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Clinical Trial 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05286359
Study type Interventional
Source Abbott Rapid Dx
Contact
Status Completed
Phase N/A
Start date May 24, 2022
Completion date November 17, 2022

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