BECKMAN
COULTER, INC.
PRIMARY CARE DIAGNOSTICS
1050 Page Mill Rd.
P.O. Box 10200
Palo Alto, California 94303-0803
United States
Beckman
Coulter, Inc.,
Primary Care Diagnostics
Rapid
Products
Technical Assistance:
800-877-6242
or askpcd@beckman.com
Hematology
Products Technical Assistance: 800-526-7694
To
Order Literature:
866-544-1234
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CORPORATE
DESCRIPTION:
Beckman Coulter Primary Care Diagnostics, the leader in
fecal occult blood testing and
COULTER® hematology, offers a range of rapid diagnostic test kits
and
hematology instruments for the hospital and physician office laboratory. Product
names recognized for their quality are Hemoccult®,
ICON® II
HCG, and COULTER®
Ac·T™ Series Hematology Analyzers.
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RAPID TEST KITS:
Beckman
Coulter offers a wide variety of rapid test kits. For
information on specific test kits, please click on one of the links below:
ICON® microALB
is a qualitative immunoassay for urinary albumin that allows for
early detection of kidney disease. The ICON® microALB
has a unique product design that enables easy handling, superior
readability and room temperature storage.
-
CLIA
Waived
-
18
mg/L sensitivity, 95% specificity
-
Albumin
specific
-
Results
in 3 minutes, readable up to 8 hours
-
Room
temperature storage
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|
CLIA
Classification |
Analytes |
CPT
Code |
Test
Methodology |
Sample
Volume |
Time
to
Result |
Units
in which the test is reported |
Waived |
ALBUMIN |
83518QW |
LATERAL
FLOW DEVICE containing specific monoclonal antibody against human
albumin |
N/A
- DIP TEST (sufficient sample to
cover the "star" symbol) |
3
MINUTES
(CAN READ UP TO 8 HOURS) |
N/A
- QUALITATIVE RESULT
(sensitivity 18 mg/L)
|
Hemoccult® is
a guaiac-based fecal occult blood test (FOBT) that detects abnormal
occult bleeding associated with gastrointestinal disorders. Hemoccult®
is the only FOBT that is safe, simple and clinically proven
to reduce the incidence and mortality of colorectal cancer
when used for annual screening. With over 300 published studies,
products that bear the Hemoccult®
name
are the only tests that can be trusted to give you confidence in
your patient’s results.
All Hemoccult®
tests are CLIA Waived.
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- All
Hemoccult®
tests are CLIA Waived
- Clinical
sensitivity for colorectal cancer 86%, specificity 98%
- Results
within 60 seconds
- Over
300 publications supporting Hemoccult® products
- Used
in colorectal cancer screening programs worldwide
- Improved
dietary instructions
- Performance
Monitor® area on each test offers built-in quality
control
|
CLIA
Classification |
Analytes |
CPT
Code |
Test
Methodology |
Sample
Volume |
Time
to
Result |
Units
in which the test is reported |
Waived |
Occult
Blood |
G0107,
82270 |
GUAIAC |
Thin
smear of fecal sample |
Within
60 seconds |
N/A
- QUALITATIVE RESULT |
Hemoccult® SENSA®
detects abnormal occult bleeding associated with gastrointestinal
disorders more reliably than standard fecal occult blood tests (FOBTs).
The Hemoccult®
SENSA®
test
includes an enhancer which makes the test more sensitive and more
readable than standard Hemoccult®
and other FOBTs.
With enhanced blood detection and improved readability, the use of Hemoccult®
SENSA®
results
in significantly improved detection of adenomas and colorectal
cancer. All Hemoccult®
SENSA®
tests
are CLIA Waived.
