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Peer-reviewedCC BYMalaria journal

A target product profile for a rapid diagnostic test to monitor mosquito gene drive presence and frequency.

  • Prateek Verma1
  • Sebald Verkuijl2
  • Calvin K Yee2
  • Filippo Randazzo3
  • Damaris Matoke-Muhia4
  • Jonathan Kayondo5
  • Nikolai Windbichler2
  • Michael R Santos6
  • Frédéric Tripet7,8
  • John M Marshall9
9 affiliations
  1. 1Divisions of Biostatistics & Epidemiology, School of Public Health, University of California, Berkeley, CA, USA.
  2. 2Department of Life Sciences, Faculty of Natural Sciences, Imperial College London, London, UK.
  3. 3Leverage Science, LLC, Berkeley, CA, USA.
  4. 4Centre for Biotechnology Research and Development, Kenya Medical Research Institute, Nairobi, Kenya.
  5. 5Department of Entomology, Uganda Virus Research Institute, Entebbe, Uganda.
  6. 6Foundation for the National Institutes of Health, North Bethesda, Maryland, USA.
  7. 7Swiss Tropical and Public Health Institute, Kreuzstrasse 2, Allschwil, Switzerland. [email protected].
  8. 8University of Basel, Petersplatz 1, Basel, Switzerland. [email protected].
  9. 9Divisions of Biostatistics & Epidemiology, School of Public Health, University of California, Berkeley, CA, USA. [email protected].
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Abstract

Malaria remains a major global health challenge, with over 263 million cases and nearly 600,000 deaths reported in 2023, the majority in sub-Saharan Africa. While conventional interventions such as insecticide-treated nets, indoor residual spraying and antimalarial drugs have reduced transmission, progress has stalled due to the limitations of these interventions and the emergence of resistance. Gene drive-modified mosquitoes represent a promising, potentially transformative vector control strategy, capable of spreading malaria-refractory traits or suppressing mosquito populations. Successful field deployment will depend upon monitoring systems to track the presence and frequency of gene drive constructs as they spread and persist. Current molecular surveillance techniques, though effective, are resource-intensive and reliant on laboratory infrastructure and technical competencies. Here, we make the case for a near-universal and low-cost rapid diagnostic test (RDT) designed to detect gene drive mosquitoes in the field, to complement existing surveillance infrastructure. Two use cases are outlined: (i) to detect the presence of the drive construct in a new population, and (ii) to provide an estimate of drive frequency prior to more accurate laboratory-based measurements. We provide a target product profile for the RDT outlining minimally essential and ideal characteristics, including test procedures, sensitivity, specificity, usability by a range of stakeholders in field settings, and compatibility with pooled testing of mosquito samples. An RDT for gene drive construct detection would support community access and participation in monitoring, enhance regulatory oversight, and promote transparency in field trials, thereby facilitating responsible deployment of gene drive-based malaria interventions.

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Cite

BibTeXRIS
BibTeX
@article{verma2026target,
  title = {{A target product profile for a rapid diagnostic test to monitor mosquito gene drive presence and frequency.}},
  author = {Prateek Verma and Sebald Verkuijl and Calvin K Yee and Filippo Randazzo and Damaris Matoke-Muhia and Jonathan Kayondo and Nikolai Windbichler and Michael R Santos and Frédéric Tripet and John M Marshall},
  journal = {Malaria journal},
  year = {2026},
  month = jul,
  doi = {10.1186/s12936-026-06065-x},
  url = {https://europepmc.org/article/MED/42894170},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - A target product profile for a rapid diagnostic test to monitor mosquito gene drive presence and frequency.
AU  - Prateek Verma
AU  - Sebald Verkuijl
AU  - Calvin K Yee
AU  - Filippo Randazzo
AU  - Damaris Matoke-Muhia
AU  - Jonathan Kayondo
AU  - Nikolai Windbichler
AU  - Michael R Santos
AU  - Frédéric Tripet
AU  - John M Marshall
PY  - 2026
DA  - 2026/07/01
JO  - Malaria journal
DO  - 10.1186/s12936-026-06065-x
UR  - https://europepmc.org/article/MED/42894170
AB  - Malaria remains a major global health challenge, with over 263 million cases and nearly 600,000 deaths reported in 2023, the majority in sub-Saharan Africa. While conventional interventions such as insecticide-treated nets, indoor residual spraying and antimalarial drugs have reduced transmission, progress has stalled due to the limitations of these interventions and the emergence of resistance. Gene drive-modified mosquitoes represent a promising, potentially transformative vector control strategy, capable of spreading malaria-refractory traits or suppressing mosquito populations. Successful field deployment will depend upon monitoring systems to track the presence and frequency of gene drive constructs as they spread and persist. Current molecular surveillance techniques, though effective, are resource-intensive and reliant on laboratory infrastructure and technical competencies. Here, we make the case for a near-universal and low-cost rapid diagnostic test (RDT) designed to detect gene drive mosquitoes in the field, to complement existing surveillance infrastructure. Two use cases are outlined: (i) to detect the presence of the drive construct in a new population, and (ii) to provide an estimate of drive frequency prior to more accurate laboratory-based measurements. We provide a target product profile for the RDT outlining minimally essential and ideal characteristics, including test procedures, sensitivity, specificity, usability by a range of stakeholders in field settings, and compatibility with pooled testing of mosquito samples. An RDT for gene drive construct detection would support community access and participation in monitoring, enhance regulatory oversight, and promote transparency in field trials, thereby facilitating responsible deployment of gene drive-based malaria interventions.
SN  - 1475-2875
ER  -