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Bio/Data Corp., Platelet Aggregation Profiler PAP 8E (Coagulation 2019)

Bio/Data Corp., Platelet Aggregation Profiler PAP 8E (Coagulation 2019)

Coagulation analyzers, January 2019

Contact Information

Bio/Data Corp.
Robert F. Wheaton III
Horsham, PA
215-441-4000 or 800-257-3282

Instrument name/First year sold Platelet Aggregation Profiler PAP 8E/2005
Number of units installed in U.S./Outside U.S. 401/267
Number of contracts signed between 1/1/18 and 11/15/18
Country where analyzer designed/Manufactured U.S./U.S.
Operational type batch, random access
Reagent type open reagent system (liquid, lyophilized, reconstituted manually)
Operates on whole blood or spun plasma spun plasma
Sample handling system electronic pipette with presets and memory
Model type benchtop
Dimensions (H × W × D)/Weight/Instrument footprint 21.5 × 27.5 × 21.7 in./40 lbs./4 sq. ft.
FDA-cleared clotting-based tests
FDA-cleared chromogenic tests
FDA-cleared immunologic tests ristocetin cofactor assay, RIPA, agglutination; open system for other Ab-Ag tests
Other FDA-cleared tests platelet activation: spontaneous platelet aggregation, sticky platelet syndrome, compound and vehicle tests; platelet aggregation: PRP, PPP, PFP washed platelet samples, multiple agonists and RUO agents, WBC aggregation
User-defined tests in clinical use >99 active
Tests submitted for 510(k) clearance
Tests in development but not yet submitted proprietary
Methodologies supported turbidimetric, immunologic (agglutination)
Operator must load sep. reagent pack per specimen/Test run no/no
Number of different measured assays onboard simultaneously 99
Number of different assays programmed and calib. at one time 99
Number of user-definable (open) channels 8
Of those defined, number active simultaneously 8
Factor assays require manual manipulation or dilutions yes (von Willebrand factor activity)
Number of reagent containers onboard at once/Tests per container/Reagents refrigerated onboard 2, with inserts for various sizes/varies/no
Multiple reagent configurations supported yes
Reagents, consumables loaded without interrupting testing yes
Same capabilities when third-party reagent used no
Maximum time same lot number of reagents can be used 1 year, extended periods may be available for projects
Walkaway capacity: Number of specimens/Number of tests 8/9
Minimum sample volume aspirated precisely at one time 25 µL
Standard specimen volume required to run PT or PTT/ Factor VIII activity
Disposables used/Price of each siliconized microtubes: 100 @ $36.25; plastic-coated microstir bars: 50 @ $21; pipette tips: 960 @ $48; MagneTubes: 50 @ $50
Supports direct-from-track sampling no
Primary tube sampling supported/Pierces caps on primary tubes no/no
Sample/Reagent barcode reading capability yes/yes
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 yes/yes
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 yes/yes
Auto shutdown/Auto startup programmable yes/no
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
Automatic transfer of QC results to LIS no
Data-management capability onboard (includes QC: L-J plots, Westgard multirules for low-volume tests); optional add-on ($275, Bio/Data)
Interface supplied by instrument vendor
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 email query
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: 15 minutes; monthly: 30 minutes
Onboard maintenance records no
Training provided with purchase 1.5 days on site; at vendor offices on special request
Approximate number of training hours needed per tech 4–6
List price $21,990
Annual service contract cost (24/7)/Warranty with purchase $2,050 (during business hours)/2 yrs., includes in-lab PC service
Distinguishing features (supplied by company) patented electro-optical circuitry sensitive to microaggregates and compromised samples; no moving parts in analyzer; 2-year warranty, incl. 2-year in-lab service on PC so patient data never leave the lab; TeleCheck calibration verification service performed in lab with telephone guidance
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
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