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Comparison and commutability study among four faecal immunochemical tests (FIT) systems.
Liesbet Deprez1, Carolyn Piggott2, Eline A E van der Hagen3,4
1European Commission, Joint Research Centre (JRC), Geel, Belgium.
Clinical Chemistry and Laboratory Medicine
|June 16, 2023
Summary
Faecal immunochemical tests (FIT) show significant bias between systems, hindering common screening thresholds. Researchers identified potential reference materials to develop a calibrator and reduce analytical bias in colorectal cancer screening.
Area of Science:
- Clinical Chemistry
- Gastroenterology
- Biomarker Analysis
Background:
- Faecal immunochemical tests (FIT) are crucial for colorectal cancer screening and symptomatic patient triage globally.
- Current FIT systems lack traceability to a common standard, leading to potential result non-equivalence.
- Quantifying bias between FIT systems is challenging due to complex pre-analytical factors.
Purpose of the Study:
- To quantify bias and correlation between four FIT systems.
- To assess the commutability of candidate reference materials (RMs).
- To investigate methods for improving FIT system standardization.
Main Methods:
- Measuring a panel of 38 faecal samples across four FIT systems, minimizing pre-analytical variability.
- Performing pairwise method comparisons.
- Evaluating the commutability of seven candidate reference materials.
Main Results:
- High correlations (0.944-0.970) were observed between FIT systems, but significant proportional bias (-30% to -35%) was found for one system.
- Sample-specific biases (RSD ~20%) limited conclusions from the commutability study.
- Two candidate RMs, prepared in system-specific buffers, showed better commutability.
Conclusions:
- Proportional bias prevents the use of a universal threshold across all FIT systems.
- Potential commutable RMs were identified for future studies aimed at developing a common calibrator.
- Reducing analytical bias between FIT systems is essential for reliable colorectal cancer screening.
