Evidence map›Paper›PMID 39930468›Full record

Trial reportMalaria journal2025

Evaluation of CareStart™ malaria HRP2/pLDH (Pf/PAN) combo rapid diagnostic test for diagnosis of Plasmodium falciparum infection in malaria co-endemic areas in association with parasite density.

Michael Christian, Lenny Lia Ekawati, Aa Raka Pratama, Syavira Cahyaningati, Hermina K Bere, Muhammad Rustam, Ichsan Kalbuadi, Jeltsin Andini, Jeng Yuliana, Ihsan Fadilah and 5 more

Registry-linked trialAbstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Malaria journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03916003 (Reducing the Risk of P. Vivax After Falciparum Infections in Co-endemic Areas - a Randomized Controlled Trial), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–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.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03916003 phase4completednot on this map

Reducing the Risk of P. Vivax After Falciparum Infections in Co-endemic Areas - a Randomized Controlled Trial

TypeinterventionalSponsorMenzies School of Health ResearchRan2019 to 2022Enrolled500ConditionsMalaria, Vivax Malaria, Falciparum MalariaArmsprimaquine
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
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  4. Article
  5. Microbiology spectrum · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Michael ChristianOxford University Clinical Research Unit Indonesia, Faculty of Medicine Universitas Indonesia, Jakarta, Indonesia. mchristian@oucru.org.
Lenny Lia EkawatiOxford University Clinical Research Unit Indonesia, Faculty of Medicine Universitas Indonesia, Jakarta, Indonesia.
Aa Raka PratamaOxford University Clinical Research Unit Indonesia, Faculty of Medicine Universitas Indonesia, Jakarta, Indonesia.
Syavira CahyaningatiOxford University Clinical Research Unit Indonesia, Faculty of Medicine Universitas Indonesia, Jakarta, Indonesia.
Hermina K BereOxford University Clinical Research Unit Indonesia, Faculty of Medicine Universitas Indonesia, Jakarta, Indonesia.
Muhammad RustamOxford University Clinical Research Unit Indonesia, Faculty of Medicine Universitas Indonesia, Jakarta, Indonesia.
Ichsan KalbuadiOxford University Clinical Research Unit Indonesia, Faculty of Medicine Universitas Indonesia, Jakarta, Indonesia.
Jeltsin AndiniOxford University Clinical Research Unit Indonesia, Faculty of Medicine Universitas Indonesia, Jakarta, Indonesia.
Jeng YulianaOxford University Clinical Research Unit Indonesia, Faculty of Medicine Universitas Indonesia, Jakarta, Indonesia.
Ihsan FadilahOxford University Clinical Research Unit Indonesia, Faculty of Medicine Universitas Indonesia, Jakarta, Indonesia.
Benedikt LeyMenzies School of Health Research and Charles Darwin University, Darwin, Australia.
Kamala ThriemerMenzies School of Health Research and Charles Darwin University, Darwin, Australia.
Ric N PriceCentre for Tropical Medicine & Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Inge SutantoDepartment of Parasitology, Faculty of Medicine Universitas Indonesia, Jakarta, Indonesia.
J Kevin BairdOxford University Clinical Research Unit Indonesia, Faculty of Medicine Universitas Indonesia, Jakarta, Indonesia.

Funding

Bill and Melinda Gates Foundation OPP1164105/INV-010504Gates Foundation INV-010504National Health and Medical Research Council GNT1132975
6 · The paper itself

Abstract

backgroundAs a widely accepted field standard diagnostic tool for malaria, microscopic examination is often difficult to perform in resource-poor settings. The immunochromatographic HRP2/pLDH (Pf/Pan) Rapid Diagnostic Tests (RDTs) serve as alternatives to microscopic examination for falciparum and non-falciparum malaria in co-endemic areas by detecting the histidine-rich protein 2 (HRP2) and pan-plasmodial lactate dehydrogenase (pLDH) antigen. However, Pf/Pan RDTs do not directly quantify parasitaemia. In this study, the diagnostic performance of Pf/Pan RDT and its association with parasite density was examined.

methodsBlood smears from patients who were screened for PRIMA Clinical Trial (Trial Registration Number: NCT03916003) conducted in East Sumba, Indonesia, and enrolled to its sub-study, ACROSS, were examined for microscopic examination and RDT using CareStart

results317 participants were included in this study and 158 (49.8%) were malaria positive by microscopy. Among all malaria-positive participants, Plasmodium falciparum infections accounted for 149 (94.3%) cases. The sensitivity and specificity of HRP2 band were 97.3% (95% CI 93.3-99.2) and 97.6% (95% CI 94.0-99.4), respectively, while that of pLDH band were 87.3% (95% CI 81.1-92.0) and 100% (95% CI 97.7-100). For each ten-fold increase in parasite density, the RDT had 12 times the odds of returning Pf/Pan-positive results (n = 126) compared to Pf-positive (n = 19) (OR: 12.1; 95% CI 5.18 to 34.8; p < 0.001).

conclusionsCareStart

Indexed as

Antigens, ProtozoanDiagnostic Tests, RoutineMalaria, FalciparumParasitemiaPlasmodium falciparumRapid Diagnostic TestsAdolescentAdultAgedChildChild, PreschoolChromatography, AffinityFemaleHumansIndonesiaInfantAntigens, ProtozoanHRP-2 antigen, Plasmodium falciparumL-Lactate DehydrogenaseProtozoan ProteinsCareStart™ Malaria HRP2/pLDH(Pf/PAN) ComboHRP2Malaria diagnosisParasitaemiaParasite densityPf/PanPlasmodium falciparum malariaPLDHRapid diagnostic testRDT

Identifiers

PMID39930468
PMCPMC11812152

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Registered trials

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.