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Preprint VersionCC BY V4.0
Preprint
Pre-clinical evaluation of a low-resource molecular rapid Plasmodium falciparum test using infected whole blood samples. [version 1]
VeriXiv, Vol.2, pp.1-14
Gates Foundation
2025
Abstract
Malaria remains a pressing global health concern, claiming over 600,000 lives annually. Eliminating Plasmodium falciparum malaria is crucial, given its role in the majority of malaria-related deaths. Detecting asymptomatic individuals with low parasite levels (<150 parasites per microliter) is vital for transmission control, yet current field diagnostics often fall short. Here, we trialled a rapid P. falciparum test (Rapid Pf test) for parasite detection in whole blood. The Rapid Pf test is a molecular diagnostic with potential for low-resource implementation, employing isothermal amplification of parasite DNA, a novel sample preparation reagent, and lateral flow detection. Analytical sensitivity testing using cultured parasites spiked into whole blood demonstrated detection down to 50 parasites/μL, with high specificity for P. falciparum. Clinical testing involving samples from participants experimentally infected with P. falciparum demonstrated that the test could detect >48 parasites/μL with 100% sensitivity (95% CI: 70–99%, n=74) and >13 parasites/μL with 75% sensitivity (95% CI: 62–86%, n=98), confirmed by ultra-sensitive quantitative PCR. Providing results within 20 minutes from whole blood samples, the Rapid Pf test offers a rapid, low-resource molecular testing option that could enhance detection of asymptomatic parasitemia. The test could facilitate prompt detection and subsequent treatment, potentially reducing both symptomatic and asymptomatic cases and limiting ongoing transmission in endemic regions.
Details
- Title
- Pre-clinical evaluation of a low-resource molecular rapid Plasmodium falciparum test using infected whole blood samples. [version 1]
- Authors
- Karla van Huyssteen - University of the Sunshine Coast, Queensland, School of Science, Technology and EngineeringGenevieve Kerr - University of the Sunshine Coast, Queensland, School of Science, Technology and EngineeringRebecca Webster - QIMR Berghofer Medical Research InstituteB E Barber - QIMR Berghofer Medical Research InstituteNina M Pollak - University of the Sunshine Coast, Queensland, Centre for BioinnovationLeon E Hugo (Corresponding Author) - QIMR Berghofer Medical Research InstituteJoanne Macdonald (Corresponding Author) - University of the Sunshine Coast, Queensland, Centre for Bioinnovation
- Publication details
- VeriXiv, Vol.2, pp.1-14
- Publisher
- Gates Foundation
- Date published
- 2025
- DOI
- 10.12688/verixiv.1174.1
- ISSN
- 3029-0988
- Copyright note
- © 2025 Kerr G et al. This is an open access work distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
- Grants
- A single rapid field test for detecting Wolbachia, malaria and dengue in caught material, OPP1140133, Gates Foundation (United States, Seattle) - BMGF
- Organisation Unit
- School of Science, Technology and Engineering; Centre for Bioinnovation
- Language
- English
- Record Identifier
- 991171942302621
- Output Type
- Preprint
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