Clinical evaluation of Malaria rapid antigen test
Phase 3
- Conditions
- Malaria
- Registration Number
- PACTR202407803149023
- Lead Sponsor
- SD Biosensor
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 2000
Inclusion Criteria
Presenting at the study site with fever or a history of fever during the preceding 48-hours
Freely agreeing to participate by providing informed consent (and assent, as applicable
Exclusion Criteria
Presence of symptoms and signs of severe illness and/or central nervous system infections as defined by WHO guidelines.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relative diagnostic sensitivity and specificity shall be determined for each claimed specimen type.
- Secondary Outcome Measures
Name Time Method RDT positivity rate