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Archive for category: Product News

Product News

C322 Siemens 01

Laboratories across Europe evaluate and adopt the Atellica Solution from Siemens Healthineers

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

LBM Bioesterel in France, Arcispedale S. Maria Nuova in Italy and Friarage Hospital in the United Kingdom are among the first laboratories to install the Atellica® Solution immunoassay and clinical chemistry analysers. The trending motivators for installing the latest innovation from Siemens Healthineers include the unprecedented flexibility to automate redundant and complex procedures to simplify testing workflows and to grow patient testing capacity. This is expected to enable the laboratories to keep up with rising demands and decreasing reimbursement rates—all in an effort to achieve long-term sustainability in a value-based healthcare delivery model.
“Our company is facing a significant reduction in margins due to lower social security payments,” explained Dr. Pierre-Antoine Flé, Associate Director at LBM Bioesterel in France. “In order to limit this impact while increasing our production capacity, our company has chosen the Atellica Solution, which responds particularly to our future needs.”
With the flexibility to combine up to 10 components into more than 300 customizable configurations, to operate either as a standalone system or connected to Aptio® Automation and to integrate seamlessly with other disciplines in a total laboratory system, the Atellica Solution offers scalability for long-term growth.
LBM Bioesterel anticipates it will be able to redeploy up to 30 percent of its staff.  This is because of the ability to manage the configuration with a single operator and because of features such as automatic quality control (QC) and calibration with on-board refrigeration in the Atellica® Sample Handler—an integrated component of the Atellica Solution. Laboratories can program the Atellica Solution to automatically deploy the right materials at the right time to specific analysers to perform QC and calibration without operator intervention. This function significantly streamlines otherwise complex procedural workflows and lessens hands-on time for the operator, while eliminating unnecessary waste and decreasing the potential for human error.
Friarage Hospital in the United Kingdom, a member of the South Tees Hospitals NHS Foundation Trust, was drawn to automatic QC and calibration and to other proactive features designed to increase efficiency in the lab.
“We are very pleased with the support from the Siemens Healthineers teams both in setting up the new instrumentation and in the handling of verification, validation and global study protocols,” said Karl Hubbert, Services Manager Pathology, at Friarage Hospital. “We are looking forward to reduced maintenance and intervention elements, on-board QC stability and programming of QC intervals, as well as sorting of samples post analytics.”
Designed with algorithms to monitor system operations, the Atellica Solution can automatically initiate alerts and recommendations for corrective actions to maximize workflow. A system check and recovery procedure is included in the daily maintenance and also available on demand. This feature increases productivity, minimizes downtime, reduces the need for sample reruns and optimizes consumables and reagent usage.
For Dr. Luigi Vecchia, Director of Clinical Chemistry and Endocrinology Laboratory at Arcispedale S. Maria Nuova in Italy, independent sample management and quality control are priorities.
“The Atellica Solution—with its advanced technical features from sample transportation to real prioritization of urgent samples, and from reagent management to calibration and quality control management—takes us to the future of the laboratory. We are proud to be among the first to test it,” said Dr. Vecchia.
The patented, bi-directional, magnetic sample-transport technology and multi-camera vision system for intelligent sample routing provide independent control over every sample, whether routine or STAT (emergency). The immunoassay analyser uses a dual incubation ring design, rigorous temperature and humidity controls of the reaction environment, powerful magnets for relevant particle separation and robust washing protocols to deliver high throughput, while contributing to rapid and high-precision results.  

www.healthcare.siemens.com/integrated-chemistry/systems/atellica-solution-analyzers
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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C322_Siemens_01.jpg 600 800 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:17:222021-01-08 11:21:20Laboratories across Europe evaluate and adopt the Atellica Solution from Siemens Healthineers
C425 Beckman Coulter Clin Flow Single Color Antibodies

