URINALYSIS INSTRUMENTATION DECEMBER 2019 | CAP TODAY 47

Part 1 of 4 ARKRAY ARKRAY Beckman Coulter

Angie Howe howea@arkrayusa.com Jane Nichols nicholsj@arkrayusa.com John Ebbs jhebbs@beckman.com
See captodayonline.com/productguides Edina, MN Edina, MN Miami, FL
for an interactive version of guide 952-646-3224 arkrayusa.com/clinical-diagnostics 952-646-3231 www.arkrayusa.com 352-647-0176 www.beckmancoulter.com

Name of urinalysis instrument AUTION ELEVEN AE-4022 AUTION MAX AX-4030 iQ Workcell Series
Type of instrument urine chemistry urine chemistry urine chemistry and microscopy/sediment combined
Instrument list price — — —
First year instrument sold in U.S. 2017 2011 2018
No. of units installed in U.S./No. of units installed outside U.S. — (also sold via Cardinal Health, Beckman Coulter, — (also sold via distribution partners) — (also sold via McKesson, Henry Schein)
Medline Industries)
Foreign countries where company markets instrument worldwide worldwide worldwide
Country where instrument designed/manufactured Japan/Japan Japan/Japan U.S. and Japan/U.S. and Japan
Intended urine sample volume per day — >15 70–600
Dimensions (HxWxD)/Weight fully loaded with reagents 6.5 × 8.3 × 12.9 in./7.9 lbs. 21 × 21 × 21 in./82 lbs. 22 × 48 × 26 in./200 lbs.
Power requirements 100–240 VAC (50–60 Hz) 100–240 VAC (50–60 Hz) 100–240 VAC
Mean time between failure of instrument 1,230 days 364 days —
Events that cause instrument to lock or stop analysis user ID failure, result error short sample, result error, sampling error QC failure, short sample, barcode/sample ID misread, result
error, sampling error, consumables replacement/expiration

Urine chemistry: (Information in this box is specific to urine chemistry)

• 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
test strip/test strip/visual read, manual entry refractometer/wavelength of absorbance within an refractometer/wavelength of absorbance within an
analyzer well/turbidity within an analyzer well analyzer well/turbidity within an analyzer well
bilirubin (0.5–14 mg/dL), hemoglobin (0.03–1.0 mg/ bilirubin (0.5–10 mg/dL), hemoglobin (0.03–1.0 mg/ bilirubin (0–>10 mg/dL), hemoglobin (0–>1 mg/dL),
dL), glucose (30–1,000 mg/dL), ketone (5–150 mg/ dL), glucose (30–1,000 mg/dL), ketone (5–150 mg/dL), glucose (0–>1,000 mg/dL), ketone (0–>150 mg/dL),
dL), leukocyte esterase (25–500 leukocytes/µL), nitrite leukocyte esterase (0–500 leukocytes/µL), nitrite (0.08– leukocyte esterase (0–500 leukocytes/µL), nitrite (–, 1+,
(0.08–0.5 mg/dL), pH (5–9), protein (10–1,000 mg/dL), 0.5 mg/dL), pH (5–9), protein (10–600 mg/dL), specific 2+), pH (5–9), protein (0–>600 mg/dL), specific gravity
specific gravity (1.005–1.030), urobilinogen (2–16 mg/dL) gravity (1.000–1.050), urobilinogen (2–12 mg/dL) (1.000–1.500), urobilinogen (0–≥12 mg/dL)
yes yes yes
— no no
loosely packed in bottles loosely packed in bottles loosely packed in bottles
no no no
— — —
— — —
semiquantitative semiquantitative semiquantitative
no no no
520 (sample results and control results combined) 2,500 sample results/200 control results 2,500 sample results/200 control results
no (protein)/no (glucose) yes (protein)/yes (glucose) yes (protein)/yes (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
— — digital flow morphology (digital imaging)
— — all of the following quantitative: pathological casts,
crystals, yeast-like cells, mucus, sperm, RBCs, WBCs,
epithelial cells, bacteria, hyaline casts, WBC clumps,
yeast, squamous and nonsquamous epithelial cells, others
— — yes
— — no
— — numeric values
— — yes
— — 10,000 sample results/200 control results

Reagent shelf life/storage temperature for unopened containers 2 years/1–30°C 2 years/1–30°C varies based on reagent type
Reagent shelf life/storage temperature for opened containers 31 days/1–30°C 31 days/1–30°C varies based on reagent type
Reagent barcode-reading capability no no yes

How often quality control samples are run daily (can use other vendors’ QC products) daily (can use other vendors’ QC products) daily
Sample throughput per hour/Time to first result for chemistry 514/1 min. 225/1 min. cycle time up to 225/<1 min.
Sample throughput per hour/Time to first result for microscopy/sediment — — up to 70 or 101, depending on model/<2 min.
Analyzer has stat mode no yes (minimum sample volume, 2 mL) yes (minimum sample volume, 2 mL for chemistry/2 mL
for sediment)
Sample dilutions required for urinalysis/body fluid analysis no (urinalysis)/— (body fluid analysis) no (urinalysis)/— (body fluid analysis) no (urinalysis)/yes (body fluid analysis)
• Special sample handling required for body fluid analysis — — yes (Lyse reagent)
Minimum width of sample tube/Minimum length of sample tube — 15.8 mm/105 mm 15.8 mm/105 mm
Conditions or substances that prevent a sample from being run — — grossly visible turbidity
Means of sample ID entry barcode scan, manual entry barcode scan, manual entry barcode scan, manual entry
Built-in liquid-level sensing for samples no yes yes

Information that can be barcode scanned on instrument operator identifier, specimen identifier specimen identifier specimen identifier, reagent lot No., reagent expiration
How LOINC codes for results are made available — e-mail query e-mail query, manual transmission
Software includes reflex testing/cross-check functionality no (reflex testing)/no (cross-check functionality) no (reflex testing)/no (cross-check functionality) yes (reflex testing)/yes (cross-check functionality)
Instrument automatically generates consolidated report* no no yes
Instrument connections to transfer information directly to LIS or via ­commercial middleware (Data directly to LIS or via ­commercial middleware (Data directly to LIS or EHR
Innovations) Innovations)
Interface standards supported ASTM 1394-91, ASTM 1381 ASTM 1394-91, ASTM 1381 ASTM with proprietary message layer
Bidirectional interface no yes (to other companies’ LISs–Cerner, Epic, Meditech, yes (to other companies’ LISs and EHRs)
Orchard, SCC Soft Computer, Sunquest)
• Tests can be transmitted to LIS as soon as completed yes yes —
Connection to LIS to upload patient and QC results direct serial or hospital network direct serial or hospital network direct serial or hospital network
Connection to EHR to upload patient and QC results option not available — direct serial or hospital network
Information included in transmission from instrument to device unique identifier, specimen ID, result, QC identifier device unique identifier, specimen ID, result device unique identifier, operator ID, patient ID, specimen
data-management software ID, result, QC identifier

No. of days of training with instrument purchase 0 1–2 days at customer site 1 day at customer site, 3 days at vendor office
Approximate scheduled maintenance time required 5 min. daily <5 min. daily; <5 min. weekly; <10 min. monthly —
• Maintenance records kept onboard instrument no no yes

Provide list of client sites to potential customers on request no (information is confidential) yes (partial list of comparable sites) yes (complete list with no restrictions regarding its use)
Clients restricted from sharing their experience with company or software no no no

Distinguishing instrument features (supplied by company)
*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
• standardized test strip technology across all ARKRAY
platforms
• clinically significant reporting ranges
• small semi-automated footprint
• proven reliability with less than one unscheduled service • advances urinalysis and body fluid testing through
event per year digital flow morphology using proprietary auto-
• abnormal color detection alerts operators to potential particle-recognition software
false-positive results • increased productivity through improved workflow,
• easy to use; strips easy to load; does not require reduced urine cultures, lower review rates, and review
calibration by exception
• advanced technology allows for testing of body fluids
and urine samples in a preservative tube

All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.  Product guide editors: Raymond D. Aller, MD, and Hal Weiner
48 CAP TODAY | DECEMBER 2019 URINALYSIS INSTRUMENTATION
Part 2 of 4 Beckman Coulter Roche Diagnostics Roche Diagnostics
John Ebbs jhebbs@beckman.com Brittany Greiner brittany.greiner@roche.com Brittany Greiner brittany.greiner@roche.com
See captodayonline.com/productguides Miami, FL Indianapolis, IN Indianapolis, IN
for an interactive version of guide 352-647-0176 www.beckmancoulter.com 317-521-2000 roche.com 317-521-2000 roche.com

