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Instrumentation Laboratory, ACL TOP 350/300 CTS (Coagulation 2019)

Instrumentation Laboratory, ACL TOP 350/300 CTS (Coagulation 2019)

Coagulation analyzers, January 2019

Contact Information

Instrumentation Laboratory
Venita Shirley
vshirley@ilww.com
Bedford, MA
800-955-9525


Instrument name/First year sold ACL TOP 350/300 CTS/2012
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 continuous random access
Reagent type open reagent system
Operates on whole blood or spun plasma spun plasma
Sample handling system racks, continuous loading of primary tubes
Model type benchtop
Dimensions (H × W × D)/Weight/Instrument footprint 29 × 32 × 33 in./200 lbs./8 sq. ft.
FDA-cleared clotting-based tests PT, APTT, fibrinogen, TT, factors, FVIII (with VWF)
FDA-cleared chromogenic tests anti-Xa, AT
FDA-cleared immunologic tests Domain 1, D-Dimer, D-Dimer HS, heparin-induced thrombocytopenia
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), direct oral anticoagulants (dabigatran, rivaroxaban, apixaban)
Methodologies supported LED optical detection: clotting, chromogenic, and immunologic
Operator must load sep. reagent pack per specimen/Test run no/no
Number of different measured assays onboard simultaneously 500
Number of different assays programmed and calib. at one time 500
Number of user-definable (open) channels 250
Of those defined, number active simultaneously 30
Factor assays require manual manipulation or dilutions no
Number of reagent containers onboard at once/Tests per container/Reagents refrigerated onboard 24/varies/yes
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 40/800
Minimum sample volume aspirated precisely at one time 4 µL
Standard specimen volume required to run PT or PTT/ Factor VIII activity 50 µL/—
Disposables used/Price of each cuvettes/varies
Supports direct-from-track sampling no
Primary tube sampling supported/Pierces caps on primary tubes yes/yes
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 optional
Auto. detects adequate reagents for aspiration and analysis yes
Hemolysis/Turbidity detection-quantitation optional/optional
Dilution of patient samples onboard yes
Automatic rerun capability/Auto reflex testing capability yes/yes
Lag time during which hypercoagulable sample not detected no
Read time extended for prolonged clotting times yes
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 not needed/not needed
Stat time to complete all analytes/Throughput per hour for:
• PT alone <3 minutes/110 specimens
• PT, PTT <6 minutes/55 specimens
• Fibrinogen <6 minutes/60 specimens
• Factor VIII activity assay <11 minutes/38 specimens
Time delay from ordering stat to aspiration of sample 0 seconds
Automatic transfer of QC results to LIS yes
Data-management capability yes
Interface supplied by instrument vendor no
Interfaces in active user sites for: most major vendors
Bidirectional interface capability yes (broadcast download and 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 in development
Time required for maintenance by lab personnel daily: <10 minutes; weekly: 10 minutes; monthly: none
Onboard maintenance records yes
Training provided with purchase 4 days at vendor offices
Approximate number of training hours needed per tech 24–40
List price
Annual service contract cost (24/7)/Warranty with purchase —/1 year
Distinguishing features (supplied by company) complete standardization solution; on-demand HIT testing; detects underfilled samples; 671-nm LED detection minimizes interferences from HIL, samples with HIL levels exceeding assay threshold are flagged; complete HemosIL assay menu, including D-Dimer HS with VTE exclusion; HemosIL plasma sets for validation of INR test system; HemosIL liquid anti-Xa with universal calibration curve for UFH and LMWH
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