NIH Expands Rapid COVID-19 Diagnostics

This week, leaders from the National Institutes of Health detailed ongoing plans to increase the number, quality, and type of tests for SARS-CoV-2 diagnostics (Tromberg et al. 2020). The Rapid Acceleration of Diagnostics (RADx) program was established on April 29 after $1.5 billion of federal stimulus funding was appropriated to the NIH. RADx aims to support the development and production of rapid, point-of-care tests to have the capacity to test 6 million people per day (2% of the US population) by December 2020. 

To do so, the program has developed a rapid screening process to funnel innovations with strong potential into further development and implementation stages quickly. 28% of Proposals received by RADx have included alternative sampling strategies utilizing saliva. Saliva tests present the opportunity to have at-home testing capabilities, are easier and quicker to collect than conventional oral or nasal swabs, and present less risk of transmission to health care workers. However, the FDA has recommended that saliva tests only be used for symptomatic individuals and that more data is needed to better understand the validity of saliva specimens. Viral load in saliva samples has been shown to be highest during the first week of disease onset (To et al. 2020). Additionally,  the specificity of saliva as a source of detection for SARS-CoV-2 is yet to be well understood . A preliminary meta-analysis has shown 91% (95%CI = 80%-99%) sensitivity for saliva tests, whereas, a 98% (95%CI 89%-100%) sensitivity for nasopharyngeal swab (Czumbel et al. 2020). Currently, one saliva test has an approved EUA (Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2-Assay). 

In addition to expanding overall testing technology, another goal of RADx is to focus on understanding factors that have led to a disproportionate burden in negative health outcomes for racial and ethnic minorities. COVID-19 has brought to light deep-rooted health disparities, which continue to be perpetuated by factors such as lack of widespread access to testing and testing centers being more likely to be located in non-Hispanic, white neighborhoods. Through RADx, the NIH has committed to understanding factors leading to health outcome disparities and supporting strategies to improve testing access to underserved, vulnerable populations. 

With these efforts, hopefully the goal of scaling up testing and producing efficient diagnostic systems that have applications for at-home and point-of-care testing can be achieved quickly.