Urinalysis instrumentation, 2023

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Company	Name of urinalysis instrument	wdt_ID	Contact	Email	City, State	Phone	Website	Type of instrument	Instrument list price	First year instrument sold in U.S.	No. of units installed in U.S./No. of units installed outside U.S.	Foreign countries where company markets instrument	Country where instrument designed/manufactured	Intended urine sample volume per day	Dimensions (HxWxD)/Weight fully loaded with reagents	Power requirements	Mean time between failure of instrument	Events that cause instrument to lock or stop analysis	• Testing methodology: specific gravity/color/clarity	• Urine chemistry tests available on instrument in the U.S.	• Color compensation pad included	• Flagging thresholds customizable	• Test strip configuration	• Calibration required after each test strip lot No. change	• Frequency of customer-performed calibration	• Form of calibration	• How results are displayed for urine chemistry	• Reporting format customizable	• No. of results that can be held in internal memory	• 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	Reagent shelf life/storage temperature for opened containers	Reagent barcode-reading capability	How often quality control samples are run	Sample throughput per hour/Time to first result for chemistry	Sample throughput per hour/Time to first result for	Analyzer has stat mode	Sample dilutions required for urinalysis/body	• Special sample handling required for body fluid	Minimum width of sample tube/Minimum	Conditions or substances that prevent a sample	Means of sample ID entry	Built-in liquid-level sensing for samples	Information that can be barcode scanned on instrument	How LOINC codes for results are made available	Software includes reflex testing/cross-check functionality yes (reflex testing)/yes (cross-check functionality) yes (reflex testing)/yes (cross-check functionality)	Instrument automatically generates consolidated report*	Instrument connections to transfer information	Interface standards supported	Bidirectional interface	Test results can be transmitted to LIS as soon as tests completed	Connection to LIS to upload patient and QC results	Connection to EHR to upload patient and QC results	Information included in transmission from instrument to data-management software	No. of days of training included with instrument purchase	Approximate scheduled maintenance time required	• Maintenance records kept onboard instrument	Provide list of client sites to potential customers on request	Clients restricted from sharing their experience with company or software	Distinguishing instrument features (supplied by company)	*chemistry and microscopy results in one report
ARKRAY	AUTION ELEVEN AE-4022	1	Jane Nichols	nicholsj@arkrayusa.com	Edina, MN	952-646-3224	https://arkrayusa.com/clinical-diagnostics	urine chemistry	—	2017	— (also sold via Cardinal Health, Beckman Coulter, Medline Industries)	worldwide	Japan/Japan	—	6.5 × 8.3 × 12.9 in./7.9 lbs.	100–240 VAC (50–60 Hz)	600 days	user ID failure, result error	test strip/test strip/visual read, manual entry	bilirubin (0.5–14 mg/dL), hemoglobin (0.03–1.0 mg/dL), glucose (30–1,000 mg/dL), ketone (5–150 mg/dL), leukocyte esterase (25–500 leukocytes/µL), nitrite (0.08–0.5 mg/dL), pH (5–9), protein (10–1,000 mg/dL), specific gravity (1.005–1.030), urobilinogen (2–16 mg/dL)	yes		loosely packed in bottles	no	—	—	semiquantitative		520 (sample results and control results combined)	no (protein)/no (glucose)		—	—	—	—	—	—	—	2 years/1–30°C	31 days/1–30°C	no	daily (can use other vendors’ QC products)	514/1 min.	—	no	no (urinalysis)/— (body fluid analysis)	—	—	—	barcode scan, manual entry	no	operator identifier, specimen identifier	—	no (reflex testing)/no (cross-check functionality)	no	directly to LIS or via commercial middleware (Data Innovations)	ASTM 1394-91, ASTM 1381	no	yes	direct serial connection or hospital network	option not available	device unique identifier, specimen ID, result, QC identifier	0	5 min. daily	no	no (information is confidential)	no	• standardized test strip technology across all ARKRAY platforms • clinically significant reporting ranges • small semi-automated footprint
