BR-17882A Hemoccult ICT Testing Highly Specific

FECAL IMMUNOCHEMICAL TEST (FIT)
Blood Banking
Centrifugation
Highly specific for lower GI bleeding.
Chemistry
Flow Cytometry
No drug or diet restrictions.
Hematology
Immunoassay
Information Systems
Lab Automation
Molecular Diagnostics
Rapid Diagnostics
As a healthcare professional, you’re constantly analyzing and
evaluating a patient’s health by asking questions, looking at the
facts, the numbers, the odds and more.
Deciding what fecal occult blood test (FOBT) is best
shouldn’t be any different. Don’t take chances with your
patient’s health—insist on a test that has been clinically proven
for safety and effectiveness over the course of time.
BR-17882A
FECAL IMMUNOCHEMICAL TEST (FIT)
Hemoccult ICT Offers
Excellent Stability
Unlike other FIT products, Hemoccult is developed with dry-sample collection method, which increases
stability of the sample, allowing for multiple-day collection and necessary transit/development time.
Clinical fact: Hemoglobin is stable in dried stool samples.1
Higher Sensitivity and Specificity
Clinically proven to have an apparent specificity of 99.1% and relative sensitivity of 100%.
Clinical fact: Sensitivity of Hemoccult ICT is based on clinical studies.2
No Drug or Dietary Restrictions
Hemoccult ICT is specific to intact human hemoglobin, eliminating interactions from red meat, Vitamin C and
other factors that lead to false positives.
Clinical fact: An FIT is highly specific for lower gastrointestinal bleeding.
Multiple-Day Testing
Meets the American Cancer Society, United States Task Force for Colorectal Cancer Foundation screening
recommendation of multiple-day testing for colorectal cancer.
Clinical fact: Clinical trials support 2- and 3-day stool sampling.3
An FIT yields inherently superior results when compared to a chemical-based test (e.g., guaiac).
Hemoccult ICT
Hemoccult Guaiac
What’s Detected
Intact Human Hemoglobin Protein
Peroxidase Activity (Heme)
Probable Location of Bleeding
Large Intestine (Lower GI) (Colon) Only
Mainly Stomach, Small Intestine and
Large Intestine
Dietary or Drug Restrictions
None
Yes
False Positivity Rate For Any
Lower GI Pathology
0.9%
1.2%
Clinical Apparent Specificity
(100% False Positivity Rate)
99.1%
98.8%
Clinical Relative Sensitivity
(Adenomas and Cancer)
100%
40%
Analytical Sensitivity
95% at 300 ug Hemoglobin/g Feces or
200 ng/mL Hemoglobin
50% at 0.3 mg Hemoglobin/gm Feces
(100% at 1 mg Hemoglobin/gm Feces)
Table data2
Step-By-Step Patient Instructions
Easy-to-follow directions are included for filling out Collection Card information, collecting stool samples and
options for returning samples to the doctor or laboratory.
Flexible Design
ICT tests are available as 2- and 3-day tests in single-card configurations, enabling you to choose the solution
that works best for your patient.
FECAL IMMUNOCHEMICAL TEST (FIT)
Support For You and Your Patients
Some of the educational tools to help you promote colorectal cancer (CRC) screening include:
- FIT screening experts at your call
- Patient checklist
- Patient reminder cards
- Technical hotline
- Webinars on-demand
- CRC awareness poster
- Patient sample collection video
- 24/7 web communication
For Hemoccult ICT product samples, information and educational support to help you understand the facts around fecal
immunochemical testing (FIT), please visit www.beckmancoulter.com
CLIA
• CPT Code*
• Waived
G0328QW, 82274QW
Ordering Information
Hemoccult ICT Products
FIT 3-Day Patient Screening Kit
395066
40 Patient Screening Kits, each containing:
• Dispensing Envelope with Patient Instructions
• Hemoccult ICT Collection Cards
• Flushable Sample Collection Tissues
• Applicator Sticks
• Mailing Pouch
FIT 2-Day Patient Screening Kit
• 1
00 Collection Cards
• 100 Applicator Sticks
• Sample Collection Instructions
395067†
• 2
0 Test Devices
• 1
Bottle Hemoccult ICT Buffer/8.0 mL
†To be used with Hemoccult ICT Collection Cards – product # 395066, 395261
and 395065
Hemoccult ICT Controls 395068
• 4
Bottles (2 Positive and 2 Negative / 0.8 mL each)
395261
50 Patient Screening Kits, each containing:
• Dispensing Envelope with Patient Instructions
• Hemoccult ICT Collection Cards
• Flushable Sample Collection Tissues
• Applicator Sticks
• Mailing Pouch
Hemoccult ICT Collection Cards Kit
Hemoccult ICT Test Kit
Hemoccult ICT Buffer
462595
• 1
Bottle of Buffer
*E
xemplar CPT provided. Refer to regional CMS fee schedule for relevant/current
CPT codes.
395065
FECAL IMMUNOCHEMICAL TEST (FIT)
Beckman Coulter is the leader in fecal occult blood testing and offers the very best in rapid tests designed to simplify the diagnostic
process. Early detection is the single most important advantage a patient can have to survive life-threatening diseases. Beckman Coulter
provides the tools and tests physicians need to aid in the diagnosis and management of a variety of disease states.
Beckman Coulter also provides a variety of Immunoassay, Chemistry, Hematology and Centrifugation instruments to aid in the diagnosis
and management of a full spectrum of medical conditions. Each system’s compact design and cost-effective performance makes it a
perfect complement to a physician’s office laboratory.
To order product, contact your medical supply distributor. For technical assistance regarding rapid test kits, call Technical Marketing at
800-877-6242 or email [email protected].
Lab Testing Made Easy
Beckman Coulter Rapid Diagnostics Product Offering
Hemoccult
Hemoccult SENSA
Hemoccult II SENSA elite
Hemoccult ICT
CLIA-waived rapid tests for the detection of hidden blood
in feces
Gastroccult
CLIA-waived rapid test for detecting hidden blood in gastric
fluid and determining gastric pH
ICON Hp
CLIA-waived (whole blood) and moderately complex (serum)
rapid test for the detection of antibodies to H. pylori
ICON 20 hCG
ICON 25 hCG
CLIA-waived (urine) and moderately complex (serum) rapid
tests for the detection of hCG
ICON Mono
CLIA-waived (whole blood) and moderately complex (serum)
antibody test for infectious mononucleosis
ICON DS Strep A
ICON SC Strep A
CLIA-waived dipstick and cassette rapid format tests for the
detection of Strep A, using throat swab sample
References:
1. Data on file, Beckman Coulter, Inc.
2. Data on file, Beckman Coulter, Inc. Hemoccult ICT Product Instructions 2010
3. Yamamoto M; Nakama H. Cost-Effectiveness Analysis of Immunochemical Occult Blood Screening for
Colorectal C
ancer Among Three Fecal Sampling Methods. Hepato-Gastroenterology 2000; 47(32):396-399
Beckman Coulter, the stylized logo, Hemoccult, Hemoccult II, SENSA, Gastroccult and ICON are trademarks of
Beckman Coulter, Inc. and are registered with the USPTO.
For Beckman Coulter’s worldwide office locations and phone numbers, please visit www.beckmancoulter.com/contact
BR-17882A B2012-13692-01
www.beckmancoulter.com
© 2013 Beckman Coulter, Inc.