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Hemostasis

Atellica COAG 360 System

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The Atellica® COAG 360 System is a fully automated high volume coagulation analyzer that simplifies lab operations by unifying five methodologies on one platform, streamlines your hemostasis workflow through intelligent reagent and consumable management, and delivers infinite possibilities by being the first to integrate LOCI® technology in specialty hemostasis testing. All of this is built into one powerful system with a lower total cost of ownership, so labs can focus on driving outcomes in addition to operations.

  • Streamline workflow through reduced manual interaction, extended walkaway time, and uninterrupted sample measurement.

  • Enhance operations through rapid throughput, superior reagent stability, traceability, service, and education.

  • Simplify lab operations with five methodologies on one platform, speeding test results for all samples.

  • Leverage flexible and multidisciplinary connectivity options for customizable integration with Siemens Healthineers automation solutions.

  • Automate determination of prothrombin fragment F 1+2 with a fast assay turnaround time—four times faster than the current testing protocol.

  • Reduce errors, minimize repeat testing with advanced preanalytical sample quality (PSI™) checks.

Features & Benefits

The Atellica® COAG 360 System offers high-volume specialty hemostasis labs a transformative array of capabilities to streamline and unify hemostasis testing.

Control: Streamline workflow through reduced manual interaction, extended walkaway time, and uninterrupted sample measurement.

  • Intelligent reagent and consumable management (true continuous loading, unloading, and real-time monitoring).

  • Continuous access to all storage areas such as cuvettes, water, waste, reagents and stir bars. Direct plumbing of water and waste.

  • Daily/weekly maintenance in less than 2/20 minutes, respectively, recorded at the touch of a button.

  • User-defined automated start-up routine.

  • Automated reflex, redilution, multidilution analysis, and repeat testing using customizable (lab-specific) rules.

Control: Enhance operations through rapid throughput, superior reagent stability and traceability.

  • Refrigerated chamber and anti-evaporation caps enable similar stability of once-opened and onboard reagents for many applications—saving you more than 1.5 hours per week. This lowers reagent-management costs, and maximizes tests per vial.

  • Rapid throughput for specialty assays and profiles with multiple tests per sample. 24 flexible reaction detector positions and a dedicated LOCI reader enable high-capacity performance for a variety of test profiles. High specialty-testing throughput of 310 results per hour delivers faster results.

  • In-depth audit and archive capabilities allow thorough traceability of results, including >5 years’ storage.

Simplicity: Simplify lab operations with five methodologies on one platform, speeding test results for all samples.

  • Combines five methodologies—clotting (optical and optomechanical), chromogenic, immunologic, platelet aggregation, and high-sensitivity immunoassay (LOCI) testing—on one hemostasis testing platform, speeding test results for all samples.

  • Deploys fully automated reaction stirring for optomechanical clotting tests and aggregation testing, enabling random access for special parameters.

  • Eases sample management with cap-piercing technology and the ability to process a large variety of primary and secondary sample tubes.

  • Intuitive system interface leverages user-friendly software structure.

Simplicity: Leverage innovative assays and/or connectivity options to consolidate routine and specialty testing.

  • Broad, easy-to-use specialty testing menu includes state-of-the-art INNOVANCE® and INNOVANCE LOCI assays, consolidating routine and specialty testing onto one system.

  • Flexible and multidisciplinary connectivity options allow customizable integration with point-in-space sample transfer design to our automation solutions: Aptio® Automation, FlexLab Automation, CentraLink® Data Management System.

  • Designed to complement the proven Sysmex® CS-5100 System.

Sysmex CS-5100 System

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The Sysmex® CS-5100 Hemostasis System is a random access, high-volume coagulation analyzer and latest addition to the Sysmex CS family of systems. Simultaneous, multiwavelength smartly designed PSITM technology enables labs to achieve high-quality results on the first test run by identifying and managing unsuitable test specimens prior to analysis. Automated sample volume checks and qualitative detection of hemolysis, icterus, and lipemia minimize the need for manual sample inspection.

  • Primary tube sample volume check identifies potential inaccuracies caused by improper sample collection

  • Detects hemolysis, icterus, and lipemia with a preanalytic scan of patient samples performed at 3 wavelengths: 405 nm, 575 nm, and 660 nm

  • User-defined criteria allows automatic handling of the result

  • Accepts or flags sample results based upon an incorrect tube fill volume according to user-programmable configuration settings

  • Simultaneous multi-wavelength scanning of clotting reactions at 340 nm, 405 nm, 575 nm, 660 nm, and 800 nm

Features & Benefits

The Sysmex CS-5100 System offers high-volume and multi-site labs advanced features and benefits—for a streamlined workflow and high-quality test results on the first run.

