Fecal Immunochemical Testing to Screen for Colorectal Neoplasia

Publication Date: January 1, 2017
Last Updated: March 14, 2022

Recommendations

With 1-time application, FIT tests are approximately 80% sensitive for cancer detection and approximately 20%–30% sensitive for advanced neoplasia detection. To enhance advanced adenoma detection, repeated applications of FIT are required. Therefore, we recommend repeated testing (see later for details) to maximize the effectiveness of cancer detection and prevention with this modality. Individuals choosing FIT should understand the need for recurring testing and for colonoscopy to evaluate a positive FIT result. Programs to track cycles of testing are encouraged to facilitate completion. (1M)
700

Given the high positive predictive value of FIT for cancer detection, colonoscopy is recommended when the test is positive, not repeat FIT. (1M)
700

When comparing FIT with gFOBT, FIT has improved sensitivity for CRC and advanced colorectal neoplasia detection at similar levels of specificity. There is RCT-level evidence that adherence is superior for single-sample FIT compared with traditional 3-card gFOBT. Given these advantages, we recommend the use of FIT over gFOBT. (1H)
700

Based on currently available evidence, including the systematic reviews discussed earlier, the Task Force suggests a 1-sample annual FIT screening approach. (2L)

Summary of key recommendations regarding FIT application
Recommendation Strength Quality of Evidence
The Task Force suggests a one-sample annual FIT screening approach. Weak Low
The Task Force suggests that quantitative FITs be selected over qualitative FITs. Weak Low
The Task Force favors a lower threshold cut-off FIT (i.e., 20 μg/g or lower) to define a positive test Weak Low
When screening FIT is positive, colonoscopy is the recommended test for subsequent evaluation. Strong Moderate
In the absence of signs or symptoms of upper gastrointestinal pathology, a positive FIT and a negative colonoscopy should not prompt upper gastrointestinal evaluation. Weak Very low
Those with a positive FIT and a recent colonoscopy (i.e. before the individual would be due for repeat endoscopic examination) should generally be offered repeat colonoscopy. Weak Low
The Task Force recommends that, patients should be explicitly instructed that they do not need to adjust diet or medications to complete a FIT Strong Moderate
The Task Force suggests that FIT screening programs rely on spontaneously passed stool specimens and not an in-office DRE sample. Weak Very Low
Programs using FIT need not adjust distribution or mailing of FIT based on ambient temperature Weak Low
Programs using FIT should establish quality assurance practices to monitor key quality metrics. The committee suggests the following targets:•FIT completion rate to those offered testing of ≥60%•Proportion returning FIT that cannot be processed by lab of <5%•Colonoscopy completion rate for those with a positive FIT ≥80%•ADR >45% in men and >35% in women on colonoscopy exams to evaluate FIT positivity Weak Very Low
700

Performance characteristics of quantitative and qualitative FITs for neoplasia appear generally similar. However, the Task Force suggests that quantitative FITs be selected over qualitative FITs. This recommendation is based on improved quality control with automated reading and the ability to adjust fecal hemoglobin cut-off concentrations to define a positive test. (2L)
700

The optimal cut-off value for FIT should be determined by its performance characteristics, cost effectiveness, FIT device, and the screening program’s available colonoscopy resources. Based on the limited evidence, the Task Force favors a lower threshold cut-off FIT (ie, ≤20 μg/g) to define a positive test. The decision to recommend use of FIT with a hemoglobin threshold including 20 μg/g (not just less than that threshold) reflects, in part, a practical consideration because that threshold currently is used by the commonly available quantitative test in the United States. (2L)
700

When FIT is positive in screen-eligible individuals, colonoscopy is the recommended test for subsequent evaluation. (1M)
700

The Task Force suggests that in the absence of iron-deficiency anemia or signs or symptoms of upper gastrointestinal pathology, a positive FIT and a negative colonoscopy should not prompt upper gastrointestinal evaluation. (2VL)
700

