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

Sponsor

Abbott Rapid Dx (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05286359

Collaborator

Bill and Melinda Gates Foundation (Other)

2,600

Enrollment

Location

Arm

6.2

Anticipated Duration (Months)

416.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malaria	Device: NxTekTM Malaria Pf Plus Rapid Diagnostic Test Device	N/A

Detailed Description

A prospective cross-sectional multi-center diagnostic accuracy trial in intended-use settings of the:

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.
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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2600 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Masking Description:

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

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

May 24, 2022

Anticipated Primary Completion Date :

Nov 30, 2022

Anticipated Study Completion Date :

Nov 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NxTekTM Malaria Plus Rapid Diagnostic Test (RDT) Devices	Device: 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. Other Names: NxTekTM Malaria Pf/Pv Plus Rapid Diagnostic Test Device

Arm

Intervention/Treatment

Experimental: NxTekTM Malaria Plus Rapid Diagnostic Test (RDT) Devices

Device: 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.

Other Names:

NxTekTM Malaria Pf/Pv Plus Rapid Diagnostic Test Device

Outcome Measures

Primary Outcome Measures

Assess the sensitivity, specificity, positive and negative predicting values (PPV and NPV) [altogether referred to hereafter as "diagnostic accuracy"] of NxTekTM Malaria Pf Plus [6 months]
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).
To assess the diagnostic accuracy of NxTekTM Malaria Pf/Pv Plus. [6 months]
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).

Secondary Outcome Measures

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 of comparator tests (05FK50, 05FK80, 05FK120, LM), using the reference test as standard of truth for the detection of P. falciparum and, when relevant, P.v. infections in patients with symptoms suggestive of malaria
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]
Estimates of diagnostic accuracy characteristics with 95% confidence intervals of the index tests for the detection of P.f. infections with hrp2 and/or hrp3 deletions in patients with symptoms suggestive of malaria

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Parasitology Research Unit, Aklilu Lemma Institute of Pathobiology (ALIPB), Addis Ababa University (AAU).	Addis Ababa		Ethiopia

Sponsors and Collaborators

Abbott Rapid Dx
Bill and Melinda Gates Foundation

Investigators

Principal Investigator: Dr. Lemu Golassa, PhD, Addis Ababa University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abbott Rapid Dx

ClinicalTrials.gov Identifier:

NCT05286359

Other Study ID Numbers:

SDRD-G-001-P

First Posted:

Mar 18, 2022

Last Update Posted:

Jul 5, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Abbott Rapid Dx

Plasmodium infection

Plasmodium falciparum

Plasmodium vivax

Additional relevant MeSH terms:

Infections

Malaria

Study Results

No Results Posted as of Jul 5, 2022