Nova Biomedical recently announced CE-mark certification for Allegro, a capillary blood analyser for point-of-care testing in primary care settings. Allegro and its StatStrip A companion meter provide 14 clinically important tests to monitor glycemic control, assess cardiac risk with a full lipids panel, and assess kidney function. All results are ready during the patient visit, simplifying clinic workflow and producing cost savings for providers, while offering clinical benefits for patients. All Allegro tests use easy capillary fingerstick sampling and disposable test cartridges or strips. To monitor glycemic control, Allegro provides HbA1c, glucose, and estimated average glucose tests. To assess cardiac risk, Allegro provides total, HDL, non-HDL, and LDL cholesterol tests, cholesterol/HDL ratio, and triglycerides tests. To assess kidney function, Allegro provides urine creatinine, urine albumin, and urine a1bumin/creatinine ratio, and blood creatinine with eGFR tests. Allegro is the only analyser that can measure HbAlc, lipids, glucose, and creatinine from a capillary sample. Its innovative design comprises dual measurement bays, which offers the ability to measure two cartridges simultaneously, doubling throughput and improving efficiency. Allegro’s companion meter wirelessly transmits results to the analyser, where they combine with all cartridge test results for one patient report. All results can be transmitted to electronic medical records for providers to review with patients during the visit. Having immediate results during the patient visit reduces clinic follow-up calls, letters, and patient re-visits, and improves patient satisfaction, compliance with care plans, and outcomes. The analysers’ HbA1c accuracy is certified by the National Glycohemoglobin Standardization program (NGSP), and total cholesterol and HDL cholesterol are certified by the U.S. Centers for Disease Control Cholesterol Reference Method Laboratory Network.
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HA5, a new 5-diff hematology system based on microfluidics, complements Biosystems’ portfolio of products addressed to routine laboratories. Implementing state-of-the-art technology, microfluidics allows reducing reagent consumption up to approximately 75% compared to other analysers on the market. That means not only saving on handling, storage and transportation cost, but also advantages in reagent management as a 400-test single pack contains all the reagents required to perform the analysis, with a weight just slightly over 5kg. HA5 works in closed mode with standard vacuum tubes. Once the tube is loaded, a built-in rotor assures correct homogenization of the sample before proceeding with the analysis, with a throughput of 60 tests/hour. The measuring method uses laser-based flow cytometry with forward-scattered light detection and volumetric impedance; it provides a 26-parameter complete blood cell count report that includes RBC and PLT histograms, as well as a 5-part WBC scattergram. A large full-colour LCD touchscreen with an intuitive interface allows clear and easy operation, including reagent and controls management through QR codes, patient identification through barcode reader, LIS communication and personalized laboratory configuration. The small footprint (283 x 226 x 333 mm) of the instrument allows its installation even in very reduced spaces, making it especially suited for Emergency Departments, ICUs, private clinics, blood banks, or even in mobile care units.

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The SEKURE TPLA (treponemal) and RPR (non-treponemal) reagents are fully automated, quantitative latex immunoturbidimetric assays that may be used as an aid in the diagnosis and treatment monitoring of syphilis. These tests are rapid with a 10 minute protocol, efficient, easy to use, and fully automated making them ideal for screening. TPLA and RPR can be run on any clinical chemistry platform (including the company’s SK500 instrument) allowing for rapid reflex testing of multiple test samples. The tests correlate with traditional methods (TPHA/ RPR Card test) and the RPR test is standardized to the WHO International Standard for Syphilitic Human Serum which will aid in standardizing results. Additionally, the RPR results are quantitative, providing a tool to aid physicians in treating syphilis and monitoring therapy.

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The DxONE information management solutions is an integrated system of technologies and capabilities, designed to ease data access and usability. DxONE is designed in response to the increasing challenges faced by laboratory technicians to expedite result times, reduce costs, manoeuver personnel shortages and navigate network consolidations. The suite of next-generation technologies applies cloud-computing to provide remote-access functionality for an “answers anywhere, anytime” approach to care and laboratory activities. The strategic combination of tools is expected to help laboratories achieve greater operational excellence and efficiency, and empower more confident decision-making. The DxONE suite of information management solutions form a cohesive system of products designed to improve efficiency, give insight into operations throughout an entire network and create a more comprehensive understanding of laboratory performance. DxONE Inventory Manager eases inventory control functions to help laboratories minimize costs, ensure tight turnaround times, track trends and reduce administrative duties through automation and electronic capabilities.  
DxONE Command Central gives personnel the ability to monitor multiple instruments in real-time from a single workstation and aids in counteracting personnel shortages. DxONE Insights streamlines workflow and efficiency by connecting instruments throughout a laboratory network: it provides greater access to actionable cloud-based analytics for closer monitoring of key performance indicators to aid in continuous improvement efforts.

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H-FABP (Heart fatty acid binding protein, FABP3) is a sensitive biomarker for myocardial infarction (MI). H-FABP is released from cardiac myocytes following an ischemic episode and can be detected in the blood within one to three hours of chest pain onset. To identify myocardial infarction and acute coronary syndrome, a combination of H-FABP with troponin shows increased sensitivity over troponin alone in patients with chest pain onset. H-FABP also has prognostic value, as it is proved to be a statistically significant predictor of death or MI, independent of troponin T, ECG and clinical examination. The FABP3 assay has been validated for human serum, plasma, urine, cerebrospinal fluid, bronchoalveolar lavage fluid, amniotic fluid and tissue homogenates and has a very high sensitivity (LOD 5.6 pg/ml). H-FABP is a small cytosolic protein expressed predominantly in the cardiac myocytes; it is found at much lower levels in skeletal muscle, kidney, liver and small intestine. H-FABP can quickly pass through the kidney and be measured noninvasively in urine.

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