The latest addition to the Stat Profile product line, Stat Profile Prime ES, has gained CE mark certification for release in CE regulated countries. Prime ES incorporates Nova Biomedical’s innovative no-maintenance sensor card technology for a smaller, faster, and less expensive electrolyte analyser. Compact and lightweight, Prime ES provides a comprehensive electrolyte profile including Na, K, Cl, iCa, and iMg in just 60 seconds from 50 microliters of whole blood. Stat Profile Prime’s no-maintenance technology comprises a single MicroSensor Card that contains all sensors for Na, K, Cl, iCa, and iMg with a 32-day use life, and a reagent cartridge containing all calibration reagents. The MicroSensor Card and reagent cartridge are both maintenance free and easily replaced in seconds. This design optimizes the life of each, improves analyser uptime, and reduces costs. Credit card-sized, the MicroSensor Card is always calibrated and ready to deliver a stat electrolyte profile. Stat Profile Prime’s Clot Block sample flow path protects the MicroSensor Card from blockages and downtime caused by blood clots. A safety sample port aspirates samples directly from syringes, tubes, cups, and ampoules, eliminating sample transfer steps and saving time. Acceptable samples include whole blood, serum, plasma, urine, and cerebrospinal fluid. Simple to operate with a colour touchscreen and built-in barcode scanner for positive patient ID, Stat Profile Prime ES may be used in a fixed location virtually anywhere in a hospital/clinic or operated on a mobile cart with a battery back-up. An optional 10-sample removable tray provides serial batch testing for serum, plasma, and urine samples. Prime ES patient results can be easily interfaced to the LIS/HIS with the industry standard POCT 1-A2 connectivity format.
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Personalized learning platform
, /in Product News /by 3wmediaSiemens PEPconnect, part of the total Personalized Education Plan (PEP), is the industry’s first personalized education and performance experience for the healthcare professional. With optimized technology and increased search capabilities, PEPconnect allows customers to access education and real-time performance support virtually anytime, anywhere, and on any device, including PCs, laptops, tablets, and smartphones. It enables users to construct a personalized learning experience and easily share and connect with others in their workgroup community. PEPconnect includes over 4,000 competency- based product education and performance support opportunities for healthcare professionals to increase proficiency, as well as general laboratory and clinical applications education events, integrated webinars and seminar and symposium administration and tracking for Siemens-hosted events. The platform delivers comprehensive transcripts with certificates of completion and CEUs. Integration with PEP Administrator and Workgroup Owner is available for existing accounts (whether customer-owned or applications specialists). The PEPConnect platform is available globally in English, with additional languages, including Spanish and Italian, being rolled out by the beginning of November 2015 and all customer languages by March 1, 2016.
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FISH probe for bladder cancer
, /in Product News /by 3wmediaAvailable in Europe, the CE-IVD labelled Cytocell Aquarius P16/3c/7c/17c Probe Kit is a cost-effective, ready-to-use fluorescence in situ hybridization (FISH) probe kit for non-invasive detection of bladder cancer. Bladder cancer is becoming increasingly prevalent, and in 2012 was reported as the 5th most common cancer in Europe. While cytology screening is commonplace for diagnosing bladder cancer, a recent update to UK NICE guidelines recommended the use of FISH. FISH methods have been shown to have the same specificity as cytology screening and greater sensitivity in detecting bladder cancer cells. FISH analysis for bladder cancer is also particularly useful for monitoring treatment outcome and can aid in reducing patient mortality by detecting bladder cancer recurrence up to six months earlier than other methods. Carrying the CE mark for in vitro diagnostic use within Europe, OGT’s product accurately detects in urine samples the three most common aneuploidies associated with bladder cancer (chromosomes 3, 7 and 17). It also detects deletions of the 9p21.3 locus containing the well-known tumour suppressor gene p16 (CDKN2A) — commonly deleted in bladder cancer. The economical Cytocell Aquarius P16/3c/7c/17c Probe Kit contains ready-to-use reagents and has an easy-to-use protocol, reducing the potential for errors and increasing convenience. Specific, clear, high-intensity signals with minimal background deliver quality, reproducible and easy-to-score results ensuring clinicians can be confident in reporting.
