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Serum total bile acid (TBA) levels are a sensitive marker of liver function and may be used for diagnosis and monitoring of various liver diseases. Increased serum TBA levels are associated with diseases such as acute and chronic hepatitis, intrahepatic cholestasis of pregnancy (ICP), liver sclerosis, cirrhosis, and cancer; TBA may as well detect hepatic dysfunction. Conventional liver tests such as ALT and AST cannot provide this because they are indicators for hepatocellular integrity. TBA measurement corresponds to the sum of more than 20 individual bile acids synthetized by the liver, modified by gut bacteria, and involved in complex enterohepatic circulation. Commercially available assays show limitations regarding the detection of individual primary and secondary bile acids. The new DiaSys reagent, Total bile acids 21 FS, is an enzyme cycling assay which enables assessment of all relevant bile acids in a sample and hence offers the possibility to precisely cover all stages of liver diseases. The new liquid-stable, ready-to-use reagent provides a wide measuring range, outstanding precision and shows significantly reduced interferences compared with nitrotetrazolium blue (NBT) methods.
Germany-based Tosoh Bioscience has introduced SkillPak 1 mL and 5 mL pre-packed process development columns designed for fast method development and resin screening of monoclonal antibodies, antibody constructs, oligonucleotides, proteins, and viruses.
Tosoh Bioscience, a subsidiary of Tosoh Corporation in Japan, specialises in providing chromatographic solutions for the separation and purification of biomolecules.
Pre-packed with TOYOPEARL®, TSKgel® or Ca++Pure-HA® process chromatography media, SkillPak 1 mL and 5 mL columns deliver high performance and offer scalability and convenience. These columns are ready to use upon receipt and show excellent physical strength and ideal flow characteristics for industrial downstream processing. The pre-packed columns are available with short delivery times in affinity, anion and cation exchange, hydrophobic interaction and size exclusion chromatographic modes. Optimal performance is guaranteed with the columns and they can be operated directly with commonly used low or medium pressure liquid chromatography systems.
SkillPak 1 mL and 5 mL pre-packed columns are available for sale in Europe, Africa and the Middle East.
For more information, visit: https://www.separations. eu.tosohbioscience.com/solutions/process-mediaproducts/ process-development/skillpak
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The Calprotectin semi-quantitative rapid test kit, distributed by BioPlastic, is a medical diag-
nostic device (immunochromatographic card) for rapid and semi-quantitative detection of calcprotectin (a cytosolic protein of neutophilic cells and inflammatory biomarker in gastrointestinal diseases) in human stool samples: the particular analytical characteristics of this method allow semi-quantitative discrimination at three levels of concentration: for analyte concentrations less than 15 μg/g, for concentrations between 15 and 60 μg/g and for concentrations above 60 μg/g, thus allowing a risk assessment (minimum, low and high risk) for inflammatory bowel disease. The test is rapid (10 minutes) and shows a correlation close to 95 % when com-pared with EIA methods. The kit contains immunochemical reactive cards (immuno-chromatographic membrane and particles coated with anti-calprotectin antibodies conjugated with colloidal gold) and sample collection tubes containing the extraction buffer. Each kit contains the necessary to quickly perform 10 semi-quantitative determinations of fecal calprotectin.
Sebia is expanding its offer with two innovative CE-IVD marked assays for the determination of serum free light chains: sebia FLC Kappa and sebia FLC Lambda. Serum free light chain assays (sFLC) form part of the diagnosis, prognosis and monitoring of multiple myeloma and other monoclonal gammopathies.
Sebia FLC Kappa and sebia FLC Lambda are clinically validated for patient diagnosis and follow-up. These tests are not affected by the analytical limits observed on the current nephelometric and turbidimetric methods used, i.e. antigen excess leading to underestimation of the result, small measuring range resulting in many re-dilutions and overestimation of the sFLC value leading to a discrepancy with electrophoresis results.
Overcoming these limitations, sebia FLC provides the added benefits of a significant cost reduction and a major improvement of the analytical performance.
With this next generation of serum free light chain assays, Sebia complements the existing range of electrophoresis tests for myeloma.
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Shimadzu introduces Analytical Intelligence value adding approach /
Fully supports ‘Excellence in Science’ brand proposition /
First solutions released with Analytical Intelligence functions /
Shimadzu, one of the world leaders in analytical instrumentation, applies a new qualitative approach to its hardware and software solutions, benefitting the users with a surplus of lab productivity and profitability. Under the umbrella of Analytical Intelligence, more and more analytical systems will be equipped with automated functions relieving users from organizational, input and processing works. As a first step, Analytical Intelligence functions are incorporated in selected system solutions such as the new Nexera series of (U)HPLC systems as well as the UV-i Selection spectrophotometers and the Nexis SCD-2030 sulfur chemiluminescence detection system.
