Image created by Dr. Michael J. Miller
On World Polio Day, 24th October, 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) is highlighting our work training multiple World Health Organisation (WHO) polio laboratories around the world using an advanced molecular direct detection method that can halve detection times – supporting the global effort to eradicate polio and helping save lives.
In collaboration with Imperial College London, the University of Edinburgh, Biosurv International and funded by the Bill and Melinda Gates Foundation, we have trained 25 countries in just over one year on the use of a technique called Direct Detection by Nanopore Sequencing (DDNS). This method can speed up the detection of polio outbreaks, saving public health authorities crucial time and money. This includes training laboratories in Pakistan, one of the last two countries where polio remains endemic, with the number of cases increasing this year.
It is vitally important to detect polio early, as the infection moves rapidly within a population. By the time the first signs of polio appear in a country, many hundreds of people are typically already infected and can unknowingly pass on the virus to others who may not be fully vaccinated and protected. The virus – most commonly transmitted through contact with infected faeces via contaminated food and water – multiplies in the intestine, from where it can invade the nervous system and cause paralysis.
Training worldwide in-country laboratories in rapid detection – using the DDNS method –enables samples to be tested in the country where the outbreak originated, rather than being sent to specialist laboratories abroad. This means the costs and delays of transport and testing can be reduced from an average of 42 days to an average of 19 days – a time saving that saves lives.
A study published in Nature Microbiology last year, showed that our research, jointly conducted with partners, using the DDNS method to detect polio outbreaks can halve the detection time. This research indicated that DDNS tests done locally, in the Democratic Republic of Congo, over a six-month period were an average of 23 days faster than the standard method, with over 99% accuracy.
Training laboratories in the DDNS method takes one to two weeks and is carried out by scientists from the MHRA, as well as colleagues from Imperial College London. It involves a combination of theoretical and practical sessions covering all aspects of the DDNS method from sample processing, nucleic acid extraction, PCR amplification, sequencing, analysis and interpretation of results.
The training also encompasses methodological troubleshooting and utility of the detailed quality assurance programme associated with the method. The University of Edinburgh provides the bioinformatics expertise and have created purpose-designed analytical software to process the sequencing data produced by the method. Biosurv International support supply chains and participate in training and quality control review of data.
Javier Martin, Principal Scientist in Virology at the MHRA said: "This worldwide training in the DDNS method for rapid detection of polio is a key strand in the global fight to eradicate polio, alongside vaccination programmes.
"Carrying out this work with our partners, which is the result of years of research, plays an essential part in managing outbreaks that threaten the global eradication effort and will help make polio a disease of the past.
"We are already initiating collaboration with laboratories in Africa training them to monitor different virus threats, such as Hepatitis E. The potential use of this faster detection technique has almost limitless possibilities for the protection of global health."
Dr Alex Shaw, Research Fellow in the School of Public Health at Imperial College London talked about the potential that this DDNS method has for use with other diseases: "The WHO has identified delays in detection as one of the major challenges facing their Polio eradication strategy 2022–2026. Training 25 countries in the past year to detect polio faster allows us to identify where outbreaks are and which polio strain is present much more quickly, allowing us to act at the earliest opportunity.
"This advanced sequencing technology is not only being used to strengthen poliovirus surveillance but is also easily adapted for the detection of other organisms. The worldwide training programme will, therefore, provide a foundation of skills and experience that can be redirected to the genomic surveillance of other pathogens, as needed."
The most recent laboratory training programme was conducted in Angola and Tanzania and included scientists from Angola, Mozambique, Tanzania, Eritrea, Malawi and Rwanda. We conducted training at the MHRA South Mimms site for European laboratories in June 2024 (Germany, France, Finland, Netherlands, Italy and Ukraine).
Scientists at the MHRA and their partners will continue to support the testing and validation of DDNS as a polio detection technique and to train WHO laboratories around the world in how to use it. We will travel to Thailand in mid-November 2024 to train scientists from Thailand, India and Indonesia. Additional training activities and implementation visits are planned for 2025 onwards.
The ‘Sensitive poliovirus detection using nested PCR and nanopore sequencing: a prospective validation study’ was published in August 2023 in Nature Microbiology. The research was jointly conducted by researchers at the Institut National de Recherche Biomédicale in Kinshasa who implemented DDNS in the Democratic Republic of the Congo (DRC) for the detection of polio outbreaks in collaboration with the MHRA, Imperial College London, the University of Edinburgh and various laboratories of the World Health Organization (WHO) Global Polio Laboratory Network (GPLN), with support from the Bill and Melinda Gates Foundation.
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All its work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
The MHRA is an executive agency of the Department of Health and Social Care.