C320 AniBiotech

RT-PCR tests and B. pertussis PT IgG EIA

Real-Time (quantitative) PCR assays for Chlamydia pneumonia and Mycoplasma pneumoniae  allow rapid and accurate detection of these pathogens in less than an hour run time and  with <10 copies sensitivity. There will be separate kits as well as a multiplex kit for simultaneous detection of the 2 bacteria in a single tube reaction. Detection of a genomic DNA target is included in all kits as an internal control for sample validity, extraction and amplification.  A separate positive control is included as well. These assays are adaptable to most Real-Time PCR instruments with commonly used fluorescence channels.  Bordetella pertussis & B. parapertussis RT-PCR kits are in the pipeline.
The new Bordetella pertussis IgG EIA assay, which uses pertussis toxin (PT) as antigen, as recommended in the European ECDC guidelines, and is calibrated against the international standard, complete the company’s respiratory panel, now totalling 10 different EIA kits for Mycoplasma pneumoniae, Chlamydia pneumoniae and B. pertussis.

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C321 TrinityBiotech

Rapid detection of enteric pathogens

Cryptosporidium and Giardia are the first two products in the Uni-Gold Enterics Rapids range of single use immunoassays for the qualitative detection of pathogenic antigens. The Uni-Gold Cryptosporidium and Uni-Gold Giardia are both CE marked tests. They feature an even more rapid and simple sample preparation, convenient storage and a 4-step device procedure, giving accurate results within 15 minutes. Developed for easy and accurate detection of enteric pathogens, the Uni-Gold rapids provide convenience and high quality.  

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Early embryo viability assessment

The Early Embryo Viability Assessment (Eeva) test is designed to improve in vitro fertilization (IVF) outcomes by providing clinicians and patients with objective information that will enable them to predict embryo viability with a new level of accuracy. Eeva uses intelligent computer vision software to measure key scientifically and clinically validated cell-division parameters from video images. It predicts with high accuracy at the cleavage stage which embryos will likely grow to the blastocyst stage, a critical milestone in embryo development. Until now, the field of reproductive medicine has been using subjective observation to determine embryo viability. With the commercial launch of Eeva, IVF clinics and their patients will now have access to a noninvasive test that delivers consistent, objective and actionable information to help identify viable embryos and determine which ones offer the greatest potential for transfer. The safety and efficacy of Eeva were validated in a prospective, multi-centre, 160-patient clinical trial, results of which were presented in July 2012 at the European Society of Human Reproduction and Embryology (ESHRE) Annual Meeting in Istanbul, Turkey. In the study, Eeva was able to predict blastocyst formation at the cleavage stage with 85% specificity, reducing the false positive rate from 43% to 15% compared with traditional morphology selection. Eeva also demonstrated the ability to track and analyse cell division timings with greater than 90% accuracy. Additionally, Eeva was able to increase the consistency of embryo assessment across embryologists. Eeva provides early results that allow for timely decision-making. During the IVF cycle, there is a checkpoint on Day 3 in which clinicians make decisions about whether to transfer embryos. Eeva provides information about embryo viability as early as Day 3, allowing clinicians to select a viable embryo in a timely manner, thereby increasing the likelihood of a successful patient outcome. Eeva consists of the Eeva Dish, which contains microwells enabling the tracking of the individual development of each embryo and allowing embryos to grow under group culture technique; the Eeva Scope that fits into most standard IVF incubators and provides automatic dark-field image capture and cell-division tracking without intervention by the embryologist or excessive light exposure to the embryos; the Eeva Scope Screen that fits on the outside of the incubator and allows the embryologist to control each patient session and view the latest images without opening the incubator or disturbing the embryos; the Eeva Station where images and videos for each Eeva patient session can be easily reviewed. The downloadable reports and videos may aid when counseling patients and improve the overall patient experience. Eeva is currently approved and available for use in the EU with the first installation at the Hewitt Fertility Centre in Liverpool.  

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C322 DiaSorin

Molecular analyser

The new Liaison Iam molecular diagnostic platform utilizes proprietary Q-LAMP technology. Q-LAMP has been developed to offer all the benefits of isothermal LAMP technology whilst adding the benefits of real time, fluorescent, multiplexed amplification as well as single tube RNA amplification. The Liaison Iam instrument is a small benchtop unit which is connected to the Iam Control Unit (ICU) via a USB interface. The ICU runs proprietary, simple to use software in which a graphical user interface (GUI) guides the operator through a series of simple setup steps. Up to six instruments can be connected to a single ICU, making the Liaison Iam perfect for laboratories who may start with a small number of tests and add units as their workload or test portfolio grows. Liaison Iam running DiaSorin Q-LAMP assays offers a viable alternative to PCR in decentralized laboratory settings.

