Fecal immunochemical tests (FITs) have been developed to address analytical problems inherent in the older guaiac-based fecal occult blood tests (g-FOBTs). Our aim was to compare the performance characteristics of one g-FOBT (Hemoccult II) and two FITs (the Hemoccult ICT and MagStream HemSp) relative to colonoscopy for the detection of colorectal cancer and significant precursor lesions. We also examined whether a 1-day collection strategy would negatively impact test diagnostic performance.
We used a prospective observational cohort design in a Canadian population eligible for screening. All participants received colonoscopy after performing the occult blood tests.
One thousand seventy-five individuals were enrolled (mean age 56.3 years, 53.8 % females). Using colonoscopy as the gold standard, the sensitivity for screen-relevant neoplasm was determined for Hemoccult II (7.2, 95 % CI: 1.1–13.4), Hemoccult ICT (23.2 %: 13.2–33.1), and MagStream HemSp using 67 μg/gram stool as the cut-off (23.2 %: 13.2–33.1). The Magstream HemSp, using a cut-off threshold of 30 μg/gram stool, had the lowest specificity at 87.6 % (85.4–89.6), while the Hemoccult II had the highest at 98.8 % (98.1–99.5). Single-day stool testing reduced the false-positive rates of all tests without significantly reducing the sensitivity.
We found that FITs have a significantly increased sensitivity but reduced specificity for screen-relevant neoplasm compared to g-FOBT using colonoscopy as the gold standard. Optimal threshold levels for hemoglobin detection depend on the desired trade off between sensitivity and false-positive rate. Single-day testing with an FIT may be an option to enhance population compliance with screening.
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Fecal occult blood tests
Fecal immunochemical tests
Guaiac-based occult blood tests
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The study was funded by the Capital Health Authority, Edmonton, Alberta, Canada. Beckman Coulter Inc, USA provided Hemoccult ICT collection cards and test devices. Fujirebio Inc, Japan provided the Magstream HT. Reagents and support were provided by Fujirebio Diagnostics Inc, USA. Grammatical revisions and manuscript formatting was performed by Joanne Simala-Grant and Kathleen Ismond (funding from Dr DC Sadowski, Academic Trust Account).
Conflict of interest
No conflicts relevant to the manuscript for all authors.
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Wong, C.K.W., Fedorak, R.N., Prosser, C.I. et al. The sensitivity and specificity of guaiac and immunochemical fecal occult blood tests for the detection of advanced colonic adenomas and cancer. Int J Colorectal Dis 27, 1657–1664 (2012). https://doi.org/10.1007/s00384-012-1518-3
- Fecal occult blood tests
- Colon cancer screening
- Tumor markers
- Disease prevention