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Archive for category: Product News

Product News

PRODUCT CLI HARVARD

Diagnostics in your hand

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

Handheld electrochemical sensors are part of the daily routine for millions of people with diabetes around the globe who monitor their blood sugar levels with electric glucometers. While such sensors have revolutionized at-home medical testing for diabetics, they have not yet been successfully applied to diagnosing other conditions.
Sensors like glucometers detect glucose in blood based on the activity of an enzyme, and there are only a limited number of enzymes that can be used to sense biomarkers of human disease. An alternative detection strategy based on binding events between antibodies and their molecular targets have been investigated to expand the use of electrochemical sensors for medicine, but these sensors fall victim to the rapid accumulation of “fouling” substances from biological fluids on their conductive surfaces, which deactivate them. Existing antifouling coatings are difficult to mass-manufacture, suffer from quality and consistency issues, and are not very effective. Now, a new diagnostic platform technology developed by researchers at the Wyss Institute for Biologically Inspired Engineering at Harvard University known as “eRapid” enables the creation of low-cost, handheld electrochemical devices that can simultaneously detect a broad range of biomarkers with high sensitivity and selectivity in complex biological fluids, using as little as a single drop of blood. The technology is described in Nature Nanotechnology.
“As long as an antibody exists for a given target molecule, eRapid can detect it,” said co-author Pawan Jolly, Ph.D., a Senior Research Scientist at the Wyss Institute. “By solving the biofouling problem with a simple yet robust design, we are now able to easily mass-produce biochemical sensors for a wide variety of applications at low-cost.” The team demonstrated the commercial utility of this approach by creating a multiplexed sensor with three separate electrodes, each coated with the BSA/gold nanowire matrix and a layer of antibodies against a specific clinically relevant target molecule: interleukin 6 (IL6), insulin, or glucagon. When they incubated the sensor with the respective target molecules in undiluted human plasma, they observed excellent electrical signals with picogramper- mL sensitivity. Conversely, electrodes coated with a published “PEG-SAM” anti-fouling coating failed to produce distinct signals, indicating that they had been irreversibly fouled by off-target molecules in human plasma samples. In addition, the BSA/gold-nanowire-coated sensors can be washed and reused multiple times with minimal signal loss, allowing serial monitoring of biomarkers easily and at low cost.
Since then, the Wyss team has been able to detect more than a dozen different biomarkers ranging from 100 Da to 150,000 Da in size with eRapid, and they are continuing to experiment with conductive nanomaterials to optimize the electrode coating and the system’s performance, as well as reduce the cost even further.
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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/PRODUCT_CLI_HARVARD.jpg 537 694 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:16:522021-01-08 11:20:37Diagnostics in your hand
C451 Instrumentation Lab GEM Premier ChemSTAT 350px

Basic metabolic panel POC analyser

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

A new and complementary member of the GEM Premier family, the GEM Premier ChemSTAT system is a whole-blood analyser designed for rapid basic metabolic panel (BMP) testing at the point of care, primarily in hospital Emergency Departments (EDs) and clinical laboratories. The system provides laboratory-quality results on-demand, in less than 70 seconds, from venous or arterial whole blood samples, with no preparation required. Ultimately, this aids in diagnosis for timely triage of life-threatening conditions and enables rapid risk stratification, prioritization and treatment of high-risk, acutely ill patients. BMP is one of the most widely ordered tests for diagnosing acute conditions, such as kidney failure, sepsis and septic shock, and diabetic ketoacidosis. Featuring a complete BMP panel, the GEM Premier ChemSTAT system offers Creatinine, Blood Urea Nitrogen (BUN) and measured tCO2 – as well as Lactate, Hematocrit, pH, pCO2, Sodium, Potassium, Ionized Calcium, Chloride and Glucose. To assure laboratory-quality results at the point of care, the GEM Premier ChemSTAT system integrates Intelligent Quality Management (iQM), providing a complete picture of quality for each sample – continuously and in real-time – and automated detection, correction and documentation of any action it performs, to ensure the quality of every test result and supporting immediate patient management decisions. No competitive system offers this assurance of sample quality and compliance. Like all GEM Premier systems, GEM Premier ChemSTAT analysers are also exceptionally easy to use. The all-in-one, multi-use GEM PAK cartridge automates the most labour- and skill-intensive processes. Stored at room temperature, GEM PAKs are simply replaced every three weeks, requiring no maintenance or additional handling. All testing components are self-contained, limiting biohazard and infection risk for operators and patients. Additionally, GEMweb Plus Custom Connectivity enables management of all GEM Premier analysers in a network, including the GEM Premier ChemSTAT system, for complete control of instruments, operators and data oversight from any location. GEM Premier systems, combined with GEMweb Plus 500 connectivity, deliver a complete solution for improved patient care and efficiency.

