FIT antibodies are immunoglobulins designed to bind specifically to the globin moiety of human hemoglobin . Unlike older guaiac-based fecal tests (gFOBT), FIT antibodies do not cross-react with non-human hemoglobin (e.g., from dietary sources) or partially digested blood from the upper gastrointestinal tract . This specificity minimizes false positives caused by dietary factors or medications .
Key characteristics:
Detection method: Immunoassays (e.g., immunochromatography, ELISA) quantify hemoglobin at concentrations as low as 15–20 µg Hb/g stool .
Clinical purpose: Early detection of CRC, advanced adenomas, and polyps .
FIT antibodies operate through antigen-antibody binding:
Stool samples are mixed with a buffer to extract hemoglobin.
Antibodies conjugated to enzymes or fluorescent markers bind to globin.
Signal intensity correlates with hemoglobin concentration, measured via automated analyzers (e.g., OC Sensor DIANA) .
| Feature | FIT Antibody Test | gFOBT |
|---|---|---|
| Specificity | Human globin only | Detects plant peroxidases |
| Dietary restrictions | None | Required |
| Sensitivity for CRC | 73–87% | 23–33% |
CRC detection: 92% sensitivity (92% true positive rate) in symptomatic populations .
Advanced adenomas: 22–42% sensitivity, outperforming gFOBT (6–23%) .
False negatives: 8% of CRC cases show Hb <10 µg/g due to non-bleeding tumors .
| Study Population | Positivity Rate | CRC Detection Rate | Advanced Adenoma Rate |
|---|---|---|---|
| Average-risk adults | 6.3% | 0.7% | 2.1% |
| Symptomatic patients | 8.5% | 1.2% | 3.4% |
Risk stratification: Quantitative FIT results (e.g., Hb >150 µg/g) correlate with higher likelihood of advanced neoplasia .
Therapeutic monitoring: Used post-polypectomy to assess recurrence risk .
Symptomatic assessment: Evaluates iron-deficiency anemia or bowel habit changes .
Temperature sensitivity: Hemoglobin degrades in high temperatures during mail transit, reducing test accuracy .
Variable thresholds: Cutoff values (10–20 µg Hb/g) impact sensitivity/specificity trade-offs .
Second-generation FIT: Automated platforms (e.g., Polymedco OC Sensor) achieve 97% accuracy (98% sensitivity, 96% specificity) .
Bispecific antibodies (BsAbs): Experimental FIT-Ig platforms (e.g., EMB-01) target dual biomarkers (EGFR/c-MET) to enhance tumor detection and therapy .