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Diagnostica Stago, Calibrated Automated Thrombogram (Coagulation 2018)

Diagnostica Stago, Calibrated Automated Thrombogram (Coagulation 2018)

Coagulation analyzers, January 2018

Contact Information

Diagnostica Stago
Paul Riley, PhD, MBA
paul.riley@us.stago.com
5 Century Drive
Parsippany, NJ 07054
973-671-1200 ext. 4238


Instrument name/First year sold Calibrated Automated Thrombogram/2006
Number of units installed in U.S./Outside U.S. 100/~200
Number of contracts signed between 1/1/17 and 11/15/17
Country where analyzer designed/Manufactured Finland/China
Operational type batch, discrete
Reagent type self-contained single-use and multiuse cartridges, packages, slides; open reagent system (lyophilized, reconstituted manually)
Operates on whole blood or spun plasma spun plasma
Sample handling system 96-well plate pipetted manually, inserted into instrument where the last reagent is automatically dispensed
Model type benchtop
Dimensions (H × W × D)/Weight/Instrument footprint 34 × 42 × 42 cm/30 lbs/2 sq ft
FDA-cleared clotting-based tests
FDA-cleared chromogenic tests
FDA-cleared immunologic tests
Other FDA-cleared tests
User-defined tests in clinical use
Tests submitted for 510(k) clearance
Tests in development but not yet submitted thrombin generation in platelet poor (PPP) and platelet rich plasma (PRP) samples
Methodologies supported quartz-halogen, fluorescence-based detection of thrombin generation
Operator must load sep. reagent pack per specimen/Test run no/no
Number of different measured assays onboard simultaneously 16
Number of different assays programmed and calib. at one time 16
Number of user-definable (open) channels 16
Of those defined, number active simultaneously 16
Factor assays require manual manipulation or dilutions
Number of reagent containers onboard at once/Tests per container/Reagents refrigerated onboard —/16/no
Multiple reagent configurations supported yes
Reagents, consumables loaded without interrupting testing no
Same capabilities when third-party reagent used yes
Maximum time same lot number of reagents can be used ~12 months
Walkaway capacity: Number of specimens/Number of tests 16/16
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
Supports direct-from-track sampling no
Primary tube sampling supported/Pierces caps on primary tubes no/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 no
Auto. detects adequate reagents for aspiration and analysis no
Hemolysis/Turbidity detection-quantitation no/no (not necessary for internal calibration technology)
Dilution of patient samples onboard no
Automatic rerun capability/Auto reflex testing capability no/no
Lag time during which hypercoagulable sample not detected no
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/no
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 no
Data-management capability onboard
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 no
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: 15 minutes
Onboard maintenance records no
Training provided with purchase 1 day on site
Approximate number of training hours needed per tech 5
List price $45,000
Annual service contract cost (24/7)/Warranty with purchase $2,900/1 year
Distinguishing features (supplied by company) software automatically calculates all thrombin generation parameters; sample-specific calibrator corrects for plasma color, turbidity, inner filter effect, substrate depletion
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.