A Highly Scalable and Rapidly Deployable RNA Extraction-Free COVID-19 Assay by Quantitative Sanger Sequencing

Devon Chandler-Brown; Anna M. Bueno; Oguzhan Atay; David S. Tsao

Coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2; COVID-19) is a public health emergency of international concern. This virus first emerged in Wuhan, China in December 2019 [1] , and spread to over 160 countries [2] . As of April 6, 2020, more than 1.3 million individuals are infected and over 70,000 deaths are reported [3] . One study found that undocumented infections were the infection source for 79% of documented cases [4] . Evidence from other reports suggests that some asymptomatic or minimally symptomatic patients have high levels of viral shedding [5, 6] . The substantial undocumented infection, along with the nonspecific clinical features and uncertainties in transmissibility and virulence of SARS-CoV-2, have presented significant challenges in containment of this virus. Until an effective vaccine or treatment is available, rapid, accurate, and widely available diagnostic tests not only for symptomatic patients but also for those who have come in contact with any positive cases are critical to curb the spread of the virus. However, such tests have been in limited supply in the US and many other countries in the world.