April 2017 Tech Guide

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Alere Inc

Alere Toxicology Inc

Arkray USA Inc

Waltham, Mass
(877) 262-4669
www.alere.com

Portsmouth, Va
(800) 340-4029
www.aleretoxicology.com

Minneapolis, Minn
(877) 538-8872
www.arkrayusa.com

1. What is the brand name of
your company’s urinalysis
system?

Alere BinaxNow Streptococcus
pneumoniae antigen card

Alere iCup Dx 14 SVT drug screen

Aution Eleven AE-4022
semiautomated urine analyzer

2. What is the intended use or
primary function of the
product?

An in vitro rapid immunochromatographic assay for the detection of
Streptococcus pneumoniae antigen
in the urine of patients with
pneumonia.

Point-of-care diagnosis and
monitoring of therapeutic and illicit
drugs.

Urine chemistry.

3. What types of specimen or
sample does the product
employ?

Urine specimens in standard
containers; store at room
temperature (59−86˚F, 15−30˚C) if
assayed within 24 hours of collection;
clean catch urine is not necessary.

Urine.

Well-mixed, unspun urine.

4. What types of diseases,
conditions, or analytes does
the system detect?

In conjunction with culture and
other methods, aids in the
diagnosis of pneumococcal
pneumonia.

Screens for 14 prescription and
illicit drugs, including amphetamines, barbiturates, benzodiazepines, buprenorphine glucuronide,
cocaine, ecstasy, marijuana,
methadone, methamphetamine 500
mg, morphine, oxycodone, phencyclidine, propoxyphene, and tricyclic
antidepressants.

Urine chemistry analysis
parameters: bilirubin, blood, color,
glucose, ketones, leukocytes,
nitrites, pH, protein, specific
gravity, and urobilinogen.

5. Where is the product used
(check all that apply)?

q At a community screening event
n In a reference lab or other
independent lab setting
n In a hospital or inpatient setting
q In a physician’s officeor
outpatient setting
q In a patient’s homeor other
self-testing
q Elsewhere

q At a community screening event
q In a reference lab or other
independent lab setting
n In a hospital or inpatient setting
n In a physician’s office or
outpatient setting
q In a patient’s home or other
self-testing
n Elsewhere

q At a community screening event
n In a reference lab or other
independent lab setting
n In a hospital or inpatient setting
n In a physician’s officeor
outpatient setting
q In a patient’s home or other
self-testing
q Elsewhere

Urinalysis

6. If you answered “elsewhere,”
explain briefly.

Workplaces, as part of drug
screening programs.

7. Under ideal conditions, what
is the time to first result; how
are the test results made
available?

15 minutes; a negative specimen
produces one control line; a
positive specimen produces two
lines, indicating that the antigen
was detected.

5 minutes; test results are made
available via visual read.

60 seconds.

8. What are the product’s
maximum specimen capacity
and throughput under ideal
conditions?

No limits.

Single use.

514 samples per hour.

9. Briefly describe any
automation or connectivity
features or options.

n/a

n/a

Performs semiautomated urine
chemistry analysis.

10. What types of technical
support are available?

Technical support available online
through the Alere website.

Technical support available
through Alere Toxicology at (800)
340-4029; training available online.

Technical support is available
24/7/365.

11. What capabilities, features,
or accessories distinguish this
product from others on the
market?

Can also aid in the diagnosis of
pneumococcal meningitis by
testing cerebral spinal fluid; it
enables use of targeted narrowspectrum antibiotics and is
advocated by worldwide
community-acquired pneumonia
guidelines.

The CLIA-waived system minimizes
urine exposure and tests for 14
drugs and five forms of specimen
validity; performance comparable
to laboratory screening methods;
in less than 5 minutes the patented
self-contained cup delivers reliable
results that can be photocopied for
result recording.

Smallest semiautomated footprint
on the market; test strips are easy
to load with no calibration required;
quality control and
operator ID lockout functionality.