Single colour CE-IVD and ASRs in flow cytometry

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

A large portfolio of single colour CE-IVD and ASR (analyte-specific reagent) conjugated antibodies is now available from Beckman Coulter Life Sciences.  With the launch of two Kappa and two Lambda polyclonal antibodies in 2018, the company has introduced more than 30 additional CE-IVD reagents and 10 new ASRs in the last couple of years. The entire portfolio of single colour antibodies for flow cytometry is manufactured under Good Manufacturing Practices (GMP). High standard, single colour reagents are at the heart of robust and consistent lab-developed tests (LDTs). Even so, establishing robust, accurate and reproducible assays can be a challenge. Several studies show the inadequacy of non-clinical-grade reagents because of inferior performance and problems around reproducibility. A recent study published in Nature showed that monoclonal antibodies were among the most commonly used tools in life sciences but also the greatest source of false findings.  Poor quality conjugated antibodies, their specifications and performance can significantly distort data interpretation, in particular when analysing abnormal populations. To be able to routinely run Lab Developed Tests (LDTs), a high-end lab needs skilled staff with significant expertise in data interpretation.  However, even with the right staff and robust procedures, poor reagent quality often leads to failed quality controls, challenges in interpreting data – and can even lead to false results. The list of potential pitfalls associated with poor antibodies is long and can have a negative impact on a study’s outcome.  This is because of lack of reproducibility across lots, poor conjugation quality, low binding affinity, and non-specific staining.
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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C425_Beckman-Coulter-Clin-Flow_Single-Color-Antibodies.jpg 533 800 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:17:222021-01-08 11:20:56Single colour CE-IVD and ASRs in flow cytometry
beckman coulter life sciences logo

Flow cytometric casebook

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

Flow cytometric immunophenotyping is a rapidly evolving IVD technology which is establishing a place in the routine lab for the assessment of leukemia and certain lymphomas.  At the heart of the test is a panel of antibodies that can detect markers or antigens on the cells.  However, this depends on the accurate interpretation of complex patterns, determining whether a pattern is consistent (normal) or inconsistent with an expected population. To aid in this complex pattern recognition,  Beckman Coulter has developed a unique educational resource, the ClearLLab CaseBook. Users can also download the data to continue their diagnostic practice.
The casebook is based on the ClearLLab 5C reagents which were the first preformulated, IVD antibody cocktails for leukemia and lymphoma immunophenotyping to be granted de novo authorization by the Food and Drug Administration (FDA) for in vitro diagnostic use.  ClearLLab reagents simplify and standardize the process removing one of the limitations to flow cytometry gaining its place in the routine lab, and eliminating the need for a lab to manually prepare and design panels, a time- consuming process.
The ClearLLab 5C Casebook provides the clinical history of 16 patients, illustrating the progressive analysis of flow cytometric immunophenotyping data by means of numerous colour-coded illustrated scatter plots.  These first assess and then assign the cells before giving a detailed characterization of the aberrant population according to the presence or absence of antigens.  It includes patients with characteristic findings typical of various lymphoid and myeloid neoplasms as well as those with clinical and/or laboratory findings suggesting an underlying neoplastic process, but in which no immunophenotypic abnormality is identified.  Specimen types include peripheral blood, bone marrow, and lymph nodes. Each case concludes with an assessment of the immunophenotypic findings as well as potential pitfalls.
Flow cytometry has several advantages over immunohistochemistry in cancer detection.  This includes its ability to define distinct cell populations by their size and granularity, exclude weakly expressed surface antigens and measure several antigens at the same time with multi-colour analysis.

