients with impaired kidney function. This kit allows a direct measurement of the Free 25OH Vitamin D, so no calculations are needed based on Total 25OH Vitamin D -, Albumin – and VDBP (vitamin D binding protein) concentrations, and this without sample pre-treatment. The assay is calibrated against Rate Dialysis, which is the golden standard method for the measurement of free hormones, and uses only 10 microliters of serum.
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Beckman Coulter achieves CE Mark for its Early Sepsis Indicator
, /in Product News /by 3wmediaEuropean CE marking has been confirmed for Beckman Coulter’s Early Sepsis Indicator, a hematology-based solution designed to alert emergency department clinicians to the possibility of sepsis or risk of developing sepsis. The first early sepsis warning solution to be offered as part of a routine CBC with differential test, the Early Sepsis Indicator gives physicians a rapid and simple tool that can aid in the fight against sepsis. The new marker will be commercially available on the recently launched DxH 900 hematology analyser. Sepsis is an often-deadly condition that affects 26 million people worldwide every year and is increasing at a rate of 1.5% annually. Timely and accurate detection solutions in the acute-care setting are key components to stopping the progression of sepsis, as patients with less severe sepsis can progress to severe sepsis or septic shock within 72 hours. Up to half of patients with sepsis die. In addition to the human toll, this global crisis places a significant clinical and economic burden on the healthcare system. A clear link exists between the timeliness of treatment and the possibility of death. When antibiotics are administered early to patients with septic shock, the likelihood of death is decreased by 7.6% per hour. Because emergency department personnel are often on the front line of care for people facing critical conditions, giving them a simple and easy tool for detecting sepsis can help make significant strides against this prevailing threat. The fact that this early warning indicator is part of a routine blood test means that clinicians receive results rapidly, with no additional workflow burden to the laboratory or emergency department. The Early Sepsis Indicator uses the DxH 900 hematology analyser’s Coulter technology, which characterizes cells in their nearnative states. The system’s powerful VCS 360 technology can uniquely detect morphological changes in monocytes – cells of the innate immune system that provide a first line of defense against infections. Monocytes play a role in the dysregulated immune response to sepsis, and identifying morphological changes provides insight into possible sepsis earlier than other indicators. The company plans to submit a 510(k) for the Early Sepsis Indicator to the U.S. FDA in the near future. After receiving 510(k) clearance, the Early Sepsis Indicator will be released to the U.S. market.
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Hematology analyser provides near native-state cellular characterization
, /in Product News /by 3wmediaBeckman Coulter recently announced the release of the DxH 900 hematology analyser, giving mid- to high-volume clinical laboratories the ability to perform complete blood count (CBC) and white blood cell differential tests with minimal repeats. The DxH 900 is now available for sale in Europe, the United States, Canada, Australia and New Zealand. The DxH 900 analyser offers advanced technologies to support patient care, by delivering the right results the first time. Foundational to the system are its core technologies, including the enhanced Coulter Principle, VCS 360 and DataFusion. These features offer high-resolution analysis of cells in their near-native states, providing a precise cellular assessment for excellent red blood cell, platelet and white blood cell test results on the first pass. The suite of technologies is intended to help laboratories deliver quality results for fast, accurate clinical decision-making. At the same time, the system includes automated solutions that streamline the number of procedural steps needed to produce those results, offering predictable performance and greater laboratory efficiency. The DxH 900 analyser demonstrates 93% first-pass throughput, providing accurate flagging and reducing the number of slide reviews. This helps to generate reportable results as quickly as possible, reducing the time, supplies and costs that may be required for systems with higher repeat rates. Adding to this is the analyser’s lean reagent portfolio, which includes four reagents compared to eleven reagents required by other analysers. Further, the DxH 900 features one of the smallest footprints in its class, making it highly efficient in utilization of laboratory space. Many of the parameters available with the DxH 900 analyser are designed to directly impact patient care by addressing critical conditions, such as thrombocytopenia, anemia and leukopenia. Beckman Coulter is evaluating a hematology sepsis parameter that is part of a routinely ordered test in the emergency department, where earlier recognition and treatment of sepsis can begin. This test can be performed on the DxH 900 analyser (see below). The DxH 900 hematology analyser complements the recently announced DxH 520 system, and further expands Beckman Coulter’s hematology portfolio.