Name of urinalysis instrument iQ200 Series: SELECT, ELITE, SPRINT † cobas u 411 cobas u 601
Type of instrument microscopy/sediment urine chemistry urine chemistry
Instrument list price — $13,500 —
First year instrument sold in U.S. 2003 2006 2019
No. of units installed in U.S./No. of units installed outside U.S. >2,000††/>4,000†† globally (also sold via McKesson, >400/>2,300 globally —/1,200 globally
Henry Schein)
Foreign countries where company markets instrument worldwide worldwide worldwide
Country where instrument designed/manufactured U.S./U.S. Switzerland/Switzerland Hungary/Hungary
Intended urine sample volume per day 70–600 10–100 ≥50
Dimensions (HxWxD)/Weight fully loaded with reagents 22 × 21 × 24 in./118 lbs. 10.24 × 16.73 × 13.34 in./~26 lbs. 25.35 × 42.48 × 20.94 in./207.5 lbs.
Power requirements 90–240 VAC, 200 watts maximum 110 VAC 100–125 VAC
Mean time between failure of instrument — — 160 days
Events that cause instrument to lock or stop analysis QC failure, short sample, barcode/sample ID misread, result — opening front cover
error, sampling error, consumables replacement/expiration
Urine chemistry: (Information in this box is specific to urine chemistry)
• Testing methodology: specific gravity/color/clarity — test strip/wavelength of absorbance within an analyzer refractometer/test strip/turbidity within an analyzer well
well/—
• Urine chemistry tests available on instrument in the U.S. — bilirubin (neg.–6 mg/dL), red blood cells (neg.–250 bilirubin (neg.–6 mg/dL), red blood cells (intact RBCs up to
erythrocytes/µL), hemoglobin (neg.–250 erythrocytes/ 50 erythrocytes/µL), hemoglobin (neg.–250 erythrocytes/µL),
µL), glucose (normal–1,000 mg/dL), ketone (neg.–150 glucose (normal–1,000 mg/dL), ketone (neg.–150 mg/dL),
mg/dL), leukocyte esterase (neg.–500 leukocytes/µL), leukocyte esterase (neg.–500 leukocytes/µL), nitrite (positive/
nitrite (positive/negative), pH (5–9), protein (neg.–500 negative), pH (5–9), protein (neg.–500 mg/dL), specific
mg/dL), specific gravity (1.000-1.030), urobilinogen gravity (1.000-1.030), urobilinogen (normal–12 mg/dL)
(normal–12 mg/dL)
• Color compensation pad included — yes yes
• Flagging thresholds customizable — no yes
• Test strip configuration — loosely packed in bottles cartridge
• Calibration required after each test strip lot No. change — no no
• Frequency of customer-performed calibration — 28 days 28 days
• Form of calibration — dry dry
• How results are displayed for urine chemistry — semiquantitative semiquantitative
• Reporting format customizable — yes yes
• No. of results that can be held in internal memory — 1,000 sample results/300 control results 10,000 sample results/300 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 no
• How results are displayed for microscopy/sediment
• Reporting format customizable
• No. of results that can be held in internal memory
digital flow morphology (digital imaging)
all of the following quantitative: pathological casts,
crystals, yeast-like cells, mucus, sperm, RBCs, WBCs,
epithelial cells, bacteria, hyaline casts, WBC clumps,
yeast, squamous and nonsquamous epithelial cells, others
yes
numeric values
yes
10,000 sample results/200 control results
— —
— —
— —
— —
— —
— —
— —

Reagent shelf life/storage temperature for unopened containers varies based on reagent type —/2–30°C —/2–30°C
Reagent shelf life/storage temperature for opened containers varies based on reagent type —/2–30°C —/2–30°C
Reagent barcode-reading capability yes no yes

How often quality control samples are run daily — (can use other vendors’ QC products) — (can use other vendors’ QC products)
Sample throughput per hour/Time to first result for chemistry — 600/1 min. 240/1 min.
Sample throughput per hour/Time to first result for microscopy/sediment up to 40, 70, 101, depending on model/<2 min. — —
Analyzer has stat mode yes (minimum sample volume, 2 mL) no (minimum sample volume for sampler or track mode yes (minimum sample volume, 1.5 mL)
is ­minimum amount necessary to immerse pads)
Sample dilutions required for urinalysis/body fluid analysis no (urinalysis)/yes (body fluid analysis) no (urinalysis)/— (body fluid analysis) no (urinalysis)/— (body fluid analysis)
• Special sample handling required for body fluid analysis yes (Lyse reagent) — —
Minimum width of sample tube/Minimum length of sample tube 16 mm/100 mm — 13 mm/65 mm
Conditions or substances that prevent a sample from being run grossly visible turbidity preservatives preservatives
Means of sample ID entry barcode scan, manual entry barcode scan, bidirectional download from host, barcode scan, manual entry, worklist download from
worklist download from host, manual entry host, bidirectional download from host
Built-in liquid-level sensing for samples yes — yes

Information that can be barcode scanned on instrument specimen identifier, reagent lot No., reagent expiration specimen identifier specimen identifier, reagent lot No.
How LOINC codes for results are made available manual transmission website, e-mail query website, e-mail query
Software includes reflex testing/cross-check functionality yes (reflex testing)/yes (cross-check functionality) no (reflex testing)/no (cross-check functionality) — (reflex testing)/yes (cross-check functionality)
Instrument automatically generates consolidated report* yes no —
Instrument connections to transfer information directly to LIS or EHR data-management system that connects to LIS data-management system that connects to LIS
or EHR, or data-management system that cannot or EHR, or data-management system that cannot
further transmit data, or directly to LIS or EHR, or via further transmit data, or directly to LIS or EHR, or via
commercial middleware (Data Innovations) commercial middleware (Data Innovations, Infinity)
Interface standards supported ASTM with proprietary message layer ASTM 1394-91, ASTM 1238-95 ASTM 1394-91, ASTM 1381
Bidirectional interface yes (to other companies’ LISs) yes (to other companies’ LISs and EHRs) yes (to other companies’ LISs and EHRs)
• Tests can be transmitted to LIS as soon as completed — yes yes
Connection to LIS to upload patient and QC results direct serial or hospital network direct serial hospital network
Connection to EHR to upload patient and QC results direct serial or hospital network — hospital network
Information included in transmission from instrument to device unique identifier, operator ID, patient ID, specimen specimen ID, result device unique identifier, operator ID, patient ID, specimen
data-management software ID, result, QC identifier ID, result

No. of days of training with instrument purchase 1 day at customer site, 2.5 days at vendor office 0 —
Approximate scheduled maintenance time required — 5 min. daily; 10 min. monthly 10 min. daily; 10 min. weekly; 10 min. monthly
• Maintenance records kept onboard instrument yes — —

Provide list of client sites to potential customers on request yes (complete list with no restrictions regarding its use) no (information is confidential) no (information is confidential)
Clients restricted from sharing their experience with company or software no no no

Distinguishing instrument features (supplied by company)
*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
• digital flow morphology using auto-particle-
recognition software
• increased productivity through improved workflow,
reduced urine cultures, lower review rates, more
• advanced technology allows for testing of body fluids
and urine samples in a preservative tube
†answers in listing apply to all three systems unless
otherwise indicated; ††combined total for iQ200 series
• 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
• fl exible sample ID entry options let user choose
barcode scan, download from host, or manual entry
options
• c obas u pack strips have virtually no interference with
ascorbic acid, minimizing false-negative glucose and
hemoglobin results
• innovative photometer with improved reflectance
technology differentiates lysed and intact erythrocytes
• 1 9-in. HD touchscreen monitor with an intuitive user
interface and convenient QC management

All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP. 
50 CAP TODAY | DECEMBER 2019 URINALYSIS INSTRUMENTATION
Part 3 of 4 Siemens Healthineers Siemens Healthineers Sysmex America
Maya Daaboul maya.daaboul@siemens-healthineers.com Maya Daaboul maya.daaboul@siemens-healthineers.com Jason Anderson andersonja@sysmex.com
See captodayonline.com/productguides Norwood, MA Norwood, MA Lincolnshire, IL
for an interactive version of guide 781-269-3000/www.siemens-healthineers.com/en-us/urinalysis 781-269-3000/www.siemens-healthineers.com/en-us/urinalysis 888-879-7639 www.sysmex.com

Name of urinalysis instrument CLINITEK AUWi PRO Automated Urine Workstation† CLINITEK Novus Automated Urine Chemistry Analzyer UF-5000 Fully Automated Urine Particle Analyzer
Type of instrument urine chemistry and microscopy/sediment combined urine chemistry microscopy/sediment
Instrument list price — — $95,000
First year instrument sold in U.S. 2015 2015 2019
No. of units installed in U.S./No. of units installed outside U.S. — (also sold via Cardinal Health, Fisher, Medline, McKesson) — (also sold via Cardinal Health, Fisher, Medline, McKesson) 3/>1,000 globally
Foreign countries where company markets instrument worldwide worldwide worldwide
Country where instrument designed/manufactured U.S./England U.S./England Japan/Japan
Intended urine sample volume per day 50–500 50–1,000 40–75 microscopic analyses
Dimensions (HxWxD)/Weight fully loaded with reagents 27 × 63 × 35 in./~425 lbs. 21 × 25 × 27 in./~100 lbs. 35 × 26 × 36 in./232 lbs. (main unit)
Power requirements 100–240 VAC (50–60 Hz) 100–240 VAC (48–62 Hz) 100–240 VAC; 15 amps; 600 VA or less (main unit)
Mean time between failure of instrument — — —
Events that cause instrument to lock or stop analysis user ID failure, QC failure, short sample, barcode/sample user ID failure, QC failure, short sample, barcode/sample user ID failure, short sample, barcode/sample ID
ID misread, result error, sampling error, consumables ID misread, result error, sampling error, consumables misread, result error, sampling error, consumables
replacement/expiration, calibration failure, other events replacement/expiration, calibration failure, other events replacement/expiration

