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Roche Diagnostics, cobas u 411 (Urinalysis, 2018)

Urinalysis instrumentation, December 2018

Contact Information

Roche Diagnostics
Brittany Greiner
Indianapolis, IN

Name of urinalysis instrument cobas u 411
Type of instrument urine chemistry
First year instrument sold in U.S. 2006
No. of units installed in U.S./No. of units installed outside U.S. >400/>2,300
Intended urine sample volume per day 40–100
Dimensions (HxWxD)/Weight 10.24 × 16.73 × 13.34 in./26 lbs.
Power requirements 110 VAC
Mean time between failure of instrument
Events that cause instrument to lock or stop analysis opening front cover
Urine chemistry: (Information in this box is specific to urine chemistry)
• Testing methodology: Specific gravity/Color/Clarity —/test strip/turbidity within an analyzer well
• Urine chemistry tests available on instrument bilirubin (neg.–6 mg/dL), red blood cells (neg.–250 erythrocyte/µL), hemoglobin (neg.–250 erythrocyte/µL), glucose (normal–1,000 mg/dL), ketone (neg.–150 mg/dL), leukocyte esterase (neg.–500 leukocytes/µL), nitrite (positive/negative), pH (5–9), protein (neg.–500 mg/dL), urobilinogen (normal–12 mg/dL)
• Color compensation pad included yes
• Flagging thresholds customizable no
• Test strip configuration loosely packed in bottles
• Calibration required after each test strip lot No. change yes
• Frequency of customer-performed calibration monthly
• Form of calibration dry
• How results are displayed for urine chemistry semiquantitative
• Reporting format customizable yes
• No. of results that can be held in internal memory 1,000 sample results/900 control results
• Specific gravity correction for protein/glucose
Microscopy/sediment: (Information in this box is specific to microscopy/sediment)
• Microscopy/sediment technology
• Microscopy/sediment analysis parameters
• Flagging thresholds customizable
• Instrument eliminates amorphous crystal interference before sample analysis
• How results are displayed for microscopy/sediment
• Reporting format customizable
• No. of results that can be held in internal memory
Reagent shelf life/storage temperature for unopened containers —/2–30°C
Reagent shelf life/storage temperature for opened containers —/2–30°C
Reagent barcode-reading capability yes
How often quality control samples are run minimum of daily
Sample throughput per hour/time to first result for chemistry 600/—
Sample throughput per hour/time to first result for microscopy/sediment
Analyzer has stat mode yes (minimum sample volume is ­minimum amount necessary to immerse pads)
Sample dilutions required for urinalysis/body fluid analysis no (urinalysis)/no (body fluid analysis)
• Special sample handling required for body fluid analysis no
Minimum width of sample tube/Minimum length of sample tube
Conditions or substances that prevent a sample from being run preservatives
Means of sample ID entry barcode scan, bidirectional download from host, worklist download from host, manual entry
Built-in liquid-level sensing for samples no
Information that can be barcode scanned on instrument specimen identifier
How LOINC codes for results are made available website, e-mail query
Software includes reflex testing/cross-check functionality no (reflex testing)/no (cross-check functionality)
Instrument automatically generates consolidated report* no
Instrument connections to transfer information data-management system, which connects to LIS/EHR, or directly to LIS/EHR/lab automation system, or via commercial middleware (Data Innovations)
Interface standards supported ASTM 1394-91, ASTM 1238-95
Bidirectional interface
Connection to LIS or EHR to upload patient and QC results direct serial (for LIS and EHR)
Information included in transmission from instrument to data-management software specimen ID, result
No. of days of training with purchase 0
Approximate scheduled maintenance time required 5 min. daily; 10 min. monthly
Instrument list price $13,500
Provide list of client sites to potential customers on request no (information is confidential)
Clients restricted from sharing their experience with company or software no
Distinguishing instrument features (supplied by company) • fast, efficient processing of urine strips; analyzer ready to test every six seconds • Chemstrip 10UA strip has virtually no interference with ascorbic acid, minimizing false-negative glucose results • flexible sample ID entry options let user choose barcode scan, download from host, or manual entry options onboard
*chemistry and microscopy results in one report
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.