Hospital analyzers, commonly used in clinical chemistry departments, can now accurately identify counterfeit liquid medicines, including vaccines and insulin, according to a study published this week in Scientific Reports.
The research, led by Professor Paul Newton of the University of Oxford’s Medicine Quality Research Group (MQRG), demonstrates a low-cost and accessible method for detecting falsified pharmaceuticals, a significant problem particularly in low- and middle-income countries. The study utilized an Abbott Architect c16000 clinical chemistry analyzer to measure the concentrations of eight analytes – sodium, potassium, chloride, calcium, magnesium, phosphate, glucose, and protein – in both genuine and falsified samples.
“There is a great need for accessible and inexpensive techniques for screening for falsified vaccines and liquid medicines,” said Professor Newton. “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 research team found that each genuine liquid product exhibited unique analyte concentrations, allowing for clear differentiation from falsified surrogates. Reproducibility was high, with samples run up to nine times over nine days, and a decision tree was created that successfully identified all samples tested. Imprecision was minimal, with ion-selective electrode methods showing a coefficient of variation (CV) of less than 1.0% and spectrophotometric methods typically under 5%.
Dr. Bevin Gangadharan, of the University of Oxford’s Department of Biochemistry and Kavli Institute for Nanoscience Discovery, explained that by measuring different salts and proteins in liquid medical products, the team was able to distinguish between 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,” she said.
The University of East London’s Dr. Hamid Merchant is too a member of the research team. The findings offer a promising tool for global health systems seeking to protect patients from substandard or falsified medical products, a problem estimated to affect one in ten medical products in low- and middle-income countries.
The Vaccine Identity Evaluation (VIE) project, led by Professor Newton, is continuing to develop tests to detect falsified vaccines in the supply chain. Further research is planned to refine the analyte profiles and expand the range of detectable falsified products.
