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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Fully automated on-demand assay for Heparin-Induced Thrombocytopenia
, /in Product News /by 3wmediaInstrumentation 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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POC diagnostic instrument development service
, /in Product News /by 3wmediaThe 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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Immunoassay for the specific detection of hydrocodone
, /in Product News /by 3wmediaA 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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Food-specific IgG determination
, /in Product News /by 3wmediaA 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
, /in Product News /by 3wmediaInnovaStar 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
, /in Product News /by 3wmediaA 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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Compact semi-automated coagulation analyser
, /in Product News /by 3wmediaIn 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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CRP-extended range test kit
, /in Product News /by 3wmediaC-Reactive Protein is an extremely useful parameter to evaluate acute phase episodes as it quickly reflects the reaction of the organism but is also a useful parameter to monitor infectious or inflammatory state. The normal level of CRP is very low but it can increase more than one thousand-fold in a very short time to decrease progressively in the next 72 hours. If CRP doesn’t return to its basal level there is a clear indication that some clinical action is required. As the range of values that CRP may show in a patient is very wide, analytical methods need to optimize their performance in terms of sensitivity at low values and measure range to cover the most common pathological ranges. BioSystems SA is now introducing its new latex immunoturbidimetry kit of CRP-extended range (CRP-er), covering a range from 1,3 to 300 mg/L, with no pro-zone up to 1000 mg/L and no interference from hemoglobin, lipemia or rheumatoid factors. The test uses a five-point calibration curve stable up to 2 months and it is suitable for use in automatic analysers. Standards and controls suitable for extended range are also available.
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Immunodiagnostic HIV combo test
, /in Product News /by 3wmediaOrtho Clinical Diagnostics received CE Mark approval for its VITROS HIV Combo test. An important addition to the company’s infectious disease portfolio, the new test is available for purchase in Europe and other countries that accept CE Mark since June 2016. The VITROS HIV Combo, a fourth-generation assay, detects both HIV-1 and HIV-2 antibodies and the p24 antigen, enabling HIV-1 acute infection detection earlier than third-generation assays. According to estimates by the World Health Organization (WHO), 37 million people worldwide are living with HIV today. Starting antiretroviral treatment as soon as possible after diagnosis can help avert millions of AIDS-related deaths and new infections. According to the U.S. Centers for Disease Control and Prevention, identifying patients in the early stages of infection is crucial. With the launch of the VITROS HIV Combo, test laboratories can provide earlier detection of HIV for the benefit of their patients. An assessment of the clinical and technical performance of the VITROS HIV Combo on VITROS Systems during routine use at two external testing laboratories in Europe and at Ortho’s research and development laboratories confirmed it provides competitive sensitivity and specificity when compared with a leading commercially available fourth-generation test. In the comparison studies, assay sensitivity was evaluated on seroconversion panels — VITROS HIV Combo showed earlier detection of acute HIV infection in five of 34 seroconversion panels (agreement for 28 of 34 panels), indicating that the assay performance is very competitive in shortening the diagnostic window (the time between HIV infection and detection) – a valuable attribute in HIV testing. The assay’s class-leading p24 sensitivity and uncompromised specificity is enhanced by the proprietary technologies and benefits only available on VITROS Systems – Intellicheck Technology with its suite of quality checks (MicroSensor, SMART Metering) and VersaTip technology – a combination that provides laboratories the accuracy needed to have the utmost trust in their results.
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Multiplex Bordetella PCR detection kit
, /in Product News /by 3wmediaPertussis is a very contagious disease which spreads from person to person usually by coughing or sneezing or when spending a lot of time near one another and sharing breathing space. The most important cause for whooping cough (pertussis) is B. pertussis, followed by B. parapertussis. Bordetella holmesii has been isolated from patients with a serious underlying disease. Despite vaccination pertussis remains endemic in most areas of the world. Reliable diagnosis is required to start appropriate treatment, particularly with non-vaccinated infants in whom pertussis might present as a life-threatening disease. The VIASURE Bordetella real time PCR detection kit is designed for the diagnosis of Bordetella pertussis, Bordetella parapertussis and/or Bordetella holmesii in respiratory samples. The real time PCR reaction generates an increased fluorescent signal which is proportional to the DNA target and can be monitored and quantitated. Thanks to its stabilized form, transport and storage of the kits can be performed at room temperature, allowing shipment to anywhere in the world.
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