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A randomised comparison of two faecal immunochemical tests in population-based colorectal cancer screening
  1. E J Grobbee1,
  2. M van der Vlugt2,
  3. A J van Vuuren1,
  4. A K Stroobants3,
  5. M W Mundt4,
  6. W J Spijker5,
  7. E J C Bongers6,
  8. E J Kuipers1,
  9. I Lansdorp-Vogelaar7,
  10. P M Bossuyt8,
  11. E Dekker2,
  12. M C W Spaander1
  1. 1Department of Gastroenterology and Hepatology, Erasmus University Medical Centre, Rotterdam, The Netherlands
  2. 2Department of Gastroenterology and Hepatology, Academic Medical Centre Amsterdam, Amsterdam, The Netherlands
  3. 3Department of Clinical Chemistry, Academic Medical Centre Amsterdam, Amsterdam, The Netherlands
  4. 4Department of Gastroenterology and Hepatology, Flevoziekenhuis Almere, Almere The Netherlands
  5. 5Regional organization for Population Screening South-West Netherlands, Rotterdam, The Netherlands
  6. 6Foundation of Population Screening Mid-West, Amsterdam, The Netherlands
  7. 7Department of Public Health, Erasmus University Medical Centre, Rotterdam, The Netherlands
  8. 8Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
  1. Correspondence to Dr Manon C W Spaander, Department of Gastroenterology and Hepatology (room Hs-312), Erasmus University Medical Centre, ‘s Gravendijkwal 230, Rotterdam 3015 CE, The Netherlands; v.spaander{at}erasmusmc.nl

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.

  • COLORECTAL CANCER SCREENING
  • COLORECTAL CARCINOMA
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