Thermo Fisher Scientific has expanded deployment model options for SampleManager LIMS software, offering laboratories end-to-end support of the software deployment in the Amazon Web Services (AWS) Cloud.
Under a contract agreement, Thermo Fisher will manage the entire deployment process from installation and maintenance to backup and recovery. As a result, laboratories will benefit from significantly reduced financial and human resource investment associated with setting-up, running and maintaining traditional on-premise deployments or deployments to their own cloud hosting service.
At the same time, laboratories will retain control over the software upgrades and validation schedule, while taking advantage of unlimited and secure access to data from anywhere at any time, which will drive well-informed decision making and easier cross-collaboration. Furthermore, AWS Cloud deployment will enable unparalleled levels of scalability, with the LIMS expanding to meet evolving business needs.
Richard Milne, vice president and general manager of Digital Science, said: “Life science and industrial laboratories are increasingly adopting a cloud-first approach to enterprise-wide LIMS implementation. However, managing deployments to a laboratory’s own cloud hosting service can be a costly and resource-intensive process. We have developed the new cloud services to alleviate this burden and enable SampleManager LIMS software customers to use the system’s superior functionality and integration capabilities without having to invest significant resources into the setup and ongoing management of a cloud environment.”
The Cloud Services offering has been designed to provide optimal data security and protection. In addition to the security features available through standard AWS Cloud deployments, Thermo Fisher also implements its own robust Corporate Information Security (CIS) program, which outlines additional measures in line with security-by-design principles to maintain the confidentiality and integrity of data.
https://clinlabint.com/wp-content/uploads/sites/2/2021/01/thermo_fisher.jpg86616643wmediahttps://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png3wmedia2020-12-23 00:00:002020-12-23 00:00:00Thermo Fisher’s new deployment model optimises LIMS implementation in Amazon Web Services cloud
ELITechGroup Molecular Diagnostics, a leading global provider of diagnostic testing products, passed a significant milestone early August with the distribution of more than 3.5 million SARS-CoV-2 tests worldwide. The company has also installed more than 500 of its lead diagnostics instrument, the ELITe InGenius polymerase chain reaction (PCR) system, globally, with over a hundred placed since the beginning of the pandemic. The system allows laboratories to reliably detect SARS-CoV2 in only a few hours, as well as conducting parallel testing for other diseases, such as flu, in order to ensure a correct diagnosis.
The ELITe InGenius has been widely used in hospitals and other healthcare settings since 2016, and ELITechGroup was among the first companies to have SARS-CoV-2 tests on a sample-to-result system.
The ELITe InGenius is a fully automated solution that can process 12 samples in parallel to deliver results in less than 2.5 hours. This brings several benefits over centralized high-throughput testing approaches as there is no waiting for a large batch of samples to accumulate before testing, and no delays from sending samples off premises to a central laboratory.
By performing extraction, amplification and result interpretation in one device, the ELITe InGenius replaces the multiple devices needed to perform such tasks separately. Full automation also means there is no need for constant supervision, allowing laboratory staff to perform other valuable work. More importantly, the limited hands-on time helps reduce the risk of infection for users. The instrument is straightforward to use, with only minimal training required from ELITechGroup’s service and support team.
The ELITe InGenius offers the widest molecular diagnostics menu available on a sample-to-result system, with 38 CE-IVD assays dedicated to the unique needs of healthcare settings, be it immunocompromised patient monitoring; detection of respiratory, gastro-intestinal, sexually transmitted or nosocomial infections; meningitis and encephalitis, as well as diagnostics of genetic factors.
Commenting on the advantages of the ELITe InGenius for hospital settings, Dr Anna Paola Callegaro, Virology Area Coordinator and Biobank UOSD Director of ASST Papa Giovanni XXIII – Bergamo (Italy), commented: “The modular configuration of the ELITe InGenius system enables us to carry out molecular virology routine with results on the day. The sample-to-result solution reduces the need for manual intervention by the technician and allows the analysis of multiple viral targets on the same sample, thereby significantly improving the lab’s efficiency.”
Christoph Gaue, ELITechGroup CEO, said the company has expanded their manufacturing capacity to help provide additional ELITe InGenius systems to hospitals and laboratories, globally.
