A combined ELISA for infection-induced and vaccine-induced mpox antibodies during the clade Ib outbreak in Rwanda
A high-performing mpox antibody test system designed, developed and manufactured in the Liverpool City Region has supported outbreak research and immunosurveillance in Rwanda during the active clade 1b Mpox outbreak. In collaboration with the University of Birmingham Clinical Immunology Service, Medtechtomarket Ltd undertook the full lifecycle responsibility for the multiplex IgG ELISA assay – from optimisation and validation through to kit assembly and international shipment. The test kits were produced within the company’s UK facility and supplied directly to Rwanda to enable in-country validation at the National Reference Laboratory in Kigali. The successful validation study, led by researchers from the University of Birmingham in partnership with the Rwanda Biomedical Centre (RBC) and the University of Rwanda, has now been published in The Lancet Infectious Diseases here.
Validated serological assays for mpox are scarce, particularly in outbreak regions where they are most urgently needed. This represents the first time a multiplex IgG ELISA has been validated within an African setting during an active clade 1b outbreak, signalling a major milestone for global health security and demonstrating the successful translation of immunological research into a deployable diagnostic system under real-world outbreak conditions.
Point-of-Care Diagnostics – Research Where Outbreaks Occur
The ELISA test kits enable accurate detection of antibodies generated following mpox infection or vaccination, helping researchers to assess immunity patterns, understand transmission dynamics and inform vaccine prioritisation strategies. Validation using locally collected Rwandan samples ensured the assay was not only scientifically sound but contextually relevant to the population it was designed to support. While academic partners led the clinical validation, Medtechtomarket’s role focused on the critical translational phase: refining assay performance, engineering a kit format, aligning production with quality-controlled manufacturing standards and enabling international supply for outbreak deployment. This industrialisation step is often unseen but essential. Diagnostics must be robust, reproducible and operationally viable in settings where rapid results are critical for immediate clinical decisions.
Medtechtomarket Founder, Matt Pearce, outlined the importance of the partnership to bridge the gap between theory and implementation, applying the scientific insights to real-world scenarios:
“Real impact in infectious disease control is only possible through partnership — combining scientific discovery with the industrial expertise needed for deployment. We are proud to translate research into robust diagnostic systems developed and manufactured here in the Liverpool City Region to support global outbreak response.”
Professor Alex Richter, Professor and Director of the Clinical Immunology Service at the University of Birmingham and Principal Investigator of the MpoxCARE project, said:
“Working collaboratively across sectors and across countries has enabled the rapid development of our test. This Mpox antibody test was designed to be used in Rwanda and so the ability to validate in a local population ensures it is fit for purpose.”
Regional Expertise, Global Impact
The successful deployment of these kits from the Liverpool City Region to Rwanda highlights the strength of the region’s advanced life sciences and manufacturing capability, strengthening the region’s role as a centre of excellence in infectious disease innovation and advanced diagnostic manufacturing. It also highlights the importance of maintaining UK-based industrial expertise in diagnostic development and production. The ability to design, optimise and manufacture outbreak-ready systems domestically strengthens both regional economic resilience and the UK’s contribution to global health security.
Recognition of Contribution
The Medtechtomarket Ltd development and production team, including Dr Matthew Pearce, Jake Hodgson, Rebecca Newman and Dr Andrea Murray are formally acknowledged as contributors within the published manuscript for their role in kit development and manufacturing.
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