When To Use

The American Cancer Society (ACS) recommends both men and women at average risk for developing colorectal cancer (CRC) beginning screening at age 45. Read more ​here.

Colorectal Screening Guidelines:

Fecal immunochemical tests (FIT) are recommended by medical guidelines for use in colorectal cancer screening programs and are recognized as being highly effective when repeated annually.
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The use of a FIT in colorectal cancer screening programs is supported by medical guidelines, including the American Cancer Society,  American College of Gastroenterology, US Preventative Task Force and US Multi-Society Task Force for Colorectal Cancer. (2, 3, 4, 5).

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Key Benefits

InSure® ONE™ is easy.
InSure® ONE™ is the only Fecal Immunochemical Test (FIT) that is performed using toilet water collected from a single bowel movement. (6)

• From a single bowel movement, the patient gently brushes the surface of the stool in water for about 5 seconds with the convenient, long-handled blue brush, and then simply transfers a sample of the toilet water on the test card.
• There is no need to collect stool in a sling or bucket, or sample feces directly; unlike other available FIT and FIT-Fecal DNA tests.  
• InSure® ONE™ is performed with a single bowel movement, unlike guaiac Fecal Occult Blood Tests (gFOBT) which require 2 or 3 separate bowel movements.
  

​InSure® ONE™ is inexpensive compared with a FIT Fecal DNA test, which is approximately 20-30 times the cost. (7)

InSure® ONE™ is highly accurate.  In a recent study demonstrated that InSure® FIT™ was found to be significantly more sensitive for advanced colorectal neoplasia than OC-FIT CHECK and Hemoccult II SENSA (8)

FIT was recommended as a Tier 1 testing option for colorectal cancer screening programs, along with colonoscopy, by the USMSTF in 2017. FIT Fecal DNA test is recommended as a Tier 2 option.(9)

How To Process A Sample

Additional Resources:

• Instructions for use
• Instructions for use - FOBT controls
• Patient Instructions - English
• Patient Instructions - Spanish
• How to process a sample - Spanish

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Answers to Common Questions

WHERE CAN I GET THE InSure® ONE™ TEST?

For information on how to order the InSure® ONE™ test please complete the Information Request Form or call us at 800-531-3681.

IS THE ​InSure® ONE™ TEST COVERED BY INSURANCE?

Most insurance providers do cover the InSure® ONE™ test under their preventive care services. Patients should contact their insurance provider to ensure that the InSure® ONE™ is covered by their insurance policy.

QUESTIONS REGARDING SAMPLE COLLECTION

Do water softeners interfere with the test? Can the patient use the test if they use well water?
No. Water softeners do not interfere with the performance of InSure® ONE™.

Yes. Patients can use the InSure® ONE™ test if their toilet uses well water.

Can a patient us the test when a rust ring is visible in the toilet bowl?
No. If the rust cannot be removed, the test must be performed in an alternate toilet without a rust ring.

Do toilet bowl deodorizers/fresheners/cleaners interfere with the test?
Yes. Patients need to remove any deodorizers/fresheners/cleaners from the toilet bowl and flush the toilet twice before performing the test.

Will patients need to change their diet or medication routine to use the InSure® ONE™ test?
No. Patients do not need to change or their diet or medications in any way before using the test.

There are no dietary changes or drug restrictions associated with using the InSure® ONE™ test.

Should I use the InSure® ONE™ test for my patients who have hemorrhoids that are bleeding?
No. The InSure® ONE™ test detects blood in and around the stool, active bleeding from hemorrhoids could produce a false-positive result.

Can the InSure® ONE™ test be used during menstruation?
No. The test should not be performed three days before, during, or three days after a menstrual period. Because the InSure® ONE™ test detects blood in and around the stool, active bleeding from menstruation could provide a false-positive result.

