Is fecal immunochemical testing effective for detecting colorectal cancer?
What is the difference between the InSure® FIT™ (lab test) and the InSure® Quik F I T™ (in-office test)?
Where can I get an InSure® Test Kit?
Is the InSure® Test covered by insurance?
Why does the Patient only have to provide two samples instead of three?
Can a DRE sample be used on the InSure® Test Card?
How does the InSure® FIT™ and InSure® Quik F I T™ Test work?
Does a positive result mean cancer?

Questions for in-house testing
Can reagents from other manufacturers be used with the InSure® FIT™ and InSure® Quik F I T™ test cards?
Once opened for testing and reagents applied, can the card be reused with the correct reagents and buffers?
Troubleshooting development of the test?

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™ use the same Patient sample collection methodology. The sensitivity and specificity are identical. InSure® FIT™ (for the lab) allows 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.
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Where can I get the InSure® 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 covered by insurance?

According to the U.S. Health & Department Services: Centers for Medicare & Medicaid Services (CMS) Medicare will cover 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
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Why does the Patient only have to provide two samples instead of one or three?

Because blood is not released constantly. Providing two samples allows more random sampling and helps ensure an accurate reading. Bleeding from early lesions may be intermittent. Taking two samples doubles the chance of detecting early lesions. Additional samples may further increase sensitivity, but at the expense of participation, so that any benefit could be lost.
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Can a DRE sample be used on the InSure® Test Card?

No.
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How does the InSure® FIT work?

InSure® Fecal Immunochemical Test (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.
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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. A positive result does not prove 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® Test kit is not recommended.
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Can reagents from other manufacturers be used with the InSure® test cards?

Absolutely not. The InSure® assay is a patented formula and will not work with different reagents and buffers manufactured by other companies. Additionally, InSure® FIT™ test cards can only be developed at Quest Diagnostics laboratories and cannot be interchanged with the conjugate and buffer used for developing the InSure® Quik F I T™ test cards in-office.
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Once opened for testing and reagents applied, can the card be reused with the correct reagents and buffers?

Absolutely not. Once the incorrect assay has been applied the test card should be disposed of and the Patient given a new test kit.
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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.
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References:
1. Mandel, J.S., Bond J.H. et al: Reducing Mortality from Colorectal Cancer by Screening for Fecal Occult Blood. N Eng. J. Med. 328:1365-1371;1993.
2. Thomas W.M., Hardcastle, J.D., An Update on the Nottingham Trial of Fecal Occult Blood Screening for Colorectal Carcinoma, In: Miller A.B., Chamberlain J., Day N.E., Hakama M., Prorok P.C., eds. Cancer Screening. Cambridge, United Kingdom: Cambridge University Press. 106-115; 1991.
3. Kronborg, O., Interim Report on a Randomized Trial of Screening for Colorectal Cancer with Hemoccult® II. In: Miller A.B., Chamberlain J., Day N.E., Hakama M., Prorok P.C., eds. Cancer Screening. Cambridge, United Kingdom: Cambridge University Press. 126-130; 1991.
4. Smith A, Young GP, Cole SR, Bampton P. 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 influenced the conclusions reached by the authors.