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Roche Diagnostics, cobas e411 (Immunoassay 2013)

Roche Diagnostics, cobas e411 (Immunoassay 2013)

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Contact Information

Roche Diagnostics
Tracy Kelly
9115 Hague Road
Indianapolis, IN 46250

Name of instrument/First year sold/Where designed cobas e411/2006/Japan
Country where manufactured/Where reagents manufactured Japan/Germany
Number of units in clinical use in U.S./Outside U.S. >385/>7,000
Operational type/Model type/Sample handling system continuous random access/benchtop/rack, disk
Dimensions in inches (H × W × D)/Instrument footprint in sq. feet disk: 31.4 × 47.2 × 28.7/94; rack: 31.4 × 67 × 37.4/17.4
Tests available on instrument in U.S. ACTH, AFP, anti-CCP, anti-HAV IgM, anti-HAV total, anti-HBc IgM, anti-HBs, Anti-HCV, anti-Tg, anti-TPO, anti-TSHR, beta-crosslaps, C-peptide, CA 125, CA 15-3, CA 19-9, CEA, CK-MB, CK-MB stat, cortisol, DHEA-S, digoxin, estradiol, ferritin, folate, folate RBC, free PSA, FSH, FT3, FT4, HBsAg, HBsAg Confirmatory, HCG II stat, HCG+ beta, HE4, hGH, HSV-1 IgG, HSV-2 IgG, IgE, insulin, LH, myoglobin, myoglobin stat, N-MID osteocalcin, proBNP, proBNP stat, progesterone, prolactin, PTH, PTH stat, rubella IgG, rubella IgM, SHBG, T3, T4, testosterone, total PSA, toxo IgG, troponin I, troponin T, others
Tests not available in U.S. but submitted for clearance anti-HBc, thyroglobulin
Tests not available in U.S. but available in other countries free ß-HCG, PAPP-A, PTH (1-84), HBeAg, anti-HBe, HIV Ag, HIV Ag confirmatory test, HIV combi, toxo IgM, CMV IgG, others
Tests in development tacrolimus, sirolimus, cyclosporine, toxo IgM, CMV IgG, CMV IgM, troponin T fifth generation, HBsAg (quant); PCT, Interleukin 6, syphilis, others
Tests not available on other manufacturers’ analyzers 9-min. TnT, 9-min. PTH, HSV-1, HSV-2, beta-crosslaps, more
Fully automated microplate system no
Number of each analyte performed in separate disposable unit
Number of wells in microplate
Methods supported/Separation methods electrochemiluminescence/magnetic particle
Number of different measured assays onboard simultaneously 18
Number of different assays programmed, calibrated at once 18
Number of user-definable (open) channels 0
Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set 18/100–200 tests per kit
Shortest/Median onboard reagent stability/Refrigerated onboard 14 days/56 days/yes
Multiple reagent configurations supported yes
Reagent container placed directly on system for use yes
Reagents bar coded/Information in bar code yes/calibration curve, application parameters, lot number, expiration, reagent name
Same capabilities when 3rd-party reagents used/Susceptibility to carryover no/zero, uses disposable sample tips
Walkaway capacity in minutes/Specimens/Tests-assays disk: 120/30/180; rack: 120/100/180
System is open (home-brew methods can be used)/Liquid or dry system no/liquid
Uses disposable cuvettes/Maximum number stored yes/360 assay tips; 180 assay cups
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/3 L for 250 tests
Noise generated <70 decibels
Has dedicated pediatric sample cup/Dead volume no/—
Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/13–16 mm diameter/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 number of tests remaining/Short sample detection yes/yes
Auto detection of adequate reagent or specimen yes
Clot detection/Reflex testing capability yes/yes (with middleware)
Hemolysis detection-quantitation/Turbidity detection-quantitation no/no
Dilution of patient samples onboard/Automatic rerun capability yes/no
Sample volume can be increased to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results yes/yes
Time between initial result and reaspiration of sample for rerun
Autocalibration or autocalibration alert yes
Number of calibrators required for each analyte 2
Calibrants can be stored onboard/Average calibration frequency no/monthly for lot; weekly for rack
Multipoint calib. supported/Multiple calibs. stored for same assay yes/yes
How often QC required once per day
Onboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes
Automatic shutdown/Startup is programmable/Startup time yes/no/4 minutes
Stat time to completion of β-hCG test 9 minutes
Time delay from ordering stat test to aspiration of sample 42 seconds
Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time) 30/86 (42 seconds)
Can auto transfer QC results to LIS/Onboard capability to review QC yes/yes
Data-management capability/Instrument vendor supplies LIS interface onboard/yes (additional cost)
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/yes
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 215 days/varies
Average time to complete maintenance by lab personnel daily: 5 minutes; weekly: 6 minutes; monthly: 10–15 min.
Onboard maintenance records/Maintenance training demo module no/no
List price/Targeted bed size or daily volume —/varies; primary immunoassay system or back-up unit
Annual service contract cost (24 hours/7 days)
Training provided with purchase/Advanced operator training 4 days on site/yes
Distinguishing features (supplied by company) ECL technology-based assays provide wide measuring ranges and excellent low-end sensitivity (for example, troponin T); ready-to-use and bar-coded reagents fully compatible with other Elecsys systems; range of stat assays with 9-minute assay time
Tabulation does not represent an endorsement by the College of American Pathologists.