Specific IgE antibodies against inhalation allergens that commonly occur in Southern Europe can be detected and differentiated using the new multiparameter immunoblot EUROLINE DPA-Dx Pollen Southern Europe 1 based on defined partial allergens (DPA, allergen components). The detailed profile identifies the precise allergy-causing proteins, distinguishing primary sensitizations from cross reactions and thus aiding therapy decision-making. The test is based on a unique combination of species-specific marker molecules, cross-reactive components and whole extracts, encompassing tree pollens (birch, olive, cypress, hazel, oak), grass pollens (timothy grass, wall pellitory) and the fungus Alternaria alternata. The native extracts provide a general screening for IgE antibodies against the respective pollen/fungus. Combination of the Southern European species-specific marker molecules (e.g. nCup a 1, rOle e 1 and rPar j 2) together with common panallergens (e.g. PR-10 proteins and profilin) enables precise discrimination between a putative primary sensitization and a persistent cross reaction. Positive reactions with species-specific markers are an indication for specific immunotherapy. Positive reactions with panallergens on the other hand indicate cross reactions. Cross-reactive molecules are prevalent among different types of plants, which often results in a high sensitization rate.  An insufficient differentiation between primary sensitization and cross reactions often results in a less effective desensitization during specific immunotherapy. The test also includes a band of cross-reactive carbohydrate determinants (CCD), which aids the differentiation of clinically relevant reactions from unspecific anti-CCD reactions and thus the interpretation of results. With this in-depth profile, true sensitizations can be reliably identified, enabling targeted selection of the most suitable specific immunotherapy and improved prognosis of the therapy success. The test is easy to perform and requires only a small sample volume. The high analytical and clinical value of the profile has been verified in an independent study (publications in preparation). A further large-scale international multicentre study is currently in progress (www.ait2020.com). Automated processing and evaluation are available for the assay.
The new profile is part of the established EUROLINE Allergy range, which encompasses a comprehensive portfolio of component- and extract-based profiles for the diagnosis of food, inhalation and insect venom allergies.

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Beckman Coulter Diagnostics has announced achievement of CE Mark of its DxH 520 hematology analyser, designed to help physician office laboratories deliver high-quality results with increased productivity and ease. With as little as two environmentally friendly reagents, the compact 5-part differential system enhances efficiency and resource management through a comprehensive feature set that automates daily tasks. This reduces the amount of time spent on laboratory operations and frees time for patient care. The company used its time-proven flagship DxH 800 hematology solution as the predicate method for the DxH 520 system, establishing a strong correlation throughout the entire DxH line of hematology analysers. This provides a high level of continuity of care for clinical laboratories, regardless of whether they are small- or high-volume facilities. The DxH 520 analyser fills a need for a comprehensive solution that increases productivity while driving down costs for physician office laboratories. It features proprietary dynamic-gating method that improves sample flagging, and reduces slide reviews and technical interpretation, while maintaining effective clinical sensitivity. As an upgrade from a 3-part to a 5-part differential instrument, the DxH 520 analyser gives the clinician more information by which to make decisions when assessing a patient. A robust IT and data-management package helps reduce clerical errors and inefficiencies, and allows for easy retrieval of up to 30,000 patient samples. The system’s small 17 µL aspiration is ideal for puncture samples from infants, geriatric, oncology and critical care patients. Closed tube aspiration capability both simplifies analysis and ensures safety for laboratory technologists by eliminating sample exposure. The easy-to-use interface enables technologists to access any screen in three clicks or less, saving valuable time. The system’s two reagents and on-board cleaner can be replaced in five minutes or less, and its aqueous-based cyanide-, azide- and formaldehyde-free reagents eliminates disposal costs. This is in contrast to competitive systems that use five or more reagents— many of which are primarily composed of organic solvents that require additional costly disposal fees. The analyser’s low-energy requirements – half the power demand of other analysers in its category – further lower operating costs.

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Fluid Metering, Inc.(FMI) introduces their new 400 μl dispensing pump ideal for medical, analytical and biotech Instrumentation. Having the identical compact design dimensions as their STH & STF OEM pump lines, the STF1-9 expands dispense and metering capabilities of previous STH designs by 100% while maintaining 0.5% precision. The STF1-9 is available in nine drive configurations ranging from 200 μl through 400 μl in 50 μl increments. Each drive model (STF1, STF2 … STF9) has an adjustable displacement of ±25 μl. A supplied adjustment tool rotates an eccentric bushing to precisely make micro-volume adjustments. There are also four standard pump head options available to provide a fluid path with maximum chemical and dispense volume/ flow rate compatibility. Fluid Metering’s STF1-9 utilizes FMI’s CeramPump valveless fluid transfer technology. One moving part accomplishes both the pumping and valveless functions within the pump, thereby eliminating valves present in other reciprocating pump designs. Sapphire- hard ceramic internal components are both chemically inert and dimensionally stable, resulting in a pump that will transfer fluid, in micro-volume amounts, at a precision of 0.5% or better for millions of maintenance-free cycles.
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Shimadzu’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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European 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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