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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

 

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.

 

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

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.

  • 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
 

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
 

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.

  • 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
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.

  • 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.

  • 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.

  • 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

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.

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

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.

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

 

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.
  • 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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Last updated: 12/08/2008 Questions or corrections: Webmaster.© 2008 Medical Automation Systems, Inc. Legal Notice.
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