Performance Evaluation of Malaria Plus RDTs

NCT03960632 | Unknown

• 1 other identifier: 7874-2/1
• Study Type: observational
• Target: 6,546
• Locations: 0 countries
• Sites: N/A

Brief Summary

Since their introduction in the late 90's, rapid diagnostic tests (RDTs) have dramatically improved our ability to control malaria, but proved insufficient to support elimination efforts because of their limited sensitivity, especially for P. vivax. In addition, the spread of P. falciparum parasites lacking hrp2 gene jeopardizes the long-term use of P. falciparum-specific HRP2-based RDTs. An existing partnership between Standard Diagnostics (SD), FIND, PATH, and Bill and Melinda Gates Foundation (BMGF) is addressing these limitations by developing two novel malaria RDTs with an analytical sensitivity ten times higher than the currently available malaria RDTs: a P. falciparum-specific test targeting both the HRP2 and PfLDH antigens (Pf Plus), and a P. falciparum/P. vivax combo test additionally targeting the PvLDH antigen (Pf/Pv Plus). These new combo tests with improved sensitivity may become promising diagnostic tools for the detection of malaria, especially in settings where current tests prove to be insufficient due to hrp2 deletion or high burden of P. vivax malaria. In this study, the investigators will perform a prospective evaluation of Pf Plus and Pf/Pv Plus tests in malaria-endemic countries to assess their clinical performance for detection of malaria in their intended-use settings.

Conditions

Malaria

Outcome Measures

Primary Outcomes (2)

• Estimates of clinical performance characteristics of Pf Plus

  Estimates of clinical performance characteristics with 95% confidence intervals (sensitivity, specificity, NPV, PPV, and DOR) of Pf Plus using the primary reference test (qPCR) as standard of truth for the detection of malaria in patients with symptoms suggestive of malaria

  Enrolment

• Estimates of clinical performance characteristics of Pf/Pv Plus

  Estimates of clinical performance characteristics with 95% confidence intervals (sensitivity, specificity, NPV, PPV, and DOR) of Pf/Pv Plus using the primary reference test (qPCR) as standard of truth for the detection of malaria in patients with symptoms suggestive of malaria

  Enrolment

Interventions

Abbott SD Bioline Malaria Pf Plus (05FK150) and Abbott SD Bioline Malaria Pf/Pv Plus (05FK160)) DIAGNOSTIC_TEST

Qualitative in vitro tests for the detection of Plasmodium antigens

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptoms suggestive of malaria seeking clinical care in health facilities

You may qualify if:

• Presenting at the study site with fever (axillary temperature ≥37.5°C) or a history of fever during the preceding 72 hours period
• Presence of symptoms and signs other than fever suggestive of malaria
• Aged 5 years or older
• 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 finger prick blood sample at enrolment

You may not qualify if:

• Presence of symptoms and signs of severe disease and/or central nervous system infections, as defined by WHO guidelines

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 23, 2019
• Study Start: June 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 16, 2020

Record last verified: 2020-09