Abstract
Background
One of the issues of fecal immunochemical test (FIT) is false-negativity caused by hemoglobin degradation by bacteria. We investigated the usefulness of the transferrin assay, which is stable toward bacteria.
Methods
The study included 1174 patients who visited our hospital and underwent colonoscopy for some symptoms or for cancer screening. We compared the hemoglobin-transferrin combination assay with the hemoglobin-alone assay using the Discrete Clinical Chemistry Analyzer NS-Plus and 1174 clinical samples. In the combination assay, two hemoglobin cutoff values (a) and (b) and one transferrin cutoff value (c) were set. Cases with values of (a) or more were defined as primary positive and values lower than (b) were defined as negative. Cases with values between (a) and (b) underwent the transferrin assay. Then, cases with values of (c) or higher were defined as secondary positive. All primary and secondary positive cases were defined as positive. Among the combination of cutoff values (a), (b) and (c), we identified Method A exhibiting high specificity and a positive predictive value (PPV), and Method B exhibiting the highest sensitivity.
Results
In Method A, the sensitivity of colorectal cancer detection increased from 67.3% to 68.2%, the specificity significantly (p = 0.0011) increased from 90.5% to 92.6%, and the PPV increased from 42.9% to 49.6% compared with the hemoglobin-alone assay. In Method B, the sensitivity increased significantly (p = 0.046) from 67.3% to 71.1% and the PPV increased from 42.9% to 44.8%.
Conclusions
This combination assay showed higher accuracy and effectiveness for colorectal cancer screening.
Acknowledgments
The author thanks Ms. Hiroko Betsuyaku, Alfresa Pharma Corporation, for her support in this report.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
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