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Electrolyte testing system
, /in Product News /by 3wmediaThe latest addition to the Stat Profile product line, Stat Profile Prime ES, has gained CE mark certification for release in CE regulated countries. Prime ES incorporates Nova Biomedical’s innovative no-maintenance sensor card technology for a smaller, faster, and less expensive electrolyte analyser. Compact and lightweight, Prime ES provides a comprehensive electrolyte profile including Na, K, Cl, iCa, and iMg in just 60 seconds from 50 microliters of whole blood. Stat Profile Prime’s no-maintenance technology comprises a single MicroSensor Card that contains all sensors for Na, K, Cl, iCa, and iMg with a 32-day use life, and a reagent cartridge containing all calibration reagents. The MicroSensor Card and reagent cartridge are both maintenance free and easily replaced in seconds. This design optimizes the life of each, improves analyser uptime, and reduces costs. Credit card-sized, the MicroSensor Card is always calibrated and ready to deliver a stat electrolyte profile. Stat Profile Prime’s Clot Block sample flow path protects the MicroSensor Card from blockages and downtime caused by blood clots. A safety sample port aspirates samples directly from syringes, tubes, cups, and ampoules, eliminating sample transfer steps and saving time. Acceptable samples include whole blood, serum, plasma, urine, and cerebrospinal fluid. Simple to operate with a colour touchscreen and built-in barcode scanner for positive patient ID, Stat Profile Prime ES may be used in a fixed location virtually anywhere in a hospital/clinic or operated on a mobile cart with a battery back-up. An optional 10-sample removable tray provides serial batch testing for serum, plasma, and urine samples. Prime ES patient results can be easily interfaced to the LIS/HIS with the industry standard POCT 1-A2 connectivity format.
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Mass spectrometry kit for ethyl glucuronide and ethyl sulphate
, /in Product News /by 3wmediaThe new MassChrom kit from Chromsystems allows the reliable determination of EtG and EtS from urine with robustness and precision. The assay is validated according to the guidelines of the GTFCh (Society of Toxicological and Forensic Chemistry) for quality assurance and enables the determination of both parameters with one sample preparation and one single injection with an analysis time of 6 minutes. The straightforward and efficient sample preparation consists of a single pipetting step that includes the instrument-specific dilution. The human-matrix based 6PLUS1 Multilevel Calibrator Set and MassCheck controls ensure precision and accuracy of results. Typically, less than 0.1 % of the consumed ethanol is present as the glucurono- or sulpho-conjugated configuration, which is excreted as ethyl glucuronide (EtG) and ethyl sulphate (EtS), both detectable for a sustained period in comparison to ethanol. Thus, EtG and EtS close the gap between short-term markers (i.e. ethanol itself) and long-term markers such as carbohydrate deficient transferrin (CDT).
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Gastric biomarker test panel
, /in Product News /by 3wmediaLike the previous version, the new (unified) GastroPanel is a quantitative ELISA test panel that measures the blood plasma concentrations of four stomach-specific biomarkers: pepsinogen I (PGI), pepsinogen II (PGII), gastrin-17 (G-17) and Helicobacter pylori IgG antibodies. In the new test version, all four biomarkers are processed under uniform reaction conditions and using common reagents, increasing its acceptance among users, while making the test less labour-intense and reducing the overall processing time. The main indications for use of 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 interpretation algorithm has been revised, and is now based on 8 distinct biomarker profiles, 5 of them reflecting morphological abnormalities and 3 others a functional disorder.
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Compact coagulation analyser
, /in Product News /by 3wmediaThree years after the launch of the STA Compact Max designed for all medium size laboratories, this new version, the STA Compact Max2, uses the STA Coag Expert software which is now totally standardized with the high throughput STA R Max to optimize user-friendliness across multi-site labs. The Stago viscosity-based (mechanical) detection system ensures reliability of results against optical interferences. The robustness of STA Compact Max2 has also been further improved to reduce user maintenance operations. With a new hardware design and improved ergonomics, the STA Compact Max2 optimizes productivity. Innovation is also supported by new software features bringing expertise to every lab: expert rules to standardize patient results validation and extended traceability to meet quality requirements. Extensive walkaway capability and true STAT management to ensure a fast turnaround time are the main features of the STA Compact Max2. Samples and reagents management have additionally been enhanced and streamlined for better efficiency with a new cap piercing module extending sample tubes compatibility. The software also provides more flexibility to manage multiple lots and calibration curves on-board.
