Identifying fake vaccines and insulin using hospital analysers

Researchers at the University of Oxford, Oxford University Hospitals NHS Foundation Trust and their collaborators have demonstrated that hospital analysers can be used to identify fake liquid medical products.

The World Health Organization estimates that 10.5% of medicines worldwide in low- and middle-income countries are substandard or are falsified (i.e. fake) medicines made by criminals. 

This threatens global health since the medicines and vaccines fail to prevent and treat the diseases for which they were intended, and they risk additional adverse health consequences if the ingredients used by criminals in the falsified products are harmful.

The Vaccine Identify Evaluation (VIE) Collaboration is developing novel tests for detecting falsified vaccines in supply chains. This international consortium has demonstrated for the first time that widely available and routine hospital analysers provide a low-cost means to accurately differentiate genuine liquid medical products from falsified surrogate samples.

The technique is not intended to replace reference assays but to screen samples that need further investigation in specialised laboratories.

The consortium includes representatives from the University of Oxford’s Nuffield Department of Medicine, Department of Biochemistry, Kavli Institute for Nanoscience Discovery, Pandemic Sciences Institute and Department of Chemistry; Oxford University Hospitals NHS Foundation Trust; STFC, part of UK Research and Innovation (UKRI); the University of East London; the World Health Organization, Geneva; the Serum Institute of India; and Agilent Technologies.

The study, ‘Biochemical profiling provides a low-cost and globally accessible method to detect falsified vaccines and insulin’, has been published in Scientific Reports. 

Study co-leader Professor Tim James, Head Biomedical Scientist and Lab Manager at OUH, said: “One of the benefits of the approach taken to screen vaccines and insulin suspected of being falsified is the ability to select from a range of simple, highly reproducible, routine methods from the instruments repertoire to meet any given testing scenario, thereby providing flexibility.”

Study co-leader Dr Bevin Gangadharan, of the Department of Biochemistry and Kavli Institute for Nanoscience Discovery, said: “By repurposing a clinical chemistry analyser to detect and measure different salts and protein in liquid medical products, we were able to successfully differentiate genuine and falsified samples. 

“This novel approach can be used globally due to the worldwide availability of biochemical analysers in hospitals and other clinical settings, including in low- and middle-income countries, where many cases of falsified medicines have been reported.”

VIE project leader Professor Paul Newton of the University of Oxford’s Centre for Tropical Medicine and Global Health, added: “There is a great need for accessible and inexpensive techniques for screening for falsified vaccines and liquid medicines. This novel approach of repurposing existing widely available hospital analysers holds promise for detecting these before they reach patients so that timely and appropriate action can be taken.”

The VIE Collaboration is an international consortium focused on developing novel, non-invasive methods to detect falsified vaccines in global supply chains. 

This research was funded by two anonymous donor families, the Oak Foundation, the Wellcome Trust and the Medical and Life Sciences Translational Fund from the Translational Research Office of the University of Oxford’s Medical Sciences Division.