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Diagnostica Stago, STart Hemostasis Analyzer (Coagulation 2018)

Diagnostica Stago, STart Hemostasis Analyzer (Coagulation 2018)

Coagulation analyzers, January 2018

Contact Information

Diagnostica Stago
Nichole Howard
nichole.howard@us.stago.com
5 Century Drive
Parsippany, NJ 07054
800-222-2624


Instrument name/First year sold STart Hemostasis Analyzer/1998
Number of units installed in U.S./Outside U.S. >700/>9,000
Number of contracts signed between 1/1/17 and 11/15/17
Country where analyzer designed/Manufactured France/France
Operational type batch
Reagent type open reagent system
Operates on whole blood or spun plasma spun plasma
Sample handling system manual
Model type benchtop
Dimensions (H × W × D)/Weight/Instrument footprint 4.7 × 16.1 × 16.5 in/12.5 lbs/1.8 sq ft
FDA-cleared clotting-based tests PT, APTT, TT, fibrinogen, reptilase, factors, proteins C and S, lupus anticoagulant, DRVV (screen and confirm)
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
Methodologies supported exclusive mechanical clot detection
Operator must load sep. reagent pack per specimen/Test run no/no
Number of different measured assays onboard simultaneously 1
Number of different assays programmed and calib. at one time 20
Number of user-definable (open) channels 4
Of those defined, number active simultaneously 1
Factor assays require manual manipulation or dilutions yes
Number of reagent containers onboard at once/Tests per container/Reagents refrigerated onboard 2/varies/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 18 months
Walkaway capacity: Number of specimens/Number of tests no (semiautomated)
Minimum sample volume aspirated precisely at one time
Standard specimen volume required to run PT or PTT/ Factor VIII activity 50 µL/50 µL
Disposables used/Price of each cuvettes, balls/varies
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/—
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)
Dilution of patient samples onboard no
Automatic rerun capability/Auto reflex testing capability no/—
Lag time during which hypercoagulable sample not detected yes (selectable on menus)
Read time extended for prolonged clotting times
User can set different-than-standard:
• Reagent volumes/Sample volumes yes/—
• No. and sources of reagent yes
• Incubation times/Reading times no/yes
Autocalib. or autocalib. alert/Multipoint calib. supported
Auto shutdown/Auto startup programmable
Stat time to complete all analytes/Throughput per hour for:
• PT alone <6 minutes/up to 120 specimens
• PT, PTT
• Fibrinogen <6 minutes/up to 120 specimens
• Factor VIII activity assay <6 minutes/up to 60 specimens
Time delay from ordering stat to aspiration of sample
Automatic transfer of QC results to LIS no
Data-management capability no
Interface supplied by instrument vendor no
Interfaces in active user sites for:
Bidirectional interface capability no (unidirectional only)
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 weekly: <5 minutes; monthly: <5 minutes
Onboard maintenance records no
Training provided with purchase 1 day on site
Approximate number of training hours needed per tech 1
List price $12,000
Annual service contract cost (24/7)/Warranty with purchase —/1 year
Distinguishing features (supplied by company) viscosity-based detection system; ideal for low-volume testing or backup for optical system; programmable and preprogrammed assays with curve storage plus four independently timed measurement wells
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
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