Distinctive Integrated Design and Clinical Utility of the Transferrin/FOB and Hb-Hp Combo Rapid Test in Gastrointestinal Bleeding Diagnosis

Gastrointestinal bleeding, a critical indicator of various disorders including colorectal cancer, upper gastrointestinal lesions and inflammatory bowel disease, requires timely and accurate detection for effective clinical management. The Transferrin/FOB and Hb-Hp Combo Rapid Test (Feces) is a chromatographic immunoassay designed for the qualitative simultaneous detection of transferrin, fecal occult blood (FOB, based on human hemoglobin) and hemoglobin-haptoglobin (Hb-Hp) complex in fecal specimens. This study aimed to systematically evaluate the clinical performance of this combo test, including its relative sensitivity, specificity, accuracy, precision and cross-reactivity, by comparing it with a commercially available reference rapid test. A total of 730 clinical specimens (240 for transferrin, 300 for FOB and 190 for Hb-Hp) were collected and tested in parallel using both the combo test and the reference test. The results showed that the combo test achieved high relative sensitivity (99.1% for transferrin, 98.3% for FOB, 97.9% for Hb-Hp), specificity (98.5% for transferrin, 99.4% for FOB, 98.6% for Hb-Hp) and accuracy (98.8% for transferrin, 99.0% for FOB, 98.4% for Hb-Hp), with narrow 95% confidence intervals indicating robust reliability. Intra-assay and inter-assay precision studies demonstrated >99% correct identification rates for all three analytes. No cross-reactivity was observed with common interfering substances. These findings confirm that the Transferrin/FOB and Hb-Hp Combo Rapid Test is a reliable, sensitive and specific tool for the detection of gastrointestinal bleeding, suitable for clinical application in screening and diagnostic evaluation of related disorders.