Retrospective on molecular assay design for detecting pan-orthopox viruses and prospective on mpox laboratory preparedness and readiness

The landscape of in vitro diagnostic (IVD) devices encompasses a broad range tests that have been used to detect and diagnose pathogens, especially tropical diseases, for decades. COVID-19 pandemic exemplified the greater need bringing IVDs from laboratory directly consumer, recent outbreaks such as mpox, Sudan ebolavirus, Marburg virus further reinforce this need. increased emergence disease requires more agile development, higher performance, mass production IVD devices. Furthermore, lessons learned previous device developments can sometimes be accelerate new applications. As an example, we describe one case history earlier pan-orthopox viral assay detected smallpox variola vaccinia strains, also discerned related strains including mpox. This work established foundation molecular detection orthopox viruses, which could mobilized address public health needs once emergency declaration was made opened FDA pathway issuing use authorization these assays. Thus, utilization knowledge investments shown enhance preparedness readiness. Here retrospective, elaborate on processes enable approach, multi-disciplinary multisectoral collaborations accomplish holistic, world.