Wide optical spectrum handles a broad range of assays for testing consolidation

  • Performs coagulation assays using 4 different measurement principles on a single platform

  • All reaction detectors can be used for clotting, chromogenic, immunoturbidimetric, and aggregation/agglutination assays

  • Reduces effects of interfering substances on the absorbance spectra by automatically selecting the appropriate wavelength

  • Sophisticated software algorithms record, monitor, and check reaction kinetics to determine the correct clotting time

Advanced workstation capabilities increase productivity

  • High throughput of up to 400 PT/APTT tests per hour

  • Onboard capacity of up to 3,000 tests and up to 40 reagents, and more than 11 hours of walkaway time

  • Continuous loading of patient samples, reagents, and consumables

  • Third-generation cap-piercing technology

  • Primary tubes, pediatric tubes, and sample cups can be loaded on the same rack, and STAT samples can be loaded for priority testing at any time

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BCS XP System

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The BCS® XP System, one of the most widely used fully automated hemostasis analyzers, delivers accurate and precise results. The high-speed, random-access analyzer performs clotting, chromogenic, immunologic, and agglutination testing while allowing the consolidation of both specialty and routine reagents onto one high throughput analyzer.

  • User-friendly software and customizable interface allow for versatile user-defined configurations to meet your lab’s specific needs

  • Automatic monitoring of reagent levels and onboard

  • stability tracking enable personnel to focus on what’s important—critical results

  • Broad routine and specialty testing menu, including vWF ristocetin and INNOVANCE® ETP, allow for platform consolidation

  • Reagent and sample probe crash sensors protect capped reagent bottles or sample tubes from damage

  • True random-access and walk-away ability for both normal and pathological samples maximize high-volume routine workloads

  • Unparalleled service and support with Siemens’ service organization—rated No. 1 by ServiceTrak

Features & Benefits

Take performance to the next level with reliable and safe testing

  • Crash sensor for sample and reagent probes

  • Operator password protection

  • Audit trail capabilities

  • Onboard operator's manual

  • Check status of individual samples

  • Automated testing with INNOVANCE® Endogenous Thrombin Potential (ETP)

 

Make specialty testing routine through convenient and consolidated testing

  • Clotting, chromogenic, immunochemical, and agglutination-based coagulation assays on one platform

  • Workflow consolidation for simultaneous specialty and routine testing

  • High dilution range (up to 1:1200) and extended measuring range for specialty testing

  • Maximize high-volume routine workloads with true random-access and walk-away ability for both normal and pathological samples

  • User-defined specialty menu and customizable reagent bar-code capability

  • Auto QC reporting, auto-calibration, and auto-start

  • STAT turnaround time priority setting

  • Automatic onboard reagent stability tracking

 

Better utilize resources with time and money saving features

  • Onboard reagent cooling

  • Configurable reagent racks (allows different-sized bottles on a single rack)

  • Minimal reagent waste (dead volume) via tilted reagent bottle placement

  • Automatic monitoring of reagent levels

  • Easy daily maintenance of less than 5 minutes

 

Sysmex CS-2500 System

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The Sysmex® CS-2500 System—a fully automated coagulation analyzer—employs smartly designed technologies including assay-based preanalytical sample-quality checks using PSI™ technology, automated mixing studies, automated platelet aggregation, and clot waveform analysis for improved efficiency, exceptional accuracy, and reliable first-run results. Equipped with next-generation PSI technologies, the Sysmex CS-2500 System takes hemostasis testing to the next level and helps labs truly excel with confidence.

  • Assay-based preanalytical sample-quality checks that detect hemolysis, icterus, lipemia interference and underfilled primary-sample tubes to minimize retesting

  • Automated mixing studies, automated platelet aggregation, and clot waveform analysis for cost-effective instrument and staff consolidation

  • Unlimited potential for high-capacity performance with extended walkaway time

  • Operational efficiency via a wide spectrum of assay parameters, testing methodologies, and sophisticated software to simplify lab operations

  • Uninterrupted workflow delivered in a compact, affordable footprint

  • True lab-to-lab consistency for confident multisite patient monitoring

 

Features & Benefits

Excel with simultaneous multiwavelength analysis and proven PSI technologies to minimize repeat testing and manual reviews.

  • Assay-based preanalytical sample-quality checks using PSI™ technology for HIL interference, primary-tube sample-volume checks and clog detection provide accurate and reliable results on the first run.

