Abstract The explosive global spread of Clade II mpox in humans and sustained human-to-human transmission of the more virulent Clade I mpox in the Democratic Republic of Congo highlight both the current lack of, and critical need for, point-of-care diagnostics to address the spread of this emergent disease. A novel point-of-care molecular diagnostic platform, Dragonfly, was developed that integrates power-free nucleic acid extraction (< 5 minutes) and lyophilized colorimetric LAMP chemistry. The platform achieved an analytical limit-of-detection of 50 genome copies/reaction for monkeypox virus, distinguishing it from other orthopoxviruses, herpes simplex virus and varizella zoster virus. Clinical validation using 164 samples, including 51 mpox positives, demonstrated 96.1% sensitivity and 100% specificity for orthopoxviruses, and 94.1% sensitivity and 100% specificity for monkeypox virus. Our platform provides a rapid, accessible and robust point-of-care solution for monitoring mpox in both low and high resource settings amidst declining worldwide smallpox immunity, with broad potential to the wider field of infectious disease diagnosis as a whole.
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Rodríguez-Manzano et al. (2024) studied this question.
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