For more information, visit: www.elitechgroup.com Read more
https://clinlabint.com/wp-content/uploads/sites/2/2021/01/7_PRODUCT_ELITECHGROUP.jpg3984673wmediahttps://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png3wmedia2020-12-23 00:00:002020-12-23 00:00:00ELITechGroup Molecular Diagnostics distributes 3.5 million SARS-CoV-2 tests
Anti-SARS-CoV-2 antibodies can be determined quickly and efficiently in capillary blood (dried blood spots) using the CE-marked test and automation systems from EUROIMMUN.
The Blood Collection Set enables fast and convenient collection of blood from the fingertip by patients or healthcare professionals. The card containing the dried blood spots is then sent to a diagnostic lab without the need for cooling.
For the serological analysis EUROIMMUN exclusively offers two ELISAs for detection of IgG antibodies against the spike protein S1 domain or against modified nucleocapsid protein (NCP). The S1 antigen includes the immunologically relevant receptor binding domain, which is a key target of neutralisation antibodies.
Results obtained with the S1-based ELISA correlate well with those of neutralisation tests. NCP is the most immunodominant antigen of coronaviruses. The antigen used in the ELISA has been modified to contain only the diagnostically relevant epitopes, thus providing optimised performance.
The S1- and NCP-based IgG ELISAs demonstrate specificities of 99.6% and 99.8% and sensitivities of 94.4% and 94.6% respectively.
Parallel use of both ELISAs maximises the accuracy of SARS-CoV-2 antibody detection and can support determination of the SARS-CoV-2 antibody status before and after administration of future S1-based vaccines or antibody therapies.
The ELISAs can be processed automatically with high throughput on the EUROLab- Workstation ELISA. During processing the samples are clearly identified by means of barcodes ensuring a smooth traceable workflow. The dried blood spot analysis enriches EUROIMMUN’s portfolio for COVID-19 diagnostics, which also includes IgM and IgA ELISAs, as well as the EURORealTime SARS-CoV-2 for sensitive direct virus detection by PCR.
For more information, visit: www.coronavirus-diagnostics.com Read more
https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png003wmediahttps://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png3wmedia2020-12-23 00:00:002023-12-15 10:23:01EUROIMMUN’s test detects SARS-CoV-2 antibodies from dried blood spots
Greiner Bio-One has launched their VeinViewer® which makes veins visible and helps to improve the success rate of an initial venipuncture. This significantly increases patient satisfaction and safety.
The VeinViewer uses harmless near-infrared (NIR) light which is directed towards the patient’s skin. Haemoglobin in the blood absorbs the NIR light and the surrounding tissue reflects it back to the VeinViewer device, where the data is processed into an image. Colour is added and the image is reflected on to the skin to provide a real time visualization of the blood vessels up to 10 mm below the skin.
High definition imaging technology helps provide clinicians with clear, sharp imaging which is particularly useful when vein visibility is poor.
Two VeinViewer devices are available. VeinViewer Flex is a portable device for use in emergency situations. It can also be made static by using the flexible arm to attach it to a table top or chair arm for example, which is useful when space is limited.
The VeinViewer Vision2 is a mobile imaging unit with an arm reaching up to 1.35 metres. It is attached to a trolley for easy transportation between beds or phlebotomy chairs.
For more information, visit: www.gbo.com Read more
https://clinlabint.com/wp-content/uploads/sites/2/2021/01/4_PRODUCT_GREINER_BIO-ONE.jpg4727103wmediahttps://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png3wmedia2020-12-23 00:00:002020-12-23 00:00:00Greiner Bio-One’s VeinViewer makes veins visible for venipuncture
Awareness Technology has recently introduced their ChemWell RPR Automated Nontreponemal analyser for the detection of syphilis. The company reports that it is the “most significant innovation to syphilis testing in the last 30 years”.
The analyser provides qualitative testing and screening for syphilis in human serum or plasma utilizing an advanced camera and software algorithm to analyse each sample.
In place of manual RPR cards, the system uses 4 standard 48-well microwell plates to analyse up to 192 samples per hour with no user intervention. High-resolution images captured by an advanced optical system are interpreted by a proven algorithm and provide an accurate and reliable negative or positive result based on the captured images.