ARKRAY	AUTION MAX AX-4030	2	Jane Nichols	nicholsj@arkrayusa.com	Edina, MN	952-646-3224	https://arkrayusa.com/clinical-diagnostics	urine chemistry	—	2011	— (also sold via distribution partners)	worldwide	Japan/Japan	>15	21 × 21 × 21 in./82 lbs.	100–240 VAC (50–60 Hz)	364 days	short sample, result error, sampling error	refractometer/wavelength of absorbance within an analyzer well/turbidity within an analyzer well	bilirubin (0.5–10 mg/dL), hemoglobin (0.03–1.0 mg/dL), glucose (30–1,000 mg/dL), ketone (5–150 mg/dL), leukocyte esterase (0–500 leukocytes/µL), nitrite (0.08–0.5 mg/dL), pH (5–9), protein (10–600 mg/dL), specific gravity (1.000–1.050), urobilinogen (2–12 mg/dL)	yes	no	loosely packed in bottles	no	—	—	semiquantitative	no	2,500 sample results/200 control results	yes (protein)/yes (glucose)		—	—	—	—	—	—	—	2 years/1–30°C	31 days/1–30°C	yes, for some tests	daily (can use other vendors’ QC products)	225/1 min. cycle time	—	yes (minimum sample volume, 2 mL)	no (urinalysis)/— (body fluid analysis)	—	15.8 mm/105 mm	—	barcode scan, manual entry	yes	specimen identifier	e-mail query	no (reflex testing)/no (cross-check functionality)	no	directly to LIS or via commercial middleware (Data Innovations)	ASTM 1394-91, ASTM 1381	yes (to other companies’ LISs–Cerner, Epic, Meditech, Orchard, SCC Soft Computer, Sunquest [Clinisys])	yes	direct serial connection or hospital network	—	device unique identifier, specimen ID, result	1–2 days at customer site		no	yes (partial list of comparable sites)	no	• proven reliability with less than one unscheduled service event per year • abnormal color detection alerts operators to potential false-positive results • easy to use; strips easy to load; does not require calibration
Beckman Coulter	DxU Microscopy Series: DxU 850m Iris, DxU 840m Iris†	3	Gabrielle Huff	gahuff@beckman.com	Brea, CA	—	https://www.beckmancoulter.com/urinalysis	microscopy/sediment	—	2003	>2,000/>4,000 globally for both systems combined (also sold via McKesson and Henry Schein in the U.S.)	worldwide	U.S./U.S.	50–600+	22 × 21 × 24 in./100 lbs.	90–240 VAC (50–60 Hz)	—	QC failure, short sample, barcode/sample ID misread, result error, sampling error, consumables replacement/expiration	—		—		—	—	—	—	—			—		digital flow morphology using auto particle recognition software	qualitative and quantitative: pathological casts, crystals, yeast-like cells, mucus, sperm, RBCs, WBCs, epithelial cells, bacteria, hyaline casts, WBC clumps		no	numeric values					yes, for some tests		—	DxU 840m: 70/—; DxU 850m: 101/	yes (minimum sample volume, 2 mL)	no (urinalysis)/yes (body fluid analysis)	yes (lyse reagent)	16 mm/100 mm	grossly visible turbidity	barcode scan, manual entry	yes	specimen identifier, reagent lot No., reagent expiration	manual transmission	yes (reflex testing)/yes (cross-check functionality)	yes	directly to LIS or EHR	ASTM with proprietary message layer	yes (to other companies’ LISs)	—	—	—	device unique identifier, operator ID, patient ID, specimen ID, result, QC identifier	1 day at customer site, 2.5 days at vendor office	—	yes	yes (complete list with no restrictions regarding its use)	no	• streamlines urinalysis workflow to achieve manual review rates of 4% • auto-classifies 12 urine particles based on size, shape, contrast, texture to provide digital images for samples • FDA-cleared body fluids module; linearity down to zero	†formerly iQ200 series; answers in listing apply to both systems unless otherwise indicated
Beckman Coulter	DxU Iris Workcell: DxU Iris 850, DxU Iris 840†	4	Gabrielle Huff	gahuff@beckman.com	Brea, CA	—	https://www.beckmancoulter.com/urinalysis	urine chemistry and microscopy/sediment combined	—	2021	>50/>70 globally for both systems combined (also sold via McKesson and Henry Schein in the U.S.)	none	U.S. and Japan/U.S. and Japan	50–600+	23 × 21 × 60 in./238 lbs.	90–240 VAC (50–60 Hz)	—	QC failure, short sample, barcode/sample ID misread, result error, sampling error, consumables replacement/expiration	refractometer/wavelength of absorbance within an analyzer well/turbidity within an analyzer well		yes		loosely packed in bottles	no	—	—	semiquantitative			yes (protein)/yes (glucose)		digital flow morphology using auto particle recognition software	qualitative and quantitative: pathological casts, crystals, yeast-like cells, mucus, sperm, RBCs, WBCs, epithelial cells, bacteria, hyaline casts, WBC clumps		no	numeric values					yes, for some tests		225/1 min.	DxU 840: 70/—; DxU 850: 101/	yes (minimum sample volume, 3 mL for microscopy/sediment)	no (urinalysis)/yes (body fluid analysis)	yes (lyse reagent)	16 mm/100 mm	grossly visible turbidity	barcode scan, manual entry	yes	specimen identifier, reagent lot No., reagent expiration	manual transmission	yes (reflex testing)/yes (cross-check functionality)	yes	directly to LIS or EHR	ASTM with proprietary message layer	yes (to other companies’ LISs)	—	—	—	device unique identifier, operator ID, patient ID, specimen ID, result, QC identifier	1 day at customer site, 2.5 days at vendor office	—	yes	yes (complete list with no restrictions regarding its use)	no	• streamlines urinalysis workflow to achieve manual review rates of 4% • auto-classifies 12 urine particles based on size, shape, contrast, texture to provide digital images for samples • FDA-cleared body fluids module; linearity down to zero	†formerly iQ Workcell; answers in listing apply to both systems unless otherwise indicated
