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Completed

NCT Number: NCT05286359

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

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.

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Key information

Conditions

Malaria Infections Malaria, Falciparum Malaria, Vivax Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Addis Ababa, Ethiopia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: NxTekTM Malaria Pf/Pv Plus Rapid Diagnostic Test Device

Primary outcomes

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

    Time frame: 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).

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

    Time frame: 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 outcomes

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

    Time frame: 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

  2. 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Abbott Rapid Dx

Industry

Collaborators

  • Bill and Melinda Gates Foundation

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 18, 2022
Registry last updated
Apr 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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