  • Simultaneous multiwavelength analytical scanning detects and manages unsuitable samples to minimize retests and reflex testing.

  • 10 flexible reaction detectors enable high-capacity performance for a variety of test profiles.

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Excel with unlimited potential for high-capacity performance and extended walkaway time.

  • Reagent capacity of up to 3000 tests,5 with onboard capacity of up to 40 reagents and five additional buffer positions.

  • Approximately 180 simultaneous PT/APTT tests/hour.

  • Anti-evaporation caps and reagent table refrigerated at approximately 10⁰C maximize onboard reagent stability.

  • Tilted vials and SLD mini cups reduce reagent dead volume to maximize tests per vial.

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Excel with operational efficiency via a wide spectrum of assay parameters, testing methodologies, and sophisticated software.

  • Optical methodology displays clot formation for evaluation of fragile clots.

  • Multidilution analysis (MDA), automated repeat, redilution, and reflex testing are consolidated on one platform.

  • 24-in. touchscreen and Windows 7-based software provide an easily customizable and user-friendly interface.

  • The system provides high test throughput using four measurement principles along with traceability of sample results and audit trails.

Excel with uninterrupted workflow delivered in a compact, affordable footprint.

  • Cap-piercing technology allows mix of capped and uncapped tubes and cups for dependable throughput.

  • Simultaneous processing of primary samples and micro mode for precious pediatric samples increase productivity.

  • Accessible reagent table provides continuous loading of reagents, consumables, and samples.

  • Automated QC checks are performed at user-defined intervals, and daily maintenance requires less than 5 minutes.

Sysmex CS-2000i/CS-2100i Systems

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The Sysmex® CS-2000i/CS-2100i Systems minimize preanalytical errors by using multi-wavelength scanning and sample liquid-sensing technologies. By using smartly designed PSI™ technology, the analyzers provide extra operator support—they identify and automatically manage potentially problematic test samples prior to analysis.

  • Detect hemolysis, icterus, and lipemia with a preanalytic scan of patient samples performed at 3 wavelengths: 405 nm, 575 nm, and 660 nm

  • User-defined criteria allows automatic handling of the result

  • Primary tube sample volume check identifies potential inaccuracies caused by improper sample collection

  • Sophisticated cap-piercing technology available for dependable throughput under all conditions1

  • Accept or flag sample results based upon an incorrect tube fill volume according to user-programmable configuration settings

  • Simultaneous multi-wavelength scanning of clotting reactions at 340 nm, 405 nm, 575 nm, 660 nm, and 800 nm

Features & Benefits

Photo-optical clot detection provides multiple advantages over mechanical detection systems

  • Measurement of light transmittance can be made over the entire course of clot formation, not just the end

  • Atypical reaction patterns can be identified easily to aid in determining the correct coagulation reaction result for patients with unusual in vitro clot reactions, such as sepsis and DIC

  • Sophisticated software algorithms record, monitor, and check reaction kinetics to determine the correct clotting time

  • Clotting reactions display the complete clot signature, not just a single data point, for complete test information

 

Wide optical spectrum handles a broad range of assays to allow high test throughput

  • Performs coagulation assays using 4 different measurement principles on a single platform

  • All reaction detectors can be used for clotting, chromogenic, immunoturbidimetric, and agglutination assays

  • Reduces effects of interfering substances on the absorbance spectra by automatically selecting the appropriate wavelength

 

Intuitive user software and automated maintenance procedures provide for simple operation and increased confidence among staff

  • Fully-automatic user maintenance logging with inspection ready checklist

  • Software supported error management and troubleshooting guide provides condition and actions for resolution

  • Automatic verification with bi-directional LIS connectivity allows results to be uploaded to physicians as soon as they are available

 

Continuous loading of patient samples, reagents, and consumables provides uninterrupted workflow

  • Enhanced reagent management functions

  • Load up to 40 reagents in the reagent table

 

Two dimensional bar-code input and advanced software enable efficient reagent management:

  • Positive reagent identification

  • Automatic input of PT ISI and reagent lot numbers

  • Automatic input of calibrator and control values

Sysmex CA-620 and 660 Systems

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The Sysmex® CA-600 Systems are compact, fully automated systems featuring clotting, chromogenic, and immunologic1 measurements in true random-access. Offering the smallest footprint in its class, the systems are ideal for low-volume laboratories or as a backup instrument for large laboratories.

