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Nanobody-based Schistosomiasis Urine Test Kit Research

NCT07500740 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2500

Last updated 2026-03-30

No results posted yet for this study

Summary

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.

Conditions

  • Schistosomiasis Haematobia

Interventions

OTHER

Because this is an observational study, participants are not assigned an intervention as part of the study.

Because this is an observational study, participants are not assigned an intervention as part of the study.

Sponsors & Collaborators

  • Jiangsu Institute of Parasitic Diseases

    collaborator OTHER

  • Pemba Ministry of Health Zanzibar

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2026-10-01
Completion
2026-12-01

Countries

  • Tanzania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07500740 on ClinicalTrials.gov