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

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