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    A randomised comparison of two faecal immunochemical tests in population-based colorectal cancer screening

    Access Status
    Fulltext not available
    Authors
    Grobbee, E.
    van der Vlugt, M.
    van Vuuren, A.
    Stroobants, A.
    Mundt, M.
    Spijker, W.
    Bongers, E.
    Kuipers, E.
    Lansdorp_Vogelaar, Iris
    Bossuyt, P.
    Dekker, E.
    Spaander, M.
    Date
    2016
    Type
    Journal Article
    
    Metadata
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    Citation
    Grobbee, E. and van der Vlugt, M. and van Vuuren, A. and Stroobants, A. and Mundt, M. and Spijker, W. and Bongers, E. et al. 2016. A randomised comparison of two faecal immunochemical tests in population-based colorectal cancer screening. Gut. 66: pp. 1975-1982.
    Source Title
    Gut
    DOI
    10.1136/gutjnl-2016-311819
    ISSN
    0017-5749
    URI
    http://hdl.handle.net/20.500.11937/49962
    Collection
    • Curtin Research Publications
    Abstract

    Objective: Colorectal cancer screening programmes are implemented worldwide; many are based on faecal immunochemical testing (FIT). The aim of this study was to evaluate two frequently used FITs on participation, usability, positivity rate and diagnostic yield in population-based FIT screening. Design: Comparison of two FITs was performed in a fourth round population-based FIT-screening cohort. Randomly selected individuals aged 50-74 were invited for FIT screening and were randomly allocated to receive an OC -Sensor (Eiken, Japan) or faecal occult blood (FOB)-Gold (Sentinel, Italy) test (March-December 2014). A cut-off of 10 µg haemoglobin (Hb)/g faeces (ie, 50 ng Hb/mL buffer for OC-Sensor and 59 ng Hb for FOB-Gold) was used for both FITs. Results: In total, 19 291 eligible invitees were included (median age 61, IQR 57-67; 48% males): 9669 invitees received OC-Sensor and 9622 FOB-Gold; both tests were returned by 63% of invitees ( p=0.96). Tests were nonanalysable in 0.7% of participants using OC-Sensor vs 2.0% using FOB-Gold (p<0.001). Positivity rate was 7.9% for OC-Sensor, and 6.5% for FOB-Gold (p=0.002). There was no significant difference in diagnostic yield of advanced neoplasia (1.4% for OC-Sensor vs 1.2% for FOB-Gold; p=0.15) or positive predictive value (PPV; 31% vs 32%; p=0.80). When comparing both tests at the same positivity rate instead of cut-off, they yielded similar PPV and detection rates. Conclusions: The OC-Sensor and FOB-Gold were equally acceptable to a screening population. However, FOB-Gold was prone to more non-analysable tests. Comparison between FIT brands is usually done at the same Hb stool concentration. Our findings imply that for a fair comparison on diagnostic yield between FIT's positivity rate rather than Hb concentration should be used. Trial registration number: NTR5385; Results.

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