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Screening Test They May Actually Use

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InSure® FIT™ Medical Professional FAQs

Why should patients take this 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 easy-to-use and patient friendly in addition to providing accurate results.

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

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 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
Is the InSure® FIT™ 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.

Do patients need to go on a special diet before or during collecting the sample?
There are no dietary restrictions required in order to use the InSure® FIT™ product.
Does the InSure® FIT™ have any medicinal restrictions?
There are no medicinal restrictions required in order to use the InSure® FIT™ product.
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.
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.6

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

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

Should patients use the InSure® FIT™ if I 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.

Can patients do the test if menstruating?

No. The test should not be performed three days prior to, during, and 3 days after a patient’s menstrual period.

Can sufferers of sickle cell anemia perform the test?

Yes. InSure® FIT™ has been tested for specificity against different hemoglobin variants, including hemoglobin from sickle cell anemia sufferers. The results from testing showed that InSure® FIT™ is as sensitive to hemoglobin from sickle cell anemia sufferers as it is for normal hemoglobin3.

How is the flap on the test card closed once the sample has been applied?

The removable labels located on the instructions for use provided in the collection kit are used to seal closed flaps on the test card after each sample has been applied to the sample pad. Remember that patients must record their name, date of birth and sample date on each label.

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 colonoscopy1.

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.

Do water softeners interfere with the test?

No. Water softeners do not interfere with the performance of InSure® FIT™ .

Do toilet bowl deodorizers / fresheners / cleaners interfere with the test?

We recommend removing any deodorizers / fresheners / cleaners from the toilet bowl and flushing the toilet twice prior to performing the test. Studies performed with the InSure® FIT™ test showed no evidence of false positive test results caused by toilet bowl deodorizers / fresheners / cleaners3. Variations in effect on test sensitivity ranged from a 4-fold decrease to no effect, however there was no correlation between deodorizer / freshener / cleaner formulation and impact3.

The patient uses well water domestically. Can they use the test?

Yes, they can use the InSure® FIT™ test.

A rust ring is visible in the toilet bowl. Can the patient use the test?

No. If the rust cannot be removed the test must be performed in an alternate toilet.

Can the patient urinate when taking the bowel movement from which a sample will be collected?

Urine in toilet bowl water has no effect on the accuracy of the test however, it may be a potential source of occult blood.

What are the blue bags for?

The blue plastic bags have been supplied for the disposal of the toilet paper used when the patient is taking a bowel movement, in addition to the long-handled brush supplied in the kit after it has been used to collect and transfer the sample.

How are the used blue bags disposed?

The blue bag containing the used toilet paper and brush can be disposed as general waste.

Does fecal matter need to be collected when sampling?

The sample is collected by brushing the surface of the stool in water for 5 seconds. Any excess water or stool is removed by gently shaking the brush prior to transferring the sample to the Test Card. Remember that the brush bristles must be applied to the sample pad for 5 seconds for sample transfer.

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.1,2 Research has shown that colorectal cancer sensitivity of a FOBT is as low as 4.9% when used with a single digital rectal exam. 8

Can a sample of feces be taken from a stool sample not in water?

No. InSure® FIT™ has been designed for collecting a sample of stool in water. If a bowel movement is taken into a dry, clean receptacle it must be transferred immediately to a container holding 2L of tap water prior to performing sample collection.

Can a sample be taken from used toilet paper?

No. InSure® FIT™ has been designed for collecting a sample of stool in water.

Can both samples be taken from the same bowel movement?

No. 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.6

How much time should pass between sampled bowel movements?

Preferably samples should be taken on two different days. You should remember that the test must be processed within 14 days of collection of the first sample so ensure that there is no significant delay between the first and second samples.

Where can the test card be stored after taking the first sample?

You can store the completed test card in your bathroom out of sunlight and heat. It is recommended that the test card be stored at room temperature (<37°C / 99°F).

USP storage temperature definitions

When developing the test I placed more than 8 drops of run buffer on the test card during test development. Will this impact the test result?

No. Placing more than the indicated 8 drops of run buffer on the test card during test development will not impact test development. Bottles of run buffer supplied with the InSure® FIT™ Developer Kit have been filled to allow slightly more than the 25 test strips supplied to be developed, however the application of additional drops should be avoided and only performed if the test has not developed 5 minutes after the initial application of 8 drops of run buffer.

I performed the test development procedure in accordance with the instructions however 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 further 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, Enterix Inc. in the US: 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, Enterix Inc. has external controls available.

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

No. External controls for 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. MSDSs for all of the InSure® FIT™ active components are available in the Medical Professionals – Resources section of the Enterix Inc. website (www.InSureTest.com).

Material Safety Data Sheets (MSDSs)
InSure® FIT™ Run Buffer
InSure® FIT™ Test Card
InSure® FIT™ Test Strip

 

 


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. 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.
    7. Mandel JS, Church TR, Bond JH, et al. “The effect of fecal occult-blood screening on the incidence of colorectal cancer.” N Engl J Med. 2000; 343; 1603-1607.
    8. 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.
    9. Collins J F, Liberman D A, Durbin T E, Weiss D G and the Veteran Affairs Cooperative Study # 380 Group.  “Accuracy of Screening for Fecal Occult Blood on a Single Stool Sample Obtained by Digital Rectal Examination: A Comparison with Recommended Sampling Practice” Annals of Internal Medicine 2005; 142 (2): 81 – 85.