Cardiac Products

Cardiac Systems

Stratus® CS 200 Acute Care™ Troponin Analyzer

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The Stratus® CS Analyzer for acute care diagnostics provides quantitative cardiac assays for fast, accurate evaluation of patients presenting with suspected myocardial ischemia. Its efficiency and ease of use make it ideal for both point-of-care testing and lab applications.

  • Easy to use and ideal for all skill levels

  • Full cardiac menu including guideline acceptable troponin I and D-dimer (with pulmonary embolism exclusion) assays

  • Results in as little as 14 minutes

  • Use in the acute care setting to decrease turnaround time, patient length of stay, and total patient costs

Features & Benefits

Managing Chest Pain to Meet the Challenge

Each year, more than eight million patients visit emergency departments in the United States with chest pain suggestive of myocardial ischemia. Yet, in around 75% of cases, objective evidence of unstable coronary syndrome is lacking after the initial clinical and ECG evaluation.


Accelerated diagnostic protocols using biochemical markers and near-patient testing strategies with the Stratus® CS analyzer can help address this challenge. Consequently, hospital stays—and the cost to manage both ACS-positive and ACS-negative patients—can be reduced.  

 

Fast, informative results

  • Rapid turnaround time: 14 minutes to first result, and 4 minutes for each subsequent result

  • A broad menu of tests to support better chest pain differentiation from a single sample, on a single run, on a single instrument 

Easy-to-use in the Emergency Department, Coronary Care Unit, STAT Lab or Central Lab

  • Simple operation for all skill levels: load sample, rotor, TestPak™ Cartridge(s)—and press Start

  • System accepts blood directly from collection tube—no sample preparation, no manual dilutions

  • Integrated centrifuge spins whole blood to plasma and automatically pipettes to test cartridges—no user manipulation needed

 

Efficient and cost-effective

  • Eliminates manual intervention steps that prolong result turnaround

  • Single use packaging for tests, calibrators, and diluents reduce reagent waste

  • Select tests based on patient need—no fixed assay panels

  • System Check (electronic QC) reduces liquid QC frequency requirements

 

Compliant

  • Barcode readers and lockout features for near-patient testing compliance

  • Fully compliant with OSHA Bloodborne Pathogens Preamble

  • First to the market with a guideline acceptable troponin I assay with the low end precision to meet the 2012 ESC/ACC Guidelines

 

Stratus® CS 200 Acute Care™ Analyzer

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The Stratus® CS 200 Acute Care™ Analyzer delivers lab-quality Troponin I results for chest-pain patients with speed and efficiency at the point of care. It delivers the first result in as fast as 14 minutes to support rapid, informed decision making that may lead to better patient care. Clinicians may individually select and test multiple assays from a single sample, on a single run, and on a single instrument. Simple operation and advanced connectivity help to promote consistent results and efficient workflow.

  • Perform critical serial testing with a guideline acceptable sensitive troponin I assay.

  • Exclude pulmonary embolism with a clinically validated D-dimer assay.

  • Select tests based on patient need. Choose from seven individually packaged assays: TnI, hsCRP, NT-proBNP, myoglobin, CKMB, D-dimer, and ßhCG.

  • Achieve lab-quality performance in a POC setting: whole blood samples and strong correlation to central lab analyzers.

  • Expect consistent results. System automation helps to minimize steps and simplify operation for users at all skill levels.

Features & Benefits

The Stratus® CS 200 Acute Care™ Analyzer is easy to use, with rapid turnaround time, an intuitive touchscreen interface, and multiple cardiac assay offerings.

Lab-quality Results
The analyzer delivers lab-quality results at the point of care and with the speed needed for cardiac patients. It offers a comprehensive cardiac menu, including guideline acceptable sensitive troponin I and D-dimer assays, and automatically spins whole blood into plasma for testing, thereby reducing the risk of biohazard exposure. The Stratus CS 200 system ensures results will be comparable to lab tests run on plasma samples.

Simple Steps for Fast and Consistent Results

  • With the first result available in as fast as 14 minutes and subsequent results within 4 minutes, the Stratus CS 200 system allows for faster diagnosis of patients.

  • The acute cardiac care system accepts whole blood samples in a collection tube; no sample preparation is required.

  • Simply input sample and walk away—minimal operator involvement.

  • A user-friendly touchscreen interface allows for easier navigation through the instrument’s screens.

  • The bar-code reader eliminates the need for manual entry and reduces potential for error.


