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Archive for category: Product News

Product News

Unique manual on major components to IVD development

, 26 August 2020/in Product News /by 3wmedia

Does your company have an idea for a novel biomarker test, but you’re unsure what the market potential will be?
Have you invented a more sensitive test to diagnose a common autoimmune disorder, but you’re unsure of which regulatory pathway to pursue?
 
The process of developing a successful in vitro diagnostic (IVD) relies on the expertise of a diverse group of individuals, including the scientists who identify the biomarkers of significance, engineers and assay developers who translate those ideas into a tangible product, and the sales and marketing staff who get the product into the market.

This unique manual will provide an overview of the major components to IVD development, from product conception through commercialization, and important considerations about individual aspects of the process including:

  • How do I approach the regulatory process?
  • How can I plan for market access, and what can I do to make sure my IVD will be reimbursed?                          

To learn more about this manual, please click here
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C272 Randox crop

Upgraded online QC software

, 26 August 2020/in Product News /by 3wmedia
Following the successful launch of version 1.6, including new features like the automatic calculation of Sigma Metrics and Measurement Uncertainty, Randox Quality Control are announcing the launch of Acusera 24.7 Live Online Version 2.0.  Following extensive development based on customer feedback, Acusera 24.7 Live Online 2.0 is faster, with a simplified user interface and an enhanced user experience. In addition to the range of features offered in earlier versions, including QC multi-rules, interactive charts and the unique dashboard interface, the following new features have been added to the Acusera 24.7 Live Online software to speed up the review process and provide at-a-glance performance assessment:  
Peer data is updated instantly allowing real-time peer comparison, faster troubleshooting and identification of trends. Levey-Jennings charts now have even more functionality with the ability to add events such as calibration and reagent lot changes for advanced review of trends. The new user interface is faster and easier to use, enhancing user experience. Bi-directional communication with LIMS, new to Acusera 24.7 Connect, is now possible.  A new histogram chart provides a quick visualization of any test system bias.  Acusera 24.7 Connect and EDI is 100 times faster at importing QC results to the software, increasing efficiency in the lab. A new Exception Report provides a count of the number of results for a given time period that exceed 2SD, allowing corrective action to be taken.  Support for multiple devices based on responsive design that will scale to fit any platform including mobile, tablet and PC is also featured. Users can create a custom configuration that can be shared across other instruments in their lab and also other labs in their group, speeding up the configuration process for lab chains.  Performance limits, QC multi-rules and peer groups may now be customized depending on user preferences for each different analyte, instrument or lot of control. 

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C243 Euroimmun 01

Food-specific IgG determination

, 26 August 2020/in Product News /by 3wmedia

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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C326 binding site

Comprehensive offering of disease state sera

, 26 August 2020/in Product News /by 3wmedia

Binding Site’s Immunologicals Group features a comprehensive offering of disease state sera in its broad portfolio of products available to in-vitro diagnostic (IVD) manufacturers and clinical/life science research facilities. The availability of these essential, but frequently overlooked constituent products, will benefit the needs of many allied health professionals, as both their sourcing and availability have been historically problematic.
Following all current regulatory and quality standards guidelines, the company is able to provide materials from a wide variety of disease state conditions – including ANA’s; ANCA’s; aPL’s; ENA’s; infectious/contagious diseases; inflammation markers; and auto-antibodies focused on a variety of human organs and tissues.  All of these materials are available in bulk formats with volumes ranging in excess of litres for use in the manufacturing of calibration and/or quality control materials. Smaller volumes may be available upon request. In addition, as the primary source supplier of these products, the company can offer comprehensive data on analyte-positive as well as negative data, along with a comprehensive Certificate of Analysis.

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DAS Drl AP22 IF BLOT ELITE portataniche

Immunochemistry processor

, 26 August 2020/in Product News /by 3wmedia

AP22 IF BLOT ELITE is a fully automated system for ELISA, IFA and BLOT methods. The instrument is able to run 2 ELISA microplates with 8 tests on line, 16 IFA slides or  24 blot strips,  starting from the sample dilution and dispensing, reagent dispensing, incubation , washing through to dot imaging processing with assessment for each strip; the software provides the data record and patient report.

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C235 Integra latest 01

Manual pipettes

, 26 August 2020/in Product News /by 3wmedia

Unlike traditional pipettes which utilize a single rotating plunger to set volumes, the new EVOLVE manual pipette range from INTEGRA features an innovative approach that allows users to set volumes more than ten times faster. Available in single, eight and twelve channel formats, covering a volume range of 0.2 – 5,000 ?l, the ultralightweight, well balanced design of the EVOLVE enhances productivity and comfort even during prolonged pipetting sessions.
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C319 Dynex crop

High throughput automated ELISA system

, 26 August 2020/in Product News /by 3wmedia

Based on an intelligent design and featuring SmartKit reagent loading technology, the Agility automated ELISA system emphasizes simplicity with an extremely intuitive, easy-to-use interface that enables effortless navigation. The system supports several major error-proofing advances, including a comprehensive monitoring system to measure consumable levels and extensive bar coding to eliminate manual data entry. The use of innovative direct-load reagent SmartKits streamlines front-end preparation and minimizes hands-on reagent loading, significantly reducing overall assay times and providing full walk-away freedom. Up to 16 SmartKits and 12 plates can be stored on-board for simultaneous runs. The system utilizes three precision robotic arms – one for sample pipetting, one for reagent pipetting and another for transporting plates and consumables – to obtain maximum process efficiency and unparalleled precision while eliminating nearly all manual steps and reducing the potential for human error. The Agility ELISA system combines ingenious design, total automation and an innovative approach to reagent loading that boosts productivity and minimizes hands-on time.

