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Diagnostica Stago, Inc., STA-R Evolution Expert Series (Coagulation 2015)

Diagnostica Stago, Inc., STA-R Evolution Expert Series (Coagulation 2015)

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Contact Information

Diagnostica Stago Inc.
Barry Ray
5 Century Drive
Parsippany, NJ 07054

Instrument name/First year sold STA-R Evolution Expert Series/2005
Number of units installed in U.S./Outside U.S. >500/~3,000
Number of contracts signed between 1/1/14 and 11/30/14
Country where analyzer designed/Manufactured France/France
Operational type continuous random access
Reagent type open reagent system, complete line of routine and specialty assays
Operates on whole blood or spun plasma spun plasma
Sample handling system rack with continuous specimen access
Model type floor standing
Dimensions (H × W × D)/Weight/Instrument footprint 49.2 × 50.3 × 32.2 inches/507 lbs/26.8 square feet
FDA-cleared clotting-based tests PT, APTT, TT, fibrinogen, reptilase, factors, proteins C and S, lupus anticoagulant, DRVVT (screen and confirm)
FDA-cleared chromogenic tests heparin (UFH and LMWH), protein C, AT, plasminogen, antiplasmin
FDA-cleared immunologic tests D-dimer, VWF, total and free protein S, AT antigen
Other FDA-cleared tests
User-defined tests in clinical use APCR, other clotting chromogenic and immunological tests with user-defined applications
Tests submitted for 510(k) clearance
Tests in development but not yet submitted Rivaroxaban and Apixaban calibrators and controls for Anti-Xa, automated Ecarin Chromogenic Assay
Methodologies supported exclusive mechanical clot detection, chromogenic, immunologic
Operator must load sep. reagent pack per specimen/Test run no/no
Number of different measured assays onboard simultaneously 200
Number of different assays programmed and calib. at one time 200
Number of user-definable (open) channels 200
Of those defined, number active simultaneously 200
Factor assays require manual manipulation or dilutions no
Number of reagent containers onboard at once/Tests per container/Reagents refrigerated onboard 70/varies/yes (15°–19°C)
Multiple reagent configurations supported yes
Reagents, consumables loaded without interrupting testing yes
Same capabilities when third-party reagent used yes
Maximum time same lot number of reagents can be used 18 months
Walkaway capacity: Number of specimens/Number of tests 215/32
Minimum sample volume aspirated precisely at one time 5 µL
Standard specimen volume required to run PT or PTT/ Factor VIII activity 50 µL/5 µL
Disposables used/Price of each cuvettes and wash solution/varies with volume
Supports direct-from-track sampling yes (Beckman Coulter, Siemens LabCell, Roche MPA, Abbott)
Primary tube sampling supported/Pierces caps on primary tubes yes/yes
Sample bar-code reading capability yes
Reagent bar-code reading capability yes
Onboard test automatic inventory yes
Measures No. of tests remaining/Short sample detection yes/yes
Clot detection as preanalytical variable in plasma sample no
Auto. detects adequate reagents for aspiration and analysis yes
Hemolysis/Turbidity detection-quantitation no/no (not necessary for mechanical detection technology)
Dilution of patient samples onboard yes
Automatic rerun capability/Auto reflex testing capability yes/no
Lag time during which hypercoagulable sample not detected no
Read time extended for prolonged clotting times yes (selectable on menus)
User can set different-than-standard:
• Reagent volumes/Sample volumes yes/yes
• No. and sources of reagent yes
• Incubation times/Reading times yes/yes
Autocalib. or autocalib. alert/Multipoint calib. supported yes/yes
Auto shutdown/Auto startup programmable no (not necessary)/no (not necessary)
Stat time to complete all analytes/Throughput per hour for:
• PT alone <6 minutes/~300 specimens
• PT, PTT <6 minutes/~200 specimens
• Fibrinogen <6 minutes/~180 specimens
• Factor VIII activity assay <6 minutes/~180 specimens
Time delay from ordering stat to aspiration of sample <15 seconds
Automatic transfer of QC results to LIS yes
Data-management capability yes (onboard)
Interface supplied by instrument vendor no
Interfaces in active user sites for: all major LIS vendors
Bidirectional interface capability yes (host query)
Results transferred to LIS as soon as test time complete yes
LOINC codes transmitted with all results no
How labs get LOINC codes for reagent kits
Electronic interface available (or will be) to automated (or robotic) specimen handling system yes (Beckman Coulter, Siemens LabCell, Roche MPA)
Modem servicing yes
Time required for maintenance by lab personnel weekly: <20 minutes; monthly: <30 minutes
Onboard maintenance records yes
Training provided with purchase varies on site, 4 days at vendor offices
Approximate number of training hours needed per tech 24
List price $165,000
Annual service contract cost (24/7)/Warranty with purchase —/1 year
Distinguishing features (supplied by company) viscosity-based detection system; connectivity to lab automation systems; software for password protection and result traceability; can standardize with other STA analyzers
Tabulation does not represent an endorsement by the College of American Pathologists.