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 refractometer/test strip/turbidity within an analyzer well —
• Urine chemistry tests available on instrument in the U.S. bilirubin (0.5–2.7 mg/dL), red blood cells (trace level), bilirubin (0.5–2.7 mg/dL), red blood cells (trace level), —
hemoglobin (0.013–0.3 mg/dL), glucose (36–820 mg/ hemoglobin (0.013–0.3 mg/dL), glucose (36–820 mg/
dL), ketone (3.6–156 mg/dL), leukocyte esterase (6–91 dL), ketone (3.6–156 mg/dL), leukocyte esterase (6–91
cells/mL), nitrite (positive/negative), pH (5.3–8.7), protein cells/mL), nitrite (positive/negative), pH (5.3–8.7), protein
(10.8–1,000 mg/dL), specific gravity (1.000–1.099), (10.8–1,000 mg/dL), specific gravity (1.000–1.099),
urobilinogen (0.24–6.24 mg/dL)†† urobilinogen (0.24–6.24 mg/dL)†
• Color compensation pad included yes yes —
• Flagging thresholds customizable yes yes —
• Test strip configuration cartridge cartridge —
• Calibration required after each test strip lot No. change yes yes —
• Frequency of customer-performed calibration with every Novus cassette change or every 24 hours when with every Novus cassette change or every 24 hours when —
multiple same-lot Novus cassettes are used within 24 hours multiple same-lot Novus cassettes are used within 24 hours
• Form of calibration liquid and dry liquid and dry —
• How results are displayed for urine chemistry semiquantitative semiquantitative —
• Reporting format customizable yes yes —
• No. of results that can be held in internal memory 7,500 sample results/400 control results 7,500 sample results/400 control results —
• Specific gravity correction for protein/glucose no (protein)/no (glucose) no (protein)/no (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 yes
• How results are displayed for microscopy/sediment
• Reporting format customizable
• No. of results that can be held in internal memory
flow cytometry with fluorescent stain
flagged: pathological casts, crystals, small round cells,
yeast-like cells, mucus, sperm; quantitative: RBCs,
WBCs, epithelial cells, bacteria, hyaline casts
yes
numeric values, scattergrams
yes
up to 2 years worth (sample results)/up to 2 years worth
(control results)
— flow cytometry with fluorescent stain
— flagged: pathological casts, crystals, yeast-like cells,
mucus, sperm; quantitative: RBCs, WBCs, epithelial
cells, bacteria, total casts
— yes
— yes
— numeric values, scattergrams
— yes
— 1,000 (sample results, including scattergrams)/2
concentrations × 3 lots, or 120 plots/lot (control results)

Reagent shelf life/storage temperature for unopened containers 365 days/15–30°C 365 days/15–30°C varies based on reagent type
Reagent shelf life/storage temperature for opened containers 180 days; onboard stability of cassette, 14 days/15–30°C onboard stability of cassette, 14 days/— varies based on reagent type
Reagent barcode-reading capability yes yes yes

How often quality control samples are run daily (can use other vendors’ QC products) follow government regulations or accreditation daily (cannot use other vendors’ QC products)
requirements (can use other vendors’ QC products)
Sample throughput per hour/Time to first result for chemistry 240/~2 min. 240/— —
Sample throughput per hour/Time to first result for microscopy/sediment 80 at 100% sediment/~4 min. — up to 105/<1 min.
Analyzer has stat mode yes (min. sample volume, 2 mL chemistry/1 mL sediment) yes (minimum sample volume, 2 mL) yes (minimum sample volume, 1.6 mL)
Sample dilutions required for urinalysis/body fluid analysis no (urinalysis)/— (body fluid analysis) no (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 mm 16 mm/95 mm 12 mm/95 mm
Conditions or substances that prevent a sample from being run mucus, high fluorescence, grossly bloody samples, others mucus, high fluorescence, grossly bloody samples blood, mucus, high fluorescence, visible turbidity
Means of sample ID entry barcode scan, worklist download from host, manual entry barcode scan, worklist download from host, manual entry, barcode scan, worklist download from host, manual entry
RFID tag on cassette for automatic entry of lot and expiration
Built-in liquid-level sensing for samples yes yes yes

Information that can be barcode scanned on instrument specimen identifier, reagent lot No., more
How LOINC codes for results are made available website, e-mail query, communications from Siemens
Software includes reflex testing/cross-check functionality yes (reflex testing)/yes (cross-check functionality)
Instrument automatically generates consolidated report* yes
Instrument connections to transfer information 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 (WAM)
Interface standards supported ASTM 1394-91, HL7
Bidirectional interface yes (to other companies’ LISs and EHRs)
• Tests can be transmitted to LIS as soon as completed yes
Connection to LIS to upload patient and QC results direct serial or hospital network
Connection to EHR to upload patient and QC results direct serial or hospital network
Information included in transmission from instrument to device unique identifier, operator ID, patient ID, specimen
data-management software ID, result, QC identifier
operator identifier, specimen identifier, reagent lot No. specimen identifier, reagent lot No.
website, e-mail query, communications from Siemens website, e-mail query
yes (reflex testing)/yes (cross-check functionality) yes (reflex testing)/— (cross-check functionality)
— —
data-management system that connects to LIS data-management system that connects to LIS or EHR,
or EHR, or data-management system that cannot or directly to LIS or EHR
further transmit data, or directly to LIS or EHR, or via
commercial middleware (WAM)
ASTM 1394-91, ASTM 1381, HL7 ASTM 1381, ASTM 1894-97
yes (to other companies’ LISs and EHRs) yes (to other companies’ LISs and EHRs)
yes yes
direct serial or hospital network hospital network
direct serial or hospital network hospital network
device unique identifier, operator ID, patient ID, specimen device unique identifier, patient ID, specimen ID, result
ID, result, QC identifier

No. of days of training with instrument purchase 1–3 days at customer site, 4 days at vendor office 1–2 days at customer site, 3 days at vendor office based on configuration–virtual instructor-led training†
Approximate scheduled maintenance time required 10 min.: per shift, daily, weekly, monthly 5–10 min.: per shift, daily, weekly, monthly 20 min. daily; 10 min. weekly
• Maintenance records kept onboard instrument no no yes

Provide list of client sites to potential customers on request yes (partial list of comparable sites) yes (partial list of comparable sites) yes (partial list of comparable sites)
Clients restricted from sharing their experience with company or software no no no

Distinguishing instrument features (supplied by company)
*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
• can upgrade CLINITEK Atlas to CLINITEK Novus and
have CLINITEK solution for dry pad chemistry
• no sample pretreatment or on-screen review required
• fluorescent flow cell technology with dedicated channels
for bacteria and sediment to drive clinical outcomes
†comprises
CLINITEK Novus and Sysmex UF-1000i
††system
does not report numeric values for most tests;
it reports negative, trace, small, moderate, large, etc.
• d igital color camera for improved accuracy of result
measurement, including detection of intact RBCs
• r eagent cassette format with RFID that provides
complete traceability and 14 days onboard stability
• u tilizes same dry pad reagent chemistry as CLINITEK
family of analyzers—that is, Multistix 10SG
†system does not report numeric values for most tests;
it reports negative, trace, small, moderate, large, etc.
• fluorescent flow cytometry methodology offers
accuracy, precision, efficiency, and standardization
• highly modular and scalable system offering flexibility
to add additional modules to meet increasing
workload demands
• BeyondCare quality monitor for urinalysis provides a
streamlined and automated QC experience
†no limit on No. of times customer can sign up

All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP. 
 URINALYSIS INSTRUMENTATION DECEMBER 2019 | CAP TODAY 51

Part 4 of 4 Sysmex America

CAP TODAY product guides

Jason Anderson andersonja@sysmex.com
See captodayonline.com/productguides Lincolnshire, IL
for an interactive version of guide 888-879-7639 www.sysmex.com

Name of urinalysis instrument UN-2000 Automated Urinalysis System

help you weigh your options when
Type of instrument
Instrument list price
First year instrument sold in U.S.
microscopy/sediment
—
2019
it's time for a new instrument
No. of units installed in U.S./No. of units installed outside U.S.
Foreign countries where company markets instrument
3/~275 globally
worldwide
or software system
Country where instrument designed/manufactured Japan/Japan
Intended urine sample volume per day 50–150 microscopic analyses
Dimensions (HxWxD)/Weight fully loaded with reagents 35 × 52 × 36 in./428 lbs. (main unit) 22 CAP TODAY | JANUARY 2018

Power requirements varies by configuration Lab needs driving coagulation analyzer market
Mean time between failure of instrument —
Valerie Neff Newitt
Customer wish lists help to define
every generation of coagulation ana-
lyzers, test menus, and related tech-
North America for Siemens Health- ity, eliminating reconstitution time, another 20 minutes to get the blank.
ineers’ chronic disease portfolio, acclimation time, and repetitive man- But we are now down to a time frame
notes that many customers are ex- ual pipetting.” HemosIL ReadiPlastin of under 10 minutes to have the two
panding and gaining more oversight for prothrombin time testing on ACL different samples that are needed. 58 CAP TODAY | OCTOBER 2018 AUTOMATED MOLECULAR PLATFORMS A

