Immunochemical faecal occult blood testing (FIT) provides quantitative test results, which allows optimisation of the cut-off value for follow-up colonoscopy. We conducted a randomised population-based trial to determine test characteristics of FIT (OC-Sensor micro, Eiken, Japan) screening at different cut-off levels and compare these with guaiac-based faecal occult blood test (gFOBT) screening in an average risk population. A representative sample of the Dutch population (n10 011), aged 50-74 years, was 1: 1 randomised before invitation to gFOBT and FIT screening. Colonoscopy was offered to screenees with a positive gFOBT or FIT (cut-off 50 ng haemoglobin/ml). When varying the cut-off level between 50 and 200 ng ml 1, the positivity rate of FIT ranged between 8.1% (95% CI: 7.2-9.1%) and 3.5% (95% CI: 2.9-4.2%), the detection rate of advanced neoplasia ranged between 3.2% (95% CI: 2.6-3.9%) and 2.1% (95% CI: 1.6-2.6%), and the specificity ranged between 95.5% (95% CI: 94.5-96.3%) and 98.8% (95% CI: 98.4-99.0%). At a cut-off value of 75 ng ml 1, the detection rate was two times higher than with gFOBT screening (gFOBT: 1.2%; FIT: 2.5%; P0.001), whereas the number needed to scope (NNscope) to find one screenee with advanced neoplasia was similar (2.2 vs 1.9; P0.69). Immunochemical faecal occult blood testing is considerably more effective than gFOBT screening within the range of tested cut-off values. From our experience, a cut-off value of 75 ng ml 1 provided an adequate positivity rate and an acceptable trade-off between detection rate and NNscope.

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Keywords Colorectal cancer screening, Cut-off, Guaiac-based faecal occult blood test, Immunochemical faecal occult blood test, Population based, Randomised trial, adult, advanced cancer, aged, article, cancer diagnosis, cancer risk, cancer screening, clinical trial, colonoscopy, colorectal cancer, controlled clinical trial, controlled study, female, guaiac, high risk population, human, immunohistochemistry, major clinical study, male, occult blood test, population based case control study, priority journal, randomized controlled trial
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Journal British Journal of Cancer
Hol, L, Wilschut, J.A, van Ballegooijen, M, van Vuuren, A.J, van der Valk, H, Reijerink, J.C.I.Y, … van Leerdam, M.E. (2009). Screening for colorectal cancer: Random comparison of guaiac and immunochemical faecal occult blood testing at different cut-off levels. British Journal of Cancer, 100(7), 1103–1110. doi:10.1038/sj.bjc.6604961