Malaria
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTNovel in vitro diagnostics and medical applications
Novel in vitro diagnostics and medical applications
Sponsors
Foundation for Innovative New Diagnostics, Switzerland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 5 years or older * Presenting at the study site with symptoms and signs suggestive of malaria * Freely agreeing to participate by signing an informed consent form (adults aged 18 and older and parent/legal guardian of a child) and providing assent (children aged 13-17) * Willing to provide sample at enrolment
Exclusion criteria
* Presence of symptoms and signs of severe disease and/or central nervous system infections, as defined by WHO guidelines
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical performance assessment | up to 6 months | 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 |
| Concordance | up to 6 months | Point estimate with 95% confidence intervals of the percentage agreement in interpreting malaria diagnostics between the app and visual reading |
Countries
Indonesia, Rwanda
Outcome results
None listed