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Clinical Trials/NCT05286359
NCT05286359CompletedNot Applicable

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

Abbott Rapid Dx1 site in 1 country1,023 target enrollmentStarted: May 24, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
1,023
Locations
1
Primary Endpoint
Assess the sensitivity, specificity, positive and negative predicting values (PPV and NPV) [altogether referred to hereafter as "diagnostic accuracy"] of NxTekTM Malaria Pf Plus

Study Overview

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.

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

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

Eligibility Criteria

Ages
5 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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).

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

  • 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)

Investigators

Sponsor
Abbott Rapid Dx
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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