Siemens Healthineers recently announced the global availability of its new Atellica CH Enzymatic Hemoglobin A1c (A1c_E) Assay to assist clinicians in diagnosing and monitoring diabetes. The International Diabetes Federation projects 642 million people worldwide will have diabetes by 2040 because of leading factors such as higher levels of urbanization, aging populations, and the growing adoption of more sedentary lifestyles which leads to insufficient physical activity, greater rates of obesity and a higher intake of unhealthy foods. When diagnosed, treated and monitored regularly, diabetes is manageable and, in some cases, reversible. Left untreated, however, blood sugar can rise to dangerous levels and lead to kidney damage and other irreversible health consequences. As diabetes awareness increases and screening for the chronic disease rises, testing options for the clinical laboratory are evolving both in sophistication and practicality. The Siemens Healthineers Atellica CH Enzymatic Hemoglobin A1c meets new standards of testing and offers laboratories improved performance – both precision and accuracy – over leading alternative methodologies. Instruments with higher throughput capabilities offer laboratories the ability to run a greater volume of tests and produce patient results more quickly, thus improving patient satisfaction. Laboratories are seeking HbA1c assays that can be integrated onto chemistry testing platforms and that provide the accurate and precise results patients deserve. The new Atellica CH Enzymatic Hemoglobin A1c Assay offers these capabilities.
Awareness Technology’s new ChemWell 2 analyzer for ELISA and chemiluminescent (CLIA) is now available.
The ChemWell 2 is a two-probe, two-plate automatic combo analyzer. For 20 years the company has produced single-plate ChemWell automatic ELISA and CLIA systems with the flexibility to run both modes simultaneously even within the same plate. With laboratories expanding serology requirements, the two-plate system is expected to be a more suitable primary instrument for lower throughput labs, and ideal for off-line assays in higher throughput settings.
ChemWell’s flexibility in both hardware and software is key to automating a wide variety of unrelated test methods. Separate probes are used for samples and reagents with an option for disposable tips. Filters range from 405 nm – 630 nm; dispense volume from 2μL to 1.95 ml; plate washing routines, temperature control, and mixing are programmable. Intuitive software offers on-board predilutions, multiple calibration options, replicates, statistics, QC tracking, barcoded sample ID and data management. Additionally, it schedules assays to prevent timing conflicts while providing optimal throughput. An optional laptop stand conserves bench space.
For more information, visit: www.awaretech.com
Featuring an ergonomically enhanced, novel industrial design complemented by a wide range of rotors, the Thermo Scientific general purpose Pro Centrifuge Series has been developed to deliver a safe and regulatory-compliant benchtop separation solution to meet an array of application needs, from clinical protocols and cell culture procedures to microplate processing. The series has been equipped with an advanced touchscreen interface that gives users easy access to prestored protocols, temperature control and system health checks to improve productivity and reduce time spent performing manual maintenance. The general purpose Pro Centrifuge Series provides scientists with: a unique glass touchscreen that facilitates a simpler user interface for immediate, effortless workflow and operation monitoring, and easy cleaning; an ergonomically enhanced industrial design that enables the quick and safe change of any of its 19 rotor types in just three seconds through its Auto-Lock rotor exchange function; superior sample capacity, performance and bio-containment through its Fiberlite carbon fibre rotors and ClickSeal biocontainment lids; a compact separation solution fea-turing connectivity-ready technology, while optimizing benchtop space. The ge-neral purpose Pro Centrifuge Series meets global compliance standards and includes the Thermo Scientific Sorvall, Thermo Scientific Multifuge and Thermo Scientific Megafuge configurations, which can be easily configured with a selection of rotors to address a range of application needs.
The new ST Genesia analyser is designed to automate and standardize results for thrombin generation. For laboratories, this is a significant step forward for assisting with assessment of thrombotic and hemorrhagic risks in patients.
ST Genesia is an automated analyser, based on the same principles as the CAT system, which measures thrombin generation. Designed to support clinical applications in the lab, the key difference between systems is that CAT’s main purpose is for research and development.
ST Genesia aims at standardizing and automating the thrombin generation test in order to make it widely accessible and available for use in in-vitro diagnostics (IVD). ST Genesia is designed to add to the information usually provided by routine tests (TP, TCA, etc.) or specialized tests (Anti-Xa, ECA) and offer an improved assessment of thrombotic and hemorrhagic risks.
A range of reagents specifically developed for ST Genesia is available including STG-ThromboScreen for thrombin generation assessment in patients who are likely to suffer from thrombophilia; STG-BleedScreen for thrombin generation assessment in patients with bleeding risk, such as hemophiliacs; STG-DrugScreen for assessment of the effect of anticoagulants on treated patients, which could be useful for people at risk of drug accumulation (impaired renal function, people over 75, etc.).
Nova Biomedical has launched their Stat EMS Basic blood testing system for ambulance and emergency care in CE mark countries. Stat EMS Basic measures fingerstick capillary lactate, glucose, ketone, hemoglobin, and hematocrit in six to 40 seconds with laboratory-quality results.
Stat EMS Basic is a smaller, non-connectivity version of Nova’s connectivity-capable Stat EMS system with the same test menu. Stat EMS Basic combines battery-operated StatStrip Xpress2 meters in a new, lightweight soft case that easily fits in a medic’s bag while holding all system components: meters, test strips, controls, and lancets. Test strips and controls require no refrigeration, making testing convenient and economical.
Specifically designed for ambulance, prehospital, and emergency use, Stat EMS Basic provides an important test menu and rapid results to aid with patient assessment and allow for faster, more effective emergency treatment. Stat EMS Basic also assists with rapid triage and determining the appropriate transport site for patients who have trauma, sepsis, anemia, acute coronary syndrome, or other critical illnesses.
