Análisis de la precisión de Ensayos de Laboratorio Para diagnóstico de Strongyloidiasis Humana en Escolares de Escuelas de áreas endémicas en Parroquias Del cantón San Lorenzo, Provincia de Esmeraldas, Ecuador
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 781
- 试验地点
- 1
- 主要终点
- Diagnostic test accuracy - primary reference standard
研究概览
简要总结
the World Health Organization (WHO) has recently committed to promote the control of strongyloidiasis within 2030 targets for STH control programmes. A specific target is to establish by 2030 an efficient strongyloidiasis control programme in school aged children (SAC), envisaging ivermectin preventive chemotherapy (PC) of SAC at risk of morbidity due to strongyloidiasis. The monitoring of such ambitious PC activity strictly requires appropriate diagnostic tools, but fundamental gaps exist in this field. Indeed, until now at the moment no consensus method for the diagnosis of S. stercoralis infection is recommended and the absence of a gold standard test limits capacity for effective diagnosis, surveillance and disease control. The aim of this project is to provide fundamental information on the performance and applicability of diagnostic methods for the assessment of S. stercoralis infection to inform the forthcoming WHO global strongyloidiasis control program to be implemented as a part of the WHO 2030 disease control targets. ESTRELLA is a cross-sectional study in an area of high prevalence of strongyloidiasis (San Lorenzo, Esmeraldas, Ecuador). The study will have a school-based approach, and each enrolled SAC will be asked to supply fecal and blood samples for testing with different methods for the diagnosis of S. stercoralis infection.
详细描述
Aim and objectives The aim of this project is to provide fundamental information on the performance and applicability of diagnostic methods for the assessment of S. stercoralis infection to inform the forthcoming WHO global strongyloidiasis control program to be implemented as a part of the WHO 2030 disease control targets.
Specific objectives are:
- To estimate the accuracy of selected diagnostic methods currently available for the diagnosis of S. stercoralis;
- To evaluate acceptability of each test and related sample collection method by the target population;
- To assess the feasibility of each assay for the deployment as a field-based diagnostic, and as a monitoring and evaluation tool in endemic areas
Methods A cross-sectional study in an area of high prevalence of strongyloidiasis, based on previously-collected, preliminary data. The study will have a school-based approach.
Study area and participants The study will be conducted in Ecuador, in San Lorenzo, Esmeraldas province. Administratively, San Lorenzo is divided into 12 rural parishes (Alto Tambo, Ancón de Sardinas (Palma Real), Calderón, Carondelet, 5 de junio, Concepción, Mataje, San Javier de Cachavíì, Santa Rita, Tambillo, Tululbíì- Ricaurte, Urbina), two of which can only be reached by sea (Tambillo which is an island, and Ancon de Sardinas or Palma Real located on the shores of the ocean).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children attending primary school in the selected communities
排除标准
- •Refusal to participate
- •Absence of written consent from parents/guardian
结局指标
主要结局
Diagnostic test accuracy - primary reference standard
时间窗: January-February 2022
The sensitivity and specificity of the serologic assays and of the rapid test will be first calculated against the results of Baermann and PCR, both considered virtually 100% specific for the study purpose. Hence, the accuracy of each test will be calculated as the proportion of positive results over all positive (for sensitivity) and negative (for specificity) samples to Baermann and/or PCR. Uncertainty will be quantified by 95% confidence intervals.
Diagnostic test accuracy - composite reference standard
时间窗: January-February 2022
Considering that Baerman and PCR may have lower sensitivities than the other tests, which may result in misevaluation of (too low) specificity of the other tests, the sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) of all tests will be calculated also against a composite reference standard\[16\]. This will be based on a combination of the results of all tests, specifically: cases of strongyloidiasis will be identified as participants with positive PCR AND/OR Baermann AND/OR a positive serologic test plus the RDT OR two positive serologic tests. Moreover, in the latent class analysis (LCA) probabilistic models will be fitted in order to classify subjects as diseased or not diseased
次要结局
- Acceptability(January 2022)
- Feasibility of in-field deployment of each test(January 2022)
研究者
Dora Buonfrate
Principal Investigator
IRCCS Sacro Cuore Don Calabria di Negrar