  • Hand-held 2-D bar-code reader automates the data entry process for calibrator and control values

  • Easy-to-use system handling with intuitive menu structure and tilted color touchscreen

  • STAT sample processing enables critical tests to be processed at any time

  • Analyzed data may be displayed or printed with reaction curves for flexibility in result management

  • Environmentally friendly system with minimized reaction tube waste

  • Menu includes the most frequently requested routine and specialty tests, including INNOVANCE® D-Dimer

Features & Benefits

Proven economy with two model configurations

Some labs need routine testing. Others need routine and specialty testing. With models custom-tailored to the needs of each, labs get the solution that fits their needs. The Sysmex CA-620 System offers clotting testing methodology for laboratories that primarily perform routine tests; the Sysmex CA-660 System offers clotting, chromogenic, and immunologic testing for laboratories that require a broader test menu and perform specialty testing.

Convenient system that saves you time and money

  • The most economical testing solution is usually the one best tailored to your needs. With the Sysmex CA-620 for routine testing, and the CA-660 adding specialty testing, labs get exactly what they need

  • The systems are so easy to learn and use that costly classroom training is not required, maximizing your personnel time and ensuring efficient workflow

  • The Siemens commitment to standardized reagents, quality control, and consumables reduces waste and saves time through streamlined ordering and maintenance

  • Because there’s nearly a year between service visits, you can be confident in consistent uptime

Reduce hands-on time and increase walkaway ability

  • Automated probe rinse eliminates manual steps

  • Simultaneous analysis of results frees up time

  • Increase D-Dimer throughput by 40%

  • Hand-held two-dimensional barcode reader simplifies the data entry process for ISI, control and calibrator values, lot numbers, and expiry information

  • Sample barcode reader provides simplified sample ID processing and enables security and integrity of patient records

INNOVANCE PFA-200 System

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The INNOVANCE® PFA-200 System provides automated assessment for inherited, acquired, or drug-induced platelet dysfunction. It measures the process of primary hemostasis and aids in the rapid detection of platelet dysfunction. Through flow technology, the system provides a realistic hemodynamic environment for the measurement of primary hemostasis.

  • Screens platelet function in patients with impaired primary hemostasis, such as von Willebrand disease

  • Provides excellent sensitivity for congenital platelet dysfunction, such as Glanzmann thrombasthenia

  • Verifies efficacy of desmopressin acetate (DDAVP) therapy in presurgical patients

  • Assesses platelet dysfunction caused by aspirin

  • Evaluates platelet dysfunction in multiple clinical settings, such as presurgical screening, high-risk pregnancy and menorrhagia

  • Detects platelet P2Y12-receptor blockades in patients undergoing therapy with P2Y12-receptor antagonists

Features & Benefits

Simple, rapid, qualitative, and precise automated assessment of platelet function

The INNOVANCE® PFA-200 System provides simple, rapid, qualitative, and precise automated assessment of platelet function and supports clinically relevant decision-making processes effecting therapies. The system quickly measures platelet plug formation in a small whole blood sample (800 μL) and reports a ”closure time” in 5-8 minutes.

Comprehensive bleeding risk assessment

The INNOVANCE PFA-200 System’s unique technology simulates in vitro hemodynamic conditions of platelet adhesion and aggregation in a vascular lesion, providing rapid detection of acquired, inherited, or drug-induced platelet dysfunction in multiple clinical settings. Combining the INNOVANCE PFA® P2Y test, the Dade® PFA Collagen/EPI Test Cartridge, and the Dade PFA Collagen/ADP Test Cartridge provides a comprehensive, cost-effective preoperative bleeding risk solution.

  • Simple 3-step process requires minimal pipetting and hands-on time

  • Results from one 800 μL sample of blood

  • One cut-off for P2Y samples in 3.2 and 3.8% buffered sodium

  • Preoperative screening results in 5-8 minutes

Detects inherited, acquired, and drug-induced platelet dysfunction

In combination with traditional coagulation screening tests such as prothrombin time and activated partial thromboplastin time, the INNOVANCE PFA-200 System provides excellent sensitivity to functional defects of hemostasis.

  • Accurate detection of acquired, inherited, or drug-induced platelet dysfunction under high-shear stress

  • Sensitive to quantitative and qualitative abnormalities of VWD in both plasma and platelets

  • Simple, rapid, semi-quantitative, and precise assessment of platelet function

  • Software supports closure curve4 illustrations for use in scientific studies​

Safe and efficient testing

  • No special sample collection requirements–only a small volume of citrated whole blood is needed (800 μL)

  • All PFA tests can be run from one patient sample tube

  • All biological material remains in the test cartridge. This feature minimizes operator/blood contact for improved safety and consistency, avoiding instrument contamination and facilitating safe biohazard disposal

  • Blood samples are stable for up to 4 hours after collection

  • Built-in quality control program reduces risk of reporting false results

  • Password/access levels protect sensitive patient data and provide enhanced traceability records

BFT II Analyzer

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The BFT II Analyzer combines the advantages of mechanical and photo-optical clot-detecting principles by employing a unique turbodensitometric detection device. The semi-automated, dual-channel coagulometer is ideal for low-volume laboratories performing routine coagulation tests.

