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临床试验/NCT04505046
NCT04505046Unknown不适用

Validation of INSPiRED Innovative Smart Diagnostic Devices for the Detection of Plasmodium Falciparum, Schistosoma Haematobium and Necator Americanus at CERMEL, Gabon.

Centre de Recherche Médicale de Lambaréné1 个研究点 分布在 1 个国家目标入组 460 人开始时间: 2020年3月20日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
460
试验地点
1
主要终点
AiDx devise is good as a conventional microscopy

研究概览

简要总结

Malaria, schistosomiasis and ancylostomiasis are three parasitic diseases which affect hundreds of millions of people and are an important cause of global mortality and morbidity. For the control of these poverty related parasitic diseases, and to complement chemotherapeutic strategies, accurate and accessible diagnostic procedures play a crucial role.

In recent years, innovative smart mobile technologies have been applied for detection and identification of cultured parasite species, which is basically based on sample imaging and parasite morphology identification. Promising advances have been made with this technology and coupled with its small size, low cost and easy to manipulate, makes it suitable for point of care diagnostics in low resource setting.

The aim of the proposed explorative study is to further validate sensitivity and specificity of each of the developed devices, using besides microscopy a range of more advanced reference tests.

详细描述

Malaria, schistosomiasis and ancylostomiasis are three parasitic diseases which affect hundreds of millions of people and are an important cause of global mortality and morbidity. For the control of these poverty related parasitic diseases, and to complement chemotherapeutic strategies, accurate and accessible diagnostic procedures play a crucial role. Especially in remote and/or low resource settings, appropriate diagnostic tests are often lacking. These tests should not only be sensitive and specific, but also affordable, reliable, and easy to operate. In recent years, innovative smart mobile technologies have been applied for detection and identification of cultured parasite species, which is basically based on sample imaging and parasite morphology identification. Promising advances have been made with this technology and coupled with its small size, low cost and easy to manipulate, makes it suitable for point of care diagnostics in low resource setting. At the Technical University of Delft, a smart optical device prototype has been recently developed for the detection of Plasmodium. This Excelscope has been tested on a small number of malaria cases in Nigeria, showing promising results. In addition, TU Delft has developed a prototype for the detection of Schistosoma haematobium eggs in urine, which is ready for further validation in the field. Still under construction is a smart optical device for the detection of helminth eggs in stool, including eggs of hookworms. For each of these three smart optical devices using respectively blood, urine or stool, a diagnostic performance is aimed which does not significantly deviate in sensitivity and specificity from the diagnostic tests commonly in use in low resource settings, e.g. basic microscopy. At the same time, the optical devices have supplementary logistical advantages, e.g. easiness to use, high throughput and low costs per sample. The aim of the proposed explorative study is to further validate sensitivity and specificity of each of the developed devices, using besides microscopy a range of more advanced reference tests. For this purpose, diagnostic samples (blood, urine, stool) collected from ongoing studies involving malaria, schistosomiasis and STHs. at CERMEL will be used. The outcome of this study will give new insight in the diagnostic performance of the innovative smart optical devices, specifically in comparison to the WHO recommended diagnostic procedures currently used at CERMEL. The study is the core activity of Work Package 3 within the INSPiRED project.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
2 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Infected with malaria
  • Infected with Schistosomiasis
  • Soil-transmitted helminths

排除标准

  • No sample provided

结局指标

主要结局

AiDx devise is good as a conventional microscopy

时间窗: 3 years

Optical diagnostic devices is specific, sensitive as well as predicting value as microscopic test

Hookworm and other STH devise is good as conventional. microscopic test

时间窗: 3 years

Optical diagnostic devices is specific, sensitive as well as predicting value as microscopic test

Schistoscope

时间窗: 3 years

Optical diagnostic devices is specific, sensitive as well as predicting value as microscopic test

次要结局

未报告次要终点

研究者

发起方
Centre de Recherche Médicale de Lambaréné
申办方类型
Other
责任方
Sponsor

研究点 (1)

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