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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C451_Instrumentation_Lab_GEM_Premier_ChemSTAT_350px.jpg 487 350 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:16:522021-01-08 11:20:47Basic metabolic panel POC analyser
C438 Thermo Fisher Sensititre ARIS HiQ System jpg 650

Instrument for automated antimicrobial susceptibility testing

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

A new benchtop automated reading and incubation system is now available in Europe for antimicrobial susceptibility testing (AST). The new instrument provides microbiology laboratories with the accurate MIC results that clinicians need to confidently select an effective antibiotic for critically-ill patients while safeguarding future patient care through more successful antimicrobial stewardship. The Thermo Scientific Sensititre ARIS HiQ AST System relies on broth microdilution, the industry’s gold standard, to provide an MIC result that supports the optimization of treatment decisions and ultimately, patient outcomes.
The new system adds value to laboratories that routinely retest invalid AST results or that require additional confirmatory testing prior to releasing results to clinicians. The immediate accuracy of phenotypically-driven MIC values delivers reliable results while minimizing re-tests and can support a reduction in hidden costs associated with reporting delays. Through close collaboration with leading pharmaceutical companies, the Sensititre System also offers one of the widest, most up-to-date selections of antimicrobials, enabling earlier access to the latest therapies for multidrug-resistant infections. In addition, laboratories can create their own custom AST plates from a selection of over 300 antimicrobials in broad dilution ranges to consolidate and reduce offline testing. The new Sensititre ARIS HiQ AST System provides microbiology laboratories with a unique combination of class-leading broth microdilution technology, for the most accurate AST, and access to cutting-edge antimicrobials. The availability of an AST device can determine whether or not a particular therapy can be used for a critically-ill patient. As the World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC) continue to report on the increasing threat of antibiotic resistance, the ability to use these newer antimicrobials is more important than ever.
The Sensititre ARIS HiQ AST System has an expanded capacity of up to 100 Sensititre plates in a limited footprint that makes it possible to process more tests at one time while conserving valuable bench space. It also features an intuitive touchscreen user interface for convenient operation; 24/7 access to critical test information; and batch load and unload capability for improved testing workflow.
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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C438_Thermo_Fisher_Sensititre-ARIS-HiQ-System_jpg-650.jpg 1200 800 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:16:522021-01-08 11:20:49Instrument for automated antimicrobial susceptibility testing
PRODUCT IMMUNOTEC

Oxford Immunotec releases T-SPOT Discovery SARS-CoV-2 kit for research into measuring T cell immune response to SARS-CoV-2

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

Oxford Immunotec Global has released the T-SPOT Discovery SARS-CoV-2 test kit. The kit is for research use only and could make a significant contribution towards development of a new tool to manage the COVID-19 pandemic.
T-SPOT Discovery SARS-CoV-2 builds on Oxford Immunotec’s experience with TB diagnosis and the assessment of immune response to CMV in transplant patients, to apply the Company’s established, proprietary T-SPOT technology to the fight against COVID-19.
While serology is able to detect antibodies to SARS-CoV-2 in the blood of some individuals after infection, little is known about how this confers immunity to COVID-19. T-SPOT technology goes further than simple serology by interrogating the immune system’s T cell response and will enable research into the measurement of the strength of that response to SARS-CoV-2. The strength of this response may be linked to protection from reinfection.
Commenting on the technology, Phill Keefe, Senior Vice President Product Design, Development and Delivery at Oxford Immunotec, said: “Not everyone with COVID-19 infection has detectable antibodies in serology tests, and this may be a bigger problem in the majority who experience only mild or no symptoms. Also, it is not yet clear whether the presence of anti-bodies confers immunity. T cell responses develop before antibody generation and can independently provide protection, so studying T cells could give us new insights into immunity to COVID-19.”
T-SPOT technology is approved in over 60 countries for clinical use to detect TB infection. With over 20 million clinical tests since release, T-SPOT technology:

