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Review
. 2025 May;70(5):1637-1645.
doi: 10.1007/s10620-024-08664-7. Epub 2024 Nov 11.

Fecal Immunochemical Test Positivity Thresholds: An International Survey of Population-Based Screening Programs

Graeme P Young  1   2 , Sally C Benton  3 , Robert S Bresalier  4 , Han-Mo Chiu  5 , Evelien Dekker  6 , Callum G Fraser  7 , Marieke A M Frasa  8 , Stephen P Halloran  9 , Michael Hoffmeister  10 , Susan Parry  11 , Kevin Selby  12 , Carlo Senore  13 , Harminder Singh  14 , Erin L Symonds  15   16
Affiliations
Review

Fecal Immunochemical Test Positivity Thresholds: An International Survey of Population-Based Screening Programs

Graeme P Young et al. Dig Dis Sci. 2025 May.

Erratum in

Abstract

Background: The fecal immunochemical test for hemoglobin (FIT) is now a widely used non-invasive test in population-based organized screening programs for colorectal neoplasia. The positivity thresholds of tests currently in use are based on the fecal hemoglobin concentration (f-Hb), but the rationale for the adopted thresholds are not well documented. To understand current global usage of FIT in screening programs we conducted an international survey of the brands of FIT used, the f-Hb positivity threshold applied and the rationale for the choice.

Methods: All members of the World Endoscopy Organization CRC Screening Committee were invited to complete an eight-element initial electronic survey exploring the key aims. Responses were obtained from 63 individuals, representing 38 specific locations in 28 countries. A follow-up survey on technical issues was offered to the 38 locations, with replies from 17 sites in 13 countries.

Results: In-use quantitative FIT were provided by four main manufacturers; Minaris Medical (2 countries), Eiken Chemical Company/Polymedco (21), Alfresa Pharma (2) and Sentinel Diagnostics (4). Of the 38 screening sites, 15 used the threshold of 20 µg hemoglobin/g feces, while thresholds ranged between 8.5 and 120 ug/g in the remainder. Seven explanations were given for adopted FIT thresholds; maximizing the sensitivity for colorectal neoplasia (n = 23) was the most common followed by the availability of colonoscopy resources (n = 18). Predictive value, specificity, and cost effectiveness were less frequently reported as the rationale. Nine sites found it necessary to change the threshold that they had initially selected.

Conclusions: This international survey has documented the wide range of FIT positivity thresholds that are in current use. Quantitative FITs enable programs to achieve the desired program outcomes within available resource constraints by adjusting the positivity threshold. This supports the need for enabling positivity threshold adjustment of emerging new screening tests based on novel predictive biomarkers, rather than providing inflexible test endpoints.

Keywords: Colorectal cancer; Non-invasive screening tests; Population screening; Positivity threshold; Quantitative fecal immunochemical test; Screening program outcomes.

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Conflict of interest statement

Declarations. Conflict of interest: Graeme P Young: Consultancy—Health First Systems, Institutional research support–Eiken Chemical Company. Han-Mo Chiu: Speaker honorarium—Olympus, Fujifilm, Boston Scientific, Research funding—Boston Scientific, Volition Rx, aether AI. Evelien Dekker: Institutional research support—FujiFilm. Consultancy—Olympus, Fujifilm, Ambu, InterVenn, Norgine, and Exact Sciences. Speaker’s fees—Olympus, GI Supply, Norgine, IPSEN/Mayoly, and FujiFilm. Harminder Singh: COI: Consultancy/advisory boards—Abbvie Canada, Amgen Canada, Roche Canada, Sandoz Canada, Organon Canada, Eli Lilly Canada, Takeda Canada, Pendopharm Inc, and Guardant Health, Inc. Institutional research support—Pfizer. Shares—VasCon. Erin L Symonds: Institutional research support—Eiken Chemical Company and Health First Systems. The authors declare no competing interests, and no financial arrangements related to the research or assistance with manuscript preparation.

Figures

Fig. 1
Fig. 1
The frequency of thresholds in use across the screening sites
Fig. 2
Fig. 2
Reasons that were considered when setting the threshold. Multiple responses were allowed
Fig. 3
Fig. 3
The main reasons for selecting the positivity threshold in responders to the follow-up survey
See this image and copyright information in PMC

References

    1. Young GP, Symonds EL, Allison JE et al. Advances in Fecal Occult Blood Tests: the FIT revolution. Dig Dis Sci. 2015;60:609–622. 10.1007/s10620-014-3445-3 - PMC - PubMed
    1. International Agency for Research on Cancer. Colorectal cancer screening IARC Handb Cancer Prev. 2019;17:1–300. - PubMed
    1. Young GP, Rabeneck L, Winawer SJ. The Global Paradigm Shift in Screening for Colorectal Cancer Gastroenterology. 2019;156:e842. - PubMed
    1. Lin JS, Perdue LA, Henrikson NB, Bean SI, Blasi PR. Screening for Colorectal Cancer: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force JAMA : the journal of the American Medical Association. 2021;325:1978–1998. - PubMed
    1. Young GP, Woodman RJ, Ang FLI, Symonds EL. Both Sample Number and Test Positivity Threshold Determine Colonoscopy Efficiency in Detection of Colorectal Cancer With Quantitative Fecal Immunochemical Tests Gastroenterology. 2020;159:e1563. - PubMed

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