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TOSOH Bioscience, AIA-900 (Immunoassay 2015)

TOSOH Bioscience, AIA-900 (Immunoassay 2015)

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Contact Information

TOSOH Bioscience Inc.
Susan Kolarik
6000 Shoreline Court, Suite 101
South San Francisco, CA 94080

Name of instrument/First year sold/Where designed AIA-900/2011/Japan
Country where manufactured/Where reagents manufactured Japan/Japan
Number of units in clinical use in U.S./Outside U.S. 320/1,300
Operational type/Model type/Sample handling system continuous random access/floor standing/rack
Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 35.04, 50.79, or 58.64 × 26.18 × 49.09/6–10
Tests available on instrument in U.S. TSH, 3rd-gen. TSH, T4, TT3, TU, FT4, FT3, TPOAb, TgAb, BHCG, estradiol, FSH, LHII, progesterone, prolactin, testosterone, AFP, CEA, PSA, CA125, CA19-9, 27.29, β2 microglobulin, C-peptide, insulin, IgEII, PAP, cortisol, HGH, B12, folate, RBC folate, ferritin, intact PTH, CK-MB, myoglobin, cTnI second generation, HbA1c, cystatin C, ACTH, DHEA-S, homocysteine, vitamin D
Tests not available in U.S. but submitted for clearance Tg, SHBG
Tests not available in U.S. but available in other countries BNP, HBsAg, HBsAb, HBcAb, HBeAb, cTnI third generation, PSA II, TrAb, HCVAb, HCG, free PSA
Tests in development D-dimer, SHBG, and osteocalcin
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 fluorescence, enzyme immunoassay/bead
Number of different measured assays onboard simultaneously 45
Number of different assays programmed, calibrated at once entire menu
Number of user-definable (open) channels
Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set unitized test cup/unitized test cup
Shortest/Median onboard reagent stability/Refrigerated onboard 72 hours/3 days/no
Multiple reagent configurations supported no
Reagent container placed directly on system for use yes
Reagents bar coded/Information in bar code yes/test, lot
Same capabilities when 3rd-party reagents used/Susceptibility to carryover no/zero (disposable tips)
Walkaway capacity in minutes/Specimens/Tests-assays 30/45/45
System is open (home-brew methods can be used)/Liquid or dry system no/dry
Uses disposable cuvettes/Maximum number stored no/—
Uses washable cuvettes/Replacement frequency no/—
Minimum specimen volume required 10 µL
Minimum sample volume aspirated precisely at once/Minimum dead volume 10 µL/100 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 no/—
Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/13 × 75, 100; 16 × 75, 100/no
Sample bar-code reading capability/Autodiscrimination yes (2 or 5 interleaved, Codabar, codes 39 and 128)/yes
Bar-code placement per CLSI standard Auto2A
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/no
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 yes/no
Time between initial result and reaspiration of sample for rerun 20 minutes
Autocalibration or autocalibration alert no
Number of calibrators required for each analyte 2 or 6
Calibrants can be stored onboard/Average calibration frequency no/90 days
Multipoint calib. supported/Multiple calibs. stored for same assay yes/yes
How often QC required 24 hours
Onboard real-time QC/Support multiple QC lot Nos. per analyte no/yes
Automatic shutdown/Startup is programmable/Startup time no/no/10 minutes
Stat time to completion of β-hCG test ~18 minutes
Time delay from ordering stat test to aspiration of sample 1 minute
Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time) 30/90 (0.67 minute sample cycle)
Can auto transfer QC results to LIS/Onboard capability to review QC yes/no
Data-management capability/Instrument vendor supplies LIS interface no/no
LIS interfaces up and running in active user sites all major LIS suppliers
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 no
Modem servicing/Can diagnose own malfunctions/ Determine malfunctioning component no/no/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 daily: 5 minutes; weekly: 15 minutes; monthly: 20 minutes
Onboard maintenance records/Maintenance training demo module no/no
List price/Targeted bed size or daily volume $60,000 base model/500+ monthly
Annual service contract cost (24 hours/7 days) $6,000 base model
Training provided with purchase/Advanced operator training —/no
Distinguishing features (supplied by company) three models (base model, base model plus nine-tray sorter, base model plus 19-tray sorter) offer increasing automation and capacity; connections and software built in for all three models; untitized test cups, no reagent preparation; automated sample dilution, pretreatment, automated reschedule, retest
Tabulation does not represent an endorsement by the College of American Pathologists.