Malaria
Conditions
Keywords
Plasmodium infection, Plasmodium falciparum, Plasmodium vivax
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.
Interventions
DIAGNOSTIC_TESTNxTekTM 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.
Sponsors
Bill and Melinda Gates Foundation
Abbott Rapid Dx
Study design
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
Sex/Gender
ALL
Age
5 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
Ethiopia
Outcome results
None listed