Trials / Completed
CompletedNCT04558515
Automated Microscopy Evaluation Study
Clinical Evaluation of Automated Microscope Solutions for Malaria Diagnosis
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 190 (actual)
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland · Academic / Other
- Sex
- All
- Age
- 5 Years
- Healthy volunteers
- Not accepted
Summary
Since the introduction of Giemsa stain in 1904 until today, malaria microscopy has been the standard of practice for malaria diagnosis. However, microscopic detection of malaria parasites is labour-intensive, time-consuming and expertise-demanding. Moreover, the slide interpretation is highly dependent on the staining technique and the technician's expertise. To address these, multiple organisations have developed next generation microscopes to move towards a next generation microscope that can improve slide preparation, interpretation or data collection, or a combination of these features. In this study, a prospective evaluation of miLab™ and other next generation automated microscope solutions as well as a malaria rapid diagnostic test (RDT) reader app will be performed in malaria-endemic countries to assess their clinical performance for detection of malaria clinical cases at POC.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Novel malaria diagnostics & tools | Next generation microscopy tools for malaria diagnosis and medical applications |
Timeline
- Start date
- 2020-02-01
- Primary completion
- 2021-07-01
- Completion
- 2021-12-31
- First posted
- 2020-09-22
- Last updated
- 2023-11-18
Locations
1 site across 1 country: Sudan
Source: ClinicalTrials.gov record NCT04558515. Inclusion in this directory is not an endorsement.