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Archive for category: Product News

Product News

PRODUCT CLI BOSCH

Multiplex assay for 10 STI’s receives CE mark

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

CE marking has been granted to one of the most comprehensive cartridge-based STI tests. The test, developed by the UK’s largest health diagnostics company, Randox Laboratories, tests simultaneously for 10 of the most common sexually transmitted infections, on the firm’s patented Biochip Technology. Quickly and efficiently testing for multiple STIs, which often have mild symptoms if any at all, ensures early diagnosis at a stage when treatment is most successful, supports the targeted use of antibiotics, and ultimately reduces their mishandling. Dr Peter FitzGerald, Managing Director of Randox Laboratories, commented; “Antibiotic stewardship is a critical issue which we all have a responsibility to embrace and drive forward. The CE marking of the STI assay, which incorporates Randox Biochip Technology, will be a game-changer for clinicians and patients across Europe, by facilitating early, accurate and comprehensive diagnoses of STIs that allows for the best possible patient outcome. Never before has there been this level of accessibility and speed with regards to STI testing.”
The Randox STI assay is performed on the Vivalytic system, an intuitive point-of-care platform, developed in partnership with German technology company Bosch that provides the broadest range of test options ever seen for an analyser of its size. Harnessing the application of multiplex assays to provide greater information from a single patient sample, the Vivalytic simplifies the testing process for otherwise complex laboratory testing procedures.
Marc Meier, Managing Director of Bosch Healthcare Solutions, a subsidiary of Bosch Group, said: “We are enthusiastic about partnering with Randox to offer their assay technology on the Vivalytic platform. The core competencies of Bosch in automation, miniaturization, sensor technology and connectivity are complemented by Randox’s expertise in developing excellent biocontent for a wide range of assays and commercializing innovative diagnostic solutions.”
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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/PRODUCT_CLI_BOSCH.jpg 467 768 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:16:522021-01-08 11:20:37Multiplex assay for 10 STI’s receives CE mark
C346 ChromSystems New Assay Drugs of Abuse Chromsystems

Drugs of Abuse Testing in Urine by LC-MS/MS

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

The LC-MS/MS-based assay MassTox drugs of abuse testing offers the target screening and quantitative confirmation of more than 100 drugs and metabolites with an analysis time of up to 12 minutes. The CE-IVD validated solution includes everything that is required for the analysis, eliminating the need for developing and maintaining several in-house methods or for preparing QC materials for a multitude of analyte compounds. It is designed to work below cut-offs defined by GTFCh and EWDTS. The assay includes a carefully selected hydrolysis enzyme that ensures a complete and selective hydrolysis of all 108 drugs covered in the assay. 99 analytes are safeguarded by isotopically labelled internal standards. The high stability of the 6PLUS1 Multilevel Urine Calibrator Set and three MassCheck urine controls ensure reliable results with highest precision.

