An Easy-to-Use Blue Brush
May Save Your Life

BrochurePrint the InSure® FIT™ Patient Education Pamplet to bring to your physician and Request The Test.

Patient FAQs

Why should I take the InSure® FIT™ test?  And… why now?

American Cancer Society guidelines recommend yearly FIT (fecal immunochemical test) or FOBT (fecal occult blood test) for people at least 50 years of age at average risk, as one of the recommended screening options.1,2

  • Colorectal cancer is the second leading cause of cancer deaths in the U.S., yet one of the few cancers that is largely curable if detected in the early stages and can even be prevented in some cases by removing polyps.
  • When colorectal cancers are detected at an early stage, the five-year survival is 90%; however, only 39% of colorectal cancers are diagnosed at this stage.

According to the United States Centers for Disease Control and Prevention (CDC), up to 60% of deaths from colorectal cancer could be avoided if people over 50 received the recommended screening tests.3
An FOBT done during a digital rectal exam in the doctor’s office is not sufficient for screening and is not recommended by American Cancer Society guidelines. If your doctor performs a DRE, you should ask him or her about the InSure® FIT™ test.

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.

The Physician Requisition portion of my Reply Form is not filled out.  What do I do?

If you have a copy of the Physician Requisition (also called a prescription or lab order) you may attach that to the InSure® Reply Form.

If you don’t have a copy, you will need to contact your physician to obtain their Client ID# (or Quest Account #), and the diagnosis code.

Physician’s signature is not required unless you are a Medicaid patient within NJ, NY, PA, or MA.

What is M M / D D / Y Y Y Y?

This is the Month, Day, and Year of each sample.  For example, if your sample was taken on the third of June in 2014, then you would write “06 / 03 / 2014”

Will my insurance company pay for the InSure® test?

The InSure® test is covered by most insurance companies.  If you would like to call your insurance company to verify their coverage, you would give them our test code “CPT 82274” and the “InSure® Fecal Immunochemical Test” name.

My Medicare Number doesn’t fit onto the reply form.  What do I do?

This section is if you have Original Medicare.  If you have Medicare Advantage, Blue-Cross, or some other HMO type, then fill out section 3.

Where do I put my information for my supplemental insurance company?

Many development centers will not bill supplemental insurance.  You should file a separate claim with your supplemental insurance.

Special Diets: Are they required for the InSure® FIT™ test?

No.  You do not need to change your diet in any way before using the InSure® FIT™ test. 

Medications:  Will I need to follow a special medication routine, or change my current medications, in order to use the InSure® FIT™ screening test?

No.  You do not need to change any medications or medication routines.

Will I have to handle my stool when using the InSure® FIT™ screening test?

No. The InSure® FIT™ test has patented long-handled blue brushes, allowing you to perform the screening test with no fecal handling or smearing. After each bowel movement, use a brush to gently brush the surface of the stool in water for about 5 seconds, and then dab it onto the test card.  We call this the Blue Brush Method!

Why will I need to provide two samples?

Because colorectal conditions may not bleed all the time, and because blood may not be uniformly distributed in the stool, multiple sample FOBT or FIT take-home tests are recommended by the American Cancer Society (ACS) as one of the screening options. A single FOBT done during a digital rectal exam in the doctor’s office is not sufficient for screening and is not recommended by the ACS.  The InSure® FIT™ test requires a sample from each of two separate bowel movements.

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 bowel movement, 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.5

How much time should pass between the two bowel movements?

There is no particular amount of time necessary, as long as the samples are from two distinct bowel movements.  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 test card in your bathroom, out of direct sunlight and away from heat.  It is recommended that the test card be stored at room temperature (between 36-99○F, or 2-37○C).

Blue Bags:  What are they 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.

What about Urine in the water?

We would prefer that no urine is present in the toilet bowl from where the sample is collected.  If urine is present, notify your physician as it is a potential alternate source of occult blood that could be detected by the test.

Can I deliver the test personally to the lab?

We prefer you mail the test.  Not every lab processes our test, and the test needs to be processed by the lab indicated on your return envelope.

I lost my envelope, where do I mail my test?

Give us a call at 1-800-531-3681.  We can help determine the development center that’s right for you.