Events that cause instrument to lock or stop analysis user ID failure, short sample, barcode/sample ID
nologies. That’s evident in the recent
and upcoming launches and the on-
going work of the companies whose
analyzers are profiled in this issue in
of their hospital-affiliated offices and
clinics. “They need simple solutions
that don’t require a lot of training.
They want small analyzers that can
Top and ACL Top Family 50 Series Since platelets are what we do, cen-
systems, for example, has onboard trifugation is getting a lot of attention Part 11 of 17 Hologic Hologic Part 12 of 17
Glenn Sawyer glenn.sawyer@hologic.com Glenn Sawyer glenn.sawyer@hologic.com
stability of 10 days, she says. from us.” He expects the new centri- See captodayonline.com/productguides San Diego, CA San Diego, CA See captodayonline.com/productguides
William Trolio, MBA, MT, vice fuge will come to the market as a for an interactive version of guide 858-410-8000 www.pantherfusion.com, www.hologic.com 858-410-8000 www.hologic.com for an interactive version of guide

misread, consumables replacement/expiration

the 2018 coagulation analyzer prod-
uct guide.
At Helena Laboratories, “We hear
demands for easier connectivity,
transmit data, directly or indirectly
via middleware, into their hospital
information system and ultimately
president and chief scientific officer, second-generation unit in the first Name of instrument Panther Fusion System Panther System Name of instrument
of Bio/Data, says shortening process- part of this year. Country where designed/Manufactured/Reagents manufactured U.S./Switzerland/U.S. U.S./Switzerland/U.S. Country where designed/Manufactured/Reagents manufactured
ing time is paramount to his custom- Instrument FDA cleared or approved/Platform
“The health care industry is con- Instrument FDA cleared or approved/Platform yes/preanalytical and analytical yes/preanalytical and analytical
First year sold in U.S./Sold internationally/Installed
First year sold in U.S./Sold internationally/Installed 2017/2017/2017 2012/2010/2010
ers. “Specimen processing time is solidating, hospitals are forming Dimensions in inches (H × W × D)/Footprint in square feet/Noise generated in dB
Dimensions in inches (H × W × D)/Footprint in square feet/Noise generated in dB 69 × 76 × 32/16.8/<60 69 × 48 × 32/10.6/<55

E T
C
smaller sample sizes, greater avail- one of the more frustrating parts groups, groups are joining together Supplied with UPS/BTU

ID U
Coagulation Analyzers, pages 25–34 Supplied with UPS/BTU yes/3,412 yes/1,878 per hr.

U D
G O
ability of more specialty tests, like of platelet testing,” he says. and reconfiguring, purchasing is in a Physical contamination control features

R
Physical contamination control features closed system, liquid level sensing, pressure-dispense verification closed system, liquid level sensing, pressure-dispense verification, onboard deactiva-

low-molecular-weight heparin and
direct thrombin inhibitors,” says The-
resa Peveto, BSCLS, MT, hemostasis
P
into their electronic medical record
systems. Additionally, they want
“Platelets are only good for about
four hours. . . . And you may beat up
the platelets so much during the
tion, deep-well reaction tube, single sample aspiration and dispense, penetrable cap List price/Price for sample extraction and amplification detection modules
constant state of flux,” says Susan L. Purchase options/Minimum test volume requirements
List price/Price for sample extraction and amplification detection modules — —
Taylor, MS, MT(ASCP), director, STA Purchase options/Minimum test volume requirements straight purchase, reagent rental, lease/— straight purchase, reagent rental, lease/variable
Co. performs installation, operation, and performance qualifications/Electrical requirem
marketing, Diagnostica Stago, “and Labor and parts warranties/Advanced operator training

Urine chemistry: (Information in this box is specific to urine chemistry)

product manager. “And everyone
wants a good activated partial throm-
boplastin time point-of-care test that
is as reliable as an in-laboratory test.”
technology that does not disrupt
flow, be it patient flow or workflow
in an office or clinic.”
For the health care networks that
preparation that you won’t get the
right results due to platelet activation
or compromised sample conditions—
icterus, hemolysis, or lipemia.”
Co. performs installation, operation, and performance qualifications/Electrical requirements yes/190–240 VAC, 50–60 Hz, 1,800 VA single phase yes/100–240 V ± 10% Delivery time/Delivery charges/Installer/Time to install on site
it is all changing how the laboratory Labor and parts warranties/Advanced operator training 1 year/yes 1 year/yes Training location/No. of techs that can receive initial training/
Delivery time/Delivery charges/Installer/Time to install on site ~1 week/variable at origin and destination/Hologic/1–2 days ~1 week/variable at origin and destination/Hologic/1–2 days
must respond. Labs, now recognized Training location/No. of techs that can receive initial training/ off site/2/2–3 days/yes on and off site/2/3 days/yes
Length of training/Retraining at company facility
as business units, are expected to be Test menu
Length of training/Retraining at company facility
centers of value.” Test menu CT-GC, CT, GC, HPV, HPV genotyping, trich, HIV-1 viral load, HCV viral load, HBV CT-GC, CT, GC, HPV, HPV genotyping, trich, HIV-1 viral load, HCV viral load, HBV

• Testing methodology: specific gravity/color/clarity —

Toward that end, Peveto says Helena
Laboratories is well into the develop-
ment of a new analyzer with an espe-
cially broad platform that will include
want to standardize equipment Bio/Data is working to modify the “‘Easy-to-use, reliable, high- viral load, M. gen, HSV 1&2, Zika, GBS, MRSA, Flu A/B/RSV, Paraflu, AdV/hMPV/RV viral load, M. gen, HSV 1&2, Zika
No. of tests for which analyzer has FDA-cleared applications/CE mark 13/17 9/12
across the network, “our customers centrifugation process “to minimize throughput equipment that promotes Tests available on instrument in U.S./Outside U.S. CT-GC, HPV, HPV genotyping, trich, HIV-1 viral load, HCV viral load, HBV viral load, CT-GC, HPV, HPV genotyping, trich, HIV-1 viral load, HCV viral load, HBV viral load
52 CAP TODAY | FEBRUARY 2019 No. of tests for which analyzer has FDA-cleared applications/CE mark
want an end-to-end enterprisewide the amount of g- efficiency and flexibility’ cannot be a HSV 1&2, Zika, GBS, Flu A/B/RSV, Paraflu, AdV/hMPV/RV/CT-GC, CT, GC, HPV, HSV 1&2, Zika/CT-GC, CT, GC, HPV, HPV genotyping, trich, HIV-1 viral load, HCV Tests available on instrument in U.S./Outside U.S.
solution,” Peluso-Lapsley says. forces applied and sales pitch,” Taylor says. “Whereas HPV genotyping, trich, HIV-1 viral load, HCV viral load, HBV viral load, M. gen, viral load, HBV viral load, M. gen, HSV 1&2, Zika

“new assays not normally seen.”
For instrumentation, the smaller
the better. “We will see the industry
move toward smaller devices, some-
A A m
HSV 1&2, Zika, MRSA, GBS, Flu A/B/RSV, Paraflu, AdV/hMPV/RV
At Instrumentation Laboratory, shorten the time so we used to demonstrate the skills and Tests not available in U.S. but submitted to FDA/Available Level-7 messages
in other countries only to stainers—now
—/CT, GC, MRSA,we Bordetella, M. gen —/CT, GC, M. gen
“We have asked customers, ‘What do that labs get decent the attributes of an instrument, now Research-use-only assays/Tests in development
are in the digital age where —/BV, CV/TV, M. gen
slides are —/BV, CV/TV, M. gen Tests not available in U.S. but submitted to FDA/Available in other countries only
you need and what would make your samples,” Trolio we must also demonstrate how they Open-channel capabilities/Start-up and preparation time yes/<15 min.
moving into the cloud and image
yes/<15 min.
Model type of sample-handling system/Maximum sample load capacity automated onboard/120, with continuous and random access automated onboard/120 Research-use-only assays/Tests in development
life better?’” says Venita Shirley, says. “Right now actually serve a specific customer in analysis andavailable
algorithms are driving
Minimum specimen volume/Sample volume flexibility/Other sample volumes 400 µL/yes (varies by sample type with open channel capability)/yes 400 µL/no/—

• Urine chemistry tests available on instrument in the U.S. —

thing like a glucometer—quick,
smaller sample sizes, smaller strips,
less dependent on technique and
technology,” Peveto predicts.
Maria Peluso-Lapsley, MBA, se-
MBA, MT(ASCP), director of hemo-
stasis marketing in North America.
One answer, she says, is time-saving
convenience. “In response we have
reengineered many reagents to be
people tend to do their work environment, in real time, Minimum dead volume/Pediatric sample volume/Primary care and where to focus250attention.
tube sampling µL/no/yes 250 µL/—/yes
very slow spins to and with their lab team. That is very Sample tube sizes/Sample barcode reading/Autodiscrimination in 1D or 2D
Rodney Schmidt, MD,
various/yes (automated onboard scanner to maintain positive sample ID)/— various/yes/no Open-channel capabilities/Start-up and preparation time
begin with—20 different for us, but customers have a Sample barcode languages/Sample types available in open mode CodabarPhD,codes 39pa- and 128, Interleaved 2 of 5, JAN13, code 93, UPC, NW7/— Codabar codes 39 and 128, Interleaved 2 of 5, JAN13, code 93, UPC, NW7/— Model type of sample-handling system/Maximum sample load capacity
Trolio Clot detection/Open extraction platform/Sample types (open thologist
extraction) consultant, Cortex
yes/no/—Medical yes/no/— Minimum specimen volume/Sample volume flexibility/Other sample volumes avail
minutes or longer— right to expect it.” Amplification reagents or methods supported Complexity in amplification, real-time TMA, real-time PCR, Invader Plus
Management Systems:transcription-mediated transcription-mediated amplification, real-time TMA
and that is only to prepare half the

