Stratus® CS Acute Care™ Diagnostic System

The Stratus® CS Acute Care™ Diagnostic System for 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.

Stratus CS in the Acute Care Setting

  • 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
  • Customize up to 4 tests to run on a single patient sample in your acute care setting, helping you make a quick diagnosis
  • Use in the acute care setting to decrease turnaround time, patient length of stay, and total patient costs

Features & Benefits

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

Extensive Support

  • Onsite training
  • Field service group
  • Technical telephone support

Assays

Click below to learn more about each assay available on the Stratus CS analyzer.

Technical Specifications

System, Sample, and Reagent Specifications.

Troponin-I

CK-MB

NT-proBNP

D-dimer

hsCRP

Myoglobin

ßhCG

Assay Range

0.03 - 50 ng/mL

0.3 –150
ng/mL (µg/L)

15 –20000
pg/mL

6 – 5000
ng/mL (µg/L)
FEU

0.1 –50 mg/L

1– 900 ng/mL
(
µg/L)

0.5 –1250
mIU/mL (IU/L)

Sensitivity

<0.03 ng/mL

0.3 ng/mL

15.0 pg/mL

6 ng/mL FEU

0.10 mg/L

1.0 ng/mL

0.5 mIU/mL

Reproducibility
(CV)

10% at 0.06 ng/mL

4.0% at
3.7 ng/mL

4.4% at
96.6 pg/mL

4.1% at
412 ng/mL

6.8% at
1.16 mg/L

3.4% at
56 ng/mL

2.5% at 27.1 mIU/mL†     

Calibration Stability

60 days

60 days

30 days
60 days
60 days
60 days
90 days

DilPak™ Automatic Dilution

Yes

Yes
Yes
Yes

Yes

Yes

Sodium Heparin Tubes

Yes
Yes
Yes
Yes
Yes
Yes

Lithium Heparin Tubes

Yes
Yes
Yes

Yes

Yes
Yes
Yes

Sodium Citrate Tubes

Yes

Please refer to the assay insert sheets or operator’s guide for more detailed information.

Automatic Alignment
Level-sensing capabilities automatically align to each TestPak and module

Computer Interface Specifications
Uni-directional through serial port

Environmental Specifications
Room Temperature: 15-30°C (65-85°F)
Humidity: 20–80%

Waste Disposal
All hazardous materials are contained within a disposable waste liner

Centrifuge Speed
Microprocessor-verified between 18,000 and 22,000 rpm

Sample and TestPak Identification
Universal bar code reader

Reagent Capacity
Single-use assay cartridges

Assay Technology
Dendrimer enhanced radial partition immunoassay

Quality Control

  • Daily system check (electronic QC) with programmable time lockout
  • Liquid controls are processed after calibration, upon receipt of a previously calibrated lot of reagents or whenever the site wishes to verify performance, and according to local, state, and/or federal regulations
  • On-board “QC Required” alert for a time element and/ or range check

Software Features

  • The last 20 results are stored and can be reprinted and/or transmitted to LIS
  • Patient ID and/or sample ID entry Sample collection time entry
  • Unauthorized operator lockout capability
  • TestPak lot expiration notification
  • Password protection of advanced setup functions

Reagent Storage Requirements
TestPaks, CalPaks, and DilPaks: 2 to 8°C (Troponin-I CalPak and NT-proBNP CalPak: -10 to -20°C)

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