Offer Your Patients a Colorectal Cancer

Screening Test They May Actually Use

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InSure® FIT™ Medical Professional FAQs

Why prescribe the InSure® FIT™ test? 

InSure® FIT™ is a non-invasive and highly accurate fecal immunochemical test (FIT) designed for annual colorectal cancer screening in patients 50 years of age and older. This easy-to-use test offers distinct advantages over traditional guaiac-based fecal occult blood tests (FOBTs) and other fecal immunochemical tests (FITs) because it is patient friendly in addition to providing accurate results.

What are the advantages of using InSure®?

InSure® FIT™ differs from other colorectal cancer screening tests that analyze fecal occult blood, because it is easy to use, is patient friendly, and provides highly accurate results.

Easy to use - Patients testing with InSure® do not have to collect fecal samples.  Rather, samples are taken by brushing across the surface of the stool while in water using a long-handled brush.

Patient Friendly - With InSure®, there is no medical or dietary restrictions.  Patients can continue to take nonsteroidal anti-inflammatory drugs, such as aspirin, and do not have to abstain from red meat or certain vegetables before or during the testing period.  A patient preference study found that patients are 66 percent more compliant with InSure® compared to traditional guaiac-based FOBTs, due to the test’s easy to use and patient-friendly attributes4.

Highly Accurate Results - Since InSure® detects only blood from the lower-GI tract where polyps and colorectal cancer develop, the test is much more specific and accurate than other traditional screening tests.  In clinical studies, InSure® demonstrated a sensitivity for colorectal cancer of 87 percent and a specificity of 98 percent.  Traditional guaiac-based FOBTs detect bleeding from anywhere between the mouth and anus.  Therefore, with traditional FOBTs, a bleeding stomach ulcer or a diet of red meat may yield a positive test result and lead to an unnecessary colonoscopy procedure for a patient.  The high specificity of InSure® minimizes the risk of false-positive results that require unnecessary colonoscopy.

Who should be screened?

The American Cancer Society and United States Preventative Services Task Force both recommend that average risk individuals from the age of 50 undergo some form of colorectal cancer screening. Both organizations recommend that annual screening using a FIT is an acceptable screening method for this population.1,2

Is fecal immunochemical testing effective for detecting colorectal cancer?

Since InSure® FIT™ detects only blood from the lower GI tract where polyps and colorectal cancer develop, the test was found to be more accurate than a leading guaiac-based FOBT. In clinical studies, InSure® FIT™ demonstrated a sensitivity for colorectal cancer of 87% and a specificity of 98%.3 When compared with a guaiac-based FOBT, InSure® FIT™ demonstrated 33% greater sensitivity for colorectal cancer.4

Where can I get the InSure® FIT™ test?

For information on how to order the InSure® FIT™ test please complete the Information Request Form, contact one of our distributors or call us at 800-531-3681.

How is the InSure® FIT™ test different from other fecal occult blood tests (FOBTs)?

InSure® FIT™ is the only water-based collection test with no fecal handling, and no dietary and medicinal restrictions.

How is the InSure® FIT™ test different from a stool DNA (sDNA) test?

Unlike the InSure® FIT™ test, stool DNA tests require patients to pack an entire bowel movement in a kit and send the sample to a laboratory for testing. InSure® FIT™ tests are more convenient and easier-to-use than sDNA tests because of the unique Blue Brush Method for sample collection.

How does patient compliance with InSure® FIT™ compare with other FOBTs or FITs?

InSure® FIT™ had up to 66% more patient compliance than Hemoccult® SENSA® and 28% greater compliance than Hemoccult® ICT (FlexSure OBT).5

What is the false-positive rate of InSure® FIT™?

According to clinical trial data, the reported false-positive rate for InSure® FIT™ is two percent, up to five times lower than that of currently available FOBTs.3

Is the InSure® FIT™ test covered by insurance?

Most insurance providers do cover the InSure® FIT™. Patients should contact their insurance provider to ensure that the InSure® FIT™ is covered by their insurance policy.

Does the InSure® FIT™ require fecal handling?

There is no fecal handling involved when performing sample collection.  Rather, samples are taken by brushing across the surface of the stool (for 5 seconds) while in water, using the long-handled brushes provided.

Can a digital rectal exam sample be used on the InSure® FIT™ Test Card?

No. The InSure® FIT™ test has not been designed for use with a digital rectal exam. Both the American Cancer Society and United States Preventative Service Task Force state that a FOBT or FIT done during a digital rectal exam in the doctor’s office IS NOT adequate for screening.1,2Research has shown that colorectal cancer sensitivity of a FOBT is as low as 4.9% when used with a single digital rectal exam. 6

Do patients need to provide two samples?

Yes. As colorectal lesions, including some polyps and colorectal cancers, may bleed intermittently, or not at all, by sampling from more than one sample the likelihood of detecting bleeding is increased. Studies have shown that FOBTs with two samples have a greater sensitivity for colorectal cancer than those with a single sample and a greater specificity for colorectal cancer than those with three samples.7

Do patients need to go on a special diet before or during collecting the sample?

No.  There are no dietary restrictions required in order to use the InSure® FIT™ product.

Does InSure® FIT™ have any medicinal restrictions?