An additional test can be run on positive samples to determine titers up to 1:2048 dilution for therapeutic monitoring. The software is included with the instrument at no additional cost and features an intuitive interface that allows for easy navigation and use.
Automated features such as fluid handling, mixing, timing, image capture, image processing, and reporting are all handled by the software.
Awareness Technology, with HQ in Palm City, Florida, US, develops, manufactures, and markets high quality in-vitro diagnostic instrumentation, and diagnostic test kits.
For more information, visit: www.awaretech.com Read more
https://clinlabint.com/wp-content/uploads/sites/2/2021/01/1_PRODUCT_AWARENESS_TECHNOLOGY.jpg3497113wmediahttps://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png3wmedia2020-12-23 00:00:002020-12-23 00:00:00Awareness Technology’s new analyser improves syphilis testing
TRIMERO’s new generation of Free Light Chain (FLC) assays, called KLoneus, includes an IVD CE marked assay for testing Kappa and Lambda FLC in non-concentrated urine samples on Siemens’ BN nephelometric systems.
The main features of the assays are:
particle enhanced nephelometric method
specifically developed to assay urine samples
based on polyclonal specific antibodies
with antigen excess control using the pre-reaction feature
values traced to the European Reference Material ERM-DA470k/IFCC (Institute for Reference Materials and Measurements, IRMM), in order to ensure consistent results and good correlation with other methods (urinary B&F Light Chain nephelometric assays, and BJP estimation by densitometry).
KLoneus FLC assays are also available for Beckman Coulter’s IMMAGE nephelometers and for the most popular clinical chemistry analysers. Other available assays for Siemens’ BN systems include: C1q Complement, C5 Complement, C3 pro-activator (Factor B) and IgD Immunoglobulins.
For more information, visit: www.3diag.com Read more
https://clinlabint.com/wp-content/uploads/sites/2/2021/01/6C_PRODUCT_TRIMERO.jpg7015603wmediahttps://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png3wmedia2020-12-23 00:00:002020-12-23 00:00:00TRIMERO’s Free Light Chain assays CE marked for testing Kappa and Lambda FLC
Haematex 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 Read more
https://clinlabint.com/wp-content/uploads/sites/2/2021/01/3B_PRODUCT_HAEMATEX.jpg7146703wmediahttps://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png3wmedia2020-12-23 00:00:002020-12-23 00:00:00Haematex introduces Direct Oral Anticoagulant “dots”
As 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 Read more
https://clinlabint.com/wp-content/uploads/sites/2/2021/01/2A_PRODUCT_BIO-RAD.jpg5129723wmediahttps://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png3wmedia2020-12-23 00:00:002020-12-23 00:00:00Biorad introduces Platelia SARS-CoV-2 Total Ab assay
A 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.
Turnaround time of 39 mins from sample entry to result.
The SARS-CoV-2 rapid test has recently received CE marking.
The SARS-CoV-2 pooling test can run up to 5 samples on-board a single cartridge.
Easy 4-step user-friendly process from sample entry to result. Minimal training required.
Detection from real-time PCR from Nasopharyngeal and/or Oropharyngeal swab.
Suitable for use in any laboratory and non-laboratory settings.
For more information, email: marketing@randox.com Read more
https://clinlabint.com/wp-content/uploads/sites/2/2021/01/randox_rapid_test__1_.jpg9409243wmediahttps://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png3wmedia2020-12-23 00:00:002020-12-23 00:00:00New 39-minute COVID test available on Randox-Bosch Vivalytic platform
A 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.
For more information, visit: https://www.vyonporousplastics.com/pipette-tip-filters/
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Thermo Fisher’s new deployment model optimises LIMS implementation in Amazon Web Services cloud
, /in Product News /by 3wmediaThermo Fisher Scientific has expanded deployment model options for SampleManager LIMS software, offering laboratories end-to-end support of the software deployment in the Amazon Web Services (AWS) Cloud.
Under a contract agreement, Thermo Fisher will manage the entire deployment process from installation and maintenance to backup and recovery. As a result, laboratories will benefit from significantly reduced financial and human resource investment associated with setting-up, running and maintaining traditional on-premise deployments or deployments to their own cloud hosting service.