Efficient Workflow

  • Bidirectional connectivity feature with third-party data managers allows for the safe and secure transmission of results.

  • Remote monitoring saves time by eliminating the need to walk to the analyzer to check when calibration is due.

  • Ample memory allows storage of up to 50 patient results and up to 500 operator IDs. 

Cardiac Assays

Guideline Acceptable Troponin I

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The Acute Care™ cTnl assay on the Stratus® CS Acute Care™ Diagnostic System was the first to the market with a guideline acceptable sensitive Troponin-I assay in 2004 and meets the ESC/ACC Joint Committee recommendations of ≤10% CV at the 99th percentile of normal population. This assay is used for the measurement of cardiac troponin I to aid in the diagnosis of AMI and in the risk stratification of patients with acute coronary syndromes (ACS).

  • One sample, one run, one instrument; increased efficiency in triaging chest pain patients

  • Rapid turnaround time - in as little as 14 minutes (with onboard centrifugation)

  • A 99% percentile at 0.07 ng/mL

  • A 10% CV at 0.06 ng/mL

Features & Benefits

  • One sample, one run, one instrument: increased efficiency in triaging chest pain patients

  • Rapid turnaround time – in as little as 14 minutes (with onboard centrifugation)
                    o  Single and ready to use TestPaks
                    o  No reconstitution
                    o  No warming to room temperature
                    o  Reduction in reagent waste
                    o  Reduction in contamination

  • Heparinized whole blood samples

  • Electronic QC (System Check) satisfies daily routine QC requirements permitting liquid QC flexibility

  • A 10% CV at 0.06 ng/mL

  • A 99% percentile at 0.07 ng/mL

CK-MB Mass

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The Acute Care™ CK-MB assay is an in vitro diagnostic test for the measurement of the MB iso-enzyme of creatine kinase in heparinized whole blood/plasma. CK-MB measurements can be used as an aid in diagnosing acute myocardial infarction.

  • One sample, one run, one instrument; increases efficiency in triaging chest pain patients

  • Rapid turnaround time - in as little as 14 minutes (with onboard centrifugation)

  • Heparinized whole blood samples

Features & Benefits

  • One sample, one run, one instrument; increases efficiency in triaging chest pain patients

  • Rapid turnaround time - in as little as 14 minutes (with onboard centrifugation)

  • Single and ready to use TestPak™ Cartridges
              o No reconstitution
              o No warming to room temperature
              o Reduction in reagent waste
              o Reduction in contamination

  • Heparinized whole blood samples

  • Electronic QC (System Check) satisfies daily routine QC requirements permitting liquid QC flexibility

Myoglobin

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The Acute Care™ myoglobin assay is an in vitro diagnostic test for the measurement of myoglobin in heparinized whole blood /plasma. Myoglobin measurements can be used as an aid in diagnosing myocardial infarction.

  • One sample, one run, one instrument; increases efficiency in triaging chest pain patients

  • Laboratory quality performance and quantitative results from whole blood in the near-patient care setting

  • Can be used as an aid in diagnosing myocardial infarction

Features & Benefits

  • One sample, one run, one instrument; increases efficiency in triaging chest pain patients

  • Rapid turnaround time - in as little as 14 minutes (with onboard centrifugation)

  • Laboratory quality performance and quantitative results from whole blood in the near-patient care setting

  • Single and ready to use TestPak™ Cartridges
              o No reconstitution
              o No warming to room temperature
              o Reduction in reagent waste
              o Reduction in contamination

  • Heparinized whole blood samples

  • Electronic QC (System Check) satisfies daily routine QC requirements permitting liquid QC flexibility 

NT-proBNP

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The Stratus® CS Acute Care™ NT-proBNP assay is an in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NT-proBNP) in heparinized plasma. In individuals suspected of having CHF, measurements of NT-proBNP are used as an aid in diagnosis and the assessment of severity. The test is further indicated for the risk stratification of patients with acute coronary syndrome and heart failure, resulting from left-ventricular dysfunction.