S
Minimum dead volume/Pediatric sample volume/Primary tube sampling

• Color compensation pad included —

nior product marketing manager in
liquid, ready to use with robust stabil-
No. of different assays onboard at once/Programmed or calibrated
AP might at oncebe divided intoup to three
32/up toareas.
32 4/4
Sample tube sizes/Sample barcode reading/Autodiscrimination in 1D or 2D
sample. Then they have to spin it for iemens launched in 2016 its first Tests per container set/Multiple reagent configurations supported 12, 100, or 250/yes 100 or 250/yes
Reagent container placed directly on system/Onboard testInboundauto inventorycomplexity relatesyes/yes to client yes/yes Sample barcode languages/Sample types available in open mode
point-of-care PT/INR device. Determines reagent volume in container/Reagent barcode complexity,
reading/Reagentslocations,
barcoded ordering
yes/yes/yesmecha- yes/yes/yes Clot detection/Open extraction platform/Sample types (open extraction)
The Xprecia Stride is a handheld Monitors expiration date/Auto lot recognition or calibrationnisms, and interfaces.yes/yes Internal com- yes/yes Amplification reagents or methods supported
No. of different assays onboard at once/Programmed or calibrated at once
coagulation analyzer that mimics the Auto detection of adequate reagent or specimen/Reagents available yes/liquid and dry yes/liquid

REVENUE CYCLE SERVICES

plexity includes instrument interfaces,

• Flagging thresholds customizable —

Tests per container set/Multiple reagent configurations supported

TELCOR
look of a smartphone and provides Reagent reconstitution required/Chemical contamination control no/yes yes/yes

We’re
integration Reagent container placed directly on system/Onboard test auto inventory
Onboard test auto inventory/Capable of inventory monitoring by barcode of results yes/yesfrom different yes/yes
results in 60 seconds or under, Pelu- System is open to homebrew/General-purpose reagents allowed sources into coherent reports, yes/yes partner- yes/yes
Determines reagent volume in container/Reagent barcode reading/Reagents barco
Monitors expiration date/Auto lot recognition or calibration
Using our same powerful RCM so-Lapsley says. “While the handheld Same capabilities when third-party reagent used/Lot sequestering available
ship or inclusion of advanced
Closed-vial stability for amplification reagents/Extraction reagents
—
testing
assay dependent/assay dependent
—
assay dependent/assay dependent
Auto detection of adequate reagent or specimen/Reagents available
concept is not new to the industry, modalities, Reagent reconstitution required/Chemical contamination control
reagents and synoptic reporting.
software, our billing service— Storage temp. requirement for amplification reagents/Extraction refrigeration/refrigeration refrigeration/refrigeration

• Test strip configuration —

what is new is that this device uses Onboard test auto inventory/Capable of inventory monitoring by barcode

Your
ACCESSIBLE TELCOR Revenue Cycle Services— the same reagents for PT/INR that Minimum/Maximum reagent shelf-life guarantee
Outbound
Shipment temp. requirement for amplification reagents/Extraction reagents complexity
bound complexity but focuses
assaymirrors
—/up to 2 years
more on
in- dependent
dependent/assay room temperature/room temperature
—/up to 2 years
System is open to homebrew/General-purpose reagents allowed
Same capabilities when third-party reagent used/Lot sequestering available
Gain efficiencies and a better are used in the large analyzer portfo- Autocalibration or autocalibration alert/Multipoint calibration supported
how to get results to yes/yes
yes/no
where they’re
yes/— Closed-vial stability for amplification reagents/Extraction reagents

understanding of your AR with full access gives laboratories unmatched access lio. This feature ties into customers’ Assay calibrations required by end user/Calibrants can be stored onboard
needed.
Multiple calibrant lots stored for same assay/Required calibration The underlying
frequency theme
no/24 hrs. is dis-
yes/yes
no/24 hrs.
Storage temp. requirement for amplification reagents/Extraction reagents
Shipment temp. requirement for amplification reagents/Extraction reagents

Team
desire to standardize equipment and
to your data and complete transparency to their AR data for complete control

• Calibration required after each test strip lot No. change —

Length of assay calibration/Typical calibration frequency crete data. All data need can to
be user-defined
be in dis-(assay dependent)/24 hrs. 24 hrs./24 hrs. Minimum/Maximum reagent shelf-life guarantee
reagents and better correlate results.” Onboard real-time QC/Supports multiple QC lot numbers per assay —/yes —/yes Autocalibration or autocalibration alert/Multipoint calibration supported
between you and TELCOR. crete form QC so they canyes/<15be effi ciently
and transparency. With metrics to Another example of coagulation Auto shutdown*/Instrument warm-up time/Onboard software reviews
Total number of controls per batch for 24 tests/48 tests/72manipulated,
tests/96 tests stored, and
min./yes
reported
— (not by
a batch analyzer)
yes/<15 min./yes
— (not a batch analyzer)
Assay calibrations required by end user/Calibrants can be stored onboard
Multiple calibrant lots stored for same assay/Required calibration frequency

METRICS successfully manage their business, innovation is preanalytical checks,

which “have been on chemistry ana-
Walkaway capacity/Tech hands-on time (both for batch ofcomputer96 samples) systems. In many
Uses disposable pipette tips/Maximum number of pipette tips stored
may require re-architecting yes/1,152
cases, this
120 samples/<15
the LIS
seconds per sample 120 samples/<15 seconds per sample
yes/576 (2.2 tips per sample)
Length of assay calibration/Typical calibration frequency
Onboard real-time QC/Supports multiple QC lot numbers per assay

• Frequency of customer-performed calibration —

From daily billing status to monthly
profitability analysis to yearly sales trends,
you control the metrics needed to effectively
manage your business.
labs have complete confidence lyzers forever,” Taylor says. “Now Time between start and initial result/Instrument automatic shutdown 2.4 hrs./yes 2.7–3.5 hrs. (assay dependent)/no Auto shutdown*/Instrument warm-up time/Onboard software reviews QC
Startup programmable/Remote system monitoring/Waste database and adding new
required for disposables functionality.
yes/yes/plastics and cardboard yes/yes/plastics and cardboard Total number of controls per batch for 24 tests/48 tests/72 tests/96 tests
coagulation analyzers are starting to Walkaway capacity/Tech hands-on time (both for batch of 96 samples)
working with our trained billing respond in kind.” Diagnostica Stago
Windows technology/Mouse or touchscreen/Modular add-on APcapability
Service contracts available/Mean time between failures/Tomarket
vendors have to beyes/touchscreen/yes
repair failures
attuned to the
on-demand, pm only, standard, standard plus, premium, premium plus/—/—
yes/touchscreen/yes
on-demand, pm only, standard, standard plus, premium, premium plus/—/—
Uses disposable pipette tips/Maximum number of pipette tips stored
and willing to make changes. Time between start and initial result/Instrument automatic shutdown
team with experience specific to has developed a module that’s in the Turnaround time for problem solving by phone/Email/Field service — —
Startup programmable/Remote system monitoring/Waste required for disposable

• Form of calibration —
No. of U.S. field reps/Service engineer on-site response time/Hours and days available —/standard and standard plus: within 24 hrs., premium and premium plus: —/standard and standard plus: within 24 hrs., premium and premium plus:
presubmission stage with the FDA; Windows technology/Mouse or touchscreen/Modular add-on capability
laboratory billing. The buzz around Web-based within 18and cloud pm only, and standard: M–F, 5 am–5 pm, PT;
hrs./on-demand, within 18 hrs./on-demand, pm only, and standard: M–F, 5 am–5 pm, PT;
Service contracts available/Mean time between failures/To repair failures
FLEXIBLE the company is aiming for a 2019 en-
try into the market. The checks, which
computing continues to grow. How do premium plus: 24–7
Guaranteed response time/Modem servicing avail./System diagnose own malfunctions
standard
yes/yes/yes
plus, premium, standard plus, premium, premium plus: 24–7
yes/yes/yes
Turnaround time for problem solving by phone/Email/Field service
Order parts via modem/Onboard error codes/Maintenancethese trainingdevelopments affect your custom- No. of U.S. field reps/Service engineer on-site response time/Hours and days ava
demo module no/yes/no no/yes/no
As payer requirements continuously will run on the company’s STA Max Guaranteed response time/Modem servicing avail./System diagnose own malfunc
change, our solution is configured to make Discover the laboratory billing service giving generation instruments, will detect
ers andrecords
Average maintenance time for lab personnel/Onboard maintenance your planning? weekly: <5 min.; monthly: <45 min./yes weekly: <5 min.; monthly: <45 min./yes
Order parts via modem/Onboard error codes/Maintenance training demo module

• How results are displayed for urine chemistry —

Preventive maintenance per year for sample extraction/Amplification detection 2/2 2/2
Johnson (Orchard): The health care Average maintenance time for lab personnel/Onboard maintenance records
sure your claims are compliant. complete access to your data and unrivaled hemolysis, icterus, and lipemia (HIL). Downtime for preventive maintenance/Spare parts on site
indu
<1 day/yes <1 day/yes
Preventive maintenance per year for sample extraction/Amplification detection
Software and LIS interface:
transparency. Discover TELCOR. Taking a somewhat different ap- Downtime for preventive maintenance/Spare parts on site
• Patient demographics and insurance data available via rules-based architecture no no Software and LIS interface:
proach, the ACL Top 50 Series sys-
EXPERIENCE tems from Instrumentation Labora-
• Data retrieval or Internet connectivity
• Online real-time help, QC, stats, and management reports/Evaluates results validity
yes
yes/yes
yes
yes/yes
• Patient demographics and insurance data available via rules-based architecture
• Data retrieval or Internet connectivity

