Evidence map›Paper›PMID 41144516›Full record

ArticlePLoS neglected tropical diseases2025

First field evaluation of novel LDH- and HRP2-based rapid tests for Plasmodium vivax and Plasmodium falciparum malaria diagnosis.

Colins O Oduma, Birhanu Lulu, Yalemwork Ewnetu, Laurel A Lown, Tolulope Adeyemi Kayode, Dawit Hawaria, Cristian Koepfli

Abstract readEvaluation Study
PubMed Full text at PMC Publisher
In one paragraph

Article in PLoS neglected tropical diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
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4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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2 · The registry

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3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

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5 · Who and what money

Authors and funding

7 authors.

Colins O OdumaUzima University, Department of Microbiology, Kisumu, Kenya.
Birhanu LuluMalaria and Other Vector-Borne Diseases Research Center, Malaria and Other Vector-Borne Diseases Research Center, Hawassa University, Hawassa, Ethiopia.
Yalemwork EwnetuDepartment of Medical Biotechnology, University of Gondar, Gondar, Ethiopia.
Laurel A LownDepartment of Biological Sciences and Eck Institute for Global Health, University of Notre Dame, Notre Dame, Indiana, United States of America.
Tolulope Adeyemi KayodeDepartment of Biological Sciences and Eck Institute for Global Health, University of Notre Dame, Notre Dame, Indiana, United States of America.
Dawit HawariaMalaria and Other Vector-Borne Diseases Research Center, Malaria and Other Vector-Borne Diseases Research Center, Hawassa University, Hawassa, Ethiopia.
Cristian KoepfliDepartment of Biological Sciences and Eck Institute for Global Health, University of Notre Dame, Notre Dame, Indiana, United States of America.ORCID 0000-0002-9354-0414

Funding

Rapigen IncUniversity of Notre Dane
6 · The paper itself

Abstract

backgroundRapid diagnostic tests (RDTs) are crucial for malaria diagnosis. Where Plasmodium falciparum and Plasmodium vivax are co-endemic, and where P. falciparum hrp2/3 deletions are frequent, RDTs need to detect either species, and P. falciparum using additional antigens to HRP2, such as LDH.

methodsClinical patients presenting for malaria diagnosis in southern Ethiopia were enrolled and tested by microscopy at the health center and by four different RDTs: (i) BIOCREDIT Malaria Ag Pf (cHL) with a line combining HRP2 and LDH for P. falciparum, (ii) BIOCREDIT Malaria Ag Pf/Pv (cHL/L) with one line combining HRP2 and LDH for P. falciparum and one with LDH for P. vivax, (iii) Bioline Malaria Ag Pf/Pf/Pv with separate lines for HRP2 and LDH for P. falciparum, and LDH for P. vivax, and (iv) First Response with an HRP2 line for P. falciparum and a LDH line for P. vivax. The two BIOCREDIT RDTs had not previously been tested in the field. qPCR and expert microscopy were conducted as reference tests. P. falciparum positive samples were typed for hrp2/3 deletion.

resultsAmong 708 patients included in the final analysis, 46.0% were positive by qPCR (77 P. falciparum mono-infections, 198 P. vivax mono-infections, and 51 mixed infections). Strong agreement was observed between results of the different RDTs, with no significant differences in sensitivity. At densities >20 parasites/µL by qPCR, all RDTs reached sensitivities of >96% for P. falciparum, compared to 63% by health center microscopy, and for P. vivax all RDTs reached sensitivities of >92%, compared to 72% by health center microscopy. Specificity was > 99% for all P. falciparum RDTs and >98% for all P. vivax RDTs. Only 2/53 P. falciparum infections typed carried hrp2 and hrp3 deletions, both were detected by all LDH-based RDTs.

conclusionsUse of RDTs improves diagnostic accuracy compared to microscopy. The novel BIOCREDIT and Bioline RDTs show high sensitivity and specificity for P. falciparum and P. vivax diagnosis.

Indexed as

Antigens, ProtozoanDiagnostic Tests, RoutineL-Lactate DehydrogenaseMalaria, FalciparumMalaria, VivaxPlasmodium falciparumPlasmodium vivaxProtozoan ProteinsAdolescentAdultChildChild, PreschoolEthiopiaFemaleHumansInfantAntigens, ProtozoanHRP-2 antigen, Plasmodium falciparumL-Lactate DehydrogenaseProtozoan Proteins

Identifiers

PMID41144516
PMCPMC12578339

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