Molecular and serological testing in the setting of a global pandemic

The coronavirus disease-2019 (COVID-19) pandemic unquestionably presents an era-defining challenge to public health, social equilibrium, and the global economy. It highlighted numerous systemic deficiencies in the healthcare system of developing and developed countries, exposing the limitations of health facility preparedness for emerging infectious disease crises. Despite the unique challenges presented by a deadly virus, advancements in molecular diagnostics and vaccine development pipelines have dramatically reduced the potential response time in which these technologies can be integrated into public health efforts to minimize disease transmission and mortality. The territorial impact in managing the crisis was evident as we saw global disparities where some countries were affected more than others. In the United States, the lack of a coordinated response plan for a pandemic of this nature resulted in numerous diagnostic challenges in the approval and dissemination of molecular and serological tests on the national level. This chapter reviews how molecular and serological testing has been applied to the identification of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), as well as the regulatory and logistical hurdles that impeded the implementation of timely diagnostic testing. Additionally, monitoring the genomic surveillance of SARS-CoV-2 has augmented our understanding of viral evolution and persistent spread around the globe. The utilization of innovative molecular technologies allowed for more rapid development of efficient SARS-CoV-2 vaccines, albeit with inefficient dissemination and unequal availability on a global scale. The chapter will endeavor to highlight lessons learned from events in the COVID-19 pandemic, and how these lessons might improve the speed and efficiency with which nations are able to develop, validate and disseminate technologies for the diagnosis and control of novel pathogens in future pandemics.