Cited by 99Malaria Research and ControlPharmaceutical Quality and CounterfeitingBiosensors and Analytical Detection

False-Negative Malaria Rapid Diagnostic Test Results and Their Impact on Community-Based Malaria Surveys in Sub-Saharan Africa

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Watson, Oliver J, Sumner, Kelsey Marie, Janko, Mark, Goel, Varun, Winskill, Peter, Slater, Hannah C, Ghani, Azra, Meshnick, Steven R +1 more·2019·BMJ Global Health

Abstract

gene deletions, poor performance of specific RDT brands and lots, and low-parasite density infections. We used RDT and microscopy results from 85 000 children enrolled in Demographic Health Surveys and Malaria Indicator Surveys from 2009 to 2015 across 19 countries to explore the distribution of and risk factors for FN-RDTs in sub-Saharan Africa, where malaria's impact is greatest. We sought to (1) identify spatial and demographic patterns of FN-RDT results, defined as a negative RDT but positive gold standard microscopy test, and (2) estimate the percentage of infections missed within community-based malaria surveys due to FN-RDT results. Across all studies, 19.9% (95% CI 19.0% to 20.9%) of microscopy-positive subjects were negative by RDT. The distribution of FN-RDT results was spatially heterogeneous. The variance in FN-RDT results was best explained by the prevalence of malaria, with an increase in FN-RDT results observed at lower transmission intensities, among younger subjects, and in urban areas. The observed proportion of FN-RDT results was not predicted by differences in RDT brand or lot performance alone. These findings characterise how the probability of detection by RDTs varies in different transmission settings and emphasise the need for careful interpretation of prevalence estimates based on surveys employing RDTs alone. Further studies are needed to characterise the cost-effectiveness of improved malaria diagnostics (eg, PCR or highly sensitive RDTs) in community-based surveys, especially in regions of low transmission intensity or high urbanicity.

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  • In malaria-endemic regions, rapid diagnostic tests (RDTs) can yield false negatives for reasons such as low parasite density and improper storage of RDTs, resulting in approximately 20% of microscopy-confirmed malaria cases being missed.

    “Similarly, in malaria-endemic regions, rapid diagnostic tests (RDTs) can yield false negatives for reasons such as low parasite density and improper storage of RDTs, resulting in approximately 20% of microscopy-confirmed malaria cases being missed [196].”

    From Toward Safer Diagnoses: A SEIPS-Based Narrative Review of Diagnostic Errors (2026) · cites this paper as [196]

    The Introduction identifies low parasite density and improper RDT storage as causes of false negatives. The Abstract reports that 19.9% of microscopy-positive subjects tested negative by RDT, but this figure comes from community-based surveys of children in 19 sub-Saharan African countries; the claim presents it more broadly as a rate for malaria-endemic regions. (LLM, conf=0.85)

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Research works printed but not linked: 1

  1. [10]World Health Organization (WHO) Malaria rapid diagnostic test performance. Results of who product testing of malaria RDTs: round 8 (2016–2018), 2018 Available: https://www.who.int/malaria/publications/atoz/9789241514965/en/ [Accessed 21 Jan 2019].

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Authors
Watson, O. J., Sumner, K. M., Janko, M., Goel, V., Winskill, P., Slater, H. C., Ghani, A., Meshnick, S. R., & Parr, J. B.
Affiliations
  • Imperial College London (GB)
  • University of North Carolina at Chapel Hill (US)
  • Duke University (US)
Corresponding author
Watson, Oliver J
Venue
BMJ Global Health
Publisher
BMJ
Published
2019-07
Volume
4
Issue
4
Pages
e001582
ISSN
2059-7908 (ISSN-L)
OpenAlex
W2966850727
Cited by
99
References
40
Citations by year
2026: 10 · 2025: 12 · 2024: 20 · 2023: 9 · 2022: 19 · 2021: 19 · 2020: 10
FWCI
11.05
Type
journal article
Language
en
Open access
Licence
cc-by
Locations
  • BMJ Global Health (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
  • Spiral (Imperial College London) (submittedVersion, cc-by)
Funders
  • National Institute of Allergy and Infectious Diseases (1R01AI13254701A1)
  • National Aeronautics and Space Administration (NNX15AP74g)
  • American Society for Tropical Medicine and Hygiene-Burroughs Wellcome Fund
  • Imperial College London
  • National Institute for Health Research (R21AI126024)
  • Medical Research Council
  • Bill and Melinda Gates Foundation (OPP1068440)
  • Department for International Development
  • Wellcome Trust (109312/Z/15/Z)
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Malaria Research and Control
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pharmaceutical Quality and Counterfeiting
  • Physical Sciences › Engineering › Biomedical Engineering › Biosensors and Analytical Detection
Keywords
malaria rapid diagnostic tests, false-negative results, malaria microscopy, parasite density, malaria transmission intensity, urban malaria, malaria diagnosis, sub-Saharan Africa, children

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