Stratus® CS Acute Care™ Diagnostic System

System, Sample, and Reagent Specifications.

	Troponin-I	CKMB	NT-proBNP	D-dimer	hsCRP	Myoglobin	ßhCG
Assay Range	0.03 – 50 ng/mL (mg/L)	0.3 –150 ng/mL (mg/L)	15 –20000 pg/mL	6 – 5000 ng/mL (mg/L) FEU	0.1 –50 mg/L	1– 900 ng/mL (mg/L)	0.5 –1250 mIU/mL (IU/L)
Sensitivity	0.03 ng/mL	0.3 ng/mL	15.0 pg/mL	6.0 ng/mL	0.1 mg/L	1.0 ng/mL	0.5 mIU/mL
Reproducibility (CV)	5.1% at 0.64 ng/mL 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	2.6% at 5.1 mIU/mL

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

Environmental Specifications
Room Temperature: 17–30°C
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

Automatic Dilutions Single-use DilPaks per method

Real-Time Fluid Management
Liquid level sensing capability combined with fluidic dispense monitoring system

Turnaround time
System provides first result in as little as 14 min and a panel of 4 tests in 26 min from a whole blood sample

Specimen Type
Sodium heparin or lithium heparin for all methods except D-dimer. Please refer to assay product inserts for more detailed information. D-dimer requires lithium heparin or sodium citrate whole blood or plasma.

Calibration
Up to 3 separate TestPak lots per assay can be stored

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
POC interface mode for connectivity

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

Calibration Stability