A randomised comparison of two faecal immunochemical tests in population-based colorectal cancer screening
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. Desi...
| Main Authors: | , , , , , , , , , , , |
|---|---|
| Format: | Journal Article |
| Published: |
2016
|
| Online Access: | http://hdl.handle.net/20.500.11937/49962 |
| _version_ | 1848758360600477696 |
|---|---|
| author | 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. |
| author_facet | 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. |
| author_sort | Grobbee, E. |
| building | Curtin Institutional Repository |
| collection | Online Access |
| description | 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. |
| first_indexed | 2025-11-14T09:42:45Z |
| format | Journal Article |
| id | curtin-20.500.11937-49962 |
| institution | Curtin University Malaysia |
| institution_category | Local University |
| last_indexed | 2025-11-14T09:42:45Z |
| publishDate | 2016 |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | curtin-20.500.11937-499622017-11-16T07:34:16Z A randomised comparison of two faecal immunochemical tests in population-based colorectal cancer screening 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. 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. 2016 Journal Article http://hdl.handle.net/20.500.11937/49962 10.1136/gutjnl-2016-311819 restricted |
| spellingShingle | 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. A randomised comparison of two faecal immunochemical tests in population-based colorectal cancer screening |
| title | A randomised comparison of two faecal immunochemical tests in population-based colorectal cancer screening |
| title_full | A randomised comparison of two faecal immunochemical tests in population-based colorectal cancer screening |
| title_fullStr | A randomised comparison of two faecal immunochemical tests in population-based colorectal cancer screening |
| title_full_unstemmed | A randomised comparison of two faecal immunochemical tests in population-based colorectal cancer screening |
| title_short | A randomised comparison of two faecal immunochemical tests in population-based colorectal cancer screening |
| title_sort | randomised comparison of two faecal immunochemical tests in population-based colorectal cancer screening |
| url | http://hdl.handle.net/20.500.11937/49962 |