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Stratus CS Acute Care Diagnostic System

System, Sample, and Reagent Specifications.

 Troponin-ICK-MBNT-proBNPD-dimerhsCRPMyoglobinßhCG
Assay Range0.03 - 50 ng/mL0.3 –150
ng/mL (µg/L)
15 –20000
pg/mL
6 – 5000
ng/mL (µg/L)
FEU
0.1 –50 mg/L1– 900 ng/mL
(
µg/L)
0.5 –1250
mIU/mL (IU/L)
Sensitivity<0.03 ng/mL0.3 ng/mL15.0 pg/mL6 ng/mL FEU0.10 mg/L1.0 ng/mL0.5 mIU/mL
Reproducibility
(CV)
10% at 0.06 ng/mL4.0% 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) 

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