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AD THERMO FISHER

Thermo Fisher Scientific introduces new mass spectrometry systems

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

Thermo Fisher Scientific has introduced several new products that build on its leading Orbitrap platform and expand research applications. The new Thermo Scientific Orbitrap Exploris 240 mass spectrometer is designed to give scientists working in proteomics, metabolomics, biopharmaceutical characterisation and small-molecules, the analytical performance required for research and high-throughput analyses. The company says the new system will advance discovery and identification with increased accuracy for confident scale-up, while providing operational simplicity and streamlining time-to-result.
Thermo Fisher Scientific pointed out that the new mass spectrometer delivers qualitative and quantitative capabilities synonymous with Orbitrap high-resolution accurate-mass (HRAM) spectrometry, with internal calibration that assures consistent data quality and decision making. These newest systems extend the Thermo Scientific Orbitrap Exploris portfolio of HRAM systems, which were introduced in 2019 with the release of the new-generation Thermo Scientific Orbitrap Exploris 480 mass spectrometer.
Software
Thermo Scientific Proteome Discoverer 2.5 software provides high confidence during peptide identification, accurate quantification and high throughput data analysis for proteomics researchers. Deep learning-based prediction of tandem mass spectra, facilitated through a new collaboration with MSAID, a software company transforming proteomics through deep learning, enables more scientists to benefit from major improvements in identification confidence and reproducibility.
To further enhance characterisation of protein biotherapeutics and oligonucleotide therapeutics, biopharmaceutical laboratories use the Thermo Scientific BioPharma Finder 4.0 software, which provides greater flexibility and customisation for this growing industry.
For small molecule researchers, Thermo Scientific Compound Discoverer 3.2 software further automates unknown compound identification performed on Thermo Scientific Orbitrap Gas Chromatography- Mass Spectrometry (GC-MS) systems to improve productivity.
In addition, the new Thermo Scientific Xcalibur 4.4 software brings the AcquireX intelligent data acquisition workflow to Thermo Scientific Orbitrap Exploris mass spectrometry platform users, enabling the fully automated acquisition of high quality MS/MS data and reducing manual input and repeat runs.
Collaboration
Thermo Fisher Scientific’s collaboration with Evosep, a leading provider of sample preparation technologies for protein-based clinical research, supports the development of high-throughput clinical research workflows for profiling large plasma sample cohorts for proteomics, translational research and pharmaceutical applications. This partnership recently led to the launch of an automated ultra-high throughput plasma protein profiling platform, combing the power of the new Thermo Scientific Orbitrap Exploris 240 mass spectrometer with the Evosep One liquid chromatography solution.
The company’s collaboration with Biognosys, a leading developer of next-generation proteomics solutions, resulted in the development of data-independent acquisition mass spectrometrybased workflows, which enhances sensitivity and coverage for proteomic research in translational and clinical labs. The collaboration includes a novel FAIMS-DIA method that features the Thermo Scientific FAIMS Pro interface, which improves selectivity, reproducibility and proteome coverage, as well as new methods that streamline discovery by combining Thermo Scientific SureQuant Targeted Assay Kits and the Biognosys PQ500 kit in a single workflow.
For more information, visit: www.thermofisher.com
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Randox Lipid Graphic

Total solution for lipid and cardiac risk testing

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

Cardiovascular disease caused by atherosclerosis is the leading cause of morbidity in Western Countries [1]. It involves the hardening and narrowing of vessels in the systemic system. The process originates from the build-up of fatty deposits through a process known as atherogenesis. If the build-up increases, plaque rupturing may occur leading to myocardial infarction [2].
The mission of The National Lipid Association (NLA) is “to enhance the practice of lipid management in clinical medicine.” NLA advocates advancing the current lipid testing profile as the traditional panel consists of testing LDL cholesterol (LDL-C), HDL cholesterol (HDL-C) and triglycerides, which only detects approximately 20 % of all atherosclerotic cardiovascular disease patients. Advanced lipid testing is recommended to optimize patient treatment [3].
Offering a total solution for lipid and cardiac risk testing, Randox has developed novel and superior performance markers to identify the true weight of lipid profiling. Its range of niche and superior performance assays comprises 13 assays including: small dense LDL-C (sdLDL-C), Lipoprotein (a) (Lp(a)) and HDL3-C.
sdLDL-C will more readily permeate the inner arterial wall having a lower affinity to the hepatic LDL-C receptor which circulates in the blood longer and more susceptible to oxidation.
As sdLDL-C is particularly atherogenic, a person with elevated sdLDL-C levels has a 3-fold increased risk of myocardial infarction [4].
Elevated Lp(a) levels are associated robustly and specifically with increased cardiovascular disease (CVD) risk. The unique Randox Lp(a) assay is one of the only methodologies on the market that detect the non-variable part of the Lp(a) molecule which suffers minimal size related bias.
HDL3-C is the scavenger of cholesterol within arterial walls and if HDL3-C levels are significantly depleted, the ability to remove this cholesterol is reduced. Therefore, it is widely accepted that there is an inverse correlation between HDL3-C and CVD risk.
It is necessary to review the traditional lipid testing panel, enabling clinicians to gain a more comprehensive view of a patient’s CVD risk and therefore take the appropriate
measures to prevent CVD related deaths.
References
1. Burnett JR. Lipids, lipoproteins, atherosclerosis and cardiovascular disease. Clin Biochem Rev 2004; 25(1): 2 [cited: 3 December 2018]. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1853363/.
2. Zimmermaann KA. Circulatory system: facts, function & diseases. Live Science [Online] 16 March 2018 [cited: 3 December 2018]. https://www.livescience.com/22486-circulatory-system.html.
3. National Lipid Association. National Lipid Association releases updated recommendations on the use of PCSK9 inhibitors at the 15th Annual Scientific Session. [Online] no date [cited: 3 December 2018]. https://www.lipid.org/nla/national-lipid-association-releases-updated-recommendations-use-pcsk9-inhibitors-15th-annual.
4. Austin MA, Breslow JL, Hennekens CH, Buring JE, Willett WC, Krauss RM. LDL subclass patterns and risk of MI. JAMA 1988; 260(13): 1917–1921.