  • Uses a standardized sample prepared from peripheral blood which:
    – Reduces the influence of factors which might affect results, such as other treatments
    – Standardises cell numbers in the test to normalise for cell number variations between samples
  • Allows the number of responding T cells to be enumerated for a more precise assessment of the T cell response
  • Is able to maintain performance, even in samples from immunosuppressed individuals
  • Can be run in high-volume labs enabling large testing programs to be rolled out.

T-SPOT technology can also be automated using the T-Cell Select reagent kit. Automation solutions are available for low, medium and high throughput settings.
For more information, visit: go.oxfordimmunotec. com/t-spot_discovery_SARS_CoV-2
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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/PRODUCT_IMMUNOTEC.jpg 326 698 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:16:522021-01-08 11:20:31Oxford Immunotec releases T-SPOT Discovery SARS-CoV-2 kit for research into measuring T cell immune response to SARS-CoV-2
NEWS CLI EUROIMMUN 01

Euroimmun releases flexible laboratory management software

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

The EUROLabOffice 4.0 system provides a flexible central interface in the diagnostic laboratory, ensuring efficient workflow for many different applications and requirements. The software encompasses indirect immunofluorescence, ELISA, chemiluminescence, immunoblot and microarray analyses in autoimmune, infection, allergy and molecular genetic diagnostics. Continuous data exchange with the LIS and instruments ensures that all processes run smoothly, making the system suitable for random access applications. The software is simple and intuitive to operate, with no unnecessary manual steps, thus saving time and reducing workload for laboratory staff. The clear user interface makes it ideal for all workplaces, including the laboratory, microscopy room and office. Predefinable workflows and automatically created protocols ensure efficient organisation of the daily workload and thus faster generation of results. The software incorporates fully automated evaluation of indirect immunofluorescence results, including pattern recognition for antinuclear antibodies (ANA, based on the ICAP consensus) and anti-neutrophil cytoplasmic antibodies (ANCA). For Crithidiae luciliae (CLIFT), cell-based assays (e.g. anti-neuronal antibodies) and antigen dots (EUROPLUS), the system offers clear positive/negative classification. Furthermore, the program provides titer estimations with confidence values. The software consolidates all results into one report per patient, which includes the patient’s complete history and all images. Different user levels provide a hierarchical review of results, thus increasing security. After the verification procedure, result reports can be signed electronically and forwarded at the click of the mouse or exported into an existing LIS. Patient data, customer details and article information are all administered and archived by the system, ensuring a streamlined laboratory routine.
For more information, visit: www.euroimmun.com
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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/NEWS_CLI_EUROIMMUN_01.jpg 680 694 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:16:522021-01-08 11:20:40Euroimmun releases flexible laboratory management software
C433 Beckman LS Controlstubes withblood boxes

Expanded portfolio of standardized CE-IVD reagents for the clinical flow cytometry lab

