NCT05286359

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

Multi-site, Prospective, Clinical Performance Evaluation of NxTekTM Malaria Pf Plus Rapid Diagnostic Test Device and NxTekTM Malaria Pf/Pv Plus Rapid Diagnostic Test (RDT) Device for the Detection of Plasmodium Infections in Patients With Symptoms Suggestive of Malaria

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,023 (actual)
• Sponsor: Abbott Rapid Dx · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A prospective cross-sectional multi-center diagnostic accuracy trial in intended-use settings of the: 1. NxTekTM Malaria Pf/Pv Plus Rapid Test Device for the qualitative detection histidine-rich protein II (HRP-II antigens) and pLDH of Plasmodium falciparum (P.f) and Plasmodium vivax (P.v) malaria in human whole blood. 2. NxTekTM Malaria Pf PlusRapid Test Device for the qualitative detection of histidine-rich protein II (HRP-II antigens) and pLDH of Plasmodium falciparum (P.f) malaria in human whole blood.

Conditions

• Malaria

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-05-24
• Primary completion: 2022-11-17
• Completion: 2022-11-17
• First posted: 2022-03-18
• Last updated: 2023-04-24

Locations

1 site across 1 country: Ethiopia