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Showing content from https://pubmed.ncbi.nlm.nih.gov/27507905/ below:

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

Randomized Controlled Trial

Affiliations

• ¹ Department of Gastroenterology and Hepatology, Erasmus University Medical Centre, Rotterdam, The Netherlands.
• ² Department of Gastroenterology and Hepatology, Academic Medical Centre Amsterdam, Amsterdam, The Netherlands.
• ³ Department of Clinical Chemistry, Academic Medical Centre Amsterdam, Amsterdam, The Netherlands.
• ⁴ Department of Gastroenterology and Hepatology, Flevoziekenhuis Almere, Almere The Netherlands.
• ⁵ Regional organization for Population Screening South-West Netherlands, Rotterdam, The Netherlands.
• ⁶ Foundation of Population Screening Mid-West, Amsterdam, The Netherlands.
• ⁷ Department of Public Health, Erasmus University Medical Centre, Rotterdam, The Netherlands.
• ⁸ Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.

• PMID: 27507905
• DOI: 10.1136/gutjnl-2016-311819

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Randomized Controlled Trial

E J Grobbee et al. Gut. 2017 Nov.

• ¹ Department of Gastroenterology and Hepatology, Erasmus University Medical Centre, Rotterdam, The Netherlands.
• ² Department of Gastroenterology and Hepatology, Academic Medical Centre Amsterdam, Amsterdam, The Netherlands.
• ³ Department of Clinical Chemistry, Academic Medical Centre Amsterdam, Amsterdam, The Netherlands.
• ⁴ Department of Gastroenterology and Hepatology, Flevoziekenhuis Almere, Almere The Netherlands.
• ⁵ Regional organization for Population Screening South-West Netherlands, Rotterdam, The Netherlands.
• ⁶ Foundation of Population Screening Mid-West, Amsterdam, The Netherlands.
• ⁷ Department of Public Health, Erasmus University Medical Centre, Rotterdam, The Netherlands.
• ⁸ Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.

• PMID: 27507905
• DOI: 10.1136/gutjnl-2016-311819

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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.

Keywords: COLORECTAL CANCER SCREENING; COLORECTAL CARCINOMA.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

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• Multiple rounds of one sample versus two sample faecal immunochemical test-based colorectal cancer screening: a population-based study.

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• Performance of two faecal immunochemical tests for the detection of advanced neoplasia at different positivity thresholds: a cross-sectional study of the Dutch national colorectal cancer screening programme.

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