• Reporting format customizable — Our industry experts understand the unique

855-489-1207 sales@telcor.com tory identify and measure the allow- • Priority processing yes yes • Online real-time help, QC, stats, and management reports/Evaluates results validity
• Supports accession No. redundancy/Specimen carrier and level identification yes/no yes/no • Priority processing
nuances of laboratory billing and revenue able threshold for HIL. “With the • Unique barcode per container/Multistop routing (1 tube to many workstations) yes/no yes/no • Supports accession No. redundancy/Specimen carrier and level identification
©
2018 TELCOR Inc. All rights reserved. For more information ACL Top 50 Series —continued on 24 • Specimen scheduling/Routes test to workstation/Automatic reflex, repeat, dilutions yes/—/yes yes/no/yes
cycle management regardless of lab type about all TELCOR solutions, please visit telcor.com. • Sample storage and retrieval software supports CLSI standards no no
• Unique barcode per container/Multistop routing (1 tube to many workstations)
• Specimen scheduling/Routes test to workstation/Automatic reflex, repeat, diluti
or size. • LIS(s) interfaced live with lab automation systems/How LIS(s) interfaced with LAS yes/LIS1-A and LIS2-A2 (ASTM) yes/LIS1-A and LIS2-A2 (ASTM) • Sample storage and retrieval software supports CLSI standards

• No. of results that can be held in internal memory —

• QC results transferred automatically to LIS/Data-management capability yes/yes yes/yes • LIS(s) interfaced live with lab automation systems/How LIS(s) interfaced with LA
• Interfaces operational in active user sites yes yes • QC results transferred automatically to LIS/Data-management capability
• Rules-based control subsystem/Process control via control subsystem yes/yes yes/yes • Interfaces operational in active user sites
• LIS operates simultaneously with assays running yes yes • Rules-based control subsystem/Process control via control subsystem
0118_22-24_Coag.indd 22 1/8/18 3:29 PM
• Uses LOINC to transmit orders and results/Unidirectional interface capability no/yes no/yes • LIS operates simultaneously with assays running
• Results immediately transmitted to LIS/Interface available to auto specimen-handling system yes/— yes/— • Uses LOINC to transmit orders and results/Unidirectional interface capability

• Specific gravity correction for protein/glucose —

• Stores QC lot files/Worklist edit capability/Viewable PCR graphs —/yes/yes
• Can print, archive, transmit data yes
Distinguishing features (supplied by company) full sample to result automation; random and continuous access; scheduled/
automated maintenance for rapid startup; no return visits required for up to
*for calibration and controls 120 samples/day; no batching requirements; multiple assays from a single
Note: a dash in lieu of an answer means company did not answer sample; ready-to-use reagents for PCR assays; 5-color fluorescence detection;
question or question is not applicable 12 independent onboard thermocyclers
—/yes/— • Results immediately transmitted to LIS/Interface available to auto specimen-handling
yes • Stores QC lot files/Worklist edit capability/Viewable PCR graphs
full sample to result automation; random and continuous access; scheduled/ • Can print, archive, transmit data
automated maintenance for rapid startup; no return visits required for up to Distinguishing features (supplied by company)
120 samples/day; no batching requirements; runs multiple assays from a *for calibration and controls
single sample; true positive sample ID; consolidated testing menu on a single
Note: a dash in lieu of an answer means company did not answer
platform; highest throughput per sq. ft.
question or question is not applicable

All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP. All information is supplied by the companies listed. The tabulation does not repre

Microscopy/sediment: (Information in this box is specific to microscopy/sediment)

1018_45-64_Molec-PG.indd 58 10/5/18 4:40 PM
JULY 2018 page 58

• Microscopy/sediment technology flow cytometry with fluorescent stain and digital image
analysis
• Microscopy/sediment analysis parameters flagged and qualitative: pathological casts, crystals,
yeast-like cells, mucus, sperm; qualitative: small round FEBRUARY 2019 page 52 FEBRUARY 2019 page 53

cells; quantitative: RBCs, WBCs, epithelial cells, bacteria,

• Flagging thresholds customizable

total casts; qualitative and quantitative: hyaline casts
yes
VISIT
• Instrument eliminates amorphous crystal interference before sample analysis yes
• How results are displayed for microscopy/sediment numeric values, scattergrams captodayonline.com /productguides
to view, print, and compare
• Reporting format customizable yes
• No. of results that can be held in internal memory 400 (sample results, including captured image and
extracted particle image information)/3 files per
analyzer, or 120 plots per file (control results) product information for the
Reagent shelf life/storage temperature for unopened containers
Reagent shelf life/storage temperature for opened containers
varies based on reagent type
varies based on reagent type
following guides:
Reagent barcode-reading capability yes
INSTRUMENTS • AP automation: tissue processors, embedders, microtomes, stainers
How often quality control samples are run daily (cannot use other vendors’ QC products)
Sample throughput per hour/Time to first result for chemistry —
• Automated molecular platforms • Bedside glucose testing systems • Chemistry
Sample throughput per hour/Time to first result for microscopy/sediment varies by configuration/<1 min. and immunoassay analyzers for mid- and high-volume laboratories • Chemistry and
Analyzer has stat mode yes (minimum sample volume, 2.1 mL) immunoassay analyzers for point-of-care and low-volume laboratories • Coagulation
analyzers • Coagulation analyzers—point of
Sample dilutions required for urinalysis/body fluid analysis no (urinalysis)/— (body fluid analysis) care, self-monitoring • Hematology analyzers
• Special sample handling required for body fluid analysis —
• In vitro blood gas analyzers • Laboratory
42 CAP TODAY | APRIL 2018

POC glucose: views on volume, critical care, ACOs

Minimum width of sample tube/Minimum length of sample tube 12 mm/95 mm Test volume, limitations on devices used in critical care, continue to be well positioned should the bar be formity in their glucose measurements so there’s

automation systems and workcells

consolidation, and population health is what CAP TODAY raised even further. consistency in their care path and mode of treating

Conditions or substances that prevent a sample from being run
blood, mucus, high fluorescence, visible turbidity
asked about when it spoke in March with the makers of three
bedside glucose testing systems. Their systems and those
of two other companies are profiled on pages 44-49.
“The customers are more aware than ever of the limita-
Corrine Fantz, PhD, director of medical and scien- the patients. When we discuss this with European
tific affairs for POC testing, Roche: Generally, the colleagues, what’s important is the alignment of the
customers are more aware than ever of the limitations glucose meter method with a definitive method. If
in the package inserts from the glucose manufacturers. you read carefully the FDA Oct. 11, 2016 guidance

• Next-generation sequencing instruments

tions that are in the package inserts from the glucose
What we’ve seen is that they’re dedicated to determin- for bedside glucose monitoring systems, they must

Means of sample ID entry barcode scan, worklist download from host, manual entry
manufacturers,” says Corrine Fantz, PhD, director of
medical and scientific affairs for point-of-care testing, ing the best testing approach for their specific popula- show alignment to a definitive method. Not all of the
Roche Diagnostics. But she and Kevin Peacock, clinical tion by first defining the right patient and the right glucose meters on the market have demonstrated,
marketing manager, HemoCue America, say there is still sample in order to achieve high-quality glucose re- through FDA submission, alignment to definitive
confusion. Here is more of what they and others told senior sults. We recently sponsored a webinar for customers methods. They were approved prior to the guidance.

Built-in liquid-level sensing for samples yes • Urinalysis instrumentation

editor Amy Carpenter Aquino.
How has the decline in reimbursement coupled with a retreat
from tight glycemic control affected test volume for patients at
the bedside?
Courtney Sweeney, group marketing manager for
point-of-care testing, Roche Diagnostics: Yes, the
hospital blood glucose market growth has slowed
down, likely due to the overall financial pressures in
that allowed the different integrated hospital networks
to share their approaches, best practices, and lessons
learned while undergoing changes in the systems that
had them, or trying to adapt what they were doing to
the new limitations with these meters in critical care
settings. They said they have to have the right people
at the table and understand what the issues are in their
particular setting and what’s relevant to physicians,
the nursing group, and the laboratory. There needs to
They’re still in the market. Nova StatStrip was not
only cleared under FDA for use in the hospitals, in-
cluding critically ill patient care settings, but also for
use in the home. Now you have a product that can
go home to clinic to hospital to clinic to home, and
there’s uniformity in glucose measurement.
Sweeney (Roche): Generally, we do see growth in
the ambulatory environment. Consolidation may be
driving a connected and standardized approach

Information that can be barcode scanned on instrument specimen identifier, reagent lot No.
the industry. Hospitals are looking for the most ef- be solid communication at all phases with the project. across the health system, which allows for better data

SOFTWARE SYSTEMS • Anatomic

fective ways to manage costs but also optimize pa- The laboratory directors are the bridge between the management as well as point-of-care oversight.
42 CAP TODAY | OCTOBER 2019 tient outcomes. We do see that point-of-care blood point-of-care and hospital medical staff responsible
glucose testing remains a critical part of patient care for the testing. Being more collaborative works, rather How does glucose testing and the management of patients with
diabetes fit into the concern laboratories have now for population

How LOINC codes for results are made available website, e-mail query
in health systems. than the laboratory directing or being an authoritarian

Hematology panel: bridging gaps, staffing, Lab 2.0

The other general trend is toward outpatient type to the clinical staff. You need manufacturers, the health and accountable care organizations?
versus inpatient care, and this is attributable to many clinical staff, and the laboratory all working in a col- Peacock (HemoCue): As medicine becomes less

pathology computer systems

variables that could drive this, including declining laborative environment. centralized and more personal, there’s not a one-size-
Automation, the workforce shortage, man-reimbursement, Reference Laboratories;
hospitalOlga Pozdnyakova,
incentives Danette, what
to do interven- are Sysmex’s
All glucose latestlimitations
meters have the table,
andbut they needfits-all
no meter education on
blueprint for patient care. For instance, a

Software includes reflex testing/cross-check functionality yes (reflex testing)/— (cross-check functionality)
ual review rates, and Laboratory 2.0 weretionsMD, thatPhD,impactof Brigham
outcomes, and Women’s
as well Hos- initiativescurrently
as modifying and howishave customers
approved for use with what it is, what
capillary samples it’s measuring,
considerable andpart of our population cannot be diag-
some of what came up in CAP TODAY’stightpital; Danette
glycemic Godfrey
control and Simon Shorter
protocols. responded? in that critically ill population. There how is it some
can impact
confu-theirnosed
workflor ow. effectively monitored with HbA1c alone.
latest gathering of hematology experts of Sysmex; and Matt Rhyner, PhD, MBA, DanettesionGodfrey, We’re also anticipating the immi-
Jeffrey A. DuBois, PhD, MBA, MS, vice presi- arounddirector
that still.of IVD Plasma blood glucose continues to be reliable in ef-

• Billing/accounts receivable/
for a roundtable on what’s new, pressing, and Rachel Burnside, PhD, MBA, of Beck- product marketing, Sysmex: We added nent launch of the DxHfectively
690T, which
dent, medical and scientific affairs, Nova Biomedical: Dr. DuBois (Nova): Our customers are adapting diagnosing and managing our growing
and in play. CAP TODAY publisher Bob man Coulter. What they said follows.

