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.
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POC quantitative immunoassay analyser
, /in Product News /by 3wmediaThe FastPack IP System is a fully automated quantitative immunoassay analyser designed for use in any size physician office laboratory. Utilizing sophisticated chemiluminescence technology, it provides the capability to produce complex immunoassay results in 12 minutes or less with a push of a button. The FastPack IP System is versatile and requires minimal space while offering a test menu that will make a clinical impact at the point-of-care. Assays include Vitamin D, Testosterone, TSH, Free T4, PSA and hCG. The system is simple to use with no specialized training required and “One Touch” operation providing an easy to use format. The innovative reagent pack contains all assay reagents for no chemical exposure with minimal hands-on time. No system maintenance is required. “On Demand” results increase office efficiencies by decreasing patient call-backs, while patient side answers allow for the adjustment of replacement therapy on the spot. The system requires minimal space, yet provides laboratory accuracy and precision at the simple push of a button. It utilizes monoclonal antibody technology coupled with a patented chemiluminescence substrate for true laboratory performance.
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Molecular diagnostics quality control
, /in Product News /by 3wmediaBio-Rad Laboratories has made its entry into the rapidly growing molecular diagnostics testing market with the launch of Amplichek II quality control, which was recently issued a de novo clearance from the U.S. Food and Drug Administration (FDA). The FDA’s de novo clearance is a classification given to devices that are considered novel, with no existing classification or predicate device on the market. Amplichek II began shipping last May and is the first in a series of infectious disease controls that Bio-Rad is introducing for the molecular diagnostic testing market. Molecular diagnostics is one of the fastest growing IVD markets, estimated to reach $9.3 billion (€8.5 billion) by 2020 with the infectious disease segment accounting for the largest share of the global market, according to a 2015 report by research firm MarketsandMarkets. The Amplichek II quality control complements the company’s already extensive range of quality controls. Amplichek II is an independent, multi-analyte quality control that monitors the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of healthcare associated infections (HAIs). HAIs can occur during the process of patient care within a healthcare facility. Millions of healthcare associated infections occur each year, leading to significantly high mortality rates. According to the Centers for Disease Control and Prevention, on any given day, about one in 25 hospital patients have at least one healthcare associated infection. Early detection of these pathogens combined with the appropriate infection control procedures can help prevent the spread of HAIs and lead to improved patient care.
The Amplichek I quality control, which was recently issued a 510(k) clearance from the U.S. Food and Drug Administration (FDA) is the second in a series of infectious disease controls that Bio-Rad is introducing for the molecular diagnostic testing this year. Amplichek I is an independent, multi-analyte quality control for the assessment of HIV-1, Hepatitis B (HBV) and Hepatitis C (HCV) nucleic acid tests that can help mitigate the limitations of manufacturer controls. Unlike some controls that are optimized for specific systems, Amplichek I can help reduce the risk associated with reporting inaccurate patient results by monitoring the performance of the complete analytical process and detecting lot-to-lot variation of assay reagents.
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Zika RNA assay receives EUA from FDA
, /in Product News /by 3wmediaThe U.S. FDA has granted Siemens an Emergency Use Authorization (EUA) for its real-time PCR Zika Virus assay, the VERSANT Zika RNA 1.0 Assay (kPCR) Kit. With respect to Zika IVD tests, FDA has been authorized to issue EUAs to allow for use of unapproved medical products or unapproved uses of approved medical products when, among other circumstances, there are no adequate, approved, and available alternatives and certain additional criteria are met. The VERSANT Zika RNA 1.0 Assay (kPCR) Kit is capable of detecting the presence of Zika virus, which can be an earlier indicator of Zika virus infection than anti-Zika antibodies. The molecular test is validated for plasma, serum, and urine (collected alongside a patient-matched serum or plasma specimen) from individuals meeting CDC Zika virus clinical criteria and/or CDC Zika virus epidemiological criteria, and is designed to run on the Siemens VERSANT kPCR Sample Prep automated platform, along with several commercially available thermal cyclers. The VERSANT Zika RNA 1.0 Assay (kPCR) Kit is only authorized for use for the duration of the declaration that circumstances exist justifying the eua.
