Evidence map›Paper›PMID 40122815›Full record

ArticleMalaria journal2025

WHO malaria nucleic acid amplification test external quality assessment scheme: results of eleven distributions over 6 years.

Rebecca M Thomson, Jane A Cunningham, Michelle M Gatton, Sean C Murphy, Maria de la Paz Ade, Xavier C Ding, Sandra Incardona, Eric Legrand, Naomi Lucchi, Didier Menard and 4 more

Abstract read
In one paragraph

Article in Malaria journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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2 · The registry

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3 · Its place in the literature

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4 · The record

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5 · Who and what money

Authors and funding

14 authors.

Rebecca M Thomson, London, UK. Rebecca.thomson@lshtm.ac.uk.
Jane A CunninghamWorld Health Organization, Geneva, Switzerland.
Michelle M GattonCentre for Immunology and Infection Control, Faculty of Health, Queensland University of Technology, Brisbane, Australia.
Sean C MurphyMalaria Molecular Diagnostic Laboratory, Laboratory Medicine & Pathology, University of Washington, Seattle, USA.
Maria de la Paz AdeDepartment of Communicable Diseases and Health Analysis, Pan American Health Organization, World Health Organization, Washington, DC, USA.
Xavier C DingAbbot Rapid Diagnostics, Baar, Switzerland.
Sandra IncardonaMCD Global Health, Paris, France.
Eric LegrandMalaria Biology and Vaccine Unit, Parasite and Insect Vector Department, Institut Pasteur, Paris, France.
Naomi LucchiMalaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, USA.
Didier MenardMalaria Biology and Vaccine Unit, Parasite and Insect Vector Department, Institut Pasteur, Paris, France.
Samuel L NsobyaDepartment of Pathology, School of Biomedical Science, Makerere University Uganda, Kampala, Uganda.
Agatha C SaezUK NEQAS Parasitology, UK Health Security Agency, London, UK.
Jaya ShrivastavaUK NEQAS Parasitology, UK Health Security Agency, London, UK.
Peter L ChiodiniUK NEQAS Parasitology, UK Health Security Agency, London, UK.

Funding

World Health Organization 001
6 · The paper itself

Abstract

backgroundThe World Health Organization (WHO) recommends parasite-based diagnosis of malaria before treatment. The use of nucleic-acid amplification (NAAT) for detection of Plasmodium spp. has expanded rapidly in recent years, for epidemiological research globally and clinical care in high-resource settings. Data from NAATs are frequently used to inform policy decisions, so quality control is essential to ensure results are reliable and comparable. Therefore, robust quality control, including an external quality assessment (EQA) scheme targeting malaria NAATs, is essential. The WHO Global Malaria Programme and the UK National External Quality Assessment Service (UK NEQAS) have collaborated since 2017 to implement a global malaria NAAT EQA scheme.

methodsPanels of specimens containing five major species of human-infecting Plasmodium at various parasite concentrations and negative samples were created in lyophilized blood (LB) and dried blood spot (DBS) formats. Two distributions per year were sent, containing five LB and five DBS specimens. Samples were validated by expert referee laboratories prior to distribution. Between 37 and 51 laboratories participated in each distribution and submitted results online. Participants were scored based on their laboratory's stated capacity to identify Plasmodium species, and individual laboratory reports were sent which included performance comparison with anonymized peers. Change in performance over time was calculated using a generalized mixed model with a logit link function.

resultsParticipating laboratories were located in 42 countries. Sample format (DBS or LB) and parasite density were found to significantly affect performance, while referee labs performed better at identifying P. falciparum samples than non-referee labs. Performance of laboratories improved significantly over time, especially for lower density and P. falciparum samples.

conclusionsResults from the first eleven distributions indicate that the EQA scheme has facilitated improved performance of laboratories over time, highlighting the value of implementing such programmes. EQA schemes are critical to safeguarding the reliability of data and diagnoses, especially in situations where NAAT methodologies and protocols are used. In future, funders should make participation in an EQA scheme a requirement for laboratories, and countries can take initiatives to embed such schemes into their own national assessment programmes.

Indexed as

MalariaNucleic Acid Amplification TechniquesPlasmodiumHumansQuality ControlWorld Health Organization

Identifiers

PMID40122815
PMCPMC11929988

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