Instrument automatically generates consolidated report* —

a new module to our hematology is a tabletop analyzer for mid-volume
McGonnagle convened a panel in AugustI don’t The think people
2019 are abandoning
hematology glycemic man-
analyzer product with a focus on patient safety, while conforming to diabetic population.
automation lines to bring even greater laboratories thatthe will have,
Dr.asFantz
does(Roche): What we see is that account-
consisting of Cordelia Sever, MD, of TriCoreagement guideprotocols.
begins on They page 51. have modified them slight- StatStrip labeling requirements. When using
ly, so they’re not as stringent. Some institutionsdifferentiation have system than our existing
to measure plat- on critically
glucose the DxHill900, the capability
patients, able for
careEarly
organizations are being incentivized to
made adjustments to the cutoff levels. That is form. not a At the low end
StatStrip of the
and marketXpress2
StatStrip we Sepsis Indicator.
are cleared for use develop health care delivery models that impact the

RCM systems • Blood bank

retreat from glycemic management; that’s just made refin- substantial changes
venous,for the heel stick, and neona-

Instrument connections to transfer information data-management system that connects to LIS or EHR,
with arterial, neonatal patient population as a whole. This includes preven-
ing the treatment protocol. Where hypoglycemia point-of-care market
tal arterial with scalable
specimens. The standardDr. Pozdnyakova,
of care in most is theretive,
anything
chronic youor outpatient care, and acute care, or the
may have been defined at 75 mg/dL and below, solutions glycemic
in the area of the XW-100
management would
protocols we’velike seen,
to raisefor at thehospitalized
outset? inpatient groups. They have interven-
REDEFINING MOLECULAR TESTINGsome THROUGH institutionsDATA nowSCIENCE
have moved the hypoglyce- and changes to thesafety
patient instrument
reasons, andfocuses
the on havingOlga Pozdnyakova,
either an MD,
tions thatPhD,
are being implemented to improve glyce-
mia threshold to 100 mg/dL and below. And markets there we serve.or a venous whole blood
arterial associate pathologist, Brigham
glucose measure- mic control andand other outcomes. Glucose testing and

or directly to LIS or EHR information systems • Laboratory

are some people who still want to be aggressive and We’re ment.
pleased with what
StatStrip we’re no
demonstrated Women’s
knownHospital;
clinicallyassociate professor,
managing diabetic patients are essential parts of
have the glycemic range between 70 to 110. Many hearing
of well into the
significant launch of our
interferences Harvard
that could cause Medical
erroneous School; andinterventions.
these medical For example, they are expanding
the institutions have moved the range so that XN-20,
it’s to de- results contributing to patient adverse events. director,
glucose B&W data management solutions to the
point-of-care
E T
C

liver next level are Harbor Medical

ID U

above 100, and it’s referred to as safe and effective Not all bedsideHematologyglucose monitoring systems
analyzers, pages 51–64 outpatient environment. That helps the providers
U D
G O

Interface standards supported ASTM 1381, ASTM 1894-97

R

glycemic management. flagging,created

with equal. Other devices in the marketplace have Physician capture and Di-report on outcomes they could not
P

information systems • Laboratory-

If you’re focusing on total glycemic control thefornew limitations
white and issues that have been addressed in agnostics previously I
Lab:capture and report, and those data are
cardiothoracic surgical patients, it depends on precursor
the channel
the peer-reviewed similar andwould
based onliterature in device likepackage
to commenthelpful on bridging
for achieving their goals and targets.
institution. With the increasing number of diabetic technology that our customers have
inserts. gaps. We use Sysmex hematology Dr. DuBois (Nova): It is probably best addressed

Bidirectional interface yes (to other companies’ LISs and EHRs)

patients admitted to the hospital, the demand grown
for to love. Being able to offer more analyzers in all labs across Partners.
by looking at the numbers. When ISO 15197:2003
monitoring patients at the bedside has not come differentiation
How has to precursor cells is cer-
system consolidation—including These are modern,
established systemsophisticated
was publishedana- and accepted as the guidance for the
tainly helping our
clinics, ERs,markets, whichphysician
and acquired lyzers that allowPOC
find practices—affected us to measure
FDA priora to lotOct. 11, 2016, that guidance permitted

provider links software • Positive

down. It’s increasing.
I’m not aware of any decline in reimbursement value in highly
glucosesensitive and specifi
testing for ambulatory patient of clinical parameters and
c testing? fiveadvanced
percent of results—below 75 mg, an absolute
having an effect on bedside glucose testing. We flagging
are of abnormal white blood cells,
Peacock (HemoCue): clinicalconsolidation
We see system parameters. I would likeofto15 mg—and above 75 mg, plus or mi-
difference

• Tests can be transmitted to LIS as soon as completed yes an increase in bedside glucose testing. automaticas refl exadvantage
testing, andfor the infor- mentionand immature
the pa- platelet
nus 20fraction
MULTIPLEXING MULTIPLIED
seeing an
mation technologists need to
the health systems
and immature
reduce professionals reticulocyte
percent. If that only has to occur 95 percent
tients they serve. Laboratory have a of thefraction
time, then that poses a significant public
How a are your customers adapting to the manual slide
limitations on glucose review
greater understanding of point-of-care parameters, which we health
testing, includ- are currently
risk. When you look at the number of glucose

patient identification products

ChromaCode is rapidly introducing menu of cost-effective, high-
throughput and flexible multiplexdevices infectious for critical care applications?
disease PCR tests using rates. At the
inglow end
regulatory risks, compliancevalidating
requirements, andand planningteststoperformed
report. on these devices globally, we’re in

Connection to LIS to upload patient and QC results hospital network

our HDPCR™ multiplexing technology. Kevin Peacock, clinical marketing manager, of the market we limitations.
testing see As ambulatoryHowever,sites integratethere with is a great need to
the neighborhood of 5.6 billion tests. If you multiply
HemoCue America: I think we could all hear anthe
expansion
hospitalof the systems, lab supervision educateplays more our
of aclinicians
role, onby
that what to
five percent that are allowed to be acceptable
HDPCR™ Tick-Borne Pathogen Panel* HDPCR™ Multi-Drug Resistance Panel*
collective sigh of relief from the industry, since understanding
the even in waived of clinics. Laboratoriansdo withget thethese parameters.
science Duethat
outliers, to ameans there is the risk of 310 million
Bacteria
2016 Gram-Negative
FDA guidance Resistance Markers
related to strip meter accuracy the positioning of
behind precision and accuracy. lack Theyofget familiarity
why our with these new
erroneous glucose results published off these devices

Connection to EHR to upload patient and QC results hospital network

Anaplasma phagocytophilum was CTX-M not nearly as restrictive as some predicted. the XW and the mar-sample is so different from
capillary parameters,
strip meters. clinicians may not fiaffect
that could nd patient care. If there is a device that
Borrelia miyamotoi Frankly, IMP many customers are still very confused and
kets we serve Dr. there.
DuBois (Nova): What is of them useful
interest and
is to will not
have orderboth
meets them, criteria and they’re held to [accuracy] 98
are uncertain as to what devices are appropriate We to have consistency
made ad- in glucose measurement
Godfrey
creatingfrom a big
home gaptobetweenor 99advanced
percent of the time, then that risk has gone
Borrelia Group #1 KPC
(B. burgdorferi and B. mayonii) use with which patients. HemoCue, having accuracy vances there in to
clinic howhospital and back to home. laboratory
One of thetechnologies
issues downandsignificantly,
their especially if it agrees with a
NDM
levels more associated with central lab results,we communicate
will this to our
care providers discussing is implementation
arecustomers that they want uni- into clinical practice.
definitive method.

