Stratus® CS 200 Acute Care™ Analyzer
Lab-quality results delivered with speed and efficiency where you need them
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.
Assays
Multiple cardiac assays are available to meet your point-of-care testing demands. Test cartridges are individually packaged, providing flexibility to select appropriate tests based on patient need. As many as four assays can be run simultaneously per patient sample on the Stratus CS 200 system*
Guideline Acceptable Sensitive Troponin I Assay
The cTnl assay meets the ESC/ACC Joint Committee recommendations of ≤10% CV at the 99th percentile of a normal population. The 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).
D-dimer Assay (with Pulmonary Embolism Exclusion†
D-dimer is a quantitative measurement of cross-linked fibrin degradation products (D-dimer) in human citrated or heparinized plasma. The 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 PE].
CKMB Mass Assay
CKMB is for the measurement of the MB isoenzyme of creatine kinase in heparinized whole blood/plasma. CKMB measurements can be used as an aid in diagnosing acute myocardial infarction.
Myoglobin Assay
Myoglobin measures myoglobin in heparinized whole blood /plasma. Myoglobin measurements can be used as an aid in diagnosing myocardial infarction.
NT-proBNP Assay
NT-proBNP is a quantitative measurement of N-terminal pro-brain natriuretic peptide (NT-proBNP) in heparinized plasma. Measurements of NT-proBNP are used as an aid in the diagnosis of individuals suspected of having congestive heart failure (CHF). The test is further indicated for the risk stratification of patients with acute coronary syndrome and heart failure, resulting from left-ventricular dysfunction.
CardioPhase® hsCRP Assay
Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders, and associated diseases. High-sensitivity CRP (hsCRP) measurements may be used as an independent risk marker for the identification of individuals at risk for future cardiovascular disease. Measurements of hsCRP, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.
Quantitative βhCG Assay
Running STAT βhCG ensures that clinicians know of any potential pregnancies in their cardiac patients, and can recommend the most appropriate diagnostic assessments for those patients.
Technical Specifications
Stratus® CS 200 Acute Care™ Analyzer* and Assay Specifications
| Troponin I Assay |
CKMB Assay |
NT-proBNP Assay | D-dimer Assay | hsCRP Assay | Myoglobin Assay | βhCG Assay | |
|---|---|---|---|---|---|---|---|
| Assay Range | 0.03–50 μg/L (30–50,000 ng/L) | 0.3–150 μg/L (ng/mL) | 15–20,000 pg/mL | 6–5000 μg/L (ng/mL) FEU | 0.1–50 mg/L | 1–900 μg/L (ng/mL) | 0.5–1250 IU/L (mIU/mL) |
| Analytical Sensitivity | <0.03 μg/L (<30 ng/L) | 0.3 μg/L | 15.0 pg/mL | 6.0 μg/L FEU | ≤0.1 mg/L | 1.0 μg/L | <0.5 IU/L |
| Assay Characteristics | 10% at 0.06 μg/L (10% at 60 ng/L) | 4.0% at 3.7 μg/L | 4.4% at 96.6 pg/mL | 4.1% at 412 μg/L | 6.8% at 1.16 mg/L | 3.4% at 56 μg/L; 4.6% at 142 μg/L‡ | 2.5% at 27.1 IU/L§ |
| Calibration Stability | 60 days | 60 days | 30 days | 60 days | 60 days | 60 days | 90 days |
Please refer to the assay package inserts for more detailed information.
| Qualified Collection Tube Types | Becton Dickinson 13 x 75 mm green Hemogard® tube, 4.0 mL draw (lithium or sodium heparin) |
|---|---|
| Becton Dickinson 13 x 75 mm lt blue Hemogard tube, 4.5 mL draw (3.2% sodium citrate) | |
| Sarstedt Monovette® tube 13 x 65 mm orange, 2.6 mL draw (lithium heparin) | |
| Sarstedt Monovette tube 13 x 65 mm blue, 2.9 mL draw (sodium citrate) | |
|
Centrifuge Speed |
Microprocessor-verified between 18,000 and 22,000 rpm |
|
Power Requirements |
115 VAC: 103–127 volt range, 47–63 Hz, ~1.5 amp, and 400 watts maximum power |
| 230 VAC: 207–253 volt range, 47–63 Hz, ~0.8 amp, and 400 watts maximum power | |
| Circuit: Separate, dedicated line with hot, neutral, and isolated ground in its own conduit | |
| Receptacle: Hospital-grade receptacle accessible to the 2.7 m (9 ft) power cord upon arrival of the instrument | |
| Software Features | Patient ID and/or sample ID scannable using universal bar-code reader |
| Sample collection-time entry | |
| Stores up to 500 operator IDs; locks out unauthorized operators | |
| Notification of TestPak lot expiration | |
| Password protection of advanced setup functions | |
| Last 50 patient results stored for later transmission | |
| Connectivity-ready | Bidirectional connectivity through network connection |
| Compatible with Conworx POCcelerator™ System | |
| Unidirectional connectivity through serial port | |
| Dimensions | Instrument: 18 in. H x 28 in. W x 23 in. D (46 cm H x 71 cm W x 58 cm D) |
| Operating clearance: 20 in. H x 31 in. W x 24 in. D (51 cm H x 79 cm W x 61 cm D) | |
| Service clearance: 37 in. H x 39 in. W x 34 in. D (94 cm H x 99 cm W x 86 cm D) | |
| Optional workstation: 39.25 in. H x 30 in. W x 27.25 in. D (99.7 cm H x 76.2 cm W x 69.2 cm D) | |