Fecal Immunochemical Testing to Screen for Colorectal Neoplasia
Publication Date: December 31, 2016
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.
700
Recommendation Grading
Overview
Title
Fecal Immunochemical Testing to Screen for Colorectal Neoplasia
Authoring Organizations
American College of Gastroenterology
American Gastroenterological Association
American Society for Gastrointestinal Endoscopy
Publication Month/Year
December 31, 2016
Last Updated Month/Year
May 20, 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
Male, Female, Adult, Older adult
Health Care Settings
Ambulatory, Hospital, Outpatient
Intended Users
Laboratory technician, medical assistant, 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
Methodology
Number of Source Documents
120
Literature Search Start Date
July 31, 2013
Literature Search End Date
September 29, 2015