- All
Hemoccult®
SENSA®
tests are CLIA Waived
- Clinical
sensitivity for colorectal cancer 92%, specificity 97%
- Results
within 60 seconds
- Enhanced
sensitivity compared to standard FOBTs
- Over
300 publications supporting Hemoccult®
products
- A
variety of package configurations satisfy individual physician
needs
- Improved
overall readability and precision
- Performance
Monitor® area
on each tests offers built-in quality control
|
CLIA
Classification |
Analytes |
CPT
Code |
Test
Methodology |
Sample
Volume |
Time
to
Result |
Units
in which the test is reported |
Waived |
Occult
Blood |
G0107,
82270 |
GUAIAC |
Thin
smear of fecal sample |
Within
60 seconds |
N/A
- QUALITATIVE RESULT |
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Hemoccult
II® SENSA® elite
fecal occult blood tests (FOBTs) are recommended for professional
use as diagnostic aids in annual patient health exams for colorectal
cancer screening and other conditions that could cause
gastrointestinal bleeding.
The
American Cancer Society and other healthcare groups have reached
consensus and recommend annual take-home, triple-slide FOBT
screening for people age 50 and older.
Hemoccult
II®
SENSA®
elite
- Easier
diet and patient instructions
- Easier
sample collection
- Easier
processing
- CLIA
Waived
|
CLIA
Classification |
Analytes |
CPT
Code |
Test
Methodology |
Sample
Volume |
Time
to
Result |
Units
in which the test is reported |
Waived |
Occult
Blood |
G0107,
82270 |
GUAIAC |
Thin
smear of fecal sample |
Within
60 seconds |
N/A
- QUALITATIVE RESULT |
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Gastroccult®
is the only rapid test designed specifically for detecting
gastric occult blood and determining gastric pH in one device.
Fecal occult blood tests do not provide reliable results when
used with gastric specimens. This
CLIA Waived test aids in the diagnosis and management of various
gastric conditions which may be encountered in intensive care areas,
emergency rooms and surgical recovery rooms.
|
- CLIA
Waived
- Results
in 30 seconds for pH, 60 seconds for occult blood
- Detects
low levels of blood in samples containing bile; eliminates
subjective visual judgments
- As
easy to learn and teach as it is to use
- Medicare
reimbursement for two tests
- Performance
Monitor® area on each test offers built-in occult
blood quality control
|
CLIA
Classification |
Analytes |
CPT
Code |
Test
Methodology |
Sample
Volume |
Time
to
Result |
Units
in which the test is reported |
Waived |
Occult
Blood, pH |
82273QW,
83986QW |
GUAIAC |
ONE
DROP IN EACH TEST AREA (one for pH & one for GOBT) |
pH
= 30 seconds; occult blood = within 60 seconds |
N/A
- QUALITATIVE RESULT |
ICON® II HCG is one of the most sensitive
and reliable rapid tests for hCG on the market today.
Considered the gold standard rapid hCG test, ICON®
II HCG detects hCG levels of 10 mIU/mL for serum samples and 20 mIU/mL
for urine. This rapid
test provides clear, accurate results in minutes.
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-
CLIA
Waived for urine; moderately complex for serum
-
Detects
hCG down to 10 mIU/mL for serum and 20 mIU/mL for urine
-
Semi-quantitative
results to aid physicians in identifying early pregnancy
-
Separate
reaction zones and clearly readable results provide easy
interpretation
- Built-in
positive and negative controls ensure reagent integrity and
procedural quality
- Dual
monoclonal antibodies improve specificity, sensitivity and
long-term reliability
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Urine
Only |
CLIA
Classification |
Analytes |
CPT
Code |
Test
Methodology |
Sample
Volume |
Time
to
Result |
Units
in which the test is reported |
Waived |
hCG |
81025 |
Immuno-
Enzymetric Assay; Two different
monoclonal antibodies which react with two different
regions of hCG molecule |
250
uL |
2
min from last reagent addition; about 4 min total |
SEMI-
QUANTITATIVE - (mIU/mL) |
Serum/Urine |
CLIA
Classification |
Analytes |
CPT
Code |
Test
Methodology |
Sample
Volume |
Time
to
Result |
Units
in which the test is reported |
Waived
(Urine), Non-Waived (Serum) |
hCG |
81025
(Urine), 84703 (Serum) |
Immuno-
Concentration Assay; Two different
monoclonal antibodies which react with two different
regions of hCG molecule |
450
uL for serum; 5 drops (about 200 uL) for urine |
3
min from last reagent addition; 5 min total |
SERUM
SEMI-
QUANTITATIVE (mIU/mL) |
ICON® 25 hCG is a one-step,
rapid, combination serum/urine test designed for the early detection
of pregnancy. Meeting top industry standards for tests of this kind,
the ICON® 25 hCG
delivers fast, reliable results. The eye-catching sleek design
and compact size will make this high quality test a welcome addition
to your busy office or lab.
