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March 2026
The leading international magazine for Clinical laboratory Equipment for everyone in the Vitro diagnostics
Prins Hendrikstraat 1
5611HH Eindhoven
The Netherlands
info@clinlabint.com
PanGlobal Media is not responsible for any error or omission that might occur in the electronic display of product or company data.
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Haematex introduces Direct Oral Anticoagulant “dots”
, /in Product News /by 3wmediaHaematex has introduced Direct Oral Anticoagulants (DOACs) in the form of rapidlydissolving 500 nanogram “dots” on disposable plastic strips. They are stabilized in a thin, flexible film supported on a clear, inert backing. The film dissolves within 2 minutes in 1 ml of fluids such as blood, plasma or urine, thereby transferring the compound into samples. The effect of such inhibitors on individual plasmas can then be assessed using clotting or chromogenic tests.
The new supported film technology is adaptable to any potent, stable agent. It allows a library of compounds to be held as a flat collection rather than in vials, thereby allowing for more easy transport and storage.
Dabigatran-like, edoxaban-like, betrixabanlike, rivaroxaban-like and apixaban-like compounds are available. Heparin (0.3 Iu) is also available. All “dots” are colour-coded for recognition. They are especially useful for checking the effect of DOAC-extracting agents such as DOAC Stop™. They are also available in smaller sizes and in mini-tubes.
For more information, email: info@haematex.com or visit: www.haematex.com
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Biorad introduces Platelia SARS-CoV-2 Total Ab assay
, /in Product News /by 3wmediaAs COVID-19 continues to impact countries worldwide, accurate screening is needed to establish serological status of different populations. Bio-Rad now offers the Platelia SARS-CoV-2 Total Ab assay, for the detection of total anti-nucleocapsid antibodies (IgM, IgA, IgG) to SARS-CoV-2. In one test, the assay helps identify the immune response to coronavirus SARS-CoV-2, the virus associated with COVID-19.
For more information, visit: https://info.bio-rad. com/cdg-sars-cov-2-ous?WT.mc_id=200814028804
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New 39-minute COVID test available on Randox-Bosch Vivalytic platform
, /in Product News /by 3wmediaA rapid new coronavirus test, which provides results for Covid-19 in just 39 minutes, is now available on the Vivalytic, a point-of-care platform brought to market by Randox Laboratories and Bosch.
The test for detection of the SARS-CoV-2 pathogen is currently the fastest PCR test (the gold standard of test methods) worldwide, and is predestined for decentralized use in mobile test centres at service stations or in airports, so that people who take the test can obtain a reliable result while at the testing site.
The CE-approved test is now available in Europe. The test has a sensitivity of 98% and a specificity of 100%.
“This new rapid test will be a game-changer in the coronavirus testing landscape by allowing patients to receive their results at the point of care faster than before,” said Dr. Heather McMillan, Molecular R&D Manager at Randox Biosciences.
Randox and Bosch launched the first rapid test for the Vivalytic analyser at the end of March, after just six weeks’ development.
As a multiplex test, it simultaneously checks samples for the SARS-CoV-2 virus as well as nine other respiratory diseases in two and a half hours, whereas the new accelerated test is exclusively for SARS-CoV-2.
Marc Meier, president of Bosch Healthcare Solutions, cmmented: “With our different coronavirus tests and variable analysis strategies, we open up a range of testing scenarios with a Vivalytic device – from screening all the way to supporting differential diagnosis for similar symptoms.”
Development work for Covid-19 tests on the Vivalytic is ongoing: As of early October 2020, by pooling samples together it will be possible to simultaneously evaluate five samples in one test cartridge and at a comparable speed – a world first.
This will increase available testing capacity by enabling fully automated processing of more than 160 samples a day using a Vivalytic device.
Key benefits
The advantages of the rapid SARS-CoV-2 test on Vivalytic lie not only in speedy analysis, but also in ease of use. A sample is taken from the nose or throat using a swab, and placed in the test cartridge. Then the cartridge, which contains all the reagents required for the test, is inserted into the Vivalytic device for automated analysis.
For more information, email: marketing@randox.com
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Porvair’s pipette tips demonstrate high Bacterial Filtration Efficiency
, /in Product News /by 3wmediaA new independent study demonstrates Porvair Sciences proprietary pipette filter tips have greater than 99% Bacterial Filtration Efficiency (BFE) even at an increased challenge level.
The independent test procedure employed was modified from a standard BFE procedure, based upon ASTM F2101, in order to employ a more severe challenge than would be experienced in normal use.