Stat EMS Basic meters are easy to use; there is no calibration or coding and the testing procedure is as simple as fingerstick glucose testing performed by people with diabetes. Tiny capillary samples eliminate the need for venipuncture, saving time and reducing costs.
Monoclonal antibodies (mAb) are important components of CE-marked IVD reagents used in diagnosis of diseases and follow-up of treatment. DIAsource Immunoassays, a BioVendor group company, recently announced the launch of 13 new antibodies for IVD applications: Adiponectin, FABP4, COMP, NT-ProANP, Uromodulin, Soluble Transferrin Receptor, Placental Protein 13, Cathepsin K and Procalcitonin antibodies are now available and offered to the IVD providers for development of Immunoassays. This follows the launches of novel Vitamin D conjugates, Vitamin D dissociation buffers, and antibodies against ACTH, PTH, IGF-1, Testosterone and Progesterone. All these antibodies were developed with special focus on sensitivity, selectivity and stability to ensure long-term supply. They are produced and fully automatically purified under strict ISO 9001 – ISO 13485 conditions. Products are available in purified unconjugated format. Large scale productions can be guaranteed in state-of-the-art facilities. DIAsource is continuously expanding its product portfolio with niche, high valued parameters and these new launches consolidate its actual position on the market, with an enlarged portfolio of proven and performing antibodies for IVD providers.
Designed to meet the demands of today’s molecular diagnostics laboratory and laboratories carrying out nucleic acid testing, our range of Molecular IQC and EQA comprises hundreds of characterized viral, bacterial and fungal targets. These targets cover a wide range of transplant associated diseases, respiratory diseases, blood borne viruses, sexually transmitted infections, gastro-intestinal diseases and central nervous system diseases amongst others ensuring our molecular IQC and EQA range covers the full laboratory portfolio. Our samples are manufactured using only the highest quality material and the availability of whole pathogen samples ensures the performance of the patient sample is mimicked throughout.
NovaTec is excited to collaborate in the fight against COVID-19 providing reliable direct pathogen and antibody detection assays to aid in the diagnosis of SARS-CoV-2. These tests are CE-IVD marked and immediately available. The development of the assays has been spearheaded by affiliate companies Gold Standard Diagnostics Inc., NovaTec Immundiagnostica GmbH, and VIROTECH Diagnostics GmbH.
The NovaLisa® SARS-CoV-2 (COVID-19) ELISA serological assays feature separate detection of IgG, IgA, and IgM antibodies. These three assays use the nucleocapsid protein (N protein) as antigen for the detection of antibodies to SARS-CoV-2, as it plays an important role in viral pathogenesis, replication and RNA packaging. NovaLisa® assays can be automated on several open ELISA systems providing quick results.
The GSD NovaPrime® SARS-CoV-2 (COVID-19) is a one-step reverse transcription multiplex Real-Time PCR for the direct detection of SARS-CoV-2. The assay simultaneously detects two target sequences inside the N gene. The multiplex PCR allows a streamlined workflow in one reaction and provides results in approximately 2 hours. An extraction/inhibition control and a positive control are included in the kits. The PCR assay demonstrates excellent performance and no cross-reactivity with common human coronavirus strains.
A ground-breaking test for the potentially fatal 2019-nCoV strain of coronavirus, is in the final stages of development at global health diagnostics company Randox Laboratories. The soon-to-be-launched test, developed on Randox’s patented Biochip Technology, will be available for immediate SARS-COV-2 testing, but an additional enhanced multiplex array will also include tests for other respiratory viruses which can display the same symptoms. The new enhanced Biochip will therefore allow clinicians to quickly and efficiently differentiate between potentially lethal and non-lethal infections.
Dr Peter FitzGerald, Managing Director of Randox Laboratories, commented; “Current technologies for the diagnosis of coronavirus are designed simply to detect the presence or lack of 2019-nCoV, and therefore neglect to differentiate between this strain and other respiratory infections. Whilst we’re very quickly developing an efficient novel test for this new strain of coronavirus, we are therefore also working on an extended Viral Respiratory Infection Array that will test simultaneously for 2019-nCoV and a range of other viruses. This will eliminate the need for multiple back-and-forth tests before the root cause of symptoms is found, and empower clinicians to make fast and informed decisions.” The test will be available for the Point of Care analyser, the Vivalytic, within 3 hours, and within 5 hours on the Randox Evidence Investigator. Benefits of the new Randox SARS-COV-2 test
- Quick Turnaround Times (3 hours on Vivalytic and 5 hours on Evidence Investigator)
- Multiplex array differentiates between mild and serious infection
- Automated and Semi-Automated options available
HER The TSQ Altis MD Series mass spectrometer offers enhanced sensitivity for demanding quantitative analyses together with speed and robustness. With superb analytical performance, this platform features maximum usability and is powered by Thermo Scientific TraceFinder LDT Software, which provides a workflow-oriented approach to robust, reliable, high-throughput quantitation. The instrument’s ultimate quantitative performance leverages enhanced Thermo Scientific Active Ion Management (AIM+) technology. QR5 segmented hyperbolic-surface quadrupoles deliver best-in-class sensitivity, consistency, and reproducibility, while fast, selected-reaction monitoring enables robust quantitation of more compounds faster. Features include automated compound optimization and intuitive instrument interface as well as optional bi-directional LIS connection available with B-link.
The TSQ Altis MD Series mass spectrometer is intended to identify and quantify inorganic and organic compounds in human specimens for in vitro diagnostic use only by trained, qualified laboratory personnel. It will be used by clinical diagnostic laboratories as a component of a laboratory developed test (LDT) method or workflow.