Given FIT’s superior performance characteristics compared with gFOBT, the Task Force suggests that those with a positive FIT and a recent colonoscopy (ie, before the individual would be due for repeat endoscopic examination) generally should be offered repeat colonoscopy. Additional considerations for offering a colonoscopy include clinical context (eg, other worrisome signs, symptoms, or laboratory values), patient factors (eg, risk factors for advanced neoplasia, patient preferences), and prior colonoscopy examination quality (eg, poor bowel preparation, endoscopist’s adenoma detection rate). (2L)
700

There is no rationale to adjust diet or anticoagulation or antiplatelet agents when using FIT-based screening. The Task Force recommends that, to simplify testing and enhance adherence, patients should be instructed explicitly that they do not need to adjust diet or medications to complete a FIT test. (1M)
700

There is limited information examining the test characteristics of FIT when applied to a stool specimen obtained by DRE. Available data suggest that test characteristics may suffer. The Task Force suggests that FIT screening programs rely on spontaneously passed stool specimens and not an in-office DRE sample. (2VL)
700

Although limited data have indicated that ambient temperature affects test positivity, current evidence is insufficient to recommend against distributing or mailing FITs when outside temperatures are above a certain level. Programs using FIT should adhere closely to test manufacturer’s specifications regarding storage and transport to minimize the effect of sample instability on FIT performance. (2L)
700

There is no strong evidence that delays in FIT kit return of up to 10 days after sample deposit affects FIT performance. Nonetheless, the Task Force suggests that participants in FIT-based programs should be informed about the importance of rapid return of the kit (ie, preferably mailing it or returning it to the laboratory within 24 hours) once the sample has been deposited. Furthermore, programs should establish quality-assurance practices to monitor return times of the FIT kits and solicit repeat samples when kits fall outside the predetermined range of acceptability based on the device used (as established by the manufacturer). (2VL)
700

Similar to colonoscopy-based programs, FIT-based screening programs require careful attendance to quality assurance in provision of the test. Studies showing improved outcomes for selected measures in this area are needed. As this information is being developed, the committee suggests the following quality metrics for FIT-based testing programs:
  • FIT completion rate to those offered testing of 60% or greater;
  • Proportion returning FIT that cannot be processed by the laboratory of less than 5%;
  • Colonoscopy completion rate for those with a positive FIT of 80% or greater;
  • Adenoma detection rate greater than 45% in men and 35% in women on colonoscopy examinations performed to evaluate a FIT-positive test that uses a hemoglobin threshold of 20 μg/g or less.
(2VL)
700

Recommendation Grading

Overview

Title

Fecal Immunochemical Testing to Screen for Colorectal Neoplasia

Authoring Organizations

Publication Month/Year

January 1, 2017

Last Updated Month/Year

January 16, 2024

Supplemental Implementation Tools

Document Type

Consensus

External Publication Status

Published

Country of Publication

US

Document Objectives

Assist health care practitioners in the use of FIT, evidence is summarized about performance characteristics and the comparative effectiveness of FIT. Assist practices or organizations developing FIT-based screening programs, evidence is summarized regarding its application, and address important clinical questions regarding FIT.

Inclusion Criteria

Female, Male, Adult, Older adult

Health Care Settings

Ambulatory, Hospital, Outpatient

Intended Users

Medical assistant, laboratory technician, nurse, nurse practitioner, physician, physician assistant

Scope

Assessment and screening, Prevention

Diseases/Conditions (MeSH)

D015179 - Colorectal Neoplasms, D003123 - Colorectal Neoplasms, Hereditary Nonpolyposis, D007120 - Immunochemistry

Keywords

fecal immunochemical test (FIT), colon capsule endoscopy, colorectal neoplasia

Source Citation

Robertson, D. J., Lee, J. K., Boland, C. R., Dominitz, J. A., Giardiello, F. M., Johnson, D. A., … Rex, D. K. (2017). Recommendations on fecal immunochemical testing to screen for colorectal neoplasia: a consensus statement by the US Multi-Society Task Force on colorectal cancer. Gastrointestinal Endoscopy, 85(1), 2–21.e3. doi:10.1016/j.gie.2016.09.025

Supplemental Methodology Resources

Data Supplement

Methodology

Number of Source Documents
120
Literature Search Start Date
August 1, 2013
Literature Search End Date
September 30, 2015