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Archive for category: Product News

Product News

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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Abbott HSQm Q S Q configuration Angle CMYK with New Centre Screen

Hematology systems

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

The Alinity h-series of systems integrates hematology workflow, from high- throughput Complete Blood Count (CBC) analysis to automated slide making and staining. With a bi-directional, internal conveyor and a throughput of 125 CBCs per m2, it delivers high performance in one of the most compact footprints available. The system is composed of two Alinity hq modules and an Alinity hs module in a hq-hs-hq configuration. The Alinity hq analyser delivers a CBC with an expanded 6-part White Blood Cell (WBC) differential that includes routine and several advanced parameters using Advanced MAPSS (Multi Angle Polarized Scatter Separation) technology. With the Alinity hs slide maker/stainer and the integrated robotic sample management, the Alinity h-series of systems delivers unprecedented uniformity, flexibility, operational productivity and confidence to the lab. The systems are not commercially available in all countries, including the USA.

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C412 Diasorin crop

Group B Strep direct molecular assay

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

Designed for use on the LIAISON MDX instrument, the highly sensitive SimplexaTM Group B Strep direct assay enables the direct in vitro detection of Group B Streptococcus (GBS DNA). GBS infection is a significant challenge in the health management of women and newborns. The new assay is more specific than traditional testing methods and features an efficient, fast workflow. This assay has also been submitted to the FDA under their Premarket Notification process, to obtain 510(k) clearance.  GBS infection is a leading cause of early-onset neonatal sepsis. An estimated one in five pregnant women around the world carries GBS bacteria, which is a major, yet preventable, cause of maternal and infant infection globally. Vertical transmission of GBS to the newborn can result in an invasive infection known as early onset disease (EOD). Infants with EOD will present with fever, lethargy, sepsis, pneumonia and, more rarely, meningitis within the first 24 to 48 hours of life. The World Health Organization estimates that GBS causes 150,000 preventable stillbirths and infant deaths every year.

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C372 Diazyme crop

2-reagent Vitamin D assay

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

Diazyme Laboratories, Inc. announced that the FDA has granted 510(K) clearance to market its two-reagent Vitamin D assay, the only fully automated two-reagent Vitamin D test for use on validated clinical chemistry analysers. Diazyme’s EZ Vitamin D assay is a universal fully automated Vitamin D test that is specifically designed for use on clinical chemistry analysers. This liquid stable, ready-to-use two reagent system measures total 25-hydroxy Vitamin D (25-OH Vitamin D2 + 25-OH Vitamin D3) levels. This assay enables clinical laboratories of almost any size to run Vitamin D test in house without the need for expensive specialized instrumentation. With no sample pre-treatment or pre-dilution steps required, this high-throughput liquid stable assay provides precise test results, is user friendly, cost effective and has excellent correlation to the existing commercial methods.

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C363 Siemens image1

Compact, 48-well thermocycler

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

At the 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2018), Fast Track Diagnostics, a Siemens Healthineers company, launched a new molecular thermocycler, the Fast Track cycler, and the complementary new FastFinder software. The Fast Track cycler is a compact platform that enables laboratories of all sizes to implement molecular testing with simplicity and speed while the FastFinder software improves workflows due to AI-powered automation.  
Weighing just two kilograms and measuring only 150 mm x 150 mm x 130 mm, the Fast Track cycler (FTC) is a compact thermocycler created to fit laboratories of all sizes. The platform is scalable: up to 10 thermocyclers can be connected to one computer, and laboratories can utilize a range of 1 to 480 wells. The Fast Track cycler uses magnetic induction technology for robust and reliable results. Because no calibration is required, the thermocycler does not drift or age and offers simple handling of the system. The FTC also comes equipped with Fast Track lyophilized technology, offering reagents for PCR experiments in a single sample tube, simplifying processes for users by eliminating the need to prepare the reaction mix before test implementation. With this technology, users simply add nucleic acid extracts to the prepared tubes before inserting into the cycler.

