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| ID | Type | Description | Link |
|---|---|---|---|
| PR00P3_179753 | Other Grant/Funding Number | Swiss National Science Foundation |
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| Name | Class |
|---|---|
| Public Health Laboratory Ivo de Carneri | OTHER |
| Enaiblers AB | INDUSTRY |
| Erasmus Medical Center | OTHER |
| Leiden University Medical Center |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants of initial screening | Schoolchildren that attend classes in grades 3-6 in each of the two study schools will be invited to submit one urine sample that will be tested with a single urine filtration (Day 1). |
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| Participants of diagnostic study | All schoolchildren that are tested S. haematobium-positive children in the initial screening plus a sex-adjusted random selection of initially negative-screened children will be included in the diagnostic study. These children will be invited to submit five urine samples in total, over five days (Day 1-5). All samples (Day 1-5) will be tested with a single urine filtration. Samples collected on Day 5 will be tested with all investigated diagnostic tests. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S. haematobium egg detection by single urine filtration | Diagnostic Test | The urine samples of children participating in the initial screening will be tested with a single urine filtration by human microscopy. |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of tests for S. haematobium diagnosis when compared with a single urine filtration | The primary endpoint will be the sensitivity of the investigated diagnostic tests to detect S. haematobium related markers by the examination of a single sample. The primary outcome variable will be the number of S. haematobium infected individuals detected through each test. | From enrollment to the end of the study after 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of each diagnostic test (human microscopy, AI microscopy, reagent strips, RPA, UCP-CAA, qPCR). | Sensitivity is defined as the proportion of positive test results out of all truly positive samples. Reference tests are human microscopy, UCP-CAA, qPCR or a combination thereof, performed with the same urine sample (human microscopy, UCP-CAA, qPCR) or quintuple urine samples (human microscopy). |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity of each diagnostic test (human microscopy, AI microscopy, reagent strips, RPA, UCP-CAA, qPCR). | Specificity is defined as the proportion of negative test results out of all truly negative samples. Reference tests are human microscopy, UCP-CAA, qPCR or a combination thereof, performed with the same urine sample (human microscopy, UCP-CAA, qPCR) or quintuple urine samples (human microscopy). | From enrollment to the end of the study after 6 weeks. |
Inclusion Criteria:
Subjects fulfilling all of the following inclusion criteria are eligible for the initial screening:
Subjects fulfilling all of the following inclusion criteria are eligible for the diagnostic study:
Exclusion Criteria:
The presence of any one of the following exclusion criteria will lead to the exclusion of the subject in the initial screening:
The presence of any one of the following exclusion criteria will lead to the exclusion of the subject in the diagnostic study:
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Children from Pemba Island, United Republic of Tanzania, that attend one among the two pre-selected study primary schools in grade 3, 4, 5 or 6.
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| Name | Affiliation | Role |
|---|---|---|
| Stefanie Knopp, PhD | Swiss Tropical & Public Health Institute | Principal Investigator |
| Said M Ali, MSc | Public Health Laboratory Ivo de Carneri | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Public Health Laboratory - Ivo de Carneri (PHL-IdC) | Chake Chake | Pemba Island | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42259467 | Derived | Ndum NC, Ali SM, Ali MN, Hattendorf J, Suleiman KR, Utzinger J, Knopp S. Day-to-day variation of Schistosoma haematobium infection and intensity estimates in the near-elimination setting Pemba, Tanzania. Acta Trop. 2026 Jun 7;280:108177. doi: 10.1016/j.actatropica.2026.108177. Online ahead of print. |
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| OTHER |
| Natural History Museum, United Kingdom | OTHER_GOV |
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The microscope slides containing the urine filters will be stored for quality control for approximately 6-12 months and disposed after quality control at PHL-IdC.
The left overs of any collected urine sample from participants of the diagnostic accuracy study on Day 1-5 will be stored in 50 ml plastic tubes labelled with the participant ID code in a freezer at PHL-IdC at -20°C for further use for research purposes.
The DNA extracted from fresh and frozen urine samples for RPA, PeakPCR and qPCR will be labelled with the participant ID code, stored at +4°C and shipped to LUMC for examination with qPCR.
| S. haematobium egg detection by quintuple urine filtration | Diagnostic Test | 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. |
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| S. haematobium egg detection by artificial intelligence (AI) microscopy | Diagnostic Test | The urine samples collected on Day 5 of the diagnostic study will be tested with artificial intelligence (AI) microscopy. |
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| Haematuria assessment using reagent strips | Diagnostic Test | The urine samples collected from children participating in the initial screening and in the diagnostic study, respectively, will be tested with reagent strips. |
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| S. haematobium antigen detection by up-converting reporter particle-lateral flow circulating anodic antigen assay (UCP-LF CAA) | Diagnostic Test | 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). |
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| S. haematobium DNA detection by recombinase polymerase amplification assay (RPA) | Diagnostic Test | The urine samples collected on Day 5 of the diagnostic study will be tested with the recombinase polymerase amplification assay (RPA). |
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| S. haematobium DNA detection by qPCR | Diagnostic Test | The urine samples collected on Day 5 of the diagnostic study will be tested with qPCR |
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| From enrollment to the end of the study after 6 weeks |
| Correlation of infection markers. | Correlation of the amount of infection markers measured by each test (human microscopy: number of S. haematobium eggs, AI microscopy: number of S. haematobium eggs, reagent strips: microhaematuria grading, RPA: fluorescence level, UCP-CAA: amount of CAA antigen, qPCR: cycle-threshold values). | From enrollment to the end of the study after 6 weeks. |
| Costs of each diagnostic test (human microscopy, AI microscopy, reagent strips, RPA, UCP-CAA, qPCR). | Costs are defined as the financial costs incurred by each test for equipment, consumables, and staff time to perform the test. | 6 month, from start of orders of equipment and material to end of laboratory work. |
| Time to conduct each diagnostic test (human microscopy, AI microscopy, reagent strips, RPA, UCP-CAA, qPCR). | Amount of time spent completing each test. | From enrollment to the end of the study after 6 weeks. |
| ID | Term |
|---|---|
| D012553 | Schistosomiasis haematobia |
| D012552 | Schistosomiasis |
| D004194 | Disease |
| ID | Term |
|---|---|
| D014201 | Trematode Infections |
| D006373 | Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D014552 | Urinary Tract Infections |
| D000079426 | Vector Borne Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008853 | Microscopy |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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