  • Light protection cap reduces the risk of user errors by keeping the pipetting channel closed unless a cuvette has been inserted

  • Pre-defined assays with stored reference curves

  • Automatic calculation of PT in sec, % of norm, INR, Fibrinogen in mg/dL or g/L

  • Dual measuring channels allow for simultaneous determinations

  • Half-volume and single cuvette testing require minimal sample volume

  • Built-in thermal printer for consolidated result handling

Features & Benefits

The BFT II Analyzer is a dual-channel coagulometer designed for the lowest volume lab. It combines the advantages of mechanical and photo-optical clot detecting principles.

Total efficiency

  • Stores reference curves

  • Automatic result calculation, e.g., PT in sec, % of norm/ PR/ INR, Fibrinogen in mg/dL or g/L

  • Temperature controlled incubation block for reagents and samples

  • Sample mixing during measurement

 

Ease-of-use

  • Light protection cap reduces the risk of user errors by keeping the pipetting channel closed unless a cuvette has been inserted

  • Built-in timer for incubation

  • Membrane keypad for easy handling of test processing

  • Pre-programmed methods

 

Labor and cost savings

  • Half-volume and single cuvette testing require minimal sample volume

  • Memory function for reference curves

  • As a back-up analyzer, the BFT II provides data comparable to those obtained with other Siemens hemostasis analyzers

Hemostasis Assays

INNOVANCE D-Dimer Assay

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The INNOVANCE® D-Dimer Assay is a particle-enhanced immunoturbidimetric assay for the quantitative determination of cross-linked fibrin degradation products (D-dimers). The INNOVANCE D-Dimer Assay is indicated for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE) in outpatients suspected of DVT or PE. The INNOVANCE D-Dimer Assay can be used for the monitoring of the relative change in D-dimer concentration.

Features & Benefits

  • Stable reagents (4 weeks at 2–8°C) allow economical operation.

  • Assay robustness combined with clinical efficiency eliminates the need for a dedicated D-dimer testing system.

  • Fast turnaround time (11 minutes or less) improves daily throughput to enhance efficiency.

  • Efficient, fully automated processing for reduced manual preparation and sample dilution.

  • Validated diagnostic sensitivity of ≥98% allows exclusion of DVT and PE.

  • Excellent clinical performance permits a broader spectrum of clinical diagnosis, monitoring, and follow-up.

INNOVANCE Heparin Assay

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The INNOVANCE® Heparin Assay generates test results with fewer steps, streamlining workflow with easy-to-use liquid reagents and a single calibration curve for both unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH).

Features & Benefits

  • Automated chromogenic assay for the quantitative determination of the activity of unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH) in citrated human plasma.

  • Broad and consistent assay range of 0.10 to 1.50 IU/mL for UFH and LMWH is supported by five calibrator levels for greater accuracy.

  • Single calibration for UFH and LMWH reduces complexity and eliminates the risk of evaluation on the wrong curve.

  • No manual preparation; easy to handle and use on Siemens Healthineers and Sysmex® hemostasis systems.

  • Runs on multiple platforms, including the BCS® XP System and Atellica® COAG 360 System, Sysmex CS-2000i, CS-2100i, and CS-2500 Systems and Sysmex CS-5100 System. Exhibits excellent correlation among systems.

INNOVANCE Antithrombin Assay

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The INNOVANCE® Antithrombin Assay is a state-of-the-art reagent for the detection of congenital or acquired antithrombin deficiencies. The ready-to-use reagent offers improved onboard stability and, due to its Xa-based activity, shows excellent sensitivity to detect antithrombin mutations.

Features & Benefits

  • Good method correlation offers harmonized result interpretation and helps avoid the need for repeat testing, saving time and reagents.

  • Available in different ready-to-use kit sizes, reducing waste and providing cost and labor efficiencies.

  • Ready-to-use liquid reagent provides excellent precision and uses standard calibrators and controls for simplified system adaption.

  • Available for any sized lab on the BCS® XP System, Sysmex® CA-600 and CS Systems, and Atellica® COAG 360 System

  • The ready-to-use reagent offers improved onboard stability and, due to its Xa-based activity, shows excellent sensitivity to detect antithrombin mutations.

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