Evidence map›Paper›PMID 41163208›Full record

ArticleMalaria journal2025

Clinical evaluation of a novel Mologic malaria Plasmodium falciparum LDH-dependent lateral flow rapid diagnostic test diagnostic accuracy: a cross-sectional study, Sudan.

Abdelrahim O Mohamed, Muzamil M Abdel Hamid, Waleed M A Jebreel, Arwa Elaagip, Fayad Osman Mohammed, Musab M Albsheer, Sayed A Mustafa, Tarig M E Ahmed, Shaden B A Ahmed, Martin Chamai and 1 more

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Article in Malaria journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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2 · The registry

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3 · Its place in the literature

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4 · The record

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5 · Who and what money

Authors and funding

11 authors.

Abdelrahim O MohamedDepartment of Parasitology and Medical Entomology, Institute of Endemic Diseases, University of Khartoum, Khartoum, Sudan.
Muzamil M Abdel HamidDepartment of Parasitology and Medical Entomology, Institute of Endemic Diseases, University of Khartoum, Khartoum, Sudan. mahdi@iend.org.
Waleed M A JebreelDepartment of Parasitology and Medical Entomology, Institute of Endemic Diseases, University of Khartoum, Khartoum, Sudan.
Arwa ElaagipDepartment of Parasitology and Medical Entomology, Institute of Endemic Diseases, University of Khartoum, Khartoum, Sudan.
Fayad Osman MohammedDepartment of Parasitology and Medical Entomology, Institute of Endemic Diseases, University of Khartoum, Khartoum, Sudan.
Musab M AlbsheerDepartment of Parasitology and Medical Entomology, Institute of Endemic Diseases, University of Khartoum, Khartoum, Sudan.
Sayed A MustafaMalaria Control Program, Federal Ministry of Health, Khartoum, Sudan.
Tarig M E AhmedMalaria Control Program, Federal Ministry of Health, Khartoum, Sudan.
Shaden B A AhmedDepartment of Parasitology and Medical Entomology, Institute of Endemic Diseases, University of Khartoum, Khartoum, Sudan.
Martin ChamaiWest African Centre for Cell Biology of Infectious Pathogens, University of Ghana, LG, Accra, Ghana.
Sabine DittrichFIND, Geneva, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMalaria diagnosis by Rapid Diagnostic Test (RDT) is challenged by the newly emerging histidine-rich protein 2 (HRP2) gene deletion in the Plasmodium falciparum species. The alternative lactate dehydrogenase (LDH)-dependent RDTs suffer from low sensitivity, and improvement in the sensitivity of LDH RDTs is the cornerstone for detecting the (HRP2) gene deletion species. This study aimed to evaluate a novel, improved Mologic Malaria Pf LDH-dependent RDT for the diagnosis of P. falciparum malaria in partnership with the Foundation for Innovative Diagnostics (FIND), Switzerland.

methodsThis is a descriptive cross-sectional study evaluating the clinical performance of the improved Mologic LDH- RDT in two rural sites in Khartoum state, Sudan. Five hundred patients presenting with symptoms suggestive of malaria in the two primary care health centres were enrolled after signing informed consent. Finger-prick blood was collected for examination with microscopy, the index Mologic LDH RDT, the comparator RDT, and preparation of DBS for PCR, the reference method.

resultsThe mean age of the study subjects was 31 years, ranging from 5 to 80 years. Out of 500 patients, 210 (42%) were positive by PCR, 200 (40%) by expert microscopy, 193 (38.6%) by index Mologic LDH RDT, and 199 (39.8%) by comparator RDT. The sensitivities of microscopy, index RDT, and comparator RDT were 95.24% (95% CI, 91.4-97.6), 91.9% (95% CI, 87.3-95.2), and 93.81% (95% CI, 89.6-96.6), respectively. All tests were nearly 100% specific for the detection of P. falciparum parasites. The concordance test showed almost perfect agreement with the reference test (κ = 0.929). Six samples were P. falciparum HRP2 Ag negative and were detected by Mologic LDH RDT. A limitation of this study is that there is no confirmation of HRP2 gene deletion by PCR.

conclusionThe novel Mologic LDH RDT showed performance concordant with standard expert microscopy and the comparator HRP2-based RDT. The sensitivity of the Mologic LDH RDT makes it suitable for the clinical management of P. falciparum HRP2 negative malaria.

Indexed as

Diagnostic Tests, RoutineL-Lactate DehydrogenaseMalaria, FalciparumPlasmodium falciparumAdolescentAdultAgedAged, 80 and overAntigens, ProtozoanChildChild, PreschoolCross-Sectional StudiesFemaleHumansMaleMiddle AgedAntigens, ProtozoanHRP-2 antigen, Plasmodium falciparumL-Lactate DehydrogenaseProtozoan ProteinsClinical evaluationDiagnostic accuracyField testingLateral flowLDH, Rapid diagnostic testMalariaPlasmodium falciparumSudan

Identifiers

PMID41163208
PMCPMC12574065

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.