|
- CLIA
Waived for urine
- 25
mIU/mL sensitivity with > 99 percent specificity
- 3-minute
result with urine; 5-minute result with serum
- Requires
just 3 drops of sample
- Simple,
one-step process for reliability
- Room
temperature storage, long shelf life
|
CLIA
Classification |
Analytes |
CPT
Code |
Test
Methodology |
Sample
Volume |
Time
to
Result |
Units
in which the test is reported |
Waived |
hCG |
81025
(Urine), 84703 (Serum) |
Chroma-
tographic immunoassay (monoclonal/
polyclonal antibodies) |
3
DROPS
(about 100 uL) |
URINE:
3 min; SERUM: 5 min |
N/A
- QUALITATIVE RESULT (mIU/mL) |
ICON® DS Strep A
is a qualitative assay for rapid detection of Strep A antigen from
throat swabs. With
outstanding performance, even in low colony count samples, ICON®
DS Strep A leaves little chance for misdiagnosis, minimizing the
risk of rheumatic fever or overprescription of antibiotics.
- CLIA
Waived
- 97%
sensitivity, 95% specificity
- Results
in minutes
- Easy
to use dipstick format
- Room
temperature storage, long shelf life
|
|
CLIA
Classification |
Analytes |
CPT
Code |
Test
Methodology |
Sample
Volume |
Time
to
Result |
Units
in which the test is reported |
Waived |
Strep
A |
87880QW |
IMMUNO-
CHROMA-
TOGRAPHY |
N/A
- THROAT SWAB |
5
MINUTES (AFTER 1 MINUTE EXTRACTION STEP; CAN READ UP TO 10 MINUTES) |
N/A
- QUALITATIVE RESULT |
ICON® FX Strep A is a qualitative assay which provides rapid detection of Strep
A antigen from throat swabs.
Diagnosis is quick so the patient can be treated in one
office visit.
The ICON®
FX Strep A has a unique product design that minimizes
specimen handling, mixing or measuring, and test disposal is
contained all in one test card.
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- CLIA
Waived
- 92%
sensitivity, 100% specificity
- Results
within 2 to 5 minutes
- Specimen
is contained for safe handling and disposal
- On-board
extraction eliminates the need for standing tubes and pipettes
- Room
temperature storage and convenient patient ID labeling
|
CLIA
Classification |
Analytes |
CPT
Code |
Test
Methodology |
Sample
Volume |
Time
to
Result |
Units
in which the test is reported |
Waived |
Strep
A |
87880QW |
IMMUNO-
CHROMA-
TOGRAPHY |
N/A
- THROAT SWAB |
5
MINUTES (AFTER 1 MINUTE EXTRACTION STEP) |
N/A
- QUALITATIVE RESULT |
FlexSure®
HP
Whole Blood
is a non-invasive, visually read, qualitative,
immunochromatographic method for rapid detection of antibodies to H.
pylori, a bacterium that grows in the stomach and is associated
with peptic ulcer disease and some gastric cancers. The simple, one
capillary fingerstick procedure is CLIA Waived, requires no
specialized equipment or instrumentation and yields results within 4
minutes. It reduces the need for invasive endoscopy and long-term
traditional therapies. Test and treat; all in the same office visit.
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- CLIA
Waived
- 90%
sensitivity vs. biopsy, 99% specificity vs. FlexSure®
HP Serum
- Test
results within 4 minutes
- Non-invasive
- Simple,
one capillary fingerstick procedure
- Up
to 30-day room temperature storage
- No
reconstitution, dilutions or wasted reagents
|
CLIA
Classification |
Analytes |
CPT
Code |
Test
Methodology |
Sample
Volume |
Time
to
Result |
Units
in which the test is reported |
Waived |
IgG
Antibodies to H. pylori |
86318 |
Immuno-
chroma-
tography |
N/A
- ONE CAPILLARY TUBE FILL |
4
minutes |
N/A
- QUALITATIVE RESULT |
|
FlexSure®
HP
Serum
is a visually read, qualitative, immunochromatographic method
for rapid detection of antibodies to H.
pylori, a bacterium that grows in the stomach and is associated
with peptic ulcer disease and some gastric cancers.