22 April 2017 | clpmag.com

EKF Diagnostics USA

Quantimetrix

Quantimetrix

Siemens Healthineers

Boerne, Tex
(800) 531-5535
www.ekfusa.com

Redondo Beach, Calif
(310) 536-0006
quantimetrix.com

Redondo Beach, Calif
(310) 536-0006
quantimetrix.com

Norwood, Mass
(877) 229-3711; usa.healthcare.
siemens.com/urinalysis

Stanbio Uri-Trak 120

Quantimetrix Dipper urinalysis
dipstick control

Quantimetrix Dip&Spin urinalysis
dipstick/microscopics control

Clinitek Novus automated urine
chemistry analyzer

Initial diagnosis and monitoring.

Intended as a control for urinalysis
reagent strips, microalbumin, and
creatinine by the listed test
methods, and as a control for
confirmatory tests such as
K-Check and Ictotest reagent
tablets, and for hCG methods.

Intended as a control for urinalysis
reagent strips, microalbumin, and
creatinine by the listed test
methods, and as a control for
confirmatory tests, and for hCG
methods; intended as a means of
validating the processing and
centrifugation of patient urine
samples prior to the microscopic
evaluation of urine sediment.

Urine chemistry.

Urine (random).

General urine specimen.

General urine specimen and
chemistry analytes.

Random urine.

Bilirubin, blood, glucose, ketones,
leukocytes, nitrite, pH, protein,
specific gravity, urobilinogen.

Provides values for all dipstick
analytes plus microalbumin and
creatinine, and qualitative results
for hCG early pregnancy detection.

Engineered calcium oxalate
dihydrate (COD) crystals that
are formulated with real human
RBCs and WBCs and are easily
recognized by both standard and
automated microscopy.

Bilirubin, clarity, color, glucose,
ketone, leukocytes, nitrite, occult
blood, pH, protein, specific gravity,
and urobilinogen.

q At a community screening event
q In a reference lab or other
independent lab setting
n In a hospital or inpatient setting
n In a physician’s office or
outpatient setting
q In a patient’s home or other
self-testing
q Elsewhere

q At a community screening event
n In a reference lab or other
independent lab setting
n In a hospital or inpatient setting
n In a physician’s office or
outpatient setting
q In a patient’s home or other
self-testing
q Elsewhere

q At a community screening event
n In a reference lab or other
independent lab setting
n In a hospital or inpatient setting
n In a physician’s office or
outpatient setting
q In a patient’s home or other
self-testing
q Elsewhere

n At a community screening event
n In a reference lab or other
independent lab setting
n In a hospital or inpatient setting
n In a physician’s office or
outpatient setting
n In a patient’s home or other
self-testing
q Elsewhere

60 seconds for the first result; test
results can be viewed on screen
and printed out using the built-in
thermal printer.

Same as patient sample.

Same as patient sample.

First result in 15 seconds,
subsequent results every 15
seconds; results sent to laboratory
information system or printed.

120 strips per hour.

n/a

n/a

Maximum capacity: 200 tubes
(single load); throughput is 240
specimens per hour.

(Stanbio Laboratory)

Self-test diagnostics at startup;
quality control (QC) program with
lockout; user lockout; laboratory
information system connectivity;
operator ID and patient ID.

n/a

n/a

Connects to CentraLink data
management system; 2D bar-code
reader captures tube type, cap
detector, and crash protection on
analyzer; can connect to Sysmex
UF-1000i system for complete
automation.

Telephone, webinar, and e-mail
support.

Phone and e-mail.

Phone and e-mail.

Onsite support, 24/7 phone
support, online education, and
references.

User lockout prevents unapproved
users from testing; up to 10 lab
operators can perform testing
but only the lab administrator
can change analyzer settings; QC
lockout prevents testing without
passing QC; QC tests can be
programmed to run once every 8
hours, daily, weekly, or monthly;
analyzer will alert when to run QC
test; barcode reader optional.

Users can monitor the
performance of visual and
instrument readings of urinalysis
dipsticks by immersing the dipstick
into the control; designed for use
with most urinalysis reagent strips;
can also be used for confirmatory
tests and refractometry.

Supplied liquid, ready-to-use in two
levels; do not require
reconstitution or dilution; prepared
from human urine to which
stabilized human red and white
blood cells, calcium oxalate
crystals, and other compounds
have been added to produce the
desired reactions.