No.  There are no medicinal restrictions on the InSure® FIT™ test.

Should the test be prescribed to patients with bleeding hemorrhoids?

No.  As the InSure® FIT™ test detects blood in and around the stool, active bleeding from hemorrhoids could provide a false positive result.

Can patients do the test if menstruating?

No.  As the InSure® FIT™ test detects blood in and around the stool, bleeding during menstruation can provide a false positive result.  The test should not be performed three days prior to, during, and three days after a patient’s menstrual period.

Should patients use the InSure® FIT™ test if they see blood in the toilet bowl?

If blood is visible in the toilet bowl the InSure® FIT™ test should not be performed and instead patients should report the presence of blood to their physician. The InSure® FIT™ test has been designed to detect hidden (occult) blood and at certain high concentrations of blood it may yield a negative result due to the prozone effect, as is the case with all FITs.

Does a positive result mean that the patient has colorectal cancer?

InSure® FIT™ detects human blood in stool. There are many gastrointestinal conditions that may cause blood in stool, aside from colorectal cancer. If a patient receives a positive test result, more testing and evaluation is necessary and the American Cancer Society recommends follow-up with a colonoscopy.1

Does a negative result mean that the patient does not have colorectal cancer?

A negative result means that human hemoglobin was not detected in the collected samples. Colorectal lesions, including some polyps and colorectal cancers, may bleed intermittently, or not at all. Additionally, blood may not be uniformly distributed in or on the stool and a test result may be negative even when blood or lower gastrointestinal disease is present. InSure® FIT™ is designed for preliminary screening and is not intended to replace diagnostic procedures such as colonoscopy or sigmoidoscopy in combination with double contrast barium x-ray.

I performed the test development procedure in accordance with the instructions, but the test has not developed.  What should I do?

Check that the patient did not apply excess specimen. Remember that the sample is collected by brushing the surface of the stool for 5 seconds. Any excess water or stool is removed by gently shaking the brush prior to transferring the sample to the Test Card. Therefore, there should not be any significant amount of fecal matter on the Test Card. If excess specimen has been collected apply 2 more drops of run buffer and wait an additional 5 minutes for test development. If the test continues to not develop, the patient should be supplied another collection kit and instructed to perform sample collection in accordance with the instructions for use.

If there is no excess specimen on the Test Card and the test still does not develop 5 minutes after the application of 2 additional drops of run buffer, please contact Technical Services: 1-800-531-3681.

I have test components from a FIT or FOBT manufactured by another company.  Can they be used to develop a returned, completed Test Card?

No. Only components supplied in the InSure® FIT™ Developer Kit can be used to develop returned, completed Test Cards.

How do I know if the test has fully developed after 5 minutes?

A white to light pink background color in the negative background control area (region just below the Control Line on the Test Strip) indicates that the reagents and conjugate-sample complex, if formed, flowed properly. If distinct areas of color (dark pink) remain in the window below the Control Line, the test is invalid. The built-in procedural controls should be observed for each patient test performed in order to monitor test validity.

Are external controls available for InSure® FIT™?

Yes, Clinical Genomics has external controls available.

I have external controls manufactured by another company.  Can I use them with InSure® FIT™?

No.  External controls for other FOBT or FIT products manufactured by other companies are not to be used with the InSure® FIT™ product.

How do I dispose of used test cards and unused test components?

Discard used test cards and any remaining unused test components in accordance with internal procedures for the disposal of clinical waste.  All specimens and used assay materials should be treated as if they are potentially infectious.  Run buffer contains non-hazardous concentrations of sodium azide, which can react with metal pipes to form explosive metal azides.  Upon disposal, flush with large volumes of water to prevent azide buildup.

 

 


References

    1. Smith, R. A., Cokkinides, V., Brooks, D., Saslow, D. and Brawley, O.W. “Cancer Screening in the United States, 2010: A Review of Current American Cancer Society Guidelines and Issues in Cancer Screening” CA Cancer J Clin 2010; 60; 99-119.
    2. U.S. Preventative Services Task Force. “Screening for Colorectal Cancer: U.S. Preventative Services task Force Recommendation Statement” Annals of Internal Medicine 2008; 149; 627 – 637.
    3. Data on file. Enterix, Inc. 2003
    4. Smith, A., Young, G. et al. “Comparison of a brush-sampling fecal immunochemical test for hemoglobin with a sensitive guaiac-based occult blood test in detection of colorectal neoplasia” Cancer 2006; 107 (9) 2152-2159.
    5. Cole, SR, Young, GP, Esterman, A, Cadd, B, Morcom, J.  A randomized trial of the impact of new faecal hemoglobin test technologies on population participation in screening for colorectal cancer. J Med Science 2003; 10:117-212.
    6. Mandel JS, Church TR, Bond JH, et al. “Reducing mortality from colorectal cancer by screening for fecal occult blood. Minnesota Colon Cancer Control Study” N Engl J Med. 1993; 328; 1365-1371.
    7. Nakama H . et al “Relationship between fecal sampling times and sensitivity and specificity of immunochemical fecal occult blood tests for colorectal cancer: a comparative study” Dis Colon Rectum 7/1/1997; 40(7): 781-784.