For the testing a suspension of Staphylococcus aureus, ATCC #6538, was delivered to the pipette filter tip at a challenge level of greater than 105 colony forming units. The challenge was aerosolized using a nebulizer and delivered to the pipette filter tip under tests at a fixed air pressure and flow rate of 5 litres per minute. The aerosol droplets were generated in a glass aerosol chamber and drawn through the pipette filter tip into all glass impingers for collection. The challenge was delivered for a one-minute interval and sampling through the all glass impingers was conducted for two minutes to clear the aerosol chamber. Across a sample set of 10 pipette filters tips the testing demonstrated a mean filtration efficiency of 99.36%. All testing was performed in compliance with US FDA good manufacturing practice (GMP) regulations 21 CFR Parts 210, 211 and 820.
Moulded from Porvair’s proprietary Vyon® porous plastics, the pipette tip filters are fully compliant with FDA, USP Class VI and European Pharmacopoeia statutory regulations as well as being free from heavy metals. The unique combination of these ultra-clean materials, with excellent porosity properties, has produced a highly reproducible filtered pipette tip with an excellent edge finish that always provides an optimum fit into the pipette tip enabling labs to routinely achieve superior liquid handling and dispensing.
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Porvair Sciences introduces optimised microplates for affinity binding assays
, /in Product News /by 3wmediaPorvair Sciences new medium and high bind Krystal microplates set a new standard for uniform and reproducible capture of a wide range of biomolecules ready for affinity binding assays such as ELISA’s.
Manufactured from high-quality crystal polystyrene, these new automation-ready plates are available in a choice of ANSI / SLAS standard (96-well and breakable 8-well strip) formats. Offering working volumes up to 320 µl the new Krystal binding plates incorporate a flat bottom to ensure accurate assay detection.
Designed for hydrophobic passive adsorption of lipid-rich large biomolecules and antigens, including viral antigens, medium binding Krystal plates offer a binding capacity of approximately 100 to 200 ng IgG/cm².
The Krystal high binding plates are optimised for passive adsorption of proteins with different grades of hydrophilicity. Offering a binding capacity of 400 to 500 ng IgG/cm² these high bind plates are ideal for immunoassay of glycoproteins and serum samples.
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CE-marked Dynex Multiplier simplifies workflow
, /in Product News /by 3wmediaThe CE-marked Dynex Multiplier is a fully automated analyser that simplifies workflow. From the research laboratory to the clinical lab, the Multiplier ease-of-use reduces the pre-analytical steps while meeting results output with the power of multiplexing and the simplicity of automated ELISA. At the core of the Multiplier efficiency are the powerful automated processes that save time for system set up, reagent preparation, and specimen loading. Dynex SmartPLEX technology allows the simultaneous processing of up to 6 assays in a single well from a single patient sample.
With its large capacity to process 100 samples and provide up to 1200 results for these samples, very high lab productivity and reagent savings can be achieved.
For more information, visit: https://www.dynextechnologies.com/multiplierelisa- mutliplexing-technology.php
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Alpha Labs’ Pyrostar provides quick, reliable endotoxin and β-glucan testing
, /in Product News /by 3wmediaEndotoxin testing is a vital, regulatory mandated assay for all injectable or implantable products. Pyrostar, now available in the UK from Alpha Laboratories, enables in-house endotoxin testing, providing full control over one of the most important aspects of quality control and offering many benefits over outsourcing.
With samples tested in-house results are available as soon as the assay finishes. The flexible system offers assays in different formats and pack sizes, at a range of sensitivities, allowing you to tailor your testing and workflow to your needs.
The FUJIFILM Wako Pyrostar range provides three highly sensitive assays; Gel Clot Assay (GCA), Kinetic Turbidimetric Assay (KTA) and Kinetic Colorimetric Assay (KCA), for use with the ET-7000 toxinometer. These are all based on the long established and trusted Limulus Amebocyte Lysate (LAL) method, testing for the presence of bacterial endotoxins and β-glucans and ensuring that your products are safe and pyrogen free. The GCA and KTA assays have been approved by the FDA when used with the Part 11 software, PC and testing module set.
Alpha laboratories can supply all the reagents, accessories, consumables, equipment and support necessary for this testing, providing you a one stop shop for all your endotoxin testing needs.
For more information, visit www.alphalabs.co.uk
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New Liquid Chromatography-Mass Spectrometry Workstream offers comprehensive solution for toxicology
, /in Product News /by 3wmediaClinical research, forensic and anti-doping toxicology laboratories facing the challenges of analysing increasing numbers of analytes in biological matrices, can now easily and rapidly optimize their liquid chromatography-mass spectrometry (LC-MS) methods for targeted screening and quantification with the new Thermo Scientific Tox Explorer Collection.
