Repurposing rapid diagnostic tests to detect falsified vaccines in supply chains

Article


Bharucha, T., Gangadharan, B., Clarke, R., Gomez Fernandez, L., Yohan Arman, B., Walsby-Tickle, J., Deats, M., Mosca, S., Lin, Q., Stokes, R., Dunachie, S., Merchant, H. A., Dubot-Pérès, A., Caillet, C., McCullagh, J., Matousek, P., Zitzmann, N. and Newton, P. N. 2024. Repurposing rapid diagnostic tests to detect falsified vaccines in supply chains. Vaccine. 42 (7), pp. 1506-1511. https://doi.org/10.1016/j.vaccine.2024.01.019
AuthorsBharucha, T., Gangadharan, B., Clarke, R., Gomez Fernandez, L., Yohan Arman, B., Walsby-Tickle, J., Deats, M., Mosca, S., Lin, Q., Stokes, R., Dunachie, S., Merchant, H. A., Dubot-Pérès, A., Caillet, C., McCullagh, J., Matousek, P., Zitzmann, N. and Newton, P. N.
Abstract

Substandard (including degraded) and falsified (SF) vaccines are a relatively neglected issue with serious global implications for public health. This has been highlighted during the rapid and widespread rollout of COVID-19 vaccines. There has been increasing interest in devices to screen for SF non-vaccine medicines including tablets and capsules to empower inspectors and standardise surveillance. However, there has been very limited published research focussed on repurposing or developing new devices for screening for SF vaccines. To our knowledge, rapid diagnostic tests (RDTs) have not been used for this purpose but have important potential for detecting falsified vaccines. We performed a proof-in-principle study to investigate their diagnostic accuracy using a diverse range of RDT-vaccine/falsified vaccine surrogate pairs. In an initial assessment, we demonstrated the utility of four RDTs in detecting seven vaccines. Subsequently, the four RDTs were evaluated by three blinded assessors with seven vaccines and four falsified vaccines surrogates. The results provide preliminary data that RDTs could be used by multiple international organisations, national medicines regulators and vaccine manufacturers/distributors to screen for falsified vaccines in supply chains, aligned with the WHO global ‘Prevent, Detect and Respond’ strategy.

JournalVaccine
Journal citation42 (7), pp. 1506-1511
ISSN0264-410X
Year2024
PublisherElsevier
Publisher's version
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File Access Level
Anyone
Digital Object Identifier (DOI)https://doi.org/10.1016/j.vaccine.2024.01.019
Publication dates
Online14 Feb 2024
Publication process dates
Deposited23 Apr 2024
FunderOak Foundation
World Health Organisation
Wellcome Trust
Medical Research Council (MRC)
Department of Biochemistry, University of Oxford
Copyright holder© 2024, The Authors
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