C231 Euroimmun CROP 01

Differential diagnosis of arbovirus infections

Serological tests for Zika virus (ZIKV), dengue virus (DENV) and chikungunya virus (CHIKV) allow differential diagnosis of infections, especially beyond the short viremic phase when direct detection is no longer effective. These infections are difficult to tell apart clinically, as they manifest with similar symptoms and are endemic in much the same regions. Antibodies against DENV, ZIKV and CHIKV are detectable from around day four to seven after symptom onset. Primary infections are characterized by the occurrence of IgM antibodies, with IgG appearing shortly afterwards. In a secondary flavivirus infection, IgM may be delayed, of reduced intensity or not detectable at all. In these cases a significant increase in the IgG concentration is indicative of an active infection.
ZIKV antibodies can be detected specifically using ELISA based on recombinant ZIKV NS1 protein. This highly specific antigen avoids cross-reactivity with other flavivirus antibodies which may be present from previous infections or vaccinations, e.g. DENV, West Nile, yellow fever, tick-borne encephalitis and Japanese encephalitis viruses. A combination of Anti-ZIKV IgM and IgG ELISA provides an overall sensitivity of 97% at a specificity of 100%. In DENV infections, detection of the highly specific early antigen NS1 by ELISA serves as a first-line screening test in both acute primary infections and re-infections with another DENV serotype. Antibodies against DENV serotypes 1 to 4 are detected using ELISA based on highly purified virus particles, while CHIKV antibodies are determined using ELISA based on a virus-specific structural protein.
Indirect immunofluorescence tests (IIFT) with virus-infected cells are also suitable for detection of DENV, ZIKV and CHIKV antibodies. However, cross reactions between flavivirus antibodies should be taken into account. Arbovirus BIOCHIP mosaics combine different substrates in one test field and aid clarification of cross reactivities, supporting differential diagnosis.

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C236 Siemens CROP 01

Mid-volume coagulation analyser

Siemens Healthineers Laboratory Diagnostics business launches the Sysmex CS-2500 System—a mid-volume, fully-automated coagulation analyser with smartly-designed PSI technology—in major markets including the U.S. The launch of the new Sysmex CS-2500 System will enable mid-volume laboratories to leverage globally-proven PSI technology, while providing regional reference laboratories and integrated delivery networks (IDNs) with the ability to standardize testing results across multiple Sysmex CS and CA hemostasis systems. Labs today are challenged to increase their output without sacrificing the accuracy or reliability of their results. The increased operational efficiency and uninterrupted workflow delivered by the Sysmex CS-5100 and CS-2500 Systems provide customers with the confidence, consistency and increased capacity they need to deliver timely and accurate hemostasis test results.
In most markets (but not in all countries), the Sysmex CS-2500 System features simultaneous multiwavelength scanning and proven PSI technologies including primary-tube sample-volume checks, clog detection, assay-based preanalytical sample-quality checks for hemolysis, icterus and lipemia (HIL) interference; automated mixing studies; automated platelet aggregation; and clot waveform analysis (CWA) – enabling labs to raise the quality of test results, achieve cost-effective method consolidation, simplify operations, and increase diagnostic confidence.The new system enhances efficiency via a wide optical spectrum, which allows clotting, chromogenic, immunologic and aggregation testing capabilities on a single platform. With an onboard capacity of up to 3,000 tests and up to 40 reagents, the Sysmex CS-2500 System delivers extended walkaway time to streamline workflow.To help labs ensure consistency and improve productivity, the systems use the same reagents, controls and calibrators as other coagulation analysers offered by Siemens Healthineers.
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Siemens Healthineers unveils highly innovative clinical chemistry and immunoassay system

Siemens Healthineers unveiled the Atellica™ Solution, a highly flexible immunoassay and clinical chemistry solution featuring patented bi-directional magnetic sample-transport technology that is 10 times faster than conventional conveyors. “We engineered the Atellica Solution based on our customers’ needs and extensive research of market trends,” said Franz Walt, President, Laboratory Diagnostics, Siemens Healthineers. “The result is a game-changer that delivers control and simplicity, so our customers can focus on driving better business and clinical outcomes and spend less time managing operations.”                                                                             
In addition to the speed afforded by the Atellica Magline™ Transport technology, the Atellica Solution offers a multi-camera vision system and intelligent sample routing for independent control over every sample from routines to STATs.
The Atellica Solution provides unprecedented flexibility to adapt to growing testing needs and space constraints. The solution can be used as a stand-alone system, is scalable up to 10 components and can be combined into more than 300 customizable configurations, including L-shaped, U-shaped, and linear formations. It can also be connected to Aptio® Automation for a comprehensive multidisciplinary solution. The system can handle more than 30 sample container types including pediatric and special containers.
Further, the same reagents can be used across configurations and locations, simplifying laboratory operations, streamlining inventory control, and enabling consistent testing results. Additionally, a single immunoassay analyser processes more than 400 tests per hour, delivering the highest productivity per square meter in the industry.
Other benefits of the Atellica Solution include remote-access monitoring and control to maximize uptime, and a broad, expanding assay menu using proven detection technologies.
The Atellica Solution is the first in a new line of Atellica products.
The products are under FDA review, and not available for sale at this point.  

