Siemens Healthineers unveiled the Atellica™ Solution, a highly flexible immunoassay and clinical chemistry solution featuring patented bi-directional magnetic sample-transport technology that is 10 times faster than conventional conveyors. “We engineered the Atellica Solution based on our customers’ needs and extensive research of market trends,” said Franz Walt, President, Laboratory Diagnostics, Siemens Healthineers. “The result is a game-changer that delivers control and simplicity, so our customers can focus on driving better business and clinical outcomes and spend less time managing operations.”
In addition to the speed afforded by the Atellica Magline™ Transport technology, the Atellica Solution offers a multi-camera vision system and intelligent sample routing for independent control over every sample from routines to STATs.
The Atellica Solution provides unprecedented flexibility to adapt to growing testing needs and space constraints. The solution can be used as a stand-alone system, is scalable up to 10 components and can be combined into more than 300 customizable configurations, including L-shaped, U-shaped, and linear formations. It can also be connected to Aptio® Automation for a comprehensive multidisciplinary solution. The system can handle more than 30 sample container types including pediatric and special containers.
Further, the same reagents can be used across configurations and locations, simplifying laboratory operations, streamlining inventory control, and enabling consistent testing results. Additionally, a single immunoassay analyser processes more than 400 tests per hour, delivering the highest productivity per square meter in the industry.
Other benefits of the Atellica Solution include remote-access monitoring and control to maximize uptime, and a broad, expanding assay menu using proven detection technologies.
The Atellica Solution is the first in a new line of Atellica products.
The products are under FDA review, and not available for sale at this point.
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QuikRead go CRP test cleared in the US
, /in Product News /by 3wmediaOrion Diagnostica’s QuikRead go CRP test received clearance from the US FDA to market the device for clinical laboratories. The QuikRead go test system measures C-reactive protein (CRP) in whole blood, plasma and serum in 2 minutes. The system consists of a small device and a ready-to-use reagent kit with all the materials for performing the test. This easy-to-use system is in wide use worldwide. The tests available for the system outside US includes CRP, CRP+Hb, Strep A and iFOBT. Measurement of CRP aids in the evaluation of injury to body tissues, and infection and inflammatory disorders. The advantages of measuring CRP lie in it being a sensitive, early, and reliable reflector of the acute-phase response. Quantitative measurement of CRP concentration has been reported to be a sensitive indicator of the efficacy of antimicrobial therapy and the course of bacterial infections. The rise in CRP level is non-specific.
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Automated liquid-based cytology instrument
, /in Pathology & Histology, Product News /by 3wmediaThe HQLCT-48 system is a highly automated LBC (liquid-based cytology) instrument for slide preparation and staining of cell smear before pathological analysis. Its major application lies in early cancer diagnosis, for example, screening of cervical cancer.
Linearity sets for Beckman and Roche analysers
, /in Product News /by 3wmediaRandox Quality Control announces the new Acusera Calibration Verification range for Beckman and Roche Cobas instruments. The new linearity sets cover a wide range of clinical testing including; cardiac markers, therapeutic drugs and proteins. Designed with convenience in mind, the new range will ultimately help laboratories to meet CLIA requirements for calibration verification and the assessment of linearity. All products are supplied liquid ready-to-use, in varying levels and are available in multiple configurations to meet the specific needs of individual analysers while challenging the instrument’s complete reportable range. The unique combination of analytes will also enable laboratories to reduce the number of individual products they require resulting in significant cost and time savings. Complementing the new linearity sets is the Randox Data Reduction Software. Easily accessed online, the software provides instant access to automatically generated charts, statistics and real-time peer group data.
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Automated cell counter system
, /in Product News /by 3wmediaAdvanced Instruments, Inc. has received clearance from the U.S. FDA to market its GloCyte Automated Cell Counter System and GloCyte Low and High Level Controls.
The patented GloCyte System is intended to provide a quantitative determination of red blood cells (RBCs) and total nucleated cells (TNCs) in cerebrospinal fluid (CSF) collected from adult and pediatric patients. CSF is collected when physicians rely on cell counts to assist the diagnosis of infections, inflammatory processes, hemorrhage, leukemia, and malignancies that may involve the central nervous system (CNS). Currently, low cell counts can present a challenge to standard methods.
GloCyte uses a novel combination of fluorescence, microscopy with digital image analysis principles, highly specific reagents, and an intelligent counting algorithm to provide accurate and precise cell counts.
