Validation of INSPiRED Innovative Smart Diagnostic Devices for the Detection of Parasites Infections. (INSPiRED-WP3)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Performance; Sensitivity; Specificity; Testing

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 460

Contacts and Locations

• Study Contact: Name: Ayola A ADEGNIKA, PhD; MD; Phone Number: +2466244472; Email: aadegnika@cermel.org
• Study Contact Backup: Name: Brice Meulah, MsC; Phone Number: +24174567447; Email: meulahfabrice@gmail.com

Study Locations

• Gabon
  • Moyen Ogooué
    • Lambaréné, Moyen Ogooué, Gabon, BP 242
      • Recruiting
      • Centre de Recherches Médicales de Lambaréné
      • Contact: Ayola A ADEGNIKA; Phone Number: 06244472; Email: aadegnika@cermel.org
      • Contact: Brice Meulah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All study participants, living in Lambaréné areas and its surrounding with parasitic infection

Description

Inclusion Criteria:

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

Exclusion Criteria:

-No sample provided

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AiDx devise is good as a conventional microscopy	Optical diagnostic devices is specific, sensitive as well as predicting value as microscopic test	3 years
Schistoscope	Optical diagnostic devices is specific, sensitive as well as predicting value as microscopic test	3 years
Hookworm and other STH devise is good as conventional. microscopic test	Optical diagnostic devices is specific, sensitive as well as predicting value as microscopic test	3 years

Collaborators and Investigators

• Sponsor: Centre de Recherche Médicale de Lambaréné
• Collaborators: Leiden University Medical Center
• Investigators: Study Chair: Romuald Mba, MSc, Centre de Recherches Médicales de Lambaréné - CERMEL

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Actual): August 7, 2020
• Last Update Submitted That Met QC Criteria: August 6, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Plasmodium; hookworm; Schistosoma
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Respiration Disorders; Hypersensitivity; Respiratory Aspiration
• Other Study ID Numbers: CEI-005/2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No