Repurposing rapid diagnostic tests to detect falsified vaccines in supply chains

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...

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Bibliographic Details
Published in:Vaccine 2024-03, Vol.42 (7), p.1506-1511
Main Authors: Bharucha, Tehmina, Gangadharan, Bevin, Clarke, Rebecca, Fernandez, Laura Gomez, Arman, Benediktus Yohan, Walsby-Tickle, John, Deats, Michael, Mosca, Sara, Lin, Qianqi, Stokes, Robert, Dunachie, Susanna, Merchant, Hamid A., Dubot-Pérès, Audrey, Caillet, Céline, McCullagh, James, Matousek, Pavel, Zitzmann, Nicole, Newton, Paul N.
Format: Article
Language:English
Subjects:
Antibodies
Antigens
Biochemistry
COVID-19 vaccines
Diagnostic systems
Diagnostic tests
Diagnostics
Falsified vaccines
Infectious diseases
Laboratories
Lateral flow tests
Malaria
Manufacturers
Meningitis
Pandemics
Public domain
Public health
Rapid diagnostic tests
Screening
Streptococcus infections
Substandard vaccines
Supply chains
Tablet computers
Vaccines
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Summary: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.
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2024.01.019