At the same time, laboratories will retain control over the software upgrades and validation schedule, while taking advantage of unlimited and secure access to data from anywhere at any time, which will drive well-informed decision making and easier cross-collaboration. Furthermore, AWS Cloud deployment will enable unparalleled levels of scalability, with the LIMS expanding to meet evolving business needs.
Richard Milne, vice president and general manager of Digital Science, said: “Life science and industrial laboratories are increasingly adopting a cloud-first approach to enterprise-wide LIMS implementation. However, managing deployments to a laboratory’s own cloud hosting service can be a costly and resource-intensive process. We have developed the new cloud services to alleviate this burden and enable SampleManager LIMS software customers to use the system’s superior functionality and integration capabilities without having to invest significant resources into the setup and ongoing management of a cloud environment.”
The Cloud Services offering has been designed to provide optimal data security and protection. In addition to the security features available through standard AWS Cloud deployments, Thermo Fisher also implements its own robust Corporate Information Security (CIS) program, which outlines additional measures in line with security-by-design principles to maintain the confidentiality and integrity of data.
Read more
ELITechGroup Molecular Diagnostics distributes 3.5 million SARS-CoV-2 tests
, /in Product News /by 3wmediaELITechGroup Molecular Diagnostics, a leading global provider of diagnostic testing products, passed a significant milestone early August with the distribution of more than 3.5 million SARS-CoV-2 tests worldwide. The company has also installed more than 500 of its lead diagnostics instrument, the ELITe InGenius polymerase chain reaction (PCR) system, globally, with over a hundred placed since the beginning of the pandemic. The system allows laboratories to reliably detect SARS-CoV2 in only a few hours, as well as conducting parallel testing for other diseases, such as flu, in order to ensure a correct diagnosis.
The ELITe InGenius has been widely used in hospitals and other healthcare settings since 2016, and ELITechGroup was among the first companies to have SARS-CoV-2 tests on a sample-to-result system.
The ELITe InGenius is a fully automated solution that can process 12 samples in parallel to deliver results in less than 2.5 hours. This brings several benefits over centralized high-throughput testing approaches as there is no waiting for a large batch of samples to accumulate before testing, and no delays from sending samples off premises to a central laboratory.
By performing extraction, amplification and result interpretation in one device, the ELITe InGenius replaces the multiple devices needed to perform such tasks separately. Full automation also means there is no need for constant supervision, allowing laboratory staff to perform other valuable work. More importantly, the limited hands-on time helps reduce the risk of infection for users. The instrument is straightforward to use, with only minimal training required from ELITechGroup’s service and support team.
The ELITe InGenius offers the widest molecular diagnostics menu available on a sample-to-result system, with 38 CE-IVD assays dedicated to the unique needs of healthcare settings, be it immunocompromised patient monitoring; detection of respiratory, gastro-intestinal, sexually transmitted or nosocomial infections; meningitis and encephalitis, as well as diagnostics of genetic factors.
Commenting on the advantages of the ELITe InGenius for hospital settings, Dr Anna Paola Callegaro, Virology Area Coordinator and Biobank UOSD Director of ASST Papa Giovanni XXIII – Bergamo (Italy), commented: “The modular configuration of the ELITe InGenius system enables us to carry out molecular virology routine with results on the day. The sample-to-result solution reduces the need for manual intervention by the technician and allows the analysis of multiple viral targets on the same sample, thereby significantly improving the lab’s efficiency.”
Christoph Gaue, ELITechGroup CEO, said the company has expanded their manufacturing capacity to help provide additional ELITe InGenius systems to hospitals and laboratories, globally.
For more information, visit: www.elitechgroup.com
Read more
EUROIMMUN’s test detects SARS-CoV-2 antibodies from dried blood spots
, /in Product News /by 3wmediaAnti-SARS-CoV-2 antibodies can be determined quickly and efficiently in capillary blood (dried blood spots) using the CE-marked test and automation systems from EUROIMMUN.
The Blood Collection Set enables fast and convenient collection of blood from the fingertip by patients or healthcare professionals. The card containing the dried blood spots is then sent to a diagnostic lab without the need for cooling.
For the serological analysis EUROIMMUN exclusively offers two ELISAs for detection of IgG antibodies against the spike protein S1 domain or against modified nucleocapsid protein (NCP). The S1 antigen includes the immunologically relevant receptor binding domain, which is a key target of neutralisation antibodies.
