Repurposing rapid diagnostic tests to detect falsified vaccines in supply chains

Tehmina Bharucha*, Bevin Gangadharan, Rebecca Clarke, Laura Gomez Fernandez, Benediktus Yohan Arman, John Walsby-Tickle, Michael Deats, Sara Mosca, Qianqi Lin, Robert Stokes, Susanna Dunachie, Hamid A. Merchant, Audrey Dubot-Pérès, Céline Caillet, James McCullagh, Pavel Matousek, Nicole Zitzmann, Paul N. Newton*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

1 Citation (Scopus)
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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.
Original languageEnglish
Pages (from-to)1506-1511
Number of pages6
JournalVaccine
Volume42
Issue number7
Early online date14 Feb 2024
DOIs
Publication statusPublished - 7 Mar 2024
Externally publishedYes

Keywords

  • Falsified vaccines
  • Substandard vaccines
  • Rapid diagnostic tests
  • Lateral flow tests
  • Diagnostics
  • Screening

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