NCT06808750

Performance of Tests for Schistosoma Haematobium Diagnosis

Schistosoma Haematobium Diagnostic Test Performance in the Elimination Setting Pemba, Tanzania

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 801 (actual)
• Sponsor: Stefanie Knopp · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Accepted

Summary

Urogenital schistosomiasis caused by infection with the blood fluke Schistosoma haematobium is a debilitating disease. The World Health Organization (WHO) has set the goal to eliminate schistosomiasis as a public health problem globally by 2030 and to interrupt transmission in selected areas. Many years of control interventions and mass drug administration have reduced substantially the prevalence and infection intensities in several areas. In areas with an infection prevalence \<10%, the WHO suggests to continue population preventive chemotherapy with praziquantel at the same or reduced frequency, or to use a clinical approach of test-and-treat. In areas that have achieved interruption of transmission, elimination needs to be validated and post-elimination surveillance be implemented. For determination of infection prevalence thresholds, for test-and-treat, for validation of elimination and for pre- and post-elimination surveillance, reliable diagnostic tools are needed. In a single-centre study conducted in Pemba, United Republic of Tanzania, the investigators aim to assess the accuracy and performance of standard and new diagnostic tests for S. haematobium diagnosis for use in elimination settings. The primary objective of the study is to assess the sensitivity and specificity of all investigated diagnostic tests, using the S. haematobium egg count results of five urine filtrations conducted on five urine samples collected over five consecutive days as reference test. Secondary objectives are: * To assess the sensitivity and specificity of all investigated diagnostic tests, using latent class analyses. * To assess the sensitivity and specificity of all investigated diagnostic tests, in relation to S. haematobium infection intensity, calculated as mean egg count derived from the egg counts in five urine samples collected over 5 consecutive days. * To assess the sensitivity and specificity of all investigated diagnostic tests, in relation to S. haematobium infection intensity, calculated from the egg counts of the urine sample that was analysed with the respective test and urine filtration. * To assess the sensitivity and specificity of all investigated diagnostic tests, using the results of the up-converting reporter particle-lateral flow circulating anodic antigen assay (UCP-LF CAA) as reference test. * To assess the sensitivity and specificity of all investigated molecular diagnostic tests, using the results of the qPCR as reference test. * To assess the cost and time needed for the implementation of single or multiple-throughput tests. Our study will evaluate the accuracy and performance of diagnostic tests, in a formerly highly endemic setting that is now approaching elimination (Pemba), and will hence provide important information about which tests can be recommended for threshold determination, and test-and-treat and surveillance.

Conditions

• Schistosoma Haematobium

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-02-10
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2025-02-05
• Last updated: 2025-09-19

Locations

1 site across 1 country: Tanzania