Siemens Healthineers has recently launched the CE-marked Atellica COAG 360 System, a fully automated high-volume coagulation analyser designed to streamline and unify hemostasis testing. The Atellica COAG 360 System is the first analyser to unify five methodologies on one testing platform – clotting (optical and optomechanical), chromogenic, immunologic, high-sensitivity luminescence based immunoassay (LOCI) technology, and platelet aggregation testing. This unification enables laboratories to potentially replace up to three stand-alone systems with just one analyser, saving space, simplifying inventory management, reducing maintenance – reducing the overall cost of ownership. The system also provides intelligent reagent and consumable management – including true continuous loading and unloading, and realtime monitoring – extending walkaway time, providing uninterrupted sample measurement, and enabling faster availability of test results. PSI checks and advanced preanalytics detect underfilled or overfilled samples and accurately identify assay-specific hemolytic, icteric, and lipemic (HIL) interferences using nine pre-defined levels. The dedicated, automated module for the detection of HIL interferences improves consistency and reproducibility of results compared to a visual check of samples. This helps to advance preanalytical protocols and improve the quality of hemostasis test results. By integrating high-sensitivity immunoassay using LOCI technology and platelet aggregation testing, Atellica COAG 360 System provides faster test results for all samples and increases insight into hemostatic disorders. Patented LOCI technology from Siemens Healthineers enables labs to test small volume samples with a high level of precision, while reducing the risk of interference. Additionally using LOCI technology, determination of F1+2 (a coagulation factor that aids in risk assessment of thrombosis and anticoagulant therapy monitoring) is automated with an assay turnaround time of less than 15 minutes – four times faster than the current testing protocol. To support labs in need of fully automated multidisciplinary testing, the Atellica COAG 360 System connects with Aptio Automation. With a rapid throughput on samples requiring multiple specialty tests, the Atellica COAG 360 System complements the fast routine testing throughput of the Sysmex CS-5100 System. The system is now available in Europe.
Read more

Different from the previous test versions, the new GastroPanel Quick test is designed for the point-of-care (POC) measurement of four stomach- specific biomarkers in the blood: pepsinogen I (PGI), pepsinogen II (PGII), gastrin-17 (G-17) and Helicobacter pylori IgG antibodies. In the new test version, sample processing is based on a lateral flow (LF) principle, with quantitative marker detection by double Ab (Ag) sandwich technique. The results are immediately read by the LF reader, which increases the test acceptance among clinicians, who are now capable of making the diagnosis onsite. The main indications of use for the GastroPanel remain unchanged. The test is designed for the diagnosis of (1) H. pylori infection (2) atrophic gastritis (AG), and (3) functional disorders among symptomatic (dyspeptic) patients as well as for screening of asymptomatic subjects for gastric cancer risk. Also the recently introduced interpretation algorithm remains valid, based on eight distinct biomarker profiles, five of which reflecting morphological abnormalities while the other three reflect a functional disorder.
Read more

The multiparameter component-based test EUROLINE DPADx Peanut allows differentiation of primary peanut allergy from pollen-associated cross reactions, enabling assessment of the patient’s risk for severe reactions. In the test, specific IgE antibodies against seven defined components from peanut and the major birch pollen allergen Bet v 1 are analysed in parallel using immunoblot technology. Patients who show IgE antibodies to the peanut seed storage proteins Ara h 1, h 2, h 3, h 6 and h 7 or the lipid transfer protein h 9 are likely to have a primary sensitization to peanut and a higher risk of a severe reaction. The severity of the allergy is, moreover, greater when multiple high-risk components are involved. Reactions with the PR 10 protein Bet v 1 (homologue of Ara h 8 from peanut) or the profilin Ara h 5 indicate a pollen-associated cross reaction and are associated with milder symptoms and a lower risk of a severe reaction. The EUROLINE DPA-Dx provides an extremely wide ranging screening in one assay. In suspected cases of peanut allergy, the test identifies reactions arising from a pollen-associated food allergy, which present a lower risk for the patient. The assay requires only a small amount of serum (100 to 400 μl), making it ideal for pediatrics. Automated processing and evaluation are available. Peanut allergy can be one of the most severe forms of allergy, with patients at a high risk of life-threatening systemic reactions, including anaphylactic shock. Even small amounts of peanut can trigger a severe reaction. Classic diagnostics based on allergen extracts cannot, however, differentiate between a primary sensitization against peanut and a pollen-associated food allergy due to a cross reaction. Only component-based diagnostics can deliver this decisive information. Establishing a precise diagnosis facilitates decisionmaking on treatment and disease management. Patients with a sensitization to high-risk components should strictly avoid the allergen source and always carry an emergency set. Patients with only a birch pollen-associated food allergy do not normally have to follow a strict peanut-free diet. If the patient also suffers from birch allergy related symptoms, specific immunotherapy for the birch pollen allergy can be undertaken, which is likely to additionally relieve the peanut-induced symptoms.
Read more

BioSystems launches a new reagent for measurement of ethanol in serum, plasma and urine. Ethanol is a small molecule found mainly in alcoholic beverages, medical preparation and food. Their consumption is widespread but often abusive. Therefore, ethanol determination is one of the most common diagnostic tests in the toxicology and forensic laboratory and it is used for both medical and legal purposes. Ethanol acts as a central nervous system (CNS) depressant and can cause loss of attention, stupor, coma and possible death. BioSystems introduces this test in dedicated presentation for the A15 and A25 analysers (code 12789: 1 x 10mL + 1 x 7 mL) and for the BA400 analyser (21789: 2 x 20mL + 2 x 7mL). It is calibrated using Ammonia/Ethanol/CO2 Calibrator (BioSystems cod. 18065). The reagent offers an improved detection limit (8 mg/dL) and is optimized to work with the company’s analysers although it can also be adapted to other models. It is recommended to use the Ammonia/Ethanol/CO2 Control level I (cod. 18063) and II (cod. 18064) to verify the accuracy of the measurement procedure.
Read more