Is fecal immunochemical testing effective for detecting colorectal cancer?
Yes. The InSure® FIT™ has 87% sensitivity for colorectal cancer.1
A randomized, controlled trial evaluated the clinical performance of the InSure FIT test and Hemoccult® II SENSA® in 2512 subjects in a diagnostic cohort of symptomatic subjects and a screening cohort of asymptomatic subjects. Subjects with positive test results underwent colonoscopy. The study found that the InSure FIT test had 33% greater sensitivity for colorectal cancer than Hemoccult II SENSA. The study was funded in part by Enterix Inc. (through Enterix Australia Pty. Ltd.), the manufacturer of the InSure FIT test. Enterix is now owned by Quest Diagnostics. However, neither Enterix nor Quest Diagnostics participated in the data analysis or influenced the conclusions reached by the authors.2
The InSure Quik FIT™ fecal immunochemical test utilizes the same brush and collection methodology as the InSure FIT and is deemed substantially equivalent to the InSure FIT assay.
What is the difference between InSure FIT (lab test) and InSure Quik F I T (in-office test)?
Both the InSure FIT and the InSure Quik F I T tests use the same patient sample collection methodology. The sensitivity and specificity are identical. InSure FIT (for the lab) is for those Physicians who would prefer to have testing completed by a Quest Diagnostics facility. The InSure Quik F I T product is for those Physicians who would prefer to process the testing in-office and bill directly. Both tests are manufactured by Enterix, Inc., a Quest Diagnostics Company.
Where can I get the InSure FIT Test Kit?
To obtain the testing kits of your choice click on one of the following:
- Contact your Quest Diagnostics Sales Rep for lab based InSure FIT kits.
- Purchase in-office InSure Quik F I T kits online or call 800-531-3681.
Is the InSure FIT test covered by insurance?
According to the U.S. Health & Department Services: Centers for Medicare & Medicaid Services (CMS) Medicare began covering the new colorectal cancer screening FOBT G0328 beginning January 1, 2004. G0328 is payable under the clinical lab fee schedule. Medicare patients aged 50 and over can only receive one FOBT per year, either G0328 (iFOBT, or immunoassay-based) or G0107 (gFOBT, or guaiac-based).
A covered screening FOBT is allowed once every 12 months for beneficiaries who have attained age 50 (i.e., at least 11 months have passed following the month in which the last covered screening FOBT was performed). Medicare will allow either one covered G0328 iFOBT or one covered G0107 gFOBT, but not both during a 12-month period.
CPT Codes:
InSure® FIT™: 82274
InSure® Quik F I T™: 82274QW
Medicare Codes:
InSure® FIT™: G0328
InSure® Quik F I T™: G0328QW
Why does the Patient have to provide two samples?
Because colorectal lesions, including some polyps and colorectal cancers, may bleed intermittently, or not at all, or blood may not be uniformly distributed in the stool, multiple sample FOBT or FIT take-home tests are recommended by the American Cancer Society, 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 American Cancer Society guidelines.
Can a DRE sample be used on the InSure Test Card?
No.
How does the InSure FIT work?
InSure FIT is based on the immunochemical detection of human hemoglobin (Hb) as an indicator of blood in the stool. The assay uses a monoclonal antibody to capture Hb on a test strip. Since globin does not survive passage through the upper gastrointestinal (g.i.) tract, the presence of globin in the stool indicates bleeding in the colon or rectum.
Does a positive result mean cancer?
A positive test only indicates that blood was detected in the samples collected. This blood may be from conditions other than colorectal cancer. If the result is positive, it is strongly recommended that you establish the source of bleeding. In general, a further test of the colon and rectum (such as a colonoscopy or X-ray examination) will be required. A repeat collection using the InSure FIT test kit is not recommended.
Questions for in-house testing
Can reagents from other manufacturers be used with the InSure® test cards?
Absolutely not. The InSure Quik F I T assay is a patented formula and will not work with different reagents and buffers manufactured by other companies. In addition, mixing reagents from one test with those from another, may invalidate the CLIA waived status of the test. Additionally, InSure FIT test cards can only be developed at Quest Diagnostics laboratories and cannot be processed/developed using the reagents from the InSure Quik F I T kit.
If an InSure FIT sample card has been opened for testing and reagents applied, can the card be reused with the correct reagents and buffers from the InSure Quik F I T?
Absolutely not. Once the incorrect assay has been applied the test card should be disposed of and the Patient given a new sample collection kit.
Troubleshooting development of the InSure Quik F I T assay?
If the buffer does not flow onto the test strip due to excess specimen, add two more drops of buffer to each reagent port and wait an additional 5 minutes.
- InSure FIT and InSure Quik F I T product inserts
- 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. Enterix is now owned by Quest Diagnostics Incorporated. However, neither Enterix nor Quest Diagnostics participated in the data analysis or influence the conclusions reached by the authors. One of the authors, GP Young, is a consultant for Enterix Australia Pty. Ltd.
