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@ARTICLE{Young:294592,
author = {G. P. Young and S. C. Benton and R. S. Bresalier and H.-M.
Chiu and E. Dekker and C. G. Fraser and M. A. M. Frasa and
S. P. Halloran and M. Hoffmeister$^*$ and S. Parry and K.
Selby and C. Senore and H. Singh and E. L. Symonds},
title = {{F}ecal {I}mmunochemical {T}est {P}ositivity {T}hresholds:
{A}n {I}nternational {S}urvey of {P}opulation-{B}ased
{S}creening {P}rograms.},
journal = {Digestive diseases and sciences},
volume = {70},
issn = {0002-9211},
address = {Dordrecht},
publisher = {Springer Science + Business Media B.V.},
reportid = {DKFZ-2024-02362},
pages = {1637–1645},
year = {2025},
note = {Volume 70, pages 1637–1645, (2025)},
abstract = {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.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.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.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.},
subtyp = {Review Article},
keywords = {Colorectal cancer (Other) / Non-invasive screening tests
(Other) / Population screening (Other) / Positivity
threshold (Other) / Quantitative fecal immunochemical test
(Other) / Screening program outcomes (Other)},
cin = {C070},
ddc = {610},
cid = {I:(DE-He78)C070-20160331},
pnm = {313 - Krebsrisikofaktoren und Prävention (POF4-313)},
pid = {G:(DE-HGF)POF4-313},
typ = {PUB:(DE-HGF)16},
pubmed = {pmid:39528850},
doi = {10.1007/s10620-024-08664-7},
url = {https://inrepo02.dkfz.de/record/294592},
}