Evidence map›Paper›PMID 29758050›Full record

ArticlePloS one2018

An assessment of false positive rates for malaria rapid diagnostic tests caused by non-Plasmodium infectious agents and immunological factors.

Michelle L Gatton, Sadmir Ciketic, John W Barnwell, Qin Cheng, Peter L Chiodini, Sandra Incardona, David Bell, Jane Cunningham, Iveth J González

Open access · goldAbstract read
In one paragraph

Article in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 pooled it
3.7field-weighted citation impact, top 7% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 1 synthesis or guideline pooled it, 48 citations in OpenAlex.

  1. Rapid diagnostic tests for Plasmodium vivax malaria in endemic countries.The Cochrane database of systematic reviews · 2020
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  16. False-positive immunochromatographic CTX-M enzyme test from direct testing of a positive blood culture.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2022
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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

9 authors at 5 institutions in 4 countries.

Michelle L GattonSchool of Public Health and Social Work, Queensland University of Technology, Brisbane, Australia.ORCID 0000-0003-1188-609X
Sadmir CiketicSchool of Public Health and Social Work, Queensland University of Technology, Brisbane, Australia.
John W BarnwellMalaria Branch, Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Center for Global Health, Atlanta, Georgia, United States of America.
Qin ChengDrug Resistance and Diagnostics, Australian Defence Force Malaria and Infectious Diseases Institute, Brisbane, Australia.
Peter L ChiodiniHospital for Tropical Diseases and London School of Hygiene and Tropical Medicine, London, United Kingdom.
Sandra IncardonaFIND (Foundation for Innovative New Diagnostics), Geneva, Switzerland.
David BellFIND (Foundation for Innovative New Diagnostics), Geneva, Switzerland.
Jane CunninghamGlobal Malaria Programme, World Health Organization, Geneva, Switzerland.
Iveth J GonzálezFIND (Foundation for Innovative New Diagnostics), Geneva, Switzerland.
FIND · CHQueensland University of Technology · AUCenters for Disease Control and Prevention · USLondon School of Hygiene & Tropical Medicine · GBWorld Health Organization · CH

Funding

World Health Organization 001
6 · The paper itself

Abstract

backgroundMalaria rapid diagnostic tests (RDTs) can produce false positive (FP) results in patients with human African trypanosomiasis and rheumatoid factor (RF), but specificity against other infectious agents and immunological factors is largely unknown. Low diagnostic specificity caused by cross-reactivity may lead to over-estimates of the number of malaria cases and over-use of antimalarial drugs, at the cost of not diagnosing and treating the true underlying condition.

methodsData from the WHO Malaria RDT Product Testing Programme was analysed to assess FP rates of 221 RDTs against four infectious agents (Chagas, dengue, Leishmaniasis and Schistosomiasis) and four immunological factors (anti-nuclear antibody, human anti-mouse antibody (HAMA), RF and rapid plasma regain). Only RDTs with a FP rate against clean negative samples less than 10% were included. Paired t-tests were used to compare product-specific FP rates on clean negative samples and samples containing non-Plasmodium infectious agents and immunological factors.

resultsForty (18%) RDTs showed no FP results against any tested infectious agent or immunological factor. In the remaining RDTs significant and clinically relevant increases in FP rates were observed for samples containing HAMA and RF (P<0.001). There were significant correlations between product-matched FP rates for RF and HAMA on all RDT test bands (P<0.001), and FP rates for each infectious agent and immunological factor were also correlated between test bands of combination RDTs (P≤0.002).

conclusionsFalse positive results against non-Plasmodium infectious agents and immunological factors does not appear to be a universal property of malaria RDTs. However, since many malaria RDTs have elevated FP rates against HAMA and RF positive samples practitioners may need to consider the possibility of false positive results for malaria in patients with conditions that stimulate HAMA or RF.

Indexed as

Antigens, ProtozoanChagas DiseaseDengueDiagnostic Tests, RoutineFalse Positive ReactionsHumansImmune SystemLeishmaniasisMalariaPlasmodium vivaxReproducibility of ResultsSchistosomiasisSensitivity and SpecificityAntigens, Protozoan

Identifiers

PMID29758050
PMCPMC5951549
OpenAlexW2803874440

What OpenQuestion holds

Textmetadata
LicenceCC0
Read underepoch 390

Registered trials

None linked

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.