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

Abbott

Status: Completed

Conditions: Malaria

Treatments: Diagnostic Test: NxTekTM Malaria Pf Plus Rapid Diagnostic Test Device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05286359

SDRD-G-001-P

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,023 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 5years old or older
• Presenting at the trial site with fever or a history of fever (axillary temp ≥ 37.5C) during the preceding 48hours
• Freely agreeing to participate by providing informed consent (and assent, if applicable)

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,023 participants in 1 patient group

NxTekTM Malaria Plus Rapid Diagnostic Test (RDT) Devices

Experimental group

Treatment:

Diagnostic Test: NxTekTM Malaria Pf Plus Rapid Diagnostic Test Device