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C436 BECKMAN DxA 5000 NEW IMAGE

Total laboratory automation solution sets new standard for turnaround time

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

Beckman Coulter announced early May that the latest addition to its automation portfolio, the DxA 5000 total laboratory automation solution, has achieved European CE Mark and China Food and Drug Administration approval. In today’s healthcare environment, laboratories are highly focused on enhancing patient care by driving faster turnaround time, delivering quality results and improving laboratory operations. The DxA 5000 helps laboratories meet these challenges through a collection of patented innovations that deliver rapid and consistent turnaround time, provide a new level of comprehensive pre-analytical sample quality detection, and reduce the number of manual processing steps to significantly improve laboratory efficiency.
Reporting results faster to physicians can positively impact patient outcomes. In the laboratory, specimen centrifugation is typically the most time-consuming pre-analytical activity. The DxA 5000 sets a new standard by utilizing a universal centrifugation protocol that significantly reduces the pre-analytical processing time by up to 73% for connected analysers across multiple disciplines.
Additionally, the DxA 5000 supports laboratories in delivering highly consistent turnaround time to their physicians. Leveraging first-of-its-kind dynamic system software, the DxA 5000 utilizes Intelligent Routing to bring automated patient-centric workflow to the laboratory. By understanding the tests requested, sample volume available and real-time analyser capacity and status, the DxA 5000 continuously calculates the most expeditious route for every patient sample – both STAT and routine.
Research shows errors that occur in the pre-analytical phase of testing may contribute up to 75% of erroneous test results, with 26% possibly having adverse effects on patient care.  Moreover, a vast majority of the factors causing erroneous results occur outside the laboratory, including inadequate volume, mislabeled samples and incorrect tube type. The DxA 5000 is designed with a sharp focus on sample quality assessment, screening each sample at multiple points to help laboratories substantially reduce the risk of errors. In three seconds, the system detects patient tube parameters such as volume, sample identification, tube type, cap colour, orders pending and tube weight. The system is also designed to check for sample volume at three separate points: pre-centrifugation, post-centrifugation and prior to sample storage to continually ensure sufficient volume is available for the tests ordered. Together, these quality assessments reduce the potential for release of erroneous results and can help accelerate time to result by quickly alerting the laboratory when a new patient sample is needed.
In addition to improving sample quality, laboratories also require workflow solutions that help them manage high volumes of outpatient, outreach and network samples, while processing urgent requests for both patient wards and emergency departments. The DxA 5000 simultaneously manages high volumes of multiple discipline requests, with a large variety of patient sample tubes and sizes, without impact to overall system throughput or STAT turnaround time. By automating sample processing steps, the DxA 5000 supports laboratories in delivering a higher number of results per hour with the same staffing level.
Based on research and work performed with the company’s laboratory partners, sample processing steps are shown to make up approximately 70% of a laboratory’s labour hours. The DxA 5000 significantly reduces the number of manual steps in sample processing to as few as one. From sample accessioning and quality assessment to add-on test management and sample disposal, the DxA 5000 enables laboratory professionals to deliver high-quality results and improve efficiency, empowering them to focus their efforts and skills on managing patient sample exceptions.
The first in a suite of DxA systems currently in development, the DxA 5000 enhances Beckman Coulter’s comprehensive portfolio of scalable solutions and is a key component of its vision to bring workflow automation to laboratories of all sizes.
Beckman Coulter has received purchase orders for more than 20 DxA 5000 systems across multiple countries where regulatory clearance has been achieved.

