Nanobody-based Schistosomiasis Urine Test Kit Research

This study aims to develop and evaluate a nanobody-based urine diagnostic test for Schistosoma haematobium infection through IPSE antigen detection. Approximately 2500 participants will be recruited and divided into five groups: confirmed S. haematobium infection, S. mansoni infection, urinary tract infection, nephritis or other renal diseases, and healthy controls (about 500 individuals per group). Each participant will provide a single morning midstream urine sample (30-50 mL), which will be used both for the development and optimization of the nanobody-based colloidal gold lateral flow assay (LFIA) and for evaluation of its diagnostic performance compared with urine-filtration microscopy.

NCT Number	NCT07500740
Lead Sponsor	Pemba Ministry of Health Zanzibar Collaborators: Jiangsu Institute of Parasitic Diseases
Conditions	Schistosomiasis Haematobia
Enrollment	2,500 participants
Start Date	2026-04-01
Primary Completion	2026-10-01 (estimated)
Study Completion	2026-12-01 (estimated)
Updated on ClinicalTrials.gov	2026-03-30