This simple procedure is moderately complex, requires no
specialized equipment or instrumentation and yields results within 4
minutes. It reduces the need for invasive endoscopy and long-term
traditional therapies. Test and treat; all in the same office visit.
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- Moderately
complex
- 97%
sensitivity vs. biopsy, 94% specificity vs. EIA
- Test
results within 4 minutes
- Non-invasive
- Up
to 30-day room temperature storage
- No
reconstitution, dilutions or wasted reagents
|
CLIA
Classification |
Analytes |
CPT
Code |
Test
Methodology |
Sample
Volume |
Time
to
Result |
Units
in which the test is reported |
Non-Waived |
IgG
Antibodies to H. pylori |
86677 |
Immuno-
chroma-
tography |
ONE
DROP (about 50 uL) |
4
minutes |
N/A
- QUALITATIVE RESULT |
HEMATOLOGY ANALYZERS: |
COULTER®
AC•T™ Series Hematology Analyzers
offers the simplicity of a touch screen with user friendly icons for the
analysis of a CBC and platelet, with optional lymph percent and lymph
number.
|
8 or 10 Parameter Systems
- Target
Volume: Ideal for performing 1-25 CBC’s a day
- Less
than 60 seconds for results
- Only
12µL
whole blood sample required
- Automated
probe wipe safely cleans the probe
- Convenient
on-board extraction package
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The
COULTER®
AC•T diff™ Hematology Analyzer
offers
immediate information to help effectively manage patient treatment.
The COULTER Ac•T
diff™ Hematology Analyzer is one in a family of small hematology
instruments that embraces our vision to simplify and automate.
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16
Parameter CBC with 3-Part Differential
-
Target
Volume: Ideal for performing 1-50 CBC’s a day
-
One
step sample processing with touch screen user interface
-
Automated
probe wipe; safely cleans the probe
-
Small
12µL sample size permits whole blood analysis from both venous and
capillary collections
-
Compact
design lets you put the Ac•T diff™
anywhere
-
Results
available is less than 60 seconds
-
Zero
routine maintenance requirement and high system reliability help
contain costs
-
Efficient
data management with patient control storage
-
Optional
Veterinary software
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The
COULTER®
AC•T diff2™
Hematology Analyzer brings
you the
added
convenience and safety of a closed vial sampling as standard.
This fully automated 16 or 18 parameter system offers a CBC
and COULTER®
Histogram
Differential, providing all the functions that make producing
results fast, accurate and easy.
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16
Parameter CBC with 3-Part Differential
-
Target
Volume: Ideal for performing 1-100 CBC’s a day
-
Closed
vial sampling accommodates a variety of collection tube sizes
-
Automated
probe wipe; safely cleans the probe
-
Small
18µL sample size in either closed or open vial modes
-
Compact
– Only 2 square feet of counter space required
-
Efficient
data management meets laboratory needs
-
Automated
quality assurance functions improve productivity
-
Controls
and calibrators designed for closed vial sampling
-
Zero
routine maintenance requirements and high system reliability
help contain cost
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The
COULTER®
AC•T™ 5diff CP
is
a fully automated system that delivers 5-part differential testing
for complete results in an affordable, easy to use package. With
the convenience of cap piercing and an extensive data management
system, the Ac•T™
5diff CP delivers
reliability, accuracy and more consistent patient care every time. |
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20
Parameter CBC with 5-part Differential
-
Target
Volume: Ideal for performing 10-100 CBC’s a day
-
Closed
vial sampling, automatic cap piercing with multiple tube
capacity
-
Extensive
data management capabilities for optimal record keeping
-
53µL
sample size for CBC with 5-part Differential
-
60
samples-per-hour throughput insures productivity
- Zero
routine maintenance requirements and high system reliability
help contain cost
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