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PRODUCT HEMCOCORP

CleanAire II Ductless Hoods designed to meet DH I as defined by SEFA 9

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

Hemco has introduced the CleanAire II Ductless Hoods, designed to meet DH I requirements as defined by SEFA 9. This hood features a built-in carbon filtration system to adsorb non-toxic fumes and odors. It is equipped with an integral blower, vapor proof light, fan and light switches.
The hood superstructure is constructed of chemical and flame resistant, non-metallic (no rust) composite resin with a molded one-piece seamless interior fume chamber. A vertical sliding clear acrylic sash protects the user and contains the process fumes. The carbon filter adsorbs the fumes and then re-circulates the air back to the laboratory.
The CleanAire II Ductless Hoods are available in 24”, 30”, 35”, and 47” models and are shipped completely assembled and ready for operation.
For more information, visit: www.hemcocorp.com/caii.html
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Eurobio t core 8

HSV1, HSV2 and VZV viral DNA test

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

The EurobioPlex HSV-1, HSV-2 and VZV kit, which obtained the CE mark, is a real-time amplification test of viral DNA of each of these viruses, with specific detection, as well as a DNA extraction and PCR inhibition control. This ready to use test is performed from extracted DNA, or directly on cerebrospinal fluid (CSF) without extraction using a reaction in a single well/tube. The test is indicated to detect and specifically differentiate the DNA of these viruses, and thus to diagnose the occurrence of infection by these viruses in humans, or to supplement a proven or undetermined diagnosis. Time from sample to result is short: less than 35 min. on standard PCR instruments such as CFX96 (Bio-Rad) or LC480 (Roche), and 1h on the 8-well, single-patient testing TCOR8-IVD instrument (Tetracore), networkable (WiFi/Ethernet) for remote access and data download. The Eurobio-Plex HSV1-HSV2-VZV has been validated on the following specimens: plasma, blood, amniotic fluid, various biological samples with cellular components (skin, eye, pharynx, tongue, colon, penis, foreskin, anogenital and vaginal areas, naso-pharyngeal aspirations), and directly on CSF.
Human herpesviruses are enveloped linear double-stranded DNA viruses belonging to the family Herpesviridae. Their DNA replication and transcription of their genes occur in the nucleus of infected cells. They are subdivided into three groups: alpha-, beta – and gamma herpesviridae. Primary infection with herpes virus is common and most infections occur during childhood. Many Infections with varying degrees can occur at any age, resulting in various diseases: skin lesion (herpes eczema), encephalitis, neonatal herpes and disseminated herpes. A special case is that of VZV, responsible for chickenpox, characterized by moderate fever and a vesicular eruption. Generally benign for children, there is a risk of severe complications when it is contracted by adults, immunosuppressed people and pregnant women. The reactivation of the virus in the body leads to the appearance of zona. Fast direct detection from CSF with EurobioPlex HSV1-HSV2-VZV constitutes a powerful tool for the diagnosis of meningitis.
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C428 MAST carba pace

Carbapenemase detection in Pseudomonas, Acinetobacter and Enterobacterales

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

An increase in antimicrobial resistance is one of the most urgent global challenges facing the field of healthcare.  Carbapenem-resistant bacteria are an emerging cause of healthcare associated infection and are particularly concerning due to the high level of antimicrobial resistance coupled with the ability for widespread transmission.  Accordingly it is important to detect carriers quickly to prevent and control spread and also to aid antimicrobial stewardship. Mast Group Ltd. has developed a colorimetric test which rapidly detects carbapenemase producing Pseudomonas spp., Acinetobacter spp. and Enterobacterales using a novel chromogenic cephalosporin analogue. The test provides rapid results in less than 10 minutes using a simple test process in 5 easy steps while featuring high sensitivity and specificity. MAST CARBA PAcE is a simple, cost effective solution providing fast results within 10 minutes, conveniently containing 48 tests per kit making it suitable for screening purposes, and supporting effective infection prevention and control.  With no special equipment required the test can be easily adaptable to any microbiology laboratory.

