Author(s)

Zhang Lei ¹, Yang Feng ², Zhu Junzhe ³

Affiliation(s)

¹ Zhejiang Gongshang University, Hangzhou, Zhejiang, 310018, China
² Community Health Service Center, Hangzhou, Zhejiang, 310000, China
³ Wenzhou Medical University, Wenzhou, Zhejiang, 310000, China

Corresponding Author

Zhang Lei

ABSTRACT

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.

KEYWORDS

Transferrin; Fecal Occult Blood (FOB); Hemoglobin-Haptoglobin (Hb-Hp) Complex; Gastrointestinal Bleeding; Rapid Immunoassay; Colorectal Cancer Screening

CITE THIS PAPER

Zhang Lei, Yang Feng, Zhu Junzhe, Distinctive Integrated Design and Clinical Utility of the Transferrin/FOB and Hb-Hp Combo Rapid Test in Gastrointestinal Bleeding Diagnosis. MEDS Clinical Medicine (2025) Vol. 6: 1-6. DOI: http://dx.doi.org/10.23977/medsc.2025.060501.

REFERENCES

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[4] Walker CW. Fecal occult blood tests reduce colorectal cancer mortality. Am Fam Physician. 2007; 75(11): 1652-1653.
[5] Chiang CH, Lin JT, Lin HC, et al. A comparative study of three fecal occult blood tests in upper gastrointestinal bleeding. Kaohsiung J Med Sci. 2006;22(5):223-228.
[6] Greenberg RA, Baron JA, Tosteson AN, et al. Colorectal cancer mortality reduction with fecal occult blood testing: update on the Minnesota Colon Cancer Control Study. Gastroenterology. 1996;110(6):1728-1735.
[7] Fleischer DE, Goldberg SB, Browning TH, et al. Detection and surveillance of colorectal cancer. JAMA. 1989; 261(4): 580-585.

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