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C240 Instrumentation lab crop 01

Fully automated on-demand assay for Heparin-Induced Thrombocytopenia

Instrumentation Laboratory has received FDA clearance for the HemosIL HIT-Ab(PF4-H) assay for use on ACL TOP® Family Hemostasis Testing Systems.  The first, fully automated, on-demand assay for Heparin-Induced Thrombocytopenia (HIT) on a hemostasis testing system, HemosIL HIT-Ab(PF4-H) detects antibodies associated with HIT.   HIT is a severe immunologic adverse reaction to a heparin complex that paradoxically causes blood clots to form, leading to venous and/or arterial thrombosis, and can be fatal.  Diagnosis of HIT is key to positive patient outcomes and may prompt initiation of alternative anticoagulants.  Unlike existing manual processes, HemosIL HIT-Ab(PF4-H) is a liquid, ready-to-use immunoassay that delivers results in minutes—on-demand, 24/7—allowing clinicians to make timely, well-informed therapeutic decisions, essential in critical scenarios.  Management of HIT involves cessation of heparin therapy and initiation of expensive alternative anticoagulants.  Delays in diagnosis caused by prolonged test turnaround time can lead to speculative treatment, increasing bleeding risk for the patient and increasing drug costs, if replacement anticoagulant therapy is used unnecessarily.  Conversely, if patients with HIT remain on heparin while awaiting laboratory confirmation of diagnosis, they may develop more serious complications leading to increased morbidity and mortality.  Therefore, the availability of on-demand HIT antibody testing plays a critical role in better managing HIT, providing results when treatment decisions are needed, and ultimately minimizing patient risk and reducing costs.

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C239 ttp 01

POC diagnostic instrument development service

The Technology Partnership plc (TTP), announced the launch of Desktop Biology™, a new service that will enable point-of-care diagnostic providers to rapidly convert their biological assay into a market-ready system capable of producing a result in as little as 15 minutes. The new service provides an accessible and rapid route to market, offering a seamless approach for companies looking to accelerate the development of their assay to a product for use in diagnostics or research. Made possible with TTP’s expertise in regulated environments and fast track system development, this advance will enable rapid translation of a customer’s biology to a product on the market. Key to this service is the ability for TTP’s team to understand the fundamental steps required to convert lab-based biological processes (for example, sample preparation, labelling and assay measurement) to a functional low-cost disposable and small instrument. Users of the Desktop Biology service will have the opportunity to benefit from TTP’s in-house platforms and technologies, that have been designed to translate complex biological assays into low-cost, disposable consumables. For example, one platform enables open-access biology and liquid handling for 30 μL to 2 mL volumes, while another is purpose-built for dealing with complex processes such as small liquid volumes in the range of 10 μL to 200 μL whilst maintaining a low disposable cost. Desktop Biology customers will also have access to TTP’s novel IP that has been especially developed to address some of the key challenges in the biological arena. This includes technologies that provide benefits for a number of assay steps, including biological and cellular deposition, methods for the rapid lysing of high sample volumes, high speed thermocycling, optical and electronic detection systems, and unique low profile and nonpulsatile pumps for highly controlled liquid movement.

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C250 Thermo 01

Immunoassay for the specific detection of hydrocodone

A new immunoassay for the specific detection of hydrocodone has received 510 (k) clearance from the U.S. Food and Drug Administration (FDA). The DRI Hydrocodone Assay is a homogeneous enzyme immunoassay featuring requisite sensitivities that meet the newly proposed Substance Abuse and Mental Health Administration (SAMHSA) guidelines using a 300 ng/mL cut-off. SAMHSA oversees the testing of federally regulated employees and many organizations follow the guidelines set forth by this agency. The DRI Hydrocodone Assay has excellent cross-reactivity to the major metabolites hydromorphone and hydromorphoneglucuronide and utilizes liquid, readyto- use reagents, which can be run in both qualitative and semi-quantitative modes. Calibrators and controls are sold separately. In addition, the assay demonstrates good correlation with LC-MS/MS and has excellent specificity and sensitivity, making it an easy-to-use screening tool for hydrocodone in urine samples with applications for a variety of clinical chemistry analysers. Some of the traditional general opiate immunoassays used to screen for hydrocodone and its metabolites may have given inaccurate results when using the opiate calibrators and controls, per the intended use. As such, they did not have the sensitivities required to meet the proposed SAMHSA guidelines whereas this new assay does. Hydrocodone, a semi-synthetic opioid, is an antitussive (cough suppressant) and narcotic analgesic agent for the treatment of moderate to severe pain. Hydrocodone is considered to be one of the most frequently prescribed and misused opiate drugs in the U.S. There are several hundred brand names and generic combinations of hydrocodone products available on the market today.
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C243 Euroimmun 01