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C409 D Tek

Customized and automated kits for autoimmune diagnosis

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

BlueDiver Combi kits contain a dispenser of 24 nitrocellulose chips on which a specific antigen has been coated in a microdot-shaped format. In addition to the antigen, 2 built-in controls have been also coated on each chip. The antigens and controls are coated in triplicate spotting to ensure the quality and the validity of the results. The test is based on a classical Enzyme Immuno Assay (eia). The user can select (out of more than 50 different antigens) and combine antigen chips (up to 6) to create a personalized immunodot test. The BlueDiver Combi therefore offers complete flexibility and customization to end-users.The BlueDiver Combi kits are automated on the BlueDiver instrument. The complete processing time lasts just 1 hour. The semi-quantitative results can be obtained thanks to the BlueScan scanner and Dr DOT software.

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C380 Biorad crop

Measurement Uncertainty Report in Unity Real Time 2

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

Bio-Rad Laboratories recently announced the availability of a new Measurement Uncertainty Report in their Quality Control Data Management Software Unity Real Time 2 Service Pack 5 upgrade. Under ISO 15189, Measurement Uncertainty is a mandatory requirement and allows labs to calculate their analytical test dispersion. This new report allows laboratories to calculate their Measurement Uncertainty according to one of three different calculations. The three different calculations include the standard expanded Uncertainty based on the lab’s imprecision (consistent with RCPA and NABL), and two combined expanded uncertainty calculations which contain either the bias or the calibrator uncertainty (consistent with the SH GTA 14 Guideline from France).
Unity Real Time 2 is Bio-Rad’s expert QC Data Management solution for desktop users which facilitates compliance under CLIA and ISO 15189. It provides run validation with real-time bench and supervisor QC data review with comprehensive audit trails. It allows labs to participate in Bio-Rad’s Unity Interlaboratory Program with over 50,000 participating instruments. All QC data can be uploaded from any LIS, middleware or instrument via the Unity Connect software. Users can also reduce non-essential retests with Analytical Goal options and implement the best QC rules with the Westgard Advisor or use Bio-Rad’s latest QC design tool Mission: Control which provides a risk based approach to Quality Control.

http://www.qcnet.com/datamanagement/
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C342 biosystems

Semi-automated coagulometers

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

BioSystems is introducing new models of semi-automated coagulometers aimed at small to medium-sized laboratories. The COAX family includes 1, 2 or 4 optical channel devices. Operation is very intuitive, with a high quality colour touchscreen, allowing easy patient data management. Including state-of-the-art optics, the instrument uses disposable cuvettes with automatic light level adjustment at each channel to avoid optical disturbances, and a high optical resolution that allows high accuracy. The absorbance of the reaction is monitored continuously so time control starts immediately after reagent addition (thus, not requiring special pipettes as triggers). Also, thanks to their neat design making them easy to clean, as well as their minimum maintenance requirements, the instruments meet the typical needs of small and medium-sized labs. For all devices in the COAX series, BioSystems offers a complete range of the most common tests: PT, APTT, FIB and TT, validated lot to lot to achieve maximum performance. Besides, COAX2 and COAX4 are able to read additional tests using either chromogenic or latex reagents, such as individual coagulation factors, Antithrombin III, Protein C or D-Dimer.

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HbA1c assay

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

DiaSys offers a new enzymatic HbA1c assay – HbA1c net FS – for diagnosis and long-term monitoring of diabetes. This innovative test is setting new standards for accuracy through its outstanding specificity and excellent precision. HbA1c net FS delivers results equivalent to HPLC. Interferences  by hemoglobin variants or other blood components are minimized. The HbA1c net FS assay is standardized against the IFCC reference method and traceable to DCCT/NGSP. Fully automated handling on clinical chemistry platforms including onboard hemolysis allows convenient management of daily workloads.

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

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