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Instrumentation Laboratory, ACL AcuStar (Coagulation 2019)

Instrumentation Laboratory, ACL AcuStar (Coagulation 2019)

Coagulation analyzers, January 2019

Contact Information

Instrumentation Laboratory
Venita Shirley
Bedford, MA

Instrument name/First year sold ACL AcuStar/2010
Number of units installed in U.S./Outside U.S. 4,000+/8,000+ (all ACL models combined)
Number of contracts signed between 1/1/18 and 11/15/18
Country where analyzer designed/Manufactured U.S./U.S.
Operational type random access
Reagent type multiuse reagent cartridges (liquid)
Operates on whole blood or spun plasma spun plasma
Sample handling system rack
Model type benchtop
Dimensions (H × W × D)/Weight/Instrument footprint 21 × 34 × 24 in./170 lbs./15 sq. ft.
FDA-cleared clotting-based tests
FDA-cleared chromogenic tests
FDA-cleared immunologic tests Domain 1, HIT IgG, anticardiolipin IgG, anticardiolipin IgM, B2GPI IgG, B2GPI IgM
Other FDA-cleared tests
User-defined tests in clinical use
Tests submitted for 510(k) clearance
Tests in development but not yet submitted VWF (RCo), VWF (Ag.), HIT total ab, ADAMTS13
Methodologies supported immunologic (chemiluminescent)
Operator must load sep. reagent pack per specimen/Test run no/no
Number of different measured assays onboard simultaneously 20
Number of different assays programmed and calib. at one time 20
Number of user-definable (open) channels 0
Of those defined, number active simultaneously
Factor assays require manual manipulation or dilutions
Number of reagent containers onboard at once/Tests per container/Reagents refrigerated onboard 20/varies/yes (4°C)
Multiple reagent configurations supported no
Reagents, consumables loaded without interrupting testing no
Same capabilities when third-party reagent used no
Maximum time same lot number of reagents can be used
Walkaway capacity: Number of specimens/Number of tests 30/280
Minimum sample volume aspirated precisely at one time
Standard specimen volume required to run PT or PTT/ Factor VIII activity
Disposables used/Price of each cuvettes/varies
Supports direct-from-track sampling no
Primary tube sampling supported/Pierces caps on primary tubes yes/no
Sample/Reagent barcode reading capability yes/yes
Onboard test automatic inventory yes
Measures No. of tests remaining/Short sample detection yes/yes
Clot detection as preanalytical variable in plasma sample yes
Auto. detects adequate reagents for aspiration and analysis yes
Hemolysis/Turbidity detection-quantitation no/no
Dilution of patient samples onboard yes
Automatic rerun capability/Auto reflex testing capability yes/yes
Lag time during which hypercoagulable sample not detected
Read time extended for prolonged clotting times
User can set different-than-standard:
• Reagent volumes/Sample volumes no/no
• No. and sources of reagent no
• Incubation times/Reading times no/no
Autocalib. or autocalib. alert/Multipoint calib. supported yes/yes
Auto shutdown/Auto startup programmable not needed/not needed
Stat time to complete all analytes/Throughput per hour for:
• PT alone
• Fibrinogen
• Factor VIII activity assay
Time delay from ordering stat to aspiration of sample <1 minute
Automatic transfer of QC results to LIS yes
Data-management capability onboard (includes QC: L-J plots and Westgard multirules)
Interface supplied by instrument vendor no
Interfaces in active user sites for:
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 no
Modem servicing no
Time required for maintenance by lab personnel daily: 5 minutes; weekly: 5 minutes
Onboard maintenance records no
Training provided with purchase
Approximate number of training hours needed per tech 6 on site
List price
Annual service contract cost (24/7)/Warranty with purchase
Distinguishing features (supplied by company) easy to use; uses sensitive chemiluminescent technology; throughput of 60 tests per hour (<30 minutes to first test result); reagent cartridges stable up to 12 weeks onboard; reagents are precalibrated; replaces the need to run manual, time-consuming ELISA assays
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.