Background: The advantage of the quantitative fecal immunochemical test (FIT) is the flexibility to set the positivity threshold. However, the diagnostic success of the FIT has not been compared for standard and low cut-off thresholds.
Aims: The purpose of this study was to compare the diagnostic success of FIT for standard and low cut-off thresholds.
Methods: In 2009 and 2010 a standard cut-off threshold (20 μg Hb/g feces) was used as positivity criterion for the FIT; in 2012 a low cut-off (10 μg Hb/g feces) was used. Diagnostic success was compared between the two groups.
Results: Of the total of 14,289 participants, 195 (1.4 %) had positive FIT results. Positivity of the FIT was significantly higher in the low cut-off group than in the standard cut-off group (1.8 vs. 1.0 %, p = 0.000). Although detection of advanced neoplasia lesions was comparable, proximal neoplasia was more frequently detected in the low cut-off group (33.3 vs. 20.9 %, p = 0.016). With the low cut-off threshold, 39 (0.7 %) participants were also classified as having positive results, and 18 (46.2 %) of these had colorectal neoplasias. The number of positive results from the FIT was increased by 54.9 %, and detection of advanced neoplasia was increased by 60 % with the low cut-off threshold compared with the standard cut-off.
Conclusions: A low cut-off threshold for the FIT resulted in better detection of proximal neoplasia in population-based screening. These results indicate the cut-off threshold for positive FIT should be properly chosen and adjusted in colorectal cancer screening.