A randomised comparison of two faecal immunochemical tests in population-based colorectal cancer screening. Issue 11 (9th August 2016)

• Record Type: Journal Article
• Authors: Grobbee, E J; van der Vlugt, M; van Vuuren, A J; Stroobants, A K; Mundt, M W; Spijker, W J; Bongers, E J C; Kuipers, E J; Lansdorp-Vogelaar, I; Bossuyt, P M; Dekker, E; Spaander, M C W
• Is Part Of: Gut. Volume 66:Issue 11(2017)
• Page Start: 1975
• Page End: 1982
• Publication Date: 2016-08-09
• Subjects: COLORECTAL CANCER SCREENING -- COLORECTAL CARCINOMA; Gastroenterology -- Periodicals; 616.33
• DOI: 10.1136/gutjnl-2016-311819
• Languages: English
• ISSNs: 0017-5749

Abstract

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 non-analysable 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.