Results obtained with the S1-based ELISA correlate well with those of neutralisation tests. NCP is the most immunodominant antigen of coronaviruses. The antigen used in the ELISA has been modified to contain only the diagnostically relevant epitopes, thus providing optimised performance.
The S1- and NCP-based IgG ELISAs demonstrate specificities of 99.6% and 99.8% and sensitivities of 94.4% and 94.6% respectively.
Parallel use of both ELISAs maximises the accuracy of SARS-CoV-2 antibody detection and can support determination of the SARS-CoV-2 antibody status before and after administration of future S1-based vaccines or antibody therapies.
The ELISAs can be processed automatically with high throughput on the EUROLab- Workstation ELISA. During processing the samples are clearly identified by means of barcodes ensuring a smooth traceable workflow. The dried blood spot analysis enriches EUROIMMUN’s portfolio for COVID-19 diagnostics, which also includes IgM and IgA ELISAs, as well as the EURORealTime SARS-CoV-2 for sensitive direct virus detection by PCR.
For more information, visit: www.coronavirus-diagnostics.com Read more
Greiner Bio-One’s VeinViewer makes veins visible for venipuncture
, /in Product News /by 3wmediaGreiner Bio-One has launched their VeinViewer® which makes veins visible and helps to improve the success rate of an initial venipuncture. This significantly increases patient satisfaction and safety.
The VeinViewer uses harmless near-infrared (NIR) light which is directed towards the patient’s skin. Haemoglobin in the blood absorbs the NIR light and the surrounding tissue reflects it back to the VeinViewer device, where the data is processed into an image. Colour is added and the image is reflected on to the skin to provide a real time visualization of the blood vessels up to 10 mm below the skin.
High definition imaging technology helps provide clinicians with clear, sharp imaging which is particularly useful when vein visibility is poor.
Two VeinViewer devices are available. VeinViewer Flex is a portable device for use in emergency situations. It can also be made static by using the flexible arm to attach it to a table top or chair arm for example, which is useful when space is limited.
The VeinViewer Vision2 is a mobile imaging unit with an arm reaching up to 1.35 metres. It is attached to a trolley for easy transportation between beds or phlebotomy chairs.
For more information, visit: www.gbo.com
Read more
Awareness Technology’s new analyser improves syphilis testing
, /in Product News /by 3wmediaAwareness Technology has recently introduced their ChemWell RPR Automated Nontreponemal analyser for the detection of syphilis. The company reports that it is the “most significant innovation to syphilis testing in the last 30 years”.
The analyser provides qualitative testing and screening for syphilis in human serum or plasma utilizing an advanced camera and software algorithm to analyse each sample.
In place of manual RPR cards, the system uses 4 standard 48-well microwell plates to analyse up to 192 samples per hour with no user intervention. High-resolution images captured by an advanced optical system are interpreted by a proven algorithm and provide an accurate and reliable negative or positive result based on the captured images.
An additional test can be run on positive samples to determine titers up to 1:2048 dilution for therapeutic monitoring. The software is included with the instrument at no additional cost and features an intuitive interface that allows for easy navigation and use.
Automated features such as fluid handling, mixing, timing, image capture, image processing, and reporting are all handled by the software.
Awareness Technology, with HQ in Palm City, Florida, US, develops, manufactures, and markets high quality in-vitro diagnostic instrumentation, and diagnostic test kits.
For more information, visit: www.awaretech.com
Read more
TRIMERO’s Free Light Chain assays CE marked for testing Kappa and Lambda FLC
, /in Product News /by 3wmediaTRIMERO’s new generation of Free Light Chain (FLC) assays, called KLoneus, includes an IVD CE marked assay for testing Kappa and Lambda FLC in non-concentrated urine samples on Siemens’ BN nephelometric systems.
The main features of the assays are:
KLoneus FLC assays are also available for Beckman Coulter’s IMMAGE nephelometers and for the most popular clinical chemistry analysers. Other available assays for Siemens’ BN systems include: C1q Complement, C5 Complement, C3 pro-activator (Factor B) and IgD Immunoglobulins.
For more information, visit: www.3diag.com
Read more
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
Read more
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
Read more
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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