  • One sample, one run, one instrument; increased efficiency in triaging chest pain patients

  • Rapid turnaround time - in as little as 14 minutes (with on-board centrifugation)

  • Single and ready to use TestPaks™ Cartridges. No reconstitution. No warming to room temperature. Reduction in reagent waste

  • Aid in diagnosing individuals suspected of having congestiv heart failure (CHF)

Features & Benefits

  • One sample, one run, one instrument; increases efficiency in triaging chest pain patients

  • Rapid turnaround time - in as little as 14 minutes (with onboard centrifugation)

  • Single and ready to use TestPak™ Cartridges
             o No reconstitution
             o No warming to room temperature
             o Reduction in reagent waste
             o Reduction in contamination

  • Heparinized whole blood samples

  • Electronic QC (System Check) satisfies daily routine QC requirements permitting liquid QC flexibility 

D-dimer

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The D-dimer assay on the Stratus® CS 200 Acute Care™ Diagnostic Analyzer is an in vitro diagnostic test for the quantitative measurement of cross-linked fibrin degradation products (D-dimer) in human citrated or heparinized plasma. The Stratus CS D-dimer assay is intended for use in conjunction with a non-high clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) disease and as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) or pulmonary embolism (PE)].

  • Rapid turnaround time—in as little as 14 minutes (with on-board centrifugation).

  • Single‐use TestPak™ cartridges significantly reduce contamination and open‐stability issues, reducing reagent waste.

  • A negative D‐dimer test in conjunction with a low pretest probability score can exclude PE and may reduce unnecessary diagnostic imaging.

Features & Benefits

  • Rapid turnaround time—in as little as 14 minutes (with onboard centrifugation)

  • Single and ready-to-use TestPak™ cartridges
                o  No reconstitution
                o  No warming to room temperature

  • Heparinized whole-blood samples
                o  D-dimer and cardiac markers—one sample, one run, one instrument

  • Substantial savings potential
                o  Single-use TestPak™ cartridges significantly reduce contamination and
                    open stability issues, reducing reagent waste.
                o  Electronic QC (System Check) satisfies daily routine QC requirements,
                    permitting liquid QC flexibility.
                o  A negative D-dimer test in conjunction with a low pretest probability score    
                    can exclude PE and may reduce unnecessary diagnostic imaging procedures. 

High Sensitivity C-Reactive Protein (hsCRP) Assay

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The high-sensitivity C-reactive protein (hsCRP) assay is a quantitative analysis test of very low levels of C-reactive protein (CRP) in the blood. The hsCRP assay is being increasingly used as a marker for cardiac risk assessment and as a prognostic tool in heart disease. The CRP test, in addition to lipid evaluation and global risk scoring systems, helps in the evaluation of cardiovascular disease risk in an individual.

  • Helps in the evaluation of cardiovascular disease risk in individuals

  • Enhances risk assessment and therapeutic outcomes in primary CVD prevention

  • Recommended as a more sensitive assay for predicting vascular disease

  • Particularly advantageous for assessing the risk in patients with Framingham 10-year risk scores of 10%-20% and/or LDL levels of <160

Features & Benefits

The AHA/CDC Scientific Statement Summary

hsCRP is a global indicator of future vascular events in adults without any previous history of cardiovascular disease (CVD), with acceptable precision levels down to or below 0.3 mg/L

  • hsCRP enhances risk assessment and therapeutic outcomes in primary CVD prevention

  • hsCRP is particularly advantageous for assessing the risk in patients with
                o Framingham 10-year risk scores of 10%-20% and/or
                o LDL levels of <160 mg/dL

  • hsCRP acts as an independent marker for evaluating the possibility of recurrent cardiac events, such as myocardial infarction or restenosis, after percutaneous coronary intervention

βhCG

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Running STAT βhCG ensures clinicians know of any potential pregnancies in their cardiac patients, and can recommend the most appropriate diagnostic assessments for those patients.βhCG on the Stratus® CS Acute Care™ Analyzer provides rapid, quantitative results for the early detection of pregnancy from a whole blood sample in as little as 14 minutes.

  • Dual monoclonal antibody allows the assay to measure total βhCG in the sample

  • Measures total βhCG - the intact hCG dimer, as well as the free beta subunit

  • Provides rapid, quantitative results for the early detection of pregnancy from a whole blood sample

  • Rapid turnaround time - in as little as 14 minutes (with on-board centrifugation)

Features & Benefits

  • Rapid turnaround time - in as little as 14 minutes (with onboard centrifugation)

  • Single and ready to use TestPak™ Cartridges
                   o No reconstitution
                   o No warming to room temperature
                   o Reduction in reagent waste
                   o Reduction in contamination

  • Heparinized whole blood samples

  • Dual monoclonal antibody allows the assay to measure total βhCG in the sample

  • Measures total βhCG – the intact hCG dimer, as well as the free beta subunit

  • Closed container sampling enhances efficiency and safety

  • Electronic QC (System Check) satisfies daily routine QC requirements permitting liquid QC flexibility