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C285 DIAsource toxo 1

ToRCH ELISA assays

, 26 August 2020/in Product News /by 3wmedia

DIAsource ImmunoAssays has announced the CE-IVD certification of 6 parameters of the ToRCH panel: Toxoplasma IgG Elisa # KAPDTOXOG; Toxoplasma IgM Elisa # KAPDTOXOM; CMV IgG Elisa # KAPDCMVG; CMV IgM Elisa # KAPDCMVM; Rubella IgG Elisa # KAPDRUBG; Rubella IgM Elisa # KAPDRUBM. The new assays have a common protocol (only 10µl of sample required) which allows their easy adaptation to most of the common automated ELISA platforms e.g. Stratec Gemini. The “IgG Elisa” are quantitative assays and include one control. The “IgM Elisa” are based on the IgM µ-capture technique, are qualitative assays and include three controls. Moreover, their high diagnostics specificity and sensitivity allow respectively the accurate detection of acute infection and the reduction of false positive cases. Lastly, the colour coded kit reagents offer easy recognition in a manual setting.

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C260 Elitech image3 01

Rapid test to detect resistance to polymyxins

, 26 August 2020/in Product News /by 3wmedia

Among the most clinically significant multidrug-resistant bacteria are carbapenemase-producing Enterobacteriaceae. Because these bacteria usually remain susceptible to polymyxins, interest in this old class of antibiotics has been recently renewed. However, the increasing use of colistin explains why Enterobacterial strains resistant to colistin are increasingly reported worldwide. Currently available polymyxins susceptibility methods are fastidious and time-consuming (24 hours). ELITechGroup Microbiology releases its new Rapid Polymyxin NP test proposed as a rapid, reliable and cost-effective test to detect polymyxins (polymyxin E or Colistin, polymyxin B) resistant Enterobacteriaceae. This test is based on the detection of the glucose metabolization related to bacterial growth in presence of a defined concentration of colistin. Formation of acid metabolites consecutive to the glucose metabolization is evidenced by a colour change (orange to yellow) of a pH indicator. The Rapid Polymyxin NP test is easy-to-perform, very sensitive and specific. It can detect in only a couple of hours polymyxin-resistant and –susceptible isolates from any enterobacterial species, regardless of the molecular mechanism of polymyxins resistance. This test offers the possibility of detecting polymyxins resistance from bacterial cultures before any antimicrobial drug susceptibility testing results are obtained. Results are obtained at least 16 hours sooner with this test than with the reference broth microdilution method. It is as reliable as the reference dilution technique but much less cumbersome and is not based on diffusion of large polymyxin molecules in agar, which therefore prevents false susceptibility results. The rapid polymyxin NP test can be used to screen resistance to polymyxins in countries facing endemic spread of carbapenemase producers and for which polymyxins are last-resort drugs. But it also enables anywhere else the rapid identification of carriers of polymyxin resistant isolates, thus leading to rapid implementation of adequate hygiene measures to control their spread.

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C283 Biosystems

200 test/h benchtop analyser

, 26 August 2020/in Product News /by 3wmedia

BioSystems is introducing BA200, a benchtop analyser with a real throughput of 200 t/h with any combination of methods and parameters (or up to 286 t/h including 4-channel ISE option), washing station, barcode identification and ISE capabilities. Offering the highest loading capacity of its segment, with 88 positions barcoded, that could be adjusted with specific adaptors to be used either as reagent, sample (primary or pediatric tubes), standard or control, it provides maximum configuration flexibility to adapt to the workload of any small or medium size laboratory, from routine to special chemistries. A BioSystems’ patented LED light source allows a precise focus in the reading spot area with no energy loss, increased signal and a sustained performance over its lifetime, over 50,000 hours of continuous operation without change of intensity, reducing their maintenance to almost zero. Also, the newly developed Dynamic Baseline procedure allows multiple readings to be made as the rotor is spinning to obtain highly accurate blank readings used to offer higher reliability for low absorbance values, thus improving significantly the CV% of the test at low values. Finally, the BA200 system introduces also a dedicated range of reagents in package size adequate to small and medium laboratories (but also fully compatible with BA400 system), ensuring the highest performance and on-board stability.

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Bio-Rad - Preparing for a Stress-free QC Audit

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