Analytical Intelligence allows systems to detect and resolve issues automatically, enabling users to easily review instrument status, optimize resource allocation and achieve higher throughput. In a nutshell, the concept
Fully supports ‘Excellence in Science’
Analytical Intelligence goes hand in hand with Shimadzu’s ‘Excellence in Science’ brand value proposition, representing the company’s scientific and technological approach to always providing business and research solutions with the most modern analytical systems. Numerous ‘world’s firsts’ which meanwhile have become industrial standards as well as increasingly sensitive measuring methods substantiate this claim. With these technologies, Shimadzu enables customers from the most diverse industries to develop new products and solutions to promote and support consumer, patient and product safety as well as environmental protection.
The first solutions being equipped with Analytical Intelligence functions
Web summary
Shimadzu, one of the world leaders in analytical instrumentation, applies a new qualitative approach to its hardware and software solutions, benefitting the users. It integrates Analytical Intelligence with automated support functions utilizing digital technology, such as M2M, IoT and Artificial Intelligence (AI) enabling higher productivity, maximum reliability and better connectivity. As a first step, selected system solutions incorporating Analytical Intelligence include the Nexera series of (U)HPLC systems, the new UV-i Selection spectrophotometers and the Nexis SCD-2030 sulfur chemiluminescence detection system.
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The Diatron Aquila 5Dretics is a new member of the Aquila family designed to deliver quality results and is suitable for use in many environments including centralized and de-centralized laboratories plus near-patient testing. The Diatron Aquila 5Dretics with a maximum throughput of 80 tests/hour will be the smallest and most compact cap piercing 5-part diff analyser with reticulocytes available on the market. The instrument has low reagent consumption (<30ml), requires only a small sample volume (40ul) and has a continuous loading autoloader, making the analyser a walk-away system convenient for all customers. User-defined rerun/reflex rules standardize decision criteria and reduce turn-around time (TAT). Being a fully optical system, the Diatron Aquila 5D uses only two reagents, meaning the instrument has low reagent consumption to position the Aquila 5Dretics as the most cost-efficient hematology instrument on the market. The newly available analyser, while requiring little bench space (32cm W x 30cm D x 37cm H without autoloader), features a large touch screen, an intuitive user interface and a protected reagent pack system with unique connection.
T2 Biosystems’ T2Bacteria® and T2Candida® Panels are the first and only FDA-cleared and CE-marked tests that identify the most serious bacterial and fungal pathogens directly from blood sample in just three to five hours, without waiting for a positive blood culture —which can take one to six or more days. These capabilities allow for faster species identification, enabling the potential for faster targeted treatment, de-escalation of empiric therapy and improved patient outcomes.
All T2Direct DiagnosticsTM panels are run on the T2Dx® Instrument using a patient’s blood sample with validated clinical sensitivity of 91 to 96% and specificity of 98 to 99%. The direct from blood capability is enabled by the proprietary T2MR-powered T2Dx® Instrument which can detect organisms at concentrations as low as 1 CFU/mL. This represents a thousandfold increase in sensitivity compared to products that detect species from positive blood culture bottles where the number of cells is typically in the range of 10,000 to 10,000,000 CFUs/mL.
T2 Biosystems recently received FDA Breakthrough Designation for the T2ResistanceTM Panel, a diagnostic panel that can detect 13 resistance genes from both gram-positive and gram-negative pathogens from a single patient blood sample in 3 to 5 hours. The T2Resistance Panel is also run on the T2Dx instrument and is expected to be CE-marked and available in Europe by the end of 2019, and offered as a Research Use Only product in the United States before yearend.
T2 Biosystems will showcase its latest innovations at ECCMID at Booth #1.22.
Beckman Coulter’s Access SARS-CoV-2 IgG assay is now available in markets accepting the CE Mark, the company said in statement 15 June. It has already shipped tests to more than 400 hospitals, clinics and diagnostics laboratories in the United States and has begun shipping to customers globally. Beckman Coulter has more than 16,000 immunoassay analysers worldwide and has increased manufacturing to deliver more than 30 million tests a month.
Many of Beckman Coulter’s analysers can deliver up to 400 routine tests an hour. The Access SARS-CoV-2 IgG test can also be run on Beckman Coulter’s Access 2 analyser, a compact table-top analyser enabling high-quality serology testing to be carried out in small hospitals and clinics.
The Access SARS-CoV-2 IgG Assay is a qualitative immunoassay that detects IgG antibodies directed to the receptor-binding domain of the spike protein of the novel coronavirus that is driving the ongoing global pandemic. It is believed that these antibodies have the potential to be neutralizing antibodies and may play a role in lasting immunity. The test has a confirmed 99.8% specificity and 100% sensitivity at 18 days post PCR confirmed positive test. The assay uses immobilized virus antigens on magnetic particles to capture IgG antibodies from patient serum or plasma samples and reveals them using labelled anti-IgG antibodies.