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Automated ESR testing instrument
, /in Product News /by 3wmediaCUBE 30 Touch is an automated instrument for high-volume erythrocyte sedimentation rate (ESR) testing in EDTA tubes. Compatible with standard 4.0 mL K2EDTA tubes, the instrument produces ESR results directly from EDTA tubes without consuming patient sample. Its internal mixing function automatically prepares up to 30 samples per batch. Random access capability enables the user to add samples as space allows. The instrument automatically prints and transmits results to the laboratory information system (LIS). Results are available in under 25 minutes and show >94% correlation to Modified Westergren Method. An internal barcode scanner ensures positive patient ID. Patient and QC data are archived and a USB port and Bluetooth connector allows connection to PC, tablet and smartphone. No reagents are needed and there is no exposure to patient sample. Utilizing plastic tubes, the instrument does not produce any liquid waste, thus saving costs for waste disposal.
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Identification of OXA-23 carbapenem-resistant Acinetobacter spp.
, /in Product News /by 3wmediaThe global spread of carbapenemresistant Acinetobacter spp., and particularly A. baumannii, in healthcare settings causes a major threat to patient survival. Worldwide, drug-resistant Acinetobacter spp. are responsible for serious nosocomial outbreaks, mostly in intensive care units. Even though different resistance mechanisms have been described, production of Amber Class D oxacillinases OXA-23-like hydrolysis enzymes is the most frequently acquired mechanism. Fast and accurate detection of OXA-23-producing strains remains challenging at the laboratory level. Specific identification of oxacillinase-expressing Acinetobacter requires genotypic molecular assays that remain expensive and not commercially available. However immunochromatography lateral flow tests are cost-effective and convenient to detect drug-hydrolysing enzymes. Today, a large panel of lateral flow tests to detect carbapenemase-expressing Enterobacteriacea, named “RESIST”, is commercialized by the Belgian company Coris BioConcept. In order to fulfill the unmet need for fast and reliable detection of drugresistant Acinetobacter, Coris BioConcept developed a new lateral flow assay, “OXA- 23 K-SeT”, for the specific identification of OXA-23-mediated carbapenem-resistant in Acinetobacter spp. from a single colony. With results available in less than 15 minutes, this easy-to-use and instrument-free rapid test represents the first phenotypic, specific and non-molecular confirmatory assay for OXA-23 detection. It will expand the RESIST range of products already adopted nowadays by routine and reference laboratories worldwide, offering an additional tool to ensure the successful treatment of patients and to prevent the spread of carbapenemase-producing bacteria in healthcare settings.
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VACUETTE CAT Serum Fast Tube
, /in Product News /by 3wmediaGreiner Bio-One’s new VACUETTE CAT Serum Fast Tube is the optimal tube whenever results are needed fast. It enables serum to be analysed as quickly as plasma. The tube is coated with a mixture of Blood Clotting Activator (BCA) and thrombin. Thrombin, as an accelerator, speeds up the coagulation process: coagulation takes just five minutes, followed by centrifugation for five to ten minutes, giving the tube a major time-saving advantage over conventional serum tubes with a usual duration of about 40 minutes. Thanks to this short coagulation time, blood collection is also possible shortly before transport to the laboratory. Furthermore, the added gel forms a stable barrier between the serum and the cellular components of the whole blood after centrifugation. So, another advantage is the better preservation of the sample quality. The five-minute coagulation time rules out post clotting in the laboratory. As a result, preanalytical errors are reduced and accurate values can be used for diagnosis. www.gbo.com
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Direct HbA1c testing using RX series clinical chemistry analysers
, /in Product News /by 3wmediaThe concentration of HbA1c in the blood of diabetic patients increases with rising blood glucose levels and is representative of the mean blood glucose level over the preceding six to eight weeks.
Randox now offers a direct HbA1c assay for the rapid direct measurement of HbA1c in human blood. This assay is available to be used on the RX daytona +, RX imola and RX modena clinical chemistry analysers which are capable of performing medium to high throughput testing. This direct HbA1c test adds to the comprehensive test menu of niche and high performing assays already available at Randox.
The latex enhanced immunoturbidimetric method makes the test simple and quick to perform as only one assay is now required. Human error inaccuracies are removed as offline preparations are no longer required and are preformed on-board the RX series analysers.
For more information about our direct HbA1c assay please visit www.randox.com/hba1c-rxseries/ or contact us at therxseries@randox.com
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CM20 Chloridemeter
, /in Product News /by 3wmediaThe Chloridemeter CM20 provides quick and exact determination of the chloride ion concentration in liquid micro samples with a minimum volume of 10 μl. This cutting-edge digital instrument has an easy, intuitive user interface with a modern touch screen and multi-language prompts which lead the operator through the entire measurement process. The instrument is factory-calibrated and equipped with an integrated printer. Results are sent in document-ready format to a PC that can be connected via USB or RS232 for data transfer.
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