I haven’t received my results, what do I do?

Your results are sent to your physician, please check with your physician.

I checked with my physician, and they have not received my results from Quest, what do I do?

Contact Quest and let them know.  (http://www.questdiagnostics.com/home/contact.html)  Quest will not give the results directly to you, but they will be able to confirm if the test was processed and if so can forward the results to your physician.

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

Removable labels located on the instructions or reply form provided with the collection kit are used to seal the flap on the test card.  Remember to record your name, date of birth, and sample date on each label.

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?

Yes, remove any deodorizers / fresheners / cleaners from the toilet bowl and flush the toilet twice prior to performing the test.  These may decrease the sensitivity of the test.6

I use well water domestically.  Can I use the test?

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

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

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

Can a sample be taken from a stool not in water, or from used toilet paper?

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

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

No.  If you see blood in the toilet bowl, you should immediately consult your physician.

Should I use the InSure® FIT™ test if I have hemorrhoids that are bleeding?

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

Can I do the InSure® FIT™ test if I am menstruating?

No.  You should not perform the test three days before, during, or three days after your menstrual period.  Because the InSure® FIT™ screening detects blood in and around the stool, active bleeding from menstruation could provide a false positive result.

Can I do the InSure® FIT™ test if someone in my house is menstruating?

You can perform the test if someone else in the house is menstruating, provided that you flush the toilet twice before beginning your sample collection process.

Are FIT™s (fecal immunochemical tests) effective for detecting colorectal cancer?

The InSure® FIT™ test has demonstrated an 87% sensitivity for colorectal cancer7,8.  FIT tests are one of the screening options recommended by the guidelines from the American Cancer Society.

What do specificity and sensitivity mean?

Sensitivity is a measure of the ability of a test to find the disease when it is present.  A highly specific test is one that rarely indicates abnormality when no abnormality is present.

How is the InSure® FIT™ screening test different from traditional guaiac-based fecal occult blood tests (FOBTs)?

With the InSure® FIT™ test, the sampling procedure is more user-friendly.  Unlike traditional guaiac-based FOBTs and some other FIT™ tests, the patented InSure® FIT™ brush requires no fecal handling, and requires only two samples.  Because the InSure® FIT™ test detects human hemoglobin from blood, there are no drug or dietary restrictions required to complete the test.

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 their unique Blue Brush Method for sample collection.  After each of two different bowel movements, the patient uses the patented long-handled blue brush to gently brush the surface of the stool in water for about 5 seconds, and then dab it onto the test card.

Does a positive result mean I have cancer?

Not necessarily.  A positive test only indicates that blood was detected in the samples collected.  This blood may be from conditions other than colorectal cancer.  If you have a positive result, we strongly urge you to discuss the findings with your physician to establish the source of the bleeding and determine treatment, if appropriate.  In general, a further test of the colon and rectum (such as a colonoscopy) may be required.

 


References:

  1. American Cancer Society. Colorectal Cancer Screening Guidelines. Accessed February 4, 2008.
  2. U.S. Preventive Services Task Force. Screening for Colorectal Cancer: Recommendations and Rationale. July 2002. Agency for Healthcare Research and Quality, Rockville, MD.
  3. Centers for Disease Control and Prevention. Colorectal Cancer: Screening Rates. http://www.cdc.gov/cancer/colorectal/statistics/screening_rates.htm
  4. Cole SR, Young FP, Esterman A, Cadd B, Morcom J.  A randomized trial of the impact of new fecal hemoglobin test technologies on population participation in screening for colorectal cancer.  J Med Screen.  In press.
  5. 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.
  6. Data on file. Enterix, Inc. 2003
  1. InSure® FIT™ product inserts
  2. Smith A, Young GP, Cole SR, et al. Comparison of a brush-sampling fecal immunochemical test for hemoglobin with a sensitive guaiac-based fecal occult blood test in detection of colorectal neoplasia. Cancer. 2006;107:2152-2159.  The study was funded in part by Enterix Inc. (through Enterix Australia Pty. Ltd), the manufacturer of InSure® FIT™ .  One of the authors, GP Young, is a consultant for Enterix Australia Pty. Ltd.