The IgG ELISA assay, which works with both serum and dried blood spots, can distinguish between infection-derived and vaccine-derived immunity.
An antibody test for mpox has been successfully validated during the active clade 1b outbreak in Rwanda, marking the first time an assay of this kind has been developed and tested within an outbreak setting. The findings are published in The Lancet Infectious Diseases.
The test, an immunoglobulin G (IgG) enzyme-linked immunosorbent assay (ELISA), was developed by researchers at the University of Birmingham in collaboration with the Rwanda Biomedical Centre (RBC) and the University of Rwanda. It was trialed at the National Reference Laboratory in Kigali, Rwanda, as part of a project called MpoxCARE.
The assay detects antibodies to the mpox virus that arise following either natural infection or vaccination. This capability allows public health authorities and researchers to map disease transmission networks, identify individuals who should be prioritized for vaccination, and monitor how immunity changes over time.
To validate the test, the MpoxCARE team collected blood samples from three groups: patients who had received an mpox vaccine, patients who had previously been infected with mpox, and individuals with no prior exposure or vaccination. Researchers designed the assay using only four key antibody signatures, a deliberate decision to keep the test affordable and ensure that necessary supplies could reach remote laboratories.
Critically, the test is compatible with dried blood spots in addition to standard serum samples, allowing it to be used in settings where phlebotomy resources are limited.
“We are proud to have the capacity to conduct high-quality research in equal partnership with talented scientists in Rwanda in a time of need,” says Christopher Green, professor at the University of Birmingham, consultant physician in infectious diseases at University Hospitals Birmingham NHS Trust, and chief investigator of the MpoxCARE project, in a release. “It is critical that science is developed in the settings and populations that reflect the need. This is a meaningful step forward to improve global health security and is a real-world demonstration of research in action.”
Validated in the Local Population
The decision to design and validate the test within Rwanda was central to the project’s approach.
“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,” says Alex Richter, professor and director of the Clinical Immunology Service at the University of Birmingham, and principal investigator of the MpoxCARE project, in a release.
The collaboration between the University of Birmingham and the RBC is part of a longstanding research partnership focused on building in-country scientific capacity. The joint research portfolio includes international PhD studentships and infectious disease research expertise from the UK’s National Health Service and the National Institute for Health and Care Research, structured to enable rapid development of countermeasures during outbreaks of vaccine-preventable diseases.
“Our work demonstrates the critical importance of conducting high-quality research where outbreaks occur,” says Claude Mambo Muvunyi, professor and director general of the Rwanda Biomedical Centre, and principal investigator of the MpoxCARE project, in a release. “This partnership continues to strengthen the capacity of our National Reference Laboratory to validate new diagnostic tools and reinforces Rwanda’s role as a regional leader in epidemic research, surveillance, and response.”
Implications for Outbreak Surveillance
The validated assay is now available as part of the broader public health toolkit for understanding and interrupting the spread of mpox virus in the East Africa region. By providing an accurate, cost-conscious method to identify immune status at the population level, the test could inform more targeted vaccination strategies and strengthen epidemiological surveillance in resource-limited settings.
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