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.
Study Type
OBSERVATIONAL
Enrollment
640
Novel in vitro diagnostics and medical applications
Eijkman Institute for Molecular Biology
Jakarta, Indonesia
Stansile
Kigali, Rwanda
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
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