The company’s extensive reagents line covers all aspects of hemostasis from routine to the most specialized tests, including a wide range of liquid ready-to-use products, with extended on-board stability, unique pre-calibration feature and a fully barcoded management for increased safety.
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Automated CRP analyser
, /in Product News /by 3wmediaBased on a dual system of nephelometry and turbidimetry test with high sensitivity, the QR-1000 fully automatic CRP analyser utilizes a replaceable laser device and integrated detection system and offers a large detecting range. Testing speed is 60T/Hour and the tests may be run on peripheral whole blood, venous whole blood, serum or plasma samples. The analyser automatically detects the remaining reagent volume and calculates the number of tests available.
All results are shown on the same screen, which can be printed. Conversion of HCT value in whole blood makes result uniform in whole blood and serum. Other features include a 5.6 inch LCD touch screen, an integrated barcode scanner, a 3 RS232C interface for data transmission to an external printer or external barcode scanner and unlimited result storage.
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Clinical chemistry system
, /in Product News /by 3wmediaA compact, affordable and efficient instrument, the SK500 Chemistry System offers a broad menu of high quality SEKURE reagents for the benefit of physicians’ office or hospital laboratory. The SK500 has a throughput of up to 580 tests/hour with ISE, 72 patient sample on-board capability, minimizes the use of water (13L/day) and has 36 onboard assays (+3 ISE) to meet the testing needs of small-to-moderate volume laboratories. A simple and intuitive interface requires minimal training, and utilization of primary tubes and cups allows for easy deployment.
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Anemia panel expanding with soluble transferrin receptor
, /in Product News /by 3wmediaSoluble Transferrin Receptor (sTfR), the latest addition to the Thermo Scientific Indiko analysers system reagent selection, is a state-of-the art solution for anemia monitoring. As sTfR is not an acute phase reactant, like ferritin, it can be used as a reliable anemia marker minimizing interferences when a chronic illness is present or suspected. Ferritin is the preferred test to evaluate stored iron but it may be increased with inflammation or chronic diseases. Anemia is one of the most widespread health problems, affecting one third of the world’s population. It is particularly a disease of children, young women and elderly people that affect the impaired immunological defense and cognitive performance. The fully automated bench-top Indiko and Indiko Plus analysers are CE marked systems offering accuracy and precision for anemia and other clinical and specialty chemistry testing. In addition of sTfR, also Iron, Transferrin and Ferritin are available as easy-to-use system solution. The system reagents are stable liquids providing ease-of-use and cost-effectiveness for small to mid-sized laboratories. They are available in optimized kit sizes to minimize waste.
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Automated and quantitative TSI thyroid assay for Graves’ disease
, /in Product News /by 3wmediaSiemens Healthcare Laboratory Diagnostics has launched the industry’s first automated quantitative thyroid stimulating immunoglobulin (TSI) assay used in the differential diagnosis of Graves’ disease, an autoimmune disorder which affects approximately 32 million people worldwide. The assay is available on the Siemens IMMULITE 2000 and IMMULITE 2000 XPi immunoassay systems. Unlike TRAb (TSH receptor antibody) assays which detect both stimulating and blocking antibodies, the Siemens TSI assay specifically detects only thyroid stimulating antibodies, which are the hallmark of Graves’ disease. This makes the assay highly specific to aid in the disease’s diagnosis. With a clinical sensitivity and specificity of 98.3% and 99.7% respectively, the new Siemens TSI assay offers laboratories a fast, easy, and specific diagnostic tool for the assessment of Graves’ disease. As the first automated quantitative TSI assay on the market, it eliminates the need for manual preparations and long incubation times. Not only does this automated assay streamline lab operations and enhance efficiency, it also delivers results to clinicians much more quickly enabling faster patient diagnosis and initiation of proper treatment. Graves’ disease is the most common form of hyperthyroidism, and is characterized by the presence of TSI, which are found in over 90 percent of patients. TSI mimic the activity of TSH, leading to an elevated production of thyroid hormone. Left untreated, Graves’ disease can lead to miscarriage, birth defects, thyroid eye disease, and can even be life-threatening. Women carry a 10 -20 fold risk of acquiring Graves’ disease compared to men.
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