Information included in transmission from instrument to device unique identifier, patient ID, specimen ID, result
Borrelia Group #2
(B. hermsii, B. parkeri, and B. turicatae) OXA-48 and to what extent our customers find
Ehrlichia chaffeensis VIM value in the solution. You have dozens if not hundreds of
mcr-1
clinicians and other people within your
Ehrlichia ewingii
Matt, what, if anything, has changed in the system who need to understand new

data-management software
Ehrlichia muris eauclarensis Gram-Positive Resistance Markers

Rickettsia spp.
0418_42_BedsidePG-Intro_2.indd 42

vanA
last year from your perspective and from
the perspective of Beckman Coulter?
APRIL 2018
assays and need to know how to handle
the information you provide. Are rules-
page 42
4/3/18 11:03 AM

Protozoa Toxigenic C. difficile Matt Rhyner, PhD, MBA, senior based applications within instruments
34 CAP TODAY | JUNE 2018 Babesia microti tcdB (C. difficile toxin B gene)
director of product management and and IT systems helpful there? Do you
global marketing for hematology, Beck- need to do in-service and visits and
✓ Whole Blood ✓ Rectal Swabs
newsletters? How do you communicate

Instrument acquisition, skilled labor on the table

✓ Synovial Fluid ✓ Perirectal Swabs
man Coulter: We’ve had two FDA
✓ Homogenized Tick ✓ Pure Colonies clearances this year—one for our low- information about the new features and
HDPCR SPECIFICATIONS volume analyzer, the DxH 520, and benefits you can provide out of hema-
MAKERS OF CHEMISTRY, IMMUNOASSAY ANALYZERS ANSWER OUR QUESTIONS the other for our Early Sepsis Indica- tology instrumentation?

No. of days of training with instrument purchase based on configuration–virtual instructor-led training†
EXTRACTION INSTRUMENT Compatible with the most common
COMPATIBILITY automated extraction instruments
tor. Both have really added clinical Dr. Pozdnyakova (Brigham and
Broad menus, efficient workflows, single platforms, rural labs, cybersecurity, and form across the system. You’re able tems, Roche Diagnostics: We’re see- value. Early Sepsis Indicator has a Women’s): The rules we use are cre-
Compatible with the most common
economics are some of what one CEO and three marketing and product managers to train one set of employees to ing increasedqPCR INSTRUMENT
interest COMPATIBILITY
in standard- qPCR instruments tremendous amount of value, but ated mostly for our clinicians and
talked to CAP TODAY about when we spoke to four companies whose analyzers are cover all hospitals. Trying to do ization and a growing when we have worked with custom- sometimes with their help. This is one
RUN TIME need to have < 3 hours

Approximate scheduled maintenance time required 20 min. daily; 10 min. weekly

profiled in the following product guide (pages 40–46). Details about their analyzers more with less and having a single a large assay menu on an integrated ers, we have had to help them bridge of the ways to accomplish that. We do
and those of eight other companies are provided in our first combined chemistry/ THROUGHPUT Scalable: 1 – 88 samples / 96-well plate
analyzer that meets the needs platform. Specifically, when it comes their own gaps between emergency have a general broadcast to commu-
immunoassay product guide, tailored in this issue to the low-volume and point-of- doctors as well as the laboratory, and nicate changes and new features,
across the hospital system is ideal to software interface and assays, it’s
FLEXIBLE REPORTING Toggle on and off targets for reporting
care markets. (See “Simpler and condensed,” page 38, for more on the revised product that’s been an interesting journey. which I do not find helpful because
guide and what to expect next month.) for purchasing agents as well as important to have the same menu,
Visit www.ChromaCode.com to learn more about the HDPCR tests Rachel Burnside, PhD, MBA, se- we see several each day. I find the

• Maintenance records kept onboard instrument yes

“The fun part of being a manufacturer,” says Nova Biomedical product manager clinicians. If you’re changing from measuring ranges, and reagents for
one analyzer to another, there can all the platforms.for tick-borne pathogens and multi-drug resistance markers nior manager of global marketing for best way is face-to-face communica-
Brad Bullen, “is trying to keep two and three steps ahead of clinical needs while
be subtle differences in the way hematology, Beckman Coulter: It’s tion and doing in-service and going
providing quality diagnostic results that impact patient care now.” Here is more of
results are produced and the timing Can the industry’s success with auto-
*HDPCR assays are for research use only. Not for use in diagnostic procedures. just an aspect of bringing on a new to physicians’ offices or to their de-
what he and others shared with senior editor Amy Carpenter Aquino.
assay. People are interested in what partments and explaining why we do
of the results. Hospitals want a mation andToease ofabout
learn more useHDPCR,
successfully
contact us at info@chromacode.com
ChromaCode, Inc. | 2330 Faraday Ave. Suite 100, Carlsbad, CA 92008 www.ChromaCode.com the Early Sepsis Indicator brings to what we do and —continued on 44
What are two key trends in instrument Laboratories are getting drugs-of- singular fix for their point-of-care match the worrying decline in skilled
acquisition? abuse screening tests from the emer- diagnostic needs. labor availability, or does there become
Wayne Brinster, CEO, MedTest gency department or saliva samples The second trend is cybersecu- a point at which this problem must be
Dx: Our customers are looking for from their occupational health rity. Somebody at a large university addressed by others (in the systems,

Provide list of client sites to potential customers on request yes (partial list of comparable sites) page 42
schools, societies)?
flexibility, with the ability to run a
broad menu of tests that allow them
group. If these samples are just
added into the normal throughput,
hospital in California said their
laboratory receives about 3,000
1019_42-50_Hematol-Round.indd

Bullen (Nova): As the mean age

42
OCTOBER 2019 10/7/19 11:05 AM

to create an efficient workflow. they tend to slow down the larger, external attempts to access their of laboratorians is increasing every
They want the instrument to change highly automated instruments. network daily. Hospital systems year, and with fewer enrollees get-

Clients restricted from sharing their experience with company or software no

with the test mix have had their patient health infor- ting into this career path, we’re
E T
C

they’re seeing, mation accessed and held for ran- seeing staff having to do more with
ID U

Chemistry and immunoassay analyzers pages 40–46

U D
G O

and they want the som. Hospital systems and patients less. We are not necessarily looking
R
P

flexibility to re-
spond to new tests and not have to
do testing offline. They haven’t re-
linquished the requirement for the
instrument to be efficient as far as
We’re seeing a desire to take differ-
ent types of samples and tests while
continuing to have a highly efficient
core laboratory. They can put one of
have to have confidence that the
systems manufacturers provide are
not going to be susceptible to mali-
cious software. For a long time,
diagnostic companies relied on the
at what’s going to happen 12
months from now but in five years.
Nova is developing analyzers that
don’t require as much hands-on
time to provide quality results,

Distinguishing instrument features (supplied by company) • powerful combination of fluorescent flow cytometry
the use of reagents, low mainte-
nance, and a long time between
failures. All of those things come
into play to help the laboratorian
increase the throughput of the highly
our instruments inside their core lab
and dedicate it to offload these less
efficient tests.
Brad Bullen, product manager,
Nova Biomedical: The first trend is
Coming in
hospital’s firewall to protect patient with plug-and-play technology
data. Nowadays we can’t do that; and no maintenance. Basically,
we need to provide multiple tiers take it out of the box, put it on the
of defense. shelf, load it up with limited con-
Brittany Greiner, marketing man- sumables, have a 15-minute train-

and digital image analysis allows for rapid screening automated core instruments. standardization of the hospital plat- ager, low-volume and specialty sys- ing session, and you should be
good to go. That’s the approach we

January:
take when developing our ana-
lyzer platform.

of UA samples
Everyone is being asked to do
more without an increase in staffing
or reimbursement. Industry has to
New Oxcarbazepine Metabolite Assay come to the table with an analyzer
NEXT GENERATION ASSAYS

• highly modular and scalable system offering flexibility

that provides outstanding quality
results with limited or no hands-on
time. Providing a flexible analyzer
platform is a necessity because what

to add additional modules to meet increasing

might be perfect for one group or

Coagulation
THERAPEUTIC DRUG MONITORING ASSAYS & URINE DRUG TESTS
department may not meet the clini-
ARK introduces its homogeneous enzyme immunoassay cal demands of another.
technology for the next generation of clinical laboratory testing.
Brinster (MedTest): The industry

workload demands
ARK assays are in liquid, stable, ready-to-use formulations that deliver has made tremendous strides in
convenience for routine use. ease of use. At the same time, there’s
ARK produces assays of high-quality that yield rapid and reliable results on this bifurcation of lab testing. You
automated clinical chemistry analyzers. have some testing that’s going to-

• BeyondCare quality monitor for urinalysis provides a

ward the patient in the format of

analyzers
EPILEPSY URINE DRUG TESTS CANCER ANTIBIOTIC waived testing; conversely, there are
FDA Cleared Forensic Use Only FDA Cleared In Development O
other testing situations where a
OH
Levetiracetam Pregabalin Methotrexate Linezolid laboratory is needed, such as in the
larger walk-in clinics. If the current

streamlined and automated QC experience

Lamotrigine In Development
O trend in reduction of med techs
Gabapentin ANTIRETROVIRAL ANTIFUNGAL
EtG Zolpidem OH continues, we will have a real short-
Topiramate N Cleared
Fentanyl Zopiclone CE Mark, Not FDA Cleared CE Mark, Not FDA
age and it will become a problem.
Zonisamide H
Tramadol Gabapentin Efavirenz H3C Voriconazole O There is a need for organizations to
Oxcarbazepine Metabolite NH 2 N
Meperidine continue to work with schools and
In Development NH 2 In Development
N
Ketamine
O Lopinavir N government to try to promote get-
Lacosamide H
Methylphenidate Metabolite
Nevirapine ting more people into medical
OH H2N N N technology. —continued on 36
48089 Fremont Blvd, Fremont, CA 94538 customersupport@ark-tdm.com
877.869.2320 www.ark-tdm.com

*chemistry and microscopy results in one report JUNE 2018 page 34

0618_34-38_Chem-Immune-Intro.indd 34 6/6/18 4:31 PM

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