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

The ClearLLab 10C system for the clinical flow cytometry lab includes the first 10-colour CE-IVD panels of immunophenotyping reagents for both lymphoid and myeloid lineages. The tubes utilize DURA Innovations dry reagent technology for the panels, which requires no refrigeration. Alongside the panels, the integrated ClearLLab 10C system comprises ClearLLab Control Cells – a liquid preparation of stabilized human erythrocytes and leukocytes (lymphocytes monocytes and granulocytes) – the first application-specific IVD control cells for L&L immunophenotyping as part of a validated system.  ClearLLab Control Cells include assay values for the 27 markers currently available on the four ClearLLab10C panels, available for both normal and abnormal controls. New ClearLLab Compensation Beads are provided for establishing compensation using the ClearLLab compensation kit, which includes 10 single colour tubes for each compensation setup.  In addition, the ClearLLab 10C system incorporates the company’s new Kaluza C software to streamline and standardize clinical QC reporting to international guidelines.  It delivers high quality results from dry unitized combinations of CD (cluster of differentiation) markers, using Beckman Coulter’s DURA Innovations dry technology.  These pre-formulated antibody combinations help the lab avoid the potential errors of manual antibody cocktail preparation.  The four ClearLLab 10C panels are designed specifically to run on Beckman Coulter’s Navios and Navios EX flow cytometers, with new, advanced Navios compensation setup software.  When using the ClearLLab 10C system, compensation is only required on initial set-up of the application, when daily QC fails, after instrument service as needed, or when switching to a new lot of Flow-Set Pro. With the ClearLLab 10C System, laboratories now have a portfolio of flow cytometric tools – enabling them to provide accurate patient results for L&L analysis in a compliant lab setting, without needing to carry out extensive manual validation, preparation and QC tasks.  ClearLLab 10C is also supported by a unique, training resource, the ClearLLab 10C case book.  This provides 24 diagnostic vignettes giving characteristic findings after flow cytometric analysis, with expert assessment by hematopathologists. Labs can also compare the interpretation of their own findings with the analysis in the casebook. With the ClearLLab 10C System, workflow is reduced to four straightforward, standardized steps – sample processing, sample acquisition, reporting and validation. The reagents can be used with peripheral whole blood (collected in K2EDTA, Acid Citrate Dextrose (ACD) or Heparin), bone marrow (collected in K2EDTA, Acid Citrate Dextrose (ACD) or Heparin) and lymph node specimens.  In 2017, the five- colour ClearLLab Reagents panels were the first pre-formulated, IVD antibody cocktails for leukemia and lymphoma immunophenotyping to be approved by the FDA de novo process for in vitro diagnostic use in the US. The FDA confirmed that they provided ‘consistent results to aid in the diagnoses of these serious cancers’ after evaluating data from a multi-site clinical study (which compared panel results to alternative detection methods).  ClearLLab reagents follow the 2006 Bethesda International Consensus Recommendations on the Flow Cytometric Immunophenotypic Analysis of Hematolymphoid Neoplasia. They are compatible with the World Health Organization (WHO) 2016-revised classification of myeloid neoplasms and acute leukemia. WHO, in collaboration with the European Association for Hematopathology and the Society for Hematopathology, recently made important changes to the classification of these diseases. These included new criteria for the recognition of some previously described neoplasms as well as clarification and refinement of the defining criteria for others.

BECKMAN COULTER LIFE SCIENCES
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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C433_Beckman_LS_Controlstubes_withblood__boxes.jpg 540 800 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:16:522021-01-08 11:20:52Expanded portfolio of standardized CE-IVD reagents for the clinical flow cytometry lab
samplix Xdrop

Samplix offers its proprietary Xdrop technology to other labs

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

Danish company Samplix has launched its comprehensive service program to grant any laboratory access to the advantages of Xdrop™ technology. By partnering with the Samplix Service Team, researchers can leverage the unique Xdrop™ approach to address complex genomic questions, including gap closing, sequencing of repeat elements, detecting viral insertion sites, revealing unintended CRISPR edits, and more.
Xdrop™ is Samplix’s proprietary technology to enrich genomic regions longer than 100 kb from as little as 1 ng human genomic DNA and with single-molecule resolution. Unlike other target enrichment methods, Xdrop™ requires knowledge of only a short sequence within or flanking the target region for efficient target selection. Following targeted selection, multiple displacement amplification is applied to single DNA molecules compartmentalized in droplets. This ensures unbiased amplification of large DNA fragments that are representative of the target variation in the original sample. The output is ready for any short-read or long-read sequencing platform.
Commenting on the service, Henrik Pfundheller, VP Commercial Operations, said: “Our services program is designed to expertly manage workflow points that impact project success. We have regular customer consultations to establish clear research objectives and thus, secure the right experimental setup and sample quality strategy.”
The complete workflow is managed by an expert team of scientists and lab technicians with more than 10 years of experience in international genomics services, handling of precious sample types, project logistics, and dedicated customer care. Upon request, Samplix Services also performs and analyses long-read or short-read sequencing. Every step, including data processing and analysis, if requested, is carefully documented and discussed in a closing consultation.
“Whatever the reason behind a service request," added Pfundheller, “our team overcomes any challenge our customers experience, whether it relates to exploring a new application, getting help in tackling a difficult sequence, or just gaining access to the right equipment."
For more information, visit: www.samplix.com/services
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CLI 180919 doc image

