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Abbott Diagnostics, ARCHITECT i2000 (Immunoassay 2012)

Abbott Diagnostics, ARCHITECT i2000 (Immunoassay 2012)

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Contact Information

Abbott Diagnostics
Shar Batley sharon.batley@abbott.com
100 Abbott Park Road CP1-4
Abbott Park IL, 60064
847-938-2348


Name of instrument/First year sold/Where designed ARCHITECT i2000/1998, i2000SR/2003, i4000SR/2007/U.S.
Country where manufactured/Where reagents manufactured U.S., Japan/U.S., Europe
No. of units in clinical use in U.S./Outside U.S. 498/6,527
Operational type/Model type/Sample handling system batch, random access, continuous random access/floor-standing/track and LAS
Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 48 × 61 × 49/20.3, i2000, 48 × 68 × 44/22.7 per module
Tests available on instrument in U.S. HIV Ag/Ab Combo, vitamin D, vitamin B12, folate, HE-4, CA 125, CA 15-3, CA 19-9 XR, CEA, Free PSA, total PSA, BNP, CK-MB, myoglobin, troponin-I, DHEA-S, estradiol, FSH, hCG (total B-hCG), LH, progesterone, prolactin, SHBG, anti-HAV IgM, anti-HBc, anti-HBc IgM, anti-HBs, anti-HCV, HBsAg, HBsAg confirmatory, C-peptide, cortisol, ferritin, homocysteine, insulin, intact PTH, digoxin, phenobarbital, phenytoin, theophylline, many others
Tests not available in U.S. but submitted for clearance HAVAB, testosterone
Tests not available in U.S. but available in other countries AFP, anti-HAV IgG, NGAL, proGRP, MPO, SCC, anti-HAV IgG, anti-HBe, HBeAg, CMV IgG, CMV IgG avidity, others
Tests in development anti-HAV IgG, methotrexate, Tg
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 Chemiflex (enhanced chemiluminescence) with 5 flexible protocols/magnetic microparticle
Number of different measured assays onboard simultaneously 25
Number of different assays programmed, calibrated at once 25
Number of user-definable (open) channels
Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set 25/100-test and 500-test per kit
Shortest/Median onboard reagent stability/Refrigerated onboard —/30 days tracked in hours/yes
Multiple reagent configurations supported yes
Reagent container placed directly on system for use yes
Reagents bar coded/Information in bar code yes/assay No., reagent serial No., lot No., tests per kit, exp. date, onboard stability time, master calibration curve
Same capabilities when 3rd-party reagents used/Susceptibility to carryover no/<0.1ppm
Walkaway capacity in minutes/Specimens/Tests-assays 300/135/12,500
System is open (home-brew methods can be used)/Liquid or dry system no/liquid
Uses disposable cuvettes/Maximum number stored yes/1,200
Uses washable cuvettes/Replacement frequency no/—
Minimum specimen volume required 50 µL
Minimum sample vol. aspirated precisely at once/Minimum dead volume 150 µL/50 µL for all tube types
Supplied with UPS (backup power)/Requires floor drain yes/no
Requires dedicated water system/Water consumption no/—
Noise generated 48–70 decibels
Has dedicated pediatric sample cup/Dead volume no/—
Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/5, 7, 10 mL/no
Sample bar-code reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes
Bar-code placement per CLSI standard Auto2A yes
Onboard test auto inventory (determines volume in container) yes
Measures No. 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/no
Time between initial result and reaspiration of sample for rerun <20 seconds
Autocalibration or autocalibration alert yes
Number of calibrators required for each analyte 2–6 point curve
Calibrants can be stored onboard/Average calibration frequency no/calibration required with new lot
Multipoint calib. supported/Multiple calibs. stored for same assay yes/yes (up to 4 curves/analyte)
How often QC required 3 levels every 24 hours for quantitative, 2 levels for qualitative
Onboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes
Automatic shutdown/Startup is programmable/Startup time —/no/10 minutes
Stat time to completion of β-hCG test 15.6 minutes
Time delay from ordering stat test to aspiration of sample <20 seconds
Throughput per hour for three analytes on each specimen, in No. of specimens/No. of tests (cycle time) 67/200 tests per hour
Can auto transfer QC results to LIS/Onboard capability to review QC yes/yes
Data-management capability/Instrument vendor supplies LIS interface onboard/no
LIS interfaces up and running in active user sites all major LIS vendors
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/yes
Can order (via modem) malfunctioning part(s) w/o operator yes, AbbottLink
On-site response time of service engineer per negotiated contract
Mean time between failures/To repair failures 13 weeks/per negotiated contract
Avg. time to complete maintenance by lab personnel daily: 16 minutes; weekly: <10 minutes; monthly: none (for both manual and auto procedures)
Onboard maintenance records/Maintenance training demo module yes/yes
List price/Targeted bed size or daily volume $169,500/>200 immunoassay tests per day
Annual service contract cost (24 hours/7 days) flexible options available
Training provided w/purchase/Advanced operator training yes/yes
Distinguishing features (supplied by vendor) Chemiflex technology delivers excellent sensitivities and extended linearities, RSH allows priority and routine samples to be processed simultaneously without compromising stats; refer to operations manual for operational precautions, limitations, and hazards; class 1 laser product
Tabulation does not represent an endorsement by the College of American Pathologists.