Evidence map›Paper›PMID 41068992›Full record

ArticleInfectious diseases of poverty2025

First report of pfhrp2 and pfhrp3 gene deletions compromising HRP2-based malaria rapid diagnostic tests in Malawi.

Johnsy Mary Louis, Ernest Mazigo, Hojong Jun, Wang-Jong Lee, Jadidan Hada Syahada, Fadhila Fitriana, Fauzi Muh, Wanjoo Chun, Won Sun Park, Se Jin Lee and 4 more

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Article in Infectious diseases of poverty, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

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4citing papers in PubMed
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1 · What the graph read from it

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3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

14 authors.

Johnsy Mary Louis *Department of Medical Environmental Biology and Tropical Medicine, School of Medicine, Kangwon National University, Chuncheon, Republic of Korea.
Ernest Mazigo *Department of Medical Environmental Biology and Tropical Medicine, School of Medicine, Kangwon National University, Chuncheon, Republic of Korea.
Hojong JunDepartment of Medical Environmental Biology and Tropical Medicine, School of Medicine, Kangwon National University, Chuncheon, Republic of Korea.
Wang-Jong LeeDepartment of Medical Environmental Biology and Tropical Medicine, School of Medicine, Kangwon National University, Chuncheon, Republic of Korea.
Jadidan Hada SyahadaDepartment of Medical Environmental Biology and Tropical Medicine, School of Medicine, Kangwon National University, Chuncheon, Republic of Korea.
Fadhila FitrianaDepartment of Medical Environmental Biology and Tropical Medicine, School of Medicine, Kangwon National University, Chuncheon, Republic of Korea.
Fauzi MuhDepartment of Epidemiology and Tropical Diseases, Faculty of Public Health, Universitas Diponegoro, Semarang, Indonesia.
Wanjoo ChunDepartment of Pharmacology, School of Medicine, Kangwon National University, Chuncheon, Republic of Korea.
Won Sun ParkDepartment of Physiology, School of Medicine, Kangwon National University, Chuncheon, Republic of Korea.
Se Jin LeeDepartment of Obstetrics and Gynecology, Kangwon National University Hospital, Chuncheon, Republic of Korea.
Sunghun NaDepartment of Obstetrics and Gynecology, Kangwon National University Hospital, Chuncheon, Republic of Korea.
Feng LuDepartment of Pathogen Biology and Immunology, School of Medicine, Yangzhou University, Yangzhou, China.
Eun-Teak HanDepartment of Medical Environmental Biology and Tropical Medicine, School of Medicine, Kangwon National University, Chuncheon, Republic of Korea.
Jin-Hee HanDepartment of Medical Environmental Biology and Tropical Medicine, School of Medicine, Kangwon National University, Chuncheon, Republic of Korea. han.han@kangwon.ac.kr.ORCID http://orcid.org/0000-0003-0836-6675

Funding

Korea Health Industry Development Institute H122C0820Korea Health Industry Development Institute RS-2025-02309009Ministry of Education RS-2023-00240627the Regional Innovation System & Education (RISE) program through the Gangwon RISE Center, funded by the Ministry of Education (MoE) and Gangwon State (G.S.), Republic of Korea 2025-RISE-10-002
6 · The paper itself

Abstract

backgroundHistidine Rich Protein 2-based rapid diagnostic tests (HRP2-based RDTs) are widely used for malaria diagnosis in Malawi, but their accuracy may be compromised by Plasmodium falciparum parasites lacking the P. falciparum histidine rich protein 2 (pfhrp2) and P. falciparum histidine rich protein 3 (pfhrp3) genes. While such deletions have been reported in other malaria-endemic countries, their presence and diagnostic impact in Malawi remain unknown. This study aimed to determine the prevalence of pfhrp2/pfhrp3 gene deletions in Malawi and their effect on the diagnostic accuracy of HRP2-based RDTs relative to light microscopy and qPCR.

methodsA cross-sectional study was conducted between December 2020 and June 2021, enrolling 1582 participants from referral hospitals in Mzuzu (n = 1186) and Lilongwe (n = 396). Malaria diagnosis was performed using RDTs, microscopy, and qPCR. A total of 391 P. falciparum positive samples were analyzed for pfhrp2/pfhrp3 gene deletions using multiplex qPCR. Diagnostic accuracy metrics, such as sensitivity and specificity, were calculated with 95% confidence intervals. Spearman correlation was applied to assess associations involving log-transformed parasitemia, unpaired t-tests were used to compare diagnostic methods, and Mann-Whitney tests were used to compare symptomatic and asymptomatic groups.

resultsMalaria prevalence was higher in Lilongwe (45.2%) than in Mzuzu (22.9%). Infections in Lilongwe were predominantly asymptomatic (94.2%), whereas Mzuzu had mostly symptomatic cases (97.1%) (P < 0.0002). RDTs demonstrated higher sensitivity of 78.5% (95% CI: 74.6-82.1%) than microscopy 64.8% (95% CI: 60.3-69.1), but slightly lower specificity, with 93.6% (95% CI: 92.0-95.0%) for RDT compared to 95.4% (95% CI: 94.0-96.6%) for microscopy. Dual pfhrp2/3 gene deletions were found in 24 (15.0%) isolates from Lilongwe and 24 (10.4%) from Mzuzu. All dual-deleted samples were false negative by RDT but were positive by microscopy and qPCR.

conclusionsThis study is the first to report pfhrp2/3 gene deletions in Malawi. The presence of these deletions may compromise the performance of HRP2-based RDTs, indicating the need to reassess diagnostic strategies in affected regions.

Indexed as

Antigens, ProtozoanDiagnostic Tests, RoutineGene DeletionMalaria, FalciparumPlasmodium falciparumProtozoan ProteinsAdolescentAdultChildChild, PreschoolCross-Sectional StudiesFemaleHumansInfantMalawiMaleAntigens, ProtozoanHRP-2 antigen, Plasmodium falciparumHRP3 protein, Plasmodium falciparumProtozoan ProteinsDiagnostic accuracyGene deletionpfhrp2pfhrp3Plasmodium falciparumRapid diagnostic test

Identifiers

PMID41068992
PMCPMC12512526

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