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Roche Diagnostics, cobas e411 (Immunoassay 2014)

Roche Diagnostics, cobas e411 (Immunoassay 2014)

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Contact Information

Roche Diagnostics
Tracy Kelly
tracy.kelly@roche.com
9115 Hague Road
Indianapolis, IN 46250
800-428-5074


Name of instrument/First year sold/Where designed cobas e411 analyzer/2008/Japan
Country where manufactured/Where reagents manufactured Japan/Germany
Number of units in clinical use in U.S./Outside U.S. >615/>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, anti-HBc, others
Tests not available in U.S. but submitted for clearance
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.