Additional benefits of the GloCyte System are that the test requires only 30 microliters of sample per test, it uses disposable test cartridges ensuring no sample carryover and easy disposal, and it includes built-in quality control of Levey-Jennings charts and an audit table.
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Anti-TG and anti-TPO tests
, /in Product News /by 3wmediaTwo new EliA IgG tests for detecting anti-Thyroglobulin (anti-TG) and anti-Thyroid Peroxidase (anti-TPO) autoantibodies in serum or plasma have received FDA clearance and are performed on the fully-automated Phadia 250/2500/5000 Laboratory Systems. Thyroid autoimmunity comprises a number of distinct but pathogenically related autoimmune disorders of the thyroid gland, such as Graves’ disease or Hashimoto’s thyroiditis. Among other things, these diseases are characterized by the presence of autoantibodies, such as anti-Thyroid Simulating Hormone (TSH) receptor, anti-thyroglobulin (TG) or anti-thyroid peroxidase (TPO). More than 98 percent of Hashimoto’s thyroiditis patients have autoantibodies directed to TG or TPO or both. EliA anti-TG and anti-TPO tests quantitatively measure a patient’s autoantibodies to thyroglobulin or thyroid peroxidase, providing information that helps clinicians in the diagnosis of autoimmune thyroid diseases. These new EliA tests, formerly offered as ImmunoCAP tests, provide higher sensitivity with similar or higher specificity. Optimized sensitivity and specificity minimizes false negative or positive results, and maximizes detection of patients with serious disease.
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CRP point-of-care test
, /in Product News /by 3wmediaQuikRead go system is an extremely fast point-of-care test system for measuring C-reactive protein (CRP) in whole blood samples: CRP results are available in two minutes. The system simplifies the daily routines of healthcare professionals by bringing reliability and speed to everyday working processes. The intuitive user interface with a large touch screen and a variety of user interface language options add to the easiness of use. The CRP test can be performed near the patient and the CRP result is immediately available to support the diagnosis. The test selection includes CRP, CRP+Hb, hsCRP+Hb, iFOBT and Strep A tests. This year two new products, wrCRP and wrCRP+Hb, will be launched in the product portfolio.
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Differential diagnosis of arbovirus infections
, /in Product News /by 3wmediaSerological tests for Zika virus (ZIKV), dengue virus (DENV) and chikungunya virus (CHIKV) allow differential diagnosis of infections, especially beyond the short viremic phase when direct detection is no longer effective. These infections are difficult to tell apart clinically, as they manifest with similar symptoms and are endemic in much the same regions. Antibodies against DENV, ZIKV and CHIKV are detectable from around day four to seven after symptom onset. Primary infections are characterized by the occurrence of IgM antibodies, with IgG appearing shortly afterwards. In a secondary flavivirus infection, IgM may be delayed, of reduced intensity or not detectable at all. In these cases a significant increase in the IgG concentration is indicative of an active infection.
ZIKV antibodies can be detected specifically using ELISA based on recombinant ZIKV NS1 protein. This highly specific antigen avoids cross-reactivity with other flavivirus antibodies which may be present from previous infections or vaccinations, e.g. DENV, West Nile, yellow fever, tick-borne encephalitis and Japanese encephalitis viruses. A combination of Anti-ZIKV IgM and IgG ELISA provides an overall sensitivity of 97% at a specificity of 100%. In DENV infections, detection of the highly specific early antigen NS1 by ELISA serves as a first-line screening test in both acute primary infections and re-infections with another DENV serotype. Antibodies against DENV serotypes 1 to 4 are detected using ELISA based on highly purified virus particles, while CHIKV antibodies are determined using ELISA based on a virus-specific structural protein.
Indirect immunofluorescence tests (IIFT) with virus-infected cells are also suitable for detection of DENV, ZIKV and CHIKV antibodies. However, cross reactions between flavivirus antibodies should be taken into account. Arbovirus BIOCHIP mosaics combine different substrates in one test field and aid clarification of cross reactivities, supporting differential diagnosis.
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Mid-volume coagulation analyser
, /in Product News /by 3wmediaSiemens Healthineers Laboratory Diagnostics business launches the Sysmex CS-2500 System—a mid-volume, fully-automated coagulation analyser with smartly-designed PSI technology—in major markets including the U.S. The launch of the new Sysmex CS-2500 System will enable mid-volume laboratories to leverage globally-proven PSI technology, while providing regional reference laboratories and integrated delivery networks (IDNs) with the ability to standardize testing results across multiple Sysmex CS and CA hemostasis systems. Labs today are challenged to increase their output without sacrificing the accuracy or reliability of their results. The increased operational efficiency and uninterrupted workflow delivered by the Sysmex CS-5100 and CS-2500 Systems provide customers with the confidence, consistency and increased capacity they need to deliver timely and accurate hemostasis test results.
