Performance of Tests for Schistosoma Haematobium Diagnosis

CompletedOBSERVATIONAL
Enrollment

801

Participants

Timeline

Start Date

February 10, 2025

Primary Completion Date

April 30, 2025

Study Completion Date

April 30, 2025

Conditions
Schistosoma Haematobium
Interventions
DIAGNOSTIC_TEST

S. haematobium egg detection by single urine filtration

The urine samples of children participating in the initial screening will be tested with a single urine filtration by human microscopy.

DIAGNOSTIC_TEST

S. haematobium egg detection by quintuple urine filtration

Five urine samples will be collected from children participating in the diagnostic study over five days. Each of the five urine samples collected per participant will be tested with a single urine filtration by human microscopy.

DIAGNOSTIC_TEST

S. haematobium egg detection by artificial intelligence (AI) microscopy

The urine samples collected on Day 5 of the diagnostic study will be tested with artificial intelligence (AI) microscopy.

DIAGNOSTIC_TEST

Haematuria assessment using reagent strips

The urine samples collected from children participating in the initial screening and in the diagnostic study, respectively, will be tested with reagent strips.

DIAGNOSTIC_TEST

S. haematobium antigen detection by up-converting reporter particle-lateral flow circulating anodic antigen assay (UCP-LF CAA)

The urine samples collected on Day 5 of the diagnostic study will be tested with the up-converting reporter particle-lateral flow circulating anodic antigen assay (UCP-LF CAA).

DIAGNOSTIC_TEST

S. haematobium DNA detection by recombinase polymerase amplification assay (RPA)

The urine samples collected on Day 5 of the diagnostic study will be tested with the recombinase polymerase amplification assay (RPA).

DIAGNOSTIC_TEST

S. haematobium DNA detection by qPCR

The urine samples collected on Day 5 of the diagnostic study will be tested with qPCR

Trial Locations (1)

Unknown

Public Health Laboratory - Ivo de Carneri (PHL-IdC), Chake Chake

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Public Health Laboratory Ivo de Carneri

OTHER

collaborator

Enaiblers AB

INDUSTRY

collaborator

Erasmus Medical Center

OTHER

collaborator

Leiden University Medical Center

OTHER

collaborator

Natural History Museum, United Kingdom

OTHER_GOV

lead

Stefanie Knopp

OTHER