Novel point-of-care rapid detection of monkeypox virus.

Monkeypox, a viral zoonotic disease caused by MPXV, has emerged as a significant global health concern since the first outbreak outside Africa in 2003. As of the current data, there have been 30 189 confirmed cases of monkeypox in 88 countries, with 29 844 cases reported in 81 countries. Given the absence of prior documented instances of the disease, swift and accurate testing is imperative to contain the spread of monkeypox. In this study, we developed a LAMP detection reagent for monkeypox and evaluated its performance in terms of sensitivity, specificity, repeatability, stability, linear range, and linearity, utilizing a commercial magnetic bead-based nucleic acid extraction system. This has led to the establishment of an integrated on-site detection platform for the monkeypox virus, utilizing a closed cartridge. The sensitivity was found to be 100 copies per μL, with no cross-reactivity observed with three other viruses, indicating robust performance. The parameters of repeatability, stability, linear range, and linearity were also assessed. For 28 simulated samples, the detection results obtained from the integrated system were consistent with those from conventional laboratory methods, specifically qPCR and LAMP detection following nucleic acid extraction. The entire process can be completed in approximately one hour, making it highly suitable for immediate rapid testing.