Turbidimetric free light chain assays for clinical chemistry analysers

, 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, has been developed specifically to quantify serum and “non-concentrated” urine samples on clinical chemistry analysers, by particle enhanced turbidimetric method. Assay parameters are available for the most extended analysers.
In order to ensure lot-to-lot consistent results, values have been traced to the European Reference Material ERM-DA470k/IFCC (Institute for Reference Materials and Measurements, IRMM).
Other available turbidimetric assays include IgD Immunoglobulins, bound & free light chains for serum and urine, C1q Complement, C5 Complement, C1 (Esterase) Inhibitor, Factor B (C3 Proactivator), Retinol Binding Protein (RBP) for serum and urine, Soluble Transferrin Receptor (sTfR), Hemopexin, Cystatin-C for serum and urine, Serum Amyloid A (SAA),…
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test analytical AYE combo

Characterising complex polymers in challenging solvents

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

The AYE Combo from Testa Analytical is a unique GPC/SEC detector designed to have a high performance refractometer as an integral part of a viscometer, allowing both concentration and viscosity to be measured at exactly the same time on the very same sample segment.
As a consequence the AYE Combo Refractometer / Viscometer detector enables a much more accurate determination of molecular parameters and is particular suitable for applications focused on determining the structure and branching of complex polymers.
GPC/SEC is widely acknowledged as a primary analytical technique for characterizing polymers. The latest generation of complex high performance polymers however, add a notable degree of complication by requiring the use of “challenging” solvents such as DMSO, DMF and HFIP to dissolve them. Unfortunately, most GPC/SEC systems require frequent maintenance when operating with these solvents.
Drawing upon pressure transducers made out the most stable alloy available combined with highest grade 316T capillary tubing the AYE Combo detector is gaining rapid recognition as the GPC/SEC detector of choice for characterizing complex polymers in challenging solvents.
For further information on the AYE Combo Refractometer / Viscometer detector, visit: https://www.testa-analytical.com/gpc-sec-chromatography.html
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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/test_analytical_AYE_combo.jpg 526 704 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:16:522021-01-08 11:20:29Characterising complex polymers in challenging solvents
PRODUCT CLI DIASYS

DiaSys assay for cardiovascular disease, stroke Lp-PLA2 biomarker

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

Lp-PLA2 (Lipoprotein-associated phospholipase A2) is an inflammatory enzyme expressed in atherosclerotic plaques. It is determined as an additional and vascular specific biomarker to predict risk for cardiovascular disease and stroke.
Guidelines from four major international societies (European Society of Cardiology, American College of Cardiology, American Heart Association and American Society of Endocrinology) recommend measurement of Lp-PLA2 for risk stratification in asymptomatic adults.
The liquid-stable, enzymatic DiaSys test Lp PLA2 FS, which determines the activity of the enzyme Lp-PLA2 in serum and plasma, has been available for many years. The assay covers a wide measuring range up to 2000 U/L, offers outstanding onboard and calibration stability and shows excellent precision at clinical cut-off levels. No significant interferences are observed by endogenous compounds; frequently used drugs for dyslipidemia and atherosclerosis do not affect the test.
As no reference method or material for Lp-PLA2 has been available, DiaSys applied the scientifically proven traceability to the reagent specific molar extinction coefficient of 4 nitrophenol to their parameter Lp-PLA2 FS. By this proceeding, DiaSys Lp-PLA2 FS is directly traceable to the Lp-PLA2 reaction product 4-nitrophenol.
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