Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2025-12-24 @ 3:07 PM
Study NCT ID:
NCT05286359
Status:
COMPLETED
Last Update Posted:
2023-04-24
First Post:
2022-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: