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| Name | Class |
|---|---|
| Jiangsu Institute of Parasitic Diseases | OTHER |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Because this is an observational study, participants are not assigned an intervention as part of the study. | Other | Because this is an observational study, participants are not assigned an intervention as part of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance of the LFIA strip, including sensitivity, specificity, positive predictive value, negative predictive value, limit of detection, repeatability, and cross-reactivity, using urine filtration microscopy as the reference method. | The diagnostic performance of the LFIA strip, including sensitivity, specificity, positive predictive value, negative predictive value, limit of detection, repeatability, and cross-reactivity, will be evaluated using urine filtration microscopy as the reference standard. Each participant will provide one urine sample at enrollment, and LFIA testing will be performed immediately after sample collection. Diagnostic performance will be assessed based on results obtained at this single time point. | At baseline (Day 1), at the time of participant enrollment and urine sample collection, with LFIA testing performed immediately. Diagnostic performance will be assessed based on results obtained at this single time point. The study will commence in April |
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Inclusion Criteria:
1) Index assay: nanobody-based lateral flow chromatography; 2) Reference assay: urine filtration microscopy; 3) Stool Kato-Katz examination if clinically indicated. 3. Complete basic demographic and clinical data (including age, sex, presenting symptoms, medical history, etc.) are available, and the participant has consented to the use of these data for study analysis.
4. Participants must fulfill one of the following group definitions:
Exclusion Criteria:
1) Unable to provide first morning midstream urine; 2) Urine volume < 30 mL; 3) Specimen is obviously contaminated, improperly preserved, or lacks complete labeling; 4) Index assay or reference assay cannot be completed, or results are uninterpretable.
3. Clinical or laboratory data are insufficient to allow for group assignment or subsequent study analysis.
4. Presence of any condition that may significantly interfere with the interpretation of study results (as assessed by the investigator or clinician), including:
5. In the investigator's judgment, the participant is otherwise unsuitable for enrollment or unable to comply with study procedures.
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A total of 2500 urine samples will be collected. These samples will be divided into five groups, each consisting of 500 individuals: Healthy control group; Schistosoma haematobium infection group; Schistosoma mansoni infection group; Nephritis patient group; Urinary tract infection patient group.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neglected tropical diseases in Pemba | Pemba | CharkChark | P.O.BOX 98 | Tanzania |
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| ID | Term |
|---|---|
| D012553 | Schistosomiasis haematobia |
| ID | Term |
|---|---|
| D012552 | Schistosomiasis |
| D014201 | Trematode Infections |
| D006373 | Helminthiasis |
| D010272 | Parasitic Diseases |
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| 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 |