Stratus® CS Acute Care™ Diagnostic System
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 |
— |
— |
— |
*Total precision measured with Bio-Rad Control Liquichek™ Level 2. Liquichek is a trademark of Bio-Rad.
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)