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Siemens Healthineers, CLINITEK AUWi PRO Automated Urinalysis System (Urinalysis, 2018)

Urinalysis instrumentation, December 2018

Contact Information

Siemens Healthineers
Maya Daaboul
Norwood, MA

Name of urinalysis instrument CLINITEK AUWi PRO Automated Urinalysis System†
Type of instrument urine chemistry and microscopy/sediment combined
First year instrument sold in U.S. 2015
No. of units installed in U.S./No. of units installed outside U.S. — (also sold via distribution partners)
Intended urine sample volume per day 75–500
Dimensions (HxWxD)/Weight 27 × 63 × 35 in./397 lbs.
Power requirements 120–240 VAC (50–60 Hz)
Mean time between failure of instrument
Events that cause instrument to lock or stop analysis user ID failure, QC failure, short sample, barcode/sample ID misread, result error, sampling error, consumables replacement/expiration, calibration failure, other events
Urine chemistry: (Information in this box is specific to urine chemistry)
• Testing methodology: Specific gravity/Color/Clarity refractometer/test strip/turbidity within an analyzer well
• Urine chemistry tests available on instrument bilirubin (0.5–2.7 mg/dL), red blood cells (trace level), hemoglobin (0.013–0.3 mg/dL), glucose (36–820 mg/dL), ketone (3.6–156 mg/dL), leukocyte esterase (6.0–91 cells/µL), nitrite (positive and negative; >0.06 mg/dL), pH (5.3–8.7), protein (10.8–1,000 mg/dL), specific gravity (1.000–1.099), urobilinogen (0.24–6.24 mg/dL)††
• Color compensation pad included yes
• Flagging thresholds customizable yes
• Test strip configuration cartridge
• Calibration required after each test strip lot No. change yes
• Frequency of customer-performed calibration with every Novus cassette change or every 24 hours when multiple same-lot Novus cassettes are used within 24 hours
• Form of calibration liquid and dry
• How results are displayed for urine chemistry semiquantitative
• Reporting format customizable yes
• No. of results that can be held in internal memory 7,500 sample results/400 control results
• Specific gravity correction for protein/glucose no (protein)/no (glucose)
Microscopy/sediment: (Information in this box is specific to microscopy/sediment)
• Microscopy/sediment technology flow cytometry with fluorescent stain
• Microscopy/sediment analysis parameters flagged: pathological casts, crystals, small round cells, yeast-like cells, mucus, sperm; quantitative: RBCs, WBCs, epithelial cells, bacteria, hyaline casts
• Flagging thresholds customizable yes
• Instrument eliminates amorphous crystal interference before sample analysis yes
• How results are displayed for microscopy/sediment numeric values, scattergrams
• Reporting format customizable yes
• No. of results that can be held in internal memory 2 years worth of data, all sample results/2 years worth of data, all control results
Reagent shelf life/storage temperature for unopened containers 365 days/15–30°C
Reagent shelf life/storage temperature for opened containers
Reagent barcode-reading capability yes
How often quality control samples are run daily
Sample throughput per hour/time to first result for chemistry
Sample throughput per hour/time to first result for microscopy/sediment 80 at 100% sediment/—
Analyzer has stat mode yes (minimum sample volume, 2 mL for chemistry/1 mL for sediment)
Sample dilutions required for urinalysis/body fluid analysis no (urinalysis)/— (body fluid analysis)
• Special sample handling required for body fluid analysis
Minimum width of sample tube/Minimum length of sample tube 16 mm/95–106 mm
Conditions or substances that prevent a sample from being run mucus, high fluorescence, visible turbidity, samples containing pyridium, grossly bloody samples
Means of sample ID entry barcode scan, worklist download from host, manual entry
Built-in liquid-level sensing for samples yes
Information that can be barcode scanned on instrument specimen identifier, reagent lot No., operator ID only for CLINITEK Novus system
How LOINC codes for results are made available website, e-mail query, other customer communication
Software includes reflex testing/cross-check functionality — (reflex testing)/yes (cross-check functionality)
Instrument automatically generates consolidated report* yes
Instrument connections to transfer information data-management system, which connects to LIS/EHR, or data-management system that cannot further transmit data
Interface standards supported ASTM 1394-91, HL7
Bidirectional interface yes (to other companies’ LISs and EHRs [requires third-party interfacing tool for LIS interface])
Connection to LIS or EHR to upload patient and QC results direct serial or hospital network (both for LIS and EHR)
Information included in transmission from instrument to data-management software device unique identifier, operator ID, patient ID, specimen ID, result, QC identifier
No. of days of training with purchase 1–3 days at customer site/4 days at vendor office
Approximate scheduled maintenance time required 10 min. daily; 10 min. weekly; 10 min. monthly
Instrument list price
Provide list of client sites to potential customers on request yes (partial list of comparable sites)
Clients restricted from sharing their experience with company or software no
Distinguishing instrument features (supplied by company) • can upgrade CLINITEK Atlas to CLINITEK Novus and have CLINITEK solution for dry pad chemistry • operational efficiency, with no pretreatment of samples or on-screen review required • fluorescent flow cell technology with dedicated channels for bacteria and sediment to drive clinical outcomes
*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 †system comprises CLINITEK Novus and Sysmex UF-1000i analyzers
All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP. ††instrument does not report numeric values for most tests; it reports such terms as negative, trace, small, moderate, and large (variable by test)