Can the InSure® ONE™ test be used if someone other than the patient in their house is menstruating?
Yes. The test can be collected if someone else in the house is menstruating, only if they flush the toilet twice before beginning the sample collection process.

Will my patient have to handle stool when using the InSure® ONE™ screening test?
No. InSure® ONE™ is an easy fecal immunochemical test that only requires one to take a sample of toilet water.

Using the long-handled blue brush included in the collection kit, one only needs to gently brush the surface of the stool in the water for about 5 seconds and then transfer a sample of the toilet water by dabbing water only onto the test card sample pad. This action is repeated for the second sample pad.

Sample collection is completed in minutes and does not require the user to collect, handle or smear fecal matter.

Can a sample be taken from a stool not in water, or from used toilet paper?
No. InSure® ONE™ has been designed for collecting a sample of water surrounding the stool.
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Can a digital rectal exam sample be used on the InSure® ONE™ test card?
No. The InSure® ONE™ test has not been designed for use with a sample collected from a digital rectal exam.

QUESTIONS REGARDING SAMPLE PROCESSING AND DEVELOPMENT

The test has not developed. I performed the test by following the instructions. 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. Proper sample application requires that any excess water or stool is removed by gently shaking the brush before 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 with another collection kit and instructed to perform sample collection by following 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.

Can I use components from other FIT or FOBT tests with the InSure® ONE™ test?
No. Only components supplied in the InSure ONE Developer Kit can be used to develop returned, completed Test Cards.

How do I know if the test has fully developed after 5 minutes?
This device contains built-in procedural control features that consist of a control line and a negative background control area on the test strip. The presence of the control line indicates that an adequate amount of run buffer was used and migrated properly through the test card and the test strip.  The control line contains immobilized conjugate-specific antibody. The presence of a control line (pink) indicates that the conjugate was properly hydrated, flowed through the test and control line areas, the control line antibodies were immunoreactive and the conjugate is intact. The test is invalid if the control line does not appear. The negative background control area is the region just below the control line on the test strip. A white to light pink background color in the negative background control area 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. Patient test results should not be reported when the built-in controls indicate an invalid test.

Are external controls available?
Yes, Clinical Genomics has external controls available for InSure®ONE™.

How do I dispose of used test cards and unused test components?
Discard used test cards and any remaining unused test components by following 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.

DOES ONE POSITIVE RESULT MEAN THAT THE PATIENT HAS COLORECTAL CANCER?

​​InSure® ONE™ is a highly accurate test for detecting blood in fecal samples. A positive result only indicates that blood was detected in the sample and this may be an indication of lower gastrointestinal bleeding which may be associated with disorders such as diverticulitis, ulcerative colitis, polyps, colorectal cancers, or large adenomas that bleed. Fecal immunochemical tests are recommended by medical guidelines for use in colorectal cancer screening programs and are recognized as being highly effective when repeated annually.

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 sample collected by the patient. 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® ONE™ 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.​

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References
(1) A randomised trial of the impact of new faecal haemoglobin test technologies on population participation in screening for colorectal cancer. Cole et al. Journal of Medical Screening 2003

(2) https://www.cancer.org/health-care-professionals/american-cancer-society-prevention-early-detection-guidelines/colorectal-cancer-screening-guidelines.html

(3) https://gi.org/wp-content/uploads/2018/04/ACG-Colorectal-Cancer-Screening-Guideline-Summary.pdf

(4) https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/colorectal-cancer-screening2

(5) https://www.ncbi.nlm.nih.gov/pubmed/28555630

(6) https://patents.google.com/patent/WO1999056103A1/en?q=~patent%2fWO1999056103A1

(7) https://www.cologuardtest.com/faq/cost

(8) Shapiro JA, et.al. Am J Gastroenterol. advance online publication, 10 October 2017; doi: 10.1038/ajg.2017.285Manufactured
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(9) https://www.questdiagnostics.com/home/physicians/testing-services/by-test-name/insureone/usmstf-guidelines