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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
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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.
A prospective cross-sectional multi-center diagnostic accuracy trial in intended-use settings of the:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NxTekTM Malaria Plus Rapid Diagnostic Test (RDT) Devices | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the sensitivity, specificity, positive and negative predicting values (PPV and NPV) [altogether referred to hereafter as "diagnostic accuracy"] of NxTekTM Malaria Pf Plus | 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). | 6 months |
| To assess the diagnostic accuracy of NxTekTM Malaria Pf/Pv Plus. | 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). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Estimates of diagnostic accuracy characteristics with 95% confidence intervals of comparator tests (05FK50, 05FK80, 05FK120, LM) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Lemu Golassa, PhD | Addis Ababa University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Parasitology Research Unit, Aklilu Lemma Institute of Pathobiology (ALIPB), Addis Ababa University (AAU). | Addis Ababa | Ethiopia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40274531 | Derived | Mandefro A, Ding XC, Farge J, Alemayehu GS, Tadele G, Mekonen B, Gebrehiwot Y, Berhe N, Erko B, Slater HC, Bizilj GT, Barney R, Golden A, Domingo GJ, Golassa L. Performance of a Novel Plasmodium falciparum Rapid Diagnostic Test in Areas of Widespread hrp2/3 Gene Deletion. Clin Infect Dis. 2026 Feb 4;81(6):e491-e501. doi: 10.1093/cid/ciaf212. |
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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
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| 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 | 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 | 6 months |
| ID | Term |
|---|---|
| D008288 | Malaria |
| D016778 | Malaria, Falciparum |
| D016780 | Malaria, Vivax |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
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