Evidence map›Paper›PMID 31948448›Full record

ArticleMalaria journal2020

Use of a highly-sensitive rapid diagnostic test to screen for malaria in pregnancy in Indonesia.

Vera T Unwin, Rukhsana Ahmed, Rintis Noviyanti, Agatha M Puspitasari, Retno A S Utami, Leily Trianty, Theda Lukito, Din Syafruddin, Jeanne R Poespoprodjo, Maria A Santana-Morales and 2 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Malaria journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05757167 (Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity), which is not on this map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
6.5field-weighted citation impact, top 3% of its field
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.

NCT05757167 phase4active not recruitingnot on this mapstarted 2023, after this paper: background citation

Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity

TypeinterventionalSponsorDuke UniversityRan2023 to 2026Enrolled2,174ConditionsMalaria,Falciparum, Malaria in Pregnancy, Malaria in Childbirth, PregnancyArmsMalaria High-Sensitivity Rapid Diagnostic Test (HS-RDT), Artemether-lumefantrine (AL)
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 44 citations in OpenAlex.

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  15. Clinical Chemistry for Developing Countries: Mass Spectrometry.Annual review of analytical chemistry (Palo Alto, Calif.) · 2021
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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

12 authors at 4 institutions in 3 countries.

Vera T UnwinDepartment of Tropical Disease Biology and Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, L3 5QA, UK.
Rukhsana AhmedDepartment of Tropical Disease Biology and Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, L3 5QA, UK.
Rintis NoviyantiMalaria Pathogenesis Laboratory, Eijkman Institute of Molecular Biology, Jakarta, Indonesia.
Agatha M PuspitasariMalaria Pathogenesis Laboratory, Eijkman Institute of Molecular Biology, Jakarta, Indonesia.
Retno A S UtamiMalaria Pathogenesis Laboratory, Eijkman Institute of Molecular Biology, Jakarta, Indonesia.
Leily TriantyMalaria Pathogenesis Laboratory, Eijkman Institute of Molecular Biology, Jakarta, Indonesia.
Theda LukitoClinesia, Jakarta, Indonesia.
Din SyafruddinMalaria Pathogenesis Laboratory, Eijkman Institute of Molecular Biology, Jakarta, Indonesia.
Jeanne R PoespoprodjoMimika District Health Authority, District Government Building, Jl. Cendrawasih, Timika, 99910, Papua, Indonesia.
Maria A Santana-MoralesUniversity Institute of Tropical Diseases and Public Health of the Canary Islands, University of la Laguna, Tenerife, Spain.
Feiko O Ter KuileDepartment of Tropical Disease Biology and Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, L3 5QA, UK.
Emily R AdamsDepartment of Tropical Disease Biology and Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, L3 5QA, UK. emily.adams@lstmed.ac.uk.ORCID http://orcid.org/0000-0002-0816-2835
Eijkman Institute for Molecular Biology · IDLiverpool School of Tropical Medicine · GBCentre for Biomedical Network Research on Rare Diseases · ESUniversitas Gadjah Mada · ID

Funding

Department for International Development G1100654/1Medical Research Council G1100654Medical Research Council (GB) CASE StudentshipMedical Research Council (GB) G1100654/1Wellcome TrustWellcome Trust Medical Research Council
6 · The paper itself

Abstract

backgroundThe sensitivity of rapid diagnostic tests (RDTs) for malaria is inadequate for detecting low-density, often asymptomatic infections, such as those that can occur when screening pregnant women for malaria. The performance of the Alere™ Ultra-sensitive Malaria Ag Plasmodium falciparum RDT (uRDT) was assessed retrospectively in pregnant women in Indonesia.

methodsThe diagnostic performance of the uRDT and the CareStart™ Malaria HRP2/pLDH VOM (Plasmodium vivax, Plasmodium ovale and Plasmodium malariae) Combo RDT (csRDT) were assessed using 270 stored red blood cell pellets and plasma samples from asymptomatic pregnant women. These included 112 P. falciparum negative and 158 P. falciparum positive samples detected by a composite test (qPCR, LAMP, nPCR) as reference standard. Diagnostic indicators: sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), diagnostic odds ratio (DOR) and the level of agreement (kappa) were calculated for comparison.

resultsCompared with the reference test, the uRDT had a sensitivity of 19.6% (95% CI 13.9-26.8) and specificity of 98.2% (93.1-99.7%). The csRDT was 22.8% (16.7-30.3) sensitive and 95.5% (89.4-98.3) specific for P. falciparum infections. Performance of the uRDT was non-significantly different to the csRDT (p = 0.169). RDT outcome was stratified by qPCR cycling threshold (Ct), and performance of the RDTs was found to be comparable across parasite loads.

conclusionThe uRDT performed similarly to the currently used csRDTs in detecting P. falciparum infections in asymptomatic pregnant women. In these settings, molecular diagnostics are currently the most sensitive for malaria.

Indexed as

CoinfectionDiagnostic Screening ProgramsDNA, ProtozoanErythrocytesFemaleHumansIndonesiaMalaria, FalciparumOdds RatioPlasmodiumPredictive Value of TestsPregnancyPregnancy Complications, ParasiticRetrospective StudiesSensitivity and SpecificityDNA, ProtozoanDiagnostic performanceDiagnosticsMalariaMolecular techniquesPregnancyRapid diagnostic test

Identifiers

PMID31948448
PMCPMC6966894
OpenAlexW3003207309

What OpenQuestion holds

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LicenceCC BY
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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.