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C362 Randox crop

CO-Oximetry EQA / PT programme

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

Co-oximetry is a methodology that measures the levels of the oxygen-carrying protein hemoglobin, which is the chief component of red blood cells. Co-oximetry is a useful tool in that it helps determine the levels of various forms of hemoglobin and can be used to diagnose a variety of conditions related to oxygen content in blood. Oxygen content is an important indicator of oxygen transport within the body. The oxygen transport of arterial blood is used to evaluate the ability of transporting oxygen from the lungs to the tissue.
Randox Quality Control announce the launch of a new CO-Oximetry programme to complement their existing Blood Gas programme. Combining 7 parameters in a user-friendly, liquid ready-to-use format, the new RIQAS CO-Oximetry EQA programme has been designed with consolidation and convenience in mind – it’s even suitable for use in point-of-care testing.
RIQAS is the world’s largest EQA scheme with 45,000 participants and 33 programmes ensuring peer groups are maximized.  The added benefit of comprehensive yet user-friendly reports available within 72 hours of the submission date allowing corrective action to be taken in a timely manner saves time, money, and reputation by eliminating the need for expensive retesting, providing peace of mind.
To complement the RIQAS CO-Oximetry EQA programme, the RIQAS Blood Gas EQA programme incorporates 10 parameters into a liquid ready-to-use format for ease of use.
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C406 Cellavison crop

Digital cell morphology analyser

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

CellaVision DC-1 is the newest addition to the CellaVision family of analysers. It has been custom-designed to meet the specific needs of smaller low-volume hematology labs – enabling them to implement the best-practice digital methodology for performing blood cell differentials that many large labs today regard as standard practice.
CellaVision DC-1 is a semi-automated single-slide analyser that, although smaller, works just like the company’s existing analysers. A single slide is loaded onto the CellaVision DC-1 for processing. During processing the slide is automatically positioned under the microscope, the monolayer is identified, cells are located, and high-quality digital images are captured. Innovative image analysis technology delivers a pre-classification of white blood cells and a pre-characterization of red blood cell morphology for review and verification by the medical technologist or pathologist on a computer screen. Structured interfaces, smart functionalities and embedded tools help speed up the review process while promoting accuracy and consistency.

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C386 Beckman

Emerging antimicrobial resistance detection system

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

The DxM MicroScan WalkAway system is a diagnostic system for bacterial identification and antibiotic susceptibility testing for microbiology laboratories. The DxM MicroScan WalkAway system uses direct minimum inhibitory concentrations (MIC) for detection of antimicrobial resistance, offering greater confidence in results through gold-standard accuracy and the broadest breadth of first-time reporting. Emerging antimicrobial resistance (AMR) threatens the effective prevention and treatment of an ever-increasing range of infections caused by bacteria, parasites, viruses and fungi, according to the World Health Organization. Up to 50,000 people die because of AMR in the U.S. and Europe alone, and one study claims that 10 million people a year could die from this global crisis by the year 2050. Timely, accurate detection of emerging AMR is of critical importance in helping to ensure patients are protected against the risk of worsening infection or its progression to life-threatening conditions such as sepsis or septic shock.
The DxM MicroScan WalkAway system allows detection of emerging resistance to the toughest pathogens. As new issues have arisen, such as carbapenemases or other resistance mechanisms, MicroScan has adapted. The panels have been updated to assist in identifying these new resistance mechanisms. At the same time, the system’s delivery of first-time gold-standard MIC accuracy helps laboratories achieve their operational goals by reducing costs associated with confirmatory—or offline—testing. Added workflow enhancements include a new fluid-level sensing technology for added assurance, easy-to-view external LED indicators that show status at a glance, quick bottle release that simplifies reagent maintenance, and integrated reliability improvements that maximize uptime. The DxM MicroScan WalkAway system is part of a full line of microbiology solutions from Beckman Coulter. Automation and standardization of all core aspects of specimen testing creates workflow efficiencies for the laboratory.
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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C386_Beckman.jpg 480 563 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:17:222021-01-08 11:21:09Emerging antimicrobial resistance detection system
C349 Shimadzu