In most markets (but not in all countries), the Sysmex CS-2500 System features simultaneous multiwavelength scanning and proven PSI technologies including primary-tube sample-volume checks, clog detection, assay-based preanalytical sample-quality checks for hemolysis, icterus and lipemia (HIL) interference; automated mixing studies; automated platelet aggregation; and clot waveform analysis (CWA) – enabling labs to raise the quality of test results, achieve cost-effective method consolidation, simplify operations, and increase diagnostic confidence.The new system enhances efficiency via a wide optical spectrum, which allows clotting, chromogenic, immunologic and aggregation testing capabilities on a single platform. With an onboard capacity of up to 3,000 tests and up to 40 reagents, the Sysmex CS-2500 System delivers extended walkaway time to streamline workflow.To help labs ensure consistency and improve productivity, the systems use the same reagents, controls and calibrators as other coagulation analysers offered by Siemens Healthineers.
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Siemens Healthineers unveils highly innovative clinical chemistry and immunoassay system
, /in Product News /by 3wmediaSiemens Healthineers unveiled the Atellica™ Solution, a highly flexible immunoassay and clinical chemistry solution featuring patented bi-directional magnetic sample-transport technology that is 10 times faster than conventional conveyors. “We engineered the Atellica Solution based on our customers’ needs and extensive research of market trends,” said Franz Walt, President, Laboratory Diagnostics, Siemens Healthineers. “The result is a game-changer that delivers control and simplicity, so our customers can focus on driving better business and clinical outcomes and spend less time managing operations.”
In addition to the speed afforded by the Atellica Magline™ Transport technology, the Atellica Solution offers a multi-camera vision system and intelligent sample routing for independent control over every sample from routines to STATs.
The Atellica Solution provides unprecedented flexibility to adapt to growing testing needs and space constraints. The solution can be used as a stand-alone system, is scalable up to 10 components and can be combined into more than 300 customizable configurations, including L-shaped, U-shaped, and linear formations. It can also be connected to Aptio® Automation for a comprehensive multidisciplinary solution. The system can handle more than 30 sample container types including pediatric and special containers.
Further, the same reagents can be used across configurations and locations, simplifying laboratory operations, streamlining inventory control, and enabling consistent testing results. Additionally, a single immunoassay analyser processes more than 400 tests per hour, delivering the highest productivity per square meter in the industry.
Other benefits of the Atellica Solution include remote-access monitoring and control to maximize uptime, and a broad, expanding assay menu using proven detection technologies.
The Atellica Solution is the first in a new line of Atellica products.
The products are under FDA review, and not available for sale at this point.
Read more
Fully automated on-demand assay for Heparin-Induced Thrombocytopenia
, /in Product News /by 3wmediaInstrumentation Laboratory has received FDA clearance for the HemosIL HIT-Ab(PF4-H) assay for use on ACL TOP® Family Hemostasis Testing Systems. The first, fully automated, on-demand assay for Heparin-Induced Thrombocytopenia (HIT) on a hemostasis testing system, HemosIL HIT-Ab(PF4-H) detects antibodies associated with HIT. HIT is a severe immunologic adverse reaction to a heparin complex that paradoxically causes blood clots to form, leading to venous and/or arterial thrombosis, and can be fatal. Diagnosis of HIT is key to positive patient outcomes and may prompt initiation of alternative anticoagulants. Unlike existing manual processes, HemosIL HIT-Ab(PF4-H) is a liquid, ready-to-use immunoassay that delivers results in minutes—on-demand, 24/7—allowing clinicians to make timely, well-informed therapeutic decisions, essential in critical scenarios. Management of HIT involves cessation of heparin therapy and initiation of expensive alternative anticoagulants. Delays in diagnosis caused by prolonged test turnaround time can lead to speculative treatment, increasing bleeding risk for the patient and increasing drug costs, if replacement anticoagulant therapy is used unnecessarily. Conversely, if patients with HIT remain on heparin while awaiting laboratory confirmation of diagnosis, they may develop more serious complications leading to increased morbidity and mortality. Therefore, the availability of on-demand HIT antibody testing plays a critical role in better managing HIT, providing results when treatment decisions are needed, and ultimately minimizing patient risk and reducing costs.
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