A new method for testing people for the SARS-CoV-2 virus, which causes COVID-19.
Developed at the University of Illinois Urbana-Champaign, covidSHIELD requires only a small amount of saliva from an individual and provides results within 24 hours. This quantitative reverse-transcription polymerase chain reaction (PCR) test process uses fewer steps and components than many other processes, avoiding supply chain shortages that have hampered COVID-19 testing worldwide since the beginning of the pandemic.
Regularly testing large numbers of people will decrease cases of COVID-19. The covidSHIELD process was used on the UIUC campus to enable in-person learning during the 2020-21 academic year. covidSHIELD was implemented on a large scale and provided quick results, which enabled rapid contact tracing and isolation.
covidSHIELD was first issued an Emergency Use Authorization (EUA) from the US Food and Drug Administration on February 24, 2021.
covidSHIELD is a protocol, not a kit – so we do not have products to distribute. Rather, for designated laboratories, we can provide a protocol for doing inexpensive saliva-based RT- qPCR testing.
The covidSHIELD process bypasses the RNA extraction step that is common to many COVID-19 test processes. This speeds up the test process and reduces the cost, while also avoiding supply chain challenges.
covidSHIELD is a protocol, not a kit – so we do not have products to distribute. Rather, for designated laboratories, we can provide a protocol for doing inexpensive saliva-based testing.
covidSHIELD is a PCR test, not an antigen test. It is done in a high-complexity, CLIA certified lab that produces results with high levels of sensitivity and specificity.
covidSHIELD has been authorized by the FDA under an emergency use authorization for use by authorized laboratories. It has not been FDA cleared or approved. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3), unless the authorization is terminated or revoked sooner.