Automated pretreatment module for cell culture LC/MS analysis

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

The new C2MAP-2000 automated pretreatment module for cell culture media analysis is intended for pretreating culture media samples by adding reagents such as a deproteinizing agent or internal standard substance, filtering of precipitated proteins, and diluting of samples. The C2MAP system combines the C2MAP-2000 module with a Shimadzu ultra-fast liquid chromatograph mass spectrometer (LC-MS/MS). By automating all the process steps from pretreatment to measurement, the C2MAP system shortens the culture media analysis time for up to 95 components in culture supernatants to one sixth of the previous level. In addition, this system can be operated by less experienced operators. After simply loading culture supernatant samples, reagents and pairs of filter and recovery vials, the C2MAP-2000 module is able to execute all steps from pretreatment to LC-MS/MS measurement without any human intervention. This seamless execution not only makes it easy to process samples unattended overnight or on non-working days, but also enables samples to be controlled using the same ID for all process steps. This minimizes the risk of selecting the wrong sample while ensuring traceability. C2MAP-TRENDS time-course viewer software loads the measurement data obtained and plots a line graph of temporal changes in each component concentration as trend graphs.

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trimero CLI 180919 doc image

Urinary free light chain assays for BN™ nephelometric systems

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

KLoneus®, the TRIMERO’s new generation of Kappa and Lambda Free Light Chain assays, based on polyclonal specific antibodies, have been developed specifically to assay “neat” urine samples on Siemens’ BN™ nephelometric systems, by particle enhanced nephelometric method, with antigen excess control using the pre-reaction feature.
In order to ensure lot to lot traceability, values have been referred to the European Reference Material ERM-DA470k/IFCC (Institute for Reference Materials and Measurements, IRMM).
KLoneus® results, with excellent repeatability, correlate well with the quantification by densitometry of the Bence Jones proteinuria.
Other available assays for Siemens’ BN™ nephelometric systems include 
C1q Complement, C5 Complement, C3 pro-activator (Factor B), IgD (with pre-reaction feature)

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C399 Beckman Life Sciences

Flow cytometry data analysis system

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

Beckman Coulter has launched the Kaluza C Flow Cytometry Analysis Software, an advanced data analysis system for the clinical laboratory. The new software streamlines clinical QC reporting and addresses standardization issues in flow cytometry.  Both CE- marked and listed with the FDA, Kaluza C software improves the visualization and analysis of rare events.  It makes it possible to process large, multi-colour, files with up to 20 million events and set the plot resolution according to the gate level.  Further, it enables the operator to focus on a limited number of events to preserve the integrity of the scatter plot.   Tools such as easy Boolean gate formation and autogating are also incorporated to improve the analysis of complex data sets.  It takes less than a second to adjust the compensation and calculate compensation values. Kaluza C offers laboratories the opportunity to improve their clinical reporting.  It provides support at several levels, from quality control and regulatory compliance to ease of use and advanced user management tools. Complex, clinical reporting can now be done in minutes, helping to improve workflow and reduce turnaround time (TAT).
Kaluza C incorporates quality control visualization tools for regulatory and quality control compliance.  The software also offers a range of user management tools, from report page generation to auditing work levels and traceability, and enables easy exporting of data into the main laboratory information system. It can analyse clinical data from any cytometer that complies with the official Flow Cytometry Standard (FCS).  

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C370 Diasource

Free 25OH Vitamin D ELISA kit

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

Free 25OH Vitamin D kit is a CE marked ELISA kit available worldwide from Diasource ImmunoAssays SA (Belgium). Recent posters and publications clearly show that Free 25OH Vitamin D is a better marker than Total 25OH Vitamin D in healthy pregnant women, in women taking hormonal contraceptives and in diabetic patients with impaired kidney function. This kit allows a direct measurement of the Free 25OH Vitamin D, so no calculations are needed based on Total 25OH Vitamin D -, Albumin – and VDBP (vitamin D binding protein) concentrations, and this without sample pre-treatment. The assay is calibrated against Rate Dialysis, which is the golden standard method for the measurement of free hormones, and uses only 10 microliters of serum.
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