Reagent cassette with reagent
cards and radiofrequency
identification chip; digital
technology detects intact red blood
cells and enables advanced
algorithms; well for quantified
specific gravity measurement;
same dry pad reagents as other
Siemens Healthineers urinalysis
products.
clpmag.com | April 2017 23

tech
guide

Siemens Healthineers

Siemens Healthineers

Sysmex America Inc

Norwood, Mass
(877) 229-3711; usa.healthcare.
siemens.com/urinalysis

Norwood, Mass
(877) 229-3711; usa.healthcare.
siemens.com/urinalysis

Lincolnshire, Ill (800)
379-7639
www.sysmex.com

1. What is the brand name of
your company’s urinalysis
system?

Clinitek Advantus urine chemistry
analyzer

Clinitek Status family of analyzers

UF-1000i

2. What is the intended use or
primary function of the
product?

Urine chemistry.

Point-of-care applications,
including urine HCG and
microalbumin.

A fully automated urine particle
analyzer intended for in vitro
diagnostic use in urinalysis.

3. What types of specimen or
sample does the product
employ?

Random urine.

Random urine.

Urine only.

4. What types of diseases,
conditions, or analytes does
the system detect?

Routine testing; frontline
assessment for albuminuria; early
detection of kidney disease;
monitoring and management of
disease states: diabetes, kidney
disease, and urinary tract infection.

Routine testing; frontline
assessment for albuminuria;
pregnancy testing; early detection
of kidney disease; monitoring and
management of disease states:
diabetes, kidney disease, and
urinary tract infection.

Provides quantitative results for
bacteria, casts, epithelial cells,
erythrocytes, and leukocytes; also
provides flagging information for
crystals, pathological casts, small
round cells, sperm, and yeast-like
cells.

5. Where is the product used
(check all that apply)?

n At a community screening event
n In a reference lab or other
independent lab setting
n In a hospital or inpatient setting
n In a physician’s office or
outpatient setting
n In a patient’s home or other
self-testing
q Elsewhere

n At a community screening event
n In a reference lab or other
independent lab setting
n In a hospital or inpatient setting
n In a physician’s office or
outpatient setting
n In a patient’s home or other
self-testing
q Elsewhere

q At a community screening event
n In a reference lab or other
independent lab setting
n In a hospital or inpatient setting
q In a physician’s office or
outpatient setting
q In a patient’s home or other
self-testing
q Elsewhere

7. Under ideal conditions, what
is the time to first result; how
are the test results made
available?

7 seconds to test result.

Dependent on test specimen; HCG
cassette, 2–5 minutes; urine strip,
60 seconds; results are viewed
on screen, printed, or available
in laboratory information system
(LIS), and/or middleware.

Under 3 minutes; results can be
viewed on screen, printed, and
sent to the laboratory information
system.

8. What are the product’s
maximum specimen capacity
and throughput under ideal
conditions?

Operator-dependent: strip analyzed
every 7 seconds; semiautomated.

Individual test strip.

100 samples per hour, with
maximum of 50 samples onboard
at one time.

Semiautomated; connects to
POCcelerator, RapidComm data
management system, Relaymed,
and other middleware or LIS;
automatic calibration at startup;
auto-checks for strip verification;
operator and quality control
lockout functionality.

Real-time quality control
monitoring.

Urinalysis

6. If you answered “elsewhere,”
explain briefly.

9. Briefly describe any
automation or connectivity
features or options.

Semiautomated; connects to
Conworx middleware or laboratory
information system; automatic
calibration at startup; auto-checks
for strip verification; quality control
lockout functionality.

10. What types of technical
support are available?

Warranty swap-out.

Warranty swap-out.

24-hour phone support via a
technical assistance center; onsite
service varies by service contract.

11. What capabilities, features,
or accessories distinguish this
product from others on the
market?

Auto-check technology allows for
automatic detection of humidity
overexposure and test strip
configuration; offers
standardization of urine testing;
end-to-end solution from lab to
physician office.

Auto-check technology allows for
automatic detection of humidity
overexposure and test strip
configuration; uniquely offers urine
test strips and hCG rapid testing
on one system; offers
standardization of urine testing;
end-to-end solution from lab to
physician office.

Two separate reaction chambers
and reagents for enhanced
classification; specific fluorescent
dye for bacteria detection and
elimination of nonspecific
staining; review-by-exception
design for fewer manual slide
reviews.

24 April 2017 | clpmag.com