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Closed tube system for compact hematology analyser
, /in Product News /by 3wmediaThe Yumizen H500 CT ‘Closed Tube’ provides enclosed, cap-piercing sample handling to meet the health and safety demands of the laboratory environment. The Yumizen H500 family provides a cost-effective hematology profile for small to mid-size laboratories and clinics. The Yumizen H500 will produce a raPid and comprehensive hematology diagnosis. It is a compact and robust hematology analyser tailored for all types of laboratories and other clinical settings demanding easy operation and reliable analysis such as routine and satellite laboratories, emergency care and physician’s offices. Based on a special 3-reagent system with low consumption, the Yumizen H500 hematology system is capable of delivering a full blood count with 27 parameters including a five-part white blood cell differential population plus immature cells on whole blood micro sampling. It is a system which is also suitable for managing pediatric samples. With minimal user training, the Yumizen H500 is simple to operate in all clinical environments and its expert flagging system delivers confidence for clinicians when validating their hematology results. The Yumizen H500 offers an equivalent level of performance to ‘top of the range’ hematology products and combines easy operability, quality and efficiency.
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Fast DNA extraction for POC IVD
, /in Product News /by 3wmediaThe Arcis DNA Blood Kit (IVD) is now available for preparation of DNA from blood using a novel three minute two step system, designed for in vitro diagnostic use. The new kit is sold in a ready-to-use format, and enables users to stabilize and extract nucleic acid from fresh or frozen whole blood samples in just three minutes, without the need for prior sample preparation steps. Arcis DNA Blood Kit is also suitable for specimens that have been stored in EDTA and heparin-containing solutions. The kit is non-hazardous, and ships and stores at room temperature for ease of handling. Designed with point-of-care in vitro diagnostics in mind, DNA extracted using the kit is also suitable for use in PCR or other applications. The new Arcis DNA Blood Kit is the first product developed specifically for use up front of IVD and point-of-care technologies. Where access to instrumentation required for traditional extraction methods is not practical, this kit’s practicality and ability to be shipped and stored at ambient temperatures has big upsides for users in emerging markets.
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High-volume specialty hemostasis analyser
, /in Product News /by 3wmediaSiemens 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.
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Manual pipettes
, /in Product News /by 3wmediaUnlike traditional pipettes which utilize a single rotating plunger to set volumes, the new EVOLVE manual pipette range from INTEGRA features an innovative approach that allows users to set volumes more than ten times faster. Available in single, eight and twelve channel formats, covering a volume range of 0.2 – 5,000 ?l, the ultralightweight, well balanced design of the EVOLVE enhances productivity and comfort even during prolonged pipetting sessions.
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New generation POC test for stomach-specific biomarkers
, /in Product News /by 3wmediaDifferent 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.
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New connectivity for point-of-care HbA1c analysers
, /in Product News /by 3wmediaA new connectivity package for EKF’s Quo-Test and Quo-Lab HbA1c analysers enables secure bidirectional communication between these POC analysers and a multitude of central data management systems. Using the industry recognized POCT1-A2 communication protocol, EKF’s connectivity solution unlocks a host of new features aimed at improving security and quality control (QC) for diabetic HbA1c testing. The new connectivity package includes a proprietary connector interface box, cables and a software upgrade. This enables EKF’s HbA1c analysers to automatically transmit patient data to the majority of Lab Information Management Systems (LIMS) or Hospital Information Systems (HIS). Traceability and results recall speed are improved by use of patient ID and increased demographic data (such as family name and date of birth). These can now be recorded through either selecting from a pre-approved list or via the barcode scanner and keyboard. Also ensuring the integrity of results generated at the POC, security and QC are enhanced on Quo-Lab and Quo-Test through user ID and QC lockout functions which are included in the connectivity package. By restricting access to trained users only, the lockout functions minimize the chances of user error and adhere to security protocols in many institutions. Furthermore, unauthorized users will be prevented from accessing patient information. Multiple user-defined QC lockout options are also available to POCT coordinators in order to enforce regular testing of QC materials and ensure compliance. HbA1c, or glycated hemoglobin, is well recognized as a reliable measure for glycemic control and managing patients with diabetes. As HbA1c levels reflect average circulating glucose concentration over a two to three month period, this means that it can offer greater clinical information than a single glucose measurement. Quo-Lab and Quo-Test analysers deliver lab-quality results for HbA1c from 4μL of blood within 4 minutes, enabling the consulting clinician to give immediate feedback to a patient. In addition to ensuring the reliability of results, the new connectivity package also allows the clinician to add commentary to any test result, further enhancing the monitoring and management of diabetes in a point-of-care setting.
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Component-based test for precise diagnosis of peanut allergy
, /in Product News /by 3wmediaThe 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.
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