Food-specific IgG determination

A new range of immunoblot profiles allows determination of IgG antibodies against foods and food additives in patient serum samples. Testing for IgG antibodies can help to establish if a food intolerance is behind chronic symptoms such as diarrhea, constipation, bloating, nausea, migraine, asthma, eczema, arthritis or fatigue. If high concentrations of IgG antibodies against a particularly food are identified, elimination of the offending substance from the diet may help to relieve symptoms. The EUROLINE profiles include 108 or 216 foods and food additives, grouped into the categories gluten- containing cereals, gluten-free cereals and alternative foods, meats, dairy and egg, fruits, herbs and spices, nuts and seeds, vegetables, legumes, salads, mushrooms, fish and seafood and other foodstuffs such as yeasts, honey, coffee and black tea. Only small volumes of patient serum are required for the analysis, just 40 μl for 108 results. Results are evaluated semiquantitatively using four calibrators corresponding to the WHO reference serum 1st IRP 67/86. IgG-mediated food intolerance results from increased permeability of the intestinal wall, the so-called leaky gut syndrome. Food components pass into the bloodstream, inducing the production of IgG antibodies and the formation of immune complexes. The complexes are deposited in tissues, leading to inflammation and aggravation of existing conditions. Symptoms of food intolerance occur hours to days after ingestion of the food and can manifest in the entire body, not just the gastrointestinal tract. The relevant IgG subclasses in chronic inflammatory processes are IgG1, IgG2 and IgG3, whereas IgG4 plays a role in classic IgE-mediated allergies.
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Automated POCT analyser

InnovaStar is an automatic compact POCT analyser for the daily practice that delivers result quality comparable to laboratory analysers for HbA1c, CRP, glucose and hemoglobin directly from a single 10 μl whole blood sample. The complete measurement procedure, including a sample individual hematocrit correction, is performed automatically thus reducing any handling errors. The newly integrated 2.8” colour touch-screen further improves the ease of use of the instrument, enabling the operator to enter any information such as patient data, user identification etc. The new graphical user interface allows a more efficient access to all soft ware functions and displays on-screen instructions where required. The up-to-date soft ware uses self-explanatory icons for a nearly languageindependent operation of the instrument.
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Human neudesin ELISA kit

A human neudesin ELISA has been developed and validated by BioVendor to measure circulating neudesin levels. Neudesin plays roles in neural functions, energy metabolism, and tumourigenesis and is considered to be a novel target for obesity and cancer treatments. Human neudesin (neuron-derived neurotrophic factor) is a unique secreted protein with a conserved cytochrome 5-like heme/steroid-binding domain belonging to the MAPR (membrane- associated progesterone receptor) family with multiple roles. Neudesin is expressed in the mouse embryonic cerebral cortex and the neural precursor cells where it significantly promotes neural cell differentiation and also transiently promotes neural cell proliferation during the early stages of development. Neudesin is also abundantly expressed in white adipose tissue of adult mice and also in hypothalamic nuclei that regulate food intake. The appetite-suppressing effect of neudesin was abrogated in obese mice fed a high-fat diet, demonstrating a diet-dependent modulation of neudesin function. Neudesin knockout mice were resistant to high-fat diet (HFD)-induced obesity due to elevated systemic sympathetic activity, heat production, and adipocytic lipolysis. Finally, neudesin is over-expressed in multiple human cancers including carcinoma of the breast, colon, lung, uterine cervix, skin and malignant lymphoma. The tumourigenesis mechanism involving neudesin might be mediated by activation via the mitogen-activated protein kinase (MAPK) and phosphatidylinositol 3-kinase (PI3K) pathways.
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C248 Stago crop 01

Compact semi-automated coagulation analyser

In addition to a new design in line with the Max Generation, the STart Max has also been enhanced in terms of functionality and practicality. This small semiautomated instrument is comparable to the larger models with new quality control and calibration menus, and a large colour touchscreen benefitting from the standardized “Max Generation” graphical user interface. Features include an effective traceability, the ability to archive patient results, quality controls, reagent lots, and a modern connectivity (to LIS and/or STA Coag Expert, with a USB port and the possibility to connect a handheld barcode reader). Its design as a “drop” shape is reminiscent of Stago logos, but it has also been devised to improve user comfort thanks for example to the configuration of the incubation and measuring positions, the reagents and pipette, and the tilted display. Combining modernity and simplicity, these semi-automated analysers can therefore be found in labs of various sizes which use the instrument with small volume of coagulation tests or as back-up of larger Max Generation instruments. But they can also present some special interest for fully automated optical systems, which may sometimes need an alternative method for their problematic samples.
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