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Inova Diagnostics, BIO-FLASH (Immunoassay 2015)

Inova Diagnostics, BIO-FLASH (Immunoassay 2015)

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Contact Information

Inova Diagnostics
Kaz Nakanishi
9900 Old Grove Road
San Diego, CA 92131

Name of instrument/First year sold/Where designed BIO-FLASH/2011/United States
Country where manufactured/Where reagents manufactured U.S./U.S.
Number of units in clinical use in U.S./Outside U.S.
Operational type/Model type/Sample handling system continuous random access/benchtop/racks
Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 21 × 34 × 24/5
Tests available on instrument in U.S. tTG IgA, tTG IgG, DGP screen, DGP IgA, DGP IgG, aCL IgG, aCL IgM, aCL IgA, B2GP1 IgG, B2GP1 IgM, B2GP1 IgA, MPO, PR3, GBM, ENA 7, RNP, Sm, centromere, SS-B, Jo-1, Ro52, Ro60, B2GP1 domain 1
Tests not available in U.S. but submitted for clearance CTD screen, Jo-1, Scl-70, DFS70, dsDNA, CCP3
Tests not available in U.S. but available in other countries CTD screen plus, SS-B, Jo-1, Scl-70, Ro52, Ro60, DFS70, dsDNA, domain 1, CCP3
Tests in development
Tests not available on other manufacturers’ analyzers
Fully automated microplate system no
Number of each analyte performed in separate disposable unit
Number of wells in microplate
Methods supported/Separation methods chemiluminescence/magnetic particle, bead
Number of different measured assays onboard simultaneously 20
Number of different assays programmed, calibrated at once 50
Number of user-definable (open) channels 0
Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set 20/50 and 100 test kits
Shortest/Median onboard reagent stability/Refrigerated onboard 24 days/40 days/yes (6°–8°C)
Multiple reagent configurations supported yes
Reagent container placed directly on system for use yes
Reagents bar coded/Information in bar code yes/type, number of tests, lot number, expiration date, master calibration curve
Same capabilities when 3rd-party reagents used/Susceptibility to carryover no/—
Walkaway capacity in minutes/Specimens/Tests-assays —/30/20
System is open (home-brew methods can be used)/Liquid or dry system no/liquid
Uses disposable cuvettes/Maximum number stored yes/280
Uses washable cuvettes/Replacement frequency no/—
Minimum specimen volume required 10 µL
Minimum sample volume aspirated precisely at once/Minimum dead volume 10 µL/50 µL
Supplied with UPS (backup power)/Requires floor drain yes/no
Requires dedicated water system/Water consumption no/—
Noise generated
Has dedicated pediatric sample cup/Dead volume yes/50 µL
Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/12–16 mm/no
Sample bar-code reading capability/Autodiscrimination yes (2 of 5 interleaved, codes 39 and 128)/yes
Bar-code placement per CLSI standard Auto2A yes
Onboard test auto inventory (determines volume in container) yes
Measures number of tests remaining/Short sample detection yes/yes
Auto detection of adequate reagent or specimen yes
Clot detection/Reflex testing capability yes/yes
Hemolysis detection-quantitation/Turbidity detection-quantitation no/no
Dilution of patient samples onboard/Automatic rerun capability yes/yes
Sample volume can be increased to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results no/yes
Time between initial result and reaspiration of sample for rerun 30 minutes
Autocalibration or autocalibration alert yes
Number of calibrators required for each analyte 2
Calibrants can be stored onboard/Average calibration frequency no/lot change or failure of controls
Multipoint calib. supported/Multiple calibs. stored for same assay yes/yes
How often QC required daily
Onboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes
Automatic shutdown/Startup is programmable/Startup time yes/yes/<10 minutes
Stat time to completion of β-hCG test
Time delay from ordering stat test to aspiration of sample less than 5 minutes
Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time) 20/60 (30 minutes)
Can auto transfer QC results to LIS/Onboard capability to review QC yes/yes
Data-management capability/Instrument vendor supplies LIS interface onboard/yes (included)
LIS interfaces up and running in active user sites
LIS interface operates simultaneously w/running assays yes
Bidirectional interface capability yes (broadcast download and host query)
Interface available (or will be) to auto specimen handling system yes
Modem servicing/Can diagnose own malfunctions/ Determine malfunctioning component yes/yes/no
Can order (via modem) malfunctioning part(s) without operator no
On-site response time of service engineer 24 hours
Mean time between failures/To repair failures
Average time to complete maintenance by lab personnel weekly: 5 minutes; monthly: 15 minutes
Onboard maintenance records/Maintenance training demo module yes/no
List price/Targeted bed size or daily volume —/100–500
Annual service contract cost (24 hours/7 days)
Training provided with purchase/Advanced operator training yes/yes
Distinguishing features (supplied by company) random access, continuous load, chemiluminescent; benchtop footprint completing up to 450 results per shift; onboard reagents with stable calibration curves to eliminate batching and improve turnaround time
Tabulation does not represent an endorsement by the College of American Pathologists.