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Clinical performance of novel malaria rapid diagnostic tests for the detection of malaria infections with pfhrp2/3 gene deletions in Ethiopia

Clinical performance evaluation of novel malaria rapid diagnostic tests for the detection of malaria infections with pfhrp2/3 gene deletions among febrile individuals in Ethiopia

Status
Recruiting
Phases
Phase 3
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN11071786
Enrollment
200
Registered
2025-12-08
Start date
2025-10-06
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria Infections and Infestations

Interventions

Index tests/investigational product: 1. STANDARD Q hs-Malaria P.f Ag Test 2. STANDARD Q hs-Malaria P.f/P.v Ag Test Comparator tests: 1. Light microscopy: standard of care and research-grade 2. Stand

Sponsors

Program for Appropriate Technology in Health
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 100 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for cross sectional component: 1. Aged 5 years of age or older 2. Presenting at the study site with fever or a history of fever during the preceding 48 hours 3. Freely agreeing to participate by providing informed consent (and assent, as applicable) Inclusion criteria for screening component: 1. Aged 5 years of age or older 2. Presenting at the study site with fever or a history of fever during the preceding 48-hours 3. Confirmed P. falciparum malaria positive by microscopy 4. Negative for P. falciparum malaria on a WHO-recommended HRP2-based RDT 5. Freely agreeing to participate by providing informed consent (and assent, as applicable)

Exclusion criteria

Exclusion criteria: Presence of symptoms and signs of severe illness and/or central nervous system infections as defined by WHO guidelines

Countries

Ethiopia

Contacts

Public ContactMiraf Mesfin
mmesfin@path.org+251 (0)912 914862

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026