MAST GROUP
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porvair chromotrap

ChIP kits for high throughput antibody validation

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

Porvair Sciences report how its Chromatrap ChIP kits provide an outstanding solution for antibodies suppliers looking to validate the performance of the antibodies they produce for chromatin immunoprecipitation (ChIP) assay kits.
With its revolutionary bead-free system, Chromatrap offers a faster, easier and more sensitive method to validate antibodies in a high throughput format. This enables antibody suppliers to easily and efficiently expand their product portfolio to target epigenetics and drug development applications.
Successful ChIP assays heavily rely on the highest quality antibodies. In-house validation of antibodies for use in ChIP is considered to be a lengthy, expensive, time consuming and challenging process. In addition, antibodies are rigorously assessed for enrichment of positive and negative gene targets, signal-to-noise ratio, chromatin-to-antibody ratio, reproducibility and lot-to-lot variations.
Dr Lindsay Parkes, a senior research scientist at Porvair Sciences commented: “We have developed our bead-free Chromatrap technology to enable maximum capture of antibody. This is achieved by correctly orientated capture proteins throughout the inert filter-based ChIP technology. Most bead-based systems have capture proteins scattered in random orientation which doesn’t allow full access of antibodies to binding pockets of proteins, thus giving an overall reduced capture efficiency. This is important for high sensitivity especially for detection of binding of low abundant targets.”
Chromatrap ChIP kits deliver fast workflow, enabling you to process up to 96 ChIP assays simultaneously in one day allowing multiple sample, antibody and gene targets to be tested in parallel on a single plate. Requiring less manual handling and fewer pipetting steps than other ChIP kits, Chromatrap ChIP kits are very easy to use, making them perfect for even inexperienced users. Using these kits, a complete ChIP protocol doesn’t require overnight incubation or blocking steps and can be completed in under five hours. Chromatrap ChIP-kits are suitable for use over a wide chromatin enrichment range (500ng – 50µg).
For further information on Chromatrap® ChIP kits for antibody validation, visit: https://www.chromatrap.com/high-throughput-chip-kits/
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PRODUCT CLI EUROIMMUN

Compact random access analyser

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

The RA Analyzer 10 is a compact random access device which provides fully automated processing of chemiluminescence immunoassays (ChLIA) for autoimmune and infection diagnostics as well as antigen detection. It is ideal for use in small- to medium-sized laboratories, or to complement high-throughput-devices in large laboratories.
The device allows continuous loading, also as part of a laboratory track system, ensuring that every sample is processed with minimal effort as a single determination. Up to 85 results can be obtained per hour. EUROIMMUN ChLIA technology offers short reaction times, with first results in just 25 minutes. Test- and lot-specific information, including stored standard curves, is imported by means of RFID codes, enabling error-free and convenient loading, along with efficient and secure test evaluation. Automatic identification of samples and reagents by means of barcodes ensures complete traceability. The system offers preferential processing of emergency samples (STAT), giving laboratories unparalleled flexibility in their laboratory routine.
New CE-marked EUROIMMUN ChLIA for use on the RA Analyzer 10 are available for detection of antibodies against Borrelia (IgG, IgM) Epstein-Barr virus (EBV-CA IgG, IgM; EBNA IgG), proteinase 3 (PR3, IgG) and phospholipase A2 receptor (PLA2R, IgG). Further ChLIA for detection of antibodies against tissue transglutaminase (tTG, IgA), CCP (IgG), myeloperoxidase (MPO, IgG), parvovirus B19 (IgG, IgM), HSV-1 (IgG) and HSV-2 (IgG), as well as calprotectin and biomarkers in Alzheimer’s disease will be available soon. Assays for many other parameters are under development.
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