AUTHOR=Yeh Kenneth B. , Powers Michael D. , Patel Ami , Parekh Falgunee , Tseng Ashley S. , Bradford Elaine , Parker Kyle , Soong Ricky , Olinger Gene , Mombo Illich 

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

JOURNAL=Frontiers in Tropical Diseases

VOLUME=Volume 4 - 2023

YEAR=2023

URL=https://www.frontiersin.org/journals/tropical-diseases/articles/10.3389/fitd.2023.1221804

DOI=10.3389/fitd.2023.1221804

ISSN=2673-7515

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