Repurposing rapid diagnostic tests for detecting falsified vaccines

An interdisciplinary study led by Prof. Nicole Zitzmann at the Department of Biochemistry and Kavli Institute and others have published their results in Vaccine demonstrating the utility of repurposed rapid diagnostic tests (RDTs), manufactured to diagnose common infections, for detecting falsified (aka counterfeit) vaccines1.  The study is part of the Vaccine Identity Evaluation (VIE) project2,3,4 that detects substandard and falsified (SF) vaccines in supply chains.

Covid Vaccines

Covid Vaccine Image: https://unsplash.com

Vaccines are vital and cost-effective interventions to prevent multiple infectious diseases. However, there is increasing recognition of substandard and falsified (SF) vaccines, that threaten the effective roll-out of vaccines. There have been numerous reports of substandard (usually due to degradation for vaccines) and falsified vaccines (e.g. for rabies, cholera, meningitis, yellow fever, hepatitis B and COVID-19). Nonetheless, this remains a relatively neglected issue with serious global implications for public health. There is an urgent need for devices to empower inspectors to screen for SF vaccine and medicines in supply chains.

RDTs are exceedingly simple, quick and cost-effective for near-patient testing of a wide range of infectious diseases. They offer similar benefits for the detection of falsified vaccines, but there are no published data on repurposing of RDTs for this purpose. Dr Tehmina Bharucha in the Zitzmann lab and the VIE team conducted 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, they demonstrated the utility of four RDTs in detecting seven genuine vaccines and distinguishing them from chemicals used in falsified vaccines. Subsequently, the four RDTs were evaluated by three blinded assessors with seven vaccines and four falsified vaccines surrogates. The team are working on expanding this work for diverse other vaccines and trials of this and other techniques in evaluations with colleagues in Nigeria.

The study provides preliminary data suggesting that further investigation of RDTs could lead to them being 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.

 

  1. Repurposing rapid diagnostic tests to detect falsified vaccines in supply chains . Bharucha T, Gangadharan B, Clarke R, Fernandez LG, Arman BY, Walsby-Tickle J, Deats M, Mosca S, Lin Q, Stokes R, Dunachie S, Merchant HA, Dubot-Pérès A, Caillet C, McCullagh J, Matousek P, Zitzmann N, Newton PN. Vaccine. 2024 Feb 13:S0264-410X(24)00019-7. doi: 10.1016/j.vaccine.2024.01.019. Epub ahead of print. PMID: 38355318. https://doi.org/10.1016/j.vaccine.2024.01.019
  2. https://www.cghr.ox.ac.uk/research/medicine-quality-research-group/mqrg-projects/vaccine-identity-evaluation
  3. https://www.bioch.ox.ac.uk/article/vaccine-identity-evaluation-vie-in-the-zitzmann-lab
  4. https://kavlinano.ox.ac.uk/article/advanced-laser-spectroscopy-detect-falsified-vaccines

 

16th February 2024