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C337 Beckman DxH 600

Benchtop hematology analyser

Building on the company’s proven cellular analysis technology, Beckman Coulter’s new UniCel DxH 600 Coulter cellular analysis system — complete with recently FDA-cleared advanced soft ware — provides laboratories with exceptional quality results, improved first-pass accuracy and automatic rerun and reflex testing, thereby reducing overall manual review rates and processes. The hematology laboratory’s single most important step, and most time consuming, is the manual review. By reducing manual differential rates, the new analyser frees mid- to high-volume labs to focus time on quickly and accurately reporting patient results. The UniCel DxH 600 is equipped with robust soft ware that provides new features, enhancements and research-use parameters to improve laboratory efficiency, reliability and quality. The soft – ware saves time by allowing labs to partially release patient results manually or automatically via decision rules and offers users the ability to create and edit decision rules during instrument operation; pre-defined decision rules are offered using Cell Population Data (for research use only). Additional features of the soft ware include the ability to track workload by the day, hour and test, as well as providing automatic notification of STAT samples that have not been processed or released within an expected time frame, helping users to report STAT results in a timely and efficient manner.
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C323 ThermoNEW Reagent bottle

Soluble transferrin receptor added to reagent line

Thermo Scientific™ system reagents are specifically developed and optimized for Indiko™ and Konelab™, random access clinical chemistry analyzers. Over 70 ready-to-go reagents mean ease of use, saving operator’s time and minimizing risk of errors. Reagent vessels are bar-coded so that reagent consumption and expiry date can be automatically monitored in real-time. Volume optimized kit sizes and on-board stability minimizes the amount of waste increasing cost-efficiency. The latest addition to Konelab specific protein system reagents is soluble transferrin receptor (sTfR). Method used is latex enhanced immunoturdimetry measured at 575 nm. The kit size is up to 200 tests. The application is CE marked and tested with system calibration set and quality controls. Fully validated and tested application protocols deliver confidence in testing accuracy and precision. Fully automated Indiko and Konelab platforms cover various testing needs ranging from routine clinical chemistry into immunoassays for drugs of abuse screening, therapeutic and immunosuppressant drug monitoring.
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C330 Partec CyFlowCube6 300dpi CMYK

Laser flow cytometer

The novel CyFlow Cube 6 2-laser flow cytometer (488nm, 638nm) has the capacity to detect four colours (plus FSC / SSC) and shows superior performance specifications, with its high sensitivity and a perfect resolution for the determination of small signal differences. Besides those superior specifications the instrument offers a small footprint, an attractive design, an easy operation procedure and a particularly competitive price. The Cube 6 instrument is perfect for all fields of research-oriented or routine applications. The performance characteristics make it a valuable and reliable tool for high-end research applications. The robustness and the well-designed operation concept, which is optimized for high sample throughput, will simplify any application in daily laboratory routine. The CyFlow Cube 6 now makes it possible to perform cell-based assays (immune staining, cell viability, apoptosis, etc.) in seconds at an instrument price far below comparable instruments.
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C329 Biovendor

Allograft inflammatory factor 1 ELISA

Designed for the measurement of AIF-1 in human serum and plasma, the innovative AIF-1 ELISA is suitable for the determination of a novel biomarker relevant particularly to the risk of transplant rejection or vasculopathy and graft versus host disease. Allograft inflammatory factor-1 (AIF-1) is an interferon gamma-inducible cytoplasmic protein constitutively expressed in inflammatory cells and inducible in vascular smooth muscle cells in response to injury or inflammatory stimuli, including rejection or balloon angioplasty. Its expression correlates with cardiac rejection and the development of cardiac allograft vasculopathy. AIF-1 expression levels and protein concentrations were also studied in atherosclerosis, nephritis, arthritis, breast cancer and others. The BioVendor assay meets all the requirements for the routine clinical use in manual manner as well as on open ELISA robotic systems.
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C328 SeraCare

Seroconversion panels for hepatitis B and HIV

Three new seroconversion panels provide difficult- to-find patient samples for Hepatitis B and HIV and have been tested on today’s market-leading assays. Each panel represents a single donor and demonstrates how that donor’s blood converts in the presence of the disease during the sample collection period, presenting a unique challenge to the assay. Each product’s data sheet provides a graphical depiction of the donor’s seroconversion, along with comparative data that enables customers to review their test results against the results of other industry assays. HBV Seroconversion Panel (PHM938) comprises six undiluted plasma samples from a single donor drawn over a six-day period and is HBV DNA positive from the first bleed. HBV Seroconversion Panel (PHM939) provides five undiluted plasma samples from a single donor drawn over a 21-day period and is also HBV DNA positive from the first bleed. These panels allow for challenging members for HBsAg assays and HBeAg assays, delivering results for both rapid and qualitative HBsAg methods. HIV-1 Seroconversion Panel (PRB978) provides seven undiluted plasma samples from a single donor and is designed to challenge HIV RNA positive members on traditional antibody methods.
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C331 BioRad Dx combo

Automated system for molecular diagnostics

The Dx Prep System and Dx Real-Time System combine high quality nucleic acid extraction (magnetic beads), PCR set up, and advanced multiplex realtime PCR. This CE-IVD automation offers a flexible batch size of up to 96 tests without tip or reagent overconsumption, a full traceability of samples and reagents and a complete process monitoring from sample to result. With their intuitive user interface, ergonomic design and minimal maintenance, the Dx Systems can easily be implemented in any laboratory. With this automation, Bio-Rad introduces the Dx CT/ NG/MG Auto Assay and the Dx HR-HPV Auto Assay, designed to offer excellent performance, full-control process and minimal hands-on time with their ready-to-use reagents. The availability of the open channel on the Dx Real-Time System further extends the range of applications.
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