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.
Siemens Healthineers’s INNOVANCE assays help improve efficiencies, workflow and resource management following a COVID-19 diagnosis.
In hospitalised COVID-19 patients, elevated D-dimer levels have been found to be strongly associated with disease severity and even mortality reflecting the procoagulant status and high thrombotic risk observed in many COVID-19 patients. Therefore, the monitoring of D-dimer levels is recommended for hospitalised COVID-19 patients to stratify their thrombotic risk including testing for deep vein thrombosis and pulmonary embolism and guiding treatment over the course of the disease.
Treating COVID-19 patients with anticoagulants has been associated with improved outcomes, both in and out of the intensive care unit setting.
Accurate antithrombin measurement in COVID-19 patients undergoing anticoagulant treatment may be useful to determine the efficacy of anticoagulant therapy as antithrombin levels might be reduced.
Siemens Healthineers has a comprehensive portfolio of assays for detection and monitoring of coagulation disorders.
For more information, visit: https://www.siemenshealthineers.com/hemostasis/ innovance-reagents-for-coagulation-disorders
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.
As COVID-19 multiplied across the globe in early 2020, IVD companies raced to provide testing solutions. However, rapid development of diagnostic solutions led in some cases to compromised reagent quality, causing confusion and concern amongst clinicians and lab professionals.
With this background, Erba Mannheim committed to develop reliable and affordable solutions to SARS-CoV-2 testing. First out have been the ErbaLisa IgG and IgM antibody ELISA kits. These were developed and manufactured by Calbiotech, Erba group’s immunoassay center of excellence in California.
Quality and performance were top priorities. The IgG kits use Spike protein antigens to ensure clinical relevance and specificity, and IgM kits use a combination of Spike and Nucleocapsid antigens. Performance and accuracy were extensively validated by multiple studies in universities and public/private laboratories. With CE mark and pending US EUA authorization, ErbaLisa COVID-19 assays gained approval by strict global regulatory bodies including Brazil’s ANVISA and ICMR in India.
Our commitment is to make quality diagnostic solutions affordable to growing labs across all emerging markets in Asia, LATAM, MEA, Eastern Europe and Russia. We believe these products answer the immediate needs and are proud to be helping in the fight against COVID-19.
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
- covers automated support functions utilizing digital technology such as M2M, IoT and Artificial Intelligence (AI), enabling higher productivity with maximum reliability
- supports the acquisition of high quality, reproducible data regardless of operator skill level for both routine use and demanding applications.
- Analytical Intelligence makes lab management simple and enables higher productivity, maximum reliability and better connectivity.
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
- The Nexera series of (U)HPLC systems maximizes reliability and uptime with fully unattended workflows that span from startup to shut-down, such as completion of auto-purge, equilibration, baseline checks and system suitability in advance as well as auto-diagnostics and auto-recovery capabilities. With remote mobile phase monitoring and integrated consumables management, the system maximizes uptime and reliability.
- Featuring high resolution and highest sensitivity, the new UV-1900i UV-Vis spectrophotometer targets food, pharmaceutical, life sciences and chemical markets. Users can analyze more samples daily than ever before. The UV-1900i’s connectivity allows for direct printing (via PictBridge) without a PC. Several systems can share one printer. Data can be transferred to a PC via a router-based laboratory network.
- The new UV-3600i Plus UV-Vis-NIR spectrophotometer includes a trinity of detectors to cover UV, UV-Vis and NIR regions. This system has been designed for highest sensitivity. The standard UV-3600i Plus is designed primarily for the measurement of liquid samples, but the wide range of accessories also enables measurement of solid samples.
- With the Nexis SCD-2030 sulfur chemiluminescence detection system, Shimadzu meets a growing demand for easy operation and maintenance as well as high stability even during long term operation for highly selective and sensitive sulfur detection systems. The Nexis GC-2030, a next generation gas chromatograph, offers world-highest level of performance. It is based on the concept of superior usability and expandability for a wide variety of analytical applications, e.g. research and development and quality control in areas such as food, beverages, fragrances, gases and fuel cells.
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.
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.
Tuberculosis is one of the most prevalent infectious diseases worldwide, with 10 million new cases and an estimated 1.8 million fatalities per year according to the WHO. It is caused by pathogens of the Mycobacterium tuberculosis complex (MTBC). EUROIMMUN’s EURORealTime MTB test provides reliable direct detection of all bacteria of the MTBC in sputum, bronchoalveolar fluid and bronchial secretion by means of real-time polymerase chain reaction (real-time PCR).
The detection is based on three MTBC-specific target regions, encompassing a large number of genetic variants. The target sequences are amplified in a single multiplex PCR using highly specific primers and detected by real-time analytics. Numerous integrated controls ensure high result integrity.
The evaluation and interpretation of results is fully automated using the EURORealTime Analysis software and is thus highly standardised. The software also guides the user through the individual work steps, ensuring a simple and error-free test procedure. The entire process from sample to report release is IVD validated and CE registered.
The direct detection of tuberculosis pathogens complements other diagnostic methods such as microscopy and detection by culturing, which takes as long as 6 to 8 weeks. The PCRbased analysis thus supports early treatment and prevention of transmission.
For more information, visit: www.euroimmun.com
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.