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Helena Laboratories, AggRAM (Coagulation 2018)

Helena Laboratories, AggRAM (Coagulation 2018)

Coagulation analyzers, January 2018

Contact Information

Helena Laboratories
David Pearman
dpearman@helena.com
1530 Lindbergh Drive
Beaumont, TX 77704
409-842-3714 ext. 265


Instrument name/First year sold AggRAM/2005
Number of units installed in U.S./Outside U.S. 100+/500+
Number of contracts signed between 1/1/17 and 11/15/17 8
Country where analyzer designed/Manufactured U.S./U.S.
Operational type batch, random access
Reagent type open reagent system
Operates on whole blood or spun plasma spun plasma, platelet rich plasma
Sample handling system manual
Model type benchtop
Dimensions (H × W × D)/Weight/Instrument footprint 6 × 10 × 17 in/15 lbs/—
FDA-cleared clotting-based tests
FDA-cleared chromogenic tests
FDA-cleared immunologic tests
Other FDA-cleared tests ristocetin cofactor and platelet aggregation
User-defined tests in clinical use ristocetin cofactor, platelet aggregation (ADP, EPI, COL, ristocetin, arachidonic acid)
Tests submitted for 510(k) clearance
Tests in development but not yet submitted lumi, chromogenics, HIT
Methodologies supported ristocetin cofactor, platelet aggregation
Operator must load sep. reagent pack per specimen/Test run no/no
Number of different measured assays onboard simultaneously 4–8
Number of different assays programmed and calib. at one time 4–8
Number of user-definable (open) channels 12
Of those defined, number active simultaneously 4–8
Factor assays require manual manipulation or dilutions yes
Number of reagent containers onboard at once/Tests per container/Reagents refrigerated onboard —/—/no
Multiple reagent configurations supported no
Reagents, consumables loaded without interrupting testing no
Same capabilities when third-party reagent used
Maximum time same lot number of reagents can be used 12 months
Walkaway capacity: Number of specimens/Number of tests no
Minimum sample volume aspirated precisely at one time
Standard specimen volume required to run PT or PTT/ Factor VIII activity platelet aggregation: 225 µL PRP; ristocetin cofactor: 50 µL/platelet aggregation: 225 µL PRP; ristocetin cofactor: 50 µL
Disposables used/Price of each cuvettes: 200 @ $55.65; pipette tips: 1,000 @ $82; stir bars: 30 @ $62.25
Supports direct-from-track sampling no
Primary tube sampling supported/Pierces caps on primary tubes no/—
Sample barcode reading capability no
Reagent barcode reading capability no
Onboard test automatic inventory no
Measures No. of tests remaining/Short sample detection no/no
Clot detection as preanalytical variable in plasma sample
Auto. detects adequate reagents for aspiration and analysis no
Hemolysis/Turbidity detection-quantitation no/no
Dilution of patient samples onboard no
Automatic rerun capability/Auto reflex testing capability no/no
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 yes/yes
• No. and sources of reagent yes
• Incubation times/Reading times yes/yes
Autocalib. or autocalib. alert/Multipoint calib. supported no/yes
Auto shutdown/Auto startup programmable no/no
Stat time to complete all analytes/Throughput per hour for:
• PT alone
• PT, PTT
• Fibrinogen
• Factor VIII activity assay
Time delay from ordering stat to aspiration of sample
Automatic transfer of QC results to LIS yes
Data-management capability onboard (includes QC: L-J plots, Westgard multirules)
Interface supplied by instrument vendor no
Interfaces in active user sites for:
Bidirectional interface capability no
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
Time required for maintenance by lab personnel daily: 15 minutes; weekly: 15 minutes; monthly: 1 hour
Onboard maintenance records yes
Training provided with purchase 2 days on site
Approximate number of training hours needed per tech 4–8
List price $15,744
Annual service contract cost (24/7)/Warranty with purchase $1,984/1 year
Distinguishing features (supplied by company) specialized coagulation instrument intended for platelet aggregation and ristocetin cofactor
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.