title: A randomised comparison of two faecal immunochemical tests in population-based colorectal cancer screening.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  NTR5385; Results.
authors: Department of Gastroenterology and Hepatology, Erasmus University Medical Centre, Rotterdam, The Netherlands.
authors: E J
authors: EJ
authors: Grobbee
authors: Department of Gastroenterology and Hepatology, Academic Medical Centre Amsterdam, Amsterdam, The Netherlands.
authors: M
authors: M
authors: van der Vlugt
authors: Department of Gastroenterology and Hepatology, Erasmus University Medical Centre, Rotterdam, The Netherlands.
authors: A J
authors: AJ
authors: van Vuuren
authors: Department of Clinical Chemistry, Academic Medical Centre Amsterdam, Amsterdam, The Netherlands.
authors: A K
authors: AK
authors: Stroobants
authors: Department of Gastroenterology and Hepatology, Flevoziekenhuis Almere, Almere The Netherlands.
authors: M W
authors: MW
authors: Mundt
authors: Regional organization for Population Screening South-West Netherlands, Rotterdam, The Netherlands.
authors: W J
authors: WJ
authors: Spijker
authors: Foundation of Population Screening Mid-West, Amsterdam, The Netherlands.
authors: E J C
authors: EJC
authors: Bongers
authors: Department of Gastroenterology and Hepatology, Erasmus University Medical Centre, Rotterdam, The Netherlands.
authors: E J
authors: EJ
authors: Kuipers
authors: Department of Public Health, Erasmus University Medical Centre, Rotterdam, The Netherlands.
authors: I
authors: I
authors: Lansdorp-Vogelaar
authors: Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors: P M
authors: PM
authors: Bossuyt
authors: Department of Gastroenterology and Hepatology, Academic Medical Centre Amsterdam, Amsterdam, The Netherlands.
authors: E
authors: E
authors: Dekker
authors: Department of Gastroenterology and Hepatology, Erasmus University Medical Centre, Rotterdam, The Netherlands.
authors: M C W
authors: MCW
authors: Spaander
mesh_terms: D000368:Aged; D023881:Colonography, Computed Tomographic; D003113:Colonoscopy; D015179:Colorectal Neoplasms / Q000175:diagnosis*; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007158:Immunologic Techniques / Q000379:methods; D008297:Male; D008875:Middle Aged; D009780:Occult Blood; D010342:Patient Acceptance of Health Care / Q000706:statistics & numerical data; D010865:Pilot Projects; D011237:Predictive Value of Tests
keywords: COLORECTAL CANCER SCREENING; COLORECTAL CARCINOMA