An observational study in Malaria, sponsored by Foundation for Innovative New Diagnostics, Switzerland. Completed at 2 sites in 2 countries. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Foundation for Innovative New Diagnostics, Switzerland · Observational
In this study, a prospective evaluation of novel malaria diagnostic tools under development will be performed in malaria-endemic countries to assess their clinical performance for detection of malaria at point-of-care (POC). This study aims to support product development efforts and aims to provide early stage (TLR\~5) technology developers with valuable information on performance and basic feasibility data that can help to accelerate development.
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 640 is close to the median of 600 across 218 observational studies indexed under Malaria.
Browse Malaria studies →Foundation for Innovative New Diagnostics, Switzerland is the lead sponsor of 61 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with symptoms suggestive of malaria seeking clinical care in health facilities
Exclusion Criteria:
Novel in vitro diagnostics and medical applications
Clinical performance assessment
Point estimates of clinical performance characteristics with 95% confidence intervals (sensitivity, specificity, NPV, PPV, and DOR) of nPOC using nPCR as reference for detecting malaria in patients with symptoms suggestive of malaria
Time frame: up to 6 months
Concordance
Point estimate with 95% confidence intervals of the percentage agreement in interpreting malaria diagnostics between the app and visual reading
Time frame: up to 6 months
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Foundation for Innovative New Diagnostics, Switzerland