Quantitative immunochemical fecal occult blood test for neoplasia in colon cancer screening

To investigate the performance of the quantitative immunochemical fecal occult blood test (qFIT) and to determine the association between the fecal hemoglobin (Hb) level and the location and size of adenomas and the stages of colorectal cancer (CRC).

A total of 692 participants were included in the study. Their fecal Hb level was measured using an OC-SENSA MICRO qFIT. The colonoscopy results, including the location, size, and histological features of the adenomas, as well as the relationship between the Hb level and different characteristics were analyzed. Performance of the qFIT at various thresholds of fecal Hb levels was evaluated.

Advanced colorectal neoplasia (ACRN) was identified in 76 patients based on the colonoscopic and pathological examinations. Large adenomas (≥10 mm) had a higher fecal Hb level than small adenomas (<10 mm). Advanced adenomas located on the left side of the colon presented with a higher fecal Hb level than those on the right side (P = 0.022). Stage III-IV CRC patients had a significantly higher Hb level than stage I-II patients (P = 0.013). The sensitivity and specificity of qFIT for ACRN was 51.3% and 86.4%，respectively, with the best cut-off level of 400 ng/mL. The sensitivity and specificity for CRC was 61.0% and 89.1%, with the best cut-off level of 500 ng/mL.

qFIT has an acceptable sensitivity and specificity for ACRN detection. Furthermore, the qFIT results are associated with the location and size of adenomas as well as the grade of CRC.