Roche Diagnostics	cobas u 411	5	Claire Rhodes	claire.rhodes@roche.com	Indianapolis, IN	317-521-2000	https://www.roche.com	urine chemistry	—	2006	>400/>2,300 globally	worldwide	Switzerland/Switzerland	10–100	10.24 × 16.73 × 13.34 in./~26 lbs.	110 VAC	—	—	test strip/wavelength of absorbance within an analyzer well/—		yes		loosely packed in bottles	no	28 days	dry	semiquantitative			—		—	—		—	—					no		600/1 min.	—	no (minimum sample volume for sampler or track mode is minimum amount necessary to immerse pads)	no (urinalysis)/— (body fluid analysis)	—	—	preservatives	barcode scan, bidirectional download from host, worklist download from host, manual entry	—	specimen identifier	website, e-mail query	no (reflex testing)/no (cross-check functionality)	no	data-management system that connects to LIS or EHR, or data-management system that cannot further transmit data, or directly to LIS or EHR, or via commercial middleware (Data Innovations)	ASTM 1394-91, ASTM 1238-95	yes (to other companies’ LISs and EHRs)	yes	direct serial connection	—	specimen ID, result	0	5 min. daily; 10 min. monthly	—	no (information is confidential)	no	• 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 and hemoglobin results • flexible sample ID entry options let user choose barcode scan, download from host, or manual-entry options
Sysmex America	Clinitek Novus Automated Urine Chemistry Analyzer	6	Jason Anderson	andersonja@sysmex.com	Lincolnshire, IL	888-879-7639	https://www.sysmex.com/us	urine chemistry	$104,995	2015	>600/>57 (in Canada†)	Canada†	U.S. and United Kingdom/U.S. and United Kingdom	>50 tests	21 × 25 × 27 in./100 lbs.	100–240 VAC (48–62 Hz)	120 days	user ID failure, sampling error, consumables replacement/expiration, calibration failure	refractometer/wavelength of absorbance in an analyzer well or test strip/turbidity within an analyzer well	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 (6–91 cells/µL), nitrite (positive/negative), 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)	yes	yes	cartridge	yes	with every new lot No. of Novus cassette loaded or when same lot No. of Novus cassette has been loaded and calibration is greater than 24 hours old	liquid	semiquantitative	yes	7,500 sample results/400 control results	no (protein)/no (glucose)		—	—	—	—	—	—	—	365 days/15–30°C	onboard stability of cassette, 14 days/15–30°C	yes, for all tests		240/—	—	yes (minimum sample volume, 2 mL)	no (urinalysis)/— (body fluid analysis)	—	16 mm/100 mm	blood, mucus	barcode scan, worklist download from host, manual entry, RFID for authentic entry of cassette lot	yes	operator identifier, specimen identifier, reagent lot No.	website, e-mail query	yes (reflex testing)/yes (cross-check functionality)	no	data-management system that connects to LIS or EHR, or directly to LIS or EHR	ASTM 1394-91, ASTM 1381, HL7	—	yes	direct serial connection or hospital network	direct serial connection	device unique identifier, operator ID, patient ID, specimen ID, result, QC identifier	½ day of virtual instructor-led training at customer site	5–10 min. daily	no	yes (partial list of comparable sites)	no	• reagent cassette format with RFID that provides complete traceability and 14-day onboard stability • digital color camera • sold as standalone system or configured for modular integration with Sysmex UN-2000, UN-3000, UN-9000	†marketed in the U.S. and Canada by Sysmex; marketed in other countries by Siemens Healthineers
Sysmex America	UN-Series Automated Urinalysis Solution (UN-2000, UN-3000, UN-9000)†	7	Jason Anderson	andersonja@sysmex.com	Lincolnshire, IL	888-879-7639	https://www.sysmex.com/us	urine chemistry and microscopy/sediment combined	dependent on configuration	UN-2000: 2019; UN-3000 and UN-9000: 2020	>600 (all units combined)/—	Canada	Japan/Japan	>80 tests	varies by configuration/varies by configuration	varies by configuration	90 days	user ID failure, consumables replacement/expiration	refractometer/wavelength of absorbance in an analyzer well or test strip/turbidity within an analyzer well	bilirubin (0.5–2.7 mg/dL), red blood cells (trace levels), hemoglobin (0.013–0.3 mg/dL), glucose (36–820 mg/dL), ketone (3.6–156 mg/dL), leukocyte esterase (6–91 cells/µL), nitrite (positive/negative), 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)	yes	yes	cartridge	yes	with every new lot No. of Novus cassette loaded or when same lot No. of Novus cassette has been loaded and calibration is greater than 24 hours old	liquid	semiquantitative	100,000 sample results (in the urinalysis data manager)/	400 QC analysis results	no (protein)/no (glucose)	flow cytometry with fluorescent stain, digital image capture on UN-3000 and UN-9000 configurations	flagged and qualitative: pathological casts, crystals, yeast-like cells, mucus, sperm; quantitative: RBCs, WBCs, epithelial cells, bacteria, casts	yes	yes	numeric values or scattergrams	yes	yes	100,000 sample results (in the urinalysis data manager)/ 2 concentrations × 3 lots (120 plots/lot) for control results	varies based on reagent type	varies based on reagent type	yes, for all tests	daily (cannot use other vendors’ QC products)	240/—	varies by configuration/—	yes (minimum sample volume, 2 mL for chemistry/1.6 mL for microscopy/sediment)	no (urinalysis)/no (body fluid analysis)	—	16 mm/100 mm	blood, mucus, high fluorescence	barcode scan, manual entry, worklist download from host	yes	specimen identifier, reagent lot No.	website, e-mail query	yes (reflex testing)/yes (cross-check functionality)	yes	data-management system that connects to LIS or EHR, or directly to LIS or EHR	ASTM 1394-91, ASTM 1381	yes (to other companies’ LISs and EHRs)	yes	hospital network	hospital network	device unique identifier, operator ID, patient ID, specimen ID, result, QC identifier	2 days of virtual instructor-led training at customer site	20 min. daily; 10 min. weekly	yes	yes (partial list of comparable sites)	no	• combines urine chemistry, fluorescent flow cytometry, and digital image analysis for rapid urine screening • modular and scalable configurations • BeyondCare quality monitor for urinalysis provides a streamlined and automated QC experience	†modular systems: UN-2000, two modules; UN-3000, three modules; UN-9000, four or more modules
Company	Name of urinalysis instrument

In urinalysis, reflex algorithms and other efficiencies

March 2023—Urinalysis was at the heart of a Feb. 7 discussion between CAP TODAY publisher Bob McGonnagle; Ron Jackups Jr., MD, PhD, of Washington University School of Medicine; and Jason Anderson of Sysmex America. “There’s a lot of room to explore what the optimal parameters are to use with the best specificity and sensitivity for a reflex to the sediment analysis or the culture,” Anderson said. Here’s what he and Dr. Jackups said about reflex testing, automation, and middleware.

Since the urinalysis roundtable in December 2021, three things continue to be hot issues regardless of instrumentation, field of analysis, and subspecialty. Number one is automation in workflow, having something that’s robust for high volume, low staffing. Number two is the need for fit of an instrument line. In other words, there’s a core lab urinalysis instrument that’s ideal and yet there are smaller clinics, hospitals, all kinds of sites that can benefit from the same technology but in a differently configured unit. Number three is understanding if we’re extracting the optimum clinical information from the analysis in fields like hematology and urinalysis.

Dr. Jackups

Ron Jackups, talk to us about reflex testing in urinalysis and then more specifically about what you’ve been working on at Barnes-Jewish Hospital.
Ron Jackups Jr., MD, PhD, associate professor of pathology and immunology, Washington University School of Medicine, and associate chief medical information officer for laboratory informatics, BJC HealthCare: Reflex testing in general has two big benefits. The first is it focuses the diagnostic process, which reduces waste. We have seen in urinalysis and other areas that providers, rather than order a test and wait for the result and then order another test based on that result and wait for the next result, et cetera, tend to do what we call shotgun testing—they order all the tests they think might be relevant at once and then react to the results after they get them. This is wasteful in many situations if the tests further down the line were not necessary and can also be dangerous if one of the tests down the line is a false-positive. Part of the goal of reflex testing is to identify situations where there’s a low diagnostic value and high risk of false-positives in future tests that could be prevented by simply not doing them. That’s the first reason to do reflex testing.
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