Commenting on the assay, Shamiram R. Feinglass, M.D., MPH, Chief Medical Officer, Beckman Coulter, said: “An IgG antibody assay such as the test Beckman Coulter has developed can provide valuable information regarding community levels of immunity that will inform public health decision making and rollout of a vaccine when one does become available. The very high sensitivity and specificity of this assay provides a high positive predictive value, even when the overall incidence of disease is low. Additionally, since our assay can be run on multiple different types of analysers, it can be adapted to a variety of healthcare settings to best meet the needs of each community.”
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Molecular diagnostics is known to have superior advantages for routine detection of infectious diseases and now has a very prominent place in clinical laboratories. Based on the principle of DNA/RNA amplification, molecular diagnostic techniques help in early diagnosis of infectious diseases, providing the added edge of excellent sensitivity and specificity. However, this technique has, thus far, been limited to centralized laboratories due to dependency on complex and expensive infrastructure, highly skilled manpower, special storage conditions and a need for batch testing. This results in high turn-around time and poses major logistics challenges, such as sample degradation, contamination, report delays, etc.
Molbio Diagnostics Pvt Ltd has developed and commercialized Truelab™, a commercial point-of-care (POC) molecular diagnostics platform that uses PCR technology with Truenat test chips. Truenat™ disease-specific test chips are available for the diagnosis of 22 infectious diseases (such as TB, H1N1, dengue, HIV, hepatitis, etc) and an additional 43 diseases (such as coronavirus, MERS, etc) are in the pipeline.
The Truelab™ platform, a global first, is a compact, battery-operated system, with single testing capability and provides sample-toresult times within 1 hour. Hence, it enables same-day reporting and initiation of evidencebased treatment for the patient. Doctors benefit from this technology by having a definitive diagnosis, early in the infection cycle, without patients/samples having to travel extensively to centralized facilities.
The Truenat™ assay is rapid and affordable with minimal infrastructure requirements. Thus, placing the Truelab™ multi-disease detection system in the most remote settings will enable mass access to advanced molecular testing for people of all socio-economic backgrounds, across the globe. The device has real-time data transfer capability (through SMS/email) for immediate reporting of results in emergency cases. Additionally, a cloud-based centralized data monitoring and surveillance network can be created and linked to all devices in a region. Complete data from tests performed can be accessed, analysed and recorded in real time. Such same-day reporting of results will strengthen the healthcare systems across countries by improving effectiveness of providing treatment and quarantining of patients, thus controlling spread of communicable diseases. The device is ideal for places that do not get regular electricity, and will work well even in primary healthcare centres, unlike other devices that require uninterrupted power supply, elaborate infrastructure and air-conditioning.
Molbio’s technology has been approved by the Indian Council of Medical Research in 2018, after 3 years of validation study across various sites in India. Internationally, the World Health Organization (WHO), after conducting a multicountry study, has released a rapid communication in January 2020 endorsing Truenat™ as an initial diagnostic test of Mycobacterium tuberculosis (MTB) and MTB-RIF (MTB rifampicin resistance) in view of its high diagnostic accuracy. The WHO has further endorsed Truenat™ for diagnosis of TB as a replacement of the less sensitive sputum smear microscopy. The performance of Truenat™ shows comparable accuracy with other WHO approved tests such as Genexpert, TB-LAMP® and line probe assay. Truenat™ will help in decentralizing and democratizing access to high quality diagnostics to millions of patients suffering from TB and other infectious diseases even at peripheral and remote settings.
At present, Truelab™ devices are installed in over 500 private laboratories, 350 government primary health centres in India and in 27 countries around the globe, extending across the continents of Asia, Africa, Europe and South America. WHO endorsement will further enable the product to be commercialized across more than 150 countries.
Truelab™ is patented across over 100 countries which enables the transition from presumptive to efficient, real-time and precise diagnosis of multiple diseases at reasonable price even in primary healthcare centres and smaller diagnostics labs, which can now deliver high-end molecular diagnostic tests.
Molbio Diagnostics is driven by the urgent need to provide world-class medical devices to enable better medicine through precise, faster, cost effective diagnosis and envisions to be a leading global player in the POC diagnostics segment by continuing to innovate and bring new technologies for social betterment.
In addition, given the current coronavirus pandemic, Molbio is pleased to announce that the Truenat™ Beta-CoV POC RT-PCR test is currently being validated through a regulatory process and is expected to be commercially available in the next couple of weeks. This rapid, portable, POC solution will enable molecular testing for COVID-19 to be performed even at the community level and will provide results within 1 hour from sampling.
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March 2024
The leading international magazine for Clinical laboratory Equipment for everyone in the Vitro diagnostics
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5616 VD Eindhoven
The Netherlands
+31 85064 55 82
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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