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

NCT05286359 | Completed

• 1 other identifier: SDRD-G-001-P
• Study Type: interventional
• Target: 1,023
• Locations: 1 country
• Sites: 1

Brief 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

Malaria

Keywords

Plasmodium infection; Plasmodium falciparum; Plasmodium vivax

Outcome Measures

Primary Outcomes (2)

• Assess the sensitivity, specificity, positive and negative predicting values (PPV and NPV) [altogether referred to hereafter as "diagnostic accuracy"] of NxTekTM Malaria Pf Plus

  To assess the sensitivity, specificity, positive and negative predicting values (PPV and NPV) \[altogether referred to hereafter as "diagnostic accuracy"\] of NxTekTM Malaria Pf Plus in intended use settings for detecting P.f. infections in capillary whole blood samples collected prospectively from patients with symptoms suggestive of malaria (e.g. febrile).

  6 months

• To assess the diagnostic accuracy of NxTekTM Malaria Pf/Pv Plus.

  To assess the diagnostic accuracy of NxTekTM Malaria Pf/Pv Plus in intended use settings for detecting P.f. and P.v. infections in capillary whole blood samples collected prospectively from patients with symptoms suggestive of malaria (e.g. febrile).

  6 months

Secondary Outcomes (2)

• Estimates of diagnostic accuracy characteristics with 95% confidence intervals of comparator tests (05FK50, 05FK80, 05FK120, LM)

  6 months

• Estimates of diagnostic accuracy characteristics with 95% confidence intervals ofthe index tests for the detection of P.f.infections with hrp2 and/or hrp3 deletions

  6 months

Study Arms (1)

NxTekTM Malaria Plus Rapid Diagnostic Test (RDT) Devices

EXPERIMENTAL

Diagnostic Test: NxTekTM Malaria Pf Plus Rapid Diagnostic Test Device

Interventions

NxTekTM Malaria Pf Plus Rapid Diagnostic Test Device DIAGNOSTIC_TEST

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.

Also known as: NxTekTM Malaria Pf/Pv Plus Rapid Diagnostic Test Device

NxTekTM Malaria Plus Rapid Diagnostic Test (RDT) Devices

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Abbott Rapid Dx: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Medical Parasitology Research Unit, Aklilu Lemma Institute of Pathobiology (ALIPB), Addis Ababa University (AAU).

Addis Ababa, Ethiopia

Location

Related Publications (1)

• Mandefro A, Ding XC, Farge J, Alemayehu GS, Tadele G, Mekonen B, Gebrehiwot Y, Berhe N, Erko B, Slater HC, Bizilj GT, Barney R, Golden A, Domingo GJ, Golassa L. Performance of a novel P. falciparum rapid diagnostic test in areas of widespread hrp2/3 gene deletion. Clin Infect Dis. 2025 Apr 24:ciaf212. doi: 10.1093/cid/ciaf212. Online ahead of print.

  PMID: 40274531 DERIVED

MeSH Terms

Conditions

Malaria; Malaria, Falciparum; Malaria, Vivax

Condition Hierarchy (Ancestors)

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

Study Officials

• Dr. Lemu Golassa, PhD

  Addis Ababa University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The staff conducting the trial assays will be blinded to any results already available from the investigational, comparator or reference test. All RDTs will be read by two blinded operators, with a third operator for discrepant results
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 18, 2022
• Study Start: May 24, 2022
• Primary Completion: November 17, 2022
• Study Completion: November 17, 2022
• Last Updated: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)