C315 IDL UBC Rapid

Urinary POC test for bladder cancer

A urinary cytokeratin test (lateral flow) for bladder cancer is now available. Cytokeratin proteins have been implicated as tumour cell activity markers and have demonstrated clinical utility in different epithelial cell carcinomas. UBC® Rapid is a POC test that measures soluble cytokeratin 8/18 fragments in voided urine. It has been showed to increase the detection of new cases of bladder cancer. UBC Rapid can also be used for surveillance after primary surgery and as predictor of recurrence. Studies have shown that the test is a useful adjunct tool to cystoscopy in the evaluation of patients at risk of bladder cancer. The combination UBC® Rapid/OMEGA Reader increases the sensitivity and specificity, making the test a useful marker to identify bladder cancer patients. The UBC® Rapid does not require expert analysis or laboratory time and provides unambiguous results during the patient visit. Its cost is low compared to cytology.
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C317 Coris SurraSeroK SeT2

Rapid test for animal Trypanosomiasis

Surra is a trypanosomiasis caused by Trypanosoma evansi. It is the most widely geographically distributed hemoprotozoan parasite. T. evansi affects domestic animals such as camels, horses, cattles, buffaloes, small ruminants and dogs. It is mechanically transmitted by hemophagus flies, such as tabanus or Stomoxys. Wild animals can act as reservoir hosts. Surra causes severe anemia, edema, various nerological disorders resulting into death of infected animals, and immunodeficiencies leading to increased susceptibility to other diseases or vaccination failure. A serological test provides the most sensitive way to detect the infection, especially in chronic cases, with healthy carriers or when the parasitemia is low. The Surra Sero K-SeT is the first rapid diagnostic test for the detection of antibodies specific to Trypanosoma evansi in animal whole blood or serum. Fast and accurate, it is suitable for laboratories as well as field testing and requires minimal sample handling.

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C316 Diazyme

25-Hydroxy vitamin D assay

In line with current clinical needs, Diazyme’s new 25-Hydroxy Vitamin D Assay measures total true 25-Hydroxy Vitamin D levels (D2 + D3 levels) in both serum and plasma samples. Furthermore, the assay fully automates the removal of non-specific protein binding and cross reactivity that may occur in competing assays, thereby assuring results will be both precise and accurate.  The 25-Hydroxy Vitamin D assay is both fast and flexible with complete testing results in under 2 hours. The test is user-friendly and can be used manually or easily adapted for use on a wide range of fully automated microtitre plate readers, making it suitable for use in laboratories of all sizes and testing needs. Traditionally, testing of Vitamin D levels has been predominantly used for the diagnosis and management of patients with Vitamin D deficiency. Recent clinical studies though have linked Vitamin D deficiency to various diseases including cancers, cardiovascular disease, diabetes, osteoporosis, multiple sclerosis, Alzheimer’s disease and all-cause mortality.  This new understanding of the importance of Vitamin D levels has driven an increase in the number of physician requests for total 25-Hydroxy Vitamin D tests in the United States and worldwide. The assay takes a much shorter time and can be fully automated when it is run on ELISA instruments such as the Dynex DS2® and DSX® platforms.

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C319 BioData

Synthetic liquid collagen

Collagen SRP (Synthetic Reactive Peptide) is a synthetic type 1 collagen-like liquid polypeptide (PHG) that self-assembles into a helix to form fibrils. Synthetic collagen may be useful in laboratories investigating platelet function and reactivity, platelet activation, and cellular analysis. Research laboratories may utilize Collagen SRP to assess aspirin reactivity, detect multiple antiplatelet agents and to investigate metabolized and spiked samples. Collagen SRP will help save time, standardize results and obtain predictable and reproducible results.  It does not contain any human, animal or bacterial source material eliminating infectious disease risk. Collagen SRP is for research use only (RUO) and not for use in diagnostic tests, assays or procedures.

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C318 Euroimmun ELISAstrip

Borrelia ELISA

Two new ELISAs provide highly sensitive and specific screening for Borrelia antibodies in the serological diagnosis of Lyme disease. The Anti-Borrelia Select ELISA (IgG) and the Anti-Borrelia Select ELISA (IgM) are based on unique combinations of highly specific recombinant antigens from different Borrelia species. The IgG ELISA includes VlsE, which is the most important target antigen for the detection of Borrelia-specific IgG antibodies. All antigens contained in the assay substrate have been carefully selected for their diagnostic value and mixed in optimized concentrations to ensure maximum test sensitivity and specificity. Moreover, many of the antigens have been modified by molecular manipulation to boost their diagnostic performance.
The most important component of the IgM ELISA is covalently bound, recombinant dimeric OspC (OspC advanced), which is exclusive to this ELISA. OspC advanced represents the biologically active form of the antigen and provides over 30% higher specificity than traditionally used monomeric forms, while maintaining a high sensitivity. Since antibodies against OspC are produced by 90% of infected persons, inclusion of this optimized antigen significantly enhances the performance of the test in early-stage borreliosis screening.
The ELISAs yield significantly fewer cross reactions than lysate-based tests, for example in patients with autoimmune diseases or other infections such as Treponema pallidum. The inclusion of antigens from different human pathogenic Borrelia species ensures reliable results regardless of the infecting species.
The Anti-Borrelia Select ELISAs are part of a complete package from EUROIMMUN for borreliosis diagnostics, which also includes immunoblots for the confirmatory diagnostic step, indirect immunofluorescence tests, CSF tests, avidity tests and comprehensive automation concepts for all products.

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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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