MedTrace Logo

Performance Evaluation of Malaria Plus Rapid Diagnostic Tests (RDTs) for the Detection of Plasmodium Infections in Patients With Symptoms Suggestive of Malaria

NCT05286359 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1023

Last updated 2023-04-24

No results posted yet for this study

Summary

This trial is part of a portfolio of studies designed to assess the clinical and operational performance of Abbott's NxTekTM Malaria Pf Plus and NxTekTM Malaria Pf/Pv Plus Rapid Test Devices.

Conditions

Interventions

DIAGNOSTIC_TEST

NxTekTM Malaria Pf Plus Rapid Diagnostic Test Device

NxTekTM Malaria Pf/Pv Plus: A sensitive rapid chromatographic immunoassay for the qualitative detection of histidine-rich protein 2 (HRP2) and Plasmodium lactate dehydrogenase (pLDH) of Plasmodium falciparum(P.f.) on one test line and of pLDH of Plasmodium vivax (P.v.) malaria on a second test line in human whole blood. This test is a lateral flow test for in vitro professional diagnostic use and intended as an aid to early diagnosis of Malaria infection in-patients with clinical symptoms. NxTekTM Malaria Pf Plus: A sensitive rapid chromatographic immunoassay for the qualitative detection of histidine-rich protein 2 (HRP2) and pLDH on a single test line of Plasmodium falciparum(P.f.) malaria in human whole blood. This test is a lateral flow test for in vitro professional diagnostic use and intended as an aid to early diagnosis of Malaria infection in-patients with clinical symptoms.

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Abbott Rapid Dx

    lead INDUSTRY

Principal Investigators

  • Dr. Lemu Golassa, PhD · Addis Ababa University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-24
Primary Completion
2022-11-17
Completion
2022-11-17

Countries

  • Ethiopia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05286359 on ClinicalTrials.gov