The Tox Explorer Collection offers a comprehensive LC-MS workstream for toxicology assays. It consists of proven methods enabling toxicology laboratories to achieve accurate, high-resolution data, regardless of analyte type, matrix complexities or user expertise.
The Tox Explorer Collection consists of a comprehensive library of analytes, allowing for faster identification and targeted screening assays with 1,500 compounds confirmed in a single analysis.
The Thermo Scientific Tox Explorer Collection is compromised of the following components:
“Toxicology laboratories must ensure they carry out reliable, reproducible and sensitive analyses with a quick turnaround, using numerous instruments and software to ensure thorough sample screening,” said Brad Hart, senior director, clinical research, chromatography and mass spectrometry, Thermo Fisher Scientific.
“The Thermo Scientific Tox Explorer Collection provides a robust, consistent, all-in-one LC-MS workstream, with an extensive library of analytes to allow for high-performance, targeted analyte screening on a daily basis.”
To accompany the Tox Explorer Collection, Thermo Fisher Scientific offers a strong customer support network, comprising a comprehensive training and application support package. The package is coupled with a complete start-up guide that includes installation and method instructions.
For more information, visit: www.thermofisher.com/ToxExplorer
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PrimeStore MTM novel viral transport media successfully evaluated by Public Health England for SARS-CoV-2 inactivation
, /in Product News /by 3wmediaEKF Diagnostics’ novel viral transport media PrimeStore MTM (Molecular Transport Medium) has been successfully evaluated for effective SARS-CoV-2 inactivation in a new study published by Public Health England (PHE). To work safely with live SARS-CoV-2 samples requires the use of high-containment laboratories. However, after inactivation SARS-CoV-2 material can be handled at a lower containment level, allowing more laboratories to undertake testing and thereby increasing COVID-19 testing capacity.
The PHE study evaluated numerous commercially available reagents and laboratory formulations commonly used for viral inactivation protocols by public health agencies and research laboratories globally. All the reagents tested have been used during the current COVID-19 pandemic for sample transportation and subsequent molecular processing. A total of 23 commercial reagents designed for virus inactivation, clinical sample transportation and nucleic acid extraction were assessed by PHE for their ability to inactivate SARS-CoV-2.
The study used TCID50 and blind passage techniques to test for any infectious virus still recoverable from all samples treated with the inactivation reagents. Notably, the study showed that PrimeStore MTM was the only commercially available transport reagent from the many tested from which no residual virus was detectable by either TCID50 or by the passaging of treated purified sample. This demonstrates the efficacy and safety of PrimeStore MTM in inactivating live SARS-CoV-2 samples whilst maintaining the ability to detect the target viral RNA.
In addition to this successful PHE evaluation of its effectiveness at deactivating SARS-CoV-2, PrimeStore MTM is also an FDA cleared and CE-IVD marked sample collection device. PrimeStore MTM removes the need for all cold chain logistics including sample storage; RNA and DNA are perfectly preserved for downstream molecular processing for up to four weeks at room temperature. Furthermore, because samples are rapidly inactivated, the risk of infection is eliminated, meaning samples are ready for safe testing immediately on arrival at a laboratory.
For more information, visit: www.ekfdiagnostics.com
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Randox Labs unveils ‘All in One’ COVID-19 diagnostic analyser
, /in Product News /by 3wmediaRandox Laboratories has unveiled Randox Discovery, a revolutionary COVID-19 diagnostic analyser. The benchtop laboratory for molecular and immunoassay diagnostics is the first of its kind to combine sample preparation techniques and Biochip Technology – a patented multiplex testing platform – in one high throughput fully-automated analyser.
Randox’s patented Biochip Technology allows simultaneous detection of hundreds of targets from a single sample. The technology is capable of detecting SARS-CoV-2 and differentiating between other respiratory pathogens with similar symptoms. It can detect all known strains of coronavirus comprising SARS-CoV-2, Sarbecovirus (SARS, SARS-like & SARS-CoV-2), coronavirus 229E, coronavirus NL63, coronavirus OC43 and coronavirus HKUI.
The combination of both SARS-CoV-2 and Sarbecovirus on the panel provides added confidence in patient diagnosis and helps to reduce false positives or negatives. This ultimately enables better treatment decisions and allows for more effective isolation and de-isolation of suspected and confirmed cases.
The Discovery has a rapid turnaround time with three hours to first batch of results and results for subsequent batches every hour after.
It is fully automated enabling a single operator to run up to 3 Discovery analysers.
For more information, visit: www.randox.com/randox-discovery/
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